Received Sep 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 2 | UNK | IM |
Atrial Fibrillation; This 82-year-old female subject was enrolled in an open label study titled A phase 3, randomized, open-label, multi-country study to evaluate the immunogenicity, safety, reactogenicity and persistence of a single dose of the RSVPreF3 OA investigational vaccine and different revaccination schedules in adults aged 60 years and above. The subject received the 2nd dose of RSVPreF3 vaccine + AS01E (intramuscular, unknown deltoid) .5 ml on 05-APR-2023, for prophylaxis. The subject's past medical history included pulmonary embolism. Concurrent medical conditions included alcohol use (twice weekly), hypothyroidism, chronic kidney disease stage 3, peripheral vascular disease, obesity and hypertension. On 01-AUG-2024, 484 days after receiving RSVPreF3 vaccine + AS01E, the subject developed moderate - grade 2 atrial fibrillation (Verbatim: Atrial Fibrillation). Serious criteria included clinically significant/intervention required. The subject was treated with amlodipine. The outcome of atrial fibrillation was resolved on 01-AUG-2024. The investigator considered that there was no 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. Linked case(s) involving the same subject: US2021107290, US2022GSK148516, US2024125639, US2024125641 GSK Receipt Date: 11-OCT-2024 On 01 AUG 2024 at Cardiologist appointment Doctor stated subject was in Atrial Fibrillation. Subject received prescription and cardiac catheterization was scheduled, which was pending. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow-up information received on 22-Oct-2024 Summary of changes: Past medical history and concurrent medical conditions added.; Sender's Comments: A case of Atrial fibrillation, 484 days after receiving 2nd dose of RSVPreF3 vaccine + AS01E in a 82-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factor (Age, past medical history included pulmonary embolism, chronic kidney disease stage 3, peripheral vascular disease, obesity and hypertension). US-GSK-US2024125639: US-GSK-US2024125641:
Alcohol use (twice weekly); Chronic kidney disease stage 3; Hypertension; Hypothyroidism; Obesity; Peripheral vascular disease
Medical History/Concurrent Conditions: Pulmonary embolism