Sex: M
Vaccine: COVID19, FLUX
Symptoms: Atrial fibrillation, Electrocardiogram, Heart rate, Influenza, Pain
Clinical narrative: AFIB; FLU (COUGHING A LITTLE BIT); PAIN; This spontaneous report received from a patient concerned a 71 year old male of unspecified race and ethnicity.  Initial information was processed along with additional information on 30-JAN-2023. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered, start therapy date for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, 1 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. Non-company suspect vaccine included: influenza vaccine (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for an unspecified indication. Concomitant medication included acetylsalicylic acid for drug used for unknown indication. The patient had an apple watch that can do ECG (electrocardiogram) all the time. Apple watch monitored for AFIB (Atrial fibrillation) as well. According to Apple watch, it was very evident when the patient's heartbeat gone twice as fast. After vaccination nothing happened within first 2 weeks. It was couple of months after the vaccine that patient got AFIB (dose number in series 2).  On NOV-2022, treatment medication included: rivaroxaban. The patient had no effect at all from vaccine itself. The patient could not even tell which arm and did not feel anything from Janssen vaccine. It was Apple watch first alerted the patient about atrial fibrillation, ran ECG and AFIB detected. Apple watch and his provider they were telling him (AFIB) went away as well. The patient had the AFIB for 2 to 3 days and had more pain (dose number in series 2) from flu shot. Today the patient had the flu and coughing a little bit (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s and influenza vaccine was not applicable. The patient recovered from afib, and the outcome of flu (coughing a little bit) and pain was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000268838. The suspected product quality complaint has been confirmed to be voided for (90000268838) this report did not meet the definition of a product quality complaint or explicitly allege a potency issue with the Janssen COVID vaccine as there was no indication that the reporter contracted COVID, based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20230158978-Atrial fibrillation. The event(s) 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(s). Therefore, this event(s) is considered unassessable.