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From the 11/19/2021 release of VAERS data:

Found 894,019 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 447 out of 8,941

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VAERS ID: 1839825 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-09-28
   Days after vaccination:175
Submitted: 0000-00-00
Entered: 2021-11-03
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: 20210928; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Sequenced variant: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101405343

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-2021-050949. An 82-year-old female patient received BNT162B2 (COMIRNATY), intramuscular on 06Apr2021 (Batch/Lot Number: ET7205) as dose 2, single; and intramuscular on 14Mar2021 (Batch/Lot Number: ET1831) as Dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient''s weight was not reported, and height was not reported. On 28Sep2021 the patient experienced SARS-CoV-2 infection, other, vaccination failure. The patient underwent lab tests and procedures which included COVID-19 PCR test on 28Sep2021: positive variant PCR-based, sequenced variant, n501y-positive: unknown. The outcome of the event was unknown.


VAERS ID: 1840888 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fibrin D dimer increased, Headache, Increased tendency to bruise
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (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: GRACIAL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20211102949

Write-up: ELEVATED D-DIMERS; HEADACHE; SPONTANEOUS BRUISING; CHRONIC HEADACHES; This spontaneous report received from a consumer via a Regulatory Authority [regulatory authority, BE-FAMHP-DHH-N2021-108114] concerned a 32 year old female. The patient''s weight was 78 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: 118386J2 expiry: UNKNOWN) dose was not reported, 1 total administered on 19-SEP-2021 for covid-19 immunisation. Concomitant medications included desogestrel/ethinylestradiol. On 28-SEP-2021, the patient experienced elevated d-dimers, headache, spontaneous bruising, and chronic headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from elevated d-dimers, headache, spontaneous bruising, and chronic headaches. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Treatment - No Evolution of the ADR - Recovering Examinations - 07-Oct-2021: blood collection at the physician -$g showed increased D-dimers (no history of clotting disorders in family) 07-Oct-2021: via emergency admission urgent Skull CT with contrast Time relation - ADR description - Chronic headache since approximately 28-Sep (still the case) Strikingly many bruises I do not remember hurting myself. Lab at the general practitioner on 07-Oct-2021 shows coagulation disorders: mainly increased D- Dimers -$g general practitioner immediately referred me to emergency for urgent Skull CT with contrast


VAERS ID: 1841068 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-09-28
   Days after vaccination:104
Submitted: 0000-00-00
Entered: 2021-11-03
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: 20210928; 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 INC202101413834

Write-up: SARS-CoV-2 infection, 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 Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-050208. A 36-year-old male patient received the first dose of BNT162b2 (COMIRNATY; solution for injection; Lot Number: EY7015) intramuscularly on 12May2021 and the second dose of BNT162b2 (COMIRNATY; solution for injection; Lot Number: FD0168) intramuscularly on 16Jun2021, both as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 28Sep2021, the patient experienced SARS-CoV-2 infection, variant PCR-based: B.1.617.2. The patient underwent lab tests on 28Sep2021 that included: COVID-19 PCR test which was positive (variant PCR-based: B.1.617.2. Sequenced variant: n501y-positive: No). The clinical outcome of the event SARS-CoV-2 infection, variant PCR-based: B.1.617.2 was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1841361 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Cardiac failure, Dyspnoea, Immunisation, Incorrect route of product administration, Off label use, Pyrexia
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Medication errors (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101414784

Write-up: Decompensation cardiac; Spiking temperature; Dyspnoea; Anemia; Booster; Inappropriate route of vaccination; Off label use; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NT20214768. A 93-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EK9788) via subcutaneous route of administration on 28Sep2021 (at the age of 93-year-old) as DOSE 3 (BOOSTER), SINGLE (off label use and booster) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the, it should be noted that cardiac decompensation was rather suggestive of anemia. Febrile syndrome possibly related to a transfusion on 30sep2021. French Blood Establishment declaration made. On 30Sep2021 the patient experienced decompensation cardiac, spiking temperature, dyspnoea, anemia. On 28Sep2021, inappropriate route of vaccination. The case assessed as serious (hospitalization). The outcome of decompensation cardiac, spiking temperature, dyspnoea, anemia was recovering. No follow-up attempts are possible. No further information expected.


VAERS ID: 1841768 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   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 FF8288 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: ITPFIZER INC202101420825

Write-up: ACUTE FLACCID PARALYSIS; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority number IT-MINISAL02-800136. A 65-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 intramuscular, administered in deltoid left on 27Sep2021 at 10:09 (Batch/Lot Number: FF8288; Expiration Date: 31Dec2021) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had acute flaccid paralysis on 28Sep2021. Seriousness criteria of the event was reported as medically significant. The adverse event resulted to visit emergency room. Therapeutic measures were taken as a result of acute flaccid paralysis. The outcome of the event was unknown. Reporter''s comment: Inoculation site: Deltoid left other information: under treatment with medrol 16 mg waiting for neurological examination. suspended vaccination Dr. privacy for persistence of paresis. No follow-up attempts possible. No further information expected.


VAERS ID: 1841779 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   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 - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypotension, Loss of consciousness, Overdose, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Drug abuse and dependence (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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:
Diagnostic Lab Data: Test Date: 20210929; Test Name: blood pressure; Result Unstructured Data: Test Result:the highest was 100 the lowest was 55.
CDC Split Type: ITPFIZER INC202101445117

Write-up: passed out; altered vision for 2 days; had low blood pressure the highest was 100 the lowest was 55; VACCINE COVID 19 COMIRNATY (PFIZER) 195FL 0.45ML; This is a spontaneous report from a contactable consumer or other non hcp (patient) downloaded from the RA, IT-MINISAL02-801937. A 22-year-old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered in arm left on 28Sep2021 at 19:00 as DOSE 1, 0.45ML SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced as passed out and had altered vision for 2 days, had low blood pressure the highest was 100 the lowest was 55 all on 29Sep2021 07:00 and VACCINE COVID 19 COMIRNATY (PFIZER) 195FL 0.45ML (overdose) on 28Sep2021. It was reported that general practitioner was called. The patient underwent lab tests and procedures which included blood pressure measurement: the highest was 100 the lowest was 55 on 29-SEP-2021. The outcome of events was unknown. Regulatory authority comment: No flu vaccination - Reaction time: 07:00 - Submitted by the RA.


VAERS ID: 1841914 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-09-28
   Days after vaccination:74
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101418894

Write-up: COVID-19 Confirmed, Asymptomatic; drug ineffective; This is a spontaneous report received from a contactable physician. This is a report received from the Regulatory Authority. The Regulatory authority report number is PH-PHFDA-300112089. A 46-year-old female patient received bnt162b2 (COMIRNATY, batch/lot number: FD5996), intramuscular on 16Jul2021 at the age of 46-year-old) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced COVID-19 confirmed, asymptomatic on 28Sep2021 07:00. The outcome of the events was resolved on unspecified date. The product quality complaint group reported that 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 ID resulted in the following conclusion, Reference ID 6168537. The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lots of the reported lot FD5996. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation, and stability. Concluded that the reported defect was not representative of the quality of the batch and the batch remained 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. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1842499 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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:
CDC Split Type: DEJNJFOC20211109334

Write-up: COVID-19; VACCINATION FAILURE; This spontaneous report received from a consumer via a Regulatory Authority [DE-PEI-202100214328] concerned a 26 year old female. The patient''s height, and weight were not reported. 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: XE395 expiry: UNKNOWN) 1 dosage forms, 1 total, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient experienced covid-19 and vaccination failure. The drug reaction relatedness for covid-19 and vaccination failure with covid-19 vaccine ad26.cov2.s was reported as Indeterminate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint and reference requested.


VAERS ID: 1842507 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-09-28
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004234 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Colitis (NOS); Tobacco user.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Pericarditis sicca; This case was received via Regulatory Agency (Reference number: FR-AFSSAPS-BX20219675) 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 PERICARDITIS (Pericarditis sicca) in a 45-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004234) for COVID-19 vaccination. The patient''s past medical history included Colitis (NOS) and Tobacco user. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced PERICARDITIS (Pericarditis sicca) (seriousness criteria hospitalization and medically significant). At the time of the report, PERICARDITIS (Pericarditis sicca) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment medication information was provided. Company Comment : This case concerns a 45-year-old, male patient with relevant medical history of Colitis and Tobacco use, who experienced the serious unexpected AESI event of Pericarditis. The event occurred approximately 1 month after the first dose of Moderna CoviD-19 Vaccine. No rechallenge was done, recurrence is not applicable. The patient''s medical history of Colitis and Tobacco use remain as confounders for the occurrence of the event. 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 document received on 29-Oct-2021 included no new information.; Sender''s Comments: This case concerns a 45-year-old, male patient with relevant medical history of Colitis and Tobacco use, who experienced the serious unexpected AESI event of Pericarditis. The event occurred approximately 1 month after the first dose of Moderna CoviD-19 Vaccine. No rechallenge was done, recurrence is not applicable. The patient''s medical history of Colitis and Tobacco use remain as confounders for the occurrence of the event. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.


VAERS ID: 1843948 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211109390

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053135] concerned a 23 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) dose was not reported, 1 total, administered on 18-JUL-2021 for an unspecified indication. No concomitant medications were reported. . On 28-SEP-2021, the patient experienced vaccination failure and SARS-COV-2 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1843996 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-28
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7204 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fall, Hypokinesia, Joint range of motion decreased, Off label use, Pain in extremity, Paraesthesia, Peroneal nerve palsy, Product use issue, SARS-CoV-2 test, Walking disability
SMQs:, Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: CAPFIZER INC202101426730

Write-up: off label use; vaccine administration in unapproved population; right foot is displaying a condition known as foot drop; experiencing pain from her hip to her ankle; She is unable to dorsiflex her right foot or move her toes.; parasthesia below her right knee; fall; could not flex her ankle or toes; walking gait has been affected; she was in pain in her ankle; This is a spontaneous report from a contactable pharmacist who reported for daughter. A 11-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Right on 11Sep2021 12:30 (Batch/Lot Number: FD7204) as single dose for COVID-19 immunisation. The patient medical history was not reported. No known allergy. No other vaccine in four weeks. No other medications in two weeks. Historical vaccine included 1st dose of BNT162B2 on 20Aug2021 11:30 AM (Batch/Lot No: FD7206) for COVID-19 immunisation. Patient''s right foot was displaying a condition known as foot drop and she was experiencing pain from her hip to her ankle. She was unable to dorsiflex her right foot or move her toes. It began with a feeling of paresthesia below her right knee that caused her to fall. Progressively over the next week she was in pain in her ankle and could not flex her ankle or toes. Her walking gait had been affected as she cannot clear her right foot adequately and was now prone to tripping multiple times during the day. The patient underwent lab test included sars-cov-2 PCR test (Nasal Swab): negative on 15Oct2021. Adverse events start date was 28Sep2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. No treatment was received. Outcome of the events was not resolved.; Sender''s Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1844514 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-09-28
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Cough, Drug ineffective, Lower respiratory tract congestion, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test positive
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Respiratory failure (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? 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: 20210928; Test Name: COVID-19 test; Result Unstructured Data: Test Result:Covid-19 infection
CDC Split Type: FRPFIZER INC202101414746

Write-up: Vaccination failure/ Drug ineffective; Covid-19 infection; fever; cough; asthenia; bronchial congestion; desaturation; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-RN20213112. An 83-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown) via intramuscular route, administered in left arm on 06Aug2021 as Dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medication were not reported. On 28Sep2021, the patient had vaccination failure/drug ineffective, COVID-19 infection, fever, cough, asthenia, bronchial congestion, and desaturation. On 28Sep2021, the patient underwent lab tests and procedures which included SARS-CoV-2 test positive: Covid-19 infection. Test was performed due to symptoms of fever, cough, asthenia and bronchial congestion with desaturation. Management was done at the residential care home with oxygen therapy using nasal cannulas. On 08Oct2021, the patient was still symptomatic and requiring oxygen. Therapeutic measures were taken as a result of desaturation. The outcome of events vaccination failure/drug ineffective, COVID-19 infection was not recovered whereas all other events was unknown. No follow-up attempts are possible. Information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1844758 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Immunisation, Lethargy, Maternal exposure during pregnancy, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Folic acid supplementation; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Date: 20210828; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101417947

Write-up: Miscarriage of pregnancy; lethargy; fever; Maternal exposure during pregnancy; Booster; Off label dose; This is a spontaneous report from a contactable consumer or other non-healthcare professional received from a Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110202045279620-A8VWB. Safety Report Unique Identifier GB-MHRA-ADR 26100663. A 31-years-old pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection; Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 28Sep2021 as DOSE 3 (BOOSTER), SINGLE (at age of 31-years) for covid-19 immunization (booster and off label dose). Medical history included pregnancy from an unknown date and not ongoing (patient no longer pregnant at the time of reporting) and folic acid supplementation from an unknown date, Covid-19 virus positive from 28Aug2021 to an unknown date. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient previously took first and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) as single dose for Covid-19 Immunization. The patient was exposed to vaccine during pregnancy on 28Sep2021. The patient experienced lethargy, and fever on 29Sep2021. The patient also presented with miscarriage of pregnancy on 30Sep2021. The mother reported she became pregnant while taking bnt162b2. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 28Aug2021 Yes - Positive COVID-19 test. It was reported that, Fever, lethargy suffered day after vaccine, following day started to miscarry. The medicine has an adverse effect on any aspect of the pregnancy. The outcome of the events miscarriage of pregnancy recovered on 04Oct2021. The outcome of the events lethargy and fever was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1845150 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-09-28
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Drug ineffective, Nasopharyngitis
SMQs:, Anaphylactic reaction (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101418895

Write-up: drug ineffective; COVID-19 Confirmed, Mild; Cough; Cold; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory authority. Regulatory authority report number PH-PHFDA-300112094. A 31-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 19Aug2021 (Lot Number: FD5996) at age of 31-year-old as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Sep2021 21:00, patient experienced covid-19 confirmed, mild (medically significant), cough (non-serious), cold (non-serious). The outcome of events was recovered in 2021. On 27Oct2021, Product investigation results received. The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, 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 FD5996 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. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1845182 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / 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: 20210930; Test Name: SARS-CoV-2 rapid diagnostic test; Test Result: Positive ; Comments: positive Iu international unit(s)
CDC Split Type: PTPFIZER INC202101411321

Write-up: vaccine impaired response; vaccine impaired response; This is a spontaneous report from a contactable other hcp downloaded from the Agency Regulatory Authority-WEB, regulatory authority number PT-INFARMED-T202110-86. A 39-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 22Jul2021 (Batch/Lot Number: FE4728) as UNKNOWN, 0.3ML SINGLE, intramuscular on an unspecified date (Batch/Lot Number: FL5435) as UNKNOWN, 0.3ML SINGLE for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 28Sep2021, the patient experienced vaccine impaired response. Symptoms suggestive of COVID-19 or whether targeted treatment were necessary are unknown. Laboratory confirmation by rapid antigen test. Patient is waiting for PCR test result. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 30Sep2021 positive Iu international unit(s). Thee outcome of the event was unknown. The complaint for PFIZERBIONTECH COVID-19 VACCINE Was investigated. The Investigation included reviewing the involved batch records, deviation investigation, 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 FE4728. 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. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The Investigative process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information-Harvest on 30Jan2021, quick test, with result on the same day. Haven''t done PCR yet.


