Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gallbladder operation, Gastrectomy, Vaccination site pain
Clinical narrative: Fatigue; COVID VACCINE ISSUE/INJECTION SITE PAIN; Gallbladder Surgery; GASTRIC SLEEVE SURGERY; This spontaneous case was reported by a consumer and describes the occurrence of GASTRECTOMY (GASTRIC SLEEVE SURGERY) and GALLBLADDER OPERATION (Gallbladder Surgery) in a 46-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 Ankylosing spondylitis.    No Medical History information was reported.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 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) 1 dosage form. On 26-May-2022, the patient experienced GASTRECTOMY (GASTRIC SLEEVE SURGERY) (seriousness criterion medically significant). In June 2022, the patient experienced GALLBLADDER OPERATION (Gallbladder Surgery) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (COVID VACCINE ISSUE/INJECTION SITE PAIN). At the time of the report, GASTRECTOMY (GASTRIC SLEEVE SURGERY), GALLBLADDER OPERATION (Gallbladder Surgery), FATIGUE (Fatigue) and VACCINATION SITE PAIN (COVID VACCINE ISSUE/INJECTION SITE PAIN) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medication was not provided.  For drug HUMIRA, the reporter causality was given as not reported for Sleeve gastrectomy, Gallbladder operation and Mfr. causality reported as No reasonable possibility. The reporter causality was given as not reported for Fatigue, Vaccination site pain and Mfr. causality reported as Not assessable  It was unknown if patient was enrolled in a covid-19 vaccine Trial.  Primary reporter contact for lot number information was unsuccessful.  Treatment information was not reported.  Company comment: This spontaneous case concerns a 46-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) events of Gastrectomy and Gallbladder operation after receiving the mRNA-1273 vaccine and co-suspect Adalimumab. It was reported that patient received Adalimumab for ankylosing spondylitis and 3 doses of mRNA-1273 vaccine, both on unspecified dates. The events occurred consecutive months within the same year of administration of the 3rd dose of mRNA-1273 vaccine. Diagnosis, indication of surgery, and clinical course were not reported. The outcome of events was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 46-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) events of Gastrectomy and Gallbladder operation after receiving the mRNA-1273 vaccine and co-suspect Adalimumab. It was reported that patient received Adalimumab for ankylosing spondylitis and 3 doses of mRNA-1273 vaccine, both on unspecified dates. The events occurred consecutive months within the same year of administration of the 3rd dose of mRNA-1273 vaccine. Diagnosis, indication of surgery, and clinical course were not reported. The outcome of events was reported as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.