Received Oct 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | IM |
severe hallucinations; she got Covid about 2 years ago; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (severe hallucinations) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. Concurrent medical conditions included Respiratory disorder. 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 (she 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 (she got Covid about 2 years ago) had resolved. At the time of the report, HALLUCINATION (severe hallucinations) had resolved. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown. No concomitant medications provided by the reporter. It was reported that patient had always Moderna vaccine but 2 times she took Pfizer dose vaccination. However, both times she had a reaction. It was reported that the Patient had severe hallucinations. When the patient slept, she used to see images in her brain. This was very disturbing for her. It was reported that patient got COVID about 2 years ago after having multiple vaccines. Patient had COVID for 3 weeks though she had treatment medication of Paxlovid. It was interpreted that she got COVID because she 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.; Reporter's Comments: Company comment: The benefit-risk relationship of the product is not affected by this report.
Respiratory disorder