VAERS ID: 1845533 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache
SMQs:

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: GBMODERNATX, INC.MOD20213

Write-up: Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26129944) on 28-Oct-2021 and was forwarded to Moderna on 28-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 23-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 08-Oct-2021, HEADACHE (Headache) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided by the reporter. Treatment medications was not provided by the reporter. It was reported that Unshakable headache for several days after vaccination. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Company Comment This case concerns a 23-year old female subject, with no relevant medical history, who experienced the serious unexpected event of Headache. The event occurred 1 day after the second dose of MODERNA COVID-19 VACCINE. Rechallenge is not applicable as no information about adverse events following the first dose is available. The benefit-risk relationship of MODERNA COVID-19 VACCINE is not affected by this report. Event was assessed as serious (seriousness criterion=other medically significant condition) by the Regulatory Authority; however, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint (outcome resolved with no intervention/treatment/hospitalization mentioned), the event is not considered serious.; Sender''s Comments: This case concerns a 23-year old female subject, with no relevant medical history, who experienced the serious unexpected event of Headache. The event occurred 1 day after the second dose of MODERNA COVID-19 VACCINE. Rechallenge is not applicable as no information about adverse events following the first dose is available. The benefit-risk relationship of MODERNA COVID-19 VACCINE is not affected by this report. Event was assessed as serious (seriousness criterion=other medically significant condition) by the Regulatory Authority; however, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint (outcome resolved with no intervention/treatment/hospitalization mentioned), the event is not considered serious.


VAERS ID: 1845565 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-28
   Days after vaccination:3
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: Bell's palsy, 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? 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: TWMODERNATX, INC.MOD20213

Write-up: Right facial nerve palsy; Bell''s palsy; This regulatory authority case was reported by a pharmacist and describes the occurrence of FACIAL PARALYSIS (Right facial nerve palsy) and BELL''S PALSY (Bell''s palsy) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced FACIAL PARALYSIS (Right facial nerve palsy) (seriousness criterion medically significant) and BELL''S PALSY (Bell''s palsy) (seriousness criterion medically significant). The patient was treated with PATEAR for Bell''s palsy, at a dose of 1 drop three times a day; FAMOTIDINE (ULSTOP [FAMOTIDINE]) (oral) for Bell''s palsy, at a dose of 20 milligram twice a day; PREDNISOLONE (COMPESOLON) (oral) for Bell''s palsy, at a dose of 20 milligram twice a day; CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE DISULFIDE (DAILYCARE ACTIBEST) (oral) for Bell''s palsy, at a dose of 5 milligram twice a day and ALPRAZOLAM (KINAX) (oral) for Bell''s palsy, at a dose of kinax(4 pieces) tab 0.5mg HS. At the time of the report, FACIAL PARALYSIS (Right facial nerve palsy) and BELL''S PALSY (Bell''s palsy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. In the afternoon of September 28, 2021, the patient went to hospital for emergency treatment because of right facial nerve palsy, which resulted in water leakage from the corners of mouth when drinking water.It was diagnosed to be Bell''s palsy. Comment comments: This case concerns a 79-year old, male subject with no relevant medical history, who experienced the serious expected events of Facial paralysis(AESI) and Bell''s palsy(AESI). The events, which resulted in hospitalization, occurred 3 days after a dose of Moderna COVID-19 vaccine, dose number unknown. The patient''s age remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Events Facial paralysis and Bell''s palsy were classified as non-serious by RA; however, based on medical judgment, they are upgraded to serious due to their medical significance.; Sender''s Comments: This case concerns a 79-year old, male subject with no relevant medical history, who experienced the serious expected events of Facial paralysis(AESI) and Bell''s palsy(AESI). The events, which resulted in hospitalization, occurred 3 days after a dose of Moderna COVID-19 vaccine, dose number unknown. The patient''s age remains a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Events Facial paralysis and Bell''s palsy were classified as non-serious by RA; however, based on medical judgment, they are upgraded to serious due to their medical significance.


VAERS ID: 1845594 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211110945

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority [AT-BASGAGES-2021-053100] concerned an 18 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-03 expiry: UNKNOWN) dose was not reported, 1 total, first dose, administered on 09-JUN-2021 for product use for unknown indication. No concomitant medications were reported. On 28-SEP-2021, the patient experienced vaccination failure and sars-cov-2 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1845740 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-09-28
   Days after vaccination:5
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: Corneal oedema, Eye pain, Iritis, Vision blurred
SMQs:, Angioedema (narrow), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Corneal disorders (narrow), Retinal disorders (broad), Ocular infections (broad), Hypersensitivity (narrow), 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:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: corneal edema; iritis complicated with anterior chamber pyogenesis; Blurred vision; Eye pain; This regulatory authority case was reported by an other health care professional and describes the occurrence of VISION BLURRED (Blurred vision), EYE PAIN (Eye pain), CORNEAL OEDEMA (corneal edema) and IRITIS (iritis complicated with anterior chamber pyogenesis) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced VISION BLURRED (Blurred vision) (seriousness criterion medically significant) and EYE PAIN (Eye pain) (seriousness criterion medically significant). On 12-Oct-2021, the patient experienced CORNEAL OEDEMA (corneal edema) (seriousness criterion medically significant) and IRITIS (iritis complicated with anterior chamber pyogenesis) (seriousness criterion medically significant). At the time of the report, VISION BLURRED (Blurred vision), EYE PAIN (Eye pain), CORNEAL OEDEMA (corneal edema) and IRITIS (iritis complicated with anterior chamber pyogenesis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Company Comment : This case concerns a 76-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Vision blurred, Eye pain, Corneal oedema, Iritis . The events occurred approximately 5 days after the unknown dose of Moderna Covid -19 vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The benefit-risk relationship of Moderna Covid -19 vaccine, is not affected by this report.; Sender''s Comments: This case concerns a 76-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Vision blurred, Eye pain, Corneal oedema, Iritis . The events occurred approximately 5 days after the unknown dose of Moderna Covid -19 vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The benefit-risk relationship of Moderna Covid -19 vaccine, is not affected by this report.


VAERS ID: 1845821 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-09-28
   Days after vaccination:95
Submitted: 0000-00-00
Entered: 2021-11-05
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: 20210928; 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 INC202101414423

Write-up: Vaccination failure; SARS-CoV-2 infection/ patient tested positive for COVID-19 PCR test; This is a spontaneous report from a contactable physician from the Regulatory Authority. The Regulatory Authority report number is AT-BASGAGES-2021-050992. A 37-year-old male patient received the second dose of bnt162b2 (COMIRNATY), intramuscular on 25Jun2021 (batch/lot number: FD6840) as DOSE 2, SINGLE and received the first dose of bnt162b2 (COMIRNATY), intramuscular on 04Jun2021 (batch/lot number: FD1921) as DOSE 1, SINGLE for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 28Sep2021, the patient experienced SARS-CoV-2 infection, other, Vaccination failure. It was reported that the patient tested positive for COVID-19 PCR test on 28Sep2021, 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: 1845856 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211110962

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician via a Regulatory Authority [AT-BASGAGES-2021-053097] concerned a 36 year old male with unspecified race, and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-03 expiry: unknown) dose was not reported, 1 total administered on 10-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 28-SEP-2021, the patient had sars-cov-2 infection, and vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). The report is associated with product quality complaints


VAERS ID: 1845858 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211110810

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority [AT-BASGAGES-2021-053243] concerned a 47 year old male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 expiry: unknown) dose was not reported, 1 total, administered on 16-JUN-2021 for an unknown indication. No concomitant medications were reported. On 28-SEP-2021, the patient experienced severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection and had vaccination failure. Laboratory data included: COVID-19 polymerase chain reaction (PCR) test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1845874 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-09-28
   Days after vaccination:108
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101437493

Write-up: ZONA intercostal (herpes zoster); This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB [Regulatory Authority report number BE-FAMHP-DHH-N2021-107857]. A 57-year-old female patient received the 2nd dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 12Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced zona intercostal (herpes zoster) (disability) on 28Sep2021 with outcome of recovering. Therapeutic measures were taken as a result of the event and included treatment with Aciclovir and Contramal. Reporter Comment: Treatment Yes Aciclovir and Contramal. Evolution of the ADR In progress. Situations Other: side effect of the vaccine ???. ADR description - ZONA intercostal (herpes zoster). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Treatment Yes Aciclovir and Contramal. Evolution of the ADR In progress. Situations Other: side effect of the vaccine ???. ADR description - ZONA intercostal (herpes zoster).


VAERS ID: 1847292 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-28
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG9428 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Electroencephalogram, Ischaemic stroke, Paradoxical embolism, SARS-CoV-2 test
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), COVID-19 (broad)

Life Threatening? Yes
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 Name: EEG; Result Unstructured Data: Test Result:No significant anomaly; Test Date: 20210930; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101490326

Write-up: Ischemic stroke; Paradoxical embolism; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PB20216738. A 74-years-old female patient received second dose of bnt162b2 (COMIRNATY), intramuscular on 10Sep2021 (Batch/Lot Number: FG9428) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY), Intramuscular injection in Left arm on 10Aug2021 (Lot Number: FE8235) as single dose for covid-19 immunisation. The patient experienced ischemic stroke and paradoxical embolism on 28Sep2021, assessed as serious with hospitalization, life threatening. The patient presented 18 days after her dose 2, an ischemic stroke of the right cerebellum caused by paradoxical embolism and requiring urgent medical intervention with hospitalization. The patient underwent lab tests and procedures which included EEG (electroencephalogram): no significant anomaly on unknown date and SARS-CoV-2 test: negative on 30Sep2021. The patient placed on XARELTO 20mg film-coated tablet at a dose of 1 tab / day until 10Apr2022. The healing was underway. The outcome of the events was recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1847343 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Chest pain, Dyspnoea, Electrocardiogram, Fatigue, Heart rate, Heart rate abnormal, Immunisation, Myocarditis, Off label use, Palpitations, Pericarditis, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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 (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (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 Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211010; Test Name: heart rate; Result Unstructured Data: Test Result:abnormal; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101417972

Write-up: arrhythmia; possible myocarditis and pericarditis; possible myocarditis and pericarditis; breathlessness; Fatigue; Chest Pain; Dyspnoea; Palpitations; Tachycardia; Heart rate abnormal; Off label use; Booster; This is a spontaneous report from a contactable healthcare professional received from the regulatory authority report number is GB-MHRA-WEBCOVID-202110191029486000-IBTWQ. Safety Report Unique Identifier is GB-MHRA-ADR 26091167. A 41-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 28Sep2021 (Batch/Lot number not reported) as dose 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient previously received the dose 1 and dose 2 of Comirnaty on unspecified dates (batch/lot numbers not reported) for COVID-19 immunisation. The patient experienced arrhythmia on an unspecified date with outcome of not recovered, breathlessness on an unspecified date with outcome of not recovered, heart rate abnormal on 10Oct2021 with outcome of not recovered, fatigue, chest pain, dyspnoea, palpitations, tachycardia, possible myocarditis and pericarditis on an unspecified date with outcome of unknown. The patient also experienced off label use and booster on 28Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included electrocardiogram (ECG): unknown results, Covid-19 virus test: No - Negative COVID-19 test, both on unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The events were reported as non-serious. Additional information: Chest pain, breathlessness coming and going plus arrhythmia , palpitations, irregular heart beat. Reaction: Does your report relate to possible myocarditis or pericarditis? If yes, we will ask you additional questions at the end of this report: "Yes". Suspect Reactions. Please provide details of any relevant investigations or tests conducted: "ECG and 24hour monitor". Myocarditis and pericarditis. Was the patient admitted to hospital?: "No" Please provide details of any diagnosis: "Ongoing". No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1847860 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   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 FC1435 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Gastrointestinal haemorrhage, Hypoprothrombinaemia
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? Yes
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: TAMSULOSIN; BURINEX; ELTROXIN; ATROVENT INHALER; SALBUTAMOL INHALER; BECLOFORTE INHALER
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal failure; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: MTPFIZER INC202101495115

Write-up: gastrointestinal bleed; severe anaemia; Hypoprothrombinaemia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number MT-ADM-10102021. A 90-year-old male patient (age at vaccination: 90-year-old) received bnt162b2 (COMIRNATY, lot FC1435), via an unspecified route of administration on 28Sep2021 as dose 3 (booster), single for Covid-19 immunisation. Medical history included chronic kidney disease, hypertension, diabetes mellitus. Concomitant medications included tamsulosin for an unspecified indication, start and stop date were not reported; bumetanide (BURINEX) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (ELTROXIN) taken for an unspecified indication, start and stop date were not reported; ipratropium bromide (ATROVENT INHALER) taken for an unspecified indication, start and stop date were not reported; salbutamol (SALBUTAMOL INHALER) taken for an unspecified indication, start and stop date were not reported; beclometasone dipropionate (BECLOFORTE INHALER) taken for an unspecified indication, start and stop date were not reported. Historical vaccine of BNT162B2 (lot EJ 6796) via unknown route of administration on 19Jan2021 as dose 1, single and BNT162B2 (lot EJ 6796) via unknown route of administration on 09Feb2021 as dose 2, single for Covid-19 immunisation. The patient experienced gastrointestinal bleed, severe anaemia and hypoprothrombinaemia on 28Sep2021, all serious life threatening. He was admitted to the hospital on 24Oct2021 due to the events. He has been tranfused. The outcome of events was unknown. Sender comments: The side effects are unexpected (not listed in the SmPC). Challenge; very suggestive since the side-effects happened on the same day of administration of the suspected medicinal product. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1847932 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-28
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Human chorionic gonadotropin, Scan
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: HCG levels; Result Unstructured Data: Test Result:HCG levels were high; Test Name: scan; Result Unstructured Data: Test Result:baby was measuring two weeks behind and the fetal; Comments: heart rate was only 58 bpm; Test Name: scan; Result Unstructured Data: Test Result:no fetal heart rate and the gestational sac; Comments: was collapsing
CDC Split Type: NZPFIZER INC202101418457

Write-up: Suffered a missed miscarriage; This is a spontaneous report from a contactable other hcp on behalf of self (patient) received via Regulatory Authority. This other hcp reported events for self (mother) and fetus. This is the maternal report. A 35-year-old pregnant female patient received BNT162B2 (COMIRNATY) (Batch/Lot number was not reported), dose 1, via an unspecified route of administration in the right arm on 06Sep2021 at 15:45 (at the age of 35-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history was not reported. Concomitant medication included folic acid (FOLIC ACID) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The pregnancy was reportedly going fine, HCG levels were high. The patient had her first dose of the vaccine and went for a scan 3 weeks later and the baby was measuring 2 weeks behind and the fetal heart rate was only 58 bpm. A second scan was performed 1 week later and there was no fetal heart rate and the gestational sac was collapsing. On 28Sep2021 at 10:30am, the patient suffered a miscarriage. The patient was hospitalized for miscarriage (abortion spontaneous) for 1 days. The mother was 7 Weeks pregnant at the onset of the event. The mother was due to deliver on 13May2022. The patient stated "the miscarriage did not happen naturally as my body did not recognize this which led to me being admitted to the hospital for a D&C. The patient underwent lab tests and procedures which included human chorionic gonadotropin (Unknown date): hcg levels were high, scan (Unknown date): baby was measuring two weeks behind and the fetal heart rate was only 58 bpm and scan (Unknown date): no fetal heart rate and the gestational sac was collapsing. Clinical outcome of the event was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : NZ-PFIZER INC-202101419136 same drug, same reporter; different event (mother/foetus case)


