Age: 61.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Pain in extremity, Product administration error
Clinical narrative: Painful lymph nodes; Swollen lymph nodes; Body aches; Weak; Arm soreness; Tired; Both flu and covid vaccine administered in left arm on the same day; This spontaneous case was received on 12-Jan-2023 from Pfizer via Communications (reference number: SEQW23-00212) with additional information retrieved on 13-Jan-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2546469-1) and on 16-Jan-2023 from Seqirus (being processed together) reported by other non-healthcare professional and concerned a 61-year-old, female patient.  The patient's medical history and concomitant medications were not reported. The patient had no covid before vaccination and not tested for covid after vaccination.  On 19-Dec-2022, at 04:45 pm, the patient was vaccinated with non-company, co-suspect Pfizer BioNTech COVID-19 vaccine (tozinameran; dose: reported as 'one', anatomical location: left arm and route of administration: not reported) for COVID-19 immunisation. The batch number reported was FR2587.  On the same date, the patient was vaccinated with Flucelvax Quadrivalent (disrepently reported as Flucelvax (TIV); Fluad TIV license had been withdrawn, effective 03-Mar-2021) (influenza vaccine inact sag 4v; dose: reported as 'one', anatomical location: left arm and route of administration: not reported) for immunisation (explicitly coded as 'Product administration error').  The batch number was not reported.  On the same date, after receiving Flucelvax Quadrivalent and non-company, co-suspect Pfizer-BioNTech COVID-19 Vaccine, Bivalent, the patient experienced body aches, patient was weak and tired, experienced arm soreness and the patient's lymph nodes was swollen and painful.  On 20-Dec-2022, 16 hours after vaccination, the patient took 1000 mg of Tylenol (paracetamol). On the same date, 24 hours after vaccination, the patient switched to Allevess (capsaicin, menthol).  On 21-Dec-2022, 38 hours after vaccination, the patient took 1000 mg of Tylenol.  At the time of the initial reporting, the patient was recovering from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 61-year-old patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect Pfizer-BioNTech COVID-19 Vaccine. On the same date, after receiving, the patient experienced body aches, asthenia, fatigue, arm soreness and the patient's lymph nodes was swollen and painful. Both vaccines were administered on the same day in same arm, which may have contributed to development of the pain in arm. However, causal role of the suspect vaccine is assessed as possibly related all events (pain in extremity, asthenia, pain, fatigue, lymphadenopathy, lymph node pain). Product administration error is assessed as unrelated per company's conventions.; Sender's Comments: A 61-year-old patient was vaccinated with Flucelvax Quadrivalent and non-company, co-suspect Pfizer-BioNTech COVID-19 Vaccine. On the same date, after receiving, the patient experienced body aches, asthenia, fatigue, arm soreness and the patient's lymph nodes was swollen and painful. Both vaccines were administered on the same day in same arm, which may have contributed to development of the pain in arm. However, causal role of the suspect vaccine is assessed as possibly related all events (pain in extremity, asthenia, pain, fatigue, lymphadenopathy, lymph node pain). Product administration error is assessed as unrelated per company's conventions.