Received Oct 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
Shaking; Chills; Body aches; Extreme exhaustion; This is a spontaneous report received from a Pharmacist. A 72-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 27Sep2025 at 14:00 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in left deltoid for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), on 26Sep2025 as dose number unknown, single, in right arm. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Peanut allergy" (unspecified if ongoing); "Soy allergy" (unspecified if ongoing). Concomitant medications included: CRANBERRY; ESTRADIOL; GABAPENTIN; GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]; LISINOPRIL HCTZ; PROBIOTIC [BIFIDOBACTERIUM INFANTIS;LACTOBACILLUS ACIDOPHILUS]; SIMVASTATIN; TURMERIC [CURCUMA LONGA RHIZOME]. The following information was reported: PAIN (non-serious) with onset 27Sep2025 at 19:00, outcome "not recovered", described as "Body aches"; CHILLS (non-serious) with onset 27Sep2025 at 19:00, outcome "not recovered"; FATIGUE (non-serious) with onset 27Sep2025 at 19:00, outcome "not recovered", described as "Extreme exhaustion"; TREMOR (non-serious) with onset 27Sep2025 at 19:00, outcome "not recovered", described as "Shaking". Therapeutic measures were not taken as a result of tremor, chills, pain, fatigue. Additional information: The vaccine was administered at a pharmacy or drug store. The patient didn't receive any other vaccines within 4 weeks prior the Pfizer vaccine. 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: Asthma; Hyperlipidemia; Hypertension; Osteoporosis; Peanut allergy; Soy allergy
CRANBERRY; ESTRADIOL; GABAPENTIN; GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]; LISINOPRIL HCTZ; PROBIOTIC [BIFIDOBACTERIUM INFANTIS;LACTOBACILLUS ACIDOPHILUS]; SIMVASTATIN; TURMERIC [CURCUMA LONGA RHIZOME]