VAERS ID: 1848004 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-28
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Disease recurrence, Thrombophlebitis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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: Thrombophlebitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: SIPFIZER INC202101440863

Write-up: recurrence of thrombophlebitis on the leg; recurrence of thrombophlebitis on the leg; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. Regulatory authority number SI-JAZMP-NCPHV-2021SI0971_0971 and Safety Report Unique Identifier JAZMP-300016844. A 54-year-old male patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: FF3318; Expiration Date: 31Oct2021), via intramuscular, on 15Sep2021 at single dose for COVID-19 immunisation. Medical history included thrombophlebitis, unknown if still ongoing (as reported). No relevant concomitant medications were provided. On 28Sep2021, the patient experienced recurrence of thrombophlebitis on the leg, medically significant. Therapeutic measures taken as result of the event included treatment at the primary level. Disease outcome: another clinically relevant condition (as reported). The event lasted 1 day. However, the outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1849932 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Conjunctival haemorrhage, Diarrhoea, Hypoaesthesia, Malaise, Periorbital pain, Pyrexia, Vaccination site pain
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Conjunctival disorders (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Numbness from little finger to middle finger, wrist to elbow; Low-grade fever; Pain at the vaccination site; Numbness; Malaise; Bleeding in the white part of the eye; Pain under the eye; Diarrhoea; This case was received via Regulatory Authority (Reference number: 2021TJP112588) on 27-Oct-2021 and was forwarded to Moderna on 05-Nov-2021. This case was reported by a patient who received the vaccine via the Regulatory Authority. Bleeding in the white part of the eye was assessed as serious. On 27-Sep-2021, the patient received the 1st dose of this vaccine. On 28-Sep-2021, pain under the eye, bleeding in the white part of the eye, malaise, and diarrhea developed. On an unknown date, the patient visited an ophthalmology. On an unknown date, the patient recovered from pain under the eye, bleeding in the white part of the eye, malaise, and diarrhea developed. On 25-Oct-2021, the patient received the 2nd dose of this vaccine. On 26-Oct-2021, low-grade fever, pain at the vaccination site, and numbness developed. Numbness subsided temporarily. On 27-Oct-2021, in the morning, numbness recurred in the little finger, ring finger, and wrist to elbow. The patient recovered from low-grade fever and pain at the vaccination site. The outcome of pain under the eye, bleeding in the white part of the eye, malaise, diarrhea, low-grade fever, pain at the vaccination site and numbness was reported as recovered. The outcome of numbness from little finger to middle finger, wrist to elbow was reported as ongoing. Follow-up was not possible due to lack of the reporters cooperation. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This is a Spontaneous via Regulatory Authority case concerning a 49-year-old female patient with no reported medical history, who experienced the serious unexpected event Conjunctival haemorrhage and the non-serious unexpected periorbital pain, malaise, diarrhea, hypoesthesia and expected events pyrexia and vaccination site pain. The events conjunctival haemorrhage, periorbital pain, malaise and diarrhea occurred 1 day after the first dose and events hypoesthesia, pyrexia and vaccination site pain occurred one day after the second dose of mRNA-1273 Moderna vaccine. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.


VAERS ID: 1850294 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-09-28
   Days after vaccination:87
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: 20210928; 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 INC202101437079

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-2021-051006. A 28-year-old female patient received the first and second dose of BNT162b2 (COMIRNATY), both taken intramuscularly on 25May2021 and 03Jul2021, respectively, for COVID-19 immunisation. Lot number for first dose was FC0681, Lot number for second dose was FD4555. Relevant medical history and concomitant medications were not reported. On 28Sep2021 the patient had SARS-CoV-2 infection. Variant PCR-based: B.1.617.2, Variant Sequenced, n501y-positive: No. Outcome of the event was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1850301 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-09-28
   Days after vaccination:116
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, 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: 20210928; 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 INC202101436726

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician from the Regulatory Authority AT-BASGAGES-2021-051019. A 57-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 04Jun2021 (Batch/Lot Number: FD1921) as DOSE 2, SINGLE, dose 1 intramuscular on 30Apr2021 (Batch/Lot Number: EY3014) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. On 28Sep2021 the patient experienced SARS-CoV-2 infection, other, Vaccination failure. The patient was positive for COVID-19 PCR test, Variant PCR-based B.1.617.2, Sequenced variant NA, n501y-positive: No. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1850640 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-09-28
   Days after vaccination:116
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, 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: 20210928; 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 INC202101436937

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-2021-051184. A 44-years-old female patient received BNT162B2 (COMIRNATY), dose 2 intramuscular on 04Jun2021 (Batch/Lot Number: FD1921) as single dose, dose 1 intramuscular on 30Apr2021 (Batch/Lot Number: EY3014) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sars-cov-2 infection (covid-19) (medically significant) on 28Sep2021, vaccination failure (vaccination failure) (medically significant) on 28Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Sep2021 (Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No). Outcome was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1851474 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-09-28
   Days after vaccination:76
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: 20210928; 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 INC202101437323

Write-up: SARS-CoV-2 infection, B.1.617.2 (Delta); SARS-CoV-2 infection, B.1.617.2 (Delta); This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-051342. This is first of two reports. A 45-year-old male patient received BNT162B2 (COMIRNATY), dose 2 intramuscular on 14Jul2021 (Lot Number: FE6208) as DOSE 2, SINGLE, dose 1 intramuscular on 02Jun2021 (Lot Number: FC2473) as DOSE 1, SINGLE for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Sep2021 the patient experienced SARS-CoV-2 infection. Variant PCR-based: B.1.617.2 (Delta), Sequenced variant: n501y-positive: no. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101456125 same patient, different dose


VAERS ID: 1851528 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-09-28
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003606 / 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: 20210928; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: positive
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: SARS-CoV-2 infection; Vaccination failure; This case was received via Regulatory Agency (Reference number: AT-BASGAGES-2021-051941) 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 COVID-19 (SARS-CoV-2 infection) and VACCINATION FAILURE (Vaccination failure) in a 48-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. Lit3004952 and 3003606) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant) and VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant). At the time of the report, COVID-19 (SARS-CoV-2 infection) and VACCINATION FAILURE (Vaccination failure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Sep-2021, SARS-CoV-2 test: positive (Positive) positive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use was unknown Treatment information was unknown Action taken with mRNA-1273 in response to the drug was not applicable. Company comment- This case concerns a 48-year-old female patient with no relevant medical history, who experienced the unexpected serious event of COVID-19 (adverse event of special interest). The event occurred approximately 1.5 months after the second dose and 2.5 months after the first dose of Spikevax. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided. Vaccination failure was coded as an additional event, as per RA, and was retained as such having in mind that the patient developed COVID-19 after vaccination with both doses of vaccine. Re-challenge was not applicable as the event happened after the second dose. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable, while the causality for the event of Vaccination failure is assessed as possible. The benefit risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 48-year-old female patient with no relevant medical history, who experienced the unexpected serious event of COVID-19 (adverse event of special interest). The event occurred approximately 1.5 months after the second dose and 2.5 months after the first dose of Spikevax. The outcome of the event was unknown at the time of the report and no information regarding the clinical course of the event was provided. Vaccination failure was coded as an additional event, as per RA, and was retained as such having in mind that the patient developed COVID-19 after vaccination with both doses of vaccine. Re-challenge was not applicable as the event happened after the second dose. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable, while the causality for the event of Vaccination failure is assessed as possible. The benefit risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1851531 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211115048

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority [EVHUMAN Vaccines, AT-BASGAGES-2021-052776] concerned a 44 year old male of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) dose was not reported, 1 total, first dose was administered on 21-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 28-SEP-2021, the patient experienced vaccination failure and sars-cov-2 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number requested.


VAERS ID: 1851538 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211114467

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [EVHUMAN Vaccines, AT-BASGAGES-2021-052883] concerned a 35 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD975 and expiry: unknown) dose was not reported, frequency time 1 total, administered on 28-MAY-2021 for product use for unknown indication. No concomitant medications were reported. On 28-SEP-2021, the patient''s laboratory data included COVID-19 PCR (polymerase chain reaction) test (NR: not provided) Positive and experienced SARS-CoV-2 (severe acute respiratory syndrome coronavirus-2) infection and had vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the SARS-CoV-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1851542 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211114790

Write-up: SARS-CoV-2 infection; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [EVHUMAN Vaccines, AT-BASGAGES-2021-053102] concerned a 49 year old female of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-03 expiry: UNKNOWN) dose was not reported,1 total, administered on 09-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 28-SEP-2021, the patient experienced sars-cov-2 infection and vaccination failure. Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) Positive. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint.


VAERS ID: 1851669 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-09-28
   Days after vaccination:227
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / -

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: GLUCOPHAGE; PANTOMED [DEXPANTHENOL]; CLOPIDOGREL; CRESTOR; COZAAR PLUS; EZETROL; NOBITEN [NEBIVOLOL]; ASAFLOW; CORUNO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular risk; Diabetes mellitus (mild)
Allergies:
Diagnostic Lab Data: Test Date: 20211001; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: BEPFIZER INC202101437070

Write-up: COVID-19 infection after vaccination; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB; regulatory authority number BE-FAMHP-DHH-N2021-107834. A 79-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 13Feb2021 (Batch/Lot Number: EJ6789; Expiration Date: 31May2021) as dose 2, single, dose 1 via an unspecified route of administration on 23Jan2021 (Batch/Lot Number: EJ6134; Expiration Date: 30Apr2021) as dose 1, single for covid-19 immunisation. Medical history included disease risk factor from an unknown date and unknown if ongoing, diabetes mellitus from an unknown date and unknown if ongoing mild. Concomitant medication included metformin hydrochloride (GLUCOPHAGE) taken for an unspecified indication, start and stop date were not reported; dexpanthenol (PANTOMED [DEXPANTHENOL]) taken for an unspecified indication, start and stop date were not reported; clopidogrel (CLOPIDOGREL) taken for an unspecified indication, start and stop date were not reported; rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, losartan potassium (COZAAR PLUS) taken for an unspecified indication, start and stop date were not reported; ezetimibe (EZETROL) taken for an unspecified indication, start and stop date were not reported; nebivolol (NOBITEN [NEBIVOLOL]) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASAFLOW) taken for an unspecified indication, start and stop date were not reported; molsidomine (CORUNO) taken for an unspecified indication, start and stop date were not reported. The patient experienced covid-19 infection after vaccination (covid-19) (hospitalization) on 28Sep2021 with outcome of recovering , vaccination failure (vaccination failure) (medically significant) on 01Oct2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (COVID-19 PCR test positive) on 01Oct2021 (as reported). Therapeutic measures were taken as a result of covid-19 infection after vaccination (covid-19) included Solu-Medrol and Clexane. Complaint record received with summary investigation from the site Puurs. Information obtained: lot#EJ6134, expiry date 31May2021 and lot#EJ6789, expiry date 31May2021. Conclusion: 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 EJ6134. 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. RA concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.


VAERS ID: 1852069 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-09-28
   Days after vaccination:121
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC202101436088

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number EE-SAM-53622110045. A 61-year-old male patient received BNT162B2 (COMIRNATY), on 30May2021 (Batch/Lot Number: FA5715; Expiration Date: 31Aug2021) as dose 2, 0.3 ml single, and on 18Apr2021 (Batch/Lot Number: EW4811; Expiration Date: 31Jul2021) as dose 1, 0.3 ml single, intramuscular for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure, COVID-19 on 28Sep2021. The patient developed COVID symptomatic infection and he was hospitalized on 28Sep2021. The course of the disease was severe, the patient has not recovered. Also reported events stop date/time as 04Oct2021. The patient underwent lab tests and procedures which included SARS-CoV-2 PCR test (in 2021, exact date unknown): positive. Outcome of events was not recovered. Investigation results received for batch: EW4811, batch expiry date: 31Jul2021 and batch: FA5715, batch expiry date: 31Aug2021. 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. The complaint for "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 EW4811 and lot FA5715. 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. PGS Agency concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The Agency process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Sender Comment: Serious vaccine ineffectiveness report. The causal relationship is considered possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1852070 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-09-28
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), 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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Alzheimer''s disease; Atrial fibrillation; Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC202101436197

Write-up: Vaccination failure; COVID-19; COVID-19 pneumonia; This is a spontaneous report from a contactable physician. This is the first of two reports. This first report is a report from the regulatory authority. A 91-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 04May2021 (Batch/Lot Number: EW6126; Expiration Date: 31Jul2021) as 0.3 ml, single and dose 1 intramuscular on 23Mar2021 (Batch/Lot Number: ER9470; Expiration Date: 31Jul2021) as 0.3 ml, single for COVID-19 immunization. Medical history included ongoing dementia, ongoing atrial fibrillation, and ongoing dementia alzheimer''s type. The patient''s concomitant medications were not reported. The patient experienced vaccination failure after vaccination with COVID-19 mRNA vaccine. The patient developed COVID-19 (COVID symptomatic infection) and was hospitalized on 28Sep2021. SARS-CoV-2 PCR test was positive on 28Sep2021. The course of the disease was severe, the patient had COVID pneumonia and she required oxygen therapy. The patient is recovering, she was discharged from the hospital to a nursing home on 1Oct2021. The patient was hospitalized for the events from 28Sep2021 to 01Oct2021. The patient underwent SARS-COV-2 test: positive on 28Sep2021. Therapeutic measures were taken as a result of the events COVID-19 and COVID-19 pneumonia. Outcome of the events was recovering. On 26Oct2021, investigation results were reported as follows: For lot number ER9470, 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 ER9470. 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. RA concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. For lot number EW6126, the investigation included reviewing the involved batch records, deviation investigation, 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 EW6126. 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. RA concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Sender Comment: Serious vaccine ineffectiveness report. The causal relationship is considered possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1852324 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-09-28
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1439 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Angiogram, Anosmia, C-reactive protein, COVID-19 pneumonia, Chest X-ray, Chest pain, Computerised tomogram, Cough, Diarrhoea, Dyspnoea, Electrocardiogram, Fibrin D dimer, Gastrointestinal disorder, Hyperthermia, Medical observation, Microbiology test, Oxygen saturation, Respiratory disorder, SARS-CoV-2 test, Troponin, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Taste and smell disorders (narrow), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 42 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CANDESARTAN ARROW
Current Illness: Hypertension arterial ((High blood pressure); treated); Lumbar spinal stenosis (narrow lumbar canal)
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Foot surgery (surgery on 2 hallux joints in childhood); Hallux limitus (surgery on 2 hallux joints in childhood); Helicobacter pylori gastritis (Helicobacter pylori)
Allergies:
Diagnostic Lab Data: Test Date: 20211005; Test Name: Computed tomography angiogram; Result Unstructured Data: Test Result:No pulmonary embolism; Test Date: 20211003; Test Name: Chest x-ray; Result Unstructured Data: Test Result:Normal; Test Date: 20211005; Test Name: CT scan; Result Unstructured Data: Test Result:atypical; Comments: atypical, but compatible with infectious pneumonia with COVID-19 (Severe acute respiratory syndrome Coronavirus 2 (SarsCov2); degree of attack: moderate (10-25%); Test Date: 20211005; Test Name: C-reactive protein; Result Unstructured Data: Test Result:124 mg/l; Test Date: 20211003; Test Name: electrocardiogram (ECG); Result Unstructured Data: Test Result:with no abnormalities; Test Date: 20211005; Test Name: D-dimers; Result Unstructured Data: Test Result:598 ug/L; Test Date: 20211002; Test Name: Medical consultation; Result Unstructured Data: Test Result:introduction of AMOXICILLINE; Comments: introduction of AMOXICILLINE in the light of likelihood of superinfection.; Test Date: 20211003; Test Name: biological assessment; Result Unstructured Data: Test Result:not indicative of anything particularly noteworthy; Test Date: 20211005; Test Name: Saturation; Test Result: 92 %; Test Date: 20211001; Test Name: COVID-19 Polymerase Chain Reaction (PCR) test; Test Result: Positive ; Test Date: 20211005; Test Name: Troponin; Test Result: Negative
CDC Split Type: FRPFIZER INC202101436777

