Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Vaccination site pain
Clinical narrative: Patient has had arm pains and blood clots since his last Moderna Covid-19 vaccine; The patient was diagnosed with Congestive Heart Failure after he received his Moderna Covid-19 vaccine.; A couple of years ago there was talk of the patient being pre diabetic and now the patient is diabetic. This happened after Moderna Covid-19; Patient says his legs are numb like a neuropathy pain and that he has shooting pains down both of his arms.; Shooting pains down both of his arms.; Patient has had arm pains and blood clots since his last Moderna Covid-19 vaccine; The patient recently was diagnosed with blood clots in his lungs on October 28, 2023; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Patient has had arm pains and blood clots since his last Moderna Covid-19 vaccine), CARDIAC FAILURE CONGESTIVE (The patient was diagnosed with Congestive Heart Failure after he received his Moderna Covid-19 vaccine.), DIABETES MELLITUS (A couple of years ago there was talk of the patient being pre diabetic and now the patient is diabetic. This happened after Moderna Covid-19) and PULMONARY THROMBOSIS (The patient recently was diagnosed with blood clots in his lungs on October 28, 2023) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027F21A, 030M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pre-diabetic (A couple of years ago there was talk of the patient being pre diabetic).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY THROMBOSIS (The patient recently was diagnosed with blood clots in his lungs on October 28, 2023) (seriousness criterion medically significant). On an unknown date, the patient experienced THROMBOSIS (Patient has had arm pains and blood clots since his last Moderna Covid-19 vaccine) (seriousness criterion medically significant), CARDIAC FAILURE CONGESTIVE (The patient was diagnosed with Congestive Heart Failure after he received his Moderna Covid-19 vaccine.) (seriousness criterion medically significant), DIABETES MELLITUS (A couple of years ago there was talk of the patient being pre diabetic and now the patient is diabetic. This happened after Moderna Covid-19) (seriousness criterion medically significant), HYPOAESTHESIA (Patient says his legs are numb like a neuropathy pain and that he has shooting pains down both of his arms.), PAIN IN EXTREMITY (Shooting pains down both of his arms.) and VACCINATION SITE PAIN (Patient has had arm pains and blood clots since his last Moderna Covid-19 vaccine). At the time of the report, THROMBOSIS (Patient has had arm pains and blood clots since his last Moderna Covid-19 vaccine), CARDIAC FAILURE CONGESTIVE (The patient was diagnosed with Congestive Heart Failure after he received his Moderna Covid-19 vaccine.), DIABETES MELLITUS (A couple of years ago there was talk of the patient being pre diabetic and now the patient is diabetic. This happened after Moderna Covid-19), HYPOAESTHESIA (Patient says his legs are numb like a neuropathy pain and that he has shooting pains down both of his arms.) and VACCINATION SITE PAIN (Patient has had arm pains and blood clots since his last Moderna Covid-19 vaccine) had not resolved and PULMONARY THROMBOSIS (The patient recently was diagnosed with blood clots in his lungs on October 28, 2023) and PAIN IN EXTREMITY (Shooting pains down both of his arms.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The patient did not know which Moderna Covid-19 vaccine caused the following reactions, maybe it was even all three. Medical Agent reported the lot number for the first Moderna Covid-19 vaccine as it was not known which Moderna Vaccine the patient experienced the reactions listed; however, he does have these reactions after receiving all three Moderna Covid-19 vaccines. The patient took blood thinners.  Company Comment: This is a Spontaneous case reported by a consumer, concerning an 81-year-old male patient, with relevant medical history of pre-diabetes, who experienced the unexpected and serious (due to medically significant) events of Thrombosis (AESI), Cardiac failure congestive (AESI), Diabetes mellitus, and Pulmonary thrombosis (AESI), which occurred related to first, second and third dose of mRNA-1273 vaccine. As reported, patient has had arm pains and blood clots since his last Moderna Covid-19 vaccine. Patient said his legs were numb like a neuropathy pain and that he had shooting pains down both of his arms. Patient was diagnosed with blood clots in his lungs approximately 23 months after the third dose of mRNA-1273 vaccine. He takes blood thinners. He was also diagnosed with congestive heart failure. A couple of years ago there was talk of the patient being pre diabetic and now the patient is diabetic. No information disclosed about diagnostic tests performed. At the time of the report, Thrombosis, Cardiac failure congestive and Diabetes mellitus had not resolved, and Pulmonary thrombosis outcome was unknown. Causality for Pulmonary thrombosis was assessed as not related, due to long latency. Patient´s elderly age and pre-diabetes could be confounding factors for the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-752092, US-MODERNATX, INC.-MOD-2023-752096 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-752096:Same Reporter Different Patient US-MODERNATX, INC.-MOD-2023-752092:Same Reporter Different Patient