Received Dec 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Influenza; feeling bad; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2025SA129771 (Sanofi), AE-021722 (BioNTech SE). A 62-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 22Oct2025 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; dupilumab (DUPIXENT), first regimen (Lot number: 4F524A, Expiration Date: 31Oct2026) at 300 mg weekly and second regimen (Lot number: 5F663A, Expiration Date: 31Oct2026) at 300 mg weekly, all subcutaneous for eosinophilic oesophagitis. The patient's relevant medical history included: "anxiety disorder" (unspecified if ongoing); "disorder of kidney" (unspecified if ongoing); "disorders of ureter" (unspecified if ongoing); "THYROID DISORDER" (unspecified if ongoing); "Major depressive disorder" (ongoing); "allergic to latex, banana, mushroom, shellfish derived, bee pollen" (unspecified if ongoing); "allergic to latex" (unspecified if ongoing); "allergic to bee pollen" (unspecified if ongoing); "allergic to latex, banana, mushroom, shellfish derived, bee pollen" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; LATUDA; PROGESTERONE; OMEPRAZOLE; LAMOTRIGINE; WELLBUTRIN XL; UNITHROID; CLONIDINE HCL; TOPIRAMATE. The following information was reported: FEELING ABNORMAL (non-serious) with onset 23Oct2025, outcome "unknown", described as "feeling bad"; INFLUENZA (non-serious), outcome "unknown". The action taken for dupilumab was unknown. Batch/lot number is not provided, and it cannot be obtained.
Major depressive disorder
Medical History/Concurrent Conditions: Anxiety disorder; Drug allergy; Food allergy; Kidney disorder; Latex allergy; Thyroid disorder; Ureteral disorder
VYVANSE; LATUDA; PROGESTERONE; OMEPRAZOLE; LAMOTRIGINE; WELLBUTRIN XL; UNITHROID; CLONIDINE HCL; TOPIRAMATE; DUPIXENT