Received Sep 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
Left arm pain at injection site and surrounding area; Left arm pit pain; headache; lethargy; feeling exhausted.; This is a spontaneous report received from a Consumer or other non HCP. A 54-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 15Sep2025 at 02:00 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 15Sep2025 at 23:00, outcome "recovering", described as "Left arm pain at injection site and surrounding area"; AXILLARY PAIN (non-serious) with onset 15Sep2025 at 23:00, outcome "recovering", described as "Left arm pit pain"; FATIGUE (non-serious) with onset 15Sep2025 at 23:00, outcome "recovering", described as "feeling exhausted."; HEADACHE (non-serious) with onset 15Sep2025 at 23:00, outcome "recovering"; LETHARGY (non-serious) with onset 15Sep2025 at 23:00, outcome "recovering". Therapeutic measures were not taken as a result of injection site pain, axillary pain, headache, lethargy, fatigue. Additional information: Patient did not receive any other vaccines on the same date as the vaccine(s) for which they are reporting and patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. Patient took other medications within 2 weeks of the event starting. Patient reported no allergies. Additionally patient took Levoxyl (Jan2006), Hydrochlorothiazide (26Aug2025), Sertraline HCl (Aug2023), Amlodipine (Jan2025), Omega-3 Fish oil (Jan2023). No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Medical History/Concurrent Conditions: Anxiety; Depression; Hypertension; Hypothyroidism; Obesity