Write-up: Vaccination failure; COVID-19 pneumonitis; abdominal pain; hyperthermia; deterioration of respiratory status; Anosmia; para-sternal pain without irradiation; Dyspnea; Cough; digestive issues; diarrhea; This is a spontaneous report from a contactable physician, downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number is FR-AFSSAPS-NY20214756. A 55-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 01Jul2021 (Batch/Lot Number: FE9174, Expiration date: unknown) as dose 1, single, and then intramuscularly on 19Aug2021 (Batch/Lot Number: FC1439; Expiration Date: 31Oct2021) as dose 2, single for COVID-19 immunization. Relevant medical history included ongoing lumbar spinal stenosis, further described as narrow lumbar canal; gastritis, further described as Helicobacter pylori from an unknown date and unknown if ongoing; asthma from an unknown date and unknown if ongoing; ongoing hypertension arterial (high blood pressure) that was treated; and hallux joints from an unknown date and unknown if ongoing, wherein a foot surgery (surgery on 2 hallux joints in childhood) was performed. Concomitant medication included candesartan cilexetil (CANDESARTAN ARROW) taken for hypertension arterial, start and stop date were not reported. On 28Sep2021, the patient experienced vaccination failure, COVID-19 pneumonitis, further described as pneumopathy of COVID-19 and there was an onset of dyspnea, cough, and digestive issues with diarrhea. The results of investigation on 01Oct2021, included COVID-19 Polymerase Chain Reaction (PCR) Test: positive. On 02Oct2021, the patient underwent medical consultation with introduction of AMOXICILLINE in the light of likelihood of superinfection. On 03Oct2021, there was an increase in dyspnea with shortness of breath on exertion and bilateral para-sternal pain without irradiation, leading to a visit to the emergency department. Additional examinations were performed, which included a normal chest x-ray, biological assessment not indicative of anything particularly noteworthy, and an electrocardiogram (ECG) with no abnormalities. The patient returned home under saturation observation once per day. On 05Oct2021, the patient had his second visit to the emergency department owing to an increase in hyperthermia and deterioration of respiratory status and anosmia. Blood test revealed C-reactive protein (CRP) of 124 mg/L, D-dimers of 598 ?g/L, and troponin negative. There was no sign of acute respiratory distress with saturation at 92 %. Computed tomography (CT) angiogram showed no pulmonary embolism. CT scan was atypical, but compatible with infectious pneumonia with COVID-19 (Severe acute respiratory syndrome Coronavirus 2 (SarsCov2); degree of attack: moderate (10-25%). Oxygenotherapy at 1L/min and LOVENOX 4,000 IU / day were initiated. On 06Oct2021, the patient was transferred to a specialised department for continued treatment. Increase of oxygenotherapy to 3L/min and LOVENOX 8,000 IU / day was initiated as well as dexamethasone 6mg / day. On 09Oct2021, there was a reduction of oxygenotherapy to 1L/min. The patient had persistent cough and some abdominal pain. On 10Oct2021, withdrawal from oxygenotherapy. On 11Oct2021, the patient had a good general state of health and was less weak. The patient returned home with visits from a home care nurse twice a day for monitoring of blood oxygen levels (SpO2) and LOVENOX anticoagulant injection 4,000 IU/day up to 15Oct2021 inclusive. The patient was in the process of recovery. In conclusion, the patient presented with COVID-19 pneumonia requiring hospitalization for 6 weeks after having received the two stages of the COMIRNATY vaccine with recovery in progress. The patient was hospitalized for vaccination failure, COVID-19 pneumonitis for 42 days (also reported as 6 weeks). Therapeutic measures were taken as a result of vaccination failure, COVID-19 pneumonitis; dyspnea; cough; hyperthermia; deterioration of respiratory status; and anosmia. At the time of the report, the patient was recovering from all the events. On 27Oct2021, investigation result from the Product Quality Complaints group was received regarding the complaint about BNT162B2 (Comirnaty) with Lot Number: FC1439; Expiration Date: 31Oct2021. The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation, 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 FC1439 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. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The Investigative process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Reporter Comment: 55-year-old man presenting with COVID-19 pneumonia requiring hospitalisation for 6 weeks after having received the two stages of the COMIRNATY vaccine. Recovery in progress. No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: 55-year-old man presenting with COVID-19 pneumonia requiring hospitalisation for 6 weeks after having received the two stages of the COMIRNATY vaccine. Recovery in progress.


VAERS ID: 1852737 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   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 FG3739 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Cranial nerve paralysis, Neuralgia, Neurological examination, Overdose, Pain, Paralysis, Peripheral paralysis
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Medication errors (broad), Immune-mediated/autoimmune 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CARDICOR; DIBASE; CONTRAMAL; MESALAZINA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthralgia; Crohn''s disease; Depression reactive; Hypertension arterial; Osteopenia; Sideropenic anaemia; Tachycardia
Allergies:
Diagnostic Lab Data: Test Date: 20211007; Test Name: neurological examination; Result Unstructured Data: Test Result:unknown result; Test Date: 20211014; Test Name: neurological examination; Result Unstructured Data: Test Result:unknown result
CDC Split Type: ITPFIZER INC202101438362

Write-up: at 0.45 ml, single booster dose; Rise in blood pressure; Neuralgia; Peripheral paralysis; Nerve paralysis; Cranial nerve paralysis; pain; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-800070. A 40-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscularly administered in right arm on 27Sep2021 at 13:28 (Batch/Lot Number: FG3739; Expiration Date: 31Dec2021) at 0.45 ml, single booster dose for covid-19 immunisation. Medical history included Depression reactive from 01Jan2012 and unknown if ongoing, Hypertension arterial from 01Mar2021 and unknown if ongoing, Sideropenic anaemia from 01Jan2013 and unknown if ongoing, tachycardia from 01Mar2021 and unknown if ongoing, osteopenia from 01Jan2016 and unknown if ongoing, arthralgia from 01Jan2013 and unknown if ongoing, Crohn''s disease from 01Jan2011 and unknown if ongoing. The patient had shown intolerance to systemic hormonal contraceptives and amoxicillin + beta-lactamase inhibitor. Concomitant medications included bisoprolol fumarate (CARDICOR) taken for hypertension arterial, colecalciferol (DIBASE) taken for vitamin D deficiency; tramadol hydrochloride (CONTRAMAL) taken for ache; mesalazina (MESALAZINA) taken for Crohn''s disease. On 28Sep2021, the patient experienced rise in blood pressure, neuralgia, peripheral paralysis, nerve paralysis, cranial nerve paralysis. Seriousness criteria was reported as medically significant. On 06Oct2021, patient was access to emergency room. On 07Oct2021, neurological consultation with diagnosis of post-vaccine right cranial VII nerve paresis, oral therapy (deltacortene, cyanofolin, gastroprotection) + artificial tears and eye bandages was set. On 14Oct2021, urgent neurologic visit, confirmed Deltacortene and set Lyrica for pain. The outcome of event "at 0.45 ml, single booster dose" was unknown, of other events was not recovered. Sender comment: 18Oct2021- the reporter sends us: Emergency Department report of 06Oct2021, neurological examination of 07Oct2021, urgent neurological examination of 14Oct2021 and medical record with essential information, entered on 19Oct2021 anonymously. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1852783 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-09-28
   Days after vaccination:115
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2336 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Pyrexia, SARS-CoV-2 test positive, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: LANSOPRAZOLE; LIORESAL; AUBAGIO; LIBRADINA; DIBASE; ESCITALOPRAM OXALATE; ALONEB; NATECAL D3
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchitis chronic; Fibromyalgia; Hypertension; Multiple sclerosis; Renal failure
Allergies:
Diagnostic Lab Data: Test Date: 20211002; Test Name: SARS-CoV-2 molecular test positive; Test Result: Positive
CDC Split Type: ITPFIZER INC202101437143

Write-up: vaccination failure; Positivity to the test for sars-cov2; Cough; Fever; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority number IT-MINISAL02-800916. A 70-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot/ Batch Number: FC2336; Expiration Date: 30Sep2021), via an intramuscular route of administration in Arm Left on 05Jun2021 12:46 as 1 DF DOSE 2, SINGLE and received first dose of bnt162b2 (COMIRNATY formulation: Solution for injection, Lot Number: EX7389; Expiration Date: 31Aug2021), via an unspecified route of administration in Deltoid Left on 01May2021 13:12 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history included renal failure, fibromyalgia, multiple sclerosis, hypertension, bronchitis chronic all from an unknown date and unknown if ongoing. Concomitant medications included (LANSOPRAZOLE), (LIORESAL), (AUBAGIO), ranitidine hydrochloride (LIBRADINA), (DIBASE), escitalopram oxalate (ESCITALOPRAM OXALATE), hydrochlorothiazide, nebivolol hydrochloride (ALONEB) calcium carbonate, colecalciferol (NATECAL D3) all from taken for an unspecified indication, start and stop date were not reported. After 19May2021 patient contacted by telephone in order to find information on concomitant diseases/drugs. Patient reports having no other adverse reactions except for a tightness in her chest that she links to the chronic bronchitis from which she suffers. On 28Sep2021 patient experienced cough (medically significant) and fever (medically significant). On 02Oct2021 had positivity to test for SAR-Cov2 (medically significant) and vaccination failure (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 02Oct2021. Patient received treatment on 04Oct2021: 2400mg (1200 + 1200mg) casirivimab + imdevimab). The clinical outcome of the events was recovered on unspecified date. Healthy Authority Comment: On 01May2021 recall dose number (1), time of administration (01:12pm), batch EX7389, left deltoid. Today, 19May2021, the patient was contacted by telephone in order to find information on concomitant diseases/drugs. She reports having no other adverse reactions except for a tightness in her chest that she links to the chronic bronchitis from which she suffers. Follow-up (26Oct2021): New information received from product quality complaint team regarding pharmacist''s complaint about Product (PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE) Conclusion: lot: FC2336, expiration date: 30Sep2021. Investigational conclusion from Puurs: For this lot Adverse Event Safety Request for Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the 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 ID6104079 (see File attachment in this investigation record). The complaint for "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 FC2336. 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. Puurs 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 or CAPA were identified as the complaint was not confirmed. Conclusion: lot: EX7389, expiration date: 31Aug2021. Investigational conclusion for Puurs: For this lot Adverse Event Safety Request for Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the-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 5966857 (see File attachment in this investigation record). The complaint for "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 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. Puurs 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 or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: On 01May2021 recall dose number (1), time of administration (01:12pm), batch EX7389, left deltoid. Today, 19May2021, the patient was contacted by telephone in order to find information on concomitant diseases/drugs. She reports having no other adverse reactions except for a tightness in her chest that she links to the chronic bronchitis from which she suffers.; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-202101468350 Same patient and product, different event


VAERS ID: 1852807 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-19
Onset:2021-09-28
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6270 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Disease recurrence, Investigation, Laboratory test, Oesophageal achalasia
SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal nonspecific dysfunction (broad), Immune-mediated/autoimmune 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Achalasia (Symptoms regressed after 8 months. Asymptomatic for three years.); Autoimmune disorder
Allergies:
Diagnostic Lab Data: Test Name: laboratory tests; Result Unstructured Data: Test Result:unkonwn results; Test Name: specialized examinations; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202101437967

Write-up: Achalasia; achalasia/ same symptoms reappeared; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number IT-MINISAL02-801214. A 48-year-old female patient (body weight: 53 kg; height: 165 cm) received the second dose of bnt162b2 (COMIRNATY; Lot Number: FG6270; Expiration Date: 31Dec2021) intramuscular, administered in left arm (left shoulder) on 19Sep2021 12:02 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. Medical history included autoimmune disorder from an unknown date and unknown if ongoing, achalasia from 2017 (Symptoms regressed after 8 months. Asymptomatic for three years). The patient''s concomitant medications were not reported. The patient previously received diphtheria vaccine toxoid/ polio vaccine/ tetanus vaccine toxoid (DIPHTHERIA,TETANUS AND POLIOMYELITIS VACCINE) and experienced achalasia. The patient experienced achalasia (medically significant) on 28Sep2021. Narrative: Onset of serious achalasia 4 years ago (2017) after tetanus diphteria polio trivalent vaccine. Symptoms regressed after 8 months. Asymptomatic for three years. After the second Pfizer shot, the same symptoms reappeared with impossibility of oral nutrition. The patient underwent laboratory tests and specialized examinations. Therapeutic measures were taken as a result of the events and included cortisone therapy. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1852917 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-09-28
   Days after vaccination:73
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Menstruation irregular
SMQs:, Termination of pregnancy and risk of abortion (narrow), Fertility 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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Polycystic ovarian syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101437946

Write-up: Miscarriage; Irregular bleeding. After miscarriage and 1 menstrual period, brown bleeding after 1.5 weeks; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00694658. A 31 years old female patient received the first dose of BNT162B2 (COMIRNATY, Lot number unknown) at single dose for COVID-19 immunisation on 17Jul2021 (31 year old at the time of vaccination). Relevant history included Polycystic ovary syndrome. Relevant concomitant drug included folic acid oral suspension 1mg/ml, multivitamin with vitamin d capsule. The patient did not have previous COVID-19 infection. The patient had Irregular bleeding (irregular menstrual cycle) since 28Sep2021 following administration of BNT162B2. The patient had vaccination during pregnancy and miscarriage (other medically important condition) on unknown date. Irregular menstrual cycle: 2 months after start. Miscarriage: latency unknown. Maternal exposure during pregnancy: latency unknown. After miscarriage and 1 menstrual period, the patient had brown bleeding after 1.5 weeks. The patient has not recovered from irregular menstrual cycle. The outcome of other events was unknown. It was unknown at what pregnancy duration the vaccination and the miscarriage took place. Sender''s comments: Since the nature of the reported reaction does imply seriousness according to one of the CIOMS criteria, the reaction was considered as serious by the Pharmacovigilance Centre Lareb. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No follow-up attempts are possible.


