Received Sep 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | RA |
Blood pressure went low; blood pressure was still very low/My reading was as low as 90 over 48; couldn't get out of bed/ wasn't able to stand; Queasy/queasiness/ Severely nauseous/severe nausea; headache; Severe body and bone ache; Severe body and bone ache; felt passing out; Could not eat; This is a spontaneous report received from a Nurse. A 72-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 07Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in right arm (right shoulder) for covid-19 immunisation. The patient's relevant medical history included: "Gastroparesis" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing), notes: it did not require medication; "Migraine" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); the patient had these medical conditions many years and she had been on medication for many years. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, in 2025 (weeks before 07Sep2025) and the patient did not have a reaction at all; LOSARTAN as 100 mg; AJOVY [FREMANEZUMAB] taken for migraine. The patient had been on AJOVY for many years and never had reactions, no issues. The patient also took other concomitant therapy, routine medication daily. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for Covid-19 Immunization, reaction(s): "viral flu symptoms". The following information was reported: HYPOTENSION (medically significant) with onset 08Sep2025, outcome "recovering", described as "Blood pressure went low; blood pressure was still very low/My reading was as low as 90 over 48"; FEEDING DISORDER (non-serious) with onset 08Sep2025, outcome "recovering", described as "Could not eat"; NAUSEA (non-serious) with onset 08Sep2025, outcome "recovering", described as "Queasy/queasiness/ Severely nauseous/severe nausea"; PAIN (non-serious), BONE PAIN (non-serious) all with onset 08Sep2025, outcome "recovering" and all described as "Severe body and bone ache"; BALANCE DISORDER (non-serious) with onset 08Sep2025, outcome "recovering", described as "couldn't get out of bed/ wasn't able to stand"; PRESYNCOPE (non-serious) with onset 08Sep2025, outcome "recovering", described as "felt passing out"; HEADACHE (non-serious) with onset 08Sep2025, outcome "recovering". The events "blood pressure went low; blood pressure was still very low/my reading was as low as 90 over 48", "couldn't get out of bed/ wasn't able to stand", "queasy/queasiness/ severely nauseous/severe nausea", "headache", "severe body and bone ache", "felt passing out" and "could not eat" required physician office visit. Therapeutic measures were not taken as a result of hypotension, balance disorder, headache, pain, bone pain, presyncope, feeding disorder. Therapeutic measures were taken as a result of nausea. The patient was calling to report a real adverse reaction. The patient had taken your COVID vaccine up until to the mensuration which she had on Monday. The patient did not have anything unusual other than her viral flu symptoms in past, but this time she had an adverse reaction. She was up to date on her COVID vaccine, and she got this last one on Sunday (07Sep2025) early in the morning between 9 and 11 AM. All day Sunday was fine. Monday (08Sep2025), the patient woke up, she had severe reaction. She was not feeling well and she tried to get up to the bathroom and could not do it. The patient couldn't get out of bed, and she just felt queasy and headache and severe body and bone ache. The patient tried to get out of bed, and she wasn't able to stand, and 'wind started getting dark' and she had terrible severe nausea. So, she laid herself down on the floor because she felt she was passing out and she just laid there for an hour or two and they called eventually called into the bathroom. The patient was severely nauseous, and 'the heat put it in and increasing up'. So that belongs for an hour and so, the patient had some medication for nausea, and she took it, and the nausea calm down, but the queasiness never did and all day she was in bed. The patient could not eat, and her blood pressure went low. Her reading was as low as 90 over 48. The patient saw her doctor on the reporting date (10Sep2025) and the doctor said it was adverse reaction. The patient was still not feeling herself. Monday (08Sep2025) was the worse, Wednesday (10Sep2025) she was pretty much better, she could move around. The patient would return to her doctor office the next day for check, follow up. When probed for treatment for all events, the patient stated there was a change in medication because her blood pressure was very low during episodes and so she personally withheld her Losartan this morning (10Sep2025) because her blood pressure was still very low; When she went to the doctor, the doctor adjusted the Losartan to instead of a 100 milligrams and decreased it to 50 milligrams, the patient took that in the afternoon when she got home. The patient did not have any treatments, so she stayed at home in bed. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.; Sender's Comments: Given the compatible time association, the reasonable possibility that the events are related to BNT162B2 OMICRON (LP.8.1) administration cannot be excluded. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Medical History/Concurrent Conditions: Gastroparesis; Hypertension; Migraine; Osteopenia (it did not require medication)
LOSARTAN; AJOVY [FREMANEZUMAB]
Test Date: 20250908; Test Name: blood pressure; Result Unstructured Data: Test Result:90 over 48; Comments: low; Test Date: 20250910; Test Name: blood pressure; Result Unstructured Data: Test Result:still very low