Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Computerised tomogram, Dyspnoea, Feeling abnormal, Fibrin D dimer
Clinical narrative: breathing issue; she got bitten by Garter Snake and didn't know it was a Garter Snake; Skin bumps; itchy; She can feel that in the throat; Swelling; red spots; Allergic reaction might have impaired breathing; having breathing issue; hives everywhere, swelling through red spots; hive on arms, hand and dorsal; fever; felt like she had been hit with a baseball bat; This is a spontaneous report from a contactable consumer. This 74-year-old female consumer (Patient) reported for herself that: A 74-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration on 06Jul2021 (at the age of 74-year-old) as single dose for covid-19 immunisation. Medical history included anaphylaxis to spider bites (taken EpiPen for anaphylaxis to spider bites), pulmonary embolisms, COVID-19, Blood clots and cancer behind her eye 25 years ago. Concomitant medication(s) included apixaban (ELIQUIS) taken for pulmonary embolism from an unspecified start date and ongoing. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration on 15Jun2021 as single dose for covid-19 immunisation and experienced the event mild headache, achy feeling and fever of 100.2. Caller stated she has received 2 doses of the Pfizer COVID19 Vaccine. After the 1st dose she had a mild headache and a fever of 100.2, all self-resolved. Then had her 2nd dose of the vaccine and again had a low-grade fever on 07Jul2021, but the following afternoon after receiving the 2nd dose she developed hives she stated that for the first 20 min she herself didn't even know what they were as she has never had hives before. Caller stated that she takes no other medications, rarely goes out, and is overall has a healthy health history. She stated the itching is driving me crazy. After contacting her HCP due to the hives, she states she was advised to go to the Emergency Room for further treatment once in the Emergency Room, the patient was given "IV (intravenous) in her arm Benadryl and Zantac." She was further advised that the hives should resolve in 48 hours, but she is now on day 3 of the hives and would like to know when she should expect for them to resolve. Patient then saw her HCP again the following day due to the hives coming back. He then wrote for a prescription for Zyrtec and advised may take Benadryl every 4 hours. Zyrtec is a 24-hour medication although caller stated it does not work for her for the full 24 hours and does wear off sooner. HCP advised that the patient may take Benadryl as well as Zyrtec. He also gave her a script for the Zantac as she was previously given in the Emergency Room. Caller said her grandson says she is covered in lumps. Caller does also speak on research she has done on line and the same symptoms of hives reported cases very similar to hers - No history of hives and same locations. She does find this data to be odd. Patients' persistent hives are located from her arms down to her thighs, including her chest. Pt has a history of anaphylaxis to spider bites and carries an EpiPen due to this, she feels she knows what anaphylaxis feels like with your throat closing up. Pt was aware of the possible heightened side effects with the second dose and states that none of these side effects would have deterred her from the vaccine. Despite HCP evaluations, guidance, treatment plan and follow up appointment for next week on Tuesday (at the rate 1000 for further blood work studies), pt. does want to know if we at Pfizer have any recommendations specifically to the length/duration of hives after the vaccine. Caller states that she still would have gotten the vaccine even if she knew that these hives would happen. She states she also understands why Pfizer does not put side effects out publicly at times because there are people who would make them the headline to their news stories. Caller states that both her and her husband contracted COVID despite being very cautious with public interactions, she even peeped out the front door before taking the dogs out. She states after testing positive for COVID 19 her and her husband were both hospitalized with blood clots. Her husband on 21Dec2020 and herself 30Dec2020. Caller goes into further detail regarding 2 instances she has had in public places with those who are not vaccinated or those having an active diagnosis of COVID19. She is very appalled by some's' behaviour and choices but feels strongly pro-vaccine for the Pfizer COVID19 Vaccine. Her and her husband were told by someone recently that they were saving the needles and selling DNA. Caller would like to thank Pfizer for the vaccine. She was a late bloomer and had a bad case of COVID on 11Dec2020. She got PE's and had to do Eliquis. Caller clarified PE's as pulmonary embolisms. Her and her husband got it on the same day. She had no trouble with the vaccine. There are