Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | — | IM |
Atrial Fibrillation; COVID 19; This 80-year-old male subject was enrolled in a blinded study. The subject received the 1st dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 11-OCT-2021, for prophylaxis. The subject's past medical history included sleep apnea. Concurrent medical conditions included dyslipidemia, type ii diabetes mellitus and blood pressure high. Concomitant products included clopidogrel, rosuvastatin, acetylsalicylic acid (Bayer Aspirin), metoprolol, metformin, dextromethorphan hydrobromide;guaifenesin;paracetamol;pseudoephedrine hydrochloride (Dayquil) and losartan. On 19-OCT-2021, 8 days after receiving RSVPreF3 vs Placebo, the subject developed severe - grade 3 covid-19 (Verbatim: COVID 19). Serious criteria included hospitalization. Additional event(s) included moderate - grade 2 atrial fibrillation (Verbatim: Atrial Fibrillation) on 23-OCT-2021 with serious criteria of hospitalization. The action taken with RSVPreF3 vs Placebo was no change. The outcome of covid-19 was resolved with sequelae on 05-DEC-2021. The outcome(s) of the additional event(s) included atrial fibrillation (resolved on 05-DEC-2021). Relevant Tests: On 23-OCT-2021 X-ray chest showed Covid-19 infection and Acute respiratory failure. On 23-OCT-2021 Echo showed Atrial fibrillation new onset On an unknown date in Oct-2021, Covid-19 test showed Positive. The investigator considered that there was no reasonable possibility that the covid-19 and atrial fibrillation may have been caused by RSVPreF3 vs Placebo. The company considered that there was no reasonable possibility that the covid-19 and atrial fibrillation may have been caused by RSVPreF3 vs Placebo. GSK receipt date:17-FEB-2022 Medical records Admitted on 23OCT2021 Discharged on 25OCT2021 Agency was no longer on site and subject was not seen in the clinic for this ARI Addition information: subject had underlying condition of hypertension (high blood pressure), sleep apnea and type 2 diabetes which are potential risk factors for atrial fibrillation. Medications for these are added to medication line. Per query, dyslipidemia also considered a risk factor Cough and fatigue were lingering sequelae symptoms of covid-19 that were reported as complications. They are updated in database. The case was diagnosed positive for COVID-19. The subject had unknown history of travel to or residence in a location reporting community transmission of COVID-19 disease during the 14 days prior to symptom onset. The subject visit any health care facility in the 14 days prior to symptom onset was unknown. The concomitant medications was taken by the subject, including experimental medications, to treat COVID-19. The subject had a Cough, Shortness of breath, Sore throat, Loss of appetite, Fatigue The subject had fever, Nausea, Vomiting, Diarrhea, Abdominal pain, Loss of smell, Loss of taste was unknown. The subject was not asymptomatic. The subject was not contact with a confirmed or probable case in the 14 days prior to symptom onset was unknown. The subject was in home quarantine or isolation was unknown. Follow-up information received on 11-APR-2022. This follow-up was considered significant Summary of Changes: Lab data updated, Investigator text updated Follow-up information received on 11-APR-2022 This follow-up was considered non significant Summary of Changes: No new significant information was received. Follow-up information received on 23-DEC-2022. Summary of changes: The additional event were added. Follow-up information was received on 18-Jan-2023 Summary of changes: Action taken of study vaccine updated, event start date of atrial fibrillation updated, Narrative updated. Follow-up information was received on 20-Jan-2023 Summary of changes: Onset date of Atrial Fibrillation updated, narrative updated. Follow-up information was received on 28-APR-2023 Summary of changes: Outcome with end date of event term Atrial Fibrillation and action taken was updated. Follow-up information was received on 03-NOV-2023, 08-NOV-2023 and 10-NOV-2023 On 10-NOV-2023 the case US2022GSK030666 was identified as duplicate case of US2022033440. All the future correspondence will be added to US2022033440. Summary of changes: Concomitant drugs Metoprolol ER, Metformin, Dayquil/Nyquil, Losartan, relevant test updated, merging performed and general narrative comments were updated. Follow-up information was received on14-NOV-2023 and 17-NOV-2023 This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). The Concomitant medication reported as Dayquil/Nyquil and Metoprolol ER Summary of changes : The outcome Recovered/Resolved with sequelae changed to Recovered/Resolved for COVID 19 and Concurrent medical conditions dyslipidemia and Concomitant medication bayer aspirin added, general narrative comments were updated. Follow-up information was received on 27-NOV-2023 The medication name reported as Metoprolol ER, Dayquil/nyquil Summary of changes: concurrent and medical condition was updated. Follow-up information was received on 13-Dec-2023 Summary of changes: Outcome of COVID-19 updated from Recovered/Resolved to Resolved with Sequelae and narrative updated. Follow up information received on 04-Jul-2024 End of study Unblinding completed.; Sender's Comments: A case of COVID-19 and atrial fibrillation, 8 days after receiving the 1st dose of RSVPreF3 , in a 80-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering alternative risk factor (h/o hypertension, dyslipidemia, sleep apnea and type 2 diabetes) based on medical history.
Blood pressure high; Dyslipidemia; Type II diabetes mellitus
Medical History/Concurrent Conditions: Sleep apnea
Clopidogrel; Rosuvastatin; BAYER ASPIRIN; Metoprolol; Metformin; DAYQUIL; Losartan
Comments: On 23-OCT-2021 X-ray chest showed Covid-19 infection and Acute respiratory failure. On 23-OCT-2021 Echo showed Atrial fibrillation new onset On an unknown date in Oct-2021, Covid-19 test showed Positive.