Age: 78.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Product storage error, Vaccination site erythema
Clinical narrative: Redness on the site of injection; Vaccine was administered after temperature excursion of -0.8°C; Vaccine was administered after temperature excursion of -0.8°C; This is a spontaneous case, initially received from physician via agency (reference number: SEQW20-00869) on 25-Aug-2020, concerning a 78-year-old, female patient.  The patient's medical history included type 2 diabetes mellitus with diabetic neuropathy unspecified, essential (primary) hypertension, hyperlipidemia unspecified, obesity unspecified, other iron deficiency anemias, overactive bladder, type 2 diabetes mellitus with hyperglycemia, localized scleroderma (morphea), edema unspecified, dependence on supplemental oxygen, sleep apnea unspecified, chronic obstructive pulmonary disease (COPD) unspecified, venous insufficiency, (chronic, peripheral), nontoxic single thyroid nodule and chronic diastolic (congestive) heart failure.  The patient's concomitant medications included fexofenadine-pseudoephedrine extended release (ER), vitamin D3, iron, glyburide, simvastatin, Aspirin (acetylsalicylic acid), irbesartan, doxazosin mesylate, atenolol, Norvasc (amlodipine besilate), bumetanide, portable oxygen concentrator, albuterol sulfate, ProAir HFA (salbutamol sulfate) and Symbicort (budesonide, formoterol fumarate), all used for an unreported indications and glucose for DXDM-2 (type 2 diabetes melitus).  The patient was also using One Touch II test strips, One Touch II glucose meter, lancets and a roller-walker (as directed).   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 18-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 the same date, after vaccination the patient developed redness on the site of injection.   The outcome of the event 'vaccination site erythema' was unknown.   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, 202004218, 202004219, 202004220, 202004222, 202004223, 202004224, 202004225, 202004226, 202004227, 202004228, 202004229, 202004230, 202004231 and 202004232 (the same reporter).  Company comment: The patient developed vaccination site erythema on the same day after vaccination with the suspect product, Fluad (TIV). Chronology is suggestive. Reportedly, vaccine was administered after temperature excursion of -0.8°C (explicitly coded as product administration error and product storage error temperature too low). Based on this information, causal relationship between the suspect product and the events of product storage error temperature too low and product administration error is assessed as not related (per company conventions), while for vaccination site erythema is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed vaccination site erythema on the same day after vaccination with the suspect product, Fluad (TIV). Chronology is suggestive. Reportedly, vaccine was administered after temperature excursion of -0.8°C (explicitly coded as product administration error and product storage error temperature too low). Based on this information, causal relationship between the suspect product and the events of product storage error temperature too low and product administration error is assessed as not related (per company conventions), while for vaccination site erythema is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).