Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Haemoptysis, Intentional dose omission, Pain in extremity, SARS-CoV-2 test
Clinical narrative: blood clots in his right leg and left leg; Emergency Room at 4am because he had trouble breathing and walking; found blood on both his lungs; chills especially at night that lasted 2 nights; He states he is still in misery; Patient was supposed to get second dose on 04-Mar-2021, but he is not going to get it; shoulder pain/hip pain; Pain in arms, leg; trouble walking due to his pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots in his right leg and left leg), DYSPNOEA (Emergency Room at 4am because he had trouble breathing and walking), HAEMOPTYSIS (found blood on both his lungs) and CHILLS (chills especially at night that lasted 2 nights) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma since an unknown date. Concomitant products included MONTELUKAST and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for Asthma, METOPROLOL and APIXABAN (ELIQUIS) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced THROMBOSIS (blood clots in his right leg and left leg) (seriousness criteria hospitalization and life threatening), DYSPNOEA (Emergency Room at 4am because he had trouble breathing and walking) (seriousness criterion hospitalization), HAEMOPTYSIS (found blood on both his lungs) (seriousness criteria hospitalization and medically significant), PAIN IN EXTREMITY (Pain in arms, leg), GAIT DISTURBANCE (trouble walking due to his pain) and ARTHRALGIA (shoulder pain/hip pain). On 04-Mar-2021, the patient experienced INTENTIONAL DOSE OMISSION (Patient was supposed to get second dose on 04-Mar-2021, but he is not going to get it). On an unknown date, the patient experienced CHILLS (chills especially at night that lasted 2 nights) (seriousness criterion hospitalization) and FEELING ABNORMAL (He states he is still in misery). The patient was hospitalized on 20-Feb-2021 due to DYSPNOEA, HAEMOPTYSIS and THROMBOSIS, and then for 2 days due to CHILLS. At the time of the report, THROMBOSIS (blood clots in his right leg and left leg), DYSPNOEA (Emergency Room at 4am because he had trouble breathing and walking), HAEMOPTYSIS (found blood on both his lungs), PAIN IN EXTREMITY (Pain in arms, leg), GAIT DISTURBANCE (trouble walking due to his pain), FEELING ABNORMAL (He states he is still in misery) and ARTHRALGIA (shoulder pain/hip pain) had not resolved and CHILLS (chills especially at night that lasted 2 nights) and INTENTIONAL DOSE OMISSION (Patient was supposed to get second dose on 04-Mar-2021, but he is not going to get it) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: (abnormal) Found blood on both of his lungs. On an unknown date, SARS-CoV-2 test: (Negative) Negative. On an unknown date, Ultrasound scan: (abnormal) Found blood clots in his right leg and left leg.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was taken to the ER (Emergency Room) on 20-Feb-2021 at 4 AM. Several tests including Chest X-Ray, MRI, Blood work, Ultrasound (groin and legs) were performed. Only few tests results were reported. Received treatment including Oxygen, Eliquis and Antibiotics.  Patient has been on oxygen full time until 7Apr2021  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these event, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these event, a causal relationship cannot be excluded. Further information has been requested.