Received Oct 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | NA0587 | LA |
arm was swollen and painful; arm was swollen and painful; heaviness in chest; tingling pain shooting around the chest; inside her mouth and lips were swollen; inside her mouth and lips were swollen; felt dizzy; room was spinning around; felt like vomiting; This is a spontaneous report received from a Consumer or other non HCP. An 83-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 26Sep2025 as dose 1, single (Lot number: NA0587) at the age of 83 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Levofloxacin, reaction(s): "Allergy". The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 26Sep2025, outcome "recovering" and all described as "arm was swollen and painful"; DIZZINESS (non-serious) with onset 26Sep2025, outcome "recovering", described as "felt dizzy"; NAUSEA (non-serious) with onset 26Sep2025, outcome "recovering", described as "felt like vomiting"; CHEST DISCOMFORT (non-serious) with onset 26Sep2025, outcome "recovering", described as "heaviness in chest"; MOUTH SWELLING (non-serious), LIP SWELLING (non-serious) all with onset 26Sep2025, outcome "recovering" and all described as "inside her mouth and lips were swollen"; VERTIGO (non-serious) with onset 26Sep2025, outcome "recovering", described as "room was spinning around"; CHEST PAIN (non-serious) with onset 26Sep2025, outcome "recovering", described as "tingling pain shooting around the chest". It was unknown if therapeutic measures were taken as a result of peripheral swelling, pain in extremity, chest discomfort, chest pain, mouth swelling, lip swelling, dizziness, vertigo, nausea. Additional information: the patient did not receive any other vaccines on the same date as COMIRNATY (2025-2026 FORMULA). The patient did not receive any other vaccines within 4 weeks prior to the COMIRNATY (2025-2026 FORMULA). The patient reported that she woke up at 3 am on 27Sep2025. Her arm was swollen and painful. She felt like a brick was on her chest, heaviness in chest, tingling pain shooting around the chest, inside her mouth and lips were swollen, felt dizzy as well the room was spinning around and she felt like vomiting. As of 28Sep2025, the patient was feeling better.