Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lethargy, Thrombosis
Clinical narrative: Lethargic; Joints in her shoulders, arms, hips and knees hurt; Blood clot in the leg; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (Blood clot in the leg) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 051F21A, 037A21B and 013M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     It was reported that patient has no allergies and no COVID history.  Concomitant products included PARACETAMOL (TYLENOL) for Pain, SIMVASTATIN, LISINOPRIL, LEVOTHYROXINE, NABUMETONE, CLONAZEPAM, GLIMEPIRIDE, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), PANTOPRAZOLE and HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, the patient experienced LETHARGY (Lethargic). In 2022, the patient experienced THROMBOSIS (Blood clot in the leg) (seriousness criterion medically significant) and ARTHRALGIA (Joints in her shoulders, arms, hips and knees hurt). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood clot in the leg), LETHARGY (Lethargic) and ARTHRALGIA (Joints in her shoulders, arms, hips and knees hurt) had not resolved.            It was reported that the patient was not hospitalized but had an emergency room visit. It was reported that patient was not taking Eliquis prior to the blood clot. The patient did not have allergies and no covid history.  Company Comment: This is a Spontaneous case concerning a 74-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) AESI of Thrombosis, which occurred on an unknown date after the fourth dose of mRNA-1273 vaccine. Patient reported she had a blood clot in the leg and stated that joints in her shoulders, arms, hips and knees hurt. She also reported being lethargic, having to visit emergency department. Apixaban was administered as treatment, at unknown dose. At the time of the report, the events had not resolved. No information disclosed about diagnostic tests performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 74-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to medically significant) AESI of Thrombosis, which occurred on an unknown date after the fourth dose of mRNA-1273 vaccine. Patient reported she had a blood clot in the leg and stated that joints in her shoulders, arms, hips and knees hurt. She also reported being lethargic, having to visit emergency department. Apixaban was administered as treatment, at unknown dose. At the time of the report, the events had not resolved. No information disclosed about diagnostic tests performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.