Received Sep 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (OTHER) | UNKNOWN MANUFACTURER | 1 | UNK | IM / LA |
Exacerbation Paroxysmal Atrial Fibrillation; Exacerbation Paroxysmal Atrial Fibrillation; This 45-year-old male subject was enrolled in an open label study. The subject received the 1st dose of RSVPreF3 vaccine + AS01E (intramuscular, left deltoid) .5 ml on 08-JUL-2024, for prophylaxis. The subject's past medical history included fecal immunochemical test positive. Previously administered products included Covid-19 mRNA vaccine Pfizer (Subject received Covid-19 mRNA vaccine Pfizer 1st dose on 10-MAR-2021 and 2nd dose on 31-MAR-2021 via intramuscular route for indication of prophylaxis). Concurrent medical conditions included paroxysmal atrial fibrillation, paroxysmal supraventricular tachycardia, hypercholesterolemia, body mass index increased (Elevated), insulin resistance, congenital hypertrophy of the retinal pigment epithelium, generalized anxiety disorder, major depressive disorder, attention deficit hyperactivity disorder, obstructive sleep apnea, achilles tendon injury (left) and back pain. Concomitant products included diltiazem and bupropion. On 14-JUL-2024, 6 days after receiving RSVPreF3 vaccine + AS01E, the subject developed mild - grade 1 paroxysmal atrial fibrillation (Non-serious, Verbatim: Exacerbation Paroxysmal Atrial Fibrillation). Additional event(s) included mild - grade 1 condition aggravated (Verbatim: Exacerbation Paroxysmal Atrial Fibrillation). The outcome of paroxysmal atrial fibrillation was resolved on 18-JUL-2024. The outcome(s) of the additional event(s) included condition aggravated (resolved on 18-JUL-2024). The investigator considered that there was no reasonable possibility that the paroxysmal atrial fibrillation and condition aggravated may have been caused by RSVPreF3 vaccine + AS01E. The company considered that there was no reasonable possibility that the paroxysmal atrial fibrillation and condition aggravated may have been caused by RSVPreF3 vaccine + AS01E. GSK Receipt Date: 08-JAN-2025 and 09-JAN-2025 Subject received IP (Investigational product) 08-JUL-2024. He had a history paroxysmal a fib. Subject reported to his PCP (Primary care physician) on 18-JUL-24 an episode of a fib occurring the "other day" and subject was noted to have an irreg rhythm during that visit 18-JUL-24. Subject only symptom was palpitations. No EKG (electrocardiogram) or other testing was done during or around the episodes. They were self-limited and resolved spontaneously. There were no changes to medication regimen (Subject took 2 tabs of 120mg diltiazem in morning and 1 tab in evening). Principal Investigator did not feel this was related to IP. They would grade it as mild. It was felt that per the protocol this qualifies as non-serious AF episode that meets AESI criteria as it occurred less than 30 days after vaccination. The protocol also states only AF (Atrial fibrillation) meeting SAE (Serious Adverse Event) definition would be reported in electronic Expedited AEs Report and in the specific AF follow-up questionnaire. Non-serious AF would be reported as non-serious adverse event eCRF screen and in the AF follow up questionnaire. Per PI, "the only information available were details of score. There would be no previous calculation different then this one. " CHADS-Vasc CHF-no 0 HTN-no-0 Age- less than 64 is equal to 0 Diabetes-no is equal to 0 Sex-Male 0 Vasc (Stroke/TIA)-no 0 Per PI, Last symptomatic episode was in April 2024. Frequency was rare: Less than monthly, more than yearly. AE was not related to study treatment. SAE was not Related to Study Participation Activities other than Study Treatment This case contains an event assessed by the investigator as a non-serious adverse event of special interest (AESI). This event was Exacerbation of existing Disease. Follow up information received on 14-Jan-2025 Summary of changes: Event verbatim updated from Atrial fibrillation to Exacerbation Paroxysmal Atrial Fibrillation. Additional event added of condition aggravated. Follow up information received on 23-JAN-2025, 27-JAN-2025 Summary of changes: General narrative comments updated.
Achilles tendon injury (left); Attention deficit hyperactivity disorder; Back pain; Body mass index increased (Elevated); Congenital hypertrophy of the retinal pigment epithelium; Generalized anxiety disorder; Hypercholesterolemia; Insulin resistance; Major depressive disorder; Obstructive sleep apnea; Paroxysmal atrial fibrillation; Paroxysmal supraventricular tachycardia
Medical History/Concurrent Conditions: Fecal immunochemical test positive
DILTIAZEM; BUPROPION