Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Body mass index, COVID-19, Constipation, Diarrhoea, SARS-CoV-2 test
Clinical narrative: Bad taste in my mouth for hours after each dose; constipation; Diarrhea; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of TASTE DISORDER (Bad taste in my mouth for hours after each dose), CONSTIPATION (constipation), COVID-19 (COVID-19) and DIARRHOEA (Diarrhea) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Asthma and Allergy. Concomitant products included ALBUTEROL [SALBUTAMOL] and BECLOMETASONE DIPROPIONATE (QVAR REDIHALER) for an unknown indication.   On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 10-May-2022 at 5:00 PM, the patient experienced TASTE DISORDER (Bad taste in my mouth for hours after each dose), CONSTIPATION (constipation) and DIARRHOEA (Diarrhea). In May 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, TASTE DISORDER (Bad taste in my mouth for hours after each dose), CONSTIPATION (constipation) and DIARRHOEA (Diarrhea) was resolving and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 20-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 23-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Body mass index: >30 (abnormal) >30.         It was reported that patient was antigen tested negative 8 days after onset of symptoms, but then symptoms worsened again and tested positive again on day 11. Patient on day 14 now and was still strongly testing positive. Device date was reported as 23-May-2022  Treatment medications were not reported.  Company comment: This spontaneous case concerns a 39 year old male patient, with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, unknown days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient took Paxlovid for COVID-19 for 5 days. He tested SARS-CoV-2 antigen negative 8 days after the onset of symptoms. However, symptoms worsened again and he tested SARS-CoV-2 antigen positive on day 11. The event was resolving. No further details on the previous doses of vaccination were available in the report. The ongoing COVID-19 pandemic could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 39 year old male patient, with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, unknown days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient took Paxlovid for COVID-19 for 5 days. He tested SARS-CoV-2 antigen negative 8 days after the onset of symptoms. However, symptoms worsened again and he tested SARS-CoV-2 antigen positive on day 11. The event was resolving. No further details on the previous doses of vaccination were available in the report. The ongoing COVID-19 pandemic could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.