Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Thrombosis
Clinical narrative: Blood clot in right leg; may be connected to COVID; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (Blood clot in right leg) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dementia (Patient was in Dementia study and goes for 5 years) and Surgery (over 10 years ago). Concurrent medical conditions included Narcolepsy, Neuropathy, Blood pressure high, Urinary urgency and Overactive bladder. Concomitant products included LOSARTAN for Blood pressure high, GABAPENTIN for Neuropathy, FESOTERODINE FUMARATE (TOVIAZ) for Overactive bladder, OMEPRAZOLE, FINASTERIDE, METHYLPHENIDATE and ATORVASTATIN for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot in right leg) (seriousness criterion medically significant) and SUSPECTED COVID-19 (may be connected to COVID). At the time of the report, THROMBOSIS (Blood clot in right leg) and SUSPECTED COVID-19 (may be connected to COVID) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Events Pain in extremity, Gait inability are the symptoms of blood clot in the leg.  Patient had narcolepsy and cut back from 9, gabapentin 300mg to one because without 1 patient couldn't walk from pain in foot. Patient reported that methylphenidate was not good for health. Patient was taking a placebo as patient was in a demenia study and goes for 5 years. Patient knows the real things as patient got rash on face for couple of days. Patient was very active and worked on roofs and trimmings and windows and was an active person. Patient got a blood clot in his right leg and had to walk so much and feet started hurt and may be connected to COVID. Patient has been vaccinated 3 times with Moderna but couldn't walk and dosed back to 9 pills of Gabapentin a day. Patient also takes Vitamins. Patient stated that blood clots and COVID were not relevant. It was reported that patient was out of medication Toviaz. Treatment information was not provided.   Company Comment: This spontaneous case concerns a 78 year-old male patient, with a relevant medical history of high blood pressure (intake of losartan) and high cholesterol (intake of atorvastatin) reported, who experienced the unexpected serious (medically significant) events of  THROMBOSIS (Blood clot in right leg) and unexpected, non-serious adverse event of special interest SUSPECTED COVID-19, which occurred unknown days after a dose of mRNA-1273 vaccine administration. Patient reported that he got a blood clot in his right leg and had to walk so much and feet started hurt and may be connected to COVID. Patient has been vaccinated 3 times with Moderna but couldn't walk and dosed back to 9 pills of Gabapentin a day due to difficulty in walking. Treatment information was not provided. Underlying history of high blood pressure (intake of losartan) and high cholesterol (intake of atorvastatin), the patient's age and the ongoing COVID-19 pandemic could be confounders for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  viaz; Sender's Comments: This spontaneous case concerns a 78 year-old male patient, with a relevant medical history of high blood pressure (intake of losartan) and high cholesterol (intake of atorvastatin) reported, who experienced the unexpected serious (medically significant) events of  THROMBOSIS (Blood clot in right leg) and unexpected, non-serious adverse event of special interest SUSPECTED COVID-19, which occurred unknown days after a dose of mRNA-1273 vaccine administration. Patient reported that he got a blood clot in his right leg and had to walk so much and feet started hurt and may be connected to COVID. Patient has been vaccinated 3 times with Moderna but couldn't walk and dosed back to 9 pills of Gabapentin a day due to difficulty in walking. Treatment information was not provided. Underlying history of high blood pressure (intake of losartan) and high cholesterol (intake of atorvastatin), the patient's age and the ongoing COVID-19 pandemic could be confounders for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.