Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory distress
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose number unknown (booster), 0.3 ml single (Lot number: GJ5342, Expiration Date: 18Nov2022) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hospice" (unspecified if ongoing), notes: hospice, Unknown how long patient was on hospice. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: RESPIRATORY DISTRESS (death, medically significant) with onset 21Sep2022 at 21:30, outcome "fatal". The patient date of death was 21Sep2022. Reported cause of death: "Respiratory distress". It was not reported if an autopsy was performed. Clinical course: Reported as, Trying to figure out her first steps. Had a clinic at an assisted living facility and had two residents die. Does not know if it is related to the vaccine or not. The two individuals received the Pfizer COVID-19 Vaccine Bivalent for 12 years and up before 12pm noon. One patient passed away at 4pm and the other after 9pm. Both patients went into respiratory distress hours after receiving the vaccine so it was not anaphylaxis related. Details she has at this time are still very vague. Respiratory Distress: Clarified patient, male on hospice but doing well, received the vaccine sometime before noon and passed away around 9:30pm 21Sep2022. Concomitant Medications: Unknown. Patient is on hospice and probably on other medications but she does not know. Other Medical Conditions: On hospice.  Unknown if there are other medical conditions. Safety report filed for 2 patients, passed away a few hours after getting vaccine 90 y/o female not sure of age of second individual is a Male on Hospice. received vaccines at noon and died hours afterwards yesterday. Response: Overall Safety Summary: It is MANDATORY for vaccination providers to report to the Vaccine Adverse Event Reporting System (VAERS) all vaccine administration errors, all serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and hospitalized or fatal cases of COVID-19 following vaccination with the Pfizer-BioNTech COVID-19 Vaccine [Monovalent]. To the extent feasible, provide a copy of the VAERS form to Pfizer Inc. Please see the REQUIREMENTS AND INSTRUCTIONS FOR REPORTING ADVERSE EVENTS AND VACCINE ADMINISTRATION ERRORS section for details on reporting to VAERS and Pfizer Inc. CLINICAL DATA Adolescents and Adults Aged greater and equal to 16 Years 2 Doses of Comirnaty AE analyses are provided for all enrolled 43,252 participants, with variable follow-up time after dose 1. Few participants in either the vaccine or placebo group had severe AEs, SAEs, or AEs leading to withdrawal from the trial (Table 1). Four related SAEs were reported among vaccine recipients (shoulder injury related to vaccine administration, right axillary lymphadenopathy, paroxysmal ventricular arrhythmia, and right leg paresthesia). Death occurred in 2 vaccine recipients (1 from arteriosclerosis, 1 from cardiac arrest) and 4 placebo recipients (2 from unknown causes, 1 from hemorrhagic stroke, and 1 from myocardial infarction). No deaths were considered by the investigators to be related to the vaccine or placebo. No COVID-19 associated deaths were observed. Explained to caller this document has additional information related to deaths and reporting responsibilities Caller agreed to receive information in writing for review. Sender's Comments: Based on the information in the case, an association between the reported event Respiratory distress and suspect product bnt162b2 cannot be ruled out. 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-202201182253 same reporter/product/AE, different patient; Report 1 of 2; Reported Cause(s) of Death: Respiratory distress.