Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Product dose omission issue, Pyrexia, Ultrasound scan, Urticaria
Clinical narrative: hematoma; sickness; weakness; nausea; high fever; under her arm and side of breast was so sore she could not touch the area; She was due for her second dose on 22may2021 in which she did not get; arm was swollen one inch bigger than her other arm; pain going down her arm; welts down to her hands; bleed internally; hemorrhaged in her arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTERNAL HAEMORRHAGE (bleed internally) and MUSCLE HAEMORRHAGE (hemorrhaged in her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (was in the hospital for a week) in November 2020. Concurrent medical conditions included Blood disorder (fibrin anemia).    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced INTERNAL HAEMORRHAGE (bleed internally) (seriousness criterion medically significant), MUSCLE HAEMORRHAGE (hemorrhaged in her arm) (seriousness criterion medically significant), PAIN (pain going down her arm), URTICARIA (welts down to her hands) and PERIPHERAL SWELLING (arm was swollen one inch bigger than her other arm). On 24-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (She was due for her second dose on 22may2021 in which she did not get). On 25-Apr-2021, the patient experienced AXILLARY PAIN (under her arm and side of breast was so sore she could not touch the area). On an unknown date, the patient experienced HAEMATOMA (hematoma), ILLNESS (sickness), ASTHENIA (weakness), NAUSEA (nausea) and PYREXIA (high fever). On 24-Apr-2021, PRODUCT DOSE OMISSION ISSUE (She was due for her second dose on 22may2021 in which she did not get) had resolved. At the time of the report, INTERNAL HAEMORRHAGE (bleed internally), MUSCLE HAEMORRHAGE (hemorrhaged in her arm), HAEMATOMA (hematoma), PAIN (pain going down her arm), URTICARIA (welts down to her hands), PERIPHERAL SWELLING (arm was swollen one inch bigger than her other arm), ILLNESS (sickness), ASTHENIA (weakness), NAUSEA (nausea), PYREXIA (high fever) and AXILLARY PAIN (under her arm and side of breast was so sore she could not touch the area) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: down (Low) down. On an unknown date, Computerised tomogram: showed hematoma (abnormal) showed hematoma. On an unknown date, Ultrasound scan: showed bleeding (abnormal) showed bleeding.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant or treatment medications were reported.  Patient stated that hematologist suggested to take cryoprecipitate prior to the second dose.  Company Comment: This case concerns a patient of unknown age who did not get mRNA-1273 when due (Product dose omission issue). Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded. Axillary pain, pyrexia and nausea are consistent with the product known safety profile.; Sender's Comments: This case concerns a patient of unknown age who did not get mRNA-1273 when due (Product dose omission issue). Based on the current available information and temporal association between the use of the product and the start date of the other events, a causal relationship cannot be excluded. Axillary pain, pyrexia and nausea are consistent with the product known safety profile.