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 |
Paroxysmal 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 furosemide (Lasix). On 31-AUG-2024, 86 days after receiving RSVPreF3 vaccine + AS01E and 117 days after receiving Comirnaty omicron XBB.1.5, the subject developed severe - grade 3 paroxysmal atrial flutter (Verbatim: Paroxysmal Atrial Flutter). Serious criteria included hospitalization. The subject was treated with amiodarone, rivaroxaban (Xarelto) and apixaban (Eliquis). The outcome of paroxysmal atrial flutter was not resolved. Relevant Tests: On 2-SEP-2024 ECG (Electrocardiogram): ST Elevations in V4-V5 Telemetry: 15 beat run of nonsustained ventricular tachycardia, 3 min run of atrial flutter, otherwise no significant events, HR predominantly 60s to 80s On 1-SEP-2024 ECHO : Dilated left ventricle w eccentric LVH and left atrial enlargement, severely reduced LVEF (22 percent) w global LV systolic dysfunction, reduced LV global longitudinal peak systolic strain On 1-SEP-2024 ECHO continued : Likely moderate to severe mitral valve regurgitation, moderate right heart enlargement/dysfunction w estimated mild-moderately elevated RV systolic pressures, Mildly dilated ascending aorta. On 31-AUG-2024 CT (Computed tomography)Angio Chest : No CTA evidence of acute aortic syndrome. Small-moderate R and small left pleural effusions w assoc. passive atelectasis of bilateral lower lobes. Mild coronary artery calcifications. On 31-AUG-2024 CR Angio Chest continued : Significant enlargement of the left ventricle measuring at least 6.9 cm intraluminally On 12-SEP-2024, TEE with Cardioversion showed Dialated hypertrophied LV w severly reduced LVEF (25 percent), global wall motion abnormalities, mild RV enl/dysfunction, bi-atrial enl, mod mitral regurgitation, mod tricuspid regurgitation On 03-SEP-2024, Cardiac Catherization showed mild (non-obstructive) CAD, elevated R/L sided filling pressures, reduced cardiac index (Vo2 calculated using Lafarge formula) On 11-SEP-2024, Chest X-Ray Frontal and Lateral Projections showed Lungs: bibasilar airspace opacities, L greater than R, increased from prior, Pleural space: small bilateral effusions, mildly increased from prior, Chest Airways: Normal, Heart/Mediastinum: Unchanged. Diagnostic results (reference ranges are provided in parenthesis if available): Blood creatine- 04-SEP-2024 1.48 mg/dL, (.67-1.17). Blood iron- 13-SEP-2024 170 ug/litre, (450-1700). Blood potassium- 02-SEP-2024 4.6 mmol/L, (3.3-5.1). Blood thyroid stimulating hormone- 02-SEP-2024 .99 m[iU]/mL (.27-4.2). Brain natriuretic peptide- 02-SEP-2024 7346 pg/mL, (0-900). C-reactive protein- 02-SEP-2024 189 mg/L, (0-8). Haemoglobin- 02-SEP-2024 12.9 g/dL, (12.0-17.0). 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). Platelet count- 02-SEP-2024 242 x10(3)/uL, (150-450). Red blood cells urine- 02-SEP-2024 32 mm/h, (0-20). Serum ferritin- 13-SEP-2024 875 ng/mL, (20-250). Transferrin saturation- 13-SEP-2024 163 mg/dL, (200-360). Troponin T- 31-AUG-2024 13 ng/L, (0-11) and 13-SEP-2024 28 ng/L, (0-11). White blood cell count- 02-SEP-2024 13.9 x10(3)/uL, (4500-11000). The investigator considered that there was no reasonable possibility that the paroxysmal atrial flutter 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 paroxysmal atrial flutter may have been caused by RSVPreF3 vaccine + AS01E and Comirnaty omicron XBB.1.5. Linked case(s) involving the same subject: US2024153241, US2025015242, US2025015245, US2025041478 GSK Receipt date: 05-FEB-2025 and 17-FEB-2025 Subject was admitted to the hospital on 31Aug2024 and discharged on 05Sep2024. Subject had paroxysmal atrial flutter throughout his