Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: moderna booster shot of covid vaccine made patient passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (moderna booster shot of covid vaccine made patient passed out) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 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) Solution for injection in pre-filled pen. In February 2022, the patient experienced LOSS OF CONSCIOUSNESS (moderna booster shot of covid vaccine made patient passed out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (moderna booster shot of covid vaccine made patient passed out) was resolving.            No concomitant medication was provided. Treatment medication was not provided by the reporter.  Patient had done with colonoscopy and the results were not reported.The patient was off Humira due to having colonoscopy.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for humira for the event(s) of moderna booster shot of covid vaccine made patient passed out was not provided.  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  Company Comment: This is a spontaneous case, reported by a consumer, concerning a 65-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Loss of consciousness, which occurred on the same month of the booster dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine on unspecified dates, prior to third mRNA-1273 vaccination. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer, concerning a 65-year-old female patient with no relevant medical history reported, who experienced the unexpected serious (medically significant) event of Loss of consciousness, which occurred on the same month of the booster dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine on unspecified dates, prior to third mRNA-1273 vaccination. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.