Age: 73.0
Sex: M
Vaccine: FLUA3
Symptoms: Pain in extremity, Product storage error
Clinical narrative: Vaccine was administered after temperature excursion at -0.8 C; Sore arm; Vaccine was administered after temperature excursion at -0.8 C; This is a spontaneous case, initially received from physician via agency (reference number: SSEQW20-00881) on 25-Aug-2020, concerning a 73-year-old, male patient.  The patient's medical history included essential (primary) hypertension, heart disease unspecified, postprocedural hypertension, atrial fibrillation, paroxysmal, mixed hyperlipidaemia, unilateral primary osteoarthritis, left hip, benign prostatic hyperplasia without lower urinary tract symptoms, type 2 diabetes mellitus with hyperglycaemia, chronic embolism and thrombosis of axillary vein, bilateral, allergy to anticoagulants, unsteadiness on feat and unspecified sequelae of cerebral infarction.  The patient's concomitant medications included long term use of insulin and unspecified anticoagulants.  On an unspecified date in 2020, Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; batch number: 279734 and expiration date: 04-May-2021] was exposed to temperature excursion of minus 0.8 degrees Celsius for 4 hours and 23 minutes (explicitly coded as 'Product storage error temperature too low').  On 21-Aug-2020, the patient was administered Fluad (TIV) vaccine after temperature excursion [dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported] (explicitly coded as 'Product administration error') for influenza prophylaxis.  On an unspecified date in Aug-2020, after vaccination, the patient developed sore arm. No treatment was given to the patient.  The case was assessed as non-serious.  The reporter did not provide causality assessment.    This case is linked to cases: 202004116, 202004159, 202004164, 202004167, 202004168, 202004170, 202004171, 202004172, 202004175, 202004177, 202004179, 202004197, 202004203, 202004210, 202004213, 202004215, 202004216, 202004217, 202004231, 202004224, 202004220, 202004222, 202004223, 202004218, 202004225, 202004226, 202004227, 202004163, 202004229, 202004230, 202004228 and 202004232 (the same reporter).  Company comment: Reportedly, Fluad (TIV) vaccine was exposed to temperature excursion of minus 0.8 degrees Celsius for 4 hours and 23 minutes. The patient was administered Fluad (TIV) vaccine after temperature excursion. The patient experienced pain in extremity after Fluad administration. Patient's medical history of osteoarthritis confounds causality for the event. However, causal role of the suspect vaccine is assessed possibly related to pain in extremity. Product storage error and product administration error are assessed as not related per company's conventions.; Sender's Comments: Reportedly, Fluad (TIV) vaccine was exposed to temperature excursion of minus 0.8 degrees Celsius for 4 hours and 23 minutes. The patient was administered Fluad (TIV) vaccine after temperature excursion. The patient experienced pain in extremity after Fluad administration. Patient's medical history of osteoarthritis confounds causality for the event. However, causal role of the suspect vaccine is assessed possibly related to pain in extremity. Product storage error and product administration error are assessed as not related per company's conventions.