Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Off label use, Pruritus, Urticaria
Clinical narrative: bleeding; started having hives/has had hives since 19September2021/it's been over 2 weeks, and it is generalized/all over the body/are very intense hives/it comes and goes/urticaria/hives (urticaria) all over her body; itching; received the 3rd Moderna shot booster and is not immunocompromised; This spontaneous case was reported by an other health care professional and describes the occurrence of HAEMORRHAGE (bleeding) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K80A, 028L20A and 039K80A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced OFF LABEL USE (received the 3rd Moderna shot booster and is not immunocompromised). On 19-Sep-2021, the patient experienced HAEMORRHAGE (bleeding) (seriousness criterion medically significant), URTICARIA (started having hives/has had hives since 19September2021/it's been over 2 weeks, and it is generalized/all over the body/are very intense hives/it comes and goes/urticaria/hives (urticaria) all over her body) and PRURITUS (itching). On 09-Sep-2021, OFF LABEL USE (received the 3rd Moderna shot booster and is not immunocompromised) had resolved. At the time of the report, HAEMORRHAGE (bleeding), URTICARIA (started having hives/has had hives since 19September2021/it's been over 2 weeks, and it is generalized/all over the body/are very intense hives/it comes and goes/urticaria/hives (urticaria) all over her body) and PRURITUS (itching) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medications included unspecified topical corticosteroids and unspecified antihistamines.  Company comment: This is a case of Off label use of vaccine for this 47-year-old, female patient with no relevant medical history, who experienced the unexpected events of Haemorrhage, Urticaria, and Pruritus. The events occurred approximately 10 days after the third dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the second dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. The case is assessed as serious as Haemorrhage is an IME and the Urticaria and Pruritus remain unresolved.   Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow-up received on 04-Oct-2021, contains additional events bleeding, itching and case upgraded to serious.; Sender's Comments: This is a case of Off label use of vaccine for this 47-year-old, female patient with no relevant medical history, who experienced the unexpected events of Haemorrhage, Urticaria, and Pruritus. The events occurred approximately 10 days after the third dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the second dose was disclosed. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. The case is assessed as serious as Haemorrhage is an IME and the Urticaria and Pruritus remain unresolved.