Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram, Electrocardiogram abnormal, Influenza virus test, Investigation
Clinical narrative: not getting rid of a huge red it's  2 inch red circle around the injection area; abnormal EKG; couldn't breath/shortness of breath; like an anaphylaxis reaction; chest pain; she was coughing a lot; having a flare up of asthma; rash started getting red and bumps started/bumps moved down her left arm; bumps on her left arm; skin colored bumps; developed a Covid rash/rash; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose via an unspecified route of administration, administered in Deltoid Left on 08Jun2021 17:30 (Lot number was not reported) at age of 53 years old as a single dose for covid-19 immunisation.  Medical history included asthma from 2014 and ongoing, hypothyroid, allergy to cat, cipro. The patient had no Family Medical History Relevant to events. Concomitant medication included levothyroxine taken for hypothyroidism from an unspecified start date and ongoing. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration on 21May2021 (Lot number was not reported) at age of 53 years old as a single dose for covid-19 immunisation and No reaction on previous exposure to vaccine. The patient experienced couldn't breath/shortness of breath (medically significant, life threatening) on 13Jun2021, like an anaphylaxis reaction (medically significant, life threatening) on 13Jun2021, developed a covid rash/rash (medically significant) on 08Jun2021, chest pain (medically significant) on 13Jun2021, rash started getting red and bumps started/bumps moved down her left arm (medically significant) on 10Jun2021, bumps on her left arm (medically significant) on 10Jun2021, abnormal ekg (medically significant) on 13Jun2021, she was coughing a lot (medically significant) on 12Jun2021, having a flare up of asthma (medically significant) on 12Jun2021, not getting rid of a huge red it's  2 inch red circle around the injection area on 14Jun2021, skin colored bumps on 09Jun2021.  The outcome of the event 'abnormal ekg, having a flare up of asthma, skin colored bumps', all was unknown, 'she was coughing a lot and like an anaphylaxis reaction' was resolving, and the other events was not recovered. The patient underwent lab tests and procedures which included chest x-ray: Negative, electrocardiogram: abnormal, Flu Test: negative, metabolic function test and Labs, Cardiac Workup: all unknown results, COVID test: negative, all on 13Jun2021. The patient went to Emergency Room on 13Jun2021. She is on her way out of town, but she just moved to that area, so she will be seeing her doctor tomorrow for follow up from the ER. Prior Vaccinations (within 4 weeks) was None. AE(s) following prior vaccinations was none. Events 'bumps on her left arm, not on the deltoid area, but in front of her deltoid, in the bicep area were 15 raised bumps that were the same color as her skin; developed a Covid rash', 'bumps moved down her left arm', 'bumps went down her other arm, right arm and fully covered it and the bumps became bumps on top of bumps and were turning red', 'couldn't breath and dyspnea; like an anaphylactic reaction', ' Red Circle Around Injection Site Related', 'Abnormal EKG', 'Chest Pain on the right side, a little stabbing pain' were reported as related to suspect vaccine.    Clinical course: After 2nd dose of Pfizer covid vaccine on 08Jun, caller experience rash that got worse 1st and 2 day and by the 4th day had shortness of breath, chest pain and like an anaphylaxis reaction, went to ER, was put on IV Decadron, prednisone, and Benadryl. Is still taking prednisone and Benadryl, looking to see if any data on 4 or 5 day effect from this?  once she goes off the prednisone and Benadryl her symptoms come back. Still taking medications , when time for next dose, her symptoms start to come back. Once someone has taken medication , what is data on medication and recovery for these side effects? she was concerned, she read up on Adverse reactions and long term effects, she had no problem with first shot., She know second shot you can have problems, when rash started gets stating red and bumprted and 3 days later woke up and couldn't breath, took Benadryl and her in halers and it startled her again in the middle of the night where she needed to get to the ER.  She had an abnormal EKG to follow up on and some chest pain. She was concerned because it's the vaccination. She had read the cardiac situation, she read it all. She read about the covid rash, but it turned into something else, now where they gave the injection, the prednisone and Benadryl not getting rid of a huge red it's  2 inch red circle around the injection area, this came up yesterday, not sure if it's because she got the other injection in her arm. When she got her second covid shot, all the symptoms that were described to you and the other agent was reported, this event didn't get written down where this red ring that just came up after the 2nd covid shot. She was currently having, on prednisone tapered dose 60mg on 2nd dose, When She waited to take it at 10, she had a hard time breathing, it was wearing off.  