Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; Revaccination with different COVID-19 vaccine; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in a 76-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   In 2022, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate Free. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form., ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. In July 2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.            Concomitant product use was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Treatment information was not provided.  The primary reporter did not have the lot number information, because the information was not available in the patients file.  The reporter's causality for the event of COVID was not provided for Humira and possible for Pfizer Biontech COVID-19 Vaccine.  Company comment: This spontaneous case concerns a 76-year-old female patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after a dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Additional vaccination with Pfizer COVID-19 vaccine could be a confounding factor. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 76-year-old female patient with no relevant medical history reported, who experienced the adverse event of special interest of COVID-19 an unknown time after a dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Additional vaccination with Pfizer COVID-19 vaccine could be a confounding factor. Outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.