Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Swelling face, Swollen tongue
Clinical narrative: trouble breathing; She noticed she kept losing her voice and then her voice would come back; throat is swollen; blood pressure was elevated; her face was swollen and distorted and broken out; severe allergic reaction; her tongue was swollen; started feeling tired/chronic fatigue/exhausted; she had bouts of diarrhea; she had an aggravating headache; she had the chills; she was itchy/She had been gouging holes in her scalp from itching; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150) at 63-year-old, on 05Apr2021 into left arm as 1st dose, single dose for COVID-19 immunisation. Medical history included diabetes, disabled and had major double surgery on her back in Jun2020. Concomitant medication was not reported. Patient calling about the Pfizer Covid 19 vaccine. She received her first dose of the Covid 19 vaccine on 05Apr2021. She stayed for 15 minutes afterward to make sure she didn't have an allergic reaction. She didn't have an allergic reaction. She left the facility and was ok. She was given paperwork with side effects. About an hour and a half or 2 hours after receiving the vaccine she started feeling tired, she had bouts of diarrhea, she was itchy. The paperwork says all of those side effects are possible. She already reported this to Pfizer, the agent told her in a week or two she would be receiving a packet in the mail. She never received anything. She's a disabled senior citizen and she's not sure how to get all this crap done. she's had no follow up from Pfizer. Does Pfizer want to know if she's dead, is she ok, is she laying brain dead in a hospital. She reports her arm was fine where she got the Covid 19 vaccine. The experience wasn't like her arm is going to fall off, it wasn't like that. She never gets headaches and she had an aggravating headache and she had the chills. That was 05Apr2021 through 08Apr2021. On the 08Apr2021 she had an appointment with her pain management doctor that was unrelated to the Covid 19 vaccine. The pain management doctor asked her to take her mask off. The doctor told her he didn't like the way her eyes looked, her face was swollen and distorted and broken out. The doctor started checking her over and told her she needs to see a doctor that can help her. She advised her to see her primary care doctor. That was the 08Apr2021. She had been gouging holes in her scalp from itching. She couldn't see her primary card doctor so she went to an urgent care. The urgent care staff didn't make her wait, they brought her back and started putting ice packs, the ice packs that you hit to activate, and the ice packs went on her scalp, her arms, her face. The urgent care doctor said this is not a side effect, this is a severe allergic reaction. By that time her voice had gotten much deeper than it normally is and her tongue was swollen because the doctor looked at her tongue. She was given a prescription of Vistaril and Pepcid. She was told to take the Vistaril for the next 24 hours. She told the doctor she didn't have problems with her stomach but the doctor told her the Pepcid has a strong antihistamine in it. She took the medications as prescribed and Saturday morning, 10Apr2021, she was in the emergency room because at that time, in her sleep, because the Vistaril makes her sleepy, she had been ripping her scalp and her vagina apart from the scratching. Even though she had these strong medications, Vistaril and Pepcid, they were doing nothing. She noticed she kept losing her voice and then her voice would come back. This voice that she has now, is not her real voice. That Saturday morning, 10Apr2021, when she got to the emergency department, a police officer saw her and grabbed a wheel chair right away and took her to the registration area. The police officer told the hospital staff that he thought this lady (the caller) was in trouble. At that time she was having trouble breathing. The first question out of the doctor's mouth was what Covid 19 vaccine did she get and when did she get it. She provided that information to the doctor. The doctor recommended she receive a massive dose of Prednisone right now. She told the doctor she wasn't supposed to have any steroids for 2 weeks after the Covid 19 vaccine. The doctor told her the options were that he could stand here and watch her die or she's going to be pumped full of Prednisone. She's 64 years old and she likes breathing. Breathing is something she needs to do to survive so she decided to get the Prednisone. She told the doctor that she couldn't take the itching and the doctor told her he would keep in her in the emergency department until the Prednisone took effect to give her some relief. The emergency room doctor told her that she needed to follow up with her primary care doctor in 2 days. She told the emergency room doctor that she was scheduled to receive her second Covid 19 vaccine on 26Apr2021 and the doctor advised her not to get the second dose. The doctor told her he sees some people with side effects after the second vaccine but her reaction with the first vaccine was pretty bad. The doctor advised her not to get the Pfizer Covid 19 vaccine second dose or the Moderna Covid 19 vaccine. She asked the doctor about the Johnson and Johnson vaccine and the doctor told her his personal opinion was that she shouldn't get any Covid 19 vaccine because what she is experiencing is an allergic reaction. She doesn't have the Pepcid bottle anymore, it's been thrown out. NDC/Lot/Expiry not known. The Vistaril is 25mg, take one capsule by mouth three times daily as needed for itching but she was taking it between 6 and 8 times a day because it wasn't helping. It's in a pharmacy bottle. NDC 00115-1803-01. Lot/Expiry not known. The Prednisone wasn't working either. NDC/Lot/Expiry not known for Prednisone. It was a hell of 6 weeks of suffering. She called Pfizer the first time on 10Apr2021. She reported her side effects on that day. She doesn't have the report number. She was 63 years old when she received her first and only dose of the Covid 19 vaccine. When probing for information about which anatomical location she received her Covid 19 vaccine, she wants to say left arm because logic told her not to use the right arm because she is right handed and if the vaccine was going to cause a lot of pain in her arm she wanted one working arm. So she received the vaccine in the left arm. When probing indication for receiving the Covid 19 vaccine, she reports she doesn't believe in the Covid 19 vaccine. Her mother is 83 years old and if something happens to her mother she has to be able to get to her. The airline might say sorry she can't go because she