Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Illness, International normalised ratio increased
Clinical narrative: INR was too high; Missed dose; She's so weak; No appetite; Fever; Got sick; felt tired and very sick; Weak and tired; This spontaneous case was reported by a consumer and describes the occurrence of INTERNATIONAL NORMALISED RATIO INCREASED (INR was too high) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2001, the patient experienced FATIGUE (Weak and tired). On 14-Feb-2012, the patient experienced ILLNESS (Got sick; felt tired and very sick). On an unknown date, the patient experienced INTERNATIONAL NORMALISED RATIO INCREASED (INR was too high) (seriousness criterion hospitalization prolonged), ASTHENIA (She's so weak), DECREASED APPETITE (No appetite), PYREXIA (Fever) and PRODUCT DOSE OMISSION ISSUE (Missed dose). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, INTERNATIONAL NORMALISED RATIO INCREASED (INR was too high), ILLNESS (Got sick; felt tired and very sick), ASTHENIA (She's so weak), DECREASED APPETITE (No appetite), PYREXIA (Fever), FATIGUE (Weak and tired) and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include, Komento 2mg. No additional treatment information was reported.  The patient was hospitalized 2 weeks after receiving the first dose of Moderna vaccine due to increased INR. She was in the hospital for two months. She reported wanting to take the second dose, but her physician is not sure if she should.   This is a 68-year-old female patient with a serious event of international normalized ratio increased and other non-serious cases. A very limited information regarding this event (INR was too high) has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of other non-serious event, a causal relationship cannot be excluded. However, hospital discharge summary is required for further assessment.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: New event added (seriousness criterion of hospitalization), event outcome updated.; Sender's Comments: This is a 68-year-old female patient with a serious event of international normalized ratio increased and other non-serious cases. A very limited information regarding this event (INR was too high) has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of other non-serious event, a causal relationship cannot be excluded. However, hospital discharge summary is required for further assessment.