Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
severe hallucinations; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789858. A patient (age and gender not provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 2023 (unspecified if ongoing); "Respiratory disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HALLUCINATION (medically significant) with onset 2023, outcome "recovered", described as "severe hallucinations". No follow-up attempts are possible. Clinical course: Patient received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (Intramuscular use) 1 dosage form. On an unknown date, received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In 2023, the patient experienced COVID-19 ( got Covid about 2 years ago). On an unknown date, the patient experienced HALLUCINATION (severe hallucinations) (seriousness criterion medically significant). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) in 2023 at an unspecified dose and frequency. In 2023, COVID-19 ( got Covid about 2 years ago) had resolved. It was reported that patient had always Moderna vaccine but 2 times took Pfizer dose vaccination. However, both times had a reaction. It was reported that the Patient had severe hallucinations. When the patient slept, used to see images in brain. This was very disturbing for . It was reported that patient got COVID about 2 years ago after having multiple vaccines. Patient had COVID for 3 weeks though had treatment medication of Paxlovid. It was interpreted that got COVID because always had Moderna vaccines and had gotten Pfizer which was premature. The Patient unable to take penicillin but it was not explained the reason. It was unknown if the patient experienced any additional symptoms or events. Company comment: The benefit-risk relationship of the product is not affected by this report. Batch/lot number is not provided, and it cannot be obtained.
Medical History/Concurrent Conditions: COVID-19; Respiratory disorder