Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound of positive test and new symptoms - congestion, watery eyes, runny nose; Lack of efficacy; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound of positive test and new symptoms - congestion, watery eyes, runny nose) and DRUG INEFFECTIVE (Lack of efficacy) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A, 018821A and 037FZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergy to Medications with red dye).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced COVID-19 (Rebound of positive test and new symptoms - congestion, watery eyes, runny nose) and DRUG INEFFECTIVE (Lack of efficacy). The patient was treated with PARACETAMOL (TYLENOL) from 08-May-2022 to 11-May-2022 at an unspecified dose and frequency; GUAIFENESIN (MUCINEX) from 09-May-2022 to 12-May-2022 for COVID-19 treatment, at an unspecified dose and frequency and NIRMATRELVIR, RITONAVIR (PAXLOVID) from 09-May-2022 to 13-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound of positive test and new symptoms - congestion, watery eyes, runny nose) had not resolved and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient's date of birth was reported as Oct-1978.  It was reported that patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  The device date was reported as 19-May-2022.  Treatment medications also included antihistamines and nasal spray. The patient received previously COVID-19 vaccine.  Company Comment: This spontaneous case concerns a 43-year-old, female patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test), which occurred 6 months after receiving the third dose of mRNA-1273 vaccine. Drug ineffective was also considered as COVID-19 occurred six months post-completion of primary vaccination of mRNA-1273 with first two doses taken within the recommended dosing interval. Patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) for six days for COVID-19.  She re-tested positive for COVID-19 after recovery and reported new onset of nasal congestion, rhinorrhea, and watery eyes. She was treated with Paracetamol, Guaifenesin, antihistamine, and unspecified nasal spray. At the time of reporting, the event has not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 43-year-old, female patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test), which occurred 6 months after receiving the third dose of mRNA-1273 vaccine. Drug ineffective was also considered as COVID-19 occurred six months post-completion of primary vaccination of mRNA-1273 with first two doses taken within the recommended dosing interval. Patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) for six days for COVID-19.  She re-tested positive for COVID-19 after recovery and reported new onset of nasal congestion, rhinorrhea, and watery eyes. She was treated with Paracetamol, Guaifenesin, antihistamine, and unspecified nasal spray. At the time of reporting, the event has not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.