Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT |
CHI (Life threatening illness); schizophrenia; bipolar one; mental fog; My heart, my hair fell out; My heart, my hair fell out; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 17Mar2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 56-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications within 2 weeks prior to the event onset. Vaccination history included: Covid-19 vaccine (DOSE 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, manufacturer unknown), for COVID-19 immunization. The following information was reported: CRANIOCEREBRAL INJURY (life threatening), outcome "unknown", described as "CHI (Life threatening illness)"; SCHIZOPHRENIA (medically significant), outcome "unknown"; BIPOLAR I DISORDER (medically significant), outcome "unknown", described as "bipolar one"; MENTAL IMPAIRMENT (medically significant), outcome "unknown", described as "mental fog"; ALOPECIA (non-serious), CARDIAC DISORDER (non-serious), outcome "unknown" and all described as "My heart, my hair fell out". The patient had post vaccination problems. Therapeutic measures were taken as a result of craniocerebral injury. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.