Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngitis, Oropharyngeal pain, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: cold; Felt tired on May 15 and tested; tested positive; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive), COVID-19 (Felt tired on May 15 and tested), NASOPHARYNGITIS (cold) and OROPHARYNGEAL PAIN (sore throat) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 028L20A, 032L20A and 012F21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer since 2015, Raynaud's syndrome and Drug allergy (Name of drug is not reported).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022 at 1:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (tested positive). On 15-May-2022 at 11:00 AM, the patient experienced COVID-19 (Felt tired on May 15 and tested). On an unknown date, the patient experienced NASOPHARYNGITIS (cold) and OROPHARYNGEAL PAIN (sore throat). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 09-May-2022 to 13-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 13-May-2022, SARS-COV-2 TEST POSITIVE (tested positive) had resolved. At the time of the report, COVID-19 (Felt tired on May 15 and tested) had not resolved, NASOPHARYNGITIS (cold) outcome was unknown and OROPHARYNGEAL PAIN (sore throat) had resolved. had mild cold symptoms except for a bad sore throat for 2 days.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 13-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 15-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient reported that I tested positive on May 8 and began Paxlovid on May 9. Tolerated it well, had mild cold symptoms except for a bad sore throat for 2 days. Felt better and tested negative on May 13. Felt tired on May 15 and tested positive.  Company comment: This spontaneous case concerns a 76-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI, SARS-CoV-2 test positive, 39 days after receiving mRNA-1273 vaccine as 4th dose. The patient experienced symptoms of cold and sore throat and was tested positive for SARS-CoV-2. She was treated with Paxlovid (Nirmatrelvir and ritonavir). The test was repeated and was found to be negative. A week later, the patient felt weak, and test was repeated  it was positive. The outcome of first event was reported resolved and second one not resolved. Details of Elderly age of the patient could be a risk factor. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 76-year-old female patient with no relevant medical history, who experienced the unexpected non-serious AESI, SARS-CoV-2 test positive, 39 days after receiving mRNA-1273 vaccine as 4th dose. The patient experienced symptoms of cold and sore throat and was tested positive for SARS-CoV-2. She was treated with Paxlovid (Nirmatrelvir and ritonavir). The test was repeated and was found to be negative. A week later, the patient felt weak, and test was repeated  it was positive. The outcome of first event was reported resolved and second one not resolved. Details of Elderly age of the patient could be a risk factor. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.