Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lip oedema, Lip swelling, Paraesthesia, Paraesthesia oral
Clinical narrative: she was so tired; Rash on both arms and inside arms/Rash on Face/rash on front and back of knees; burning and itching with bleeding; swelling in lips; Blood in stool/she had blood in her stool, leaking blood around rectum and it had like a burning itch; Blood leaking around rectum/she had blood in her stool, leaking blood around rectum and it had like a burning itch; Face and Neck Burning/hot face and neck was flushed; hot face and neck was flushed; Tingling in tongue, lips, face; Tingling in tongue, lips, face; throat felt tight; lips were puffy; thought she was starting to shake; anaphylactic event; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration in left arm (left shoulder area) on 06Mar2021 17:45 at SINGLE DOSE for COVID-19 immunisation. The patient had no additional vaccines administered on same date of the Pfizer vaccine. The patient had no prior vaccination within 4 weeks. Medical history included upset stomach after eating banana's last year (2020). There were no concomitant medications. The patient had no family medical history relevant to events. The patient previously took bactrim and pneumonia vaccine and experienced anaphylactic reaction to both. On 06Mar2021, the patient experienced anaphylactic event, allergic reaction, face and neck burning, hot face and neck was flushed, tingling in tongue, lips, face, swelling lips, throat felt tight, and lips were puffy. On 07Mar2021, the patient experienced rash, blood in stool, blood leaking around rectum, burning and itching with bleeding. The patient further reported that she had a 'serious life threatening event' after first dose of the Pfizer Covid 19 vaccine on 06Mar2021. Hospital papers say 'anaphylactic event.' Tingling in lips tongue and face, hot face and neck after vaccine, swelling in lips, rash started yesterday evening (07Mar2021), bloody stools for a few hours yesterday evening (07Mar2021) but has resolved. The patient was seen in emergency room (ER) via ambulance. The patient asked if there was a chance the preservative in the vaccine caused her reaction and if the potassium in the vaccine causing her anaphylactic reaction. Additionally, the patient reported that she had a severe allergic reaction this past Saturday to the Covid Vaccine, stated the nurse sent her back to the pharmacist who told her she was having an allergic reaction to the vaccine. The patient reported having a hot face and neck was flushed, after the vaccine, she stated she had tingling in her tongue, lips, and face. And she stated her throat felt tight also, her lips were puffy, and a lot of heat of neck and face, thought she was starting to shake. The patient reported the pharmacist gave EpiPen in thigh and 20 mg tablet of Benadryl and called 911, and took her to the local hospital. Patient also reported that she has not seen this doctor yet she asked to see her and has an appointment with her. The patient also stated that her new PCP was not aware of the reaction to the vaccine at this time. The patient further mentioned that she was still having a rash that broke out. She reported that her tongue was tingling and she still has some swelling in her lips. Patient continues to clarify she still has swelling and some tingling on the tip of tongue and half back on her tongue. She stated that the swelling was persisting and that Benadryl or Prednisone does give some relief but it comes back. Patient mentioned being on a 4 day cycle of Prednisone, takes two in the morning with food. The patient clarified the location of the rash as a rash on both arms that was inside of both of the arms, like a pink rash, she states it was on face and on knees around the front and back of her knees like a red rash. She continues it was on the neck down to the collar bone around the back of her neck, like if she was a bust statue it would be all in that area from the collar bones at that point up and around the back of the shoulder blades. It goes all the way around face and neck. Patient also further reported that she had a scary reaction last night (07Mar2021), she said she had blood in her stool, leaking blood around rectum and it had like a burning itch, when she wiped it was blood, she continued to say when she wiped it was like 'giblets.' She stated was stool, blood, and giblets. Patient stated this lasted for about and hour and half or 2 hours until the stool stopped and it was about 1:30 am before she finally went to sleep, she was so tired on an unspecified date. She stated she took Benadryl right away. She continued to report the bleeding has resolved completely as of this point and reported a regular bowel movement today (08Mar2021). She has two Epi Pens from the drug store that was prescribed but she was afraid to use it, and she thought to see what happens if she uses the Benadryl. She received the Epi shot at the drug store, at (pharmacy), when her reaction broke out, on 06Mar2021, in her thigh, for the allergic reaction. This was her first time ever receiving EpiPen (Lot 029F20AA, expiration Mar2022, and NDC is 0093-5986-27). The ER doctor prescribed her 0.3 mg every 5-15 minutes as needed for anaphylaxis, and not to exceed 3 doses. She received the Benadryl at the drug store, 120mg tablet, first dose was given at drug store. Patient reported she was given prednisone IV in hand through IV at ER, she doesn't know how much that was, then was given Prednisone to go home with- 20mg tablets take 2 a day for 4 days, which she started Sunday morning, 07Mar2021. She was told she experienced a life threatening allergic reaction. Patient was taken to the ER in the ambulance, the paramedic who was with her said she was his first COVID reaction patient. ER doctor told her not to take the second dose of Pfizer vaccine, and to be cautious if taking the EpiPen, she states her heart was racing because of the EpiPen and was told it was because she was not younger that her body did not handle the Epi like younger people do and was told she could have a heart attack from the EpiPen. She was scared because she was not covered fully, since she can't get the second shot of Pfizer, and she was afraid of the Epi Pen, so she was really in a tough spot. ER doctor stated she may be able to take the Johnson and Johnson vaccine, as the second, but she needs to talk to her Primary care about that. The ER doctor continued to tell her it would have to be a special case where she was in a hospital setting in case she has another serious reaction, she was concerned for not receiving the second dose because that means she was not completely covered with one vaccine. She was afraid of the Epi-Pen since she can get a heart attack from it because of her age. The patient mentioned she was tested in Oct (clarified as 14Oct2020) for Covid due to having a viral infection at that time but was negative. Added the ER paper work says ED anaphylaxis. The patient wanted to ask about finding out the ingredients in Pfizer vaccine and the ingredients in the Johnson and Johnson vaccine. She saw the list on the fact sheet of Pfizer's ingredients and in a few places it says Potassium, 3 different ingredients, and several months ago, she quit eating bananas, bananas have potassium, and they were giving her stomach upset, diarrhea, she used to eat them all her life, she noticed that there was a lot of potassium in the medicine. Doctor wanted to know if she would be able to take the Johnson and Johnson vaccine. He said if she got the second shot, of the Johnson and Johnson, that it would have to be a special case, like in a hospital setting, and there would have to be medical people in a medical center, to take care of her was she has a reaction to it as well. He advised that she take the Johnson and Johnson than not taking it, because by not taking it, she was very vulnerable to catching COVID 19. And patient wanted to know was it a preservative that was causing the reaction. It was reported that rash began around 10PM, bloody stool began between 11 PM and 12:30 AM, all other symptoms within 15-20 minutes, it began around 6PM, maybe sooner 5:55 PM, she was in denial, it felt like tongue and lips tingling, she did have a reaction before to a different shot. The anaphylactic reaction required emergency room visit. Patient was not hospitalized and was in observation in ER. On 08Mar2021, the patient recovered from blood in stool, rectal bleeding, and burning and itching with bleeding. The patient had not yet recovered from severe allergic reaction, hot face and neck was flushed, tingling in tongue, lips, face; lips were puffy, and rash. The outcome of throat felt tight, thought she was starting to shake, she was so tired, and swelling in lips was unknown.