Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fibrin D dimer increased, Scan
Clinical narrative: one that was send to the ER with shortness of breath and elevated D-dimer; one that was send to the ER with shortness of breath and elevated D-dimer; This is a spontaneous report from a contactable nurse. This nurse reported for a female patient that she received a dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number: EL9269; Expiry date: 01May21) via an unspecified route of administration on 26Mar2021 as a single dose for COVID-19 immunization. The patients past medical history and concomitant medications were not reported. On an unknown date, the patient experienced Shortness of breath and elevated D-dimer. The clinical outcome for the events was unknown.  Caller is an RN (Registered Nurse), caller's  title, Infection Preventionist, she is calling from the nursing home (300 bed long term facility)  stated that she was trying multiple times today and she needed to speak to someone to report adverse reactions,  she had been reporting to the VAERS system since they started giving vaccines in Jan, stated: "I  had summitted probably 30 reports at this point  of all different various things in any of our patients even if they were in hospice if they  had a vaccine and proceeded to pass away, I 've done all the reporting. I have a very abnormal large volume of patients that got vaccinated on 16th of Apr, with the first doses of Pfizer (PFIZER-BIONTECH COVID-19 VACCINE)  one specific lot number and I have 7 adverse events in one group of patients out of 30. And it is way too complicated to get that information to you guys quickly, so I need to speak to somebody as there is a chance that those could be a significant events and I need to be able to tell somebody what is going on" Verified that caller was trying to get in touch with someone in our safety group to report that, wanted to speak to the live agent. Offered assistance. Caller stated: "I've actually left several messages that have gotten no callbacks, sometimes they don't even go through your phone system, or keep me on hold for 20 -30 minutes and then finally say please leave a message so I've had to do that already couple times" Both she and her colleague were trying to get through and her colleague phone started to ring so she transferred a phone to the caller. When attempted to determine what number they were calling, caller provided #, option #1 ( I explained that was a number to FDA/CDC (VAERS)Vaccine Adverse Event Reporting System to report side effects) at this point caller stated that she also called # this morning and left a message as well. At this point attempted to warm transfer the caller to safety. All safety agents were busy (20 calls ahead of us). Due to the long hold time, e-transmitting AE. Caller aware of the option to submit the information online, aware of the fax # as well, wanted to share details to live agent.  Caller stated: "because all those reports involving one lot # it is more suspicious than even all the other reports that I've ever done. This is just one whole group and now I have 3 deaths. I have 3 deaths and I have 2 strokes in this group" Caller stated that she will file reports online she just wanted someone to call her back about the side effects and the lot # involved. Stated" I've got this whole group, this whole entire group due to get their second dose on Friday, two days from now, so obviously I am not giving it to any of these people there is a 7 of them out of 33. I have 20 staff that have received it the same day I did not have any side effects in any of the staff but I am definitely little weary at the moment." Offered to forward provided information to safety. Caller provided lot# EL9269, exp. Date 01May21 ( stated that it was weird because it was very close to the expiration date). Caller stated: "All those people were dosed on Mar 26th. Caller stated that she was going to give me just basics (in terms of information to start the process) and that she will file a forms online. Caller stated: "That day 31 patients received a vaccine and she had 7 patients worth investigating (caller stated that she had that portion written if there was a way to forward that to us? Explained that there was an option to contact us through our website (website withheld)) but for adverse reports specifically I would refer them to Pfizer safety (website withheld) explained that I also had a fax# but caller declined she already had that information. Verified that she was reporting adverse events [7 patients, gender: 5 females and 2 males; all (ethnicity), (ethnicity)] Caller stated" Three people (patients) were send out and subsequently passed away in the hospital, one (patient) we send with bradycardia, hypotension and she (female) passed away in the ER, critical labs, she didn't even make it one day, we send her out and she passed away in the ER. I have one male (patient) who had acute stroke I don't have all the details because he is still hospitalized in ICU. I have one (patient) who we sent to the ER hypoxic, hypotensive, short of breath, she (female) she ended up passing away in the hospital, her diagnosis there was hypoxia and acute CHF. I have another male (patient) who had an acute CVA we send him to the hospital he had acute CVA, he had a right artery occlusion, he passed away. I had another female (patient) who we sent out with shortness of breath and increased confusion, she wound up in the ER with hypoxia and sepsis and she (female) passed away. I am sure there is more we do not have hospital records we only know what we were told. And then I have two others one that was send to the ER with shortness of breath and elevated D-dimer, she ( female) actually returned to us her scans were negative, so she is one of those we are not really 100 % sure, but she did get send out to the ER. And we have another one (female) chest pain, shortness of breath, she was not send out her D-dimer and her studies that we have done here were within normal limits but definitely had some acute shortness of breath and chest pain, we did troponin and bunch of cardiac labs here, she did not go out. So those are the seven that I have at the moment that are concerning." attempted to warm transfer the caller to safety. All safety agents were busy (20 calls ahead of us). Due to the long hold time, e-transmitting AE/PC  DSU/PQC: Caller requested callback from safety and product quality group regarding her concern about that particular lot# and reported adverse reactions. F/ u pending.; Sender's Comments: Based on the limited information, a causal relationship between the suspect drug BNT162B2 and the events dyspnea and d dimer increased 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