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 |
Worsening of Atrial Fibrillation; This 65-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 17-JUN-2024, for prophylaxis. The subject received the 1st dose of Comirnaty omicron XBB.1.5 (intramuscular, right deltoid) 30 µg on 16-MAY-2024, for prophylaxis. The subject's past medical history included appendectomy. Previously administered products included Covid 19 AstraZeneca (Subject received Covid 19 AstraZeneca 1st dose on 4-DEC-2020 via Intramuscular route for indication of Prophylaxis.). Concurrent medical conditions included attention deficit hyperactivity disorder, back pain and paroxysmal atrial fibrillation. Concomitant products included ibuprofen and gabapentin. On 18-NOV-2024, 154 days after receiving RSVPreF3 vaccine + AS01E and 186 days after receiving Comirnaty omicron XBB.1.5, the subject developed moderate - grade 2 atrial fibrillation aggravated (Verbatim: Worsening of Atrial Fibrillation). Serious criteria included hospitalization. The subject was treated with apixaban (Eliquis), flecainide, metoprolol succinate, enoxaparin sodium (Lovenox) and zinc. The outcome of atrial fibrillation aggravated was resolved on 18-NOV-2024. Relevant Tests: On an unspecified date in NOV-2024 ECHO (Echocardiogram) demonstrated normal left ventricular size abnormal septal wall motion consistent with intraventricular conduction delay, possible diastolic dysfunction. On an unspecified date in NOV-2024 Cardiac pharmacologic non-stress test showed negative for ischemia. Diagnostic results (reference ranges are provided in parenthesis if available): Chest X-ray- 18-NOV-2024 No acute cardiopulmonary disease (negative). Ejection fraction-In NOV-2024 estimated at 50-55 percent. Troponin- 18-NOV-2024 x3 which were negative and 18-NOV-2024 0.03 ng/mL, (0-0.04). The investigator considered that there was no reasonable possibility that the atrial fibrillation aggravated 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 fibrillation aggravated may have been caused by RSVPreF3 vaccine + AS01E and Comirnaty omicron XBB.1.5. GSK Receipt Date- 09-JAN-2025 and 10-JAN-2025 PI (principal investigator) reached out to subject by phone on 09JAN2025 to review symptoms that led to hospitalization on 18NOV2025. Subject reported a history of intermittent atrial fibrillation. In November, subject stated he woke up one morning and started having symptoms of palpitations, lightheadedness, poor effort tolerance, chest pain and dyspnea. He was admitted to the hospital and cardiology was consulted. They moved him to a different hospital to perform cardioversion; however, prior to cardioversion he went back into sinus rhythm spontaneously. Subject also reported that he received an echocardiogram and a stress test during his stay. He did smoke 1/2 ppd and took a zinc supplement. He was very active; he walked 2-3 miles a day and did manual labor. He was placed on Eliquis and Flecainide during his hospitalization. Subject agreed to sign a medical record release. No known family history of Atrial fibrillation.Update - After reviewing subject's medical records it was discovered that he was admitted from 18-NOV-2024 to 20-NOV-2024. Testing was completed during that time. A 12 lead ECG was obtained; however, the record that was sent was incomplete and not legible. ECG records had been requested to be resent. Subject was also started on metoprolol succinate and enoxaparin sodium during their hospital stay. AE(Adverse event) was not related to study treatment. SAE (Serious adverse event) was not Related to Study Participation Activities other than Study Treatment. This event was Exacerbation of existing Disease. Date event became serious:18-NOV-2024. This case contains an event assessed by the investigator as a serious adverse event of special interest (AESI). Follow up information received on 17-JAN-2025 Summary of changes: The event term was updated as Atrial Fibrillation from Worsening of Atrial Fibrillation. Follow up information received on 27-JAN-2025 Summary of changes: The event term was updated as Worsening of Atrial Fibrillation from Atrial Fibrillation. Follow up information received on 18-Feb-2025. Summary of changes: Treatment medications Eliquis and flecainide added. General narrative and lab data was updated. Follow up information received on 14-MAR-2025 Summary of changes: Event start date and hospitalization admission date was updated from unk-DEC-2024 to 18-NOV-2024, Hospitalization details, general narrative and TTO was updated. Concomitant medication and historical vaccine were added. Upon internal review case was updated on 21-MAR-2025 Lab test with unknown results added in relevant test and removed from diagnostic test. Follow up information received on 17-MAR-2025 Summary of changes : Event end date was updated to 20-Nov-2024.Date event became serious was updated from UNK-DEC-2024 to 18-NOV-2024.General narrative was updated. Lab data was updated.Treatment medication Metoprolol Succinate XL and Lovenox were added in product tab. Follow up information received on 21-MAR-2025 Summary of changes : Treatment medication Zinc supplement was added. Follow up information received on 27-MAR-2025 Summary of changes: End date of event was updated to 18-Nov-2024 from 20-Nov-2024. Treatment medication details of Eliquis (start date and end date), Fleccanide (start date) were updated. Follow up information received on 28-MAR-2025 Summary of changes: general narrative was updated. Upon internal review case was updated on 04-APR-2025 Generic name for treatment medication Lovenox was updated to enoxaparin sodium, Lab test pharmacological non-stress test was coded with Cardiac pharmacologic stress test. Follow-up information received on 04-APR-2025 Summary of changes: General narrative comments were updated. Follow-up information received on 07-APR-2025 Summary of changes: Concurrent medical condition Paroxysmal Atrial fibrillation was updated. Upon internal review case was updated on 10-APR-2025 Lab test Cardiac pharmacologic stress test was updated in relevant test section. Follow up information received on 08-Apr-2025. Summary of changes: Lab data of Tropnin 0.03 was added.; Sender's Comments: A case of Atrial fibrillation aggravated, 154 days after receiving the 1st dose of RSVPreF3 vaccine + AS01E and 186 days after receiving 1st dose of Comirnaty omicron XBB.1.5, in a 65-year-old male subject. Report is inconsistent with causal relation to the vaccine product, considering implausible time to onset.
Attention deficit hyperactivity disorder; Back pain; Paroxysmal atrial fibrillation
Medical History/Concurrent Conditions: Appendectomy
IBUPROFEN; GABAPENTIN
Test Date: 20241118; Test Name: Chest XRay; Result Unstructured Data: (Test Result:No acute cardiopulmonary disease (negative),Unit:unknown,Normal Low:,Normal High:); Test Date: 202411; Test Name: EF; Result Unstructured Data: (Test Result:estimated at 50-55,Unit:percent,Normal Low:,Normal High:); Test Date: 20241118; Test Name: TROPONI; Result Unstructured Data: (Test Result:0.03,Unit:ng/mL,Normal Low:zero,Normal High:0.04); Test Date: 20241118; Test Name: Troponin; Result Unstructured Data: (Test Result:x3 which were negative,Unit:unknown,Normal Low:,Normal High:); Comments: On an unspecified date in NOV-2024 ECHO (Echocardiogram) demonstrated normal left ventricular size abnormal septal wall motion consistent with intraventricular conduction delay, possible diastolic dysfunction. On an unspecified date in NOV-2024 Cardiac pharmacologic non-stress test showed negative for ischemia