hospitalization and was started on xarelto and low dose beta blocker. Paroxysmal atrial flutter (AESI due to Atrial Fibrillation) was all felt to be unrelated to his previous study vaccines (given on 06-MAY-2024 and 06-JUN-2024). Subject prescribed Amiodarone and Rivaroxaban for treatment of Paroxysmal Atrial Flutter. Diagnosis was believed to be related to recent diagnosis of cardiomyopathy. As of EOS (End of Study), adverse event was still ongoing. Addendum. Late entry. Subject's initial diagnosis of CHF(Congestive heart failure) felt to be due to newly diagnosed Cardiomyopathy. Cardiomyopathy was added as AE (adverse event). Cardiomyopathy was felt likely to be secondary to heavy alcohol use. Please refer to progress notes in source. SAE of Paroxysmal Atrial Flutter is a chronic condition therefore, is no end date. AE was not related to study treatment SAE was not Related to Study Participation Activities other than Study Treatment This event is a New Disease. This case contains an event assessed by the investigator as a non-serious adverse event of special interest (AESI). Follow-up information received on 24-FEB-2025 Summary of changes: Lab test updated. Follow-up information received on 06-MAR-2025 Summary of changes: General narrative comments were updated. Follow-up information received on 10-MAR-2025 Summary of changes: Lab data of TIBC, iron, Transferrin Saturation, FERRITIN, TROPONT, NT-pro BNP were updated. Follow-up information received on 11-MAR-2025 Summary of changes: Historical conditions Sleep Apnea / Chronic Obstructive and alcohol use disorder were updated, treatment medication Apixaban (Eliquis) was updated. Follow-up information received on 21-MAR-2025 Summary of changes: Lab data was updated. Follow up information received on 27-MAR-2025 Summary of changes : Lab data was updated. Upon internal review case was updated on 30-MAR-2025 Lab test NT-pro BNP was coded with N-terminal prohormone brain natriuretic peptide instead of Brain natriuretic peptide and RBCU was coded with red blood cells urine. Follow up information received on 02-APR-2025 Summary of changes: General narrative was updated. Upon internal review case was updated on 08-APR-2025 Dose for suspect vaccine was updated from 20 to 120ug Follow up information received on 03-APR-2025 Summary of changes: Lab data K, TSH (Thyroid Stimulating Hormone), HGB and PLAT deleted. Lab units and normal ranges updated. Upon internal review case was updated on 16-APR-2025. AESI statement updated. Follow up information received on 21-APR-2025 Summary of changes: Lab data section updated. Follow up information received on 22-APR-2025 Summary of changes: General narrative comment was updated. Follow up information received on 23-APR-2025 Summary of changes: Lab unit for TSH (Thyroid Stimulating Hormone) was updated to m[iU]/mL Upon internal review case was updated on 25-APR-2025 Lab date for Troponin T was updated from 02-SEP-2024 to 31-AUG-2024 Follow up information received on 28-APR-2025 Summary of changes: General narrative comments updated. Follow up information received on 30-May-2025 Summary of changes: Case upgraded to serious from non-serious. Seriousness criteria Hospitalization updated. Severity of the event upgraded to Severe. General narrative comment, hospital admission date and discharge date updated.; Sender's Comments: A case of Atrial flutter, 86 days after receiving the 1st dose of RSVPreF3 vaccine + AS01E and 117 days after receiving the 1st dose of Comirnaty omicron XBB.1.5, in a 69-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset, absence of biological plausibility and alternative etiology(alcohol use disorder, newly diagnosed Cardiomyopathy;On 1-SEP-2024 ECHO showed : Dilated left ventricle w eccentric LVH and left atrial enlargement, severely reduced LVEF (22 percent) ,Likely moderate to severe mitral valve regurgitation). US-GSK-US2025015242: US-GSK-US2025015245: US-GSK-US2024153241: US-GSK-US2025041478:
