Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: mild arm soreness; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Ashtma", start date: 2010 (ongoing); "COPD" (not ongoing); "Brain Surgery", start date: 2007 (unspecified if ongoing); "anaphylaxis" (unspecified if ongoing); "Bradycardic" (unspecified if ongoing), notes: States her BP usually runs 90/45. Concomitant medication(s) included: SPIRIVA RESPIMAT taken for asthma, chronic obstructive pulmonary disease (ongoing); PROAIR HFA taken for asthma, chronic obstructive pulmonary disease (ongoing); ADVAIR HFA taken for asthma, chronic obstructive pulmonary disease (ongoing); VENTOLIN [SALBUTAMOL] taken for asthma, chronic obstructive pulmonary disease (ongoing); MONTELUKAST taken for asthma, chronic obstructive pulmonary disease (ongoing); CLARITIN [CLARITHROMYCIN] (ongoing); OMEPRAZOLE (ongoing); PHENYTOIN SODIUM (ongoing); AZELASTINE (ongoing); IPRATROPIUM BROMIDE (ongoing); FLONASE [FLUTICASONE PROPIONATE] (ongoing); DUONEB (ongoing); PREDNISONE, start date: 2021; AZITHROMYCIN taken for immune system disorder (ongoing). Past drug history included: Propofol, reaction(s): "allergies"; Versed, reaction(s): "allergies"; Nitrous oxide, reaction(s): "allergies"; Percocet, reaction(s): "Anaphylactic shock"; Nicotine, reaction(s): "caused her arm to get red and swollen", notes: patch. Vaccination history included: Bnt162b2 (Site Of injection- Right arm, Route- Intramuscular), administration date: 10Mar2021, for Covid-19 Immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "recovered" (01Apr2021), described as "mild arm soreness".  Additional information: Reporter stated on 10Mar2021, she 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. States she was given a shot with an Epi-pen in her thigh at the clinic and transferred to the ER. States in the ER, she was given Benadryl and watched for 4 hours. States she would state this was medically significant because of Airway, Breathing, Circulation and she felt like she couldn't breathe. Reporter Stated that it was kind of weird and freaky. Reporter states along with that, shortly before she was released from the ER, she experienced a very sore arm where she was given the injection. States she heard that was very common so she dealt with it. States however as the night progressed, it got increasingly worse. States it almost felt like she was punched several times in her arm. States it probably started between hour 3 and 4 after receiving the vaccine. States it was not serious, just annoying and it was gone 3 days later. Reporter states she knows this because she was a nurse, but a lot of times, people experience this reaction when they are given dilaudid. States 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. States this was kind of what the feeling was like for her and it was scary because she didn't expect it. Reporter Stated that the ER team that assessed her said, because she wasn't used to that feeling, she may had a panic attack and that may had made it worse. States 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. States 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. States she would say within under 5 minutes of her injection. Reporter stated he told her he had the same feeling and it lasted 5 minutes and then it went away. Reporter states since she got scared, it made it worse. States she doesn't know if she had a panic attack that made it worse. States of course her husband didn't tell her that until she was out of the ER, that it does go away. States 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. Reporter states 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 is an asthmatic and would panic and start feeling worse. Reporter stated 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. States the hospital said they were not giving her the second dose unless an allergist says it was safe and sets a protocol and he had to write a letter to the hospital. States 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. States she will have full immunity on 14Apr2021. Reporter states after the second shot, she had mild arm soreness not as severe, and it was over with in a day. States she had a pulmonary doctor, brain cancer doctor, ENT doctor, states 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. Patient received treatment of EpiPen, Benadryl, DuoNeb. States her husband had her vaccine card and she was not with him right now. States she was on a lot of medications period and most are for her pulmonary and stomach issues. States she takes antibiotics prophylactically because her immune system is low. Reporter was driving and doesn't had the dosages. Reporter states she was happy to be able to get her second shot. States at first they didn't want to give it to her because of her reaction but she kept calling. States so she went to hospital and saw an allergist and he had to sign off that it was safe to give her the second shot and under what circumstances. States she had the letter from 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. States to go through what she went though, and not be able to get would have been disappointing. States because of her immune system, it was important to get the shot and there was a way around the reaction which worked for her. States even having an anaphylactic reaction from the vaccine, she was able to recover quickly. States with having asthma, COPD and a low immune system, she may not recover from Covid. States 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 was important. Reporter states if the hospital refused to give her the second shot, they were telling her that she could go and get the Johnson and Johnson which they say had protection against the new variant but she didn't had to do that. States she knows Pfizer was one of first to come out with the vaccine and the new variant wasn't around at that time. States they are telling her the cards are there to identify people and for also possible boosters for the future. Patient was not hospitalized as she was immunocompromised, it was better to watch herself at home and because she has an Epi Pen at home in case she has that sort of reaction returning over a 72 hour period. States they instructed her husband and told them if she felt any different to come back to ER. Patient was not admitted to an Intensive Care Unit. Patient increased Respiratory, Wheezing, Difficulty Breathing and Respiratory Distress. Patient was allergic to Medications of Cephalosporins. EpiPen since she had multiple medication allergies and has a history of quickly going into anaphylaxis. The patient had not received any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient did not received any other vaccines around the time of the Pfizer-BioNTech COVID-19 Vaccine vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.