Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Computerised tomogram, Fibrin D dimer, Headache, Pain
Clinical narrative: fever of 100.2; mild headache; Achy feeling stayed until the next morning when she woke up; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 74-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8729) via an unspecified route of administration on 15Jun2021 07:00 (at the age of 74-year-old) at dose 1, single for covid-19 immunisation. Medical history included on an unspecified date pulmonary embolism, cancer behind her eye (25 years ago), got bitten by snake, anaphylaxis (anaphylaxis to spider bites and carries an EpiPen due to this), from 11Dec2020 to an unknown date covid-19, from 30Dec2020 hospitalized with blood clots. Concomitant medication included apixaban (ELIQUIS) at 5 mg, 2x/day taken for pulmonary embolism. The patient previously took xarelto for pulmonary embolism, epipen for spider bite allergy. On 15Jun2021 14:00 the patient experienced fever of 100.2, on 15Jun2021 mild headache, achy feeling stayed until the next morning when she woke up. First dose events: she got her first dose at 7am. She had a little headache and 100.2 fever around 2 or 2:30PM. She took Tylenol and within an hour it broke. The headache went away with Tylenol. The achy feeling stayed until the next morning when she woke up. Patient states 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. Patient then had her 2nd dose of the vaccine and again had a low grade fever 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. Patient states 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 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. Advised may take Benadryl every 4 hours. Zyrtec is a 24 hour medication although caller states 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. Patient says her grandson says she is covered in lumps. Patient does also speak on research she has done on  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. Patient 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. Patient 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. Patient stated 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 stated after testing positive for COVID 19 her and her husband were both hospitalized with blood clots. Her husband on 21Dec2020 and herself 30Dec2020. 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 first one she had a little headache and 100.2 fever. With the second one she came home and felt like she had been hit with a baseball bat. 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. How long can she expect this. Patient 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. Patient stated 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. There is a local hospital 10 minutes away and it is politely referred to as Ain't Going Home because you won't go home. You sign out if the ambulance takes you there. Caller states she got bitten by Snake and didn't know it was a  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. Patient clarified that she took Tylenol on the first and second day. 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. Pfizer COVID Vaccine: first dose given on 15Jun2021, lot number: ER8729, expiration: Unknown, NDC: unknown. Pfizer COVID Vaccine: second dose given on 06Jul2021, lot: EW0167, expiration: unknown, NDC: unknown. Hives: 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 Pepcid. The itchy went away almost instantly, but the hives didn't. By 10pm they were fading only a little bit. The next morning hey were back. Patient clarified that she has been off of Eliquis. It was a 6 month course. After the first 90 days the ulmonologist did a repeat CT 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, expiy: 07Oct2022. The lot and expiration are an impression and it is white n white. She is not sure why they do that. It is 24 capsules. Strength: 25mg. Manufacturer: Johnson and ohnson. ylenol: lot: SJA066, expiry: Jul2024, strength: 500mg, manufacturer: Johnson and Johnson. Caller states Johnson and Johnson makes everything beside Bayer spirin 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. 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. It is 497 copays with good Rx. 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. It is in the pharmacy bottle and she doesn't have NDC, lot, and expiry to provide. She takes it once a day. 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. Patient states she takes no other medications. Last night she was in itch heaven. She googled Covid vaccine and hives. Was the first thing that popped up with 9 people. There was this woman that said she took Pfizer COVID and had hives. On the second day she got hives on her arms, torso, and thighs. That is where caller has them. Caller has no hives on lower leg, hands, or neck. They told the woman on Channel 4 to take man antihistamine and then moved on to next call. Caller states she doesn't have information for that woman and did not wish to do a report for her. Additional PC field Information: First dose she had a little headache and 100.2 fever. She took Tylenol and within an hour it broke. Headache went away with Tylenol. Achy feeling stayed until the next morning when she woke up. Clarified that she took Tylenol on the first and second day. With 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. Tylenol: lot: SJA066, expiry: Jul2024, strength: 500mg, manufacturer: Johnson and Johnson. 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. Is there a product complaint to report Yes. Please describe the product complaint Reporting hives after second dose of COVID Vaccine. Doctor told her to take two Benadryl before going to ER. Were going to put her on a stomach medicine and histamine blocker. Clarified medication as Pepcid. Said would go away in 24 to 48 hours. She is into third day. They keep coming back. Is itchy a lot with hives and can only take Xarelto once a day. Told she can add Benadryl to it when she needs it. Antihistamine works when she first takes it, but when the times wears off they come back with a roar. Hives are ongoing. She didn't have space left on her skin for them to get worse. At hospital, gave her IV Benadryl, IV antihistamine, and IV Pepcid. Itchy went away almost instantly, but hives didn't. By 10pm, were fading only a little bit. Next morning they were back. Doesn't have NDC, lot, and expiry for medications given in hospital. Discharge papers said she received IV Benadryl and IV Zantac, but no strength listed. 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's 24 capsules. Strength: 25mg. Manufacturer: Johnson and Johnson. Pepcid 40mg: is the generic, Famotidine, in pharmacy bottle, doesn't have NDC, lot, and expiry to provide, takes it once a day. Taking Zyrtec, over the counter, Lot: 1813363, expiry: Oct2023. Strength:10mg. Taking 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. 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. First dose she had a little headache and 100.2 fever. She took Tylenol and within an hour it broke. Patient stated, I never had hives in my life, I got the second dose on Tuesday morning this week and Thursday 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 December 2020 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 Google Pfizer second shot there is lot of people getting hives. Vaccine name: Pfizer, Covid-19 Vaccine Consumer stated, I would like to know what caused the hives and can I get rid of it. When paraphrased 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). The patient underwent lab tests and procedures which included body temperature: 100.2 fahrenheit on 15Jun2021, computerised tomogram: none on an unspecified date in 2021 They also did a scan of her leg, fibrin d dimer: none on an unspecified date in 2021 They also did a scan of her leg and D-Dimer and there was none, sars-cov-2 test: positive on 11Dec2020. Outcome of the event achy feeling stayed until the next morning when she woke up was unknown and fever of 100.2, mild headache was resolved on an unspecified date in Jun2021.