Age: 45.0
Sex: F
Vaccine: FLUC3
Symptoms: Pain, Paraesthesia, Pruritus, Sensory disturbance, Swollen tongue
Clinical narrative: Possible anaphylactic reaction; Allergic reaction; Mouth started to feel numb; Tongue swelling; Breathing problems; All body started itching; Taste metal on her mouth; Feet was tickling; Felt the vaccine going through the body; Get tired very easily; Body pain; This spontaneous case was received on 14-Dec-2023 from other non-healthcare professional (consumer) via Communications (reference number: SEQW23-04850) and concerned a 45-year-old, female patient.  The patient's concurrent condition included allergy to peanuts. The patient's concomitant medications were not reported.  On 11-Dec-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration, anatomical location, and indication: not reported). The batch number was not reported.  On the same date, two hours after receiving Flucelvax Quadrivalent, the patient felt the vaccine going through the body, feet were tickling and could taste metal on mouth. One hour after that, all body started itching with extreme severe. Ten minutes after that, the patient's mouth started to feel numb and tongue swelling and because of that breathing problems started to happen. So, the patient took one Benadryl (diphenhydramine hydrochloride) which took 20 minutes to take effect and only helped on 25% of the symptoms. The patient went to the urgency hospital because of a possible anaphylactic reaction, and they gave the patient prednisone and 20 minutes after that all symptoms started to disappear.   On an unspecified date in Dec-2023, the patient got tired very easily and had some body pain and was worried that it stayed like that for a long time.  At the time of initial reporting, the patient was recovering from the events of 'anaphylactic reaction', allergic reaction, 'numb mouth', 'swelling of tongue', 'breathing difficult', 'itching all over', 'taste metallic', 'tingling feet/hands' and had not recovered from the events of 'tiredness' and 'general body pain'. As reported, until that day the patient wasn't clear at 100% healthy state.  The reporter assessed all events as related to Flucelvax Quadrivalent. As reported, the patient wanted to know about possible reimbursement as she had to activate her insurance at the hospital and said that it was because of the vaccine. The patient asked if Flucelvax contained Polysorbate 80 as one of the possible reasons for allergic reaction.  The events of 'anaphylactic reaction', allergic reaction, 'numb mouth', 'swelling of tongue', 'breathing difficult', 'general body pain', 'itching all over', and 'tiredness' were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance Department.  Company comment: A patient was vaccinated with Flucelvax Quadrivalent. Two hours after vaccination, the patient felt the vaccine going through the body, feet were tickling and could taste metal on mouth. One hour later, whole body started itching. In addition, the patient's mouth started to feel numb, tongue swelled, and breathing problems started. The patient went to the urgency hospital because of a possible anaphylactic reaction. Following treatment with prednisone all symptoms started to disappear. As reported, sometime after, the patient got tired very easily and had some body pain. The patient asked if Flucelvax contained Polysorbate 80 as one of the possible reasons for allergic reaction. Information regarding laboratory findings and diagnostic data was not provided. The patient's concurrent condition included allergy to peanuts. The patient's concomitant medications were not reported. Causal role of the suspect vaccine is assessed as possibly related for the events anaphylactic reaction, hypersensitivity, hypoaesthesia oral, swollen tongue, dyspnoea, pain, pruritus, fatigue, dysgeusia, paraesthesia and feeling abnormal, due to chronological plausibility. The presented symptoms corresponds to level 2 of Brighton Collaboration criteria for anaphylaxis.; Reporter's Comments: As reported, the patient wanted to know about possible reimbursement as she had to activate her insurance at the hospital and said that it was because of the vaccine. The patient asked if Flucelvax contained Polysorbate 80 as one of the possible reasons for allergic reaction.; Sender's Comments: A patient was vaccinated with Flucelvax Quadrivalent. Two hours after vaccination, the patient felt the vaccine going through the body, feet were tickling and could taste metal on mouth. One hour later, whole body started itching. In addition, the patient's mouth started to feel numb, tongue swelled, and breathing problems started. The patient went to the urgency hospital because of a possible anaphylactic reaction. Following treatment with prednisone all symptoms started to disappear. As reported, sometime after, the patient got tired very easily and had some body pain. The patient asked if Flucelvax contained Polysorbate 80 as one of the possible reasons for allergic reaction. Information regarding laboratory findings and diagnostic data was not provided. The patient's concurrent condition included allergy to peanuts. The patient's concomitant medications were not reported. Causal role of the suspect vaccine is assessed as possibly related for the events anaphylactic reaction, hypersensitivity, hypoaesthesia oral, swollen tongue, dyspnoea, pain, pruritus, fatigue, dysgeusia, paraesthesia and feeling abnormal, due to chronological plausibility. The presented symptoms corresponds to level 2 of Brighton Collaboration criteria for anaphylaxis.