Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | — | IM |
Paroxysmal Atrial Fibrillation; Aspiration Pneumonia; This 76-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 28-SEP-2021, for prophylaxis. The subject's past medical history included tobacco abuse. On 28-NOV-2021, 61 days after receiving RSVPreF3 vs Placebo, the subject developed moderate - grade 2 paroxysmal atrial fibrillation (Verbatim: Paroxysmal Atrial Fibrillation). Serious criteria included hospitalization. Additional event(s) included moderate - grade 2 aspiration pneumonia (Verbatim: Aspiration Pneumonia) on 28-NOV-2021 with serious criteria of hospitalization. The subject was treated with metoprolol succinate and apixaban (Eliquis). The action taken with RSVPreF3 vs Placebo was no change. The outcome of paroxysmal atrial fibrillation was resolved with sequelae on 01-DEC-2021. The outcome(s) of the additional event(s) included aspiration pneumonia (resolved on 01-DEC-2021). Relevant Tests: On 29-Nov-2021 CT chest w/o contrast RLL/RUL PNA On 29-Nov-2021 CT Brain Neg result On 28-Nov-2021 CT neck w/ contrast On 28-Nov-2021 CT Brain w/ contrast Quest perfusion (L) Cerebellum On 29 and 30-Nov-2023 MRI Brain w/w/o contrast showed Negative result G.I swallow x-ray negative result.. The investigator considered that there was no reasonable possibility that the paroxysmal atrial fibrillation and aspiration pneumonia may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the paroxysmal atrial fibrillation and aspiration pneumonia may have been caused by RSVPreF3 vs Placebo. Linked case(s) involving the same subject: US2022033223, US2023004717 Additional Information: GSK Receipt Date: 12-APR-2022, 21-APR-2022. This follow-up was considered significant. Site was conducting safety call and asked subject start date of medication Eliquis ( blood clot preventative) and reply was DEC2021and subject reported SAE of Aspiration Pneumonia associated with blood clots that occurred around 10DEc2021. Subject was unsure of how many days he stayed admitted. Site requested for medical records and will update SAE upon receipt of records. Thank you. Med records reviewed on 01APR2022. Dates of admission updated. Subject had slurred speech in ER - admitted for neuro work up - negative. Subject had aspiration PNA - cleared by pulm - D/C on antibiotics. Also had new onset of paroxysmal A-Fib - started on Eliquis. D/C home in good condition. subject was admitted on 28NOV2021 and was discharged 01DEC2021 per records. Follow-up information received on 06-May-2022, 09-May-2022, 10-May-2022, 13-May-2022. This follow-up was considered significant. Summary of changes: The SAE Aspiration Pneumonia with associated blood clot start date and stop date updated. Laboratory data, concomitant medication and Investigator text updated. Follow-up information received on 27-May-2022. This follow-up was considered -significant Summary of Changes: SAE term updated to Aspiration Pneumonia from Aspiration Pneumonia with associated blood clot. Lab data updated. Follow-up information received on 30-Jun-2022. This follow-up was considered significant. Summary of changes: Lab data added, Investigator text updated, Treatment medication updated. Follow-up information received on 24-apr-2023. Summary of changes: action taken updated. Follow-up information received on 01-MAY-2023. Sumary of changes: Product Metoprolol Succinate updated as treatment medication. Follow up information received on 16-May-2023. Summary of changes: Event paroxysmal atrial fibrillation added. Follow up information received on 03-NOV-2023. Summary of changes: The relevant medical history were updated. Upon internal review the case was updated on: 03-DEC-2023 This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Summary of changes: AESI Sentence updated. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of atrial fibrillation and pneumonia aspiration, 61 days after receiving 1st dose of RSVPreF3 in a 76-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factors (multiple chronic comorbidities; small cell lung cancer with brain metastasis, diagnosed later, as given in linked cases). US-GLAXOSMITHKLINE-US2022033223: US-GSK-US2023004717: US-GSK-US2022033223:
Medical History/Concurrent Conditions: Tobacco abuse
Comments: On 29-Nov-2021 CT chest w/o contrast RLL/RUL PNA On 29-Nov-2021 CT Brain Neg result On 28-Nov-2021 CT neck w/ contrast On 28-Nov-2021 CT Brain w/ contrast Quest perfusion (L) Cerebellum On 29 and 30-Nov-2023 MRI Brain w/w/o contrast showed Negative result G.I swallow x-ray negative result.