Age: 80.0
Sex: F
Vaccine: COVID19, FLUA3, UNK
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Injection site mass, Injection site pain, Product administered at inappropriate site
Clinical narrative: Arm pain and a painful red lump at injection site; Painful, red lump at injection site; Painful, red lump at injection site; One vaccine was given too high; Fluad Quadrivalent and Moderna COVID-19 vaccines were administered on the same day, in the same left arm; This spontaneous case from retrieved on 27-Sep-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1697396-1), reported by other health professional and concerned a 80-year-old, female patient.   The patient's medical history and concomitant medications were not reported.  On 28-Aug-2021, the patient was vaccinated with non-company, co-suspect Covid-19 vaccine (Moderna mRNA-1273 vaccine; dose: reported as three, route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was 004F21A.  On the same day, 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 and indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was 312832. The patient thought that one of vaccines was given too high (explicitly coded as 'Product administered at inappropriate site').  On the same day, after receiving Fluad Quadrivalent and Covid-19 vaccine, the patient experienced severe arm pain and developed a painful, red lump at injection site. She went to urgent care and was told that one vaccine was given too high and they suggested to patient to report the incident.  On an unspecified date in 2021, the patient visited physician's office, however, the further details were not reported.   The outcome of the events was not reported.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A 80-year-old, female patient was vaccinated with the suspect product Fluad Quadrivalent and non-company, co-suspect Covid-19 vaccine.  Both products have been administered in the same arm (explicitly coded as 'Product administration error'). The patient thought that one of the vaccines was given too high (explicitly coded as 'Product administered at inappropriate site'). Both events are assessed as not related as per company specific guidelines. On the same day after vaccination the patient developed arm pain and a painful, red lump at injection site. Causality for these three events is assessed as possibly related although confounded by co-suspect vaccine and the reported medication errors.; Sender's Comments: A 80-year-old, female patient was vaccinated with the suspect product Fluad Quadrivalent and non-company, co-suspect Covid-19 vaccine.  Both products have been administered in the same arm (explicitly coded as 'Product administration error'). The patient thought that one of the vaccines was given too high (explicitly coded as 'Product administered at inappropriate site'). Both events are assessed as not related as per company specific guidelines. On the same day after vaccination the patient developed arm pain and a painful, red lump at injection site. Causality for these three events is assessed as possibly related although confounded by co-suspect vaccine and the reported medication errors.