Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Rash, Respiratory disorder
Clinical narrative: rash with hives down the arm where I got the shot; rash on my face/rash with hives down the arm she got the shot in; rash on her face that was swollen; a rash on her face that was red/it was going down her arm and she had hives, was itchy and red; hot to touch and extended to my ear; strange respiratory thing/kooky respiratory thing; had a raspy kind of voice; she couldn't breathe; wheezing; she knew it was an allergic one/ showed a mild reaction to something in the Covid 19 vaccine; itchy; ear was also swollen; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included autoimmune problems. Concomitant medications included epinephrine (EPIPEN) and influenza vaccine (reported as 'flu shot'). The patient previously took amoxicillin sodium, clavulanate potassium (AUGMENTIN) and had a reaction. The patient got her first dose of Pfizer BioNTech Covid-19 Vaccine at the end of Feb2021 on Thursday at 5pm and woke up the following Friday morning (Feb2021) with a rash on her face that was red, swollen and hot to touch and extended to her ear. The patient took Benadryl and the rash lasted to the beginning of the following week (Mar2021) and after that went away, she developed a rash with hives down the arm she got the shot in. She was given Prednisone and that got better. A month or 2 later (2021), she developed a strange respiratory condition that lasted 2 months. She saw multiple doctors and was on several medications. As strangely as it came, it went. The patient saw an allergist who did a scratch test with the Pfizer BioNTech Covid-19 Vaccine in 2021 that showed a mild reaction to something in the Covid 19 vaccine, she did not have a big reaction but something in the vaccine. The allergist suggested she could get the second dose of the vaccine but prescribed an extreme amount of antihistamine, the strangest regime she has ever heard of. The patient was told to take Singulair the night before and the morning of her vaccination appointment, then two Zyrtec before the vaccine and 2 Zyrtec after the vaccine, as well as a dose of Pepcid. She has an epi pen and rescue inhaler as well. The patient was very concerned about this regime and asked for Pfizer's guidance on the use of antihistamines before and after taking the Pfizer BioNTech Covid-19 Vaccine. The patient was told that in the Pfizer-BioNTech COVID-19 vaccine study, people were allowed to take antihistamines, like diphenhydramine. This included the use of antihistamines for seasonal allergies. The Centers for Disease Control & Prevention (CDC)'s Advisory Committee on Immunization Practices (ACIP) has provided interim considerations for the use of COVID-19 mRNA vaccines (like Comirnaty also known as the Pfizer-BioNTech COVID-19 Vaccine). These interim considerations state that antihistamines (like diphenhydramine) should not be taken prior to vaccination to prevent allergic reactions, including anaphylaxis (anaphylaxis is a serious and potentially life-threatening allergic reaction). The ACIP states that antihistamines do not stop anaphylaxis from happening. Antihistamines may cover up skin symptoms of an allergic reaction, which could lead to a delay in diagnosis and treatment of anaphylaxis. The patient was asked to be sure to discuss any questions about taking an antihistamine before or after vaccination with her vaccination provider, doctor, or other health care professional. The patient stated that her concern with the allergist as well as relating to her primary she doesn't feel with the scratch test under the Covid reaction they were supposed to be checking what element is in that vaccine and she has a sheet that tells what exactly is part of the shot.  What's in there that she is allergic to may not have been the actual medication, it could have been something in it. She got no clarity as to why she got the reaction and the strange phases. She had taken Augmentin and had a reaction. The patient also started that her ear was also swollen, and she had hives down her neck, and she didn't think it was an anaphylactic reaction but she knew it was an allergic one. She contacted her doctor and was told to take 2 Benadryl 2-3 times a day which she did and that was under control and then she started having hives down her neck again and called her doctor again and was told to take a long-lasting antihistamine like Allegra, something that lasted 24 hours. By Wednesday it was going down her arm and she had hives, was itchy and red and she took a picture for when she went to her doctor, she showed her what was happening. She was on Prednisone 20mg for 6 days and that cleared. The kooky respiratory thing happened, and she doesn't have asthma but that was wheezing, she couldn't breathe, had a raspy kind of voice, and she was put on ventilators and medications. A month and a half or 2 months it just left like it came. She is only 1 shot vaccinated and what does she do, she has some protection but not full. States she is apprehensive about antihistamine-ing herself to death to get the shot so thought she would go to the manufacturer for advice, that on the paper it says if you have an adverse event don't get the shot so what does she do. Her medical doctor is as perplexed as she is, that she is saying let's go with what the allergist is saying, and she is not comfortable with so much antihistamine. She stated that the CDC guidelines are not encouraging that level before getting that shot. Her allergist that did the test said she has found with 40 patients that have had some kind of problem. She may not have a reaction at all with the 2nd one, that her doctor thought she could get the booster and then thought maybe she could get the J&J as it's completely different than the Moderna or Pfizer but then the thrombosis issues came out and her grandfather died from thrombosis. She also has autoimmune problems and if she doesn't get another shot what would be the right way she can't get answers about reactions that would help her through if she takes the chance or doesn't. She doesn't think it would be anaphylactic. The patient stated that if you get Covid you would be in bed a day and then be good. She is as perplexed as they are and she is not 100% confident with antihistamines and her doctor is the same and says she doesn't know what to tell her. Her doctor was going to reach out to another doctor and she thinks she forgot, it might be an infectious disease doctor or an epidemiologist or something with better knowledge as to what she should look for or how to prepare. She stated that she takes Singulair and doesn't have asthma what good does that do her. She is looking for information, she looked at the paperwork and it says if you have an adverse event don't get the 2nd shot. She figured it's been lots of months now and there still has to be something in her system and is still out there with her mask and is partially vaccinated and she tries to stay away from crowds. Her doctor said with the variant it brings pneumonia right away. She doesn't know if she should chance it and hope for the best. She is beginning to believe are they even on board with that. The agent is sending her information for the CDC guidelines and she would assume her doctor would take credence to say ah-ha. The patient is willing to take Singulair in the morning and go about her business and when she comes home take a Zyrtec or 2 but she doesn't even know if she needs to do all that and see what happens before she gets aggressive. It's like her judgement call if she is going to do all that, she is going in speculating the worst and she doesn't know what will or will not happen. Stated she needs to speak with someone in medical that says that sounds crazy. She worked at a pharmaceutical company and helped people with adverse events and having a conversation with the manufacturer helps and it may be better to talk to a pharmacist than a doctor as they seem to know more about side effects than doctors. The information may help her understand and her doctor is understanding if she is able to let them know what is going through again, she might say what she has said, it's on you she would suggest no but then again, she doesn't want to get sick either. She states it came so fast and treating it has been like a beat the clock thing.  She is 72 years and gets the flu shot, the jumbo super deluxe one and it has some properties in there to help protect against some of this viral invasion. She wanted to be as protected as she possibly can be. She doesn't know anyone else with this type reaction, that some people get a flu like feeling and some have nothing. She gets whatever strange thing that nobody has heard of and it's frustrating and people look at her like this crazy lady has problems again. The outcome of the events "strange respiratory thing", wheezing, couldn't breathe and raspy kind of voice, itchy, hives and erythema was recovered in 2021 while the other events were unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.