Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, Fear, Impaired work ability, Interchange of vaccine products, Mental impairment
Clinical narrative: feeling anonymous fear; Revaccination with different covid-19 vaccine; Interchange of vaccine products; could not work; mental problem; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (mental problem) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products TOZINAMERAN (COMIRNATY) for an unknown indication and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    The patient's past medical history included COVID-19 in February 2021.   In April 2021, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In April 2021, the patient experienced MENTAL IMPAIRMENT (mental problem) (seriousness criterion medically significant). In December 2021, the patient experienced IMPAIRED WORK ABILITY (could not work). On an unknown date, the patient experienced FEAR (feeling anonymous fear), COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, MENTAL IMPAIRMENT (mental problem), FEAR (feeling anonymous fear), IMPAIRED WORK ABILITY (could not work), COVID-19 IMMUNISATION (Revaccination with different covid-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Both time after receiving vaccine patient felt mental problem and In April patient could not work for almost four month and after booster also unable to work properly. Patient experienced anonymous fear and  mind was not working properly.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No treatment information was reported.  Company Comment: This is a spontaneous case concerning a female patient of unknown age with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Mental impairment, after receiving a dose of mRNA-1273 vaccine (reported as booster dose). Revaccination with different COVID-19 vaccine and Interchange of vaccine products was also reported as an additional event as the patient received other COVID-19 vaccine (Pfizer) prior to the mRNA-1273. The patient reported to experienced mental problem and could not work for almost 4 months after receiving the Pfizer vaccine. The patient again experienced mental problem after receiving the booster dose of mRNA-1273 and still could not work properly. The patient also had feeling of anonymous fear and her mind is not working properly. Exact date of vaccinations, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no relevant medical history, who experienced the unexpected, serious (medically significant) event of Mental impairment, after receiving a dose of mRNA-1273 vaccine (reported as booster dose). Revaccination with different COVID-19 vaccine and Interchange of vaccine products was also reported as an additional event as the patient received other COVID-19 vaccine (Pfizer) prior to the mRNA-1273. The patient reported to experienced mental problem and could not work for almost 4 months after receiving the Pfizer vaccine. The patient again experienced mental problem after receiving the booster dose of mRNA-1273 and still could not work properly. The patient also had feeling of anonymous fear and her mind is not working properly. Exact date of vaccinations, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.