Age: 73.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Gait disturbance, Somnolence, Vaccination site mass
Clinical narrative: having to use a wheelchair/She used to use a walker, she still uses her walker, when she feels betters; Couldn't stay awake; had a hard knot on the arm where she got the COVID vaccine/There was a hard knot for 2-3 weeks or maybe longer; This is a spontaneous report received from a Nurse.  A 73-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 20Oct2023 as unk, single) for immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: COPD Diagnosed probably in her early 30s; "stroke" (unspecified if ongoing); "allergic to everything" (unspecified if ongoing); "anemic" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Moderna covid vaccine (Previously she took the Moderna COVID vaccines. She never had any reaction to Moderna, only this Pfizer COVID vaccine.), for COVID-19 immunization, reaction(s): "no adverse reaction"; Flu shot (she never had any trouble with the Flu shot before), for Immunization, reaction(s): "no adverse effect". The following information was reported: VACCINATION SITE MASS (non-serious) with onset 2023, outcome "unknown", described as "had a hard knot on the arm where she got the COVID vaccine/There was a hard knot for 2-3 weeks or maybe longer"; GAIT DISTURBANCE (medically significant), outcome "unknown", described as "having to use a wheelchair/She used to use a walker, she still uses her walker, when she feels betters"; SOMNOLENCE (non-serious), outcome "unknown", described as "Couldn't stay awake". The event "couldn't stay awake" required physician office visit. Therapeutic measures were not taken as a result of somnolence. Additional information: Prior Vaccinations (within 4 weeks): Had no other vaccines within 4 weeks of 20Oct2023. No Family Medical History Relevant to Adverse Events. She did, at one time, because she was anemic, and it was several months before this reaction. Had a lot of the same symptoms, but since she has been on the iron and vitamins and stuff, she has had no problem with anemia since. She had the COVID shot and had a terrible reaction. She could not stay awake. She still is sleeping too much, and is having to use a wheelchair. She used to use a walker, she still uses her walker, when she feels betters, but is having to use her wheel chair. She got the shot on 20Oct2023, it was the only Pfizer COVID vaccine she has ever had. Clarifies her terrible reaction is that she could not stay awake. She was sleeping all the time for a month or two. She still is sleeping 12-13 hours a day or better. Could not stay awake: Started a day or two later. She had nothing else that had happened. She hates to not be able to take it, but she does not want it. Treatment: none, nobody seems to know what to do. COVID Vaccine dose/route: she got the flu shot and COVID shot in her arm, but does not know which arm was which. For a week or two, she had a hard knot on the arm where she got the COVID vaccine, but she cannot remember that far back. The papers are probably there but she does not know where. Clarifies the Flu shot was also given on 20Oct2023, she never had any trouble with the Flu shot before. She knows it was the Flu shot for seniors. Indication: She has COPD and is afraid if she got COVID, she might not make it, because of her respiratory problems. States she has not worked as a nurse for 31-32 years. Had a baby at age 42 and had a stroke after that. She is allergic to everything. Causality: Yes, nothing else could have caused it. Clarifies she thinks it was the right arm her COVID shot was given it. It is hurting right now and that's what its done since the COVID vaccine was given. There was a hard knot for 2-3 weeks or maybe longer. She is sitting with her elbow on the chair, states she should not do that with her arm doing that.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on the limited information available in the case, the relationship between the event Gait disturbance  and the suspect drug cannot be excluded. 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.