hasn't' had both doses of the Covid 19 vaccine. Her mother might have to rot dead in her house. She still doesn't believe in the Covid 19 vaccine. She was not admitted to the hospital. She was discharged from the emergency room. She doesn't remember the emergency room doing any tests or taking any blood. The trip to the emergency room was on the 10Apr2021 and after she received the Prednisone her sugar shot up to the ceiling. She is diabetic. The Prednisone made her hyper too. On Monday morning, 12Apr2021, she called her primary care doctor and she was told to come to the office right away. She saw her doctor, her blood pressure was elevated and she doesn't have blood pressure issues. The doctor told her the blood pressure was related to the Prednisone. Her doctor told her her voice was horrible, it keeps breaking up. Her doctor told her he was going to have to put her on a continuous dose of Prednisone, a Prednisone protocol. The palms of her hands were blood red and her doctor told her she had all these little bumps on her scalp and her breathing still wasn't normal. Her doctor told her if she started feeling worse, to call 911 or get to the emergency room. She continued taking the Prednisone with no relief. The doctor called in more Prednisone and Vistaril. She saw her primary care doctor a week later because she still wasn't having any relief. She's exhausted and she can't do anything. Her voice and her throat are killing her. It feels like her throat is swollen. Her doctor told her these are not side effects, this is a severe allergic reaction. Her doctor did tell her he thought she was past the life and death situation. She didn't have a reaction to that statement but her aid she brought with her to the appointment had a reaction. The doctor told her this reaction could have killed her because of her other medical issues. The doctor said she is past that because of the Prednisone. Then May2021 came and she's still itching and now it's Jun2021 and she's still exhausted and can't get over this chronic fatigue. Her voice is still going in and out. Her voice sounds like she's been out all night drinking, smoking, and screaming like she's been at a concert. Her partying days are over. She's usually in bed at night by 8:00PM. She doesn't understand the exhaustion or her voice. She does know that every doctor she saw from her primary to the emergency room doctor to the doctor at the urgent care, they all told her not to get the second Covid 19 vaccine. She called her lung specialist and his recommendation was to get the Johnson and Johnson Covid 19 vaccine. He told her the Pfizer and Moderna have the same binders. The same day she was considering getting the Johnson and Johnson Covid 19 vaccine, it was suspended. A week or two later and the Johnson and Johnson Covid 19 vaccine is available again. She's 64 years old and she's not about to take a change with her life and she's not going to go through this living hell again. She's not herself and she's not the same person she was 5 minutes before getting the Covid 19 vaccine. If Pfizer would ask her doctors, her doctors would tell Pfizer she doesn't cry wolf. She's the world's worse patient. She feels like if it's not broken don't fix it, she's fine. For an example, in Jun2020, she had major double surgery on her back. She spent 24 hours after that surgery without pain medication because of a mix up. She had notches made in her spine and wires slid into those notches in her spine and a battery pack put into her muscle. This wasn't a little surgery. It was a big surgery. Her aid and her cousin who came over after surgery said they couldn't believe she isn't crying her head off in pain. She's not impressed by pain or discomfort. She's had a lot happen to her in her life. Since she was a kid she's always been a tough, old broad. Meaning a tough, old lady. She wants to know what happens to people that can't get the Covid 19 vaccine. When she asked the doctor in the emergency room when she would feel better, he told her he didn't know. It could be hours, days, weeks, or months until the itching stopped. He told her, he didn't know enough about the Covid 19 vaccine. He told her, it's not like she has pneumonia or bronchitis and he can tell her about it and prescribe medications to treat it. He said he doesn't know anything about the Covid 19 vaccine, that he was flying blind. He said it was frustrating to not be able to tell her anything or is she'd ever get better. The doctor said he hoped that her case wasn't the norm but he didn't know. She's trying to figure out now what her options are. Can Pfizer access, with her permission, her records to show that she did have a severe allergic reaction. Can she get documentation that says that she can't tolerate the Covid 19 vaccine. That the vaccine would cause more damage. Something that shows she did try to get the Covid 19 vaccine. Just showing her Covid 19 vaccine card with one dose isn't the complete protocol of the Covid 19 vaccine. Right now she's just half vaccinated. No one will accept her Covid 19 vaccine card because she's not full vaccinated. She doesn't know what her next step is. She needs to be able to get travel around. She feels it is very unprofessional on Pfizer, Moderna, and Johnson and Johnson that there wasn't a solution set up before the Covid 19 vaccines were rolled out. There would be people that wouldn't be able to receive some medications. Any pharmaceutical company from Pfizer to Abbott to Merck all know that some medications aren't meant for everybody. The Covid 19 vaccine is something new and something should have been set up in place for people who can't tolerate the Covid 19 vaccine and who aren't able to get the second dose. Is she just screwed and can't do anything about it. She asked if there was. her triple whammy is she didn't tolerate the Covid 19 vaccine, she's disabled and she's a senior citizen. To put it in plain English, shit happens when she's still alive. She uses this as an example: she wouldn't know if she had a peanut allergy until she ate a peanut. There are things that the pharmaceutical companies should have taken into consideration like the people who might have allergic reactions to the vaccine. Treatment received for the events. Outcome of she had bouts of diarrhea was recovered. Outcome of headache and chills was recovered on 08Apr2021. Outcome of blood pressure was elevated was unknown. Outcome of other events was not recovered.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between event blood pressure increased and suspect drug BNT162B2 cannot be totally excluded. However, consider other factors such as patients concomitant medications.   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.