Received Sep 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | NA0587 | — |
slept most of the day; side effects that night burning up; a bad headache; hurting from her head to her feet; extremely tired; lymph nodes were swollen; Her arm was hot to the touch where she got the shot, swollen and later bruised; Her arm was hot to the touch where she got the shot, swollen and later bruised; Her arm was hot to the touch where she got the shot, swollen and later bruised; This is a spontaneous report received from an Other HCP. A 40-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 11Sep2025 as dose 1, single (Lot number: NA0587) at the age of 40 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "rheumatoid arthritis" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "ehlers danlos syndrome" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing); "gluten allergy" (unspecified if ongoing); "food allergy" (unspecified if ongoing), notes: shrimp pork. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "allergy"; Lyrica, reaction(s): "allergy"; Morphine, reaction(s): "allergy". The following information was reported: VACCINATION SITE WARMTH (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE BRUISING (non-serious) all with onset 11Sep2025, outcome "recovered" (12Sep2025) and all described as "Her arm was hot to the touch where she got the shot, swollen and later bruised"; HEADACHE (non-serious) with onset 11Sep2025, outcome "recovered" (12Sep2025), described as "a bad headache"; FATIGUE (non-serious) with onset 11Sep2025, outcome "recovered" (12Sep2025), described as "extremely tired"; PAIN (non-serious) with onset 11Sep2025, outcome "recovered" (12Sep2025), described as "hurting from her head to her feet"; LYMPHADENOPATHY (non-serious) with onset 11Sep2025, outcome "recovered" (12Sep2025), described as "lymph nodes were swollen"; BURNING SENSATION (non-serious) with onset 11Sep2025, outcome "recovered" (12Sep2025), described as "side effects that night burning up"; HYPERSOMNIA (non-serious) with onset 12Sep2025, outcome "recovered" (12Sep2025), described as "slept most of the day". Therapeutic measures were taken as a result of headache, pain. Additional information: The patient had side effects that night burning up. By the Friday morning she was hurting from her head to her feet. She had a bad headache. She was extremely tired, her lymph nodes were swollen. Her arm was hot to the touch where she got the shot, swollen and later bruised. She called out to work that Friday morning. She took two tylenol arthritis. By that afternoon her headache was gone. She slept most of the day. The patient did not receive any other vaccines on the same date as the vaccine, the patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine, the patient was not taking any other medications within 2 weeks of the event starting.
Medical History/Concurrent Conditions: Ehlers-Danlos syndrome; Fibromyalgia; Food allergy (shrimp pork); Gluten intolerance; Osteoarthritis; Penicillin allergy; Rheumatoid arthritis; Sulfonamide allergy