Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Skin warm, Spinal pain
Clinical narrative: A warm feeling in lower back; Chest has a dull ache; Could not move and had to hold to the shelf; Chest felt like it was caving in; A huge pain in the spine; Pain on the right side below rib cage; This spontaneous case was received on 21-Sep-2020 from other non-health professional (consumer) via agency (reference number: SEQW20-02007) and concerned a 68-year-old female patient.  The patient's concurrent conditions included hypertension and type 2 diabetes (T2D). The patient's past vaccination history included flu shots before without any issues. The patient's concomitant medications included carvedilol, Bupropion (bupropion hydrochloride), Synthroid (levothyroxine sodium) and metformin, all used for unreported indications.  On 18-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, anatomical location: upper left arm- deltoid, and route of administration: intramuscular) for flu prevention at pharmacy. The batch number reported was 279790 and expiry date was 25-May-2021. This was the patient's first senior shot. After getting vaccinated the patient was able to walk to other side of the pharmacy.  On the same day, while the patient was still in the store, within minutes after receiving Fluad Quadrivalent, the patient developed a warm feeling in lower back and a huge pain in the spine. In addition, the patient could not move and had to hold to the shelf. The patient was not sure how long she stood there and then she walked back to the pharmacy and sat down. The pharmacist measured the patient's blood pressure and it was high (could not tell how high). Also, the patient's chest felt like 'it was caving in'. Ten minutes after, the pain went away, but the patient's chest had a dull ache.   On 19-Sep-2020, one day after receiving Fluad Quadrivalent, the patient referred having pain on the right side below the rib cage. The patient did not receive any treatment measures associated with the events.  On an unspecified day in Sep-2020, the patient recovered from 'chest ache' and 'pain localised'. The patient referred having no pain.  The outcome of 'localized feeling of warmth' and 'chest abnormal feeling of' was not reported.  The reporter did not provide a causality assessment to Fluad Quadrivalent.  The reporter assessed the events as non-serious.  Company comment: A 68-year-old female patient was administered Fluad Quadrivalent vaccine. On the same day, after receiving Fluad Quadrivalent, the patient developed chest pain, chest discomfort, feeling hot, mobility decreased and spinal pain. One day after receiving Fluad Quadrivalent, the patient referred having pain (on the right side below rib cage). Causality was confounded by patient's current conditions, hypertension and type 2 diabetes, and multiple concomitant medications. More information regarding diagnostic findings is needed. However, with information available causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: A 68-year-old female patient was administered Fluad Quadrivalent vaccine. On the same day, after receiving Fluad Quadrivalent, the patient developed chest pain, chest discomfort, feeling hot, mobility decreased and spinal pain. One day after receiving Fluad Quadrivalent, the patient referred having pain (on the right side below rib cage). Causality was confounded by patient's current conditions, hypertension and type 2 diabetes, and multiple concomitant medications. More information regarding diagnostic findings is needed. However, with information available causal role of the suspect vaccine cannot be excluded and is assessed as unlikely related. (defaults to ''related'' in the safety database for reporting purposes).