Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.  Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (left arm, dose 1) on 24-Feb-2021, PFIZER BIONTECH COVID-19 VACCINE (right arm, dose 2) on 17-Mar-2021, Pfizer / BioNTech (right arm and dose 3) on 19-Oct-2021. Past adverse reactions to the above products included No adverse reaction with PFIZER BIONTECH COVID-19 VACCINE, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Drug allergy (unspecified drug). Concomitant products included VITAMIN B COMPLEX from 01-May-2022 to 22-May-2022 and CIPROFLOXACIN (LYCINE) from 27-May-2022 to 29-May-2022 for an unknown indication.  On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 30-May-2022 to 02-Jun-2022 for COVID-19 treatment, at a dose of 1 dosage form. At the time of the report, COVID-19 (COVID-19) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The patient received unspecified medications/products within 2 weeks of starting COVID-19 treatment. On 31-May-2022, the patient experienced diarrhea, nauseous, metallic taste on tongue and mouth, dizzy which were ongoing at the time of reporting. The device date was reported as 02-Jun-2022.  Company comment: This spontaneous case concerns a 73-year-old, female patient, with no relevant medical history reported, who experienced an unexpected, non-serious AESI COVID-19 in association with a dose of mRNA-1273 vaccine as her 4th COVID-19 vaccination. Exact onset latency of the event COVID-19 cannot be determined with an unknown event onset date. She received a 2-dose primary series and a 3rd dose of Pfizer's COVID-19 vaccine before receiving a dose of mRNA-1273 vaccine. Paxlovid treatment for COVID-19 started 38 days after her vaccination with mRNA-1273 vaccine. Patient had diarrhea, felt nauseous & dizzy, and noted metallic taste on her tongue and inside her mouth the following day after completing paxlovid treatment. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Age-related immune system changes could predispose the patient to COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.; Sender's Comments: This spontaneous case concerns a 73-year-old, female patient, with no relevant medical history reported, who experienced an unexpected, non-serious AESI COVID-19 in association with a dose of mRNA-1273 vaccine as her 4th COVID-19 vaccination. Exact onset latency of the event COVID-19 cannot be determined with an unknown event onset date. She received a 2-dose primary series and a 3rd dose of Pfizer's COVID-19 vaccine before receiving a dose of mRNA-1273 vaccine. Paxlovid treatment for COVID-19 started 38 days after her vaccination with mRNA-1273 vaccine. Patient had diarrhea, felt nauseous & dizzy, and noted metallic taste on her tongue and inside her mouth the following day after completing paxlovid treatment. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Age-related immune system changes could predispose the patient to COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement and the available information.