Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, COVID-19, Cardiac disorder, Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: had to get three heart stents, never had any heart troubles before; lymph nodes; Caller did get covid in the first part 2023 and they gave her the Paxlovid.; Inappropriate schedule of vaccine administered; she has had watery blisters in their face/sores on her nose; Caller had double pneumonia back in 2021.; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (Caller had double pneumonia back in 2021.) and CARDIAC DISORDER (had to get three heart stents, never had any heart troubles before) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043620A, 024MZOA and 003F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had No known allergies.  Concurrent medical conditions included Lipids increased since August 2018, Transient ischemic attacks (two TIA strokes) since August 2018, Blood pressure high since August 2018, Leukemia since August 2018 and Arthritis.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced PNEUMONIA (Caller had double pneumonia back in 2021.) (seriousness criterion medically significant) and BLISTER (she has had watery blisters in their face/sores on her nose). On an unknown date, the patient experienced CARDIAC DISORDER (had to get three heart stents, never had any heart troubles before) (seriousness criterion medically significant), LYMPHADENOPATHY (lymph nodes), COVID-19 (Caller did get covid in the first part 2023 and they gave her the Paxlovid.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency; MINOCYCLINE at an unspecified dose and frequency; IMMUNOGLOBULIN HUMAN NORMAL (GAMMAGARD) at an unspecified dose and frequency; NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency and Radiotherapy for Lymphadenopathy. At the time of the report, PNEUMONIA (Caller had double pneumonia back in 2021.) and BLISTER (she has had watery blisters in their face/sores on her nose) had not resolved and CARDIAC DISORDER (had to get three heart stents, never had any heart troubles before), LYMPHADENOPATHY (lymph nodes), COVID-19 (Caller did get covid in the first part 2023 and they gave her the Paxlovid.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  Patient had been to several dermatologists and they don't know what was wrong with her. Patient says they prescribed her ointments. Every morning when patient wakes up there was a water blister on her. It will get full and then burst open. Patient had one at the corner of her mouth in morning and its already watery. Patient says when she had them they start leaking and it will last for 2 days or more. Patient was ashamed to go out in public. Patient was disgusted with the face thing. Right after they started the vaccines, they had to get three heart stents, patient never had any heart troubles before. Patient was on heart medicine now. Patient did got covid in the first part 2023 and they gave her the Paxlovid. Company comment-This spontaneous case concerns an 81-year-old, female patient with reported medical history of high lipids, two TIA strokes, high blood pressure and leukemia since Aug2018, who experienced the serious (medically significant) unexpected events of Pneumonia and Cardiac disorder. Pneumonia occurred on the same day after first dose of mRNA-1273 vaccination, Cardiac disorder on unknown date. Additionally, Inappropriate schedule of product administration was noted as time interval between first and second dose was 4 days. It was reported that patient had double pneumonia back in 2021. She had to get three heart stents, right after vaccinations with no prior history of cardiac disorder. She is on heart medicine at present. Patient had covid infection in 2023 and treated with Paxlovid. She also has persistent watery blisters on face and sores on her nose, consulted dermatologists and treated with ointments, doxycycline, minocycline and gamma guard IV. No further information on risk factors, detailed clinical course, investigations, treatment of the events was available in the report. The relevant medical history of high lipids, high blood pressure could be confounder and advancing age risk factor to the event Cardiac disorder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.