VAERS ID: 1852925 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast pain, Mastitis
SMQs:, Lipodystrophy (broad), Functional lactation 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? No
Previous Vaccinations:
Other Medications: MIRENA; PAROXETINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101432534

Write-up: Mastitis; Breast pain; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority (the regulatory authority number is NL-LRB-00695914). A 28-year-old female patient received bnt162b2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration on 24Sep2021 (lot number: FF2834) as single dose for COVID-19 immunisation. Medical history was not reported. No previous COVID-19 infection. Historical vaccine included bnt162b2 (COMIRNATY, solution for injection, 0.3ml), dose 1, on 27Aug2021 for COVID-19 immunisation and experienced adverse drug reactions (ADRs) included fatigue and breakthrough bleeding. Concomitant medications included levonorgestrel (MIRENA) and paroxetine. The patient experienced mastitis on 01Oct2021 (7 days after start) and breast pain on 28Sep2021 (4 days after start), following administration of covid-19 vaccine Pfizer solution for injection. It was also reported as 4th day after vaccination chest pain 7th day chest infection. Treatment was reported as that breast pain and mastitis were both treated with antibiotica. The patient had not recovered from breast pain and mastitis. Diagnostic procedures were reported as no first finish the cure. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1853037 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-28
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (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: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101438085

Write-up: Stroke; Visual impairment; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB SE-MPA-2021-088031, Sender''s (Case) Safety Report Unique Identifier: SE-VISMA-1633614850938. A 57-year-old male patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Sep2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension from 2005 and ongoing. The patient''s concomitant medications were not reported. The patient experienced stroke, visual impairment both on 28Sep2021 with outcome of not recovered. Events were reported as serious with hospitalization. Still not recovered when the report is received a little more than a month after the vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1853471 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-09-28
   Days after vaccination:89
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003187 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: positive
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: vaccine failure; This case was received via European Medicines Agency (Reference number: FR-AFSSAPS-LL20216978) on 01-Nov-2021 and was forwarded to Moderna on 01-Nov-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of VACCINATION FAILURE (vaccine failure) in an 86-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3004738 and 3003187) for COVID-19 vaccination. The patient''s past medical history included COVID-19. In July 2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced VACCINATION FAILURE (vaccine failure) (seriousness criterion hospitalization). At the time of the report, VACCINATION FAILURE (vaccine failure) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Sep-2021, SARS-CoV-2 test: positive (Positive) positive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered VACCINATION FAILURE (vaccine failure) to be possibly related. No concomitant medication information was provided. No treatment product information was provided. company''s comment: This case concerns an 86-year-old, female patient with no relevant medical history, who experienced the event of vaccination failure. The event, which resulted in hospitalization, 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 patient''s age remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. Of note, the specific date the first dose of the Moderna COVID-19 Vaccine was administered was not provided. Because of this, it cannot be confirmed whether both doses were given as per the approved dosing interval of 25 to 35 days apart. However, the event vaccination failure was retained as per Regulatory Authority report. Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Translated document attached on 03-Nov-2021 contains Verbatim of event updated to english; Sender''s Comments: This case concerns an 86-year-old, female patient with no relevant medical history, who experienced the event of vaccination failure. The event, which resulted in hospitalization, 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 patient''s age remains a confounder. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. Of note, the specific date the first dose of the Moderna COVID-19 Vaccine was administered was not provided. Because of this, it cannot be confirmed whether both doses were given as per the approved dosing interval of 25 to 35 days apart. However, the event vaccination failure was retained as per Regulatory Authority report.


VAERS ID: 1855090 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
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: 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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211117184

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053274] concerned a 23 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C11-01 expiry: UNKNOWN) dose was not reported, 1 total administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-SEP-2021, the patient experienced vaccination failure and sars-cov-2 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint and reference requested.


VAERS ID: 1855105 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
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: 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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211116990

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053421] concerned a 43 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: unknown) dose was not reported, frequency time 1 total administered on 01-JUN-2021 for product use for unknown indication. No concomitant medications were reported. On 28-SEP-2021, the patient experienced vaccination failure and sars-cov-2 infection (severe acute respiratory syndrome coronavirus 2). Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1855114 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
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: 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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211117048

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053668] concerned a 33 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: UNKNOWN) dose was not reported, 1 total administered on 09-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 28-SEP-2021, the patient experienced vaccination failure and sars-cov-2 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number requested.


VAERS ID: 1855115 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
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: 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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211117186

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053671] concerned a 50 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD975 and expiry: unknown) dose was not reported, 1 total, administered on 02-JUN-2021 for an unknown indication. No concomitant medications were reported. On 28-SEP-2021, the patient had COVID-19 polymerase chain reaction (PCR) test and found positive. He was diagnosed with severe acute respiratory syndrome coronavirus 2 (SARS COV-2) infection (vaccination failure). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and Sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report is associated with Product Quality Complaint.


VAERS ID: 1855148 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
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: Headache, Retinal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retinal 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101452158

Write-up: This is a spontaneous report from a contactable other healthcare professional, via the regulatory authority (report number: 646308). A 55-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on unspecified date, single dose, for COVID-19 immunization. The patient''s medical history and concomitant medication not reported. On Sep 28, 2021, patient had a headache and retinal hemorrhage (medically significant); with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.


VAERS ID: 1855174 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-09-28
   Days after vaccination:5
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: Cardiac flutter, Chest pain, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (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:
CDC Split Type: AUPFIZER INC202101452745

Write-up: Cardiac flutter; Chest pain; Palpitations; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority . Regulatory authority report number is 647177. A 34-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 23Sep2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced cardiac flutter on 28Sep2021, chest pain on 28Sep2021, palpitations on 28Sep2021. The outcome was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.


VAERS ID: 1855269 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   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 FF8845 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Gastritis, Hypersensitivity, Inappropriate schedule of product administration, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific inflammation (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (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: Medical History/Concurrent Conditions: Allergy to chemicals; Autism spectrum disorder; Celiac disease; Food allergy; Gluten intolerance; Lactose intolerance
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 test; Result Unstructured Data: Test Result:Unknown results; Comments: post vaccination
CDC Split Type: BRPFIZER INC202101456695

Write-up: severe, generalized allergic reaction all over the body (skin), including the head; Severe muscle pain; breathing difficulty; allergic gastritis; Administration Date: 17Jul2021 / Administration Date: 28Sep2021; This is a spontaneous report from a contactable consumer (patient) received through Regulatory Authority portal. This is the 1st of 2 reports for the second dose. A 45-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in Arm Left on 28Sep2021 12:00 AM at 45 years old (Batch/Lot Number: FF8845) as single dose for covid-19 immunization. Medical history included autism spectrum disorder (TEA), lactose and coeliac intolerance, allergies to Gluten, lactose, malts, corn starch, and drugs with these components- chlorine. No Covid prior to vaccination. The patient didn''t receive other vaccine in 4 weeks and other medications in two weeks. The patient previously received the first dose of bnt162b2 (Batch/Lot number: FF9094) on 17Jul2021 12:00 AM at 45 years old in Left arm for COVID-19 immunization, experienced severe muscle pain, tingling in the legs and arms. After the 2nd dose, patient experienced allergic gastritis and severe, generalized allergic reaction all over the body (skin), including the head, severe muscle pain and breathing difficulty on 29Sep2021. No treatment was received for the events. The outcome of the events was recovering. Patient was tested COVID-19 post vaccination and results were unknown.; Sender''s Comments: Linked Report(s) : BR-PFIZER INC-202101486714 Same patient, different dose/events


VAERS ID: 1856092 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Sensory loss
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Medication errors (broad), COVID-19 (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 Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101457245

Write-up: Balance disorder; loss of feeling in her feet; off label use; Interchange of vaccine products; Booster; This is a spontaneous report from a contactable consumer. This is report received from the Regulatory Agency (UK-MHRA), Safety Report Unique Identifier number is (GB-MHRA-ADR 26123767). A 78-year-old female patient received third dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 28Sep2021 (Lot Number: FF8222) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included influenza vaccine (INFLUENZA VIRUS) taken for an unspecified indication from 11Oct2021. The patient previously received the COVID-19 VACCINE ASTRAZENECA (batch/lot number and expiration date not provided) first dose on 22Jan2021, and second dose on 24Mar2021, both via unspecified route of administration, at single dose, for COVID-19 immunization. The patient experienced balance disorder (medically significant) on unknown date (reported as "01Apr2021"). Case Narrative: Because patient was also having loss of feeling in her feet, patient was having blood tests and been referred to a podiatrist. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial Reaction. Reporter did not relate reaction to possible inflammation of the heart (myocarditis or pericarditis). Tests was reported as "to be carried out". The patient underwent lab tests and procedures which included Sars-Cov-2 test was negative on an unknown date (No - Negative COVID-19 test). The outcome of event "balance disorder" was not recovered; of "loss of feeling in her feet" was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1856167 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Lymphadenopathy
SMQs:, 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:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Vestibular migraine
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101498321

Write-up: Lymphadenopathy/large lymphnode swelling on my left collarbone on my neck; Anxiety; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Authority (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202110291112024530-BTFTF with Safety Report Unique Identifier of GB-MHRA-ADR 26139103. A female patient of an unspecified age received the first dose of BNT162b2 (COMIRNATY; Lot Number: FF8222) via an unspecified route of administration on 27Sep2021 as a single dose for COVID-19 immunisation. Medical history included vestibular migraines. It was reported that the patient was unsure whether she had symptoms associated with COVID-19. The patient did not undergo a COVID-19 test and was not enrolled in the clinical trial. Concomitant medications were not reported. On 28Sep2021, 1 day after the vaccination, the patient experienced lymphadenopathy/large lymph node swelling on my left collarbone on my neck; on an unknown date in 2021, the patient experienced anxiety; both the events were reported as serious for being medically significant. The clinical course was reported as follows: the patient had a large lymph node swelling on her left collarbone and on the neck which was the size of a grape and still had not gone down which was causing the patient so much anxiety. The patient had not been tested positive for COVID-19, since having the vaccine. The clinical outcome of the events anxiety and lymphadenopathy/large lymph node swelling on my left collarbone on my neck was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1856419 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-09-28
   Days after vaccination:217
Submitted: 0000-00-00
Entered: 2021-11-10
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? 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: 20211001; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: LTPFIZER INC202101446695

Write-up: vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB with regulatory authority number LT-SMCA-6355N. A 48-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 23Feb2021 (Lot Number: EJ6136; Expiration Date: 30Apr2021) as dose 2, single; and dose 1 intramuscular on 26Jan2021 (Lot Number: EJ6136; Expiration Date: 30Apr2021) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 28Sep2021, the patient experienced covid-19 and vaccination failure. The patient underwent lab tests and procedures which included COVID-19 PCR test was positive on 01Oct2021. It was further reported that a medical doctor LP (licenced practicioner) has submitted a spontaneous and non-serious report on 12Oct2021. After the immunisation, the patient had COVID-19. On 01Oct2021, the positive Covid-19 PCR was received. The outcome of the events was recovered on 08Oct2021. According to the investigation performed provided on 27Oct2021 for the lot number of EJ6136 and expiration date of 30Apr2021, it was concluded that 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 EJ6136. 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. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1858656 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-09-28
   Days after vaccination:90
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: 20210928; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: POLYMERASE CHAIN REACTION (PCR) variant: B.1.617.2 not differentiated Sequenced variant: n501y-positive: no
CDC Split Type: ATPFIZER INC202101462615

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-2021-052097. A 38-year-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FD6840, Expiry date was not reported), via intramuscular route of administration on 30Jun2021 as dose 2, single for COVID-19 immunization and patient received dose 1 bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FD1921, Expiry date was not reported), via intramuscular route of administration on 09Jun2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On 28Sep2021, the patient experienced vaccination failure (medically significant), sars-cov-2 infection (medically significant). The patient underwent lab tests and procedures which included investigation: COVID-19 PCR test: Positive, POLYMERASE CHAIN REACTION (PCR) variant: B.1.617.2 not differentiated Sequenced variant: n501y-positive: no. The outcome for the events was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1858675 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-09-28
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-11-10
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: 20210928; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC202101462075

Write-up: Vaccination failure (drug ineffective); 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-2021-052124. A 27-years-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: FD4555) via intramuscular route of administration on 23Jun2021 as dose 1, single for covid-19 immunisation and second dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: FE6208) via intramuscular route of administration on 04Aug2021 as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 28Sep2021, the patient experienced SARS-CoV-2 infection, other and vaccination failure (coded to drug ineffective). The events were assessed as serious (medically significant) by health authority. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Sep2021. The outcome of both the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1858678 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-09-28
   Days after vaccination:112
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD 1921 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Polymerase chain reaction, 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Name: Variant PCR-based; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No; Test Date: 20210928; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC202101462046

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-2021-052129. A 62-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FD 1921), dose 2 via intramuscular on 08Jun2021 as dose 2, single and dose 1 via intramuscular on 30Apr2021 (Lot Number: EY 3014) as dose 1, single for COVID-19 immunisation. No medical history and concomitant medication were not reported. On 28Sep2021, the patient experienced vaccination failure, sars-cov-2 infection. The patient underwent lab tests and procedures which included polymerase chain reaction resulted positive, variant PCR-based: B.1.617.2, variant sequenced: n501y-positive: No, sars-cov-2 test resulted positive on 28Sep2021. The clinical outcome of the events was reported as unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1858706 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211120067

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053678] concerned a 38 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 expiry: UNKNOWN) dose was not reported, 1 total, administered on 26-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 28-SEP-2021, the patient experienced SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection and vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1858707 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211119805

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053679] concerned a 33 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 expiry: unknown) dose was not reported, 1 total administered on 26-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 28-SEP-2021, the patient had sars-cov-2 infection and vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1858710 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211120390

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053749] concerned a 52 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD975 expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-JUN-2021 for product used for unknown indication. No concomitant medications were reported. On 28-SEP-2021, the patient experienced vaccination failure and had SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection. Laboratory data included: COVID-19 PCR (Polymerase chain reaction) test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and SARS-CoV-2 infection was not reported. This report was serious (Other Medically Important Condition). The case is associated with Product quality complaint.


VAERS ID: 1859195 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 - / 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMIODARONE; PANTOPRAZOLE; TORASEMIDE; RAMIPRIL; ACETYLSALICYLIC ACID; SIMVASTATIN
Current Illness: Atrial fibrillation; Heart failure; Hypertension; Ischaemic heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Old cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC202101454930

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable consumer and a healthcare professional downloaded from the regulatory authority number EE-SAM-545821100731. A 92-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on an unspecified date (Batch/Lot Number: ER9480; Expiration Date: 31Jul2021) as dose 1, 0.3 mL single and intramuscular on 05May2021 (Batch/Lot Number: EW6126; Expiration Date: 31Jul2021) as dose 2, 0.3 mL single, for covid-19 immunisation. Medical history included ongoing hypertension, old cerebral infarction, ongoing heart failure, ongoing ischaemic heart disease, and ongoing atrial fibrillation. Concomitant medications included amiodarone, pantoprazole, torasemide, ramipril, acetylsalicylic acid, and simvastatin. The patient experienced vaccination failure and covid-19 on 28Sep2021. On 28Sep2021, the patient was hospitalized as Covid-19 positive, he had weakness and cough. The patient has recovered, but the need for supplemental oxygen remains. On 07October2021, the patient was referred to the nursing department for further treatment. The patient underwent lab tests and procedures which included SARS-CoV-2 PCR test: positive on 28Sep2021. The outcome of the events was recovered with sequel on 07Oct2021. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5973683 (see File attachment in this investigation record). The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, 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 EW6126. 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. PGS 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 or CAPA were identified as the complaint was not confirmed. The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, 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 ER9480. 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. PGS 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 or CAPA were identified as the complaint was not confirmed. Sender Comment: Serious vaccine ineffectiveness report. The causal relationship is considered possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1859248 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4721 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Immunisation, Oxygen saturation, Oxygen saturation decreased
SMQs:, Acute central respiratory depression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad), Infective pneumonia (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: 20210929; Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased; Comments: desaturation
CDC Split Type: ESPFIZER INC202101463067

Write-up: Oxygen saturation decreased/desaturation; Arrhythmia; received third dose (booster) of bnt162b2; This is a spontaneous report from a contactable other health professional downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-1035315. An 89-years-old female patient received third dose (booster) of bnt162b2 (COMIRNATY), intramuscular on 28Sep2021 (at the age of 89-years-old) (Batch/Lot Number: FE4721) as 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of COVID-19 Vaccine and second dose of COVID-19 Vaccine for covid-19 immunisation (Primary Immunization series complete but unknown manufacturer). The patient experienced oxygen saturation decreased and arrhythmia on 29Sep2021. At 24 hours she presented desaturation and arrhythmia. The outcome of the events was unknown. The events were serious with the criteria of medically significant. No follow-up attempts are needed. No further information expected.