Caller states she is a nurse as well. Caller states she is going to write this up of course. Caller states she got her first vaccine and it seemed to go well and then she got the second vaccine and apparently from the literature she was reading, she developed a Covid rash. Caller states on the second day after the vaccine, she had bumps on her left arm, not on the deltoid area, but in front of her deltoid, in the bicep area were 15 raised bumps that were the same color as her skin. Caller states she thought all was fine, she saw this was a common effect. Caller states the day after that, the bumps moved down her arm and she thought no problem, she wasn't concerned, she could breath and was fine. Caller states she called the pharmacy and they said she doesn't need to be worried, patients get bumps some times, so she said okay fine. Caller states the next day, so the 3rd day after, the bumps went down her other arm. Caller states on the 4th day after, she was coughing a lot. Caller states she has asthma and used her inhaler. Caller states she was going to the gym, and said oh, this is getting worse, so she took half of a  Benadryl. Caller states she went to meet her daughter for dinner and it was getting worse, so she took the other half, and it seemed to help. Caller states she woke up at 02:00a.m. and she couldn't breath. Caller states the ER is 4 miles away, and when she got there they gave her IV Decadron. Caller states she had an abnormal EKG and dyspnea. Caller states she is now on a tapered dose of prednisone and Benadryl 2-3 times a day. Caller states  now she has a big red lump on her arm,  even with the medicine, the big red lump is probably 1-2 inches in circumference around the injection site. Caller states she is looking for any data as far as this 4-5 day effect she had or if there are any long term effects from this? Caller states she needs to ease her mind,  once she is out of the prednisone and Benadryl, is she going to be alright? Caller states she wants to find out if there are any other reports like this. Caller clarifies the first day after, on her left deltoid muscle, she got risen skin colored bumps. Then the second day after, the bumps went down her left arm. Then on the third day, the bumps went down her other arm and fully covered it and the bumps became bumps on top of bumps and were turning red. Caller states on the fourth day after, when she went to the gym on the 12Jun2021, that evening she thought she was having a flare up of asthma and she was ignoring the bumps because she looked up the Covid rash thing and then started having problems breathing and on 13Jun2021 she went to the ER for like an anaphylactic reaction and cardiac workup. Caller states she still has a red circle around the injection site that has worsened, like where the medication was injected. Caller states the Prednisone and Benadryl aren't helping it. Benadryl: UPC, Lot, Expiration Unknown, states it is ordered every 4-6 hours 50mg. Prednisone: NDC, Lot, Expiration Unknown. States it is a tapered dose 60mg x 2 days, 40mg next 2 days and then 20 mg for the following 2 days and she wants to say it is at least 6-8 days of prednisone. Caller states she also had chest pain on the right side and she is still having it on the right side area, it is a little stabbing pain. Caller states her side effects prodromal effect, they came in stages and built on one another. Caller states her symptoms are persisting, if she doesn't take the prednisone dose, when it is time to take medicine. Caller states when she woke up, she tried to wait as long as she could and the side effects started up again and she couldn't breathe good, states she took it around 10:00am. Treatment: Caller states she has Asthma and took her Inhalers Dulera 100mcg/5mcg and Albuterol, Benadryl, Prednisone, IV Decadron, Breathing Treatments. Caller states she went to the ER at 3:25a.m. on the morning of 13Jun2021 and they observed her for a while in the ER. Suspect product: First vaccine dose received on 21May2021, LOT:UNKNOWN. Second vaccine received on 8Jun2021, LOT: Unknown. Caller states they were given at the drug store given directly on time. Caller states when the SARS 1 vaccine came out, she was working in the ER and he got the vaccine for that but was fine. The patient had not receive any recent vaccines for any other conditions prior to the event being reported. The patient had not received any recent vaccines for SARS-CoV2 other than PfizerBioNTech COVID-19 Vaccine prior to the event being reported. The patient had not received any other vaccines around the time of PfizerBioNTech COVID-19 Vaccine vaccination. The patient was not hospitalized. The patient require medical intervention included Adrenaline; Corticosteroids; Antihistamine; IV fluids;Oxygen; Bronchodilators; Other  Details: ER 13Jun2021. IV Decadron, Benadryl, Breathing Treatments, Prednisone. Organ involvement Multiorgan involvement included below Respiratory; Cardiovascular; Dermatological Respiratory Unknown. The event require the initiation of new medication included Benadryl and Prednisone, Z Pack. Caller stated she still has a red circle around the injection site that has worsened, like where the medication was injected. Caller states the Prednisone and Benadryl aren't helping it. Benadryl: UPC, Lot, Expiration Unknown, states it is ordered every 4-6 hours 50mg. Prednisone: NDC, Lot, Expiration Unknown. States it is a tapered dose 60mg x 2 days, 40mg next 2 days and then 20 mg for the following 2 days and she wants to say it is at least 6-8 days of prednisone.  Follow-up attempts are needed; information about lot/batch number has been requested.; Sender's Comments: based on available information, the events were considered related to suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).