Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Hypoaesthesia, Lethargy, Mobility decreased, Thrombosis
Clinical narrative: Blood clots in her nose; Nose bleed; her arms are both numb on her; Couldn't move them; She feels lethargic; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, enquired have people died from the vaccine or not. Enquired what do you know about the news in the media about reports of death in nursing home elderly patients. Response: Pfizer and BioNTech are aware of reported deaths following administration of Pfizer-BioNTech COVID-19 vaccine . We are working with the (withheld) to gather all the relevant information. (Withheld) Authorities have prioritized the immunization of residents in Nursing Homes, most of whom are very elderly with underlying medical conditions and some which are terminally ill. (Withheld) confirm the number of incidents so far was not alarming, and in line with expectations. All reported deaths would be thoroughly evaluated by (Withheld) to determine if these incidents are related to the vaccine. (Withheld) Health Authorities have now changed its recommendation in relation to vaccination of the terminally ill (Clinical Frailty Scale 8 or higher). Our immediate thoughts are with the bereaved families. The COVID-19 Vaccine Safety subcommittee met virtually on Tuesday, 19Jan2021, to review available information and data on deaths reported in frail, elderly individuals who had received the Pfizer BioNTech COVID-19 mRNA vaccine, BNT162b2 (hereafter, BNT162b2). Experts invited from the (Withheld) and the (Withheld) provided an overview of deaths reported in (Withheld) and in the WHO global database (VigiBase) following vaccination with BNT162b2." Based on a careful scientific review of the information made available, the subcommittee came to the following conclusions: The current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of BNT162b2. Reports are in line with the expected, all-cause mortality rates and causes of death in the sub-population of frail, elderly individuals, and the available information does not confirm a contributory role for the vaccine in the reported fatal events. In view of this, the committee considers that the benefit-risk balance of BNT162b2 remains favourable in the elderly, and does not suggest any revision, at present, to the recommendations around the safety of this vaccine." Enquired what was the efficacy after one dose. Caller had a terrible experience after her first dose of the Pfizer BioNTech COVID19 vaccine. She had blood clots in her nose, every time she blew her nose, blood clots would come out. She never had a nose bleed before. She also added that her arms are both numb on her. She couldn't move them, she feels lethargic. She's supposed to get her second dose next Friday. Enquired do we have any information regarding blood clots or not. Caller was upset and disconnected the call before some of the answers were given. Caller also asked the following questions: Has there been deaths reported from the vaccine or not, what was the efficacy after 1 dose, any guidance on getting the second dose after having side effects after the first dose. Response: Proposed response : CONS-Blood clots. Caller said "this was ridiculous" when I tried providing her with a long website with more information. She feels like we are withholding information from the public. She thinks the deaths should have been on the media. Caller hung up. Enquired do you have any guidance on getting the second dose after having side effects with the first dose. I had a side effect after the first dose of the vaccine. Should I get the second dose or not. Caller disconnected before agent could provide response. Response: Proposed response: As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason could not be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.