Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Colitis ulcerative, Feeling drunk, Inappropriate schedule of product administration, Lactose intolerance, Nausea
Clinical narrative: Insulin dependent diabetic; Ulcerative colitis; Lactose intolerant; Felt Drank even though did not drink; Lot of pain; Nauseous; Inappropriate schedule of product administration; This spontaneous case was reported by a consumer and describes the occurrence of TYPE 1 DIABETES MELLITUS (Insulin dependent diabetic) and COLITIS ULCERATIVE (Ulcerative colitis) in a 58-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 Psoriatic arthritis.    No Medical History information was reported.   On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-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) at an unspecified dose. On an unknown date, the patient experienced TYPE 1 DIABETES MELLITUS (Insulin dependent diabetic) (seriousness criterion medically significant), COLITIS ULCERATIVE (Ulcerative colitis) (seriousness criterion medically significant), LACTOSE INTOLERANCE (Lactose intolerant), FEELING DRUNK (Felt Drank even though did not drink), PAIN (Lot of pain), NAUSEA (Nauseous) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, TYPE 1 DIABETES MELLITUS (Insulin dependent diabetic), COLITIS ULCERATIVE (Ulcerative colitis), LACTOSE INTOLERANCE (Lactose intolerant), FEELING DRUNK (Felt Drank even though did not drink), PAIN (Lot of pain), NAUSEA (Nauseous) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) outcome was unknown.            No Concomitant medication reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  There was no reported medical history.  The reporter's causality with Humira for the event(s) of Insulin dependent diabetic, Lactose Intolerant, Felt drank even though did not drink, Lot of pain, Nauseous and Ulcerative colitis 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 spontaneous case concerns a 58-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) events of Type 1 diabetes mellitus and Colitis ulcerative on an unknown date after receiving a dose of mRNA-1273 vaccine and co-suspect Adalimumab. The events were reported along with non-serious lactose intolerance and nausea. Patient was treated with cortisone. Clinical course was not reported. The outcome of events was reported as unknown. Patient received 1st and 2nd dose of mRNA-1273 vaccine 36 days apart (Inappropriate schedule of product administration noted). Co-suspect Adalimumab for psoriatic arthritis could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 58-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) events of Type 1 diabetes mellitus and Colitis ulcerative on an unknown date after receiving a dose of mRNA-1273 vaccine and co-suspect Adalimumab. The events were reported along with non-serious lactose intolerance and nausea. Patient was treated with cortisone. Clinical course was not reported. The outcome of events was reported as unknown. Patient received 1st and 2nd dose of mRNA-1273 vaccine 36 days apart (Inappropriate schedule of product administration noted). Co-suspect Adalimumab for psoriatic arthritis could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.