Received Jan 2, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | 00069-2528-10 | LA |
Psychosis; violent suicidal ideation; non-arteritic ischemic optic neuropathy; sudden right eye vision loss; Increased peripheral neuropathy (formerly mild tingling became burning with bottom of feet having altered sensation impacting balance); Increased peripheral neuropathy (formerly mild tingling became burning with bottom of feet having altered sensation impacting balance); swollen hands and ankles; swollen hands and ankles; Migraine headache; Constant mild headache; nausea; This is a spontaneous report received from a Consumer or other non HCP. A 70-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 11Dec2025 at 16:00 as dose 1, single (Lot number: 00069-2528-10) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "medications allergy" (unspecified if ongoing); "mild tingling" (unspecified if ongoing); "peripheral neuropathy" (ongoing). Concomitant medication(s) included: ESOMEPRAZOLE; OXCARBAZEPIN; FORTEO; CALCIUM; VITAMIN D+K; MAGNESIUM; B COMPLEX [AMINOBENZOIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE;CYANOCOBALAMIN;FOLIC ACID;INOSITOL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE]; TURMERIC [CURCUMA LONGA]. The patient also took other concomitant therapy. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE; MANUFACTURER UNKNOWN, event outcome resolved within a day), administration date: Oct2021, when the patient was 66 years old, for Covid-19 Immunization, reaction(s): "swollen hands and ankles"; Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE; MANUFACTURER UNKNOWN, event cleared completely without medication within 24 hours of onset), administration date: Oct2021, when the patient was 66 years old, for Covid-19 Immunization, reaction(s): "violent suicidal ideation"; Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE; MANUFACTURER UNKNOWN, event cleared completely without medication within 24 hours , of onset), administration date: Oct2021, when the patient was 66 years old, for Covid-19 Immunization, reaction(s): "Psychosis"; Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE; MANUFACTURER UNKNOWN, event outcome resolved within a day), administration date: Oct2021, when the patient was 66 years old, for Covid-19 Immunization, reaction(s): "swollen hands and ankles". The following information was reported: HEADACHE (hospitalization, disability, life threatening) with onset 12Dec2025 at 21:00, outcome "recovering", described as "Constant mild headache"; NEUROPATHY PERIPHERAL (hospitalization, disability, medically significant, life threatening), CONDITION AGGRAVATED (hospitalization, disability, medically significant, life threatening) all with onset 12Dec2025 at 21:00, outcome "not recovered" and all described as "Increased peripheral neuropathy (formerly mild tingling became burning with bottom of feet having altered sensation impacting balance)"; MIGRAINE (hospitalization, disability, life threatening) with onset 12Dec2025 at 21:00, outcome "not recovered", described as "Migraine headache"; PSYCHOTIC DISORDER (hospitalization, disability, medically significant, life threatening) with onset 12Dec2025 at 21:00, outcome "recovered" (Dec2025), described as "Psychosis"; NAUSEA (hospitalization, disability, life threatening) with onset 12Dec2025 at 21:00, outcome "recovering"; OPTIC ISCHAEMIC NEUROPATHY (hospitalization, disability, medically significant, life threatening) with onset 12Dec2025 at 21:00, outcome "not recovered", described as "non-arteritic ischemic optic neuropathy"; BLINDNESS UNILATERAL (hospitalization, disability, medically significant, life threatening) with onset 12Dec2025 at 21:00, outcome "not recovered", described as "sudden right eye vision loss"; PERIPHERAL SWELLING (hospitalization, disability, life threatening), JOINT SWELLING (hospitalization, disability, life threatening) all with onset 12Dec2025 at 21:00, outcome "recovered" (Dec2025) and all described as "swollen hands and ankles"; SUICIDAL IDEATION (hospitalization, medically significant, life threatening) with onset 12Dec2025 at 21:00, outcome "recovered" (Dec2025), described as "violent suicidal ideation". The patient was hospitalized for psychotic disorder, suicidal ideation, optic ischaemic neuropathy, blindness unilateral, neuropathy peripheral, condition aggravated, peripheral swelling, joint swelling, migraine, headache, nausea (hospitalization duration: 2 day(s)). Therapeutic measures were taken as a result of psychotic disorder, suicidal ideation, optic ischaemic neuropathy, blindness unilateral, neuropathy peripheral, condition aggravated, peripheral swelling, joint swelling, migraine, headache, nausea. Clinical course: It was reported that patient received other medications 2 weeks product: multi vitamin. Psychosis with violent suicidal ideation at approximately 30 hours post injection that required psychiatric hospital intervention. It was the 2nd such nearly identical event, that occurred following a covid vaccine in Oct2021. Both episodes cleared completely without medication within 24 hours of onset. (This event included swollen hands and ankles which mostly resolved within a day.). Migraine headache and sudden right eye vision loss at 67 hours post injection, requiring another hospital workup for stroke protocol. Dx the following day by eye specialist of non-arteritic ischemic optic neuropathy. Likely permanent damage. Constant mild headache and nausea since injection and continuing to date. Improving slightly. Increased peripheral neuropathy (formerly mild tingling became burning with bottom of feet having altered sensation impacting balance) approximately 3 days post injection, and continuing to date, but with improvement.ae resulted in: Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage no days hospitalisation: 2 and patient was not recovered ae treatment received with testing, imaging, monitoring, medications and patient had other medical history. Patient vaccinated on left upper arm.
Peripheral neuropathy
Medical History/Concurrent Conditions: Drug allergy; Tingling
ESOMEPRAZOLE; OXCARBAZEPIN; FORTEO; CALCIUM; VITAMIN D+K; MAGNESIUM; B COMPLEX [AMINOBENZOIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE;CYANOCOBALAMIN;FOLIC ACI; TURMERIC [CURCUMA LONGA]