Age: 52.0
Sex: F
Vaccine: FLUC3
Symptoms: Throat tightness, Urticaria, Vaccination site urticaria
Clinical narrative: Flushed; Throat felt like it was closing; Red areas over several spots all over the body; Skin was warm; Skin was dry; Felt like face was swelling; Hives at face; Hives at the injection site; This spontaneous case was received on 25-Oct-2023 from pharmacist via Communications (reference number: SEQW23-03764) and concerned a 52-year-old, female patient.  The patient's medical history was not reported. The patient's historical vaccine included Influenza vaccine (reported as Fluquad vaccine) (brand not specified) on 15-Dec-2022, after which she experienced an anaphylactic reaction. The patient's concomitant medications included Proventil inhaler (Salbutamol), Wellbutrin xl (Bupropion hydrochloride), Ibuprofen, and Gabapentin, all used for unreported indications.  On 25-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) for influenza immunization. The batch number reported was 370661 and the expiry date 30-Jun-2024.  On the same date, 15 minutes after receiving Flucelvax Quadrivalent vaccine, the patient had hives at the vaccination site and face, then she became flushed with red areas over several spots all over the body. The patient's skin was warm and dry, and she felt like her face was swelling. The patient was in the emergency room (ER) of  Hospital. While in the ER, the patient stated that her throat felt like it was closing. The patient was treated with Benadryl (diphenhydramine hydrochloride) and epinephrine and she was discharged from the emergency room.  At the time of follow up reporting, on 26-Oct-2023, the patient was recovering from the events. As reported the patient was feeling better in the morning.  The reporter assessed the events to be related to Flucelvax Quadrivalent vaccine. Reporter stated that the patient had reacted to Flucelvax vaccine.  All events were considered to be medically significant by Physician within the CSL Seqirus Pharmacovigilance Department.  Company comment: A patient was vaccinated with Flucelvax Quadrivalent. Fifteen minutes after vaccination, the patient developed hives at the vaccination site and face, flushing, skin warmth and dry, and face swelling. In addition, the patient stated that her throat felt like it was closing. The patient was treated with Benadryl and epinephrine. Information regarding relevant laboratory findings and diagnostic data was not provided. The patient's historical vaccine included Influenza vaccine, after which she experienced an anaphylactic reaction. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events vaccination site urticaria, flushing, skin warm, dry skin, swelling face, throat tightness, erythema, and urticaria, with the currently available information and chronological plausibility. The presented symptoms corresponds to level 2 of Brighton Collaboration criteria for anaphylaxis.; Reporter's Comments: Reporter stated that the patient had reacted to Flucelvax vaccine.; Sender's Comments: A patient was vaccinated with Flucelvax Quadrivalent. Fifteen minutes after vaccination, the patient developed hives at the vaccination site and face, flushing, skin warmth and dry, and face swelling. In addition, the patient stated that her throat felt like it was closing. The patient was treated with Benadryl and epinephrine. Information regarding relevant laboratory findings and diagnostic data was not provided. The patient's historical vaccine included Influenza vaccine, after which she experienced an anaphylactic reaction. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events vaccination site urticaria, flushing, skin warm, dry skin, swelling face, throat tightness, erythema, and urticaria, with the currently available information and chronological plausibility. The presented symptoms corresponds to level 2 of Brighton Collaboration criteria for anaphylaxis.