Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: COVID-19; COUGH; DYSPNOEA; ASTHENIA; PYREXIA; ANGIOPLASTY; EXPOSURE TO SARS-COV-2; SARS-COV-2 TEST POSITIVE; VACCINE BREAKTHROUGH INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via Regulatory Authority VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1920817) concerned a 63 year old male of an unspecified race and ethnic origin. The patient's height and weight were not reported. The patient's concurrent conditions included dyslipidemia, spinal stenosis and squamous cell carcinoma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A and expiry: unknown) dose was not reported, 1 total administered to left arm on 05-APR-2021 for an unspecified indication (Dose number in series 1). No concomitant medications were reported.  On 20-NOV-2021, the patient experienced vaccine breakthrough infection, covid-19 (confirmed covid-19 infection), had symptoms of cough, dyspnoea (shortness of breath), asthenia (weakness) and pyrexia (fever) for 1 week, Dose number in series 1, exposure to severe acute respiratory syndrome coronavirus 2 (Sars-cov-2) and angioplasty (percutaneous transluminal angioplasty). On the same day laboratory data included: SARS-CoV-2 test with positive result which confirmed clinical vaccination failure. On an unspecified date he was hospitalized. The number of days hospitalized was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough, dyspnoea, asthenia, and pyrexia, and the outcome of angioplasty, covid-19, exposure to sars-cov-2, sars-cov-2 test positive, vaccine breakthrough infection and confirmed clinical vaccination failure was not reported.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000207908. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 23-DEC-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V1: Additional information in this version updates: PQC investigations result. This updated information does not alter the causality of previously reported events. 20211241053-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. 20211241053-JANSSEN COVID-19 VACCINE Ad26.COV2.S -Vaccine breakthrough infection, COVID-19, Cough, Dyspnoea, Asthenia, Pyrexia, Angioplasty, Exposure to SARS-CoV-2, SARS-CoV2 test positive. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).