Age: 87.0
Sex: F
Vaccine: FLUA4
Symptoms: Insomnia, Mobility decreased, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Excruciating pain all over the body; Can barely move; Arm was hurting; Can't sleep/ woke up; This spontaneous case was received on 20-Sep-2023 from other non-healthcare professional (consumer) via company (reference number: SEQW23-02441) and concerned an 87-year-old, female patient.   The patient's concurrent conditions included high blood pressure. The patient's concomitant medications included spironolactone, potassium, ezetimibe, and B12 (mecobalamin), all for unreported indications.  On 09-Sep-2023, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza immunization. The batch number was not reported.  On 10-Sep-2023, the next day, as reported, after receiving Fluad Quadrivalent, the patient's arm was hurting, but the patient did not pay much attention to it. Then, at 3 AM, the patient woke up with excruciating pain all over the body. The patient went to hospital and was admitted. The patient could not sleep, could barely move and had trouble getting out of bed. The patient was drinking lots of fluids.   On an unspecified date in Sep-2023, an unknown amount of time receiving Fluad Quadrivalent, the patient was discharged from the hospital. The treatment measures associated with the events included low dose morphine, and unspecified anti-nausea medications.  On 18-Sep-2023 (also discrepantly reported as on 19-Sep-2023), on Monday, the patient went to a Primary Care, however, no further details were provided.  On an unspecified date in Sep-2023 (reported as 'yesterday before bed'), the patient took one Tylenol (paracetamol).  The outcome of the events was unknown.  The reporter did not provide a causality assessment.  All events were assessed as serious due to the seriousness criterion of hospitalization.  Company comment: A patient was vaccinated with Fluad Quadrivalent. One day after vaccination, the patient was unable to sleep and developed arm pain. As reported, the patient experienced excruciating pain all over the body and could barely move. Information regarding relevant laboratory findings and diagnostic data was not provided.  Causal role of the suspect vaccine is assessed as not related for the event sleep disorder, considering that pain provides alternative aetiology. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events pain in extremity, pain and mobility decreased, due to chronological plausibility.; Sender's Comments: A patient was vaccinated with Fluad Quadrivalent. One day after vaccination, the patient was unable to sleep and developed arm pain. As reported, the patient experienced excruciating pain all over the body and could barely move. Information regarding relevant laboratory findings and diagnostic data was not provided.  Causal role of the suspect vaccine is assessed as not related for the event sleep disorder, considering that pain provides alternative aetiology. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events pain in extremity, pain and mobility decreased, due to chronological plausibility.