Age: 52.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Extrasystoles, Heart rate, Tachycardia
Clinical narrative: Skipping beats; Heart rate was 120-130; This spontaneous case was retrieved on 10-Jan-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2722180-1), reported by other non-healthcare professional (consumer) and concerned a 52-year-old, male patient.  The patient's concurrent conditions included idiopathic peripheral neuropathy, high blood pressure (HBP), and obesity. The patient's concomitant medications included enalapril, hydrochlorothiazide, Norco (hydrocodone bitartrate; paracetamol), metformin, taurine, saw palmetto, and unspecified multivitamin, all used for unreported indication. The patient had no allergies. The patient's historical vaccines included second shot of Moderna Covid-19 vaccine (elasomeran) received on an unspecified date after which the patient experienced an adverse event.   On 07-Dec-2023, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; dose: reported as '1', route of administration: intramuscular, anatomical location: right arm, and indication: not reported). The batch number was not reported.  On the same date, the patient was vaccinated with non-company, co-suspect COVID-19 vaccine (reported as both 'Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula)' and 'COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (SARS-CoV-2 SPIKE PROTEIN (Omicron variant XBB.1.5))'); dose: reported as '1', route of administration: intramuscular, anatomical location: left arm) for COVID-19 immunisation. The batch number was not reported.  On the same date, within an hour of after receiving Afluria Quadrivalent and non-company, co-suspect COVID-19 vaccine, the patient's heart rate was 120-130 beats per minute (BPM) and was skipping beats.  On an unspecified date in Dec-2023, the patient had emergency room (ER) visit. The patient underwent electrocardiogram (ECG) 12 lead, chest X-ray, complete blood count, comprehensive metabolic panel, magnesium, and troponin T quant high sensitivity tests were performed, however, no further information was provided.  The outcome of the events of 'skipped beats' and 'tachycardia' was unknown.  The reporter did not provide a causality assessment.  The events of tachycardia and skipped beats were considered to be medically significant by a Physician within Seqirus' Pharmacovigilance Department.  Additional information was received on 22-Jan-2024 via Med Communications reported by other non-healthcare professional: The co-suspect was changed from 'Novavax COVID-19 Vaccine (covid-19 vaccine prot. subunit (nvx cov2373)' to 'COVID-19 vaccine'. Also, 'COVID-19 immunisation' was added as an indication. Discrepancies in reporting enalapril as 'enepril', Norco (hydrocodone bitartrate; paracetamol) as 'Norcor', and taurine as 'tuarine' were corrected. Additional reference numbers were added, and the narrative was updated accordingly.  Case updated on 01-Feb-2024: Correction made to information received on 22-Jan-2024: The options for Medically confirmed and Health Care Professional were updated from 'Yes' to 'No'. The Reporter type was also changed from 'Other Health Professional' to 'Other Non Health Professional'. Medical confirmation by a healthcare professional (HCP) was modified from 'Yes' to 'No' for both events. The Follow-up summary paragraph was updated to include 'reported by other non-healthcare professional'. An Action Item (AI) was created with proposed follow-up queries, and the narrative was amended accordingly.   Company comment: A 52-year-old male patient experienced extrasystoles and tachycardia within an hour after receiving suspect product Afluria Quadrivalent and non-company, co-suspect COVID-19 vaccine. Patient's medical history is significant for high blood pressure and obesity. Reportedly, patient had to go to the emergency room (ER), but no further information regarding relevant laboratory and diagnostic data was provided (patient underwent electrocardiogram, chest X-ray, complete blood count, comprehensive metabolic panel, magnesium and troponin T quant high sensitivity were performed). Due to suggestive temporal relationship, causal role of the suspect vaccine cannot be excluded for above-mentioned events, therefore is assessed as possibly related, even though co-suspect vaccine is a confounder.; Sender's Comments: A 52-year-old male patient experienced extrasystoles and tachycardia within an hour after receiving suspect product Afluria Quadrivalent and non-company, co-suspect COVID-19 vaccine. Patient's medical history is significant for high blood pressure and obesity. Reportedly, patient had to go to the emergency room (ER), but no further information regarding relevant laboratory and diagnostic data was provided (patient underwent electrocardiogram, chest X-ray, complete blood count, comprehensive metabolic panel, magnesium and troponin T quant high sensitivity were performed). Due to suggestive temporal relationship, causal role of the suspect vaccine cannot be excluded for above-mentioned events, therefore is assessed as possibly related, even though co-suspect vaccine is a confounder.