Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Oedema peripheral, Urticaria
Clinical narrative: both of my hands began to swell/swelling continued to worsen/severe edema in both hands; hives on my body my body, increasing in severity; suffered from intermittent diarrhea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022.    This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA PERIPHERAL (both of my hands began to swell/swelling continued to worsen/severe edema in both hands) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (suffered from intermittent diarrhea). On 31-Dec-2021, the patient experienced OEDEMA PERIPHERAL (both of my hands began to swell/swelling continued to worsen/severe edema in both hands) (seriousness criterion hospitalization) and URTICARIA (hives on my body my body, increasing in severity). The patient was hospitalized from 02-Jan-2022 to 08-Jan-2022 due to OEDEMA PERIPHERAL. The patient was treated with PREDNISONE for Oedema peripheral, at an unspecified dose and frequency. On 30-Dec-2021, DIARRHOEA (suffered from intermittent diarrhea) had resolved. At the time of the report, OEDEMA PERIPHERAL (both of my hands began to swell/swelling continued to worsen/severe edema in both hands) and URTICARIA (hives on my body my body, increasing in severity) outcome was unknown.            No concomitant medication was reported  Patient was treated with various antihistamines and prednisone, among other treatments. Patient remained in outpatient therapy.  Company comment: This case concerns a patient of an unknown age and gender, with no medical history provided, who experienced serious unexpected event of Oedema peripheral (which required hospitalization) and non serious unexpected events of Diarrhoea and Urticaria. The event of Diarrhoea (reported as intermittent diarrhoea) occurred the day after the patient had received the mRNA-1273 vaccine (as third dose, booster). This event had resolved after 8 days. Nine days after this vaccination the patient developed Urticaria (reported as hives on body) and Oedema peripheral. Reportedly, since the swelling of the patient's hands continued to worsen, the patient was hospitalized 10 days after vaccination. The hospitalization had lasted for 7 days. The patient was treated with various antihistamines and prednisone, among other treatments (as stated). In addition, it was stated that the patient was on outpatient therapy after hospitalization. At the time of this report, the event of Diarrhoea had resolved, while the outcome of the remaining events remained unknown. The re-challenge is not applicable as the events occurred after the vaccination with the booster dose. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no medical history provided, who experienced serious unexpected event of Oedema peripheral (which required hospitalization) and non serious unexpected events of Diarrhoea and Urticaria. The event of Diarrhoea (reported as intermittent diarrhoea) occurred the day after the patient had received the mRNA-1273 vaccine (as third dose, booster). This event had resolved after 8 days. Nine days after this vaccination the patient developed Urticaria (reported as hives on body) and Oedema peripheral. Reportedly, since the swelling of the patient's hands continued to worsen, the patient was hospitalized 10 days after vaccination. The hospitalization had lasted for 7 days. The patient was treated with various antihistamines and prednisone, among other treatments (as stated). In addition, it was stated that the patient was on outpatient therapy after hospitalization. At the time of this report, the event of Diarrhoea had resolved, while the outcome of the remaining events remained unknown. The re-challenge is not applicable as the events occurred after the vaccination with the booster dose. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.