Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dysgeusia, Pollakiuria
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of DYSGEUSIA (Extremely bitter (not metallic!) taste in mouth, lingers throughout the day and varies in intensity), POLLAKIURIA (Increased urination), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of effect) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. Concurrent medical conditions included Drug allergy. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 10-May-2022, the patient experienced DYSGEUSIA (Extremely bitter (not metallic!) taste in mouth, lingers throughout the day and varies in intensity). On an unknown date, the patient experienced POLLAKIURIA (Increased urination), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of effect). At the time of the report, DYSGEUSIA (Extremely bitter (not metallic!) taste in mouth, lingers throughout the day and varies in intensity) had not resolved and POLLAKIURIA (Increased urination), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of effect) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. Company Comment: This spontaneous case of Lack of effect, concerns a 43-year-old female patient, with concurrent use of co-suspect product Paxlovid, who experienced the unexpected AESI of COVID-19, and the unexpected events of Dysgeusia and Pollakiuria. The event Dysgeusia occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine (Primary doses - mRNA-1273) while COVID-19 and Pollakiuria occurred on an unknown date. The patient had Dysgeusia on the same day of taking Paxlovid as treatment for COVID-19. The outcome of the events was reported as unknown. The patient's medical history of Paxlovid use, remain as a confounder for the occurrence of the events Dysgeusia and Pollakiuria. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This spontaneous case of Lack of effect, concerns a 43-year-old female patient, with concurrent use of co-suspect product Paxlovid, who experienced the unexpected AESI of COVID-19, and the unexpected events of Dysgeusia and Pollakiuria. The event Dysgeusia occurred approximately 6 months after receiving the third dose of mRNA-1273 Vaccine (Primary doses - mRNA-1273) while COVID-19 and Pollakiuria occurred on an unknown date. The patient had Dysgeusia on the same day of taking Paxlovid as treatment for COVID-19. The outcome of the events was reported as unknown. The patient's medical history of Paxlovid use, remain as a confounder for the occurrence of the events Dysgeusia and Pollakiuria. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.