Received Oct 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | RA |
Arm enlarged; red, swollen hot; Arm enlarged; red, swollen hot; Arm enlarged; red, swollen hot; Fatigue; Nausea; Vomiting; Dizziness; Weakness; Fever; Heart palpitations; Sweating; Dehydrated; This is a spontaneous report received from a Consumer or other non HCP. A 76-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 07Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High BP" (unspecified if ongoing); "Heart palpitations" (unspecified if ongoing); "Apnea" (unspecified if ongoing); "COVID", start date: Nov2024 (unspecified if ongoing). Concomitant medications included: VIT D [VITAMIN D NOS], start date: 03Sep2025, stop date: 26Sep2025; METOPROLOL, start date: 03Sep2025, stop date: 26Sep2025. The following information was reported: PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious), FEELING HOT (non-serious) all with onset 15Sep2025, outcome "not recovered" and all described as "Arm enlarged; red, swollen hot"; DEHYDRATION (non-serious) with onset 15Sep2025, outcome "not recovered", described as "Dehydrated"; DIZZINESS (non-serious) with onset 15Sep2025, outcome "not recovered"; FATIGUE (non-serious) with onset 15Sep2025, outcome "not recovered"; PYREXIA (non-serious) with onset 15Sep2025, outcome "not recovered", described as "Fever"; PALPITATIONS (non-serious) with onset 15Sep2025, outcome "not recovered", described as "Heart palpitations"; NAUSEA (non-serious) with onset 15Sep2025, outcome "not recovered"; HYPERHIDROSIS (non-serious) with onset 15Sep2025, outcome "not recovered", described as "Sweating"; VOMITING (non-serious) with onset 15Sep2025, outcome "not recovered"; ASTHENIA (non-serious) with onset 15Sep2025, outcome "not recovered", described as "Weakness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of peripheral swelling, erythema, feeling hot, fatigue, nausea, vomiting, dizziness, asthenia, pyrexia, palpitations, hyperhidrosis, dehydration. 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 patient reported her arm was enlarged; red and swollen hot. Then fatigue set in; nausea, vomiting, dizziness, weakness, fever, heart palpitations, sweating, dehydrated, and she was bedridden. The symptoms were still ongoing at the time of the report which was going on for about 12 days. Onset was on 15Sep2025. 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: Apnea; Blood pressure high; COVID-19; Palpitations
VIT D [VITAMIN D NOS]; METOPROLOL
Test Date: 202509; Test Name: BP; Result Unstructured Data: Test Result:unknown result; Test Date: 202509; Test Name: Body temperature; Result Unstructured Data: Test Result:fever; Test Date: 202509; Test Name: COVID test; Result Unstructured Data: Test Result:no diagnosis