Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity, Product temperature excursion issue
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: SEQW20-00900) on 25-Aug-2020, concerning a 74-year-old, female patient.  The patient's medical history included type 2 diabetes mellitus with hyperglycemia and without complications, unspecified hyperlipidemia, gastro-esophageal reflux disease without esophagitis, occlusion and stenosis of left carotid artery, solitary pulmonary nodule, unspecified anxiety disorder, aneurysm of the other specified arteries, age-related osteoporosis without current pathological fracture, unspecified, recurrent major depressive disorder and unspecified allergic rhinitis.   The patient's concomitant medications included melatonin, Ventolin HFA (salbutamol sulfate), glipizide metformin hydrochloride (HCL), Actos (pioglitazone hydrochloride), simvastatin, Aspirin 81 (acetylsalicylic acid), mirtazapine, calcium, alendronate sodium and escitalopram oxalate, all used for unreported indication. The patient was also using Truedraw lancing device, True Metrix air glucose meter, Trueplus lancer 33g, BD Swab single use regular and True Metrix blood glucose test, as directed, all used for unreported indication.   On an unspecified date in 2020, the Fluad (TIV) vaccine [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 at minus 0.8 degrees Celsius for 4 hours and 23 minutes (explicitly coded as 'Product storage error temperature too low').  On 20-Aug-2020, after temperature excursion happened, the patient was administered Fluad (TIV) vaccine [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.  At the time of initial reporting, the utcome of the event of sore arm was not reported.   The case was assessed as non-serious.  The reporter did not provide causality assessment.    This case is linked to cases 202004116, 202004159, 202004163, 202004164, 202004167, 202004168, 202004170, 202004171, 202004172, 202004175, 202004177, 202004179, 202004197, 202004203, 202004210, 202004213, 202004215, 202004216, 202004218, 202004219, 202004220, 202004222, 202004223, 202004224, 202004225, 202004226, 202004227, 202004228, 202004229, 202004230, 202004231 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. Product storage error and product administration error are assessed as not related per company's conventions. Causal role of the suspect vaccine is assessed possibly related to pain in extremity.; 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. Product storage error and product administration error are assessed as not related per company's conventions. Causal role of the suspect vaccine is assessed possibly related to pain in extremity.