Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose abnormal, COVID-19
Clinical narrative: Sugar over 700; COVID; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE ABNORMAL (Sugar over 700) 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) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. On an unknown date, the patient experienced BLOOD GLUCOSE ABNORMAL (Sugar over 700) (seriousness criterion hospitalization) and COVID-19 (COVID). At the time of the report, BLOOD GLUCOSE ABNORMAL (Sugar over 700) was resolving and COVID-19 (COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: over 700 abnormal over 700.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The patient was hospitalized due to sugar over 700. She was off Humira since Dec 2021. She started to felt difference since off Humira and it was better. She had COVID after first booster and only lost taste. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date blood sugar was tested. No treatment medication was reported.   Causality for HUMIRA (ADALIMUMAB) The reporter's causality for the event (s) of SUGAR OVER 700 and COVID was not provided. tTere was no reasonable possibility that the events of SUGAR OVER 700 and COVID are related to HUMIRA (ADALIMUMAB). Action(s) taken with drug ADALIMUMAB for Blood sugar abnormal was Drug discontinued and COVID-19 was unknown. De-challenge was positive for  Blood sugar abnormal  and Not applicable for COVID-19.  Company comment-This spontaneous case concerns an adult female patient of unknown age with no relevant medical history reported, who experienced the unexpected serious (hospitalization) event of Blood glucose abnormal and unexpected non serious AESI of Covid 19 unspecified days after receiving a dose (booster) of mRNA-1273 vaccine in the covid 19 vaccination series. Patient was hospitalized due to sugar over 700. She was off co suspect Humira since Dec2021 and felt better. She had covid after first booster and had only lost taste. No further details on other lab test results and treatment received were reported. Outcome of the event Blood glucose abnormal was resolving and Covid 19 was not known at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns an adult female patient of unknown age with no relevant medical history reported, who experienced the unexpected serious (hospitalization) event of Blood glucose abnormal and unexpected nonserious AESI of Covid 19 unspecified days after receiving a dose (booster) of mRNA-1273 vaccine in the covid 19 vaccination series. Patient was hospitalized due to sugar over 700. She was off co suspect Humira since Dec2021 and felt better. She had covid after first booster and had only lost taste. No further details on other lab test results and treatment received were reported. Outcome of the event Blood glucose abnormal was resolving and Covid 19 was not known at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.