Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | LA |
suicidal ideation; Acute psychosis onset day 3; Paranoia; feelings of persecution; aggression; anger; disorganized thoughts; anxiety; This is a spontaneous report received from a Consumer or other non HCP. A 52-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Sep2025 at 13:15 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 06Sep2025 as dose number unknown, single, in left arm for immunisation. The patient's relevant medical history included: "Fybromyalgia" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "alcoholism" (unspecified if ongoing); "bipolar disorder" (unspecified if ongoing); "anxiety disorder" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "cptsd" (unspecified if ongoing). Patient had no known allergies. There were no concomitant medications. There was no other vaccine in four weeks, no other medications in two weeks. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (DOSE 7 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: ACUTE PSYCHOSIS (disability) with onset 08Sep2025, outcome "not recovered", described as "Acute psychosis onset day 3"; PARANOIA (disability) with onset 08Sep2025, outcome "not recovered"; AGGRESSION (disability) with onset 08Sep2025, outcome "not recovered"; ANGER (disability) with onset 08Sep2025, outcome "not recovered"; ANXIETY (disability) with onset 08Sep2025, outcome "not recovered"; THINKING ABNORMAL (disability) with onset 08Sep2025, outcome "not recovered", described as "disorganized thoughts"; PERSECUTORY DELUSION (disability) with onset 08Sep2025, outcome "not recovered", described as "feelings of persecution"; SUICIDAL IDEATION (disability, medically significant) with onset 08Sep2025, outcome "not recovered". Clinical course: Acute psychosis onset day 3. Paranoia, feelings of persecution, aggression, anger, disorganized thoughts, anxiety and suicidal ideation. Events were resulted in Disability or permanent damage. Therapeutic measures were taken as a result of suicidal ideation, acute psychosis, paranoia, persecutory delusion, aggression, anger, thinking abnormal, anxiety which included antipsychotics, anxiety medications and ketamine. The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Alcoholism; Anxiety disorder; Bipolar disorder; Fibromyalgia; Hypertension; Hypothyroidism; Post-traumatic stress disorder