Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products
Clinical narrative: Revaccination with different COVID-19 vaccine; Interchange of vaccine products; COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate To Severe Adult Crohn's Disease).   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. In 2021, received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free. In May 2022, the patient experienced COVID-19 (COVID). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, COVID-19 (COVID), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.            There was no reported medical history.  Primary reporter contact for lot number information was unsuccessful for 2nd dosing regimen for Humira.  The reporter's causality for the evens of Covid was not provided for Humira and possibly related with Pfizer Biotech Covid-19 Vaccine.  It was unknown if patient was enrolled in a covid-19 vaccine trial.   No treatment information was reported.  Company comment: This spontaneous case concerns a 60 year-old male patient with medical history of Crohn's disease, who experienced the unexpected non-serious AESI event of COVID-19 approximately 5 months after the third dose of mRNA-1273 vaccine in covid-19 vaccination series. Patient received two doses of PFIZER BIONTECH COVID-19 VACCINE in 2021 (exact dates not provided) followed by another two doses of mRNA-1273 vaccine (with an approximate interval of 9 months). Further information on the risk factors, clinical course additional vaccination details and treatment details were not provided. The event outcome was unknown at the time of report.  Ongoing COVID-19 pandemic and interchange of vaccine product remain as confounders. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events' seriousness was assessed as per medical judgement and available information.   This case was linked to MOD-2022-587227 (Patient Link).; Sender's Comments: This spontaneous case concerns a 60 year-old male patient with medical history of Crohn's disease, who experienced the unexpected non-serious AESI event of COVID-19 approximately 5 months after the third dose of mRNA-1273 vaccine in covid-19 vaccination series. Patient received two doses of PFIZER BIONTECH COVID-19 VACCINE in 2021 (exact dates not provided) followed by another two doses of mRNA-1273 vaccine (with an approximate interval of 9 months). Further information on the risk factors, clinical course additional vaccination details and treatment details were not provided. The event outcome was unknown at the time of report.  Ongoing COVID-19 pandemic and interchange of vaccine product remain as confounders. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events' seriousness was assessed as per medical judgement and available information.