Reporte zur Charge 04j21n

Symptomtext

phlegm; lack of drug effect; Caught Covid after taking Both Moderna Vaccine/positive covid test; coughing; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 24-May-2021. The most recent information was received on 24-May-2021 and was forwarded to Moderna on an unknown date. This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Caught Covid after taking Both Moderna Vaccine/positive covid test), COUGH (coughing), PRODUCTIVE COUGH (phlegm) and DRUG INEFFECTIVE (lack of drug effect) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0421 and 029A21A) for COVID-19 vaccination. Concomitant products included MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) for Immunosuppressant drug therapy, LOSARTAN POTASSIUM (COZAAR), WARFARIN and FLECAINIDE for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced COUGH (coughing). On 22-May-2021, the patient experienced COVID-19 (Caught Covid after taking Both Moderna Vaccine/positive covid test) and DRUG INEFFECTIVE (lack of drug effect). On an unknown date, the patient experienced PRODUCTIVE COUGH (phlegm). On 22-May-2021, DRUG INEFFECTIVE (lack of drug effect) outcome was unknown. At the time of the report, COVID-19 (Caught Covid after taking Both Moderna Vaccine/positive covid test) outcome was unknown and COUGH (coughing) and PRODUCTIVE COUGH (phlegm) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2021, SARS-CoV-2 test: positive (Positive) Received positive results 22MAY2021. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient also takes other concomitant drugs for Thyroid, Cholesterol, allergy and water pills. Patient reported having conditions which cause immune suppressant. Patient just want to report catching COVID to Moderna so they can add it to their study. Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19 and mRNA-1273 use is assessed as not applicable. The other events are in consistence with COVID_19. The event of drug ineffective remains as possible. Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Upon internal review on 15 Jul 2021, an event (lack of efficacy) was added at Moderna's request. On 23-Jun-2021: The follow up Source document received on 23-JUN-2021 contains No New Information.; Sender's Comments: Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19 and mRNA-1273 use is assessed as not applicable. The other events are in consistence with COVID_19. The event of drug ineffective remains as possible.