VAERS ID: 1859318 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-09-28
   Days after vaccination:134
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood culture, Body temperature, COVID-19, COVID-19 pneumonia, Computerised tomogram, Dependence on oxygen therapy, Dyspnoea, Electrocardiogram, HIV test, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: REPAGLINIDE; METFORMIN; OZEMPIC
Current Illness: Aortic stenosis; Non-insulin-dependent diabetes mellitus; Obesity
Preexisting Conditions: Medical History/Concurrent Conditions: Shoulder dislocation
Allergies:
Diagnostic Lab Data: Test Date: 20211007; Test Name: Thoracic angioscan; Result Unstructured Data: Test Result:No pulmonary embolism; Test Date: 20211012; Test Name: Blood cultures; Test Result: Negative ; Test Date: 20211007; Test Name: Body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20211007; Test Name: Computed tomography scan; Result Unstructured Data: Test Result:very suggestive of COVID-19 pneumopathy with exten; Comments: Very suggestive of COVID-19 pneumopathy with extensive involvement of the anomalies; Test Date: 20211007; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Regular sinus rhythm; Test Date: 20211012; Test Name: HIV serology; Test Result: Negative ; Test Date: 20210928; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Positive; Comments: positive with the L452R mutation; Test Date: 20211008; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101454957

Write-up: Increase in oxygen tolerance; Fever; COVID-19 pneumopathy; Dyspnoea; Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BS20211946. A 53-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 17May2021 (Batch/Lot Number: FA4598) as dose 2, single, then intramuscular on 19Apr2021 (Batch/Lot Number: EW4815; Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunisation. Medical history included ongoing obesity, ongoing non-insulin-dependent diabetes mellitus, ongoing aortic stenosis , joint dislocation from 2017 to an unknown date. Concomitant medication(s) included repaglinide, metformin, semaglutide (OZEMPIC); all taken for an unspecified indication, start and stop date were not reported. On 25Sep2021, the male patient is in contact with a positive person. The patient experienced vaccination failure and covid-19 on 28Sep2021, dyspnoea 30Sep2021, fever (pyrexia) on 07Oct2021, covid-19 pneumopathy on 07Oct2021, increase in oxygen tolerance on 12Oct2021. Clinical course was as follows:Day 134, 28Sep2021, COVID reverse transcription polymerase chain reaction test comes back positive with the L452R mutation. Day 136, on 30Sep2021, the male patient experienced progressively worsening dyspnoea. Day 143, on 07Oct2021, the male patient went to the emergency room due to dyspnoea at rest and a fever of 39 degrees C. He was admitted to the infectious diseases department. Electrocardiography: regular sinus rhythm. Thoracic angioscan: no pulmonary embolism. Computed tomography scan very suggestive of COVID-19 pneumopathy with extensive involvement of the anomalies. Day 148, on 12Oct2021, increase in oxygen tolerance and transfer to intensive care on 13Oct2021. 12Oct2021: HIV serology negative. Negative blood cultures. The male patient showed a favourable evolution with oxygen therapy and prone and lateral decubitus sessions. The blood did not reveal any other aetiology. Diagnosis of a serious form of Sars Cov 2 pneumonia despite a complete COMIRNATY vaccination scheme. The male patient is still hospitalised in infectious diseases on 19Oct2021. In conclusion, vaccine failure on Day 134 of a complete COMIRNATY vaccination scheme. Patient was hospitalized from 07Oct2021 to an unknown date for all events and was transferred to intensive care on 13Oct2021. The patient underwent lab tests and procedures which included: On 28Sep2021:SARS-CoV-2 test: positive, positive with the L452R mutation. On 08Oct2021: SARS-CoV-2 test: positive. Outcome of the events was recovering. On 29Oct2021, investigation from the product quality complaint team was received. Investigational report conclusion from Puurs division was: 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 EW4815 and FA4598. 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. PGS concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are needed. No further information expected.


VAERS ID: 1859334 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-28
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EU/1/20/1528 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Blood pressure measurement, Gynaecological examination, Haemorrhage, Human chorionic gonadotropin, Migraine with aura, Physical examination, Scan, Ultrasound scan
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hashimoto''s disease
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:110 per 60; Test Name: Pelvic examination; Result Unstructured Data: Test Result:doubt on left latero-uterine mass, painful; Test Date: 20210910; Test Name: BHCG; Result Unstructured Data: Test Result:1821; Test Date: 20210923; Test Name: BHCG; Result Unstructured Data: Test Result:505; Test Date: 20210927; Test Name: BHCG; Result Unstructured Data: Test Result:368; Test Date: 20210928; Test Name: BHCG; Result Unstructured Data: Test Result:315; Test Date: 20211001; Test Name: BHCG; Result Unstructured Data: Test Result:170; Test Date: 20211011; Test Name: BHCG; Result Unstructured Data: Test Result:3; Comments: 3 IU/L --$g < 5 IU/L = pregnancy unlikely; Test Name: clinical examination; Result Unstructured Data: Test Result:apyretic; Comments: apyretic, painless depressed soft abdomen, marooned blood, painless pelvic examination; Test Name: Spec; Result Unstructured Data: Test Result:brown blood at the neck; Comments: brown blood at the neck, not active; Test Name: echo; Result Unstructured Data: Test Result:uterus with gestation sac; Comments: uterus with gestational sac aspect of uterine infection (IU) without VV(?) --$g doubt about SG (?) on left ovary? (right ovary clear) No effusion; Test Name: echo; Result Unstructured Data: Test Result:uterine vacuity, no effusion, ovaries visualized,; Comments: no MLU
CDC Split Type: FRPFIZER INC202101463311

Write-up: Miscarriage; abdominal pain; migraine with aura; bleeding; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-CN20213222. A 26-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 03Sep2021 (Lot Number: EU/1/20/1528) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Hashimito''s Hypothyroidism. History of COVID-19: no. History of PCR testing: no. The patient''s concomitant medications were not reported. The patient previously received first dose of COVID-19 vaccine (MANUFACTURER UNKNOWN) on an unspecified date for covid-19 immunisation. The patient experienced miscarriage on 30Sep2021, bleeding on 28Sep2021, abdominal pain on 29Sep2021, migraine with aura on 29Sep2021. The mother was 8 Weeks pregnant at the onset of the event. The mother was due to deliver was on 11May2022. The pregnancy resulted in spontaneous abortion. Date of last menstrual period on 04Aug2021. The beginning of pregnancy was on 18Sep2021. Emergency room report on 29Sep2021: This day she presents to the emergency room for progressive left abdominal pain. Beginning of bleeding yesterday afternoon (28Sep2021), not very abundant. Migraine with known aura this morning (hand tremor, vision problems, then headache). Examinations: BP 110/60, soft depressible abdomen tender in left hypochondrium. Spec: brown blood at the neck, not active. Pelvic examinination : doubt on left latero uterine mass, painful. Echo: uterus with gestational sac aspect Urinary Infection (IU) without VV(?) --$g doubt about SG (?) on left ovary? (right ovary clear). No effusion. Emergency room report of 30Sep2021: loss of clot yesterday, decrease in bleeding since + persistence of low abdominal pain in bar relieved by rest. No headache, no nausea, no vomiting, no dizziness. Examinations: BHCG (Beta human chorionic gonadotropin hormone) of 10Sep2021 at 1821. BHCG of 23Sep2021 at 505. BHCG of 27Sep2021 at 368. BHCG of 28Sep2021 at 315. BHCG of 01Oct2021 at 170. Clinically: apyretic, painless soft depressed abdomen, marooned blood, painless TV. Echo: uterine vacuity, no effusion, ovaries visualized, no MLU. Conclusion: very probable miscarriage. BHCG control on 11Oct2021: 3 IU/L --$g < 5 IU/L = pregnancy unlikely. Outcome of miscarriage was recovered, other events was unknown.


VAERS ID: 1860652 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211117080

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [AT-BASGAGES-2021-053263] concerned a 44-year-old male of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 expiry: unknown) dose was not reported, 1 total, administered on 09-JUN-2021 for an unknown indication. No concomitant medications were reported. On 28-SEP-2021, Covid-19 polymerase chain reaction (PCR) test result was Positive. On same day patient experienced severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection and reported vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the SARS-CoV-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000201303.


VAERS ID: 1860654 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211123655

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority [AT-BASGAGES-2021-053462] concerned a 28 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: UNKNOWN) dose was not reported, 1 total, administered on 21-JUN-2021 for product used for unknown indication. No concomitant medications were reported. On 28-SEP-2021, the patient experienced vaccination failure and had SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection. Laboratory data included: COVID-19 PCR (Polymerase chain reaction) test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and SARS-CoV-2 infection was not reported. This report was serious (Other Medically Important Condition). The case is associated with Product quality complaint.


VAERS ID: 1860655 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211123612

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [AT-BASGAGES-2021-053486] concerned a 33 year old male of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 and expiry: unknown ) dose was not reported, 01 total, administered on 02-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 28-SEP-2021, the patient had experienced severe acute respiratory syndrome coronavirus 2 (SARS COV-2) infection and vaccination failure. Laboratory data included: COVID-19 Polymerase Chain Reaction (PCR) test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report is associated with Product Quality Complaint.


VAERS ID: 1860656 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211123969

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority [AT-BASGAGES-2021-053517] concerned a 39 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-03 expiry: unknown) dose was not reported, 1 total administered on 09-JUN-2021 for an unknown indication. No concomitant medications were reported. On 28-SEP-2021, the patient experienced severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection and had vaccination failure. Laboratory data included: Covid-19 polymerase chain reaction (PCR) test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1860658 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211116826

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [AT-BASGAGES-2021-053623] concerned a 40 year old female of unspecified ethnicity and race. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C16-04 expiry: Unknown) dose was not reported, 1 total, administered on 12-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 28-SEP-2021, the patient had laboratory test: COVID-19 polymerase chain reaction (PCR) test which showed positive result and had severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection and vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint (PQC) number: 90000201245


VAERS ID: 1860660 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211120418

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority [AT-BASGAGES-2021-053754] concerned a 31 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD955 expiry: unknown) dose was not reported, 1 total, administered on 04-MAY-2021 for an unknown indication. No concomitant medications were reported. On 28-SEP-2021, Covid-19 polymerase chain reaction (PCR) test result was positive. On the same day, the patient experienced severe acute respiratory syndrome (SARS-CoV-2) infection and had vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the SARS-CoV-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1861915 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-22
Onset:2021-09-28
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004219 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Deafness bilateral, Erythema, Fatigue, Headache, Injection site reaction, Musculoskeletal pain, Nasopharyngitis, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Hypersensitivity (broad), Tendinopathies and ligament 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: TIROSINT
Current Illness: Cancer of skin; Pollen allergy; Thyroid cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20213

Write-up: blocked ears; Fever; Nausea; Headache; Injection site reaction; Common cold; Arthromyalgia; Erythema; Lassitude; This regulatory authority case was reported by a consumer and describes the occurrence of DEAFNESS BILATERAL (blocked ears) in a 78-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 3004494 and 3004219) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Pollen allergy, Thyroid cancer and Cancer of skin. Concomitant products included LEVOTHYROXINE SODIUM (TIROSINT) from 01-Jan-2010 to an unknown date for an unknown indication. On 22-Sep-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Oct-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced INJECTION SITE REACTION (Injection site reaction), NASOPHARYNGITIS (Common cold), MUSCULOSKELETAL PAIN (Arthromyalgia), ERYTHEMA (Erythema), FATIGUE (Lassitude) and HEADACHE (Headache). On 20-Oct-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced DEAFNESS BILATERAL (blocked ears) (seriousness criterion medically significant), PYREXIA (Fever) and NAUSEA (Nausea). On 25-Oct-2021, DEAFNESS BILATERAL (blocked ears), NASOPHARYNGITIS (Common cold), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) had not resolved. At the time of the report, INJECTION SITE REACTION (Injection site reaction), MUSCULOSKELETAL PAIN (Arthromyalgia), ERYTHEMA (Erythema) and FATIGUE (Lassitude) had not resolved. Treatment information was not provided. Reporter mentioned that Due to temporal correlation, the causality for all ADRs is considered possible. The reported reactions Common cold Deafness both ears are not listed (not labeled) in the Summary of Product Characteristics. Company comment: This case concerns a 78 year-old male patient with no relevant medical history, who experienced the unexpected serious event of Deafness. The event occurred 29 days after the first dose of mRNA-1273 vaccine. The concurrent non-serious event of Nasopharyngitis may have contributed to the event considering the description of the event Deafness as blocked ears and resolution of both Deafness and Nasopharyngitis on the same day. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Translation Received on 05-NOV-2021 includes senders comments translated added in inarrative.; Sender''s Comments: This case concerns a 78 year-old male patient with no relevant medical history, who experienced the unexpected serious event of Deafness. The event occurred 29 days after the first dose of mRNA-1273 vaccine. The concurrent non-serious event of Nasopharyngitis may have contributed to the event considering the description of the event Deafness as blocked ears and resolution of both Deafness and Nasopharyngitis on the same day. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1861988 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-09-28
   Days after vaccination:118
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8889 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective
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:
CDC Split Type: DEPFIZER INC202101501075

Write-up: COVID-19; Vaccination failure (drug ineffective); This is a spontaneous report from a non-contactable consumer or other non-HCP downloaded from the Regulatory Authority. -WEB, regulatory authority number DE-PEI-202100215041. This consumer or other non-HCP reported different events after different vaccine doses. This is the first of two reports. A 62-years-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection; Batch/Lot Number: ET3045), via intramuscular on 21Apr2021 as dose 1, single for covid-19 immunization and second dose of bnt162b2 (COMIRNATY, Solution for injection; Batch/Lot Number: FC8889), via intramuscular on 02Jun2021 as dose 2, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced covid-19 and vaccination failure (drug ineffective) on 28Sep2021. The events were assessed as serious (medically significant) by health authority. Symptoms were reported as cough, rhinitis, loss of smell, headache, exhaustion, shortness of breath, accelerated pulse. Result of assessment: Comirnaty/ all events:/ assessed as B. Indeterminate. The clinical outcome of the events was resolving. Health authority comment: initial: privacy symptoms: cough, rhinitis, loss of smell, headache, exhaustion, shortness of breath, accelerated pulse. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101531442 same reporter/patient, different event/dose


VAERS ID: 1862260 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7898 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Immunisation
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? 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: ESPFIZER INC202101462795

Write-up: Fatigue; Dyspnoea; Booster; This is a spontaneous report from a contactable healthcare professional downloaded from the Regulatory Authority-WEB. The regulatory authority report number is ES-AEMPS-1035279. A 93-year-old female patient received BNT162B2 (COMIRNATY, lot number: FG7898), intramuscular on 28Sep2021 (at the age of 93-years-old) at dose 3 (booster), 0.3 mL single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received COVID-19 Vaccine (primary immunization series complete but unknown manufacturer, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at dose 1, single and via an unspecified route of administration on an unspecified date at dose 2, single for COVID-19 immunisation. The patient received a booster dose of COMIRNATY on 28Sep2021. On 30Sep2021, she went to the hospital''s emergency room for fatigue/ tiredness and dyspnoea which were reported as medically significant. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1862262 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4721 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Chest pain, Dyspnoea, Oxygen saturation, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (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: Test Date: 20210928; Test Name: o2 saturation; Result Unstructured Data: Test Result:desaturation
CDC Split Type: ESPFIZER INC202101463226

