Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Having a little bit more expression; Having laryngitis that started the day after received the vaccine; Had a lot of fatigue; Needed to sleep a lot; Flu-like symptoms; This is a spontaneous report received from a Pharmacist. An 84-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious), 1 day after the suspect product(s) administration, outcome "recovering", described as "Having a little bit more expression"; LARYNGITIS (non-serious), 1 day after the suspect product(s) administration, outcome "recovering", described as "Having laryngitis that started the day after received the vaccine"; FATIGUE (non-serious), 1 day after the suspect product(s) administration, outcome "recovering", described as "Had a lot of fatigue; Needed to sleep a lot"; INFLUENZA LIKE ILLNESS (non-serious), 1 day after the suspect product(s) administration, outcome "recovering", described as "Flu-like symptoms". Additional information: the patient had some concern about some side effects she was experiencing the day after getting her COVID vaccine, so the latest formulation of the Comirnaty and she wanted the reporter (pharmacist) to reach out and see if it is normal. The reporter thought that it is just that she was elderly. The patient was 84 years old, and reporter thought that she was just having a little bit more expression of it, but essentially she was stating that she was having laryngitis that started the day after received the vaccine and that she had a lot of fatigue where she needed to sleep a lot, like 6 hours the first day, 3 hours the next day, she was able to speak to the reporter on the phone, so the reporter believed everything was improving. So, the reporter thought that it was fine that she had what reporter like to call flu-like symptoms. The reporter did not believe she was contagious. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.