Alcohol use disorder; Hearing loss unilateral (Right Ear); Obstructive sleep apnea (Chronic); Tinnitus
LASIX
Test Date: 20240904; Test Name: CREAT; Test Result: 1.48 mg/dl; Test Date: 20240913; Test Name: Iron; Result Unstructured Data: (Test Result:170,Unit:ug/litre,Normal Low:450,Normal High:1700); Test Date: 20240902; Test Name: K; Result Unstructured Data: (Test Result:4.6,Unit:mmol/L,Normal Low:3.3,Normal High:5.1); Test Date: 20240902; Test Name: TSH (Thyroid Stimulating Hormone); Result Unstructured Data: (Test Result:.99 m[iU]/mL,Unit:unknown,Normal Low:.27,Normal High:4.2); Test Date: 20240902; Test Name: BNP; Result Unstructured Data: (Test Result:7346,Unit:pg/mL,Normal Low:0,Normal High:900); Test Date: 20240902; Test Name: CRP; Result Unstructured Data: (Test Result:189,Unit:mg/L,Normal Low:0,Normal High:8); Test Date: 20240902; Test Name: HGB; Result Unstructured Data: (Test Result:12.9,Unit:g/dL,Normal Low:12.0,Normal High:17.0); 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: 20240902; Test Name: PLAT; Result Unstructured Data: (Test Result:242,Unit:x10(3)/uL,Normal Low:150,Normal High:450); Test Date: 20240902; Test Name: RBCU; Result Unstructured Data: (Test Result:32,Unit:mm/h,Normal Low:0,Normal High:20); 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: 20240831; Test Name: TROPONT; Result Unstructured Data: (Test Result:13,Unit:ng/L,Normal Low:0,Normal High:11); Test Date: 20240913; Test Name: TROPONT; Result Unstructured Data: (Test Result:28,Unit:ng/L,Normal Low:0,Normal High:11); Test Date: 20240902; Test Name: WBC; Result Unstructured Data: (Test Result:13.9,Unit:x10(3)/uL,Normal Low:4500,Normal High:11000); Comments: On 2-SEP-2024 ECG (Electrocardiogram): ST Elevations in V4-V5 Telemetry: 15 beat run of nonsustained ventricular tachycardia, 3 min run of atrial flutter, otherwise no significant events, HR predominantly 60s to 80s On 1-SEP-2024 ECHO : Dilated left ventricle w eccentric LVH and left atrial enlargement, severely reduced LVEF (22 percent) w global LV systolic dysfunction, reduced LV global longitudinal peak systolic strain On 1-SEP-2024 ECHO continued : Likely moderate to severe mitral valve regurgitation, moderate right heart enlargement/dysfunction w estimated mild-moderately elevated RV systolic pressures, Mildly dilated ascending aorta. On 31-AUG-2024 CT (Computed tomography)Angio Chest : No CTA evidence of acute aortic syndrome. Small-moderate R and small left pleural effusions w assoc. passive atelectasis of bilateral lower lobes. Mild coronary artery calcifications. On 31-AUG-2024 CR Angio Chest continued : Significant enlargement of the left ventricle measuring at least 6.9 cm intraluminally On 12-SEP-2024, TEE with Cardioversion showed Dialated hypertrophied LV w severly reduced LVEF (25 percent), global wall motion abnormalities, mild RV enl/dysfunction, bi-atrial enl, mod mitral regurgitation, mod tricuspid regurgitation On 03-SEP-2024, Cardiac Catherization showed mild (non-obstructive) CAD, elevated R/L sided filling pressures, reduced cardiac index (Vo2 calculated using Lafarge formula) On 11-SEP-2024, Chest X-Ray Frontal and Lateral Projections showed Lungs: bibasilar airspace opacities, L greater than R, increased from prior, Pleural space: small bilateral effusions, mildly increased from prior, Chest Airways: Normal, Heart/Mediastinum: Unchanged