Age: 7.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Syncope
Clinical narrative: Momentary syncope/ passed out on a bench; Pale; Sweaty; Twitching; This spontaneous case from the United States was retrieved on 10-Jan-2024 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2721731-1), reported by other healthcare professional and concerned a 7-year-old, female patient.   The patient had no relevant medical history and no known allergies. The patient's concomitant medication included multivitamin (MVI) (unspecified vitamins), used for unreported indication.   On 07-Dec-2023, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; route of administration: intramuscular (IM); anatomical location: right arm (RA); dose and indication: not reported). The batch number reported was AU1078A.  On the same date, the patient was vaccinated with a non-company, co-suspect Pfizer BioNTech COVID-19 vaccine (tozinameran; dose: reported as '3'; route of administration: intramuscular (IM); anatomical location: left arm (LA); indication: not reported). The batch number reported was HE239.  On the same date, shortly after receiving Afluria Quadrivalent and a non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, the patient became pale, sweaty, and passed out on a bench (no fall or injury). The mild twitching was noted. The patient was lifted by the emergency response team (ERT) to position and returned to consciousness in less than 10 seconds without any postictal state. Initial blood pressure (BP) was mildly elevated, but the team believed it was because the patient was moving the arm. On arrival, the patient was supine on the bed, oriented, pale, and a little sweaty. The patient denied any nausea, sobbing, or mouth symptoms. There was no rash. The patient indicated resolution of symptoms and had a return of normal color to the face. The patient was allowed to sit up (did so quickly and without issue). Repeated BP was normal, and heart rate (HR) was in the 70-80s. The patient's father confirmed that looked like was 'herself' again. The patient stood and was observed for a minute without return of the symptoms. The patient was released from the routine post-vax observation period.  On the same date, the patient recovered from the events.  The reporter did not provide a causality assessment.  The events of passed out and 'syncope' were considered to be medically significant by Physician within Department.  Company comment: A 7-year-old female patient became pale, sweaty and passed out on a bench shortly after receiving suspect product Afluria Quadrivalent and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine. In addition, mild twitching was also noted.  The patient was lifted by the emergency response team (ERT) to position and returned to consciousness in less than 10 seconds without any postictal state. In post/vax observation period, patient recovered from all events. Causality is confounded by concurrently administered co-suspect vaccine. Based on available information, causality for the suspect vaccine is assessed as possibly related for all reported events (syncope, pallor, hyperhydrosis and muscle twitching) due to suggestive temporal relationship, even though confounded by co-suspect vaccine.; Sender's Comments: A 7-year-old female patient became pale, sweaty and passed out on a bench shortly after receiving suspect product Afluria Quadrivalent and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine. In addition, mild twitching was also noted.  The patient was lifted by the emergency response team (ERT) to position and returned to consciousness in less than 10 seconds without any postictal state. In post/vax observation period, patient recovered from all events. Causality is confounded by concurrently administered co-suspect vaccine. Based on available information, causality for the suspect vaccine is assessed as possibly related for all reported events (syncope, pallor, hyperhydrosis and muscle twitching) due to suggestive temporal relationship, even though confounded by co-suspect vaccine.