Age: 80.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Nocturia, Urine output increased
Clinical narrative: Sore deltoid muscle/pain in the Left deltoid; At night wake up 5 times to urinate; it was reffered that every time produced more-than-trivial urine volume; At night wake up 5 times to urinate; it was reffered that every time produced more-than-trivial urine volume; This spontaneous case was received on 13-Sep-2022 from other non-healthcare professional (consumer) (reference number: SEQW22-02988) and concerned an 80-year-old, female patient.  The patient's concurrent conditions and concomitant medications were not reported. As reported, the patient was in a very good health. The patient's historical vaccine included Fluad Quadrivalent (reported as 'Fluad HD'), administered on 13-Sep-2021, when the patient barely felt the needle and after which the patient had no follow-on pain.  On 07-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid) as prevention of influenza disease. The batch number was not reported.  On the same day, within two hours after receiving Fluad Quadrivalent, the patient had a moderately sore deltoid muscle. At night, the patient woke five times to urinate and each time she produced more-than-trivial urine volume. The patient usually woke up only once per overnight to urinate. In the hour and a half interval between the patient's fifth urination and awakening at dawn, the pain in her left deltoid completely disappeared. As described, it was like 'flipping a switch'. The patient reported that her persistent deltoid pain was unusual because she completely relaxed her arm muscle before the injection.   On 08-Sep-2022, the patient recovered from all events. As reported, the patient was back to normal.   The reporter did not provide a causality assessment. The patient wondered if an excipient in the Fluad HD vaccine was changed. The patient thought that her body might reacted so strongly to an ingredient that was new to her or the 2021 vaccine excipient might sensitized her to more of it in 2022.   The case was assessed as non-serious.  Company comment: An 80-year-old female patient was vaccinated with the suspect Fluad Quadrivalent vaccine. On the same day, within two hours the patient experienced myalgia in deltoid muscle. At the night patient reported having nocturia with urine output increased. Information regarding the related diagnostic findings was not provided. Next day the patient recovered from all events. Based on chronological and biological plausibility, causality for the event of myalgia is assessed as possibly related. Due to limited information provided, causality for nocturia and urine output increased is unassessable.; Sender's Comments: An 80-year-old female patient was vaccinated with the suspect Fluad Quadrivalent vaccine. On the same day, within two hours the patient experienced myalgia in deltoid muscle. At the night patient reported having nocturia with urine output increased. Information regarding the related diagnostic findings was not provided. Next day the patient recovered from all events. Based on chronological and biological plausibility, causality for the event of myalgia is assessed as possibly related. Due to limited information provided, causality for nocturia and urine output increased is unassessable.