Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Sinus congestion, Sneezing
Clinical narrative: worsened sinus congestion; sneezing; Drug ineffective; Treatment of COVID-19 / positive PCR test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Treatment of COVID-19 / positive PCR test), SINUS CONGESTION (worsened sinus congestion), SNEEZING (sneezing) and DRUG INEFFECTIVE (Drug ineffective) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 010M20A and 013L20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Obesity. Previously administered products included for Product used for unknown indication: PENICILLIN [PENICILLIN NOS], Wellbutrin and Keflex/cephalosporins. Past adverse reactions to the above products included Allergy with Keflex/cephalosporins, PENICILLIN [PENICILLIN NOS] and Wellbutrin. Concurrent medical conditions included Asthma, Migraine, Polycystic ovarian syndrome and Seasonal affective disorder. Concomitant products included MONTELUKAST, FLUOXETINE HYDROCHLORIDE (PROZAC), SPIRONOLACTONE, ROSUVASTATIN CALCIUM (CRESTOR), MULTIVITAMIN [VITAMINS NOS], ZINC and BIOTIN for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 06-May-2022, the patient experienced COVID-19 (Treatment of COVID-19 / positive PCR test) and DRUG INEFFECTIVE (Drug ineffective). On an unknown date, the patient experienced SINUS CONGESTION (worsened sinus congestion) and SNEEZING (sneezing). At the time of the report, COVID-19 (Treatment of COVID-19 / positive PCR test) and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown, SINUS CONGESTION (worsened sinus congestion) was resolving and SNEEZING (sneezing) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2022, SARS-CoV-2 test: positive (Positive) positive. On 12-May-2022, SARS-CoV-2 test: negative (Negative) Negative with Binax Nowhome test. On 16-May-2022, SARS-CoV-2 test: positive (Positive) Positive with Binax Nowhome test. On 19-May-2022, SARS-CoV-2 test: positive (Positive) positive with iHealth test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Fatigue continued over the week.  On 15-May-2022, she developed sinus congestion that worsened and then had strong sneezing  Company Comment: This is a spontaneous case concerning a 60-year-old female patient with no medical history, who experienced the unexpected non-serious events of Drug Ineffective, and adverse event of special interest, COVID-19 which occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine which had an interval of 9 months from the second dose of mRNA-1273. As reported, the patient took Paxlovid from May 6-10, 2022, after a positive PCR test on May 6. Initial symptoms were asthma, chest tightening, fever, headache, fatigue, and then an occasional productive cough. Fatigue continued over the week and had a negative self-administered test on 12-May-2022. On 15-May-2022 the patient developed sinus congestion that worsened and then had strong sneezing. The next day, patient retested and was positive. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 60-year-old female patient with no medical history, who experienced the unexpected non-serious events of Drug Ineffective, and adverse event of special interest, COVID-19 which occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine which had an interval of 9 months from the second dose of mRNA-1273. As reported, the patient took Paxlovid from May 6-10, 2022, after a positive PCR test on May 6. Initial symptoms were asthma, chest tightening, fever, headache, fatigue, and then an occasional productive cough. Fatigue continued over the week and had a negative self-administered test on 12-May-2022. On 15-May-2022 the patient developed sinus congestion that worsened and then had strong sneezing. The next day, patient retested and was positive. No other clinical or treatment details were given. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.