Received Sep 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | — | IM |
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | — | IM |
Pneumonia both lower lobes; Atrial fibrillation; This 78-year-old female subject was enrolled in a blinded study. The subject received the 2nd dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 12-SEP-2022, for prophylaxis. Concomitant products included tetrofosmin, zinc chloride (Myoview), simeticone (Simethicone), potassium chloride, sodium chloride, iopamidol (Isovue 370), atorvastatin (Atorvastatine), acetylsalicylic acid (Aspirin) and pantoprazole. On 31-OCT-2022, 49 days after receiving RSVPreF3 vs Placebo, the subject developed severe - grade 3 lower lobe pneumonia (Verbatim: Pneumonia both lower lobes). Serious criteria included hospitalization. Additional event(s) included mild - grade 1 atrial fibrillation (Verbatim: Atrial fibrillation) on 31-OCT-2022 with serious criteria of hospitalization. The subject was treated with ceftriaxone, cefepime, heparin (Heparine), metoprolol succinate, metoprolol tartrate and furosemide (Lasix). The action taken with RSVPreF3 vs Placebo was no change. The outcome of lower lobe pneumonia was resolved on 20-DEC-2022. The outcome(s) of the additional event(s) included atrial fibrillation (resolved on 13-JAN-2023). Relevant Tests: On 02-NOV-2022 Transesophageal Echo (TEE) with possible cardioversion Diagnosis a-fib On 31-OCT-2022 ECG showed Paroxysmal atrial fibrillation with RVR.. Diagnostic results (reference ranges are provided in parenthesis if available): Electrocardiogram- 31-OCT-2022 abnormal. The investigator considered that there was no reasonable possibility that the lower lobe pneumonia and atrial fibrillation may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the lower lobe pneumonia and atrial fibrillation may have been caused by RSVPreF3 vs Placebo. GSK Receipt Date: 04-Nov-2022 Subject went to PCP (Primary care physician )on 10/31/2022 to follow-up on Upper Respiratory Infection, due to PI informing her at ARI (Acute respiratory infection) visit that he heard crackles on Left lung. PCP (Primary care physician) completed EKG (Electrocardiogram) at visit which was abnormal and sent subject straight to hospital where she was admitted from 10/31/22-11/3/22. Subject was diagnosed with Atrial fibrillation Per medical records subject was diagnosed with Pneumonia of both lower lobes due to Streptococcus pneumoniae, atrial fibrillation with rapid ventricular response 10/31/2022 and pleural effusion, bilateral Acute diastolic heart failure 11/3/2022 This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow-up information received on 18-NOV-2022, Summary of change: Investigator text and Lab data updated. Follow-up information received on 09-DEC-2022 Summary of Changes: Outcome of event updated. Follow-up information received on 16-Feb-2023 Summary of Changes: Outcome of event updated. Follow-up information received on 02-MAR-2023. Summary of Changes: Medical history added, lab data added. Follow-up information received on 21-MAR-2023. Summary of Changes: Event term Pneumonia both lower lobes added and narrative updated. Follow-up information received on 03-APR-2023. Summary of changes: Medical history removed Follow-up information received on 23-MAY-2023. The subject received concomitant medication sennosides docusate sodium (8.6-50 mg) at a dose of 1 tablet, Once only, Oral, from 1/Nov/2022 to 1/Nov/2022, for indication Irritable Bowel Syndrome. The subject received treatment medication Diltiazem in NaCl at a dose of 100 mg, CO, from 31/Oct/2022 to 2/Nov/2022, for indication Atrial Fibrillation. Medical indication of ISOVUE 370 was CT Prep. Summary of Changes: Concomitant and treatment medication added. Follow-up information received on 31-MAY-2023. Summary of changes: End date for treatment drug metoprolol tartrate and ceftriaxone updated and route updated for drug Lasix. Upon internal review the case was updated on:01-Dec-2023 The subject received treatment concomitant SODIUM CHLORIDE 0.9% BOLUS for indication Dehydration Prevention with start date and stop date 31-OCT-2022 at dose 1797 ml Frequency single ROA Intravenous. The subject received treatment medication Heparin bolus for indication Atrial fibrillation with start date and stop date 31-OCT-2022 at dose 3708 ml Frequency single ROA Intravenous. Summary of changes: AESI and narrative updated. Follow-up information received on 02-Jul-2024 Summary of changes: The SAE Pneumonia both lower lobes LLT updated to as Lower lobe pneumonia from Lobar pneumonia. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of pneumonia and atrial fibrillation, 49 days after receiving 2nd dose of RSVPreF3 in a 78-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and absence of biological plausibility.
Myoview; SIMETHICONE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; ISOVUE 370; ATORVASTATINE; ASPIRIN; PANTOPRAZOLE
Test Date: 20221031; Test Name: EKG; Result Unstructured Data: (Test Result:abnormal,Unit:unknown,Normal Low:,Normal High:); Comments: On 02-NOV-2022 Transesophageal Echo (TEE) with possible cardioversion Diagnosis a-fib On 31-OCT-2022 ECG showed Paroxysmal atrial fibrillation with RVR.