Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Dose 3; Verbally unresponsive; Pale; Temp of 100.6; Cool to the touch; This is a spontaneous report received from contactable reporter (Pharmacist). A 99 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Oct2021 (Lot number: FD0810) at the age of 99 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "A.fib" (unspecified if ongoing); "CHF" (unspecified if ongoing); "Dysphagia" (unspecified if ongoing); "Asthenia" (unspecified if ongoing); "Post-stroke aphasia" (unspecified if ongoing); "HLP" (unspecified if ongoing); "hx TIA" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "CRF" (unspecified if ongoing). Concomitant medication(s) included: DIGOXIN; ELIQUIS; FUROSEMIDE; LOSARTAN; TYLENOL; METOPROLOL XL; Multivitamin. Past drug history included: Quinine, reaction(s): "Known allergies: Quinine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9269, Location of injection: Left Arm , Route of Administration: Intramuscular), administration date: 11Feb2021, when the patient was 99 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3302, Location of injection: Right arm, Route of Administration: Intramuscular), administration date: 21Jan2021, when the patient was 99 years old, for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: IMMUNISATION (hospitalization) with onset 28Oct2021, outcome "unknown", described as "Dose 3"; UNRESPONSIVE TO STIMULI (hospitalization, medically significant) with onset 28Oct2021, outcome "recovering", described as "Verbally unresponsive"; PALLOR (hospitalization) with onset 28Oct2021, outcome "recovering", described as "Pale"; PYREXIA (hospitalization) with onset 28Oct2021, outcome "recovering", described as "Temp of 100.6"; PERIPHERAL COLDNESS (hospitalization) with onset 28Oct2021, outcome "recovering", described as "Cool to the touch". The patient was hospitalized for immunisation, unresponsive to stimuli, pallor, pyrexia, peripheral coldness (start date: 2021, discharge date: 2021, hospitalization duration: 7 day(s)). The patient underwent the following laboratory tests and procedures: body temperature: 100.6. Reported Event: On 28Oct2021, Resident was pale, cool to the touch, temp of 100.6 and verbally unresponsive. Did arouse with sternal rub. Was sent to hospital and remained there several days. Event resulted in hospitalization for 7 days. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, unknown if the patient has been tested for COVID-19.; Sender's Comments: As per available information, the causal association between the events IMMUNISATION, UNRESPONSIVE TO STIMULI, PALLOR,  PYREXIA, PERIPHERAL COLDNESS 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.