Write-up: Chest pain; Oxygen saturation decreased; Dyspnoea; Abdominal pain; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-1035331. A 96-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 28Sep2021 (Batch/Lot Number: FE4721) (at age 96- year-old) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The first and second doses of covid-19 vaccines (manufacturer unknown) were received on unspecified date. The patient''s medical history and concomitant medications were not reported. The patient was treated in the hospital emergency room for oxygen saturation decreased, dyspnea, abdominal and thoracic pain on the same day who receives Comirnaty vaccine third dose 28Sep2021. Outcome of the events was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1862559 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye swelling, Immunisation, Lip swelling, Off label use, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN; CALCI-D; FINASTERIDE; FLUCLOXACILLIN; FUROSEMIDE; LANSOPRAZOLE; MONOMIL XL; NICORANDIL; RAMIPRIL; TAMSULOSINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cellulitis of leg; Discomfort; Gout; Heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101311125

Write-up: This is a spontaneous report from a contactable consumer or health care professional received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110011946162080-FQ330. Safety Report Unique Identifier GB-MHRA-ADR 26026523. A 91-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FF8222), via an unspecified route of administration on 28Sep2021 (at the age of 91-year-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included discomfort, gout, cellulitis of leg, cardiac failure; all from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (ASPIRIN) taken for an unspecified indication from 2005 to an unspecified stop date, calcium carbonate, colecalciferol (CALCI-D) taken for an unspecified indication from 2017 to an unspecified stop date, finasteride (FINASTERIDE) taken for gout from an unspecified start date to 2016, flucloxacillin taken for cellulitis of leg from 19Sep2021 to 26Sep2021, furosemide taken for heart failure, start and stop date were not reported, lansoprazole taken for an unspecified indication from 2005 to an unspecified stop date, isosorbide mononitrate (MONOMIL XL) taken for an unspecified indication from 2005 to an unspecified stop date, nicorandil taken for an unspecified indication from 2005 to an unspecified stop date, ramipril taken for an unspecified indication from 2005 to an unspecified stop date, tamsulosin hydrochloride (TAMSULOSINE) taken for an unspecified indication from 2005 to an unspecified stop date. The patient previously took BNT162b2 on an unknown date as dose 1 and dose 2 for COVID-19 immunization and experienced mild discomfort in arm only (Had only mild reaction to previous Covid vaccinations.). The patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. It was reported that booster received on 28Sep2021, itchiness all over body but particularly back on an unspecified date, hives on 30Sep2021, lip swelling, eye swelling on 01Oct2021 with outcome of not recovered. The clinical course was as follows: It was started with itchiness all over body but particularly back, gradually swelling of eyes followed by lips until very swollen causing difficulty in eating, drinking, and speaking which has continued for 12 hours. Itching stopped after 6 hours. The patient was taken antihistamine as treatment for all the events. The outcome of itchiness all over body but particularly back, itching was resolved on an unknown date in 2021; hives was resolved on 01Oct2021 and lip swelling, eye swelling was not resolved. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1862740 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Antibody test, COVID-19, Cerebral venous thrombosis, Computerised tomogram head, Drug ineffective, Fibrin D dimer, Headache, Hyperhidrosis, Immunisation, Influenza like illness, Nasopharyngitis, Off label use, Pain, Photophobia, Platelet count, Platelet count decreased, Product use issue, Prothrombin time ratio, SARS-CoV-2 test, Thrombosis, Venogram, Visual impairment, Vomiting
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: INFLUENZA VACCINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast lump (had breast clinic appt next week); Familial hypercholesterolemia (patient mother in her 70s); Headache; Myocarditis; Non-smoker; Pericarditis; Photophobia; Pulmonary embolism (patient mother in her 70s); Visual disturbance
Allergies:
Diagnostic Lab Data: Test Name: Activated partial thromboplastin clotting time; Result Unstructured Data: Test Result:APTR 0.9; Test Date: 20211011; Test Name: Anti-PF4 antibodies; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211011; Test Name: CT head; Result Unstructured Data: Test Result:CT head suggested cerebral venous sinus thrombosis; Test Date: 20211011; Test Name: D dimer; Result Unstructured Data: Test Result:Unknown results; Test Date: 20200825; Test Name: Platelet count; Result Unstructured Data: Test Result:189; Test Date: 20211011; Test Name: Platelet count; Result Unstructured Data: Test Result:326; Test Name: Prothrombin ratio; Result Unstructured Data: Test Result:PTR 1.0; Test Date: 20211001; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test; Test Date: 20211011; Test Name: CT venogram; Result Unstructured Data: Test Result:Confirmed cerebral venous sinus thrombosis. Abs...; Comments: Confirmed cerebral venous sinus thrombosis. Absence of opacification in the transverse sinuses bilaterally and in the R sigmoid sinus"
CDC Split Type: GBPFIZER INC202101513935

Write-up: Cerebral venous thrombosis; Severe headache; Visual disturbance; photophobia; Vomiting; /positive for COVID-19 on 01Oct2021; SARS-CoV-2 infection/positive for COVID-19 on 01Oct2021; Flu like symptoms; Sweaty; Aches++; Cold; The patient received 3rd dose of Comirnaty; low platelet counts; blood clots; COVID booster and flu vaccination on same day; COVID booster and flu vaccination on same day; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202111031431180480-3XA4Z, Safety Report Unique Identifier GB-MHRA-ADR 26155670. A 49-year-old female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2153) via an unspecified route of administration on 28Sep2021, as a single dose for COVID-19 immunisation. Medical history included visual disturbance, pericarditis, photophobia, myocarditis, headache, breast lump (had breast clinic appt next week), and non-smoker. The patient was not pregnant and was not breast feeding. It was unsure whether the patient was enrolled in clinical trial. And unknown if patient have history of malignancy. Patient mother had pulmonary embolism and familial hypercholesterolemia in her 70s. Concomitant medication included influenza vaccine (MANUFACTURER UNKNOWN) for immunisation on 28Sep2021. The patient previously took heparin (MANUFACTURER UNKNOWN) on an unknown date and for an unknown indication and unknown if ongoing. Patient previously received first and second dose of covid-19 vaccine on unspecified date, for COVID-19 immunisation (Primary Immunization series complete but unknown manufacturer). On 25Aug2021, the patient underwent platelet count and the result was 189 (unspecified unit, normal range was 150-450)). On 29Sep2021 the patient experienced flu like symptoms, sweaty, aches++ and cold. On 01Oct2021 the patient experienced SARS-CoV-2 infection. On 11Oct2021, cerebral venous thrombosis. On 11Oct2021, severe headache, visual disturbance, photophobia and vomiting. The events flu like, sweaty, SARS-CoV-2 infection and cerebral venous thrombosis was reported as serious for hospitalization. The clinical course was reported as follows: It was reported that the patient during the night (early hours of 29Sep2021) awoke with aches++, sever flu like symptoms, cold and sweaty and she was tested positive for COVID-19 test on 01Oct2021. She was self-isolated and in early hours of 11Oct2021 she awoke with a severe headache, visual disturbance, photophobia and vomiting resulting in hospitalization. The report related to possible blood clots or low platelet counts and not related to possible myocarditis or pericarditis. On 11Oct2021 the patient underwent CT (computed tomography) head suggested cerebral venous sinus thrombosis which was confirmed on a CT venogram and the result reported as - absence of opacification in the transverse sinuses bilaterally and in the R sigmoid sinus. The platelet count was measured on 11Oct2021 and the result was 326 (unspecified units), the D-dimer and anti-PF4 antibodies was also measured and the result was unknown. The patient reviewed by a hematologist and no hemorrhage was identified. On an unknown date, the patient underwent prothrombin ratio and the result was PTR 1.0. On an unknown date, the patient underwent activated partial thromboplastin clotting time and the result was APTR 0.9. The clinical outcome of the event SARS-CoV-2 infection and cerebral venous thrombosis was resolving while events flu like symptoms, sweaty, aches++, cold, severe headache, visual disturbance, photophobia and vomiting, blood clots and low platelet counts was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1862912 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2018 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Dizziness, Feeling abnormal, Heart rate, Oxygen saturation, Oxygen saturation decreased, Pharyngeal disorder, Rash, Urticaria, Walking disability
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: ALLELOCK
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia (checked in health diagnose); Asthma; Food allergy; Rhinitis allergic atopic
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:107/84; Test Date: 20210928; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Name: P; Result Unstructured Data: Test Result:67; Test Date: 20210928; Test Name: SpO2; Result Unstructured Data: Test Result:99; Test Date: 20210928; Test Name: SpO2; Result Unstructured Data: Test Result:96
CDC Split Type: JPPFIZER INC202101288838

Write-up: swaying feeling; became not be able to walking; SpO2 decreased; urticaria appeared on precordium and both fingers; feels poorly; Rash appeared on both fingers; Throat abnormal feeling; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21128046. A 38-year-old (reported as 38-year and 1-month-old) received bnt162b2 (COMIRNATY, Solution for injection, Lot number FF2018, Expiration date 31Dec2021) intramuscular on 28Sep2021 at 8:48 (the day of vaccination, at age of 38-year-old) as dose 1, single for COVID-19 immunization. Body temperature before vaccination (28Sep2021) was 36.5 degrees centigrade. The patient''s medical history included asthma, arrhythmia (checked in health diagnose) and rhinitis allergic atopic. History of any previous allergies to specific products or any conditions indicative of an allergy was reported as follows: in the view inspection, wheat class 1, shrimp class 1, the patient didn''t fit penaeus merguiensis via the patient''s history. The patient''s concomitant medications included olopatadine (ALLELOCK) oral from unspecified date and ongoing for rhinitis allergic atopic. The patient took (or have readily available) ALLELOCK 5 ml 2 tablets one time (as reported) related to the allergy history. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Sep2021 at 09:03 (the day of the vaccination), the patient experienced the reported events. The course of the event was as follows: after vaccination on 28Sep2021 at 09:03, the patient experienced feels poorly, and urticaria appeared on precordium and both fingers, and Pharynx strange sensation of occurred. SpO2 decreased from 99 to 96. The patient experienced swaying feeling and became unable to walk on 28Sep2021 at 09:03 (15 minutes after the vaccination). On 28Sep2021 (the day of the vaccination), the outcome of the events was not recovered (transported to hospital). All the signs and symptoms of the event included rash appeared on both fingers, and throat abnormal feeling occurred, swaying feeling and became unable to walk. Blood pressure (BP) 107/84, pulse (P) 67, oxygen saturation (SpO2) 99 to SpO2 96. The time course of the event was reported as 08:48, the patient received vaccination. At 09:03, rash, throat abnormal feeling, swaying feeling and became unable to walk. The patient required medical intervention, included corticosteroids, antihistamine, intravenous (IV) fluids. Details: No. KN3 200 ml intravenous drip, dexamethasone (DECADRON) injection 1.65ml (0.5 ml), loratadine/bethamethasone (CELESTAMINE) 1 tablet taken via oral. The patient had no multiorgan involvement: no Cardiovascular involvement, no gastrointestinal involvement. The patient had dermatological/mucosal involvement including other. Details reported as rash appeared on fingers. The patient had other signs and symptoms. Details were reported as swaying feeling and became unable to walk. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The last outcome of the events was resolved on Oct2021 with treatment of KN3B 200 ml intravenous drip, DECADRON (1.65) 0.5ml; CELESTAMINE 1 tablet taken via oral for "swaying feeling" and "became not be able to walk", unknown for "rash" and "throat abnormal feeling", and not resolved for all other events. The reporting physician commented as follows: Transported to emergency department of the hospital. Follow-up (15Oct2021): Follow-up attempts are completed. No further information is expected. Follow-up (29Oct2021): New information received from the same contactable physician included: new events ("rash appeared on both fingers" and "throat abnormal feeling"), clinical details, patient''s relevant medical history ("wheat class 1, shrimp class 1, the patient didn''t fit Penaeus merguiensis via the patient''s history"), suspect drug details (administration route), and lab data were added, outcome of events ("swaying feeling" and "became not be able to walk") was updated. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1863003 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram, Duodenitis, Intra-abdominal haemorrhage, Oesophagogastroduodenoscopy, Pyrexia, Weight
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal nonspecific inflammation (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211002; Test Name: CT scan; Result Unstructured Data: the patient''s abdomen was full of blood; Test Date: 20211011; Test Name: Esophagogastroduodenoscopy; Result Unstructured Data: there is inflammation to the patient''s duodenum; Test Date: 202111; Test Name: Weight; Result Unstructured Data: lost 10 Kgs
CDC Split Type: KRMODERNATX, INC.MOD20213

Write-up: Dueodenitis; Hemorrhage intraabdominal; Mild fever; This spontaneous case was reported by a consumer and describes the occurrence of (Dueodenitis) and INTRA-ABDOMINAL HAEMORRHAGE (Hemorrhage intraabdominal) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, the patient experienced PYREXIA (Mild fever). On 02-Oct-2021, the patient experienced INTRA-ABDOMINAL HAEMORRHAGE (Hemorrhage intraabdominal) (seriousness criteria hospitalization and medically significant). On 11-Oct-2021, the patient experienced DUODENITIS (Dueodenitis) (seriousness criterion hospitalization). The patient was hospitalized on 02-Oct-2021 due to DUODENITIS and INTRA-ABDOMINAL HAEMORRHAGE. The patient was treated with Surgery (Open abdomen surgery) for Intra-abdominal haemorrhage. At the time of the report, DUODENITIS (Dueodenitis) had not resolved and INTRA-ABDOMINAL HAEMORRHAGE (Hemorrhage intraabdominal) and PYREXIA (Mild fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2021, Computerised tomogram: abnormal (abnormal) the patient''s abdomen was full of blood. On 11-Oct-2021, Oesophagogastroduodenoscopy: abnormal (abnormal) there is inflammation to the patient''s duodenum. In November 2021, Weight: decreased (Low) lost 10 Kgs. No concomitant product information was provided. Patient past history reported include that, he played every day for over 20 years and he was healthy, did not smoke and drink. After 2nd dose patient had some mild fever but other than that was fine. He was able to continue with daily activities of living. Additional information about events include that the abdominal pain was severe enough to roll on the living room floor. Patient was treated with 2 doses of narcotic pain medications. Even after the medications, the patient was still screaming of pain. Information about emergency open abdomen surgery include that the surgery took 2.5 hours. According to the doctor, the abdomen was full of blood that organs were not distinguishable and vessels could not be found so organs had to be lifted to find the cause of bleeding. The two vessels behind the pancreas, close to the back were the cause of bleeding. According to the doctor, these vessels were not easily ruptured and usually only rupture with either a motor vehicle accident or a severe trauma. Therefore, the doctor had check if the patient had a severe injury in the back. On 6-OCT-2021, after 5 days in the intensive care unit (ICU), the patient was transferred to the ward and was recovering. However, then on 11-OCT-2021, the patient had started vomiting 1.5 liters of green water after only drinking water. The patient has vomited for 5 days and then through esophagogastroduodenoscopy, it was confirmed that there was inflammation to the patient''s duodenum and therefore nothing could pass through. At one month, the patient still cannot drink water and has a tube connecting the nose to the stomach to empty out gastric fluids. The doctor mentioned if this doesn''t work, a surgery is needed to connect the stomach to the small intestine. This case concerns a 50-year-old male patient, with no relevant medical history, who experienced the serious unexpected events of INTRA-ABDOMINAL HAEMORRHAGE and DUODENITIS. The event of intra-abdominal haemorrhage occurred approximately 4 days after receiving the second dose of the Moderna COVID 19 vaccine and the event of duodenitis occurred approximately 10 days after receiving that second dose. The rechallenge is not applicable since the events outcome are unknown and not resolved and no information about further dosing has been disclosed. The benefit-risk relation of the Moderna COVID 19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow up received with No New Information On 04-Nov-2021: Follow up received contains no new information.; Sender''s Comments: This case concerns a 50-year-old male patient, with no relevant medical history, who experienced the serious unexpected events of INTRA-ABDOMINAL HAEMORRHAGE and DUODENITIS. The event of intra-abdominal haemorrhage occurred approximately 4 days after receiving the second dose of the Moderna COVID 19 vaccine and the event of duodenitis occurred approximately 10 days after receiving that second dose. The rechallenge is not applicable since the events outcome are unknown and not resolved and no information about further dosing has been disclosed. The benefit-risk relation of the Moderna COVID 19 vaccine is not affected by this report.