a lot of anti-vaccine people where she lives. She got the first dose 3 weeks ago. Her family doctor said to make sure she was done with Eliquis and then wait 3 weeks and get the second one. With the second one she came home and felt like she had been hit with a baseball bat on 07Jul2021. She went to bed with no problem. The next day she had a 100 fever she took a second Tylenol and by 4:00 in afternoon she was covered in hives she has never had hives this is a new thing she called her family doctor who did a tele-visit and he said go to ER because she had a lot of hives and could end up with a breathing issue. She only has one allergy and that is a spider bite allergy she has a EpiPen she had not been bitten, so she shouldn't have been having hives. The doctor told her to take two Benadryl before going to the ER, but to go to ER to double check and get blood. In the ER they didn't do blood only her oxygenation. They said she was fine and to go home. Her family doctor drove in and put her on Xarelto. The Xarelto is 24 hours long and won't give her the ups and down. They were going to put her on a stomach medicine and histamine blocker and said everything was fine. Caller clarified the medication was Pepcid. They said it would go away in 24 to 48 hours and she is into the third day. They keep coming back she is just wondering she went to the site and she doesn't blame Pfizer. It is a rhetorical question that doesn't have to be answer. She understands why information is not put out there. Caller states she still has hives she is itchy a lot with the hives and can only take the Xarelto once a day. She was told she can add Benadryl to it when she needs it. It hasn't got insane yet. She went online who else go this because the website doesn't have hives listed that she can find. Believe it or not there are a lot of people that had hives on the second day on their torso, upper legs, and hives. Those are the only places caller has hives. The antihistamine works when she first takes it, but when the times wears off, they come back with a roar. Caller reported cancer behind her eye 25 years ago. Caller states the doctor's PA just called and wanted to know if caller still had hives. Caller told the PA she still had them, and they are big, ugly, and itchy. Caller stated she got bitten by Garter Snake and didn't know it was a Garter Snake. She had to go up there and wait. She was on Eliquis and if on a blood thinner you can't take snake venom antidote. She had to get a tetanus shot and go home. They put she had a swollen leg because they didn't have a button in the system for foot. Caller told them not to put swollen on there because her doctor would be upset since she is on blood thinner. She had to go on the portal and say that she didn't have a swollen leg. When she got home the doctor was laughing because they had it documented that she was bit on the left leg, and she was bitten on the right foot. She had to sit there for an hour and a half. Caller worked on the railroad for 32 years. Snakes are big on the railroad metal every safety meeting she had from March to November started off about snakes. She kept information about the people in the yard that might be on blood thinner like coumadin because she could call it in to the ambulance correctly if someone got bit. Bears are also big on railroads. When the bears come down to hibernate the sap gets warm and they climb on the railroad cars. Then DNR would come out and tag the bear, tranquilize them, and take them back. One bear showed up 3 times. With the second vaccine it was 100.3 or 100.4. When she took second Tylenol, it was gone by the end of that day. Everything was gone. Caller clarified that she did the same thing with the Tylenol when she had the second dose that she had done with the first dose. She took Tylenol on the first and second day. The hives started on Wednesday, 07Jul2021, about 2:30 PM. The hives are ongoing. She didn't have space left on her skin for them to get worse. That is how bad they were she has never had hives. She called immediately with the hives the hospital gave her a shot when she was there and said she wouldn't have anaphylaxis. She can feel that in the throat she knows from the spider bite she has been bitten twice she knew her throat wasn't going to close. When she was at the hospital on the 07Jul2021 they gave her IV Benadryl, IV antihistamine, and IV (intravenous) Pepcid. The itchy went away almost instantly, but the hives didn't. By 10pm they were fading only a little bit. The next morning, they were back. Caller clarified that she has been off of Eliquis. It was a 6-month course. After the first 90 days the pulmonologist did a repeat CT (computerized tomography) scan and kept her on Eliquis another 90 days to make sure none came back. They also did a scan of her leg and D-Dimer and there was none. Benadryl: lot: 1807907, expiry: 07Oct2022. The lot and expiration are