Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | NA4452 | LA |
Neck pain; Migraine headache; Mild nausea; Pain in the left arm at the injection site; arm pain; This is a spontaneous report received from a consumer. A 40-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 31Oct2025 at 15:30 as dose 1, single (Lot number: NA4452) at the age of 40 years, in left arm for covid-19 immunisation, Device Lot Number: NA4452. The patient's relevant medical history included: "Postural orthostatic tachycardia" (unspecified if ongoing); "Hypotension" (unspecified if ongoing). Concomitant medication(s) included: ELDERBERRY [SAMBUCUS NIGRA]. The patient also took other concomitant therapy. Past drug history included: Percocet, reaction(s): "Allergy". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 01Nov2025 at 03:00, outcome "recovered" (02Nov2025), described as "Pain in the left arm at the injection site; arm pain"; NAUSEA (non-serious) with onset 01Nov2025 at 05:30, outcome "recovered" (01Nov2025 at 06:30), described as "Mild nausea"; MIGRAINE (non-serious) with onset 01Nov2025 at 06:30, outcome "recovered" (01Nov2025 at 18:30), described as "Migraine headache"; NECK PAIN (non-serious) with onset 01Nov2025 at 06:30, outcome "recovered" (01Nov2025 at 18:30). Therapeutic measures were not taken as a result of vaccination site pain, nausea, neck pain, migraine. Additional Information: Other concomitant medications included which included unspecified Women's Multi-Vitamin and OSTEVA (as reported). Around 12 hours post-vaccine, pain in the left arm at the injection site. Arm pain lasted about 24 hours and stopped approximately 36 hours post-injection. 14 hours post vaccine, mild nausea started which lasted about 1 hour. 15 hours post-vaccine, neck pain and migraine headache started. Neck pain and headache lasted about 12 hours. No follow-up attempts are possible.
Medical History/Concurrent Conditions: Hypotension; Postural orthostatic tachycardia syndrome
ELDERBERRY [SAMBUCUS NIGRA]