Received Dec 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | MY9550 | OT |
smell hallucinogen, a hallucinogenic smell, cigarette smoke up to ten times per day; This is a spontaneous report received from an Other HCP from medical information team. A 54-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 22Oct2025 as dose 1, 30 ug, single (Lot number: MY9550) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Chronic low back pain" (unspecified if ongoing); "HIV" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for hyperlipidaemia; CYCLOBENZAPRINE taken for back pain; IBUPROFEN; PHENTERMINE; VITAMIN D [VITAMIN D NOS]. The patient also took other concomitant therapy reported as HIV medication. Vaccination history included: spikevax/COVID vaccine moderna (received 0.5 mL, expiry date: 01Apr2024, intramuscular into his right deltoid), administration date: 10Jan2024, for COVID-19 Immunization; Shingles shot (dose 1), administration date: Aug2025, for Immunization. The following information was reported: HALLUCINATION, OLFACTORY (medically significant) with onset 29Oct2025, outcome "not recovered", described as "smell hallucinogen, a hallucinogenic smell, cigarette smoke up to ten times per day". The patient underwent the following laboratory tests and procedures: Blood HIV RNA: (20Nov2025) undetectable. Therapeutic measures were not taken as a result of hallucination, olfactory. Clinical course: On 22Oct2025, the patient received the 2025-2026 Adult formulation of Comirnaty. On 29Oct2025, after receiving vaccine, patient experienced hallucinogenic smell of cigarette smoke up to 10 times per day. His smell was of cigarette smoke. He is still experiencing it, said on average 5 times a day and some days it is up to 10 times a day and sometimes, it is suppose three times a day. It is still persisting, he thinks it might be improving but he was unsure. On 20Nov2025, he had his HIV viral load or RNA test and it was undetectable. He had blood work in Oct2025 but that was before he got that shot (Comirnaty). He got the flu shot (Flucelvax) and second shingles shot (Shingrix, lot number: 3X97J, expiration date: 25Mar2027) but that was on 31Oct2025, so that was after he stated smelling the cigarette smoke. The patient is also enrolled in a clinical trial and receiving a study drug and reporter is trying to determine if the hallucinogenic smell might be attributable to the covid vaccine or if it's more likely from study drug. The reporter asked if there have been any care reports at all regarding hallucinogenic smells after receiving the Pfizer covid vaccine. The reporter feels like it is more likely related to the vaccine because it started a week after his vaccination. was his first time receiving Pfizer COVID vaccine. He has been previously vaccinated with COVID vaccine but they were Moderna, so this is first Pfizer one and then the week afterwards this started and has continued since then.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the event Hallucination, olfactory and the suspect drug Comirnaty. 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
Medical History/Concurrent Conditions: Blood pressure abnormal; HIV disease; Hyperlipidemia; Immunocompromised; Low back pain
ATORVASTATIN; CYCLOBENZAPRINE; IBUPROFEN; PHENTERMINE; VITAMIN D [VITAMIN D NOS]
Test Date: 20251120; Test Name: HIV viral load/RNA test; Result Unstructured Data: Test Result:undetectable