Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Mechanical urticaria, Urticaria
Clinical narrative: dermatographia; tested positive for Covid after complete vaccination; tested positive for Covid after complete vaccination; hives; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (tested positive for Covid after complete vaccination), URTICARIA (hives), MECHANICAL URTICARIA (dermatographia) and COVID-19 (tested positive for Covid after complete vaccination) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 011L20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives). On 08-Feb-2022, the patient experienced DRUG INEFFECTIVE (tested positive for Covid after complete vaccination) and COVID-19 (tested positive for Covid after complete vaccination). On an unknown date, the patient experienced MECHANICAL URTICARIA (dermatographia). The patient was treated with CETIRIZINE at a dose of 10 milligram once a day and PREDNISONE on 28-Nov-2021 at a dose of 40Mg for 5 days. At the time of the report, DRUG INEFFECTIVE (tested positive for Covid after complete vaccination) and COVID-19 (tested positive for Covid after complete vaccination) outcome was unknown and URTICARIA (hives) and MECHANICAL URTICARIA (dermatographia) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2022, COVID-19: positive (Positive) positive.         No concomitant medication were provided Patient visited Urgent care on 28-Nov-21.  Company comment: This regulatory authority case concerns a 33 year old female who experienced the non-serious, unexpected event of drug ineffective (AESI) and COVID-19 positive 85 days after, and non-serious unexpected events of urticaria and mechanical urticaria 10 days after the third dose of mRNA-1273. Treatment was with prednisone and antihistamines and testing was positive for COVID-19 and the event is reported as ongoing. The history of multiple allergies to medications and foods is a confounder as it would predispose the patient to the events of urticaria. The risk-benefit relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This regulatory authority case concerns a 33 year old female who experienced the non-serious, unexpected event of drug ineffective (AESI) and COVID-19 positive 85 days after, and non-serious unexpected events of urticaria and mechanical urticaria 10 days after the third dose of mRNA-1273. Treatment was with prednisone and antihistamines and testing was positive for COVID-19 and the event is reported as ongoing. The history of multiple allergies to medications and foods is a confounder as it would predispose the patient to the events of urticaria. The risk-benefit relationship of mRNA-1273 vaccine is not affected by this report.