Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | — | IM |
Atrial Fibrillation; This 73-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 04-NOV-2021, for prophylaxis. The subject's past medical history included coronary stent placement. Concurrent medical conditions included coronary artery disease and hypertension. Concomitant products included irbesartan and amlodipine. On 13-JAN-2022 06:31, 70 days after receiving RSVPreF3 vs Placebo, the subject developed severe - grade 3 atrial fibrillation (Verbatim: Atrial Fibrillation). Serious criteria included hospitalization. The subject was treated with calcium chloride;potassium chloride;sodium lactate (Lactated Ringers), diphenhydramine and diltiazem. The action taken with RSVPreF3 vs Placebo was no change. The outcome of atrial fibrillation was resolved on 22-APR-2022 11:21. Relevant Tests: On 13-JAN-2021 Ekg (electrocardiogram) confirmed Atrial Fibrillation in the ER (Emergency Room). On UNK-JAN-2022 Echocardiogram shows the following abnormal findings, left atrium mildly dilated, mild to moderate aortic valve regurgitation, mild tricupsid valve regurgitation. Diagnostic results (reference ranges are provided in parenthesis if available): Blood pressure measurement-In JAN-2022 148/83. Body temperature-In JAN-2022 97.5. Cardiac stress test-In AUG-2022 Not provided. Heart rate-In JAN-2022 116. Respiratory rate-In JAN-2022 15. The investigator considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the atrial fibrillation may have been caused by RSVPreF3 vs Placebo. Linked case(s) involving the same subject: US2022135753 GSK Receipt Date: 14-JAN-2022. 13Jan2022, subject underwent a colonoscopy/polypectomy. During procedure it was noted that the subject had become hypotensive. Subject was admitted to the hospital for hypotension and was found to be in Atrial Fibrillation. Subject had complained of feeling light headed the night prior but thought it was from the colonoscopy prep. Subject had not been started on anticoagulation currently, due to his history of severe epistaxis. Subject currently still admitted to the hospital awaiting plan of care. Subject had a history of coronary artery disease but not atrial fibrillation. Subject was discharged from the hospital on 15Jan2022. This event was documented and assessed by PI as a AESI. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow-up information received on 28-SEP-2022. This follow-up was considered significant. Summary of changes: SAE outcome updated. SAE end date added. Follow-up information received on 03-Oct-2022. This follow-up was considered significant. Summary of changes: Other relevant history updated. Follow-up information received on 27-APR-2023 Summary of changes: Action taken updated. Follow-up information received on 24-OCT-2023 Summary of changes: Relevant medical condition updated. Follow-up information received on 30-OCT-2023 Summary of changes: Concurrent and past medical condition start date, lab result, past medical condition (coronary stents) were updated. Follow-up information received on 2-Nov-2023 Summary of changes: Start date of historical condition updated as hypertension Follow-up information received on 13-NOV-2023 Summary of changes: Concomitant products Irbesartan, Amlodipine were updated. Follow-up information received on 27-NOV-2023. The medication name reported as "IV diltiazem". Summary of changes: Narrative was updated. Follow-up information received on 21-MAY-2024, 28-MAY-2024. Summary of changes: Start date and ongoing check updated for concomitant product IRBESARTAN. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of Atrial fibrillation, 70 days after receiving the 1st dose of RSVPreF3, in a 73-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factors (concurrent hypertension and coronary artery disease). US-GSK-US2022135753:
Coronary artery disease; Hypertension
Medical History/Concurrent Conditions: Coronary stent placement
IRBESARTAN; AMLODIPINE
Test Date: 202201; Test Name: BP; Result Unstructured Data: (Test Result:148/83,Unit:unknown,Normal Low:,Normal High:); Test Date: 202201; Test Name: Temp; Result Unstructured Data: (Test Result:97.5,Unit:unknown,Normal Low:,Normal High:); Test Date: 202208; Test Name: stress test; Result Unstructured Data: (Test Result:Not provided,Unit:unknown,Normal Low:,Normal High:); Test Date: 202201; Test Name: Heart Rate; Result Unstructured Data: (Test Result:116,Unit:unknown,Normal Low:,Normal High:); Test Date: 202201; Test Name: Resp; Result Unstructured Data: (Test Result:15,Unit:unknown,Normal Low:,Normal High:); Comments: On 13-JAN-2021 Ekg (electrocardiogram) confirmed Atrial Fibrillation in the ER (Emergency Room). On UNK-JAN-2022 Echocardiogram shows the following abnormal findings, left atrium mildly dilated, mild to moderate aortic valve regurgitation, mild tricupsid valve regurgitation