Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Congestive cardiomyopathy, Cough, Diarrhoea, Fatigue, Investigation
Clinical narrative: fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; Dilated cardiomyopathy; fever; chills; vomiting; severely low potassium; fluid build up around her heart and lungs; fluid build up around her heart and lungs; This is a spontaneous report from a contactable consumer (patient's husband). A 49-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location; Arm) on 22Jan2021 13:00 as SINGLE DOSE for COVID-19 immunisation.  Patient's medical history was not reported. Concomitant medication included biotin from an unspecified date and unknown if ongoing. The patient previously took 1st dose of the Pfizer COVID Vaccine on 29Dec2020 (around 10:00 am to 12:00 pm at a hospital) and had the usual side effects of a little bit of nausea, developed a dry cough, some fatigue, and diarrhea and that kind of stuff. The reporter called about the Pfizer COVID vaccine and was calling on behalf of his wife who was the patient. Reporter stated that before the Pfizer COVID vaccine, patient used to walk the dogs 6 miles a very fast pace and had no problem, then she got her 1st dose of the Pfizer COVID vaccine on 29Dec2020 and had the usual side effects of a little bit of nausea, developed a dry cough, some fatigue, and diarrhea and that kind of stuff. The reporter stated that after the 1st dose of the Pfizer COVID vaccine, the symptoms she reported have worsened and the cough, fatigue, nausea, and diarrhea began immediately after the 1st dose of the vaccine where the cough started a week or so after the 1st dose and then after the 2nd dose, the cough never went away and got worse and worse and worse. Reporter stated the fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse. Reporter mentioned that for the cough after the first dose of the Pfizer COVID vaccine, it was still there but was occasional and was not too bad but when the patient had the 2nd dose on 22Jan2021 and was knocked on her butt for about three days; also stated that the patient had fever, chills, diarrhea, vomiting, nausea and the works and had all the symptoms. It was also reported that the patient was very sick for 3-4 days with same symptoms. Reporter mentioned that fatigue was getting worse and the cough never went away and always had the dry cough which was getting worse and worse and worse with any activity and was a dry cough and she never had any phlegm. Reporter also stated the patient got to where she did less and less activity and was worse and the dry cough was worse with nothing coming up. It was reported that the patient sought treatment for everything she believed last week on Monday but was unsure of the dates. Monday of last week, patient went to the emergency room in a hospital and was told that they thought that the patient had an enlarged heart and severely low potassium and the patient was put on an IV drip of potassium because she could not tolerate the oral potassium and threw up the oral potassium so she was put on two bags of IV potassium. On an unknown date, it was reported that patient started having pain in her chest from the IV drip of potassium but she was released from the emergency room and the 2nd day of last week which was the next day, patient went back to the emergency room because she was having issues and everything was getting worse. Reporter also stated that the 2nd of last week, the patient collapsed and an ambulance came and got her on Tuesday of last week though reporter was unsure of the dates. Reporter also mentioned that patient went to a hospital and had severe chest pain and collapsed pressure on her chest. Reporter stated that the patient at that time had the dry cough and stuff and the hospital told the patient that the patient had fluid build up around her heart and lungs which was maybe due to the treatment from the IV potassium and was told she has a weakened heart. It was reported that with a weakened heart, the heart can't process fluid around the lungs and the heart and it puts pressure on heart supposedly. It was reported that on Wednesday last week, the patient went to the emergency room for the 3rd day in a row and already had an appointment with the HCP which was an appointment with her new primary Nurse Practitioner for the first appointment and she confirmed that the patient had fluid on the lungs when she saw the patient. Reporter stated that the nurse practitioner could not admit the patient because the hospital she admits too was full so she sent the patient to a hospital emergency room where they did all the tests and everything confirmed what they said and they transferred the patient to another hospital where the patient stayed in the hospital  a total of three days and was diagnosed with cardiomyopathy and they started treatment on the patient. The patient was started on Entresto later on and tomorrow there was a follow up visit with her primary HCP and they have to follow up because the patient was released from the hospital and was very weak and she has to wear a lifevest because she is a heart patient and has a weak heart. It was reported that patient is going to be taking medications and stuff and will go see the HCP and they gave her beta blockers and other stuff and she will follow up with the HCP. It was reported that any of the medications including the beta blockers the patient was taking, reporter has no names of the medications, dosages or lot numbers or other information to provide at this time and stated that the patient was treated with those medications in the hospital and that was the hospital in another city and state. Reporter mentioned that it was last week when the patient collapsed while trying to walk across the yard and she was diagnosed with dilated cardiomyopathy where part of the heart shrunk which is the expelling chamber of the heart and the HCP stated where a normal 20-30 year old would have heart function of 55, the patient had an output of 15. Reporter stated that the HCP said that stroke, disease or things like that can cause cardiomyopathy and there are various things that can cause it but they can't diagnose what caused this in the patient because she has not had various things and the only she had was the Pfizer COVID shots that hit her very hard and she just turned age 50. Reporter stated that the patient was age 49 at the time she began experiencing the symptoms that were reported and just turned age 50. Reporter clarified to state the potassium drip the patient had was not at this hospital but was at another hospital. Reporter stated he has no lot numbers, expiry dates or NDC numbers to provide as he does not have the patient card for the Pfizer COVID Vaccine that the patient received and that paperwork is with the patient who is staying at her sister's house so the sister can help monitor the patient. Reporter also mentioned that patient was not taking medications at the time she received the Pfizer COVID Vaccine at that time but was taking over the counter Biotin and states he has no lot, expiry date or UPC to provide. Reporter mentioned that patient has no family history of heart conditions but he thinks the patient's mother is diabetic but she is the only who is diabetic and there is no other history he is aware of. Outcome of the events was not recovered.   Information on the lot/batch number has been requested.