Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Haemorrhage, Hyperhidrosis
Clinical narrative: Experienced more bleeding than usual.; 2nd dose of vaccine was administered 21 days after first dose; Excessive sweat; Sneezing; Runny nose; Back pain around the kidney area; Joint pain; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Experienced more bleeding than usual.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003RB1A and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hemorrhage. Concurrent medical conditions included Anemia.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced HAEMORRHAGE (Experienced more bleeding than usual.) (seriousness criterion medically significant), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of vaccine was administered 21 days after first dose), HYPERHIDROSIS (Excessive sweat), SNEEZING (Sneezing), RHINORRHOEA (Runny nose), BACK PAIN (Back pain around the kidney area), ARTHRALGIA (Joint pain) and FATIGUE (Extreme fatigue). The patient was treated with NORETHINDRONE ACETATE for Hemorrhage, at an unspecified dose and frequency; CARVEDILOL at an unspecified dose and frequency; SPIRONOLACTONE at an unspecified dose and frequency and ERGOCALCIFEROL at an unspecified dose and frequency. On 05-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of vaccine was administered 21 days after first dose) had resolved. At the time of the report, HAEMORRHAGE (Experienced more bleeding than usual.), HYPERHIDROSIS (Excessive sweat), SNEEZING (Sneezing), RHINORRHOEA (Runny nose), BACK PAIN (Back pain around the kidney area), ARTHRALGIA (Joint pain) and FATIGUE (Extreme fatigue) outcome was unknown.            There was no concomitant medication reported. Patient was treated with zitrone C  for unknown indication.  Very limited information regarding this event (hemorrhage) 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 the all other events, a causal relationship cannot be excluded.  This report also refers to a case of (Inappropriate schedule of product administration) for mRNA-1273, lot # 003RB1A with no associated AEs. Details regarding the type of hemorrhage is required for further assessment.; Sender's Comments: Very limited information regarding this event (hemorrhage) 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 the all other events, a causal relationship cannot be excluded.  This report also refers to a case of (Inappropriate schedule of product administration) for mRNA-1273, lot # 003RB1A with no associated AEs. Details regarding the type of hemorrhage is required for further assessment.