Received Sep 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19-2 | COVID19 (COVID19 (PFIZER-BIONTECH BIVALENT)) | PFIZER\BIONTECH | 1 | UNK | IM / RA |
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | UNK | IM / RA |
Rapid Atrial Flutter; This 69-year-old male subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, right deltoid) 120 µg on 06-JUN-2024, for prophylaxis. The subject received the 1st dose of Comirnaty omicron XBB.1.5 (intramuscular, right deltoid) 30 µg on 06-MAY-2024, for prophylaxis. Concurrent medical conditions included hearing loss unilateral (Right ear), tinnitus, obstructive sleep apnea (Chronic) and alcohol use disorder. Concomitant products included atorvastatin, metoprolol succinate, empagliflozin, rivaroxaban (Xarelto), sacubitril;valsartan (Entresto), spironolactone, furosemide (Lasix), colchicine, apixaban (Eliquis), losartan potassium (Cozaar), valsartan (Diovan), thiamine, folic acid and carvedilol (Coreg). On 10-SEP-2024, 96 days after receiving RSVPreF3 vaccine + AS01E and 127 days after receiving Comirnaty omicron XBB.1.5, the subject developed severe - grade 3 atrial flutter with rapid ventricular response (Verbatim: Rapid Atrial Flutter). Serious criteria included hospitalization. The subject was treated with digoxin. The outcome of atrial flutter with rapid ventricular response was resolved on 14-SEP-2024. Relevant Tests: On 11-SEP-2024 Chest X-Ray Frontal and Lateral Projections showed Lungs: bibasilar airspace opacities, L more than R, increased from prior, Pleural space: small bilateral effusions, mildly increased from prior, Chest Airways: Normal, Heart/Mediastinum: Unchanged On 12-SEP-2024 TEE with Cardioversion showed Dilated hypertrophied LV (left ventricular) w severely reduced LVEF (Left Ventricular Ejection Fraction) (25 percent), global wall motion abnormalities, mild RV (right ventricular) enl/dysfunction, bi-atrial enl, mod mitral regurgitation, mod tricuspid regurgitation.. Diagnostic results (reference ranges are provided in parenthesis if available): Blood iron- 13-SEP-2024 170 ug/litre, (450-1700). Brain natriuretic peptide-In SEP-2024 16k. Iron binding capacity total- 13-SEP-2024 2200 ug/litre, (2500-4000). N-terminal prohormone brain natriuretic peptide- 13-SEP-2024 16598 pg/mL, (0-900). Serum ferritin- 13-SEP-2024 875 ng/mL, (20-250). Transferrin saturation- 13-SEP-2024 163 mg/dL, (200-360). Troponin T- 13-SEP-2024 28 ng/L, (0-11). The investigator considered that there was no reasonable possibility that the atrial flutter with rapid ventricular response may have been caused by RSVPreF3 vaccine + AS01E and Comirnaty omicron XBB.1.5. The company considered that there was no reasonable possibility that the atrial flutter with rapid ventricular response may have been caused by RSVPreF3 vaccine + AS01E and Comirnaty omicron XBB.1.5. Linked case(s) involving the same subject: US2024153241, US2025015242, US2025015244, US2025015245 GSK Receipt Date: 07-APR-2025 Per medical records, subject presented 12-Sep at the direction of outpatient cardiologist after being found in acute heart failure likely secondary to rapid atrial flutter with 2:1 conduction. Subject underwent TEE (Transesophageal Echocardiogram)/Cardioversion on 12-Sep which was successful in conversion to NSR(Normal Sinus Rhythm) after one shock. Subject then initiated on oral amiodarone for rhythm control. NICM, (Nonischemic Cardiomyopathy) Moderate MR (Mitral Regurgitation), Moderate TR (Tricuspid Regurgitation), HFrEF (Heart Failure with Reduced Ejection) Exacerbation likely secondary to significant alcohol use; exacerbation likely 2/2 recurrent rapid atrial flutter. Per PI - The diagnosis in the medical records was "Atrial Flutter (by a cardiologist). Since atrial flutter and atrial fibrillation are typically considered in the same medical category, PI (Principal Investigator) considered atrial flutter as an equivalent to atrial fibrillation and reported this as an AESI (Adverse Event of Special Interest). Additionally, the cardiology fellow noted a diagnosis of atrial fibrillation/atrial flutter in a hospital progress note. SAE (Serious adverse event) was not related to study treatment. Hospital Admission date was 12-Sep-2024 Hospital Discharge date was 14-Sep-2024 SAE (serious adverse event) was not Related to Study Participation Activities other than Study Treatment. This a new disease of an existing disease Date event became serious was 10-Sep-2024 Reported medication name Metoprolol Succinate (Toprol XL and Kapspargo Sprinkle) This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow up information was received on 21-APR-2025 Summary of changes: Lab test Troponin T unit updated from ng/dL to ng/L.; Sender's Comments: A case of Atrial flutter, 96 days after receiving 1st dose of RSVPreF3 vaccine + AS01E and 127 days after receiving 1st dose of Comirnaty omicron XBB1.5, in a 69-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset and alternative risk factors (Concurrent medical conditions included obstructive sleep apnea (Chronic) and alcohol use disorder. Age, h/o Cardiac failure congestive) as per linked case. US-GSK-US2024153241: US-GSK-US2025015244:
Alcohol use disorder; Hearing loss unilateral (Right ear); Obstructive sleep apnea (Chronic); Tinnitus
ATORVASTATIN; METOPROLOL SUCCINATE; EMPAGLIFLOZIN; XARELTO; ENTRESTO; SPIRONOLACTONE; LASIX; COLCHICINE; ELIQUIS; COZAAR; DIOVAN; THIAMINE; FOLIC ACID; COREG
Test Date: 20240913; Test Name: Iron; Result Unstructured Data: (Test Result:170,Unit:ug/litre,Normal Low:450,Normal High:1700); Test Date: 202409; Test Name: BNP; Result Unstructured Data: (Test Result:16k,Unit:unknown,Normal Low:,Normal High:); Test Date: 20240913; Test Name: TIBC; Result Unstructured Data: (Test Result:2200,Unit:ug/litre,Normal Low:2500,Normal High:4000); Test Date: 20240913; Test Name: NT-pro BNP; Result Unstructured Data: (Test Result:16598,Unit:pg/mL,Normal Low:0,Normal High:900); Test Date: 20240913; Test Name: FERRITIN; Result Unstructured Data: (Test Result:875,Unit:ng/mL,Normal Low:20,Normal High:250); Test Date: 20240913; Test Name: Transferrin Saturation; Test Result: 163 mg/dl; Test Date: 20240913; Test Name: TROPONT; Result Unstructured Data: (Test Result:28,Unit:ng/L,Normal Low:0,Normal High:11); Comments: On 11-SEP-2024 Chest X-Ray Frontal and Lateral Projections showed Lungs: bibasilar airspace opacities, L more than R, increased from prior, Pleural space: small bilateral effusions, mildly increased from prior, Chest Airways: Normal, Heart/Mediastinum: Unchanged On 12-SEP-2024 TEE with Cardioversion showed Dilated hypertrophied LV (left ventricular) w severely reduced LVEF (Left Ventricular Ejection Fraction) (25 percent), global wall motion abnormalities, mild RV (right ventricular) enl/dysfunction, bi-atrial enl, mod mitral regurgitation, mod tricuspid regurgitation.