Age: 68.0
Sex: F
Vaccine: FLUA4
Symptoms: Skin warm, Swelling
Clinical narrative: Coughing; Sore throat; Some shortness of the breath; Allergy on the upper arms, chest, down waist, hands, top of the legs, palm of hands; Skin feels warm, swollen and red; Skin feels warm, swollen and red; Skin feels warm, swollen and red; This spontaneous case from the Regulatory Authority was received on 07-Oct-2021 from other healthcare professional (nurse) (reference number: SEQW21-03475) and concerned a 68-year-old, female patient.  The patient's concurrent conditions included allergy to latex, Phenergan (promethazine) and Midrin (isometheptene/acetaminophen/dichloralphenazone). The patient's concomitant medications included Metformin (metformin hydrochloride), hydrochlorothiazide, Levothyroxine (levothyroxine sodium), Kreon (pancreatin) and metaxalone, all used for an unreported indication.   On 04-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number was not reported.  On 05-Oct-2021, one day after receiving Fluad Quadrivalent, the patient experienced allergy on the upper arms, chest, down waist, hands, top of the legs and on palm of hands and her skin felt warm, swollen and red.  On 06-Oct-2021, two days after receiving Fluad Quadrivalent, the patient experienced coughing, sore throat and some shortness of the breath. At night, she started treatment with Benadryl (diphenhydramine hydrochloride), 25 mg and had to take 50 mg later.  On an unspecified date in Oct-2021, the patient's doctor put her on a Medrol (methylprednisolone) dose pack, for the reaction.  The outcome for all events was not reported.  The reporter assessed all events as related to Fluad Quadrivalent. She thought she was having a reaction to the vaccine and stated that when she worked at the hospital, she had a similar reaction in the same areas, but now four times worse.  The case was assessed as non-serious.  Company comment: A 68-year-old patient developed cough, oropharyngeal pain, warmth, swelling, and redness of skin, as well as dyspnoea and allergic reaction on upper arms, chest, down waist, hands, top of the legs and on palm of hands within two days after receiving Fluad Quadrivalent. Causality is confounded by therapy with concomitant drugs Metformin (metformin hydrochloride), hydrochlorothiazide, and metaxalone. However, due to compatible chronology, causality is assessed as possibly related.; Reporter's Comments: She thinks she is having a reaction to the vaccine. Stated she is allergic to latex and back when worked at the Hospital had a similar reaction in the same areas but now is 4x times worst.; Sender's Comments: A 68-year-old patient developed cough, oropharyngeal pain, warmth, swelling, and redness of skin, as well as dyspnoea and allergic reaction on upper arms, chest, down waist, hands, top of the legs and on palm of hands within two days after receiving Fluad Quadrivalent. Causality is confounded by therapy with concomitant drugs Metformin (metformin hydrochloride), hydrochlorothiazide, and metaxalone. However, due to compatible chronology, causality is assessed as possibly related.