Age: 67.0
Sex: M
Vaccine: COVID19-2, FLU4, UNK
Symptoms: Atrial fibrillation, Blood test normal, Condition aggravated
Clinical narrative: Afib attack/had this in the past/I have not had another incident since; This spontaneous case was retrieved on 02-Feb-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2562321-1), reported by other non-healthcare professional (consumer) and concerned a 67-year-old, male patient.  The patient's concurrent conditions included high blood pressure and allergy to sulfonamide (sulfa). The patient's past medical history included multiple episodes of atrial fibrillation (afib) attacks. As reported, the patient had it in the past but did not have many episodes of it. The patient visited his doctor and was told to take his blood pressure medications and the patient did not have another incident since. The patient's concomitant medications included losartan, used for unreported indication.   It was reported that on 17-Oct-2022, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; route of administration: injection (reported as 'SYR'), anatomical location: reported as 'arm', dose and indication: not reported). The batch number reported was 346361. The reported batch number was identified by Seqirus to be linked to suspect product Fluad Quadrivalent (influenza vaccine inact sag 4v) instead of reported suspect product Afluria Quadrivalent. Based on the reported batch number, the suspect product was changed to Fluad Quadrivalent.  On the same day, the patient was vaccinated with non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, Bivalent (tozinameran, riltozinameran; dose: reported as 'four', route of administration: injection (reported as 'SYR'), anatomical location: reported as 'arm', and indication: not reported). The batch number reported was GH9693.  On 14-Jan-2023, two months and 28 days after receiving Fluad Quadrivalent and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, Bivalent, the patient had an afib attack. As reported, the patient had prescription for this and took one of each.   On an unspecified date in Jan-2023, the patient visited emergency room. Blood panel was taken, but everything looked good, as reported.  On 17-Jan-2023, the patient recovered from the event.  The reporter did not provide a causality assessment.  The event of 'recurrent atrial fibrillation' was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 67-year-old male patient experienced atrial fibrillation attack two months and 28 days after vaccination with Fluad Quadrivalent and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, Bivalent. Reportedly, the patient visited emergency room, blood work was done, and results were normal. The patient's past medical history included multiple episodes of atrial fibrillation (afib) attacks and had prescription for it. Causality is assessed as not related to the suspect vaccine due to implausible temporal relationship and the patient's relevant medical history.; Sender's Comments: A 67-year-old male patient experienced atrial fibrillation attack two months and 28 days after vaccination with Fluad Quadrivalent and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, Bivalent. Reportedly, the patient visited emergency room, blood work was done, and results were normal. The patient's past medical history included multiple episodes of atrial fibrillation (afib) attacks and had prescription for it. Causality is assessed as not related to the suspect vaccine due to implausible temporal relationship and the patient's relevant medical history.