Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary haemorrhage, Thrombosis
Clinical narrative: in early 2022, there was a blood in the lung/damage done to the lung tissue/he has shortness of breath which he never had before the blood clot and pain sometimes in the chest; blood clot in the leg; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (blood clot in the leg) and PULMONARY HAEMORRHAGE (in early 2022, there was a blood in the lung/damage done to the lung tissue/he has shortness of breath which he never had before the blood clot and pain sometimes in the chest) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Hip surgery, Foot surgery and Knee surgery NOS. Concurrent medical conditions included Seasonal allergy and Allergy to antibiotic (allergic to Gentamicin Opthalmic). Concomitant products included FAMTOZINAMERAN, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/5)) and TOZINAMERAN (COMIRNATY ORIGINAL) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Aug-2022, received sixth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jul-2021, the patient experienced THROMBOSIS (blood clot in the leg) (seriousness criterion medically significant). In 2022, the patient experienced PULMONARY HAEMORRHAGE (in early 2022, there was a blood in the lung/damage done to the lung tissue/he has shortness of breath which he never had before the blood clot and pain sometimes in the chest) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood clot in the leg) and PULMONARY HAEMORRHAGE (in early 2022, there was a blood in the lung/damage done to the lung tissue/he has shortness of breath which he never had before the blood clot and pain sometimes in the chest) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient was generally very healthy as verbalized. Patient had no underlying diseases such as diabetes or cancer and no previous diagnosis of COVID-19.  On 03-Jul-2021, patient visited the ER due to a blood clot in the leg and in early 2022, there was a blood in the lung and added that it was possible that the blood clot travelled to the leg and to the lung but that nobody's sure. Patient was then switched to Pfizer afterwards and was a little concerned it might have been the Moderna.  No history in the family with a blood clot and said that it was quite suspicious that it might have been the vaccine. Patient had volumes of blood work to try to find out there was any genetic factor and was found none. Patient stated that it all points out to the Moderna vaccine but obviously we'll never know. It was added that from where patient had read, the statistics of people having blood clots is very low maybe 1 in 2 million but then stated isn't sure with the ratio and perhaps was the "very lucky one" to have it.  Patient still had symptoms from the blood clot because the blood clot damaged the part of the lung. Patient stated that had a shortness of breath which never had before the blood clot and pain sometimes in the chest. Patient had been to cardiologist and pulmonologist and had done a thorough medical workup because of the damage done to the lung tissue and had visited the ER.  Patient found it as suspicious that would have a blood clot 3 vaccinations later despite not having any family history of it. It was not conclusive that these were the results of the vaccine. Apparently, it's been advised by the primary doctor and other medical professionals that should notify to Moderna.  No treatment medications were reported.  Company Comment: This is a spontaneous case concerning a 75-year-old male patient with a history of Hip surgery, Foot surgery and Knee surgery NOS, who experienced the serious (due to medically significant) unexpected, event of thrombosis (AESI) and pulmonary haemorrhage.  The event thrombosis occurred approximately 3 months after a dose of mRNA-1273 vaccine, received as the third dose of COVID-19 vaccination schedule. Event pulmonary haemorrhage occurred on an unknown date on the following year after a dose of mRNA-1273 vaccine, received as the fifth dose of COVID-19 vaccination schedule. Patient received 6 doses of mRNA-1273 vaccine, starting in feb 2021, and receivieng sixth dose on august 2022. Patient was then switched to Pfizer COVID-19 vaccines. It was reported that on 03-Jul-2021, patient visited the ER due to a blood clot in the leg and in early 2022, there was a blood in the lung and added that it was possible that the blood clot travelled to the leg and to the lung but that nobody's sure. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.