Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Body temperature increased, Chills, Diarrhoea
Clinical narrative: numbness on the left side of her face; vision was blurry, it was like she had a film over her eyes; severe rash all over chest, neck, cheeks, forehead; overwhelming warmth that started from her head down to her toes; lost color in face and lips; right hand and right leg were uncontrollably shaking; right calf started pulsating and twitching uncontrollably; blood pressure was slightly up; legs were weak; tops of her hands were tightening where the muscles are; involuntary twitching in her thighs and everywhere; Severe tiredness; fever that comes and goes; stomach problems; abdominal area started hurting; Diarrhea; headaches that won't go away; brain fog; difficult time getting out words; heart palpitations in throat region; lymph nodes feel sore; Dizziness; Muscle pain; Joint pain; Chills; swelling where the injection was; feeling nauseated; severe pain in left armpit; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: FC3181, expiration date was not reported), via an unspecified route of administration, administered in left arm on 30Aug2021 11:45 (at the age of 43-years-old) as dose 1, single for covid-19 immunization at physician office. The patient medical history included anxiety (Verbatim: Anxiety), COVID, When she had COVID, she was blacking out. There were no concomitant medications. The patient historical vaccine included TB shot (caller had a TB shot and shots when she was little, but she never had a reaction to any of them.). No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered to patient on same date of the Pfizer suspect. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. It was reported that, the patient states she is calling to report the side effects she is having after receiving her first dose of the Pfizer COVID-19 vaccine. She clarifies she is referring to the Pfizer COVID vaccine. She mentions she is Dental assistant. She makes the comment as her address is being confirmed that she is having a lot memory problems. The patient explains within the first 15 minutes they kept her there, she broke out in a severe rash all over her chest, neck, cheeks. She states one could see a redness over her forehead. She was told this was her anxiety and given an icepack and was told it was okay to leave. The patient states the person didn't go over the packet or anything with her. She didn't ask her health history or if she had Covid before, which the patient did. Patient states the rash comes and goes. She has been taking Benadryl every 4-6 hours. She states it burns and itches. The rash has not improved, its consistent. The patient ended up in the emergency room after she left the vaccine facility. She clarifies right after she left the facility and was told it was her anxiety, which it wasn't, the patient states she was completely calm, not even 5 minutes of being in the car, she developed numbness on the left side of her face. She states she works in the dental field so she know how it feels to be numb and it was numb. Her mom suggested to keep squeezing it and smiling. This happened right away and then 2 minutes later, she was talking and felt this overwhelming warmth that started from her head down to her toes. She lost color in face and lips at that time. The patient asked her mother to pull over and it started with her right hand and right leg were uncontrollably shaking back and forth. Her right calf started pulsating and twitching uncontrollably and she could not stop it.  The patient states she had to call because she didn't know what was going on. Her oxygen was good, her blood pressure was slightly up which was to be expected, and that subsided a little bit. She went to the Emergency Room and her vision was blurry, it was like she had a film over her eyes.  Her legs were weak and the tops of her hands were tightening where the muscles are. She was put in wheelchair. Her right hand and right leg stopped, but then she had involuntary twitching in her thighs and everywhere. From there, she has been having the rash as she previously mentioned. She has had severe tiredness and fever that comes and goes. Her temperature was at 100 last night. She has had stomach problems. Her abdominal area started hurting right after the injection and by the time she went to not the ER, it stopped. She has been having diarrhea. She is having headaches that won't go away. She has had brain fog, pretty much like she did when she had COVID. It's like she is having a difficult time getting out words. She has had heart palpitations not in her chest, but in the middle of her throat region, she doesn't know how else to describe it.  Her lymph nodes feel sore. She is experiencing, dizziness, muscle pain, chills, joint pain, swelling where the injection was. She has been feeling nauseated. She had severe pain for 2 days in left armpit to where she had to push it to make it stop. She confirms all of these side effects began right after she walked of vaccine facility. There was no hesitation the vaccine ran through her body and happened immediately. She states it happened at the facility, but she was told it was her anxiety. When probed for the outcome of these events, the patient explains its hard to say because nothing has been consistent. This morning, she feels good but that is not to say in a couple of hours, she won't. An hour ago, she can feel that she will have to take a Benadryl. She won't have a fever, but then she will have a fever. Her sight is clear and then it's not clear. It's moment to moment. She almost feels like she did when she COVID. When she had COVID, she was blacking out in the middle of conversations. The patient confirms this was her first dose. The patient mentions seeing RTWFP on her vaccine record card but confirms she doesn't see any other numbers including NDC or expiry date. She sees the date of her second dose, which she states she will not be getting. She states at her doctor's office where she received the vaccine the person saw the rash but told her it was anxiety. The ER doctor can't relate it to the vaccine because no one will, and stated its possibly an allergic reaction but was unable to pinpoint. The patient clarifies she was seen in the ER only and was not hospitalized. They kept her for a little bit just to watch her. She has never even gotten a flu shot. The nurse pulled up her health history and saw the patient had a TB shot and shots when she was little, but she never had a reaction to any of them. She has no underlying health issues. Patient states the ER did an EKG on her, She was taken to the ER and She was given Benadryl and Valium, which she doesn't know why they did it just made her extremely drowsy. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement): slightly up on an unspecified date, body temperature: 100 (Her temperature was at 100 last night) on 29Aug2021, EKG (electrocardiogram): unknown results (Relevant Tests: Caller states the ER did an EKG on her) on 30Aug2021, oxygen (oxygen consumption): good on an unspecified date. Therapeutic measures were taken as a result of numbness on the left side of her face, vision was blurry, it was like she had a film over her eyes, severe rash all over chest, neck, cheeks, forehead, overwhelming warmth that started from her head down to her toes, lost color in face and lips, right hand and right leg were uncontrollably shaking, right calf started pulsating and twitching uncontrollably, blood pressure was slightly up, legs were weak, tops of her hands were tightening where the muscles are, involuntary twitching in her thighs and everywhere, severe tiredness, fever that comes and goes, stomach problems; abdominal area started hurting, diarrhea, headaches that won't go away, brain fog; difficult time getting out words, heart palpitations in throat region, lymph nodes feel sore, dizziness, muscle pain, joint pain, chills, swelling where the injection was, feeling nauseated, severe pain in left armpit. The outcome for event severe rash all over chest, neck, cheeks, forehead was not recovered and outcome was unknown for other events.  No further details were provided or obtained.