Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rnning temperature below normal 95-97F.; she tested positive for COVID-19 on 20Nov2021; drug ineffective; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE DECREASED (Rnning temperature below normal 95-97F.), COVID-19 (she tested positive for COVID-19 on 20Nov2021) and DRUG INEFFECTIVE (drug ineffective) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-2021, the patient experienced BODY TEMPERATURE DECREASED (Rnning temperature below normal 95-97F.) and COVID-19 (she tested positive for COVID-19 on 20Nov2021). 20-Nov-2021, the patient experienced DRUG INEFFECTIVE (drug ineffective). On 20-Nov-2021, DRUG INEFFECTIVE (drug ineffective) had resolved. At the time of the report, BODY TEMPERATURE DECREASED (Rnning temperature below normal 95-97F.) and COVID-19 (she tested positive for COVID-19 on 20Nov2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, Body temperature: 95-97 f (Low) running temperature below normal 95-97F.. On 20-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  Company Comment: This spontaneous case concerns a 75-year-old female patient, with unknown medical history, who experienced the non-serious unexpected AESI of COVID-19. Drug ineffective was also captured as an event. Event of COVID-19 occurred approximately 12 days after receiving a booster dose of mRNA-1273. This was the third dose administered of mRNA-1273. The first two doses were administered in an appropriate schedule of vaccination, approximately 9 months and 12 days prior to the occurrence of the reported event. Patient has experienced cough, headache, and rhinorrhea. It is not mentioned if the patient received treatment. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-266851 (Patient Link).; Sender's Comments: This spontaneous case concerns a 75-year-old female patient, with unknown medical history, who experienced the non-serious unexpected AESI of COVID-19. Drug ineffective was also captured as an event. Event of COVID-19 occurred approximately 12 days after receiving a booster dose of mRNA-1273. This was the third dose administered of mRNA-1273. The first two doses were administered in an appropriate schedule of vaccination, approximately 9 months and 12 days prior to the occurrence of the reported event. Patient has experienced cough, headache, and rhinorrhea. It is not mentioned if the patient received treatment. The benefit-risk relationship of mRNA-1273 is not affected by this report.