Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | 623732 | IM |
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | 126616 | IM |
Atrial fibrillation with fast ventricular response; This 67-year-old female subject was enrolled in a blinded study. The subject received the 2nd dose of RSVPreF3 vs Placebo (intramuscular, unknown deltoid) on 13-OCT-2022, for prophylaxis. Concurrent medical conditions included hypertension, atrial fibrillation, obesity and hypercholesterolemia. Concomitant products included ezetimibe, apixaban (Eliquis), amlodipine, lisinopril, sotalol and rosuvastatin. On 12-JAN-2023, 91 days after receiving RSVPreF3 vs Placebo the subject developed moderate - grade 2 atrial fibrillation with rapid ventricular response (Verbatim: Atrial fibrillation with fast ventricular response). Serious criteria included hospitalization. The subject was treated with sotalol, sucralfate (Carafate), metoprolol and sodium chloride (Normal Saline). The outcome of atrial fibrillation with rapid ventricular response was resolved on 19-JAN-2023. Relevant Tests: On 19JAN2023 showed EKG showed Atrial fibrillation with rapid ventricular response, 117, nonspecific ST/T wave abnormalities. On 19JAN2023 LABS TSH was 1.41uIU/mL (0.35-4.94) On 19JAN2023 CXR showed Negative. Cardiac device in Left pectoral with leads through the Right atrium and ventricle. No airspace consolidation. Prior tests mentioned: On Unknown Date In MAY22 echocardiogram showed normal L ventricular size and EF:55-59 percent, mildly increased LV wall thickness, mild MR/TR. On Unknown date In APR22 Lexi scan stress test showed normal myocardial SPECT perfusion with no scintigraphic evidence of ischemia. Negative pharmacological stress test by EKG criteria. On an UNK-JAN-2023 BP showed 126/88 and 115/80. On an UNK-JAN-2023 HR showed 74 and 111. On an UNK-JAN-2023 O2sat showed 96 percent. On JAN2023, EKG and found with heart rate in 120s so referred to ER. On Unk-Jan-2023, She went to her PCP(primary care physician) who did an EKG and found with heart rate in 120s so referred to ER(emergency room). In ER(emergency room), she had an EKG that showed Atrial fibrillation with Fast ventricular response 117, but as per cardiology consult notes it spontaneously converted to sinus and paced rhythm at 60bpm (per Discharge). On Unk-May-2022 she had ECHO(echocardiogram) that showed normal L ventricular size and EF(ejection fraction). On Unk-Apr-2022 had a L Exiscan stress test, result was normal myocardial SPECT perfusion. Troponin as above were negative x 2.. Diagnostic results (reference ranges are provided in parenthesis if available): Blood chloride- 19-JAN-2023 110 mmol/L, (98.00-107.00). Blood creatinine- 19-JAN-2023 0.78 mg/dL, (0.60-1.10). Blood magnesium- 19-JAN-2023 2.0 mg/dL, (1.60-2.60). Blood pressure measurement- 19-JAN-2023 fluctuating. Haemoglobin- 19-JAN-2023 12.5 g/dL, (11.40-14.70). Heart rate- 19-JAN-2023 elevated. Troponin- 19-JAN-2023 less than 4 ng/L, (0.00-14.00). 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. GSK Receipt Date: 30-JAN-2023 Virtual surveillance call informed "Went to hospital for tachycardia, stayed overnight for observation. No meds prescribed, she needs to follow up with cardiologist'. Update, 02FEB2023- she said saw PCP(primary care physician) who found her with some tachycardia, contacted cardiology and sent her to the hospital for further evaluation of heart rate. Normotensive. Further info to be added when get Medical Records. Update, 04APR2023- obtained Medical records today. She was admitted from 19JAN2023 and discharged 20JAN2023. She presented with a chief complaint of palpitations with hx (history) of intermittent elevated heart rate and fluctuating Blood pressure readings in the week before admission (not reported on call 16JAN2023). Cardiology evaluated subject and indicated hx of atrial fibrillation ablation approx 17yrs ago and on med management but had pacemaker placed on 19JUN2022. They cleared subject for discharge on Metoprolol if needed. Follow-up information received on 02-Feb-2023. Summary of changes: SAE onset date, end date, TTO and investigator text updated. Follow-up information received on 03-APR-2023, 04-APR-2023. Summary of changes: Event term updated from tachycardia to Atrial fibrillation with fast ventricular response, start date of event, Lab data, Current condition, Treatment drugs, End date of event and Narrative updated. