Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Dysgeusia, Maternal exposure before pregnancy
Clinical narrative: COVID-19; Metallic taste in mouth; Diarrhea; Maternal exposure before pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in mouth), DIARRHOEA (Diarrhea), COVID-19 (COVID-19) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient is pregnant. Last menstrual period was on 23-Jan-2022 and the estimated date of delivery is 28-Oct-2022.  Concomitant products included ZINC and PARACETAMOL (TYLENOL) from 01-May-2022 to 03-May-2022 for an unknown indication, PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]).    On 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-Oct-2022. On 13-Dec-2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy). On 04-May-2022, the patient experienced DYSGEUSIA (Metallic taste in mouth) and DIARRHOEA (Diarrhea). On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 03-May-2022 to 08-May-2022 for COVID-19, at an unspecified dose and frequency. On 13-Dec-2021, MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) had resolved. At the time of the report, DYSGEUSIA (Metallic taste in mouth) and DIARRHOEA (Diarrhea) had not resolved and COVID-19 (COVID-19) outcome was unknown.            Other concomitant medication included Robitussin and Pedialyte. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Company comment: This is a spontaneous case reported by a consumer. A 33-year-old female patient experienced non serious events of dysgeusia, diarrhea and COVID-19 (AESI) after receiving mRNA-1273 vaccine, reported as the third dose of the COVID-19 vaccination schedule. Onset latency for dysgeusia and diarrhea was approximately 4 months and these events occurred after starting treatment with Paxlovid for COVID-19 infection, for which onset date was not provided. Additionally, patient got pregnant approximately 1,5 months after vaccination; last menstrual period was on 23-Jan-2022 and the estimated date of delivery is 28-Oct-2022. Paxlovid remains a confounding factor as patient developed metallic taste in mouth 2 hours after each dose and diarrhea 1.5 days after starting treatment. Concomitant product Sudafed (pseudoephedrine) could be a contributory factor for dysgeusia. Also, diarrhea and dysgeusia could be associated with the underlying COVID-19 infection. No further details regarding medical history, course of pregnancy or previous vaccine doses were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A 33-year-old female patient experienced non serious events of dysgeusia, diarrhea and COVID-19 (AESI) after receiving mRNA-1273 vaccine, reported as the third dose of the COVID-19 vaccination schedule. Onset latency for dysgeusia and diarrhea was approximately 4 months and these events occurred after starting treatment with Paxlovid for COVID-19 infection, for which onset date was not provided. Additionally, patient got pregnant approximately 1.5 months after vaccination; last menstrual period was on 23-Jan-2022 and the estimated date of delivery is 28-Oct-2022. Paxlovid remains a confounding factor as patient developed metallic taste in mouth 2 hours after each dose and diarrhea 1.5 days after starting treatment. Concomitant product Sudafed (pseudoephedrine) could be a contributory factor for dysgeusia. Also, diarrhea and dysgeusia could be associated with the underlying COVID-19 infection. No further details regarding medical history, course of pregnancy or previous vaccine doses were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.