Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I took another rapid antigen test where I was positive/ I started the antiviral medication on Saturday, May 7. By day 3, I was feeling much better. By Wednesday or Thursday my symptoms were gone/ I started getting cold symptoms (stuffed up badly); Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I took another rapid antigen test where I was positive/ I started the antiviral medication on Saturday, May 7. By day 3, I was feeling much better. By Wednesday or Thursday my symptoms were gone/ I started getting cold symptoms (stuffed up badly)) and DRUG INEFFECTIVE (Lack of drug effect) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 031M20H and 030L20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Food allergy (Garlic) and Latex allergy (Latex). Concomitant products included ROSUVASTATIN, LEVOTHYROXINE and FAMOTIDINE for an unknown indication.   On 29-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021 at 12:00 PM, 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 07-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 16-May-2022, the patient experienced COVID-19 (I took another rapid antigen test where I was positive/ I started the antiviral medication on Saturday, May 7. By day 3, I was feeling much better. By Wednesday or Thursday my symptoms were gone/ I started getting cold symptoms (stuffed up badly)) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (I took another rapid antigen test where I was positive/ I started the antiviral medication on Saturday, May 7. By day 3, I was feeling much better. By Wednesday or Thursday my symptoms were gone/ I started getting cold symptoms (stuffed up badly)) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 16-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.   Rosuvastatin was stopped while taking paxlovid.  Patient started antiviral medication on 07 May 2022. By day 3, patient was feeling much better. By Wednesday or Thursday symptoms were gone. On 13 May 2022, patient tested negative with a rapid antigen test. On 15 May 2022, patient started getting cold like symptoms (stuffed up badly). It was worse on 16 May 2022, and patient took another rapid antigen test which was positive. On 18 May 2022, patient was still experiencing cold-like symptoms.  Company Comment: This spontaneous case pertaining to Drug ineffective, concerns a 70-year-old female patient, with co-suspect product Paxlovid, who experienced the unexpected AESI of COVID-19. The event occurred approximately 7 months after completing the primary and booster doses of mRNA-1273 Vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19. However, the patient developed Nasopharyngitis and had a positive SARS-CoV-2 antigen test 8 days after completing Paxlovid treatment. The outcome of the event was reported as unknown. The patient's medical history of Paxlovid treatment remain as a confounder for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case pertaining to Drug ineffective, concerns a 70-year-old female patient, with co-suspect product Paxlovid, who experienced the unexpected AESI of COVID-19. The event occurred approximately 7 months after completing the primary and booster doses of mRNA-1273 Vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19. However, the patient developed Nasopharyngitis and had a positive SARS-CoV-2 antigen test 8 days after completing Paxlovid treatment. The outcome of the event was reported as unknown. The patient's medical history of Paxlovid treatment remain as a confounder for the occurrence of the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.