Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Dyspnoea, Feeling hot, Injection site bruising
Clinical narrative: Felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe; almost like she couldn't breathe/Difficulty Breathing; Felt funny in her chest, like a really weird, really warm and heavy feeling/ warm feeling in the chest; having an anaphylactic reaction from the vaccine; Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress; Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress; Very sore right arm where she was given the injection; felt like she was punched several times in her arm; Injection site bruising; This is a spontaneous report from a contactable nurse(patient). The nurse reported similar events for herself and her husband. This is the first of two reports.  A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 54 years of age), dose 1 intramuscular, administered in arm right on 10Mar2021 16:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included severe asthma which started as a child and then it went away and then as an adult it got severe around 2010 and ongoing, she was an asthmatic and would panic and start feeling worse. She had ongoing chronic obstructive pulmonary disease (COPD), brain surgery in 2007, low immune system, allergies to cephalosporins, pulmonary and stomach issues; and bradycardia (as her BP usually runs 90/45 and she is bradycardic). Concomitant medications included tiotropium bromide (SPIRIVA RESPIMAT), salbutamol sulfate (PROAIR HFA), fluticasone propionate, salmeterol xinafoate (ADVAIR HFA), salbutamol (VENTOLIN [SALBUTAMOL]), and montelukast (MONTELUKAST), all taken for asthma, chronic obstructive pulmonary disease from an unspecified start date and ongoing; clarithromycin (CLARITIN [CLARITHROMYCIN], omeprazole, phenytoin sodium, azelastine, ipratropium bromide, fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), and ipratropium bromide, salbutamol sulfate (DUONEB), all taken for an unspecified indication from an unspecified start date and ongoing; prednisone taken for an unspecified indication from 2021 and ongoing as she was on this steroid 2 weeks before the vaccine; and  azithromycin which she takes prophylactically for her low immune system from an unspecified start date and ongoing. She was on a lot of medications period and most are for her pulmonary and stomach issues. The patient previously took propofol, Versed, Nitrous Oxide, and Percocet wherein the patient had drug hypersensitivity and anaphylactic shock with these; adhesive from nicotine patch made her arm to get red and swollen (Dermatitis contact). She previously took EpiPen for anaphylaxis. It was reported that on 10Mar2021, the patient had the first dose of the vaccine and it felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe. She got her vaccine at a hospital in their clinic and she was transferred from the vaccine clinic to the ER. Stated she was given a shot with an Epi-pen in her thigh at the clinic and transferred to the ER. In the ER, she was given Benadryl and watched for 4 hours. She would state this was medically significant because of airway, breathing, circulation and she felt like she couldn't breathe. She added that it was kind of weird and freaky. She mentioned that along with that, shortly before she was released from the ER, she experienced a very sore arm where she was given the injection. She heard that was very common so she dealt with it. However as the night progressed, it got increasingly worse, it almost felt like she was punched several times in her arm. It probably started between hour 3 and 4 after receiving the vaccine. She added that she had a very sore right arm where she was given the injection; felt like she was punched several times in her arm.  It was not serious, just annoying and it was gone 3 days later. She had injection site bruising on 10Mar2021. She stated that she knows this because she was a nurse, but a lot of times, people experienced this reaction when they are given Dilaudid wherein they  get a warm feeling in their chest, so they push it really slow and dilute it with saline so it doesn't have the respiratory factor. She stated that this was kind of what the feeling was like for her and it was scary because she didn't expect it. She stated that the ER team that assessed her said, because she wasn't used to that feeling, she may have had a panic attack and that may have made it worse. After she was treated, she spoke with her husband and he had the shot two minutes before her and he had the same feeling but he didn't freak out and didn't want to appear weak. Stated he told her he had the same feeling and it lasted 5 minutes and then it went away. Stated since she got scared, it made it worse. She doesn't know if she had a panic attack that made it worse. She stated that of course her husband didn't tell her that until she was out of the ER, that it does go away. That made her feel better because she wasn't the only one that experienced that. States he didn't say anything about it, because he was worried about her,  he said it was a warm feeling in the chest and not being able to breathe but he didn't want to say anything because she was an asthmatic and