Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Breakthrough infection as Lack of drug effect; consumer had confirmed positive results of Covid-19/ Consumer reports having chills, fever, some cough, tiredness, loss of taste, consumer was feeling ill (not that ill); This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Breakthrough infection as Lack of drug effect) and COVID-19 (consumer had confirmed positive results of Covid-19/ Consumer reports having chills, fever, some cough, tiredness, loss of taste, consumer was feeling ill (not that ill)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced DRUG INEFFECTIVE (Breakthrough infection as Lack of drug effect) and COVID-19 (consumer had confirmed positive results of Covid-19/ Consumer reports having chills, fever, some cough, tiredness, loss of taste, consumer was feeling ill (not that ill)). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 06-Oct-2021, COVID-19 (consumer had confirmed positive results of Covid-19/ Consumer reports having chills, fever, some cough, tiredness, loss of taste, consumer was feeling ill (not that ill)) had resolved. At the time of the report, DRUG INEFFECTIVE (Breakthrough infection as Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 01-OCT-2021, Patient had tested COVID-19 positive and had symptoms associated with COVID such as chills, fever, cough, tiredness and loss of taste and symptoms lasted for 5 days. No concomitant medications were provided by the reporter. Company comment: This is a spontaneous case concerning a 77-year-old, female patient who experienced AESI of Covid-19. Drug Ineffective is also reported.  COVID-19 is not listed in company core data sheet for mRNA 1273 vaccine. The events occurred approximately 208 days after the second dose of mRNA 1273 vaccine. On 01-OCT-2021, Patient had tested COVID-19 positive and had symptoms associated with COVID such as chills, fever, cough, tiredness and loss of taste and symptoms lasted for 5 days. The rechallenge was not applicable.  Due to limited information on the further clarification of the events, circumstances leading to the events, immune status of the patient, concurrent diseases,  specific triggering factors, etiological and complete diagnostic work-up (full diagnostic laboratory panel, imaging studies of chest and clinical examination),The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 77-year-old, female patient who experienced AESI of Covid-19. Drug Ineffective is also reported.  COVID-19 is not listed in company core data sheet for mRNA 1273 vaccine. The events occurred approximately 208 days after the second dose of mRNA 1273 vaccine. On 01-OCT-2021, Patient had tested COVID-19 positive and had symptoms associated with COVID such as chills, fever, cough, tiredness and loss of taste and symptoms lasted for 5 days. The rechallenge was not applicable.  Due to limited information on the further clarification of the events, circumstances leading to the events, immune status of the patient, concurrent diseases,  specific triggering factors, etiological and complete diagnostic work-up (full diagnostic laboratory panel, imaging studies of chest and clinical examination),The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.