Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | — | IM |
SYMPTOMATIC ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RATE; This 74-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 19-JUL-2021, for prophylaxis. The subject's past medical history included ex-smoker (Previous smoker status). Concurrent medical conditions included thrombosis, congestive heart failure, hypertension and atrial fibrillation. Concomitant products included apixaban (Eliquis), diltiazem and furosemide (Lasix). On 29-DEC-2021, 163 days after receiving RSVPreF3 vs Placebo, the subject developed moderate - grade 2 atrial fibrillation with rapid ventricular response (Verbatim: SYMPTOMATIC ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RATE). Serious criteria included hospitalization. The outcome of atrial fibrillation with rapid ventricular response was resolved on 31-DEC-2021. Diagnostic results (reference ranges are provided in parenthesis if available): Blood sodium- 29-DEC-2021 135 mmol/L, (136.00-146.00). Haematocrit- 29-DEC-2021 45.2 percent, (40.50-52.50). Haemoglobin- 29-DEC-2021 15.1 g/dL, (13.50-17.50). Lymphocyte count- 29-DEC-2021 14.7 percent, (25.00-40.00). Lymphocyte percentage- 29-DEC-2021 14.7 percent, (25.00-40.00). Mean cell haemoglobin- 29-DEC-2021 29.8 pg, (28.00-33.00). Mean cell volume- 29-DEC-2021 89 fL, (83.00-97.00). Neutrophil percentage- 29-DEC-2021 74.6 percent, (50.00-70.00). Red blood cell count- 29-DEC-2021 5.06 million per microlitre, (4.05-5.64). White blood cell count- 29-DEC-2021 7.7 million per microlitre, (5.10-10.80). The investigator considered that there was no reasonable possibility that the atrial fibrillation with rapid ventricular response may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the atrial fibrillation with rapid ventricular response may have been caused by RSVPreF3 vs Placebo. Linked case(s) involving the same subject: US2022040213 GSK receipt date: 05-JAN-2022 The subject informed the agency today during the phone contact that on 28Dec2021 the subject started feeling sick and per PCP recommendation the subject went to the ER. Medical Records were requested today. Any new information regarding the SAE will be provided once available. After review of the medical records received, the subject was admitted to the hospital on 29-DEC-2021 for symptomatic atrial fibrillation and discharged on 31-DEC-2021. Follow-up information received on 28-SEP-2022. This follow-up was considered significant. Summary of Changes: SAE outcome updated Follow-up information received on 07-OCT-2022. This follow-up was considered significant. Summary of Changes: Event outcome updated. Follow-up information received on 12-OCT-2022 Summary of changes: Investigator Text updated, Event term Symptomatic atrial fibrillation with rapid ventricular rate updated, Event outcome date updated, Lab data updated. Follow-up information received on 10-NOV-2023. Summary of changes: Relevant medical condition added. Upon internal review the case was amended on 29-NOV-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, 163 days after receiving 1st dose of RSVPreF3 vaccine, in a 74-year old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, presence of risk factor that may contribute to the exacerbation of the pre-existing medical condition (heart failure), and alternative etiology (known atrial fibrillation) based on medical history. US-GLAXOSMITHKLINE-US2022040213:
Atrial fibrillation; Congestive heart failure; Hypertension; Thrombosis
Medical History/Concurrent Conditions: Ex-smoker (Previous smoker status)
ELIQUIS; Diltiazem; Lasix
Test Date: 20211229; Test Name: Sodium; Result Unstructured Data: (Test Result:135,Unit:mmol/L,Normal Low:136.00,Normal High:146.00); Test Date: 20211229; Test Name: Hematocrit; Test Result: 45.2 %; Test Date: 20211229; Test Name: Hemoglobin; Result Unstructured Data: (Test Result:15.1,Unit:g/dL,Normal Low:13.50,Normal High:17.50); Test Date: 20211229; Test Name: Lymphocytes; Test Result: 14.7 %; Test Date: 20211229; Test Name: Lymphocytes; Test Result: 14.7 %; Test Date: 20211229; Test Name: Mean corpuscular hemoglobin; Test Result: 29.8 pg; Test Date: 20211229; Test Name: Mean corpuscular volume; Test Result: 89 fL; Test Date: 20211229; Test Name: Neutrophils; Test Result: 74.6 %; Test Date: 20211229; Test Name: Red blood cell count; Result Unstructured Data: (Test Result:5.06,Unit:million per microlitre,Normal Low:4.05,Normal High:5.64); Test Date: 20211229; Test Name: White blood cell count; Result Unstructured Data: (Test Result:7.7,Unit:million per microlitre,Normal Low:5.10,Normal High:10.80)