Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | — | IM |
Worsening of A-Fib; This 62-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 09-SEP-2021, for prophylaxis. Concurrent medical conditions included hypertension and atrial fibrillation. On 09-SEP-2021, less than a day after receiving RSVPreF3 vs Placebo, the subject developed moderate - grade 2 atrial fibrillation aggravated (Verbatim: Worsening of A-Fib). Serious criteria included hospitalization. The action taken with RSVPreF3 vs Placebo was no change. The outcome of atrial fibrillation aggravated was resolved on 11-SEP-2021. The investigator considered that there was no reasonable possibility that the atrial fibrillation aggravated may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the atrial fibrillation aggravated may have been caused by RSVPreF3 vs Placebo. GSK Receipt Date : 08-OCT-2021 Subject reported at Visit 2 that they were hospitalized for an A-Fib episode and monitored for 2 days. They stated that no meds were given. States the E is now resolved as of 11SEP2021. AE was reported to site staff on 07OCT2021. Medical records were requested. Patient also experienced the following AEs. Leukocytosis, contact dermatitis , Transaminitis ,Fatty liver. Patient has a history of atrial fibrillation, hypertension. Patient has a Holter monitor and was called to ED after an arrhythmia was noted and found to be in Afib. Admit Date: 10SEP2021 Discharge Date: 11SEP2021 This case contains an event assessed by the investigator as a adverse event of special interest (AESI) Follow up information received on 27-APR-2023. Summary of changes: Action taken and narrative updated. Follow up information received on 08-Jun-2023. Summary of changes: Medical history (atrial fibrillation and hypertension) added. Follow up information received on 15-Jun-2023. Summary of changes: Hospitalization details updated Follow up information received on 19-JUN-2023. Summary of changes: Event term changed from A-Fib Epipode to worsening of A-Fib. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of Atrial fibrillation aggravated less than a day after receiving 1st dose of RSVPreF3 vs Placebo in a 62-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering alternative etiology (atrial fibrillation and hypertension as risk factors) based on medical history.
Atrial fibrillation; Hypertension