Age: 36.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Bell's palsy, Product administration error
Clinical narrative: Bell's Palsy on left side of face; Flucelvax Quadrivalent and Pfizer BioNTech COVID-19 vaccine were administered on the same date in the same arm; This spontaneous case from the United States was retrieved on 09-Jan-2024 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2719499-1), reported by other healthcare professional with additional information received on 10-Jan-2024 (being processed together), and concerned a 36-year-old, female patient.  The patient had no medical history and was not taking any concomitant medications. The patient had no allergies.  On an unspecified date in Nov-2023 (discrepantly reported as 30-Nov-2023), the patient was vaccinated with non-company, co-suspect Pfizer BioNTech COVID-19 vaccine (tozinameran; dose: reported as '1', route of administration: injection (reported as 'SYR'), anatomical location: left arm (LA), and indication: not reported). The batch number reported was HF9275.  It was reported that on the same date, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; dose: reported as '1', route of administration: injection (reported as 'SYR'), anatomical location: left arm (LA), indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was 944467. The reported batch number was identified by Seqirus to be linked to suspect product Flucelvax 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 Flucelvax Quadrivalent.   On an unspecified date in Nov-2023 (discrepantly reported as 30-Nov-2023), an unknown amount of time after receiving Flucelvax Quadrivalent and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, the patient experienced Bell's Palsy on left side of face.  On 16-Nov-2023, the patient visited the emergency room (ER) and was hospitalized.  On an unspecified date in Nov-2023, the investigations included computed tomography (CT) scan and magnetic resonance imaging (MRI) with and without contrast, for which the results were not provided.  On 17-Nov-2023, after one day (discrepantly reported as two days), the patient was discharged.  At the time of initial reporting, the patient had not recovered from the event of Bell's palsy.  The reporter did not provide a causality assessment.  The event of Bell's palsy was assessed as serious due to seriousness criterion of hospitalization. Additionally, the event of Bell's palsy was considered to be medically significant by Physician within Seqirus' Pharmacovigilance Department.  Company comment: A patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, both vaccines were administered on the same day and in the same arm. An unknown amount of time during the same month after vaccination, the patient experienced Bell's Palsy. The computed tomography (CT) scan and magnetic resonance imaging (MRI) with and without contrast were performed, however the results were not provided. The patient had no medical history and was not taking any concomitant medications. The patient had no allergies. Causality is confounded by concurrent administration of co-suspect vaccine. Causal role of the suspect vaccine is assessed as possibly related for the event Bell's palsy, with the currently available information and chronological plausibility. Product administration error is assessed as unrelated per company conventions. Brighton Collaboration criteria for the event facial nerve palsy could not be assessed due to insufficient information.; Sender's Comments: A patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect Pfizer BioNTech COVID-19 vaccine, both vaccines were administered on the same day and in the same arm. An unknown amount of time during the same month after vaccination, the patient experienced Bell's Palsy. The computed tomography (CT) scan and magnetic resonance imaging (MRI) with and without contrast were performed, however the results were not provided. The patient had no medical history and was not taking any concomitant medications. The patient had no allergies. Causality is confounded by concurrent administration of co-suspect vaccine. Causal role of the suspect vaccine is assessed as possibly related for the event Bell's palsy, with the currently available information and chronological plausibility. Product administration error is assessed as unrelated per company conventions. Brighton Collaboration criteria for the event facial nerve palsy could not be assessed due to insufficient information.