Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling hot
Clinical narrative: Nausea and vomiting; Nausea and vomiting; eyes started swelling and almost shut the left; Eyes and face swollen up; there was a big old sore like staph like someone had poured acid on her/ sores on scalp; she doesn't have any taste; rash forehead/ the side of her forehead was red, like fire red, but it was "kicking"/ rash on nose/ rash all over the place; She was very warm that day/ she started feeling hot; she started burning on left side of her head; pain on top of the forehead/ pain at top of head shooting left side of face; This is a spontaneous report from a contactable nurse (patient; retired nurse). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on the left arm on 29May2021 11:45 (at the age of 82-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included sensitive skin. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): None. No other vaccines administered on the same date of the Pfizer suspect. The patient had no other prior vaccinations within 4 weeks. Family medical history relevant to adverse events was reported as none. There were no relevant tests done. On 29May2021, the patient received the first dose of BNT162B2. She had the worse reaction and didn't know what to do as she hedn't read about it and now she was reading it and added that she was not taking another one. She should have gone to the emergency room, but she was afraid they would admit her. She had read this paper on what she should, and she had almost every time. She went to her physician on 25May2021, and that they were giving the vaccine at his office and that it would be on the Friday (28May2021). Her physician had said that she needed to take the virus shot, but Friday (28May2021), it would be like to 12 o'clock and she had been there on Tuesday for a physical. She said that they wanted her to make sure if she wasn't coming and reschedule. She said that she went to store on the following Saturday on 29May2021. After she got the shot, she sat there for 15 minutes and read a brochure and then stated that she had been there for 30 minutes. She was very warm that day and she went and did her little shopping and it was very hot. After she did all of the shopping that day (29May2021), she went somewhere else and when she did, she started feeling hot and it was hot outside and she thought she had better get out of the heat. She got home about 17:30. She got to feeling heat so bad and she sat on her porch which she always did before she goes in the house. She said later that day (29May2021), she started burning on left side of her head. Started burning like her head was on fire on left side of her forehead and it kept on. She had a sensitive skin, so she couldn't understand why it was burning so. She then stated that it was burning so bad she went to mirror to see what it was doing and added that the side of her forehead was red, like fire red, but it was "kicking". Her son told her to put some cold compresses on it. She stated that she had been putting warm and that it had helped. The patient had rash forehead and she had put warm compresses on it and laid down because it was feeling so bad and she went back and looked in mirror and it had turned into fire and rash all across left side of forehead. She said she thought she must be having reaction to this shot. The patient stated that she loved coffee but hadn't even drank her coffee because she doesn't have any taste on 29May2021. She then looked at the information that was provided and the next day (on 30May2021), there was a big old sore like staph like someone had poured acid on her and for 2 days, she didn't put anything on her head to touch it. The patient considered the events feeling hot as serious and persisting, rash on nose as serious, rash all over the place as disabling, but then commented it was medically significant, nausea and vomiting had improved but was serious, eyes and face swollen up and pain on top of the forehead as very serious (even with her sitting, she could feel the pain arising on the left side), and sores on scalp and head as serious as serious. The patient experienced heat at night and added that it felt like something was hitting her on the side of her head. She tried to get some ease and she got and tried to eat some soup. She then went to the bathroom and threw up (confirmed it was on 01Jun2021). The patient was still having pain on the left side, top of forehead and added that it was "shooting everything now and then". She then mentioned that it was coming back now. The patient then stated that it had been over a week and she was finally getting better. The patient stated that she wasn't going to the emergency room because they would want to admit her. She further stated that "you could to the emergency room with a thumbtack and be put on Intensive Care Unit" and reiterated that she wasn't going. The patient had rash in her hair and didn't want anything touching it as it was just painful and felt like a big old sore, like a scab. After two days on 31May2021, her eyes started swelling and almost shut the left. She applied Cortisone cream to rash on the 2nd day for one day only.  Doesn't not have it available.  No other treatment sought. The patient then stated that the rash, feeling hot, burning on left side of her head, rash on nose, pain at top of head shooting left side of face occurred later in the afternoon of 29May2021; while not provided for the other events. The events did not require a visit to the emergency room and/or physician office. The outcome of the events erythematous rash, nausea, and vomiting was recovering; for the events feeling hot, burning sensation, loss of taste, pain on top of the forehead/ pain at top of head shooting left side of face was not recovered; while for skin lesion, eyes swollen and swelling of face was unknown. The reporter considered the events to be related to the Pfizer COVID 19 vaccine.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE0 cannot be excluded. 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.