Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Expired product administered, Fear, Headache
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Feb2022 (Lot number: FDC809) at the age of 71 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Type 2 Diabetes" (ongoing), notes: Type 2 Diabetes, Caller states she was diagnosed over 20 years ago; "Blood pressure" (unspecified if ongoing); "a little heart problem" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure measurement; PROPANOL [PROPRANOLOL HYDROCHLORIDE] taken for heart rate; GLIPIZIDE taken for diabetes mellitus. Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: EW0175 , Anatomical location: left arm), administration date: 03Aug2021, when the patient was 70 years old, for Covid-19 Immunization; Bnt162b2 (Dose: 2, Lot Number: FC3182, Anatomical location: right arm), administration date: 25Aug2021, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: FEAR (death) with onset Mar2022, described as "scared"; HYPERTENSION (death) with onset Mar2022, described as "Blood pressure has been up"; HEADACHE (death) with onset Mar2022, described as "headache"; ANXIETY (death) with onset Mar2022, described as "anxious"; NERVOUSNESS (death) with onset Mar2022, described as "nervous"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 28Feb2022, described as "received an expired Pfizer-BioNTech Covid19 Vaccine booster dose on 28Feb2022". The patient underwent the following laboratory tests and procedures: blood pressure measurement: 181/101, notes: Blood pressure high. Therapeutic measures were taken as a result of hypertension. The patient date of death was unknown. The reported cause of death was "Death". It was not reported if an autopsy was performed. Therapeutic measures were taken as a result of hypertension. Additional information: Patient and her 51-year old son received an expired Pfizer-BioNTech Covid-19 Vaccine booster dose on 28Feb2022. Per Patient, the pharmacy called her and informed that the booster dose given was an expired one. Upon Follow-up (28Mar2022) Additional Information: Reaction / Event as Reported by the Primary Source for Translation: unspecified event, term highlighted by the reporter: Yes, Highlighted by the reporter, serious, results in death: True, life threatening: No Information, caused/prolonged hospitalization: No Information, disabling/Incapacitating: No Information, congenital anomaly/birth defect: No Information, other medically important condition: No Information, outcome of reaction/event at the time of last observation: Fatal. The report is cross referenced to report ID: # Caller reports her name as (withheld) and her son (withheld). Caller states she and her son were given an expired booster dose of the Pfizer COVID-19 vaccine 3 weeks ago today. Caller states she does know people that have died. Caller reports her sister had 2 of her COVID-19 vaccines and the flu shot. Caller states she doesn't know what kind of condition she had. Caller reports her sister died 28Oct2021. Caller states she can't talk about her sister's stuff because she don't know. Caller reports she hadn't seen her sister in 5 years and she doesn't know what she died from. Caller declined to complete a report on her sister. No further details to provide. The lot number for bnt162b2 was not provided and will be requested during follow up. Follow-up (28Mar2022): This is a spontaneous follow-up report received from the same contactable consumer. This consumer (patient) reported that: Updated Information Included: Reporter Information (Postal Address. Email address). Reporter Information/ patient Information (Middle Name), Correspondence reporter. Patient Details (DOB. Height. Weight. Ethnic Group. Race). Historical vaccine. RMH. Lab Test. Dosage Regimens (Dose Description. Lot Number and Anatomical Location). Best Doctor / Health Care Professional Information. New event. Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202200485375 Same reporter/ drug/ event for different patients; Reported Cause(s) of Death: Death.