Age: 80.0
Sex: M
Vaccine: FLUA4
Symptoms: Foreign body, Injection site pain, Injection site reaction, Pain in extremity
Clinical narrative: Pain in arm / arm was still sore and hurt a lot; Injection site sore; Removed two hard black particles of the injection site, resembling metal or rubber; This spontaneous case from was received on 29-Nov-2021 from other non-healthcare professional (consumer) via Regulatory Authority (reference number: SEQW21-05676), with additional information (being processed together) received on 30-Nov-2021 and on 02-Dec-2021 (reference number: 1091839), and concerned an 80-year-old, male patient.  The patient's medical history was not reported. The patient's concomitant medications included unspecified blood pressure medicine and prostate medicine. The patient's historical vaccines included Fluad vaccines (which patient had been receiving in previous years, as reported) and after which he had no side effects observed and unspecified COVID-19 vaccines however it was not reported whether the patient experienced any adverse events after administration.  On 01-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 312850 and expiry date 08-Jun-2022.  On 15-Oct-2021, reported as two weeks after receiving Fluad Quadrivalent, the patient experienced severe pain in arm and injection site sore.  On an unspecified date in Oct-2021, unknown amount of time after receiving Fluad Quadrivalent, the patient went to the doctor who prescribed prednisone for five days. The symptoms got better but the arm was still sore and hurt a lot. The patient stated that his daughter, a dentist, examined his arm and removed two hard black particles of the injection site, resembling metal or rubber.   At the time of initial reporting, the patient was recovering from the event of 'vaccination site pain' and had not recovered from the event of 'pain in arm'.  The outcome or the event of 'foreign body' was not reported.   The reporter assessed all events as related to Fluad Quadrivalent.  The case was assessed as non-serious.  Company comment: Two weeks, after receiving Fluad Quadrivalent, the patient experienced severe pain in arm and injection site pain. Reportedly, an unknown amount of time after vaccination, the patient's daughter, examined his arm and removed two hard black particles of the injection site, resembling metal or rubber. Causal role of the suspect vaccine is assessed as not related for the event foreign body, due to biological implausibility but related to luer lock syringe. Causal role of the suspect vaccine is assessed as possibly related for other events considering chronological plausibility.; Sender's Comments: Two weeks, after receiving Fluad Quadrivalent, the patient experienced severe pain in arm and injection site pain. Reportedly, an unknown amount of time after vaccination, the patient's daughter, examined his arm and removed two hard black particles of the injection site, resembling metal or rubber. Causal role of the suspect vaccine is assessed as not related for the event foreign body, due to biological implausibility but related to luer lock syringe. Causal role of the suspect vaccine is assessed as possibly related for other events considering chronological plausibility.