Received Dec 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
feeling anxious; jittery; generally unwell; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2025SA140270 (Sanofi), AE-021723 (BioNTech). A 70-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 21Oct2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), since Apr2025 at 300 mg (300 mg, every other week (eow).), subcutaneous for dermatitis atopic. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious) with onset Oct2025, outcome "unknown", described as "feeling anxious"; MALAISE (non-serious) with onset Oct2025, outcome "unknown", described as "generally unwell"; FEELING JITTERY (non-serious) with onset Oct2025, outcome "unknown", described as "jittery". The action taken for dupilumab was unknown. Additional information: Patient reported she just got the covid vaccine yesterday and is feeling anxious, jittery, and generally unwell (onset, severity unknown). Patient was wondering if she can still take the dupixent dose today. Advised patient that patient could take it as scheduled, it should not have an impact on the vaccine's overall effectiveness or vice versa. patient stated she prefers to wait until tomorrow. Unknown if md is aware. Unknown if md is aware. No further information provided." Action taken: unknown for anxiety, malaise, feeling jittery and No action taken for rest events. COMIRNATY (2025-2026 FORMULA) under agreement with BioNTech Batch/lot number is not provided, and it cannot be obtained.
DUPIXENT