Received Oct 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Body aches; Headache; Chills; This is a spontaneous report received from a Consumer or other non HCP. A 48-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 29Sep2025 as dose 1, single (left shoulder) (Batch/Lot number: unknown) at the age of 48 years for COVID-19 immunisation. The patient's relevant medical history included: "Anxiety, ADHD" (unspecified if ongoing); "Anxiety, ADHD" (unspecified if ongoing). Concomitant medication(s) included: LISDEXAMFETAMINE, start date: 09Sep2025; ESCITALOPRAM, start date: 04Sep2023. The patient had no allergy. The vaccine was administered in Workplace Clinic. The patient did not receive any other vaccines on the same date as COMIRNATY and did not receive any other vaccines within 4 weeks prior COMIRNATY. The following information was reported: PAIN (non-serious) with onset 29Sep2025 at 23:00, outcome "recovering", described as "Body aches"; CHILLS (non-serious) with onset 29Sep2025 at 23:00, outcome "recovering"; HEADACHE (non-serious) with onset 29Sep2025 at 23:00, outcome "recovering". Therapeutic measures were taken as a result of pain, headache, chills which included Tylenol. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Medical History/Concurrent Conditions: ADHD; Anxiety
LISDEXAMFETAMINE; ESCITALOPRAM