Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID 19) and DRUG INEFFECTIVE (Lack of drug effect) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 1822811, 001B21A and 041220A) for COVID-19 vaccination.     Concurrent medical conditions included Topical adhesive allergy (topical adhesives allergy) and Drug allergy (iodine/betadine allergy). Concomitant products included CALCIUM CITRATE (CITRACAL [CALCIUM CITRATE]) from 30-Apr-2020 to an unknown date, COLECALCIFEROL (VITAMIN D3) from 30-Apr-2020 to an unknown date, CENTRUM SILVER +50 from 30-Apr-2022 to an unknown date, PARACETAMOL (TYLENOL EXTRA STRENGTH) from 03-May-2022 to 07-May-2022, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PARACETAMOL (COLD AND FLU RELIEF NIGHTTIME ORIGINAL) from 03-May-2022 to 08-May-2022 and LORATADINE, PSEUDOEPHEDRINE SULFATE (ALLERCLEAR D) from 20-Jan-2020 to 01-May-2022 for an unknown indication.   On 09-Feb-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022 at 4:45 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID 19) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 09-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID 19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2022, SARS-CoV-2 test: positive (Positive) positive.         The patient's concomitant medication reported included: Tylenol extra 500 mg, (acetaminophen) batch no. 5AA026, start date was 03-May-2022 and date of last administration-07-May-2022 and cold and flu day-time and nighttime, (cough syrup) batch no. 2CK0959, start date - 03-May-2022 and date of last administration- 08-May-2022.  It was reported that the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.   On 14-May-2022 at 16:30, the patient experienced relapse of COVID 19 with symptoms headache, chills, cough, congestion, fatigue.  The device date reported as 14-May-2022.  Company Comment: This spontaneous case of Drug Ineffective concerns a 68-year-old female patient, with a no relevant medical history, who experienced the unexpected AESI of COVID-19. The event occurred on an unknown date after receiving primary and booster doses of mRNA-1273 Vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19. The patient however, experienced relapse of COVID 19 with symptoms headache, chills, cough, congestion, fatigue and tested positive for SARS-CoV-2, 5 days after completing Paxlovid treatment. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case of Drug Ineffective concerns a 68-year-old female patient, with a no relevant medical history, who experienced the unexpected AESI of COVID-19. The event occurred on an unknown date after receiving primary and booster doses of mRNA-1273 Vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19. The patient however, experienced relapse of COVID 19 with symptoms headache, chills, cough, congestion, fatigue and tested positive for SARS-CoV-2, 5 days after completing Paxlovid treatment. The outcome of the event was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.