Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Carpal tunnel syndrome, Fatigue, Hernia, Pancreatitis
Clinical narrative: RIGHT CARPAL TUNNEL; TRIGGER FINGER/RIGHT MIDDLE FINGER; PANCREATITIS; HERNIA; BEAT UP; TIRED; FEELING WEAK AFTER SECOND COVID VACCINE,; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATITIS (PANCREATITIS), CARPAL TUNNEL SYNDROME (RIGHT CARPAL TUNNEL) and TRIGGER FINGER (TRIGGER FINGER/RIGHT MIDDLE FINGER) in a 59-year-old male 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 Psoriatic arthritis.    Concurrent medical conditions included Psoriatic arthritis.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second 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) Citrate Free. On 18-Jan-2021, the patient experienced PANCREATITIS (PANCREATITIS) (seriousness criteria hospitalization and medically significant). In 2021, the patient experienced ASTHENIA (FEELING WEAK AFTER SECOND COVID VACCINE,), PHYSICAL ASSAULT (BEAT UP) and FATIGUE (TIRED). On an unknown date, the patient experienced CARPAL TUNNEL SYNDROME (RIGHT CARPAL TUNNEL) (seriousness criterion hospitalization), TRIGGER FINGER (TRIGGER FINGER/RIGHT MIDDLE FINGER) (seriousness criterion hospitalization) and HERNIA (HERNIA). The patient was hospitalized on 18-Jan-2021 due to PANCREATITIS. The patient was treated with Surgery (18-Jun-2021 right carpal tunnel surgery) for Carpal tunnel syndrome and Surgery (18-Jun-2021: right middle trigger finger released) for Trigger finger. At the time of the report, PANCREATITIS (PANCREATITIS), CARPAL TUNNEL SYNDROME (RIGHT CARPAL TUNNEL), TRIGGER FINGER (TRIGGER FINGER/RIGHT MIDDLE FINGER), ASTHENIA (FEELING WEAK AFTER SECOND COVID VACCINE,), HERNIA (HERNIA), PHYSICAL ASSAULT (BEAT UP) and FATIGUE (TIRED) outcome was unknown.         Company comment: This is a spontaneous case concerning a 59-year-old female patient with Psoriatic arthritis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected events pancreatitis, carpal tunnel syndrome and trigger finger. Patient was hospitalized due to pancreatitis approximately two months before receiving the first dose of mRNA-1273 and outcome was unknown. Stop date, clinical course, diagnostic tests and treatment details were not provided. Two months after second dose had right carpal tunnel surgery and also had right middle trigger finger released. Start date for conditions that lead to surgery were not provided and no complications were reported. Non-serious events fatigue and asthenia were reported related to second dose. Adalimumab was reported as a co-suspect product. Events seriousness captured as per SD. The benefit-risk relationship of mRNA-1273 is not affected by this report.   No concomitant medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient mentioned that feeling weak, tired and beat up after second dose of Covid 19 Vaccine. The reporter's causality for the event(s) of PANCREATITIS, RIGHT CARPAL TUNNEL, TRIGGER FINGER/RIGHT MIDDLE FINGER, FEELING WEAK AFTER SECOND COVID VACCINE, HERNIA, TIRED AND BEAT UP AFTER SECOND COVID VACCINE onset in 2021 and TIRED AND BEAT UP AFTER SECOND COVID VACCINE onset in 2021 was not provided. The event of PANCREATITIS was not assessable. There was no reasonable possibility that the events of RIGHT CARPAL TUNNEL, TRIGGER FINGER/RIGHT MIDDLE FINGER, FEELING WEAK AFTER SECOND COVID VACCINE, HERNIA, TIRED AND BEAT UP AFTER SECOND COVID VACCINE onset in 2021 and TIRED AND BEAT UP AFTER SECOND COVID VACCINE onset in 2021 are related to HUMIRA(ADALIMUMAB). No treatment medication 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.; Sender's Comments: Company comment: This is a spontaneous case concerning a 59-year-old female patient with Psoriatic arthritis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected events pancreatitis, carpal tunnel syndrome and trigger finger. Patient was hospitalized due to pancreatitis approximately two months before receiving the first dose of mRNA-1273 and outcome was unknown. Stop date, clinical course, diagnostic tests and treatment details were not provided. Two months after second dose had right carpal tunnel surgery and also had right middle trigger finger released. Start date for conditions that lead to surgery were not provided and no complications were reported. Non-serious events fatigue and asthenia were reported related to second dose. Adalimumab was reported as a co-suspect product. Events seriousness captured as per SD. The benefit-risk relationship of mRNA-1273 is not affected by this report.