VAERS ID: 1863259 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-09-28
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8274 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram thorax, Investigation, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (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: 20210928; Test Name: CT pulmonary angiogram; Result Unstructured Data: Test Result:pulmonary embolism; Test Name: examinations; Result Unstructured Data: Test Result:No clear trigger for pulmonary embolism was detect
CDC Split Type: SIPFIZER INC202101465007

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number SI-JAZMP-NCPHV-2021SI0980_0980. A 39-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 25Aug2021 (Batch/Lot Number: FD8274; Expiration Date: 31Oct2021) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 28Sep2021, the patient experienced pulmonary embolism. Pulmonary embolism was proven with CTA; history of dyspnoea or reduced capacity after the first dose of the vaccine. No clear trigger for pulmonary embolism was detected with examinations (performed according to protocol). The patient was hospitalised. This case report was assessed as medically significant. Outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1864384 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211123128

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053496] concerned a 61 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) dose was not reported, 1 total (first dose), administered on 13-AUG-2021 for an unknown indication. No concomitant medications were reported. On 28-SEP-2021, the patient experienced sars-cov-2 infection and hence vaccination failure. Laboratory data included: COVID-19 PCR (Polymerase chain reaction) test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1864601 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-09-28
   Days after vaccination:238
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 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: 20210928; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Sequenced variant: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101490785

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. -WEB, regulatory authority number AT-BASGAGES-2021-052285. A 37-years-old female patient received second dose of bnt162b2 (COMIRNATY; Formulation, solution for injection), via intramuscular route on 02Feb2021 (Batch/Lot Number: EL1491) as dose 2, single and first dose via intramuscular on 08Jan2021 (Batch/Lot Number: EJ6796) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced vaccination failure and sars-cov-2 infection on 28Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Sep2021. Outcome of the event is unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1864635 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211123749

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority [AT-BASGAGES-2021-053448] concerned a 20 year old female of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C11-01 expiry: unknown) dose was not reported, 1 total, administered on 02-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 28-SEP-2021, the patient had laboratory test: COVID-19 polymerase chain reaction (PCR) test which showed positive result and had the severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection and vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000201715.


VAERS ID: 1864636 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211125529

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [AT-BASGAGES-2021-053770] concerned a 27 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-03 expiry: UNKNOWN) dose was not reported, 1 total administered on 21-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 28-SEP-2021, the patient experienced sars-cov-2 infection and vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number requested.


VAERS ID: 1864637 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211126292

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician via a Regulatory Authority [AT-BASGAGES-2021-053788] concerned a 35 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-03 expiry: UNKNOWN) dose was not reported, 1 total administered on 16-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 28-SEP-2021, the patient experienced sars-cov-2 infection and vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1864638 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211125801

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician via a Regulatory Authority [AT-BASGAGES-2021-053803] concerned a 51 year old male of unspecified ethnic origin and race. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: UNKNOWN) dose was not reported, 1 total administered on 08-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 28-SEP-2021, the patient experienced sars-cov-2 infection and vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1864639 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211125714

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority [AT-BASGAGES-2021-053804] concerned a 26-year-old male of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: unknown) dose was not reported, 1 total, administered on 01-JUL-2021 for an unknown indication. No concomitant medications were reported. On 28-SEP-2021, the patient had Covid-19 polymerase chain reaction (PCR) test and its result was positive. On the same day, he experienced severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection and had vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and SARS-CoV-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1864640 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211126124

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [AT-BASGAGES-2021-053811] concerned a 49 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD975 and expiry: unknown) dose was not reported, 1 total, administered on 07-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 28-SEP-2021, the patient experienced sars-cov-2 (severe acute respiratory syndrome coronavirus 2) infection and vaccination failure. Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1865821 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-28
Onset:2021-09-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8845 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Impaired healing, Inappropriate schedule of product administration, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Medication errors (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: VITAMIN D [VITAMIN D NOS]; COLLAGEN; CREATINE
Current Illness: Pruritus (itchiness in some parts of the body); Skin eruption (there were eruptions on skin, on the back, neck, and under the breasts)
Preexisting Conditions: Medical History/Concurrent Conditions: Tachycardia (Tachycardia 4 times)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101482802

Write-up: Administration Date: 28Sep2021; eruptions increased and appeared in some other places; intense itching; Eruptions do not even heal with application of corticoid ointments; This is a spontaneous report from a contactable consumer (patient) received through the portal. A 36-year-old non-pregnant female patient received the second dose of BNT162B2 (COMIRNATY; lot number FF8845) via an unspecified route of administration in the left arm on 28Sep2021 at 13:15 (at 36-years-old) as a single dose for COVID-19 immunisation. The patient''s medical history included eruptions on skin, on the back, neck, and under the breasts and itchiness in some parts of the body in Aug2021 and ongoing; and tachycardia 4 times on 04Aug2021 and unknown if ongoing. The patient reported she never had tachycardia or skin reactions before. Concomitant medications included vitamin D, collagen, creatine, and whey, all from unknown dates for unknown indications. The patient had no known allergies and was not diagnosed with COVID-19 prior to vaccination. Concomitant vaccines included the first dose of HEPATITIS B VACCINE (lot number WVX19004) on 14Sep2021 as a single dose in the right arm for immunisation; and the first dose of diphtheria vaccine toxoid, tetanus vaccine toxoid (DIPHTHERIA AND TETANUS VACCINE; lot number 2330L004B), reported as "double adult," on 14Sep2021 as a single dose in the left arm for immunisation. The patient previously received the first dose of BNT162B2 (lot number FA9095) via an unspecified route of administration on 16Jul2021 at 09:15 (at 36-years-old) in the left arm for COVID-19 immunisation and experienced itchiness in some parts of the body and later there were eruptions on skin, on the back, on the lap, and under the breasts, and tachycardia. The patient reported after second dose, eruptions increased and appeared in some other places of the body accompanied by intense itching. Until now (10Sep2021) there was no sign of improvement and the eruptions did not even heal with application of corticoid ointments. The events resulted in a doctor''s office visit and the patient was treated with loratadine and fludroxycortide (DRENISON) ointment. The clinical outcomes of intense itching, eruptions increased and appeared in some other places, and eruptions did not even heal with application of corticoid ointments were not recovered. The outcome of the other event was unknown. It was also reported the patient had not been tested for COVID since vaccination.; Sender''s Comments: Linked Report(s) : 202101488127 same patient/drug; dfferent dose/event


VAERS ID: 1865876 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-09-28
   Days after vaccination:66
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004217 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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: Spikevax
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: COVID-19; This case was received via Agency (Reference number: DE-PEI-202100211381) on 05-Nov-2021 and was forwarded to Moderna on 05-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 44-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004217) for Prophylactic vaccination. No Medical History information was reported. Concomitant products included mRNA-1273 (Spikevax) for Prophylactic vaccination. On 24-Jul-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion medically significant). At the time of the report, COVID-19 (COVID-19) outcome was unknown. Treatment information was not provided. Company Comment: This case concerns a 44-year-old female patient, with no relevant medical history, who experienced the unexpected, serious, and AESI event of COVID-19. The event occurred approximately 2 months and 5 days after the second dose of Moderna COVID-19 vaccine. The rechallenge is not applicable, as no additional dosing will be given. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 44-year-old female patient, with no relevant medical history, who experienced the unexpected, serious, and AESI event of COVID-19. The event occurred approximately 2 months and 5 days after the second dose of Moderna COVID-19 vaccine. The rechallenge is not applicable, as no additional dosing will be given. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1865879 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-09-28
   Days after vaccination:94
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 2003609 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, 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:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: COVID-19; Vaccination failure; This case was received via Agency (Reference number: DE-PEI-202100212227) on 05-Nov-2021 and was forwarded to Moderna on 05-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination failure) in a 44-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3004217 and 2003609) for Prophylactic vaccination. No Medical History information was reported. On 26-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion medically significant) and VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant). At the time of the report, COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination failure) had not resolved. Patient was tested positive for PCR. Concomitant medications were not provided. Treatment information was not provided. This case concerns a 44-year-old, female, with no relevant medical history reported in this case, who experienced the serious unexpected events of COVID-19 (AESI) and Vaccination failure. The events occurred approximately 2 months after the second dose of a proper schedule of product administration of Moderna COVID-19 Vaccine. Vaccination failure and COVID-19 (AESI) were reported as serious as per medically significant by the RA, conservatively, seriousness has been captured as reported by RA for both events. The rechallenge is not applicable since the events occurred after the second dose and no additional dosing will be given. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 44-year-old, female, with no relevant medical history reported in this case, who experienced the serious unexpected events of COVID-19 (AESI) and Vaccination failure. The events occurred approximately 2 months after the second dose of a proper schedule of product administration of Moderna COVID-19 Vaccine. Vaccination failure and COVID-19 (AESI) were reported as serious as per medically significant by the RA, conservatively, seriousness has been captured as reported by RA for both events. The rechallenge is not applicable since the events occurred after the second dose and no additional dosing will be given. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1868896 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-28
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214021 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cell death, Cholestasis, Jaundice
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (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: Chronic alcoholism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Cholestasis; Cytolysis; Jaundice; This case was received via Regulatory Agency (Reference number: FR-AFSSAPS-RE20212795) on 05-Nov-2021 and was forwarded to Moderna on 05-Nov-2021. This regulatory authority case was reported by a physician and describes the occurrence of CHOLESTASIS (Cholestasis) in an 80-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214021) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Chronic alcoholism. On 09-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced CHOLESTASIS (Cholestasis) (seriousness criterion medically significant), CELL DEATH (Cytolysis) and JAUNDICE (Jaundice). At the time of the report, CHOLESTASIS (Cholestasis), CELL DEATH (Cytolysis) and JAUNDICE (Jaundice) was resolving. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 09-Sep-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication provided. No treatment medication reported. Company comment: This case concerns a 80-year-old, male patient with relevant medical history of Chronic alcoholism, who experienced the unexpected events of Cholestasis, Cell death and Jaundice. The events occurred approximately 19 days after the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable as the events occurred after the first dose and no information about second dose is available. The patient''s medical history of Chronic alcoholism remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Translation document received on 07-Nov-2021 with Medical product and substance name translated and updated.; Sender''s Comments: This case concerns a 80-year-old, male patient with relevant medical history of Chronic alcoholism, who experienced the unexpected events of Cholestasis, Cell death and Jaundice. The events occurred approximately 19 days after the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable as the events occurred after the first dose and no information about second dose is available. The patient''s medical history of Chronic alcoholism remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1868975 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-28
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211126365

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-053787] concerned a 34 year old adult female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C16-04 expiry: unknown) dose was not reported, 01 total, administered on 30-JUL-2021 for an unknown indication. No concomitant medications were reported. On 28-SEP-2021, the patient experienced severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection and vaccination failure. Laboratory data included: COVID-19 polymerase chain reaction (PCR) test (NR: not provided) Positive. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint: 90000202028.


VAERS ID: 1869061 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-27
Onset:2021-09-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast pain, Dyspnoea, Fatigue, Myocarditis, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Lipodystrophy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101490376

Write-up: Myocarditis; Dyspnoea; Fatigue; Pyrexia; Breast pain; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority, regulatory authority number AT-BASGAGES-2021-049976. A 35-years-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on 27Sep2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of covid-19 vaccine on an unknown date, with unknown manufacturer. On 28Sep2021, the patient experienced dyspnoea, myocarditis, fatigue, pyrexia and breast pain. Seriousness criteria was assessed as medically significant for dyspnoea and myocarditis. The outcome of events was reported as not recovered. Patient''s notes included Not known risk factors. Reporter comment: Treatment of side effect 1: Shortness of breath with the slightest physical exertion. Exhaustion. Pain behind the sternum. Light fever. Prescribed bed rest. Long sick leave. No follow-up attempts are needed. No further information expected. Information about batch number cannot be obtained.


VAERS ID: 1870294 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-09-28
   Days after vaccination:97
Submitted: 0000-00-00
Entered: 2021-11-15
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: 20210928; 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 INC202101490011

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-052186. A 46-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: FD4555, Expiration date: Unknown), via an intramuscular route of administration on 23Jun2021, as DOSE 2, SINGLE and dose 1, BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: FA4598, Expiration date: Unknown), via an intramuscular route of administration on 19May2021, as DOSE 1, SINGLE for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 28Sep2021, the patient experienced SARS-COV-2 infection. The patient underwent lab tests and procedures which included SARS-COV-2 test: Positive on 28Sep2021, Variant PCR-based: B.1.617.2, Sequenced variant: N501Y-positive: No. The outcome of the event was unknown at the time of this report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1870398 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-09-28
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-11-15
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: 20210928; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive; Comments: Variant PCR-based: variant sequenced: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101491108

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from a Regulatory Authority, authority number AT-BASGAGES-2021-052553. A 26-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 21Jul2021 (Lot Number: FF0680) as dose 2, single and dose 1 intramuscular on 08Jun2021 (Lot Number: FD1921) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 28Sep2021 the patient experienced SARS-CoV-2 infection and Vaccination failure (Drug ineffective). The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 28Sep2021 (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: 1870466 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-09-28
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 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: 20210928; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR base: B.1.617.2 Variant Sequenziert: n501y positive: No
CDC Split Type: ATPFIZER INC202101490021

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician and downloaded from the Regulatory authority-WEB. Regulatory authority number is AT-BASGAGES-2021-052581. A 57-year-old male patient received first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, lot number: FD4555, expiry date: not reported), on 30Jun2021 as dose 1, single; Second dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, lot number: FF0680, expiry date: not reported), on 04Aug2021 as dose 2, single; both doses via intramuscular route of administration for COVID-19 immunization. Medical history and concurrent conditions were not reported. Concomitant medications were not reported. On 28Sep2021, the vaccination was considered failure as patient experienced SARS-CoV-2 infection. Events were considered serious (medically significant). The patient''s lab data on 28Sep2021 included: COVID-19 PCR test (Variant PCR-based/Sequenced variant): n501y-positive. Outcome of events was unknown. No follow-up attempts possible. No further information expected.


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