Age: 26.0
Sex: F
Vaccine: COVID19, UNK
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 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Crohn's, Egg allergy, Milk allergy and Food allergy (Gluten). Concomitant products included FLUOXETINE for an unknown indication.   In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) negative, positive (Positive) positive and negative (Negative) negative.         Patient was taking other products/ medications within 2weeks of starting COVID-19 treatment. Patient developed rebound of COVID-19 after taking Paxlovid and tested negative for COVID. Patient stated that the symptoms were mild during the rebound. Patient had mild congestion and headache but no cough nor fever.  It was reported that Day 0- symptom onset. On day 1-tested positive and on Day 2 started Paxlovid. Patient tested negative on Days 8 and 10. However tested positive on Day 12 (on the day of reporting).  Company comment:This spontaneous case concerns a 26 year old female patient with relevant medical history of Crohn s disease, who experienced the unexpected non serious AESI of COVID-19, unspecified days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient was symptomatic and tested positive for COVID-19. She was treated with Paxlovid and subsequently tested negative. However, patient developed rebound COVID-19 after 2 days after the last negative test. Patient stated that the symptoms were mild during the rebound. Patient had mild congestion and headache but no cough or fever. The event was resolving. No information on the details pertaining to primary doses was available in the report. The COVID-19 pandemic and the medical history of Crohn s disease could be risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 26 year old female patient with relevant medical history of Crohn s disease, who experienced the unexpected non serious AESI of COVID-19, unspecified days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. Patient was symptomatic and tested positive for COVID-19. She was treated with Paxlovid and subsequently tested negative. However, patient developed rebound COVID-19 after 2 days after the last negative test. Patient stated that the symptoms were mild during the rebound. Patient had mild congestion and headache but no cough or fever. The event was resolving. No information on the details pertaining to primary doses was available in the report. The COVID-19 pandemic and the medical history of Crohn s disease could be risk factors for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.