Received Jun 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | UNK | IM / LA |
Atrial Fibrilation; This 75-year-old male subject was enrolled in an open label study titled A phase 3b, randomized, open label, multi-country,multi-center, extension and crossover vaccination study to evaluate the immunogenicity and safety of different revaccination schedules and persistence of a single dose of the RSVPreF3 OA vaccine in adults aged 60 years and above who participated in the RSV [withheld] study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, left deltoid) 120 µg on 02-AUG-2024, for Prophylaxis. Previously administered products included PFIZER BIONTECH COVID-19 VACCINE (Subject received first dose on 04-MAR-2021, second dose on 27-SEP-2021, third dose on 25-MAR-2021 and forth dose on 24-OCT-2022 via intramuscular.), Influenza Vaccine (Subject received first dose on ??-OCT-2020, second dose on 24-OCT-2023 and third dose on 21-NOV-2023 via intramuscular.) and Shringrix (Zoster) (Subject received first dose on ??-???-2019 and second dose on ??-MAY-2021 via intramuscular.). Concomitant products included alprazolam, ramipril (Altace), zolpidem tartrate (Ambien), amoxicillin, docusate sodium (Colace), apixaban (Eliquis), chondroitin sulfate sodium;glucosamine hydrochloride (Cidaflex), levothyroxine, atorvastatin calcium (Lipitor) and tadalafil (Adcirca). On 07-AUG-2024, 5 days after receiving RSVPreF3 vaccine + AS01E, the subject developed severe - grade 3 atrial fibrillation (Verbatim: Atrial Fibrilation). Serious criteria included clinically significant/intervention required. The outcome of atrial fibrillation was resolved on 21-AUG-2024. Diagnostic results (reference ranges are provided in parenthesis if available): Cardiac monitoring- show subject was in sinus rhythm. Cardiac stress test- AFib. Electrocardiogram- AFib. 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: US2024110202 Additional Information: GSK receipt date: 03-JUN-2026 Subject was seen by his Primary Care Physician (PCP) prior to this event, who said subject was a bit concerned with his heart rate and thought that he may be in atrial fibrillation (Afib) again. Subject went in to see his Cardiologist. Subject stated that he was not having any symptoms prior and was very surprised. A Cardiac Ablation was completed on 21-AUG-2024. This procedure was successful This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). The event was exacerbation of existing Disease The Date event became serious: 07-AUG-2024; Sender's Comments: A case of Atrial fibrillation, 5 days after receiving 1st dose of RSVPreF3 vaccine + AS01E in a 75-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering alternative risk factors (concomitant ramipril, tadalafil and levothyroxine and age).
ALPRAZOLAM; ALTACE; AMBIEN; AMOXICILLIN; COLACE; ELIQUIS; CIDAFLEX; LEVOTHYROXINE; LIPITOR; ADCIRCA
Test Name: cardiac monitoring; Result Unstructured Data: (Test Result:show subject was in sinus rhythm,Unit:unknown,Normal Low:,Normal High:); Test Name: stress test; Result Unstructured Data: (Test Result:AFib,Unit:unknown,Normal Low:,Normal High:); Test Name: EKG; Result Unstructured Data: (Test Result:AFib,Unit:unknown,Normal Low:,Normal High:)