Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Immunisation
Clinical narrative: Patient died approximately 20 minutes after receiving booster dose.; booster dose; This is a spontaneous report received from contactable reporter (Pharmacist). The reporter is the patient.  A 92-year-old female patient (not pregnant) received bnt162b2 (PFIZER COVID-19 VACCINE), intramuscular, administered in arm left, administration date 29Oct2021 09:10 (Lot number: FD0810) at the age of 92 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic pain"; "GERD"; "HTN"; "DM II"; "hx DVT"; "hx. malignant neoplasm of other digestive organs"; "activated protein C resistance"; "hx of malignant neoplasm of breast"; "hx malignant neoplasm of other parts uterus"; all unspecified if ongoing. It was unknown if patient diagnosed with COVID-19 prior vaccination. Patient had not been tested for COVID-19 post vaccination. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included: chlorthalidone; ergocalciferol (VIT D); acetaminophen; omeprazole; metoprolol tartrate (LOPRESSOR); metformin; tramadol; plantago ovata (METAMUCIL); insulin lispro (HUMALOG); warfarin; kcl. Past drug history included: Morphine, reaction: "Known allegies: Morphine"; Meperidine, reaction: "Known allegies: Meperidine"; Metoprolol, reaction: "Known allegies: Metoprolol"; Lisinopril, reaction: "Known allegies: Lisinopril"; Aleve, reaction: "Known allegies:Aleve"; Altace, reaction: "Known allegies:Altace"; Boniva, reaction: "Known allegies:Boniva"; Doxycycline, reaction: "Known allegies:Doxycycline"; Oxycodone, reaction: "Known allegies:Oxycodone". Vaccination history included: Bnt162b2 (Dose Number: 2, Lot No: EL9269, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 09Feb2021, when the patient was 91 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Lot No: EJ1686, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 19Jan2021, when the patient was 91 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (death) with onset 29Oct2021, outcome "fatal", described as "booster dose"; DEATH (death, medically significant) with onset 29Oct2021 09:30, outcome "fatal", described as "Patient died approximately 20 minutes after receiving booster dose". Therapeutic measures were not taken as a result of death. The patient date of death was 29Oct2021. The reported cause of death was "Patient died approximately 20 minutes after receiving booster dose". No autopsy was performed. Clinical course: Patient died approximately 20 minutes after receiving booster dose.; Sender's Comments: Based on the limited information available and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events immunization and death cannot be totally 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.; Reported Cause(s) of Death: Patient died approximately 20 minutes after receiving booster dose.