Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dysgeusia, Insomnia, Taste disorder
Clinical narrative: Initial COVID-19 infection prior to COVID-19 treatment; Insomnia (Energy increased); metallic taste; impaired taste; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment), INSOMNIA (Insomnia (Energy increased)), DYSGEUSIA (metallic taste) and TASTE DISORDER (impaired taste) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, RA and Allergy (no drug reported). Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) and ESCITALOPRAM for an unknown indication.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2022 at 8:30 PM, the patient experienced INSOMNIA (Insomnia (Energy increased)), DYSGEUSIA (metallic taste) and TASTE DISORDER (impaired taste). On an unknown date, the patient experienced COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 02-Jun-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment) outcome was unknown and INSOMNIA (Insomnia (Energy increased)), DYSGEUSIA (metallic taste) and TASTE DISORDER (impaired taste) had resolved.            The patient received other medications/products within 2 weeks of starting COVID-19 treatment.  The onset time of Moderna COVID-19 vaccine was 04:00 PM.  The stop date of concomitant medications was Jun-2022.  The stop date for the events insomnia (insomnia), dysgeusia (metallic taste), taste disorder (impaired taste) were reported as Jun-2022  Company Comment: This spontaneous case concerns a 29 year-old female patient, with a relevant medical history of asthma, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, and the non-serious events Insomnia, Taste disorder and Ageusia. The event COVID-19 occurred unknown days after the third dose of mRNA-1273 vaccine administration while the non-serious events Insomnia, Taste disorder and Ageusia occurred on the same day after starting the COVID-19 treatment Paxlovid. The ongoing COVID-19 pandemic and underlying history of asthma could be confounders for the event COVID-19. The date of the initial COVID-19 diagnosis and Sars-CoV-2 test result were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 29 year-old female patient, with a relevant medical history of asthma, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, and the non-serious events Insomnia, Taste disorder and Ageusia. The event COVID-19 occurred unknown days after the third dose of mRNA-1273 vaccine administration while the non-serious events Insomnia, Taste disorder and Ageusia occurred on the same day after starting the COVID-19 treatment Paxlovid. The ongoing COVID-19 pandemic and underlying history of asthma could be confounders for the event COVID-19. The date of the initial COVID-19 diagnosis and Sars-CoV-2 test result were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.