Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
chills started; she slowly developed a stiff neck; headache; little tenderness at the injection site; really fatigued; no appetite; a little of upset stomach; This is a spontaneous report received from a Consumer or other non HCP. An elderly female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 24Sep2025 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 04Sep2025 as dose number unknown, single; BUPROPION; DOXYCYCLINE MONOHYDRATE; MULTIVITAMIN [VITAMINS NOS]; MAGNESIUM; CITRACAL + D [CALCIUM CITRATE;COLECALCIFEROL]. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 24Sep2025, outcome "recovered" (25Sep2025), described as "a little of upset stomach"; CHILLS (non-serious) with onset 24Sep2025, outcome "recovered" (25Sep2025), described as "chills started"; HEADACHE (non-serious) with onset 24Sep2025, outcome "recovered" (25Sep2025); VACCINATION SITE PAIN (non-serious) with onset 24Sep2025, outcome "recovered" (25Sep2025), described as "little tenderness at the injection site"; DECREASED APPETITE (non-serious) with onset 24Sep2025, outcome "recovered" (25Sep2025), described as "no appetite"; FATIGUE (non-serious) with onset 24Sep2025, outcome "recovered" (25Sep2025), described as "really fatigued"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 24Sep2025, outcome "recovered" (25Sep2025), described as "she slowly developed a stiff neck". Therapeutic measures were taken as a result of chills, musculoskeletal stiffness, headache, vaccination site pain, fatigue, decreased appetite, abdominal discomfort. Additional information: Patient was vaccinated on Left arm/shoulder. Facility where vaccine was administered was reported as Pharmacy or Drug Store. Patient received other vaccines on the same date as the vaccine. The patient was taking other medications within 2 weeks of the event starting. 12 Hours after getting the shot, patient felt a little chilly, but they weren't chills. patient took 1000 mg Tylenol at 8:30 pm and kept a heating pad on and off her for a couple of hours. The heating pad did the trick and soon she had taken off the warm pjs and just slept in lightweight ones. She didn't use the heating pad anymore after that. When the vaguely chilly chills started, she slowly developed a stiff neck and headache that the Tylenol didn't cure. Just a little tenderness at the injection site. The next morning, she felt headachey, stiff necked, really fatigued and no appetite. She took 1000mg Tylenol at 8:15 am. patient took only 500 mg Tylenol at 4:15 pm and then at 5:00 pm she felt just about normal again. Still no appetite but still a little of upset stomach. She felt all better by 9:00 pm. So side effects lasted 36 hours. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Drug allergy; Osteoporosis
BUPROPION; DOXYCYCLINE MONOHYDRATE; MULTIVITAMIN [VITAMINS NOS]; MAGNESIUM; CITRACAL + D [CALCIUM CITRATE;COLECALCIFEROL]