Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Thrombosis, Vaccination site pain
Clinical narrative: Greater than 35 days between Moderna Covid-19 vaccinations; Second Blood Clot; soreness in her left injection site arm; Blood clot within a week of receiving her Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot within a week of receiving her Moderna Covid-19 vaccine), VACCINATION SITE PAIN (soreness in her left injection site arm) and THROMBOSIS (Second Blood Clot) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. lot 088D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced VACCINATION SITE PAIN (soreness in her left injection site arm) (seriousness criterion disability). In August 2021, the patient experienced THROMBOSIS (Blood clot within a week of receiving her Moderna Covid-19 vaccine) (seriousness criteria disability and medically significant). On 23-Sep-2021, the patient experienced THROMBOSIS (Second Blood Clot) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19 vaccinations). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood clot within a week of receiving her Moderna Covid-19 vaccine), VACCINATION SITE PAIN (soreness in her left injection site arm), THROMBOSIS (Second Blood Clot) and PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19 vaccinations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications included Hot compresses and leg elevation.  This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected event of Vaccination site pain, Thrombosis (August, 2021 and 23-SEP-2021) and Product dose omission. The event Vaccination site pain occurred the same day as the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the patient did not receive the second dose. The events were considered related to the product per the reporter's assessment.  The event of Vaccination site pain is consistent with the current understanding of the mechanism of action of the vaccine.  The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Sender's Comments: This case concerns a 30-year-old, female patient with no relevant medical history, who experienced the unexpected event of Vaccination site pain, Thrombosis (August, 2021 and 23-SEP-2021) and Product dose omission. The event Vaccination site pain occurred the same day as the first dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as the patient did not receive the second dose. The events were considered related to the product per the reporter's assessment.  The event of Vaccination site pain is consistent with the current understanding of the mechanism of action of the vaccine.  The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.