Age: 70.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Contusion, Skin discolouration, Skin warm
Clinical narrative: Large left arm discoloration; Bruising from vaccines in same arm shingles/Flu; Hot to touch; Fluad Quadrivalent and Shingrix administered in the same arm; This spontaneous case was retrieved on 24-Dec-2020 from Vaccine Adverse Event Reporting System (reference number: 892542-1), reported by other health professional and concerned a 70-year-old, female patient.  The patient's medical history was not reported. The patient's concomitant medications included just prescribed medications (Rx's), used for an unreported indication. The patient had no known allergies.  On 18-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as one, route of administration: intramuscular, anatomical location: left arm, dose and indication: not reported) in same arm as Shingrix (explicitly coded as 'Product administration error'). The batch number reported was 279813.  On the same day, the patient was vaccinated with non-company, co-suspect Shingrix (varicella zoster vaccine rge (cho); dose: reported as second, route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was H552G.  On the same day, after receiving Fluad Quadrivalent and co-suspect Shingrix, the patient developed large left arm discoloration and bruising from vaccines received in the same arm. Caused very red large hand sized bruise on arm and still not right after one week. It was hot to touch, still after five days. It was reported that the area was mapped and watched for spreading. This was the second shot and the patient had no issues at the first shot.  On an unspecified date in Oct-2020, the patient visited physician's office, however further details were not provided.  At the time of initial reporting on 24-Dec-2020, the patient had not recovered from the events.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment:The patient developed all events on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. Reportedly, Fluad Quadrivalent and Shingrix were administered in the same arm. Causality may have been confounded by treatment with co-suspect vaccine Shingrix. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes). Product administration error is assessed as not related based on company's conventions.; Sender's Comments: The patient developed all events on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. Reportedly, Fluad Quadrivalent and Shingrix were administered in the same arm. Causality may have been confounded by treatment with co-suspect vaccine Shingrix. Considering all above mentioned, causal relationship for all events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes). Product administration error is assessed as not related based on company's conventions.