Received Sep 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | UNK | IM / LA |
Atrial Fibrillation; This 84-year-old female subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular use, left deltoid) 120 µg on 03-SEP-2024, for prophylaxis. Previously administered products included Influenza vaccine (The subject received first dose of Influenza vaccine on 01-Oct-2023 via intramuscular route for prophylaxis) and Shingrix Vaccine (The subject received first dose of Shingrix Vaccine on 20-Jun-2022 and second dose on 11-Nov-2022 via intramuscular route for prophylaxis). Concurrent medical conditions included hypertension and chronic obstructive pulmonary disease (moderate). Concomitant products included metoprolol, amlodipine, alprazolam, salbutamol (Albuterol), carmellose sodium (Theratears), ibuprofen, paracetamol (Acetaminophen), acetylsalicylic acid (Aspirin), fluticasone furoate;umeclidinium bromide;vilanterol trifenatate (Trelegy Ellipta) and fluoxetine. On 12-FEB-2025, 162 days after receiving RSVPreF3 vaccine + AS01E, the subject developed moderate - grade 2 atrial fibrillation (Verbatim: Atrial Fibrillation). Serious criteria included hospitalization. The subject was treated with flecainide acetate (Tambocor). The outcome of atrial fibrillation was resolved on 14-FEB-2025. The investigator considered that there was a reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vaccine + AS01E. GSK Receipt date: 13-Mar-2025 Subject was admitted to hospital and diagnosed with Atrial Fibrillation on 12-FEB-2025. Subject was discharged home on 14-FEB-2025. Site was awaiting hospital records for details. 28-MAR-2025, site continued to await medical records, per PI (principal investigator) discretion AF (Atrial Fibrillation) would be considered related to investigational product until records determine that is not true. No updates as of 21-Apr-2025. Participant was a former smoker. Participant was taking Metoprolol but Rx for hypertension, participant did not receive rhythm or rate-control medication prior to event onset, Participant did not received any anticoagulation medication prior to event onset. SAE was related to study treatment RSVPreF3 OA Vaccine. SAE was not related to Study Participation Activities other than Study Treatment This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). This was a new disease and not the exacerbation of an existing disease. Date event became serious: 12-FEB-2025 The subject received Vitamin D from 2013 to ongoing at a dose of 2000 iu, qd, orally for osteoporosis Follow-up information received on 13-MAR-2025 Summary of changes: Type of drug from concomitant to treatment for Tambocor were updated. Upon internal review case was updated on 25-MAR-2025. The event was upgraded from non-serious to serious with seriousness criteria hospitalization, events causality was upgraded from no to yes, hospitalization dates, general narrative comments were updated. Follow up information received on 28-MAR-2025 Summary of changes: General narrative comment updated. Follow up information received on 03-APR-2025 Summary of changes: Concurrent medical conditions hypertension and chronic obstructive pulmonary disease were updated. Follow up information received on 21-APR-2025 Summary of changes: General narrative comment updated. Follow up information received on 09-MAY-2025 Summary of changes : Concomitant medication Fluoxetine was added.General narrative was updated. Follow up information received on 20-Jun-2025 Summary of changes: General narrative comment updated. Follow up information received on 27-Jun-2025 Summary of changes: General narrative comment updated.; Sender's Comments: It is reported as a case of atrial fibrillation, 162 days after receiving 1st dose of RSVPreF3 vaccine + AS01E in a 84-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, age, and concurrent medical conditions hypertension as an alternative risk factor.
Chronic obstructive pulmonary disease (moderate); Hypertension
METOPROLOL; AMLODIPINE; ALPRAZOLAM; ALBUTEROL; THERATEARS; IBUPROFEN; ACETAMINOPHEN; ASPIRIN; TRELEGY ELLIPTA; FLUOXETINE