Sex: F
Vaccine: COVID19, FLUC3, COVID19, FLUC3, VARZOS
Symptoms: Pain of skin, Urticaria
Clinical narrative: Painful when touched; Raised, hard welt about 2 inches in diameter; This spontaneous case was retrieved on 07-Nov-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2691528-1) reported by other non-healthcare professional (consumer) with additional information received on 16-Nov-2023 from Seqirus PTC Reporting (being processed together) and concerned an adult female patient of unreported age.  The patient's concurrent conditions included allergy to unspecified drug. The patient's concomitant medications were not reported. The patient's historical vaccine included Moderna COVID-19 vaccine (route of administration: intramuscular, anatomical location: left arm, dose reported as '4', batch number: 066K21A) for COVID-19 immunization, and three doses of Pfizer vaccine reported as Bnt162b2, all received in the left arm, for COVID-19 immunization with batch numbers: FF8841, EW0102, and EPP6955. The date of vaccination was discrepantly reported as 30-Sep-2023, for all historical vaccines. The patient was not pregnant.   On 10-Sep-2023, the patient was vaccinated with non-company, co-suspect Shingrix (varicella zoster vaccine rgE (CHO); dose, route of administration, anatomical location, and indication: not reported). The batch number was not reported.   It was reported that on 30-Sep-2023, the patient was vaccinated with Flucelvax (TIV) (influenza vaccine inact sag 3v; dose reported as '1', anatomical location: right arm (RA), route of administration, and indication: not reported). The batch number reported was 944484. The reported batch number was identified by Seqirus to be linked to the suspect product Flucelvax Quadrivalent (influenza vaccine inact sag 4v) instead of the reported suspect product Flucelvax (TIV). Based on the reported batch number, the suspect product was changed to Flucelvax Quadrivalent.  On the same date, the patient was vaccinated with a non-company, co-suspect COVID-19 vaccine (reported as Comirnaty omi xbb.1.5 (bnt162b2, 2023-2024 formula) (active ingredients not specified)) (dose reported as '6 (booster)', route of administration: intramuscular, anatomical location: left arm) for COVID-19 immunization. The batch number reported was HD9876.  On 01-Oct-2023, one day after receiving Flucelvax Quadrivalent and non-company co-suspect COVID-19 vaccine and 21 days after receiving the Shingrix vaccine, the patient experienced raised, hard, warm red welt about 2 inches in diameter which was painful when touched.  At the time of initial reporting, the patient was recovering from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Case updated on 27-Nov-2023: Correction made to information received on 07-Nov-2023: Intermediary removed and Report Sent to Regulatory Authority by Reporter? ticked as UNK, suspect vaccine recorded to Flucelvax Quadrivalent, indication, and listedness amended. Batch number conformation (BNC) reassesed as Process together (PT). Narrative updated accordingly.  Company comment: A patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect Covid-19 vaccine. Twenty days earlier, the patient was vaccinated with non-company, co-suspect Shingrix vaccine. One day after vaccination, the patient experienced raised, hard, warm red welt painful when touched. Causality is confounded by concurrent administration of co-suspect vaccine. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events pain of skin and urticaria, due to chronological plausibility.; Sender's Comments: A patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect Covid-19 vaccine. Twenty days earlier, the patient was vaccinated with non-company, co-suspect Shingrix vaccine. One day after vaccination, the patient experienced raised, hard, warm red welt painful when touched. Causality is confounded by concurrent administration of co-suspect vaccine. Causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the events pain of skin and urticaria, due to chronological plausibility.