Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Blood test, Inappropriate schedule of product administration
Clinical narrative: Believed between August 2021 and November 2021 he had COVID however, he had no symptoms of COVID; Inappropriate schedule of vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of ASYMPTOMATIC COVID-19 (Believed between August 2021 and November 2021 he had COVID however, he had no symptoms of COVID) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced ASYMPTOMATIC COVID-19 (Believed between August 2021 and November 2021 he had COVID however, he had no symptoms of COVID). On 02-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, ASYMPTOMATIC COVID-19 (Believed between August 2021 and November 2021 he had COVID however, he had no symptoms of COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, Blood test: abnormal (abnormal) End Protein - Antibody was 0, Spike protein was 718. On 23-Nov-2021, Blood test: high (High) End Protein - Antibody was 20.1, Spike protein gone up to greater than 2500..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Patient was registered in the Study, done a lab regarding spike protein. They tested for two things: COVID Virus and the Spike protein. A Study representative told him that they believed between August 2021 and November 2021 he and his wife had COVID however, consumer stated neither he or his wife had symptoms of COVID.     Company comment: This spontaneous case concerns a 83-year-old female patient with no medical history reported, who experienced the unexpected non serious event of Asymptomatic COVID-19 after mRNA- 1273 vaccine. The event occurred approximately 6 months after the second dose of mRNA- 1273 vaccine. Schedule of vaccination was inappropriate (window between doses 38 days). The patient experienced COVID-19 seroconversion for N-protein antibodies, thus asymptomatic COVID-19 was suspected. Patient´s age is a risk factor for severe disease, however, the disease was asymptomatic. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 83-year-old female patient with no medical history reported, who experienced the unexpected non serious event of Asymptomatic COVID-19 after mRNA- 1273 vaccine. The event occurred approximately 6 months after the second dose of mRNA- 1273 vaccine. Schedule of vaccination was inappropriate (window between doses 38 days). The patient experienced COVID-19 seroconversion for N-protein antibodies, thus asymptomatic COVID-19 was suspected. Patient´s age is a risk factor for severe disease, however, the disease was asymptomatic. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.