Age: 33.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Product administration error, Vaccination site urticaria
Clinical narrative: Large hive around vaccination site; Afluria Quadrivalent and Novavax COVID-19 vaccine were administered on the same day, at the same anatomical location; This spontaneous case was retrieved on 09-Jan-2024 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2720372-1), reported by other healthcare professional and concerned a 33-year-old, female patient.  The patient's concurrent conditions included myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), fibromyalgia, postural orthostatic tachycardia syndrome (POTS), allergy to nickel, garlic and onions, and laryngitis. The patient's concomitant medications included metoprolol, duloxetine, naltrexone, vitamin D, and probiotics, all used for unspecified indications.  On 01-Dec-2023, the patient was vaccinated with the fourth dose of non-company, co-suspect Novavax COVID-19 Vaccine (COVID-19 vaccine prot. subunit (NVX CoV 2373); dose: 0.5 mL, route of administration: intramuscular, and anatomical location: left arm (LA)) for COVID-19 immunization. The batch number was not reported.  On the same date, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; route of administration: intramuscular; anatomical location: left arm (LA); dose: not reported) (explicitly coded as 'Product administration error') for active immunization against influenza disease. The batch number was not reported.  On 02-Dec-2023, one day after receiving the Afluria Quadrivalent and non-company, co-suspect Novavax COVID-19 vaccine, the patient experienced a large hive around vaccination site.  The outcome of the event was unknown.  The reporter did not provide a causality assessment with Afluria Quadrivalent however the event of 'vaccination site urticaria' was considered as possibly related to non-company, co-suspect, Novavax COVID-19 Vaccine.  The case was assessed as non-serious.  Additional information was received on 22-Jan-2024, reported by other healthcare professional via Med Communications (reference number: SEQW24-00342): Intermediary removed for primary reporter information; 'Report sent to regulatory authority by reporter field' was updated from yes to unknown. Additional reporter added. Dose, route of administration, and indication added for co-suspect Novavax COVID-19 vaccine, and route of administration and indication added for Afluria Quadrivalent. The start date for the concurrent condition of laryngitis updated. Reporter causality assessment between co-suspect Novavax COVID-19 Vaccine and the event added.  Company comment: The event of vaccination site urticaria is assessed as possibly related to Afluria Quadrivalent due to plausible temporal relationship. However, the causality is confounded by administration of non-company co-suspect COVID-19 vaccine.; Reporter's Comments: The event of 'vaccination site urticaria' was considered as possibly related to non-company, co-suspect Novavax COVID-19 Vaccine.; Sender's Comments: The event of vaccination site urticaria is assessed as possibly related to Afluria Quadrivalent due to plausible temporal relationship. However, the causality is confounded by administration of non-company co-suspect COVID-19 vaccine.