Age: 66.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Anal incontinence, Fall, Hyperhidrosis, Loss of consciousness, Urinary incontinence
Clinical narrative: she remembers holding on to the door frame, but when got herself together, was laying on the floor, in the entry way.; she remembers holding on to the door frame, but when got herself together, was laying on the floor, in the entry way.; Puked on herself; wet from sweat; lost control urine and bowels; lost control urine and bowels; This is a spontaneous report received from a Nurse.  A 67-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 03Oct2024 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years, in arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 03Oct2024 as dose number unknown, single), in arm for immunisation. Patient made sure they had them in separate arms. She had Covi-19 shot in one arm and flu shot in other arm. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4, manufacturer unknown), for COVID-19 immunization. The following information was reported: VOMITING (non-serious) with onset 03Oct2024, outcome "recovered", described as "Puked on herself"; URINARY INCONTINENCE (non-serious), ANAL INCONTINENCE (non-serious) all with onset 03Oct2024, outcome "recovered" and all described as "lost control urine and bowels"; LOSS OF CONSCIOUSNESS (medically significant), FALL (non-serious) all with onset 03Oct2024, outcome "recovered" and all described as "she remembers holding on to the door frame, but when got herself together, was laying on the floor, in the entry way."; HYPERHIDROSIS (non-serious) with onset 03Oct2024, outcome "recovered", described as "wet from sweat". The events "she remembers holding on to the door frame, but when got herself together, was laying on the floor, in the entry way.", "puked on herself", "wet from sweat" and "lost control urine and bowels" required physician office visit. Therapeutic measures were not taken as a result of loss of consciousness, fall, vomiting, hyperhidrosis, urinary incontinence, anal incontinence. Patient has been taking flu shot but, when she took with that Covid shot, knew something kind of strange. That week, 02Oct2024, went to doctor, the very next day, 03Oct2024, had the Covid shot. Came straight home from getting shot, before she could get in door, was on the floor. When she came to her self, puked on her self and was wet from sweat. Patient had also lost control of urine and bowels, lasted 5 minutes, just going to estimate that because, she soothed her into her home, didn't want to just be lying there. Had to scoot in, remembers crawling. Patient remembers holding on to the door frame, but when got herself together, was laying on the floor, in the entry way. Described as a one time occurrence. This is the first time she ever had reaction like this. Patient commented that the vaccine information papers they give after they gave the shot, that should be received before taking the shot. Would like to receive that before taking the shot. Plenty of times, before getting the shot, they have to draw it up, get it all ready. If receiving the paper before the shot, that would be very nice so, anybody could look on the back. Once you start having symptoms, you don't think, hurry up, look at the paper, you are thinking of getting to safe place.  Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: The event loss of consciousness is conservatively assessed as related to the suspect drug BNT162B2 OMICRON (KP.2) based on plausible temporal association but consider also possible contributory effects from medical history of the patient (hypertension) and/or concomitant medications. 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.