Reporte zur Charge 1015M20A

Symptomtext

cough; phlegm; don't have the energy as before; Lack of drug effect; sick/pretty sick; Tested positive for covid; Didn't feel well at all; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (cough), ILLNESS (sick/pretty sick), COVID-19 (Tested positive for covid), MALAISE (Didn't feel well at all) and PRODUCTIVE COUGH (phlegm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 1015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced ILLNESS (sick/pretty sick), COVID-19 (Tested positive for covid), MALAISE (Didn't feel well at all) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced COUGH (cough), PRODUCTIVE COUGH (phlegm) and ASTHENIA (don't have the energy as before). On 02-Sep-2021, DRUG INEFFECTIVE (Lack of drug effect) had resolved. At the time of the report, COUGH (cough) had not resolved and ILLNESS (sick/pretty sick), COVID-19 (Tested positive for covid), MALAISE (Didn't feel well at all), PRODUCTIVE COUGH (phlegm) and ASTHENIA (don't have the energy as before) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Her daughter took her to urgent care and they decided she needed the infusion to keep her out of the hospital. She still has a cough and is slowly getting her energy back. On the 3-SEP infusion treatment was given. No concomitant product information was provided. No treatment information was provided. Company comment This case concerns an 84-year-old female patient, with no reported medical history, who experienced the unexpected non-serious event of COVID-19 (AESI). The events occurred approximately 6 months after the administration of the second dose of mRNA-1273 vaccine. Drug ineffective was considered as an additional event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 30-Dec-2021: Follow up received contains significant information new event added.; Sender's Comments: This case concerns an 84-year-old female patient, with no reported medical history, who experienced the unexpected non-serious event of COVID-19 (AESI). The events occurred approximately 6 months after the administration of the second dose of mRNA-1273 vaccine. Drug ineffective was considered as an additional event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.