Received Feb 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (JANSSEN)) | JANSSEN | UNK | — | — |
atrial fibrillation; This spontaneous report received from a patient concerned a male patient of unspecified age. The patient's height and weight were not reported. Age at time of vaccination was unknown. No past medical history, concurrent conditions or pre-existing medical conditions were reported. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced atrial fibrillation. (dose series 1) The action taken with janssen covid-19 vaccine was not applicable. The outcome of atrial fibrillation was not reported. The reporter considered the causality between janssen covid-19 vaccine and atrial fibrillation as related. Company causality between janssen covid-19 vaccine and atrial fibrillation as possible. This report was serious (other medically important condition).; Sender's Comments: V0; Atrial fibrillation; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.