Age: 58.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products, Transient global amnesia
Clinical narrative: TRANSIENT GLOBAL AMNESIA; received Pfizer-BioNTechCOVID-19 vaccine as booster dose; received Pfizer-BioNTechCOVID-19 vaccine as booster dose; CONTRACTED COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (CONTRACTED COVID), TRANSIENT GLOBAL AMNESIA (TRANSIENT GLOBAL AMNESIA), INTERCHANGE OF VACCINE PRODUCTS (received Pfizer-BioNTechCOVID-19 vaccine as booster dose) and COVID-19 IMMUNISATION (received Pfizer-BioNTechCOVID-19 vaccine as booster dose) in a 58-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Crohn's disease (MODERATE TO SEVERE ADULT CROHN'S DISEASE).   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form., ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. In July 2022, the patient experienced COVID-19 (CONTRACTED COVID). On an unknown date, the patient experienced TRANSIENT GLOBAL AMNESIA (TRANSIENT GLOBAL AMNESIA), INTERCHANGE OF VACCINE PRODUCTS (received Pfizer-BioNTechCOVID-19 vaccine as booster dose) and COVID-19 IMMUNISATION (received Pfizer-BioNTechCOVID-19 vaccine as booster dose). At the time of the report, COVID-19 (CONTRACTED COVID), TRANSIENT GLOBAL AMNESIA (TRANSIENT GLOBAL AMNESIA), INTERCHANGE OF VACCINE PRODUCTS (received Pfizer-BioNTechCOVID-19 vaccine as booster dose) and COVID-19 IMMUNISATION (received Pfizer-BioNTechCOVID-19 vaccine as booster dose) had resolved.            No concomitant medications were reported.  There was no reported medical history.  In Jul-2022, the patient experienced contracted Covid and in 2022, the contracted Covid was resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the event(s) of transient global amnesia and contracted Covid with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of transient global amnesia and contracted Covid with PFIZER BIONTECH COVID-19 vaccine (TOZINAMERAN) was possible.  No treatment information was provided by the reporter.  Company Comment: This is a spontaneous case concerning a 58-year-old male patient with a concurrent medical condition of Crohn's disease treated with Humira (Adalimumab), vaccinated with the primary series of COVID-19 vaccine mRNA-1273, who experienced the unexpected non-serious events of COVID-19 (AESI) and Transient global amnesia which occurred unknown number of days after receiving a dose of mRNA-1273 Vaccine, dose number unknown. Patient also received a booster dose of COVID-19 vaccine Tozinameran. Revaccination with different COVID-19 vaccine and Interchange of vaccine products noted. There is no available information regarding clinical course, diagnostic tests, and treatment medication. Vaccination date and event onset date were also not provided; hence, onset latency could not be assessed. The patient's use of Humira, which is an immunosuppressant, remains a predisposition risk factor for event COVID-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 58-year-old male patient with a concurrent medical condition of Crohn's disease treated with Humira (Adalimumab), vaccinated with the primary series of COVID-19 vaccine mRNA-1273, who experienced the unexpected non-serious events of COVID-19 (AESI) and Transient global amnesia which occurred unknown number of days after receiving a dose of mRNA-1273 Vaccine, dose number unknown. Patient also received a booster dose of COVID-19 vaccine Tozinameran. Revaccination with different COVID-19 vaccine and Interchange of vaccine products noted. There is no available information regarding clinical course and treatment medication. Vaccination date and event onset date were also not provided; hence, onset latency could not be assessed. The patient's use of Humira, which is an immunosuppressant, remains a predisposition risk factor for event COVID-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.