Sex: F
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Diabetes mellitus, Electric shock sensation, Hidradenitis
Clinical narrative: Diabetes mellitus aggravated; Electric shock sensation; Back pain (with radiation); Pain; COVID-19; Hidradenitis suppurativa; Spot-like rash; This spontaneous case was reported by a consumer and describes the occurrence of DIABETES MELLITUS (Diabetes mellitus aggravated) in an adult 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 Hidradenitis suppurativa.    The patient's past medical history included Liver disorder.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-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 an unknown date, the patient experienced DIABETES MELLITUS (Diabetes mellitus aggravated) (seriousness criterion medically significant), ELECTRIC SHOCK SENSATION (Electric shock sensation), BACK PAIN (Back pain (with radiation)), PAIN (Pain), COVID-19 (COVID-19), HIDRADENITIS (Hidradenitis suppurativa) and RASH MACULAR (Spot-like rash). At the time of the report, DIABETES MELLITUS (Diabetes mellitus aggravated) was resolving, ELECTRIC SHOCK SENSATION (Electric shock sensation), BACK PAIN (Back pain (with radiation)), PAIN (Pain), HIDRADENITIS (Hidradenitis suppurativa) and RASH MACULAR (Spot-like rash) outcome was unknown and COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Concomitant medications were not reported. Treatment information was not provided.  Company Comment: This is a spontaneous case concerning  an adult female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Diabetes mellitus and unexpected non-serious events of Electric shock sensation, Back pain, Pain, COVID-19, Hidradenitis and expected non-serious event of Rash macular. The exact date of the onset of events was not specified, hence latency could not be assessed. Patient tested positive for SARS COV 2 Test. No further details on clinical course and treatment received were reported. Outcome of the events had resolved at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  an adult female patient with no relevant medical history, who experienced the unexpected serious (medically significant) event of Diabetes mellitus and unexpected non-serious events of Electric shock sensation, Back pain, Pain, COVID-19, Hidradenitis and expected non-serious event of Rash macular. The exact date of the onset of events was not specified, hence latency could not be assessed. Patient tested positive for SARS COV 2 Test. No further details on clinical course and treatment received were reported. Outcome of the events had resolved at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.