Age: 77.0
Sex: M
Vaccine: FLUA3
Symptoms: Diarrhoea, Product storage error, Vomiting
Clinical narrative: Vaccine was administered after temperature excursion of -0.8°C; Diarrhea; Vomiting; Vaccine was administered after temperature excursion of -0.8°C; This is a spontaneous case, initially received from physician via agency (reference number: SEQW20-00875) on 25-Aug-2020, concerning a 77-year-old, male patient.  The patient's medical history included atherosclerotic heart disease of native coronary artery without angina pectoris, essential (primary) hypertension, hyperlipidaemia unspecified, generalized anxiety disorder, Barrett's oesophagus without dysplasia, disorder of carbohydrate metabolism unspecified, vitamin D deficiency unspecified, tendinitis, upper arm unspecified side, age-related cataract Morgagnian type bilateral, bilateral primary osteoarthritis of first carpometacarpal joints, secondary osteoarthritis right hand, osteoarthritis left hand, obstructive sleep apnoea, type 2 diabetes mellitus without complications, strain of unspecified quadriceps muscle fascia and tendor sequela, diverticulosis if intestine part unspecified without perforation or absces without bleeding, benign prostatic hyperplasia without lower urinary tract symptoms and rash.  The patient's concomitant medications included clotrimazole anti-fungal for rash, Ventolin HFA (salbutamol sulfate ), pantoprazole sodium, hydrochlorthiazid, metoprolol succinate, bupropion HCL ER (XL), metformin HCL, Crestor  (rosuvastatin calcium), clonazepam, lisinopril, Aspirin (acetylsalicylic acid), Plavix (clopidogrel bisulfate), Nitroglicerin (glyceryl trinitrate), cyclobenzaprine HCL, all used for an unreported indication.  On an unspecified date in 2020, the Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; batch number: 279734 and expiration date: 04-May-2021] suffered temperature excursion of minus 0.8 C 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 [dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported] (explicitly coded as 'Product administration error') for influenza prophylaxis.  On an unspecified day in Aug-2020, an unknown amount of time after vaccination, the patient experienced diarrhoea and vomiting. That lasted for 24 hours. The patient reported that he thought that was due to fish he had eaten.  On an unspecified day in Aug-2020, the patient recovered from diarrhoea and vomiting.  This case was assessed as non-serious.   The reporter did provide causality assessment  This case is linked to cases 202004116, 202004159, 202004163, 202004164, 202004167, 202004168, 202004170, 202004171, 202004172, 202004175, 202004177, 202004179, 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 events of 'diarrhoea' and 'vomiting' are assessed as related to Fluad (TIV). The events of  'Product storage error temperature too low' and 'Product administration error' are assessed as not related to Fluad (TIV).; Sender's Comments: The events of 'diarrhoea' and 'vomiting' are assessed as related to Fluad (TIV). The events of  'Product storage error temperature too low' and 'Product administration error' are assessed as not related to Fluad (TIV).