Sex: F
Vaccine: FLUC3
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth, Product administration error
Clinical narrative: Site was hot and itchy and roughly 4"X2"; Site was hot and itchy and roughly 4"X2"; Injection site was firm and sore circle; Injection site was firm and sore circle; Had Flucelvax/At the same time, she had the Pfizer Comarity bivalent vaccine. Both were administered in her right arm; This spontaneous case was received on 09-Nov-2022, from other non-healthcare professional (consumer) with additional information received 11-Nov-2022  (being processed together) (reference number: SEQW22-05603) and concerned a female patient with unspecified age.   The patient's medical history and concomitant medications were not reported.  On 03-Oct-2022, the patient was vaccinated with non-company co-suspect Pfizer-BioNTech COVID-19 Vaccine, bivalent (tozinameran, riltozinameran; anatomical location: right arm, dose, route of administration, and indication: not reported). The batch number was not reported.  On the same day the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, anatomical location: right arm, route of administration: not reported) for prevention of influenza disease (explicitly coded as 'Product administration error'). The batch number reported was 94244.   On 04-Nov-2022, in the morning after receiving Flucelvax Quadrivalent and co-suspect Pfizer-BioNTech COVID-19 Vaccine, bivalent, the patient noticed that her injection site was firm and has sore circle.   On 05-Nov-2022, the patient stated that her site was hot, itchy and roughly 4x2 (reported as 4"X2"). The patient's dermatologist told her to apply unspecified corticosteroid cream, and to take Benadryl 2-3 times per day, and to apply ice.   By 07-Nov-2022 the symptoms had greatly improved.  At the time of initial reporting 09-Nov-2022, the patient was recovering from the events 'vaccination site pruritus', 'vaccination site pain', 'vaccination site induration', and 'vaccination site warmth'.  The reporter did not provide a causality assessment. However, as reported, it was unclear which vaccination caused the reaction.  The case was assessed as non-serious.  Company comment: A female patient of an unknown age was vaccinated with Flucelvax Quadrivalent and non-company co-suspect Pfizer-BioNTech COVID-19 Vaccine, on the same day and in the same arm (explicitly coded as 'Product administration error'). In the next two days following vaccination, patient experienced vaccination site warmth, vaccination site pruritus, vaccination site pain, and vaccination site induration. Despite confounding by co-suspect vaccine, causal role of the suspect product cannot be excluded. Therefore, causality for the reported events is assessed as possibly related due to biological and chronological plausibility. Product administration error is assessed as not related per company's conventions.; Reporter's Comments: However, as reported, it was unclear which vaccination caused the reaction.; Sender's Comments: A female patient of an unknown age was vaccinated with Flucelvax Quadrivalent and non-company co-suspect Pfizer-BioNTech COVID-19 Vaccine, on the same day and in the same arm (explicitly coded as 'Product administration error'). In the next two days following vaccination, patient experienced vaccination site warmth, vaccination site pruritus, vaccination site pain, and vaccination site induration. Despite confounding by co-suspect vaccine, causal role of the suspect product cannot be excluded. Therefore, causality for the reported events is assessed as possibly related due to biological and chronological plausibility. Product administration error is assessed as not related per company's conventions.