Age: 37.0
Sex: M
Vaccine: COVID19, FLUA4, PNC20, COVID19, FLU4, PNC20
Symptoms: Incorrect product formulation administered, Rash, Rash pruritic
Clinical narrative: Had a rash about 4 inches in diameter on Left arm/Rash was itchy; Had a rash about 4 inches in diameter on Left arm/Rash was itchy; Afluria Quadrivalent and Moderna COVID-19 vaccine were administered in the same arm at the same day; This spontaneous case was retrieved on 21-Oct-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2470729-1), reported by other healthcare professional and concerned a 37-year-old, male patient.  The patient's concurrent conditions included diabetes, hypertension and sleep apnea. The patient's concomitant medications included pantoprazole, buspirone, metformin, hydralazine, Viagra (sildenafil citrate), Xarelto (rivaroxaban), Trulicity (dulaglutide), all used for unreported indication. The patient had no allergies.  On 08-Sep-2022, the patient was vaccinated with non-company, co-suspect Moderna COVID-19 vaccine (elasomeran; dose: reported as 'three (booster)', route of administration: intramuscular (IM), anatomical location: left arm (LA), indication: not reported). The batch number reported was 011B22A.  It was reported that on the same day, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular, (IM) anatomical location: left arm (LA), dose and indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was AS3402B. The reported batch number was identified by Seqirus to be linked to suspect product Afluria Quadrivalent (influenza vaccine inact split 4v) instead of reported suspect product Fluad Quadrivalent. Based on the reported batch number, the suspect product was changed to Afluria Quadrivalent.  On the same date, the patient was vaccinated with non-company, co-suspect Prevnar 20 (pneumococcal vaccine conj 20v (crm197); route of administration: intramuscular (IM), anatomical location: right arm (RA), dose and indication: not reported). The batch number reported was FL2935.  On 09-Sep-2022, one day after receiving Afluria Quadrivalent and non-company, co-suspects Moderna COVID-19 vaccine and Prevnar 20, the patient experienced rash about four inches in diameter on left arm. Rash was itchy. The patient did not take any medications.  On 12-Sep-2022, the patient recovered from the events of 'localised rash' and 'itchy rash'. As reported, the rash went away on it's own after three days.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 37-year-old, male patient experienced rash about four inches in diameter on left arm and the rash was itchy one day after receiving non-company, co-suspects Prevnar 20 in the right arm and Moderna COVID-19 vaccine with Afluria Quadrivalent at the same time and in the same anatomical location: left arm (explicitly coded as 'Product administration error'). The patient did not take any medication and the rash went away on it's own after three days. Despite confounding by co-suspect Moderna COVID-19 vaccine, causal role of the suspect product cannot be excluded. Therefore, causality for the reported events is assessed as possibly related due to plausible temporal relationship. Causality for product administration error is assessed as not related as per company's conventions.; Sender's Comments: A 37-year-old, male patient experienced rash about four inches in diameter on left arm and the rash was itchy one day after receiving non-company, co-suspects Prevnar 20 in the right arm and Moderna COVID-19 vaccine with Afluria Quadrivalent at the same time and in the same anatomical location: left arm (explicitly coded as 'Product administration error'). The patient did not take any medication and the rash went away on it's own after three days. Despite confounding by co-suspect Moderna COVID-19 vaccine, causal role of the suspect product cannot be excluded. Therefore, causality for the reported events is assessed as possibly related due to plausible temporal relationship. Causality for product administration error is assessed as not related as per company's conventions.