Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Dizziness, Erythema, Eye swelling
Clinical narrative: Dizzy; Vision blurred; Face felt like it was on fire; Eyes felt swollen; Chills; felt tired; her face feeling like it was on fire and being beet red, she felt fine; face being hot, on fire, flushed, or redness; This is a spontaneous report from a contactable consumer. This 61-year-old female consumer (patient) reported that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206, Expiry Date, NDC Number: Unknown), via an unspecified route of administration, administered in right arm on 08Mar2021 (at 11:52, as reported) (at the age of 61 years) as dose 1, single for covid-19 immunization. Medical history included ongoing crohn's disease. Doctor told was an auto-immune disease and she had fear of getting sick due to this. However, medication she was on for Crohn's was not one to suppress immune system. She was allergic to sulfa drugs and phenobarbital. She was allergic to this as a child. She stated that she had reaction to these medications when she was little, and she was unsure if she was still allergic. Family history included that her mom had heart conditions and her dad had cancer. Concomitant medication(s) included mesalazine (MESALAMINE DELAYED RELEASE) taken for crohn's disease from an unspecified start date and ongoing. Mesalamine: Lob 8612773, expiration Sep2021. It disagrees if she took the full dose, she could take a reduce dose she did not get sick and also controls the Crohn's. Concomitant Products mesalamine DR: Caller started taking 6 months to a year ago, previously on Aprizo but couldn't it get any more. She only took twice daily as it made her feel sick if she took it three times per day. The patient previously took phenobarbital and experienced drug hypersensitivity, shingrix and experienced pain in extremity. Caller stated that she had a reaction from shingles shot, it was a typical reaction. She stated that her arm was so sore that couldn't lift it, that the vaccine knocked her out completely and she slept for 12 hours after she received the shot. Caller stated that she did not know the brand name, but it was the shingles shot and was told that it was the newer shot. Vaccination date: May2019 or Jun2019 at her annual physical after her birthday (at the age of 60 years). Prior Vaccinations (within 4 weeks) was none. No investigation assessment. Caller received first dose of Pfizer vaccine Monday, 08Mar2021. Caller believed that it was at 11:52. There was a sticker placed on her shirt for when the 15 minute post vaccine waiting period ended, and the time listed on the sticker was 12:07. Caller stated that she had a rather immediate response. She called doctor afterwards and he suggested that she not get the second shot and stated that he had not heard of this reaction before. Caller wanted to get the opinion on if it was ok for her to get the second dose and also wanted to know if they had this reaction reported before. Caller declined to share HCP information. She was somewhere in the area of 155-157 weight. Caller stated that by time she got to the waiting room, she felt dizzy and had blurred vision. It lasted might be a minute but resolved quickly. Immediately after the dizziness and blurred vision resolved, caller stated that her face felt like it was on fire and turned bright red. The staff in the waiting room went for help, and a nurse sat with her to monitor. The nurse checked her pulse, looking inside of her mouth, asked if she was breathing ok, if the heat was traveling through body or staying in her face. Caller stated that apart from her face feeling like it was on fire and being beet red, she felt fine. The nurse stayed with her for 30-40 min until redness started to subside, at which time the heat level started to subside as well. Caller stated that it took might be 3 full hours for face to go back to normal. After this occurrence she did not have any additional occurrences of face being hot, on fire, flushed, or redness. Caller stated that she experienced chills the night of 08Mar2021, but that they were not too bad and that she felt fine the next morning. Stated the chills were minor. She has heard horror stories about people having teeth chattering with the chills. She did not have any of that. She just put on a sweatshirt and she was fine. Caller stated that she felt a little more tired than usual on 08Mar2021 after receiving the Covid-19 vaccine, but that the tiredness had resolved the next morning. It was not like she needed to go to sleep. Caller stated that she did not have to do anything about the side effects she experienced. Caller believed that her eyes were also swollen, she wasn't able to look in a mirror to confirm, so she did not know for sure but it felt that way. Caller stated that on 09Mar2021, she felt like her eyes were a little swollen again. She went to see if her face was red, but it was not red. She stated that her eyes looked like they were a little swollen but it came and went quickly. It felt more like it was swollen than it looked. Caller had no history of allergic reactions to vaccines or anything like that, but she felt like the AE, she experienced was an allergic reaction. Her doctor also believed that it was an allergic reaction and suggested that she not get the second dose of the Covid-19 vaccine. However, if she really wanted to get the second shot, he recommended that if she were to get the second dose, that she take Benadryl beforehand and take an Epi-Pen with her. Caller called the hotline for the location where she received her vaccine and they stated that they believed the initial dizziness and blurred vision were a result of anxiety about getting the vaccine, which the caller stated her doctor told her as well. Caller stated that the staff member she spoke with on the hotline did recommend that she get the second dose of the vaccine. Caller stated they also instructed her to inform the nurse before she received the second vaccine about the reaction she had to the first dose so that they could have a nurse standing by with an Epi-Pen. NDC number and expiration date not listed on the vaccination card. Caller wanted to know when the pfizer covid 19 vaccine was out of her system. No emergency room or physician visit required. Relevant tests were none. The patient underwent lab tests and procedures which included weight: 155-157 on an unspecified date, heart rate: unknown results on 08Mar2021. The outcome of events dizzy, vision blurred, Face felt like it was on fire, Redness of face, Flushed face was recovered on 08Mar2021 while the outcome of events Eyes felt swollen, chills, felt tired was recovered on 09Mar2021.  No follow-up attempts are possible. No further information is expected.