Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Hysterectomy
Clinical narrative: Hysterectomy; Bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of HYSTERECTOMY (Hysterectomy) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease (MODERATE TO SEVERE ADULT CROHN'S DISEASE).   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, 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) UNK,Solution for injection in pre-filled pen. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In March 2021, the patient experienced HYSTERECTOMY (Hysterectomy) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced BRONCHITIS (Bronchitis). In 2021, HYSTERECTOMY (Hysterectomy) had resolved. At the time of the report, BRONCHITIS (Bronchitis) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Aug-2021, the patient experienced tired due to booster covid vaccine, fever due to booster covid vaccine and felt achy due to booster covid vaccine. In 2021, all resolved. No concomitant medication information was reported. No treatment medication information was reported.  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 spontaneous case concerns a female patient aged 65 years with no relevant medical history reported, who experienced the unexpected serious (medically significant/Hospitalization) event of Hysterectomy that occurred on an unknown date (in March 2021) after second dose of mRNA-1273 vaccination. No further information on risk factors, clinical course, investigations and surgical details was available in the report. Outcome of the event was resolved at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   This case was linked to US-MODERNATX, INC.-MOD-2021-623429 (E2B Linked Report).; Sender's Comments: This spontaneous case concerns a female patient aged 65 years with no relevant medical history reported, who experienced the unexpected serious (medically significant/Hospitalization) event of Hysterectomy that occurred on an unknown date (in March 2021) after second dose of mRNA-1273 vaccination. No further information on risk factors, clinical course, investigations and surgical details was available in the report. Outcome of the event was resolved at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement. US-MODERNATX, INC.-MOD-2021-623429:Booster dose