Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Coughing, 6 months after the 1st booster; Runny Nose, 6 months after the 1st booster; Not Feeling Well, 6 months after the 1st booster; COVID Disease Symptoms, 6 months after the 1st booster/ Positive Home Rapid COVID-19 Test, 6 months after the 1st booster/ She is still COVID Positive and she has symptoms; Lack of drug effect; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (Coughing, 6 months after the 1st booster), RHINORRHOEA (Runny Nose, 6 months after the 1st booster), MALAISE (Not Feeling Well, 6 months after the 1st booster), COVID-19 (COVID Disease Symptoms, 6 months after the 1st booster/ Positive Home Rapid COVID-19 Test, 6 months after the 1st booster/ She is still COVID Positive and she has symptoms) and DRUG INEFFECTIVE (Lack of drug effect) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 029L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2022, the patient experienced COUGH (Coughing, 6 months after the 1st booster), RHINORRHOEA (Runny Nose, 6 months after the 1st booster), MALAISE (Not Feeling Well, 6 months after the 1st booster) and COVID-19 (COVID Disease Symptoms, 6 months after the 1st booster/ Positive Home Rapid COVID-19 Test, 6 months after the 1st booster/ She is still COVID Positive and she has symptoms). 10-May-2022, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COUGH (Coughing, 6 months after the 1st booster), RHINORRHOEA (Runny Nose, 6 months after the 1st booster), MALAISE (Not Feeling Well, 6 months after the 1st booster) and COVID-19 (COVID Disease Symptoms, 6 months after the 1st booster/ Positive Home Rapid COVID-19 Test, 6 months after the 1st booster/ She is still COVID Positive and she has symptoms) had not resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2022, SARS-CoV-2 test: negative (Negative) Her first home rapid test was Negative in the morning. and positive (Positive) second Home Rapid Test of a different brand and she received a Positive Rapid Test..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that reporter was pharmacy technician. Company comment: This spontaneous case concerns a 65-year-old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 that occurred 194 days after receiving the third dose of mRNA-1273 Vaccine. Additionally, Drug ineffective was also reported. The initial two doses were given 9 months prior, the interval between the first and second doses of mRNA was noted to be 28 days. It has been reported that the patient experienced COVID-19 symptoms on May 10, 2022, rapid test was done which revealed a positive result. She experienced coughing, malaise and runny nose, sought online consult and was prescribed with Paxlovid. Details of concomitant medications, medical history, clinical course and outcome were not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-568298, MOD-2022-568296, MOD-2021-024069, MOD-2021-024069 (Patient Link).; Sender's Comments: This spontaneous case concerns a 65-year-old female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19 that occurred 194 days after receiving the third dose of mRNA-1273 Vaccine. Additionally, Drug ineffective was also reported. The initial two doses were given 9 months prior, the interval between the first and second doses of mRNA was noted to be 28 days. It has been reported that the patient experienced COVID-19 symptoms on May 10, 2022, rapid test was done which revealed a positive result. She experienced coughing, malaise and runny nose, sought online consult and was prescribed with Paxlovid. Details of concomitant medications, medical history, clinical course and outcome were not provided. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.