would panic and start feeling worse. She mentioned that they weren't going to let her get the second dose, so she went to an allergy doctor and told them what happened and about her husband having the same reaction and because she was severely immunocompromised. Stated the hospital said they were not giving her the second dose unless an allergist says it is safe and sets a protocol and he had to write a letter to the hospital. Stated she was pre-medicated 24 hours before the vaccine with 50mg Benadryl, 50mg Benadryl the day of the shot and 50mg of Benadryl two days after the shot. Stated she will have full immunity on 14Apr2021. She added that she had a pulmonary doctor, brain cancer doctor, ENT doctor, stated they don't know if it was caused by the vaccine, but they are pretty sure she had a reaction but they can handle it with pre-medicating her. She received the second vaccine on 31Mar2021. She mentioned that she was happy to be able to get her second shot. She stated that at first they didn't want to give it to her because of her reaction but she kept calling. So she went to a hospital to saw an allergist and he had to sign off that it was safe to give her the second shot and under what circumstances. Stated she had the letter from the hospital that she was seen by them and she needed to be pre-medicated and it had to be given at a hospital that had the ability to intervene quickly and she needed to be watched for at least 30 minutes after the vaccine. She mentioned that to go through what she went though, and not be able to get would have been disappointing. Because of her immune system, it is important to get the shot and there was a way around the reaction which worked for her. She added that even having an anaphylactic reaction from the vaccine, she was able to recover quickly. Stated with having asthma, COPD and a low immune system, she may not recover from Covid. It makes sense they evaluated it and came up with a solution and a pre medication protocol and when and how long and she was still able to get the shot because it is important. Answers to follow up questions indicated that on 10Mar2021, the patient had the first dose of the vaccine and it felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe. She was given the shot and getting ready to get out of the chair and her husband was about to sit down for his shot. Stated she would say the time of the course of the reaction was within under 5 minutes of her injection. The patient required medical intervention with Epi-Pen, Benadryl, and Duo-Neb. The patient was not hospitalized because she was immunocompromised, it was better to watch herself at home and because she had an Epi Pen at home in case she has that sort of reaction returning over a 72 hour period. Stated they instructed her husband and told them if she felt any different to come back to ER. She was not admitted to the ICU. Organ involvement included: Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress. The event required initiation of new medication or other treatment or procedure including Epi-Pen, Benadryl, DuoNeb. Patient have a history of previous allergies: Medication Allergies to Cephalosporins, Anesthesia medications: Propofol, Versed, Nitrous Oxide, Percocet: Anaphylactic shock; Adhesive from nicotine patch, caused her arm to get red and swollen. She takes EpiPen as she had previous history of allergies and since she had multiple medication allergies and had a history of quickly going into anaphylaxis, stated her BP usually runs 90/45 and she was Bradycardic. She did not receive any recent vaccines for any other conditions prior to the events being reported. She did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. She has not received any other vaccines around the time of the Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient recovered from 'felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe', Difficulty breathing, and 'warm feeling in the chest' on 10Mar2021; while having an anaphylactic reaction from the vaccine, Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress were recovered on an unknown date; Vaccination site pain recovered on 13Mar2021 and Injection site bruising recovered on 18Mar2021. Therapeutic measures were taken as a result of all events except Vaccination site pain and Injection site bruising. Relatedness of drug to reactions/events: Reaction assessed for events "felt funny in her chest, like a really weird, really warm and heavy feeling, almost like she couldn't breathe", 'very sore right arm where she was given the injection; felt like she was punched several times in her arm.' and Injection site bruising: Method of assessment: Global Introspection: Drug result: Related.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, the Company considered all serious and non-serious events as possibly associated to BNT162B2 injection, due to a plausible chronological sequence. Current patient conditions of asthma, chronic obstructive pulmonary disease and allergic diathesis may have been considered as favoring factors in development of reported events.   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-2021406773 same reporter and drug, similar events, different patient