Age: 20.0
Sex: F
Vaccine: COVID19, FLUA4, COVID19, FLU4
Symptoms: Herpes zoster, Pain in extremity, Product administration error, Rash pustular
Clinical narrative: Pustule like rash under left arm; Symptoms of shingles; Afluria Quadrivalent and Moderna COVID-19 vaccine administered in the same arm on the same date; Sore arm; This spontaneous case from the Country was retrieved on 15-Nov-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2700236-1), reported by the other healthcare professional, and concerned a 20-year-old, female patient.  The patient's concurrent condition included latent tuberculosis (LT). The patient was not taking any concomitant medications and had no allergies.   On 19-Oct-2023, the patient was vaccinated with non-company, co-suspect Moderna COVID-19 vaccine (elasomeran; route of administration: intramuscular (IM), anatomical location: left arm (LA), dose and indication: not reported). The batch number reported was 3030592.  It was reported that on 19-Oct-2023 the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: reported as '1', route of administration: intramuscular (IM), anatomical location: left arm (LA), and indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was AU4541A. 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 an unspecified date in Oct-2023, reported as 'prior to shingles symptoms', the patient had a sore arm from shot.  On 22-Oct-2023, three days after receiving Afluria Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine, the patient started having symptoms of shingles and developed a pustule like rash that appeared under left arm.   On an unspecified date in Oct-2023, the patient visited the physician's office, however, no further information was provided.    At the time of initial reporting, the patient had not recovered from the events shingles, pain in arm and pustular rash.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A 20-year-old patient was vaccinated with suspect Afluria Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine on the same day, in the same arm (explicitly coded as 'Product administration error'). Within three days following vaccination, the patient experienced pain in extremity, pustular rash and Herpes Zoster. Product administration error is assessed as not related per company's conventions. Causality of event Herpes Zoster is assessed as not related, due to biological implausibility. Although causality is confounded by co-suspect vaccine, it is assessed as possibly related for events pain in extremity and rash pustular, due to chronological plausibility.; Sender's Comments: A 20-year-old patient was vaccinated with suspect Afluria Quadrivalent and non-company, co-suspect Moderna COVID-19 vaccine on the same day, in the same arm (explicitly coded as 'Product administration error'). Within three days following vaccination, the patient experienced pain in extremity, pustular rash and Herpes Zoster. Product administration error is assessed as not related per company's conventions. Causality of event Herpes Zoster is assessed as not related, due to biological implausibility. Although causality is confounded by co-suspect vaccine, it is assessed as possibly related for events pain in extremity and rash pustular, due to chronological plausibility.