Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cardiac disorder, Clostridium difficile infection, Heart rate, Heart rate increased
Clinical narrative: Contracted C-diff and now is on going; Malabsorption, cannot hold down fluids; BPM over 200; blood clots; Got Covid; Heart issues started; pneumonia/double pneumonia/pleurisy/pleuritic pain; First a rash and swelling of the face - the day after 2nd dose, last a few days; First a rash and swelling of the face - the day after 2nd dose, last a few days; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PULMONARY THROMBOSIS (blood clots), PNEUMONIA (pneumonia/double pneumonia/pleurisy/pleuritic pain), CLOSTRIDIUM DIFFICILE INFECTION (Contracted C-diff and now is on going) and CARDIAC DISORDER (Heart issues started) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced SWELLING FACE (First a rash and swelling of the face - the day after 2nd dose, last a few days) and RASH (First a rash and swelling of the face - the day after 2nd dose, last a few days). In September 2021, the patient experienced PNEUMONIA (pneumonia/double pneumonia/pleurisy/pleuritic pain) (seriousness criterion medically significant). On 31-Oct-2021, the patient experienced CARDIAC DISORDER (Heart issues started) (seriousness criterion medically significant). In August 2022, the patient experienced PULMONARY THROMBOSIS (blood clots) (seriousness criterion medically significant) and COVID-19 (Got Covid). On an unknown date, the patient experienced CLOSTRIDIUM DIFFICILE INFECTION (Contracted C-diff and now is on going) (seriousness criterion medically significant), MALABSORPTION (Malabsorption, cannot hold down fluids) and HEART RATE INCREASED (BPM over 200). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, PULMONARY THROMBOSIS (blood clots), PNEUMONIA (pneumonia/double pneumonia/pleurisy/pleuritic pain), CARDIAC DISORDER (Heart issues started), HEART RATE INCREASED (BPM over 200) and COVID-19 (Got Covid) outcome was unknown, CLOSTRIDIUM DIFFICILE INFECTION (Contracted C-diff and now is on going) and MALABSORPTION (Malabsorption, cannot hold down fluids) had not resolved and SWELLING FACE (First a rash and swelling of the face - the day after 2nd dose, last a few days) and RASH (First a rash and swelling of the face - the day after 2nd dose, last a few days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: BPM over 200.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Patient first had a rash and swelling of the face and lasted a few days. Next had major reaction was in September, contracted pneumonia, double pneumonia, pleurisy, pleuradinia, went to a ER and then lung specialist. On 31-oct-2021 Heart issues started, ER stopped heard and started again. Patient had been in the ER at least 12 time since then. Patient then had Contracted C-diff and was on going. Malabsorption, cannot hold down fluids. Got Covid in Aug 2022 and went on Paxlovid. Patient had to go to the hospital around end August 2022 for blood clots in her lungs. Patient had Heart ablation on 10-feb-2022. Patient now receives infusions every 6 weeks to help the keep down fluids, Antibodies to control C-diff colonization. Patient was on went on blood thinner for blood clots in her lungs.  Company comment: This spontaneous case concerns a 53-year-old female patient with no reported medical history who experienced the unexpected serious (medically significant) events of Pneumonia after about 4 months, Cardiac disorder after about 5 months, Pulmonary thrombosis after about 16 months and Clostridium difficile infection which occurred unknown days after administration of second dose of mRNA-1273 vaccine. Patient contracted pneumonia and went to an Emergency room (ER) and then lung specialist. About a month later Heart issues (cardiac disorder) started. Heart rate increased upto 200 beats per minute. Patient had been in the ER at least 12 time since then. Heart ablation was performed for the unspecified heart issue. Patient then contracted C-difficile and was on going. She contracted COVID in Aug 2022 received Paxlovid. Patient had to go to the hospital around end August 2022 for blood clots in her lungs (pulmonary thrombosis). The benefit-risk relationship of mRNA-1273 is not affected by this report.