Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, COVID-19, Computerised tomogram, Diverticulum, Heart rate
Clinical narrative: Patient also mentioned that she had a CT scan, and was diagnosed with severe diverticular disease and had half of my colon and rectum removed in June 2023.; I was diagnosed with Interstitial Lung Disease in February 2023; Got covid again; I believe, Paxlovid caused My heart rate (arrhythmias) go to 120s; I got the sick, with the Delta variant of Covid and I was Super Super sick, and was not hospitalized; This spontaneous case was reported by a patient and describes the occurrence of INTERSTITIAL LUNG DISEASE (I was diagnosed with Interstitial Lung Disease in February 2023) and ARRHYTHMIA (I believe, Paxlovid caused My heart rate (arrhythmias) go to 120s) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A and 022J21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2023, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. In October 2022, the patient experienced COVID-19 (I got the sick, with the Delta variant of Covid and I was Super Super sick, and was not hospitalized). In January 2023, the patient experienced COVID-19 (Got covid again). In February 2023, the patient experienced INTERSTITIAL LUNG DISEASE (I was diagnosed with Interstitial Lung Disease in February 2023) (seriousness criterion medically significant). In 2023, the patient experienced ARRHYTHMIA (I believe, Paxlovid caused My heart rate (arrhythmias) go to 120s) (seriousness criterion medically significant). On an unknown date, the patient experienced DIVERTICULUM (Patient also mentioned that she had a CT scan, and was diagnosed with severe diverticular disease and had half of my colon and rectum removed in June 2023.). The patient was treated with Surgery (Had half of colon and rectum removed in June 2023) for Diverticulum. At the time of the report, INTERSTITIAL LUNG DISEASE (I was diagnosed with Interstitial Lung Disease in February 2023), ARRHYTHMIA (I believe, Paxlovid caused My heart rate (arrhythmias) go to 120s), DIVERTICULUM (Patient also mentioned that she had a CT scan, and was diagnosed with severe diverticular disease and had half of my colon and rectum removed in June 2023.), COVID-19 (I got the sick, with the Delta variant of Covid and I was Super Super sick, and was not hospitalized) and COVID-19 (Got covid again) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Heart rate: 120 heart beats per minute. On an unknown date, Computerised tomogram: Diagnosed with severe diverticular disease and had half of colon and rectum removed in June 2023.. On an unknown date, Immunology test: (Negative) Did all kinds of immune testing and all results came back negative.. On an unknown date, Laboratory test: The patient also reported that tests showed she had problems with lungs and was diagnosed with Interstitial Lung Disease in February 2023, and believes that it was related to Covid..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ARRHYTHMIA (I believe, Paxlovid caused My heart rate (arrhythmias) go to 120s) to be not related. No further causality assessments were provided for INTERSTITIAL LUNG DISEASE (I was diagnosed with Interstitial Lung Disease in February 2023), DIVERTICULUM (Patient also mentioned that she had a CT scan, and was diagnosed with severe diverticular disease and had half of my colon and rectum removed in June 2023.), COVID-19 (I got the sick, with the Delta variant of Covid and I was Super Super sick, and was not hospitalized) and COVID-19 (Got covid again).    It was reported that she got the monoclonal antibodies. Patient continued, that Jan 2023 she got covid again, and took Paxlovid. She believed that Paxlovid caused heart rate (arrhythmias) go to 120s and they put her on blood pressure medication which she continues now, if not, she would have had a heart attack by now. Patient also mentioned that she had a CT scan, and was diagnosed with severe diverticular disease and had half of my colon and rectum removed in June 2023. Patient states that she breathes fine and does not take any medication.   Company Comment: This spontaneous case concerns an elderly female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant), events of interstitial lung disease and arrhythmia (AESI) and the non-serious events of COVID-19, in the context of the third dose of mRNA-1273. It was reported that 8 months after the third dose, the patient got sick with COVID-19 delta variant but was not hospitalized. She got the monoclonal antibodies. About 3 months later, she got COVID-19 again and took Paxlovid. She believed that Paxlovid caused her heart rate to increase to 120 bpm (arrhythmias) and was treated with blood pressure medication. The patient reported tests that showed lung problems and was diagnosed with Interstitial Lung Disease about 4 months after the 3rd dose and believed that it was related to COVID-19. Patient explained that her doctor did all kinds of immune tests, and all results came back negative. They were planning to repeat tests in 6 months. Patient stated she that she had no breathing problems and did not take any medication. She had a CT scan and was diagnosed with severe diverticular disease on an unknown date and half her colon and rectum was removed around 8 months after the 3rd dose. No further clinical information was provided for review. Paxlovid which was used as treatment drug for COVID-1 could be a co-suspect for arrhythmia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-745156 (Linked Report).; Sender's Comments: This spontaneous case concerns an elderly female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant), events of interstitial lung disease and arrhythmia (AESI) and the non-serious events of COVID-19, in the context of the third dose of mRNA-1273. It was reported that 8 months after the third dose, the patient got sick with COVID-19 delta variant but was not hospitalized. She got the monoclonal antibodies. About 3 months later, she got COVID-19 again and took Paxlovid. She believed that Paxlovid caused her heart rate to increase to 120 bpm (arrhythmias) and was treated with blood pressure medication. The patient reported tests that showed lung problems and was diagnosed with Interstitial Lung Disease about 4 months after the 3rd dose and believed that it was related to COVID-19. Patient explained that her doctor did all kinds of immune tests, and all results came back negative. They were planning to repeat tests in 6 months. Patient stated she that she had no breathing problems and did not take any medication. She had a CT scan and was diagnosed with severe diverticular disease on an unknown date and half her colon and rectum was removed around 8 months after the 3rd dose. No further clinical information was provided for review. Paxlovid which was used as treatment drug for COVID-1 could be a co-suspect for arrhythmia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2023-745156:Case for Spikevax 2023-2024 PFS