Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Condition aggravated, Diabetes mellitus, Vaccination site pain
Clinical narrative: The patient's blood glucose was 400 and more (no unit provided) on 10Apr2021; Blood glucose levels started rising; glucose level had reached 400 and more; Blood glucose levels started rising; glucose level had reached 400 and more; Soreness at the injection site; This is a spontaneous report from a contactable nurse (patient's grandmother). A 16-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration, administered in left arm on 09Apr2021 10:45 (at the age of 16-year-old) as a single dose for COVID-19 immunization. Medical history included type 1 diabetes mellitus and hypothyroidism. Concomitant medications included levothyroxine (manufacturer unknown) and insulin lispro (HUMALOG) via insulin pump; both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, the patient experienced soreness at the injection site and blood glucose levels started rising. The patient's blood glucose was 400 and more (no unit provided) on 10Apr2021 and blood glucose was normal on 11Apr2021 at 2-4 AM.  The clinical course was reported as follows: "I am retired RN and grandmother reporting for my grandson who has type 1 diabetes and uses insulin pump. Initially he experienced no adverse events after injection of vaccine. Approximately 6-7 hours after receiving the vaccine (09Apr2021), his blood glucose levels started rising. He had dosed insulin correctly upon eating. Throughout the evening his blood glucose continued to rise and did not respond to usual doses on insulin. We changed the insertion site for the pump 2x, changed pump cassette and added insulin to the cassette from a new insulin cartridge. On Saturday 10Apr2021, glucose level had reached 400 and more. Glucose level returned to his normal on 11Apr2021 @ 2-4 AM. He had no other adverse symptoms other than a bit of soreness at the injection site. We did not see anything specific in vaccine info about diabetics getting elevated blood glucose. I would like to suggest this be added to patient educational materials." No treatment was received for the adverse events (as reported). The clinical outcome of the event "blood glucose levels started rising; glucose level had reached 400 and more" was resolved on 11Apr2021 and the event "soreness at the injection site" was resolved on an unspecified date in Apr2021.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events: Diabetes Mellitus, Condition Aggravated, Blood Glucose Increased  and the administration of the vaccine cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.