Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
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. 071F21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Doxicylline). Concomitant products included CELECOXIB (CELEBREX), VITAMIN D3 and METOPROLOL for an unknown indication.    On 27-Oct-2021, the patient received third 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 25-May-2022 to 29-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 03-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that patient had previously received a COVID-19 Vaccine. It was reported that the patient had a rebound of Covid and had tested positive occurring 5 days after completing Paxlovid treatment. Patient had tested negative and feeling well after finishing Paxlovid. With device date as 04-Jun-2022.  Company comment-This spontaneous case concerns a female patient aged 73 years with no relevant medical history reported, who experienced the unexpected non serious Covid 19 on an unknown date after receiving the 3rd dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated for covid infection with Paxlovid from 25th May 2022 to 29th May 2022 for 5 days. Patient reported feeling well after Paxlovid and was tested negative. Five days later patient had rebound covid with symptoms and a positive test. No further details on clinical course, other lab test results were reported. The current pandemic situation of COVID 19 may remain as confounder and elderly age of the patient as a risk factor to the event Covid-19.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This spontaneous case concerns a female patient aged 73 years with no relevant medical history reported, who experienced the unexpected non serious Covid 19 on an unknown date after receiving the 3rd dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient was treated for covid infection with Paxlovid from 25th May 2022 to 29th May 2022 for 5 days. Patient reported feeling well after Paxlovid and was tested negative. Five days later patient had rebound covid with symptoms and a positive test. No further details on clinical course, other lab test results were reported. The current pandemic situation of COVID 19 may remain as confounder and elderly age of the patient as a risk factor to the event Covid-19.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.