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow-up information received on 17-Apr-2023. Summary of changes: Treatment medication added. Follow-up information received on 24-Apr-2023. Summary of changes: Aspirin deleted, Carafate updated from treatment to concomitant and action taken updated. Follow-up information received on 17-Aug-2023. Summary of changes: No new information. Follow-up information received on 25-SEP-2023. Summary of changes: Dose details for Metoprolol updated. Follow-up information received on 28-SEP-2023 and 02-OCT-2023. Summary of changes: SAE start date, TTO updated and concomitant medication Carafate changed to treatment. Follow-up information received on 04-OCT-2023. Summary of changes: Event outcome date updated. Follow-up information received on 25-OCT-2023. Summary of changes: concomitant, treatment drugs added, general narrative updated. Follow-up information received on 02-Nov-2023. Summary of changes: Medical history and concomitant product updated. Follow-up information received on 13-NOV-2023. Summary of changes: End date removed for concomitant medication Ezetimibe, Eliquis. Follow-up information received on 01Dec2023. Summary of changes: For concomitant medication Ezetimibe continue at the end of study updated as yes Follow-up information received on 18Dec2023. Summary of changes: action taken updated from no change to not applicable Follow-up information received on: 14-May-2024 Summary of changes: Medications Amlodipine; Rosuvastatin and metoprolol end date updated as Continuing at the end of the study. Follow up information received on 06-Jun-2024. Summary of changes: Unit of treatment medication Sotalol updated from tablet to mg Follow up information received on 04-JUL-2024 End of study Unblinding completed.; Sender's Comments: A case of Atrial fibrillation, 502 days after receiving 1st dose of RSVPreF3 in a 67-year-old female subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternate risk factor (previous known atrial fibrillation) based on clinical history.
Atrial fibrillation; Hypercholesterolemia; Hypertension; Obesity
EZETIMIBE; ELIQUIS; Amlodipine; Lisinopril; Sotalol; Rosuvastatin
Test Date: 20230119; Test Name: Chloride; Result Unstructured Data: (Test Result:110,Unit:mmol/L,Normal Low:98.00,Normal High:107.00); Test Date: 20230119; Test Name: Creatinine; Test Result: 0.78 mg/dl; Test Date: 20230119; Test Name: Magnesium; Test Result: 2.0 mg/dl; Test Date: 20230119; Test Name: Blood pressure; Result Unstructured Data: (Test Result:fluctuating,Unit:unknown,Normal Low:,Normal High:); Test Date: 20230119; Test Name: Hemoglobin; Result Unstructured Data: (Test Result:12.5,Unit:g/dL,Normal Low:11.40,Normal High:14.70); Test Date: 20230119; Test Name: heart rate; Result Unstructured Data: (Test Result:elevated,Unit:unknown,Normal Low:,Normal High:); Test Date: 20230119; Test Name: Troponin; Result Unstructured Data: (Test Result:less than 4,Unit:ng/L,Normal Low:0.00,Normal High:14.00); Comments: On 19JAN2023 showed EKG showed Atrial fibrillation with rapid ventricular response, 117, nonspecific ST/T wave abnormalities. On 19JAN2023 LABS TSH was 1.41uIU/mL (0.35-4.94) On 19JAN2023 CXR showed Negative. Cardiac device in Left pectoral with leads through the Right atrium and ventricle. No airspace consolidation. Prior tests mentioned: On Unknown Date In MAY22 echocardiogram showed normal L ventricular size and EF:55-59 percent, mildly increased LV wall thickness, mild MR/TR. On Unknown date In APR22 Lexi scan stress test showed normal myocardial SPECT perfusion with no scintigraphic evidence of ischemia. Negative pharmacological stress test by EKG criteria. On an UNK-JAN-2023 BP showed 126/88 and 115/80. On an UNK-JAN-2023 HR showed 74 and 111. On an UNK-JAN-2023 O2sat showed 96 percent. On JAN2023, EKG and found with heart rate in 120s so referred to ER. On Unk-Jan-2023, She went to her PCP(primary care physician) who did an EKG and found with heart rate in 120s so referred to ER(emergency room). In ER(emergency room), she had an EKG that showed Atrial fibrillation with Fast ventricular response 117, but as per cardiology consult notes it spontaneously converted to sinus and paced rhythm at 60bpm (per Discharge). On Unk-May-2022 she had ECHO(echocardiogram) that showed normal L ventricular size and EF(ejection fraction). On Unk-Apr-2022 had a L Exiscan stress test, result was normal myocardial SPECT perfusion. Troponin as above were negative x 2.