Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Echocardiogram normal, Electrocardiogram normal, Endoscopy normal, Hypersensitivity
Clinical narrative: Severe allergic reaction; Itching in the mouth and the throat; Itching in the mouth and the throat; Coughing; she lost her voice/She became unable to speak; Her face get dark; This is a spontaneous report from a contactable consumer (mother). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. Medical history included hypertension, diabetes mellitus and renal failure from 17Feb2020 to an unknown date; dialysis from 04Dec2020 to an unknown date and kidney transplant on 12Aug2004. The patient's concomitant medications were not reported. Reporter stated, "I am calling for a patient, patient can't speak right now. She had a very severe allergic reaction to the Pfizer vaccine. I am her mother. I just wanted to be on the right page. I am calling because I called the vaccine advocate system because my daughter took the Pfizer vaccine on the 17th and after the Pfizer vaccine, the first dose, she had underlying issues. She started coughing, she lost her voice. She became unable to speak. It began between 4-5 minutes after the vaccine. I have the number of Pfizer Vaccine that she took. She took the vaccine and because of the underlying issue of renal failure as she almost died, her face got black, I would have never thought that my child could have died of the shot. She is renal person. Lab work: "Yes, she had because of her kidney problem, they did a blood work, for this problem she was admitted to the hospital for observation on the 17th, for day or two ago at (hospital name). They did ECG, chest X-ray, blood work, endo test to make sure that respiratory area was not swollen or anything. The medication was given for that." Treatment: "Solu-Medrol, Albuterol, to open respiratory area, Pepcid, Benadryl, IV Cetirizine." Reporter then stated, "My problem is right now, after the vaccine the observation which was started within 4-5 minutes. She spoke with me before the vaccine and after the vaccine. She called and I don't know who was on the phone. I said who is this? Save me, she said I can't speak. It is sounding like people making love funny jokes to you as she was coughing and terribly itching in the mouth and the throat. Her face get dark, she got very nervous because of course something's going over you. She is 45, young person. So right now why I am calling because she can't speak on the phone, she cannot speak. She is speaking the same way. All what they did to her, they gift to her, she cannot speak. Because was in the hospital. She had to be admitted in hospital for observation. Her vitals all came normal, her blood work and everything was normal. So, they discharged her with the medications here, Prednisone 40mg. So, that would ever help to combat the allergy? So, I am very concerned about her speaking because tomorrow will make it 4 days. Pfizer has to know this. Because of the underlying issue. They have to be very careful. Is somebody is going to get back to me? Yes or no? Or what happens?" The patient underwent lab tests and procedures which included chest x-ray and electrocardiogram: unknown and blood work: everything was normal on an unspecified date. Therapeutic measures were taken as a result of coughing, she lost her voice/she became unable to speak and itching in the mouth and the throat. The outcome of the events was unknown.