Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: interchange of vaccine product; COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine product) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O13FZ1A) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 immunisation and NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Hypertension and Allergy. Concomitant products included METOPROLOL SUCCINATE and CHLORTHALIDONE for an unknown indication.   On 18-Dec-2020, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 07-Jan-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 19-May-2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine product). At the time of the report, COVID-19 (COVID-19) was resolving and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine product) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: This spontaneous case concerns a 60-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19, which occurred 186 days after receiving third dose of mRNA-1273 vaccine. The patient was noted to have received two doses with COMINARTY 10 months 7 days prior to mRNA-1273 (Interchange of vaccine products). It was reported that patient was treated with Paxlovid from 12-may-2022 to 16-may-2022. She was rebound teste positive 7 days after the treatment with Paxlovid, The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2022: Follow-up received with no new information; Sender's Comments: This spontaneous case concerns a 60-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19, which occurred 186 days after receiving third dose of mRNA-1273 vaccine. The patient was noted to have received two doses with COMINARTY 10 months 7 days prior to mRNA-1273 (Interchange of vaccine products). It was reported that patient was treated with Paxlovid from 12-may-2022 to 16-may-2022. She was rebound teste positive 7 days after the treatment with Paxlovid, The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.