Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Cognitive disorder, Headache
Clinical narrative: A lack of balance; Headache; Falling along with confusion; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Mar2022 at 14:15 as dose 4 (booster), single (Lot number: FK9895) at the age of 74 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lymphoma" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: If COVID prior Vaccination: Yes. Concomitant medication(s) included: ALPRAZOLAM; TRAZODONE; ROSUVASTATIN. Past drug history included: Sulfa, reaction(s): "Known allergies: Sulfa Antibiotics", notes: Known allergies: Sulfa Antibiotics; Iodides, reaction(s): "Known allergies: Iodides", notes: Known allergies: Iodides. Vaccination history included: Covid-19 vaccine (Dose 3, Manufacture Unknown), for COVID-19 immunization; Covid-19 vaccine (primary Immunization series complete, Manufacture Unknown), for COVID-19 immunization. The following information was reported: BALANCE DISORDER (hospitalization) with onset 28Mar2022 at 21:15, outcome "recovered" (Mar2022), described as "A lack of balance"; FALL (hospitalization) with onset 28Mar2022 at 21:15, outcome "recovered" (Mar2022), described as "Falling along with confusion"; HEADACHE (hospitalization) with onset 28Mar2022 at 21:15, outcome "recovered" (Mar2022). The patient was hospitalized for balance disorder, headache, fall (hospitalization duration: 3 day(s)). The events "a lack of balance", "headache" and "falling along with confusion" required emergency room visit. Therapeutic measures were taken as a result of balance disorder, headache, fall.  Clinical Course: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Reported Event withheld reported a lack of balance without vertigo and a headache starting the night of the vaccine. The following day, patient experienced a continuation of both the headache and lack of balance/falling along with confusion. Patient didn't know how to use her cell phone but knew what the phone was for. Patient had no shortness of breath or vertigo the entire time but almost fell on several occasions in her home. Patient husband took her to the hospital once patient told him she had no idea how to use her phone. Prior to vaccination, was the patient had diagnosed with COVID-19 was reported.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Balance disorder", "Headache", "Fall" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.