Received Mar 12, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
dementia and i believe her condition worsened after a covid vaccine; dementia and i believe her condition worsened after a covid vaccine; This is a spontaneous report received from Consumer or other non HCPs and an Other HCP from License Party. Other Case identifier(s): AE-022913 (BioNtech SE), 2026SA041337 (Sanofi). A 71-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPILUMAB), from 06Jan2026 at 12:00 (Lot number: 5F803A, Expiration Date: 31Mar2028) to 06Jan2026 at 12:00 at 300 mg (300 mg, qow (every other week)), subcutaneous for emphysema, asthma. The patient's relevant medical history included: "dementia" (ongoing). Concomitant medication(s) included: ALBUTEROL SULFATE; AMLODIPINE BESYLATE; ELIQUIS; FOLIC ACID; LORAZEPAM; LASIX [FUROSEMIDE]; MAGNESIUM; PREPARATION H [HAMAMELIS VIRGINIANA]; BUDESONIDE; DILTIAZEM HCL; B COMPLEX [BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE]; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; PROZAC; PREDNISONE; DIGOXIN; VITAMIN D3. The following information was reported: DEMENTIA (medically significant), CONDITION AGGRAVATED (medically significant) all with onset 2026, outcome "unknown" and all described as "dementia and i believe her condition worsened after a covid vaccine". The action taken for dupilumab was unknown. Clinical course: On 06Jan2026, the patient started taking dupilumab 300mg/2ml, Solution for injection 300 mg QOW (every other week) subcutaneously for centrilobular emphysema, asthma. On an unknown date, the patient received a dose of suspect COVID-19 Vaccine not produced by PRIVACY lot number not reported with an unknown formulation, strength, dose, route, frequency as a prophylaxis. She was in hospice (hospice care) and she had dementia and husband believed her condition worsened after a covid vaccine (dementia) (onset date: 2026; unknown latency, batch number: 5F803A and expiry date on 31Mar2028). patient's spouse advised that patient Hasn't had dupixent in a month and informed that she was experiencing side effects. No other details given. Action taken with Dupilumab: Unknown for both events. No known drug allergies and no known food allergies. Reporter causality reported as related. Company Comments: Sanofi follow up company comment dated 24Feb2026: The new follow up information does not change the previous assessment of case: This case involves a 71 year old female patient who experienced dementia and believed her condition worsened after a covid vaccine while receiving covid-19 vaccine and while being treated with dupilumab [Dupixent] delivered via dupixent single dose pre-filled pen. Based on the information received, the causal role of the company suspect product cannot be excluded. Dementia is a progressive neurodegenerative condition with multiple risk factors including advanced age, cardiovascular disease( based on concomitant medications), and potential cerebrovascular complications, all of which represent significant confounding factors in this patient. The lack of critical information severely limits comprehensive case assessment, including absence of event latency, past medical history, particularly any pre-existing cognitive impairment, cerebrovascular disease, or other neurological conditions baseline cognitive function assessment, duration and progression of cognitive symptoms prior to Dupilumab initiation, neurological examination findings, brain imaging results, formal dementia diagnostic workup, family history, personal and lifestyle related risk factors. The presence of concomitant drugs can complicate the assessment of causality in isolation for suspect drug. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. COMIRNATY is under agreement with BIONTECH SE.
Dementia
ALBUTEROL SULFATE; AMLODIPINE BESYLATE; ELIQUIS; FOLIC ACID; LORAZEPAM; LASIX [FUROSEMIDE]; MAGNESIUM; PREPARATION H [HAMAMELIS VIRGINIANA]; BUDESONIDE; DILTIAZEM HCL; B COMPLEX [BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTIN