Age: 1.33
Sex: F
Vaccine: COVID19, FLUC4, HEP, HIBV, COVID19, HEP, HIBV, UNK
Symptoms: Hypersomnia, Product use issue, Pyrexia
Clinical narrative: Low grade temp; Pt slept a bit longer for her nap; Patient received Flucelvax Quadrivalent and Recombivax hb vaccine on the same date on the same site; This spontaneous case was retrieved on 08-Mar-2024 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2745770-1), reported by other healthcare professional and concerned a 16-month-old, female patient.   The patient's medical history and concomitant medications were not reported. The patient had no known allergies.  On 05-Feb-2024, the patient was vaccinated with non-company, co-suspects Pfizer BioNTech COVID-19 vaccine (tozinameran; anatomical location: left leg (LL), route of administration: intramuscular (IM), dose and indication: not reported) the batch number reported was HH3252, Recombivax hb (hepatitis b vaccine rHBsAg (yeast); dose: reported as '4' , anatomical location: right leg (RL), route of administration: intramuscular (IM) and indication: not reported) the batch number reported was X011082 and Acthib (HIB vaccine conj (tet tox); dose: reported as '4' , anatomical location:left leg (LL), route of administration: intramuscular (IM) and indication: not reported) the batch number reported was UJ964AD.   On the same date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4V, route of administration: intramuscular (IM), anatomical location: right leg (RL) and indication: not reported (explicitly coded as 'Product administration error'). The batch number reported was 371204.  On the same date, after receiving Flucelvax Quadrivalent and non-company, co-suspects Pfizer BioNTech COVID-19 vaccine, Recombivax hb vaccine and Acthib vaccine, the patient's mom said that the patient slept a bit longer for her nap after the vaccines were administered and had a low-grade temp, but otherwise was feeling fine. No signs or symptoms noted, as reported.   On an unspecified date in Feb-2024, the patient had recovered from the events of 'sleep excessive' and 'low grade fever'.   The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: On the same day following vaccination with Flucelvax Quadrivalent and non-company, co-suspects Pfizer BioNTech COVID-19 vaccine, Recombivax hb vaccine and Acthib vaccine, a 16-month-old patient experienced hypersomnia and pyrexia. Flucelvax Quadrivalent and Recombivax hb were both administered in left leg (explicitly coded as 'Product administration error'). Product administration error is assessed as not related as per company's conventions. Although confounded by administration of co-suspect vaccines, causality is assessed as possible for event pyrexia, due to suggestive temporal relationship. Causality is assessed as not related for event hypersomnia, due to lack of biological plausibility.  Case correction (08-Mar-2024) upon review, event coding was updated from Product administration error to product code issue for event Patient received Flucelvax Quadrivalent and Recombivax hb vaccine on the same date on the same site. Narrative was updated accordingly.; Reporter's Comments: Event of Low grade temp was considered related. Event of Pt slept a bit longer for her nap and Patient received Flucelvax Quadrivalent and Recombivax hb vaccine on the same date on the same site were not related