Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Oral discomfort, Pain, Pyrexia
Clinical narrative: Fell on the floor and could not get herself up; Felt a shock; Puking and throwing up; Headache; Dizziness and could not get self up; Feeling like throwing up; Tightening of the lips; stomach was so painful; Unable to eat; Feeling so weak; Fever; Feeling so tired; Lost a lot of weight; She could not do anything; GI issues like feeling like things in her stomach and not feeling comfortable at all.; She was out of breath from the puking.; Not constipation but a sharp pain.; She does fasting and does not have an appetite; This is a spontaneous report from Other HCP (Nurse assistant; patient herself). A 39-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0186; Expiration Date: 31Aug2021) via an unspecified route of administration, administered in Arm Left on 08Jun2021 as single dose for COVID-19 immunization. Medical history included vitamin D from an unknown date and unknown if ongoing she used to take Vitamin D, accident from 2020 to an unknown date She states there was one time she had an accident and took a baby aspirin. History: Caller used to take supplement but not she did not, she used to take Vitamin D which was a supplement she takes every day like a Vitamin D and a women's pill and she used to take a fish pill but since this time she was not taking anything because she did not want anything that would be contraindication. Caller did not clarify statement or provide any additional details. She states there was one time she had an accident and took a baby aspirin but she did not take it anymore. Caller confirmed she was not taking these at time of vaccination and that her accident occurred prior to the vaccine. Caller added she was not allergic to anything, she had never reported an allergic reaction, and any medication she did not have anything she feels she was allergic to. She was good. Her health was good. Patient had not any other history and products. The patient's concomitant medications were not reported. It was reported that, she received her first injection on 08Jun2021 and she felt like that night and the whole day she threw up, had some puking and stomach, heavy headache, and a lot of dizziness. She called back her husband and her husband called back because she could not do anything. She had a headache, dizziness, fell on the floor and could not get herself up. Caller added that she started feeling like throwing up and her lips would tighten up and her stomach was so painful she has not been able to eat and has been throwing up which is a problem. Right now, she had one week without eating well. She feels like she have to go to the bathroom or like her stomach was upset and she has to throw up instead of having a BM. She had a headache and was feeling so tired and like a headache. She decided to call to see if Pfizer had experienced something like this because of how her stomach was acting. Caller was asked for clarification as she was speaking fast and states she was having GI issues like feeling like things in her stomach and not feeling comfortable at all. Caller stated that night they called 911 because it was serious and was told to take tylenol and she just had been taking tylenol and drinking water for her headache. Caller stated that she was continuing that thing - she was feeling fever and wanted to know. They were taking her temperature and it was 98 points and she was concerned about her fever. Caller stated that they told her husband to give her water and rest which did not work. She did not call because she was so weak and she usually has a good appetite but she did not have an appetite. Caller got her injection at this hospital and this was where she has her primary. Caller did not provide any additional details. Her stomach was hurting, she could not eat anything it was so terrible. Puking and throwing up: first of all, that day, when she went for her vaccine she went to come from work in the morning at 9:45 and went for the injection and they said it was horrible, she felt dizziness, she was sleepy the whole night so she thought she was sleeping like she felt the need to sleep and fell asleep immediately at 11 so that night she was feeling dizzy and weak. She was weak and dizzy and because she was sleepy she woke up around 7 in the evening to get ready for work and that was when she woke up. She fell on the floor, felt a shock and a fall. She started throwing up and her husband came and picked her up because he did not want her to choke because she was sleeping down on the floor. That is when she started throwing up and he gave her a container to throw up. He gave her one to do it, but she was feeling like she could not hold anything and was puking and felt a headache pounding up and felt like everything was going around like she was feeling dizzy. Caller clarifies she does not know what it is called, everything is going around and at that time she was out of breath from the puking. She did not eat because she slept there and there was nothing to puke so she was forcing something to come out so it was just she did not have anything in her stomach to come up. She woke up, and was asleep, she did not know what happened when she went to sleep and when she woke up too. Caller did not provide clear timeline and was asked regarding if events are still occurring and she states for now, the dizziness is not now and was not coming. The headache she takes tylenol now and she takes tylenol when she feels feverish. Caller stated what led her to call Pfizer was about the stomach problems and not eating. Also, the pain that was sharp and was going and it was not constipation but a sharp pain. She did not know how she can describe it a lot, she was having troubles like a stomachache. When she ate something, like the more she eats, like a little pancake one week, he said do not eat because she did fasting and did not have an appetite. When she ate and drinks it was like drinking a lot of water, she could not even drink things she likes. Caller added she was sure she did not have Covid because of every week they get a test. The reporter seriousness for all the events was unspecified. Patient was taking tylenol for headache and fever. The patient underwent lab tests and procedures which included body temperature: 98 points on 08Jun2021, and COVID-19: negative on an unspecified date. The outcome of event dizziness and could not get self up was recovered on an unspecified date while unknown for all other events.; Sender's Comments: Based on plausible temporal relationsip the causal role of the suspect vaccine bnt162b2 cannot be excluded for reported adverse events 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