Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Fracture, Gastrointestinal haemorrhage, Hypotension, Syncope
Clinical narrative: Syncope episode; GI bleed; Hypotension; Abdomen pain; Fracture; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 18Oct2021, this case now contains all required information to be considered valid. This is a spontaneous serious report received from a contactable pharmacist. This pharmacist reported events after the first and the second dose of vaccine. This is the first of two reports (first dose). Only this case is serious. An 84-year-old female patient received bnt162b (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), administered in arm on 12Jan2021 (at the age of 84-year-old) as dose 1, single for COVID-19 immunisation. Vaccine was not administered at  facility. The patient had not received additional vaccines on same date of the bnt162b2. The patient's medical history included Parkinson's, dementia and prior breast cancer. Patient came from an assisted living facility and was there prior to getting the first dose. The patient's concomitant medications were reported as none. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. It was unknown if patient had adverse event following prior vaccinations. It was reported that patient received the first dose of the vaccine 12Jan2021. She was hospitalized recently and she could not receive the second dose of the vaccine. She had been in the hospital and did not receive the full series.  Reason for hospitalization was syncope episode. The event syncope episode required emergency room visit and it was unknown if it required physician office visit. About illness/adverse event she initially stated unknown and then later stated patient came from an assisted living facility and was there prior to getting the first dose. She had Parkinson's, dementia, prior breast cancer, recent fracture on 08Oct2021, and gastrointestinal (GI) bleed, hypotension, and abdomen pain. All coincided with syncopal episode that she was admitted for on 09Oct2021. At the time of this report the patient was still hospitalized (ongoing). The outcome of the events was not resolved for syncope episode and unknown for all other events.; Sender's Comments: Considering the temporal gap between the date of vaccination and the event onset, there was not a reasonable possibility that the events syncope episode, fracture and gastrointestinal (GI) bleed were related to suspect vaccine BNT162B2. The events were most likely due to the elderly patient's underlying conditions. 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. ,Linked Report(s) : US-PFIZER INC-202101393254 Same patient/drug, different dose/AE