Sex: F
Vaccine: COVID19
Symptoms: Asthma, Diabetes mellitus, Diarrhoea, Inappropriate schedule of product administration
Clinical narrative: Diabetic; Asthma; Patient got sick after her booster shot with diarrhea; Inappropriate schedule of vaccine administration; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (Diabetic) in a 76-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) solution for injection for an unknown indication.    The patient had no known allergies.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-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) at an unspecified dose. On 01-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration). On an unknown date, the patient experienced DIABETES MELLITUS (Diabetic) (seriousness criterion medically significant), ASTHMA (Asthma) and DIARRHOEA (Patient got sick after her booster shot with diarrhea). The patient was treated with BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) at an unspecified dose and frequency and FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]) at an unspecified dose and frequency. At the time of the report, DIABETES MELLITUS (Diabetic), ASTHMA (Asthma), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) and DIARRHOEA (Patient got sick after her booster shot with diarrhea) outcome was unknown.            No concomitant drugs were taken by patient.  Causality for Humira (solution for injection in pre-filled syringe): the reporter's causality for the event(s) of diabetic, asthma 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 an elderly female patient of an unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Diabetes mellitus on an unknown date after receiving the mRNA-1273 vaccine along with the other non-serious events. Clinical course was not reported. The outcome of event was reported as unknown. Patient received 3 doses of mRNA-1273 vaccine, with primary series given approximately 4 months apart, and 3rd dose was given 5 months later. On unknown date, patient received co-suspect Adalimumab (unknown indication) which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-620173 (Patient Link).; Sender's Comments: This spontaneous case concerns an elderly female patient of an unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Diabetes mellitus on an unknown date after receiving the mRNA-1273 vaccine along with the other non-serious events. Clinical course was not reported. The outcome of event was reported as unknown. Patient received 3 doses of mRNA-1273 vaccine, with primary series given approximately 4 months apart, and 3rd dose was given 5 months later. On unknown date, patient received co-suspect Adalimumab (unknown indication) which could be a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.