Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Depression, Diarrhoea, Headache
Clinical narrative: First dose: diagnosed with the Covid 19 virus; First dose: developed Covid induced asthma and was on oxygen for 4 months; First dose: thought she had bronchitis; First dose: cough was so severe; First dose: oxygen level plummeted again when she got home; First dose: heaviness in her chest; First dose:  headache; First dose: throwing up; First dose: diarrhea; Both doses: depression and anxiety; Both doses: depression and anxiety; This is a spontaneous report from a contactable consumer.    This 74-year-old female consumer (patient) reported for herself that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6198) via an unspecified route of administration into the left arm on 25Feb2021 (at the age of 74-year-old) as single dose for COVID-19 immunisation. The patient medical history included cholesterol, blood pressure measurement and thyroid disorder/issue all from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 06Mar2021, the patient experienced first dose: diagnosed with the Covid 19 virus. On an unspecified date in 2021, she experienced first dose: developed Covid induced asthma and was on oxygen for 4 months, first dose: thought she had bronchitis, first dose: cough was so severe, first dose: oxygen level plummeted again when she got home, first dose: heaviness in her chest, first dose:  headache, first dose: throwing up, first dose: diarrhea and both doses: depression and anxiety. The patient underwent lab tests which showed chest x-ray as unknown, oxygen saturation decreased as 84 % and sars-cov-2 test as positive on 06Mar2021.   She got her first Pfizer Covid 19 vaccine on 25Feb2021 and on 06Mar2021 she was diagnosed with the Covid 19 virus. She developed Covid induced asthma and was on oxygen for 4 months. After she was feeling better, she went to get her second Pfizer Covid 19 vaccine. About 2 weeks after her second dose, she developed asthma again and her oxygen saturation level is about 84 percent. The caller had heard that there might be a third dose and she will never, ever put anything of Pfizer in her body again. She has cholesterol and blood pressure issues but they are under control because she takes medicine. She also has a thyroid issue. She does not have diabetes or heart issues. And she was never, ever had asthma or COPD. She did have bronchitis as a child. She was a pretty healthy person. She was going to the gym 4 times a week before this happened. She was very healthy. She was doing Zumba 4 times a week which is a workout with an hour of continual movement. She was very proactive where cancer is concerned because cancer is prevalent in her family. She reports while in the emergency department she had a blood test that was positive for the Covid 19 virus. The emergency department doctor thought she had bronchitis because her cough was so severe.  She was not admitted to the hospital, she was discharged from the emergency department once her oxygen level reached an acceptable point. Her oxygen level plummeted again when she got home. She was given oxygen for her home and one oxygen machine had a mechanism that turned to add moisture to her oxygen. She states it was mostly vitamins, multivitamins, calcium that the pharmacist was giving her. She also had a nebulizer and Albuterol. She also experienced a headache and she was throwing up and she had diarrhea. Those symptoms only lasted a few days, maybe 72 hours and then went away. The cough continued, the cough lingered on, it lasted several weeks. And she had the heaviness in her chest. She knows when her oxygen level was going down because her face would flush brilliant red. Her face was red, brilliant red so she checked her oxygen level last night and it was 84%. She has a cough now but it was not nearly as bad as with the first Covid 19 vaccine. She did not have a fever with the Covid 19 vaccine. She may have had pneumonia when she first got sick in Mar2021, ordered a CAT scan and a breathing test and a blood test. She had her second Covid 19 vaccine on 13Jul2021 and saw her doctor for regular check up on 15Jul2021 and she was telling him how well she was doing. She was feeling good and was back at her Zumba. Then on 19Jul2021 she had an appointment with her heart doctor and she was telling him that she was doing good. Then on 22Jul2021, that's when it hit her, she started having symptoms. After the second dose she had the chest heaviness again, a little cough, depression and anxiety. She had depression and anxiety with both vaccines but she thinks it was because she is so frustrated, she is very upset that she received the vaccines. Last night when her oxygen level dropped to 84-85 percent she thought what is going on. She thought about going to the emergency room but what good is that. They will tell her to take deep breaths and then she gets dizzy. She was able to get her oxygen level back up to 93 percent but when she woke up this morning her oxygen level was 91 percent. She has not had any oxygen at all with the second dose. She was wondering if she should have oxygen.  Outcome was unknown for all the events.  Follow up (29Jul2021): The is a follow-up spontaneous report received from product quality complaints group. This report included PQC details with conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6198 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6198, fill lot EN5330, and the formulated drug product lot EN5319. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.