Received Sep 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | NA0587 | OT / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUBLOK) | SANOFI PASTEUR | UNK | TFAA2504 | — |
her bandage was very moist and not just with blood.; her bandage was very moist and not just with blood.; This is a spontaneous report received from a Pharmacist from medical information team. A female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 07Sep2025 as dose 1, single (Lot number: NA0587, Expiration Date: 16Jun2026) intramuscular, in left arm for covid-19 immunisation; influenza vaccine rha 3v (baculovirus) (FLUBLOK), on 07Sep2025 as dose number unknown, single (Lot number: TFAA2504) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious), VACCINATION SITE DISCHARGE (non-serious) all with onset 07Sep2025, outcome "unknown" and all described as "her bandage was very moist and not just with blood.". Additional information: Patient was administered a Covid vaccine, 2025-2026 formula, over the weekend. When patient got home about 2 hours later, she noticed that her bandage was very moist and not just with blood. It appeared that the vaccine had possibly leaked out onto the bandage and patient is concerned that she did not get the full dose. The pharmacist looked at the bandage as well and there was blood from vaccine on the bandage, but it was difficult to tell if vaccine had leaked out on the bandage as well. Caller wanted to know if Pfizer had reported of there being a defective lot of Comirnaty which might cause vaccine leakage from the needle or syringe. Patient was immunocompromised. Transferring agent stated, "I have a Pharmacist to transfer to you. She is reporting on the Comirnaty, 2025-2026 formula. She states that a patient received the vaccine and two hours later after arriving home, noticed that their band aid was very moist. Patient felt like some of the vaccine might have leaked out of her arm because the bandage was more moist than it just being blood. The bandage was more moist than they are just being blood. The patient felt that the vaccine leaked out of her arm onto the bandage. Patient has a history of being Immunocompromised." Reporter stated, "I just do not have the height. I can guess the height, but I do not have the height." Reporter stated, "The date was Sunday, the 7th (Clarified as 07Sep2025) around noon, but it is around noon, I do not have time in record, but for sure 07Sep2025." Any vaccination on same date or any four weeks prior vaccination: Reporter stated, "Same day vaccination with the Flu shot." (Further details about Flublok not available on which arm Patient got the vaccine, hence Flublok captured as suspect). Name of Flu shot: Reporter stated, "So, patient also got Flublok for the 25-26 season." Other medical conditions and concomitant medications: Reporter stated, "Not that I know of, no, nothing else." Caller, a pharmacist was calling about the Vaccine Comirnaty 2025-2026 formula that was administered to a patient. Caller mentioned that the patient went back to their office claiming that the vaccine was not fully administered since the injection sight was leaking as the band aid was moist. Causality: Reporter stated, "I do not know. I was not the one who administered so, I would not know how much was their vaccine that leaked out. So, in honest with me, I would not know."