Age: 56.0
Sex: F
Vaccine: UNK
Symptoms: Insomnia, Product administered to patient of inappropriate age, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: The injection site had a red square, the size of a large band aid. It was also warm to touch; The injection site had a red square, the size of a large band aid. It was also warm to touch; The site of injection was sore/it was very painful; 56-year old patient was given Fluad Quadrivalent; Hasn't been able to sleep properly; This spontaneous case  was received on 01-Oct-2020, from other non-health professional via agency (reference number: SEQW20-02680) and concerned a 56-year-old, female patient.  The patient's medical history included hypertension and thyroid problems. The patient's concomitant medications included losartan, levothyroxine, aspirin low dose (acetylsalicylic acid), and probiotic unspecified, all used for unreported indication.   On 28-Sep-2020, patient was vaccinated with unspecified Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported) (explicitly coded as 'Inappropriate age at vaccine administered') for influenza prophylaxis. The batch number reported was 279808, expiry date: 30-Jun-2021.  On the same day, after the administration of Fluad Quadrivalent, the site of injection was sore.  On an unspecified date in 2020, the patient hadn't been able to sleep properly, because she was not able to lay on that arm side in the bed.   On 29-Sep-2020, on Tuesday, the injection site had a red square, the size of a large and aid. It was also very painful and warm to the touch, but not hot.  On 01-Oct-2020, it was reported that it hadn't gone away, but it had improved a little bit, and it was not as red as before. However, it was still sore. Despite that, the patient could still use her arm.  At the time of initial reporting on 01-Oct-2020, the patient was recovering from the events 'vaccination site warmth', 'vaccination site erythema' and 'vaccination site pain'. The patient was not recovered from the event of 'sleep difficult'.  The reporter did not provide a causality assessment.  The reporter assessed this case as non-serious.  Case updated on 02-Dec-2020: Correction made to information received on 01-Oct-2020: The company causality for the event of 'sleep difficult' was changed from related to not related. Company comment updated. No changes in narrative.  Company comment: A 56-year-old patient developed insomnia, vaccination site warmth, vaccination site pain and vaccination site erythema within one day after vaccination with the suspect product, Fluad Quadrivalent. (explicitly coded as 'Inappropriate age at vaccine administered'). Chronology is plausible. Although onset date for the event of insomnia was not provided, narrative suggested that the patient could not sleep due to pain. Therefore, causality is assessed as not related for insomnia. Causal relationship for vaccination site warmth, vaccination site pain and vaccination site erythema is assessed as possibly related. Inappropriate age at vaccine administered is assessed as not related per company's conventions.; Sender's Comments: A 56-year-old patient developed insomnia, vaccination site warmth, vaccination site pain and vaccination site erythema within one day after vaccination with the suspect product, Fluad Quadrivalent. (explicitly coded as 'Inappropriate age at vaccine administered'). Chronology is plausible. Although onset date for the event of insomnia was not provided, narrative suggested that the patient could not sleep due to pain. Therefore, causality is assessed as not related for insomnia. Causal relationship for vaccination site warmth, vaccination site pain and vaccination site erythema is assessed as possibly related. Inappropriate age at vaccine administered is assessed as not related per company's conventions.