Received Oct 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
my great uncle died and nobody ever told him that people were dying after taking this; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "my great uncle died and nobody ever told him that people were dying after taking this". The date and cause of death for the patient were unknown. Clinical course: Reporter inquired about legally required Pfizer as a corporation to report any and all medical malpractice issues for example, if the patient has been administered a Comirnaty vaccine, and got forbit they died and whether it was a vaccine or not and it was now a medical malpractice case, because they just got the vaccine walked out of the doctor's office now they are dead it is debatable, they are going to do some evaluation, why the patient died or maybe a patient got very sick, when they were hospitalized for 6 months after taking covid 19 vaccine reporter was just using the example, per caller speaking hypothetically if the patient has died or become very very sick. or they got a terrible injury, or they got a giant sore on their arm, and they lost their arm, was being a little silly here, if there was some serious injury that patient has experienced it. where it was a vaccine whether a patient had an abscess on the arm. and had nothing to do with the vaccine, Comirnaty vaccine, reporter was asking legally required as a company any and all issues to the prospective patient such is myself who is wanting to take this vaccine, are you legally obligated to tell me about any and all documented cases of medical malpractice issues as such? Do you know?. per caller he was looking at the consultative function of the company, wanted to find out form the representative at the interactive level, to resolve his questions, per caller not sure if that that effective in terms of writing (verified with caller no legal matter with Pfizer at the time of the call, per caller just wanted to know his rights as an (withheld) citizen, per caller reporter wanted to know his legal rights and protections as a citizen before he were to get the vaccine) inquiring as a corporate entity required to divulge any in all malpractice cases associated with the vaccine such as Comirnaty 2025-2026 formula? so if he call he know you are legally required to tell me any in all issues, so he was safe as a consumer not like well you never asks as about it so we never told you, oh well gilt by omission or whatever they say. if yo never tell me how would I know to ask, reporter was relaying on the fact that he was legally protected that you would tell me ahead of time. Explained again that if he would have adverse event to report we would connect him to our safety department to report the feedback. per caller he want to protect himself as a patient in terms of potential adverse reactions, instead of working retroactively he took this vaccine and nobody ever tell me and now you know I am very sick, I got malpractice case or god forbit died you know they died well what they can do my great uncle died and nobody ever told him that people were dying after taking this, particular vaccine he just don't know, he just don't know if the patient as a legal (withheld) citizen has a right to be informed mandatory to receive mandatory communication, from the pharmaceutical company about a serious issues pertaining to the vaccine. Explain that in terms of any legal matter we would refer him to Pfizer legal department, in terms of regulatory agency we would refer him to FDA, explained that he has reached Pfizer medical information and we can provide information about a product. per caller I know you are just one representative, you are not a company but I wanted to know if there is any issues with the vaccine I want to know upfront. per caller I never going to read enough literature and know enough knowledge to interpret information as a patient because I have to be a doctor or scientist to understand the implications of thematical information. per caller I am calling you to day for you to alert me any medical malpractice, a patient died a patient lost their arm or got very sick I wanted to know that you tell me before the end of the conversation before I take that vaccine, before I call my doctor's office I want to know ahead of time because I don't want to walk in to take the vaccine that could kill me or injure me. give me medical malpractice and you never told me. you never asked why we should tell you that's not enough legal defense for me. Reporter want to know that you are required by law to any and everything bad about the vaccine, I don't care what it I want to know upfront. per caller I am not taking about oh well 10 % of people had their arm itching for a week, that is not going to kill me that is not going to permanently disable me, explained that a product labeling has all the information approved by the FDA including warnings precautions, adverse reactions listed there also refer caller to treating HCP, at this point caller moved on to other questions about a vaccine. If there were serious reactions to the vaccine if your company was experiencing a serious issue like patients were dying and or patients were getting very sick with something very serious, they became paralyzed in heir left arm or right arm or whatever but after taking they vaccine they were permanently paralyzed, serious medical malpractice issue, would you tell me as a patient that was going on? would you legally be require to do that or would you voluntarily said we have an issue with this vaccine we are not goanna allow you to become trapped. in a terrible deathly situation. or situation that can be seriously injurious to you as a patient, would you tell me that or is it possible that as a patient, I could talk to you ask you any question under the sun and you would never tell me that there was a serious issue with the vaccine. Explained to the caller that I can provide them with the information as approved by the FDA included in the product labeling, Anything outside of that as he has mentioned legal matters, I would refer to legal department. Explained that if he would report the adverse event we would connect him to our safety department to document that. If the patietns were getting very sick and dying from the vaccine, is the healthcare provider required to inform your organization? Are the healthcare providers who administering the vaccine 2025-2026 are legally required to report to you any and all medical malpractice cases? Refer caller to the HCP providers he was questioning regarding legal implications, refer to FDA and Pfizer legal department. Explained that reporter can speak to the medical information department only, again explained that if we would receive report of adverse event, we would connect person or forward information to our safety group. per caller in the topic with medical malpractice that he was discussing are you as an entity required, as an organization are you required to communicate issues upfront? to the caller such as myself, to say we are legally required to inform you of a serious issues of the vaccine there were x number of malpractice cases and would you like more information on malpractice cases? there have been serious side effects that have been recognized by a medical community and they are considerable and we want to alert you ahead of time, would you like more information on the serious side effect that have been reported. would safety department be able to help me with those questions? Explained that I can connect him to our safety department so he could check directly with them, in terms of legal matters again refer caller to Pfizer legal department. Explained that I had information specific to the product as approved by the FDA. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Reported Cause(s) of Death: Death