Age: 61.0
Sex: F
Vaccine: COVID19-2, FLUA4, FLUC3
Symptoms: Bell's palsy, Magnetic resonance imaging head normal
Clinical narrative: Bell's palsy; This spontaneous case was retrieved on 10-Nov-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2490194-1), reported by other healthcare professional and concerned a 61-year-old female patient.  The patient's concurrent conditions included rheumatoid arthritis (RA), ductal carcinoma in situ (DCIS), and depression. The patient's concomitant medications included Plaquenil (hydroxychloroquine sulfate), Zoloft (sertraline hydrochloride), meloxicam, Mv (vitamins nos), and turmeric, all used for unreported indications. The patient had no known allergies.  It was reported that on 05-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose reported as '1'; route of administration: intramuscular; anatomical location: right arm; indication: not reported). The batch number reported was 942416. 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 Fluad Quadrivalent. Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.  On the same date, the patient was vaccinated with non-company, co-suspect Moderna COVID-19 vaccine, bivalent (elasomeran, imelasomeran; dose reported as '5'; route of administration: intramuscular; anatomical location: left arm; indication: not reported). Batch number reported was 060F22A.  On 14-Oct-2022, nine days after receiving Flucelvax Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine, bivalent, the patient experienced Bell's palsy.   On an unspecified date in Oct-2022, the patient visited physician's office and emergency room (ER). The patient had magnetic resonance imaging (MRI) of brain and the result was negative.  At the time of initial reporting, the patient had not recovered from the event.  The reporter did not provide causality assessment.   The event of Bell's palsy was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 61-year-old female patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine. Nine days after vaccination, the patient experienced Bell's palsy. The patient had magnetic resonance imaging (MRI) of brain and the result was negative. Causality was confounded by concurrent administration of co-suspect vaccine. Nevertheless, causal role of the suspect vaccine is assessed as possibly related, with the currently available information and plausible temporal relationship. Agency criteria for Bell's palsy could not be assessed, with the currently available information.; Sender's Comments: A 61-year-old female patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine. Nine days after vaccination, the patient experienced Bell's palsy. The patient had magnetic resonance imaging (MRI) of brain and the result was negative. Causality was confounded by concurrent administration of co-suspect vaccine. Nevertheless, causal role of the suspect vaccine is assessed as possibly related, with the currently available information and plausible temporal relationship. Agency criteria for Bell's palsy could not be assessed, with the currently available information.