Received Nov 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | NA0589 | OT / RA |
he felt a little bit ill; sore arm; his glucose levels were still really high; This is a spontaneous report received from a Pharmacist from medical information team. A 33-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 25Oct2025 as dose 1, 0.3 ml single (Lot number: NA0589, Expiration Date: 23Jun2026) intramuscular, in right arm for covid-19 immunisation, Device Lot Number: NA0589, Device Expiration Date: 23Jun2026. The patient's relevant medical history was not reported. Concomitant medication(s) included: HUMALOG subcutaneous taken for type 1 diabetes mellitus. The following information was reported: MALAISE (non-serious) with onset 2025, outcome "recovered" (2025), described as "he felt a little bit ill"; BLOOD GLUCOSE INCREASED (non-serious) with onset 2025, outcome "not recovered", described as "his glucose levels were still really high"; PAIN IN EXTREMITY (non-serious) with onset 2025, outcome "recovered" (2025), described as "sore arm". Therapeutic measures were taken as a result of blood glucose increased. Additional information: Pharmacist went to the site just to look at the side effects that patients could have after they get the vaccination and then one of my patients reported a side effect that she did not see there. But she was wondering if you had any idea if anybody else had it because she was not sure if it was related to the vaccine or if it was maybe just due to something else, and it was maybe a coincidence and timing. The patient was a type 1 diabetic, and then he noticed that, basically, so after he received the Comirnaty vaccination he had his usual side effects where he felt a little bit ill sore arm, but then he said about maybe 5 or a couple of days later he noticed that like no matter how much insulin he was using like his glucose levels were still really high, have you heard any of that?. We usually had an insulin pump, but then he was saying that he was just using more insulin than he usually does. He thought he was almost becoming resistant to the insulin. He asked his doctor as well and thinks his doctor was aware of this. The patient was not sure if it was a side effect so that was why pharmacist called and wanted to ask if it was a side effect that was known and when she looked it up online she didn't find anything. Patient didn't know if it was related to the vaccine. He received Comirnaty on 25Oct2025. Indication: Thinks he gets his annual flu shot and got the covid shot. He did not mention any treatment to her regarding him feeling a little bit ill and his sore arm. She was assuming it was his right arm that was sore but he didn't tell her which arm was sore. Glucose levels really high outcome: States this was ongoing as of yesterday afternoon but she had not called him today and needs to call him.
HUMALOG