Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | — | IM |
atrial Flutter; This 72-year-old female subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular) on 8th July 2021, for prophylaxis. On 8th March 2022, 243 days after receiving RSVPreF3 vs Placebo, the subject developed severe - grade 3 atrial flutter. Serious criteria included hospitalization. The outcome of atrial flutter was not recovered/not resolved. The investigator considered that there was no reasonable possibility that the atrial flutter may have been caused by RSVPreF3 vs Placebo. Investigator text: Subject was admitted to the hospital 08 March 2022-20 March 2022 with aflutter. She was eventually found to have Rhinovirus/Enterovirus pneumonia. She had symptoms of dyspnea, cough, wheezing, fever, and hypoxia. At that time, she was noted to be in Atrial Flutter. She was discharged on Eliquis for this. The study participant could not afford Eliquis at discharge and the cardiologist's office (per participant's report) would not call her back about this issue. So she had been without anticoagulation for this condition and is in the process of finding a new cardiologist to manage this. She also had been symptomatic with heart palpitations, so this condition appears to be ongoing. She was withdrawn from the study for this condition as, in my opinion as the PI, it was an unstable chronic illness. GSK Receipt Date : 26SEP2022 Follow-up information received on 29-Sep-2022. This follow-up was considered significant. Summary of changes: Event onset date and Investigator text , hospitalization start and end date and also time to onset for the event Atrial flutter was updated Follow-up information received on 29-Sep-2022. This follow-up was considered significant. Case update: The study ID has been updated. Follow-up information received on 18 Oct 2022 Summary of Changes: narrative updated. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of Atrial flutter, 243 days after receiving 1st dose of RSVPreF3 , in a 72-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility.