Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood calcium, Echocardiogram, Electrocardiogram, Fatigue, Magnetic resonance imaging
Clinical narrative: Enlarged spleen, after second vaccine; Fever, after second vaccine; Feeling exhausted, after second vaccine; "This is a spontaneous report from a contactable (patient's Husband: reporting on his wife) consumer.   A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8730, NDC and expiration: unknown), via an unspecified route of administration in right arm on 26Mar2021 UTC as a 2nd dose single for COVID-19 immunization. Patient received her historical dose of vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6203, NDC and expiration: unknown), via an unspecified route of administration on 05Mar2021 around noon as a 1st dose single for COVID-19 immunization. Patient had High Blood Pressure since, Apr2020, High Cholesterol since, Jan2020, Asthma since, 2020 and Fatty liver From an Unspecified date, which were ongoing. Additional Information for Other Conditions reported as, probably in 1996 or 1997. patient was allergic to multiple medications, like Codeine causes headache. Contrast medium resulted in flushing, itchy skin. Fexofofenadine HCL reported with unknown effect. Iodine used to cause skin reaction, Lansotrazole and Latex to skin rash. Patient also had itchy tongue due to Lisinopril, headache and nausea due to Metoprolol Fumarate and Oxycodone. Patient's concomitant medications included, Aspirin from Unspecified date, 15 years ago and Vitamin D3 from Unspecified date, sometime in Mar2019 as per prescribed by her doctor both for an unknown indication. He was also having Zocor since, Jan2020, Carvidol since, Apr2020 and Benicar since, Apr2020 all for high blood pressure. Advair Discus since, Apr2020 Stop for an unknown indication. All the concomitant medications were ongoing. Reported stated that, he did not realize it was the vaccine, causing his wife's issues. after she was in the emergency room, physician office and seeing the cardiologist, and after the recent reports of the vaccine's effects with the heart, the cardiologist thought the vaccine, caused patient's effects. Reporter mentioned that, her effects started after she had the first vaccine on 05Mar2021. Patient had breathing difficulty and felt that her heart was pumping in her chest, and this was making it hard for her to walk, when they were outside walking about 5-7 days after the shot, around the 10Mar2021 or 11Mar2021 at afternoon and it was isolated to the same day as it started. when patient stopped, she still had some breathing difficulty. Over the next week, she had chest pain under her left breast. It was also reported that, went to the emergency room and she had an EKG and a Troponin blood test, on 19Mar2021 which were all negative. patient occasionally feels a twinge, reclarified, and she had to go to the emergency room and get evaluated. On 21Mar2021, she had a stress test which was normal, but she still had chest pain. Patient's cardiologist sent her for a Calcium CT Scan, which was a normal result, and reasonable for her age. patient was still having chest pain, and the doctor thought, it could be from the vaccine, since all the tests were normal. patient had the second vaccine, and then reclarified, all of the symptoms went away. Reporter mentioned that, the CT Scan was done first then the MRI was done after the CT Scan. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine and did not have any AEs following any prior vaccinations. Patient's Family Medical History Relevant to AEs were none. On 26Mar2021 she had a fever, of 102 degrees (evening which lasted about a day and a half later) and felt exhausted for two days (lasted for about a week), after the second vaccine. Reporter mentioned that, because all of the heart tests were negative, the liver specialist ordered an MRI elastograph of the liver and spleen, and that test showed she had an enlarged spleen on 27Apr2021. On 29Apr2021, patient had normal for age, enlarged spleen. Reporter seriousness for all the events, after vaccination was Unspecified. Outcome of Fever, after second vaccine and felt exhausted were resolved on an unspecified date 2021 and enlarged spleen was unknown.  Information on lot/batch number has been requested.