Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | UNK | IM |
Atrial Fibrillation; This 83-year-old female subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, unknown deltoid) .5 ml on 07-DEC-2022, for prophylaxis. Concomitant products included heparin sodium (Heparin). On 25-JAN-2023, 49 days after receiving RSVPreF3 vaccine + AS01E, the subject developed severe - grade 3 atrial fibrillation (Verbatim: Atrial Fibrillation). Serious criteria included hospitalization. The subject was treated with atorvastatin calcium (Atorvastatin) and apixaban. The action taken with RSVPreF3 vaccine + AS01E was unknown. The outcome of atrial fibrillation was resolved on 30-JAN-2023. Diagnostic results (reference ranges are provided in parenthesis if available): Computerised tomogram head-In JAN-2023 cerebrovascular accident. Electrocardiogram-In JAN-2023 new onset a-fib. Magnetic resonance imaging head-In JAN-2023 showed cerebrovascular accident. 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. GSK receipt date: 10-MAR-2023. Subject presented to emergency dept on 25Jan2023 following a fall and altered mental state. Subject had left sided weakness and abnormal speech. Cause of stroke likely related to new onset atrial fibrillation. subject discharged home on 30jan2023 with instructions to f/u with neurology and start physical therapy. Follow-up information received on 19-APR-2023 Summary of changes: lab data and blinding Status were updated. Follow-up information received on 22-AUG-2023. SAE was not caused by activities related to study participation other than Study Treatment. Hospitalization Admission Date was 25-Jan-2023. Hospitalization Discharge Date was 31-Jan-2023. Summary of changes: SAE term (From Cerebrovascular accident to Atrial Fibrillation) updated, Narrative updated. Follow-up information received on 08-Nov-2023. Summary of changes: New concomitant medication ATORVASTATIN added. Follow up information received on 15-NOV-2023 Summary of changes: Treatment medication apixaban updated. Follow up information received on 22-NOV-2023 Summary of changes: Concomitant drug heparin , type of drug of Atorvastatin was updated from concomitant to treatment. Follow up information received on 06-Dec-2023. Summary of changes: General narrative updated.; Sender's Comments: A case of atrial fibrillation, 49 days after receiving 1st dose of RSVPreF3 vaccine + AS01E, in an 83-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative etiology (stroke likely related to new onset atrial fibrillation).
Heparin
Test Date: 202301; Test Name: CT of the head; Result Unstructured Data: (Test Result:cerebrovascular accident,Unit:unknown,Normal Low:,Normal High:); Test Date: 202301; Test Name: EKG; Result Unstructured Data: (Test Result:new onset a-fib,Unit:unknown,Normal Low:,Normal High:); Test Date: 202301; Test Name: MRI of the brain; Result Unstructured Data: (Test Result:showed cerebrovascular accident,Unit:unknown,Normal Low:,Normal High:)