an impression, and it is white on white. She is not sure why they do that. It is 24 capsules. Strength: 25mg. Manufacturer: Johnson and Johnson. Tylenol: lot: SJA066, expiry: Jul2024, strength: 500mg, Manufacturer: Johnson and Johnson. Caller states Johnson and Johnson makes everything beside Bayer aspirin, and she thinks they might make that too. Caller clarified that she thought Xarelto and Eliquis were the same thing and that she was referring to them interchangeably. She has a copay for 500 dollars. She used all the Eliquis and doesn't have the bottle. They were 5mg and she took it twice a day. It is 497 copays. Caller clarified that the discharge papers said she received IV Benadryl and IV Zantac, but there is no strength listed. Caller states she didn't realize that was an antihistamine. She was given a prescription for Pepcid 40mg. It is the generic, Famotidine. She also is taking Zyrtec. It is over the counter. Lot number: 1813363, expiry: Oct2023. Strength: 10mg. Taking it once a day and that is the trouble, it wears off. Manufacturer: Johnson and Johnson. Count size: 30 tablets. She would be willing to send a sample if requested. It surprised her. When she took the Benadryl, she was able to take it every 4 hours. The Zyrtec is supposed to last 24 hours and it surprised her when it wore off. It maybe lasted 7 or 8, but it did not last 24 hours. She took one this morning and somewhere around this afternoon around 4. The hives are there now and look lumpy. Yesterday afternoon it was gone. She took a cold shower and that helped calm it down so she could eat. They say to take this and then take a little more. It says if over 60 don't combine them, but the hospital said to take them. She takes them and doesn't want them to get carried away. They also told her not to eat a whole lot of one thing while having the reaction because the body will pick it up. Then the next time she would eat that she might have the same reaction. She had bad case of COVID on 11Dec2020 prior to COVID vaccines. She got PE's and had to do Eliquis. The Xarelto is 24 hours long and won't give her the ups and down. After the first 90 days the pulmonologist did a repeat CT scan and kept her on Eliquis another 90 days to make sure none came back. Caller clarified that she thought Xarelto and Eliquis were the same thing and that she was referring to them interchangeably. Confirmed that caller does not have Xarelto or Eliquis to provide NDC, lot, and expiry. They were 5mg and she took it twice a day. Consumer stated, I never had hives in my life, I got the second dose on Tuesday on 06Jul2021, morning this week and Thursday on 08Jul2021, afternoon I was covered in hives everywhere, swelling through red spots. I called my family Doctor, told me that it was sudden a type of allergic reaction, might have impaired breathing. I don't have allergic issues (no history), I don't take any medications nothing. The only thing I got was my shot (vaccine) I had Covid last Dec2020 I don't want to ever get it again. I got my second shot and went to Emergency room and they told me that they couldn't tell what was causing it, but they suspected that I was reacting to vaccine. I had been to an allergist and I really have to find the cause. I have more hives and that's the only thing they gave me an antihistamine (Zyrtec) to try. Consumer stated, My Doctor's office called me to talk to Pfizer Medical information to find out what are the components in the vaccine might be, I got my first shot I had a little bit of headache, fever. I started with this hive on my arms hand, my dorsal if you go online, Pfizer second shot there is lot of people getting hives. Pfizer, Covid-19 Vaccine Consumer stated, "I would like to know what caused the hives and can I get rid of it?" When paraphrase the concern, consumer stated, "Yes, they said first time you got hives and you don't have history of swelling up, skin bumps are concerned. I was having a breathing issue to see an allergist because it was an allergy. I know that giving the second shot my immune system recognized Covid. I need to know how many other people called about this and what is the solution (treatment). Consumer was informed about Pfizer Medical Information Department. The patient underwent lab tests and procedures which included body temperature: 101.2 on an unspecified date, body temperature: 101.3 on an unspecified date, computerised tomogram: unknown results on an unspecified date, fibrin d dimer: unknown results on an unspecified date. sars-cov-2 test: positive on 11Dec2020 and x-ray: unknown results on an unspecified date. Event resulted to visit emergency room. Therapeutic measures were taken as a result of the events. The outcome of the event hives everywhere, swelling through red spots; hive on arms, hand and dorsal was not recovered and all other events were unknown.   Follow-up attempts are completed. No further information is expected.