Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Contracted Covid-19 or Omicron/ Sore throat/ headache/ ill/ occassional cough; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted Covid-19 or Omicron/ Sore throat/ headache/ ill/ occassional cough) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and NIRMATRELVIR, RITONAVIR (PAXLOVID) for Illness.    Concomitant products included ROSUVASTATIN for an unknown indication.   In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form., dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose and NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (Contracted Covid-19 or Omicron/ Sore throat/ headache/ ill/ occassional cough). At the time of the report, COVID-19 (Contracted Covid-19 or Omicron/ Sore throat/ headache/ ill/ occassional cough) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         The patient could not able to chew or swallowed Paxlovid as the tablet size was bigger which the reporter called and stated the same.  No treatment medication was reported.  Company comment: This is a spontaneous case reported by a consumer, concerning a female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, non- serious AESI of COVID-19 (Contracted Covid-19 or Omicron/ Sore throat/ headache/ ill/ occassional cough) on an unknown date after receiving a dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient received 2 previous doses with Moderna vaccines on unknown dates, a dose of p[fizer covid 19 vaccine on an unknown date also received Paxlovid, which could be considered as a confounding factor. Interchange of vaccine products was noted. On an unknown date, SARS-CoV-2 test was positive. No details on risk factors, comorbidities, labs, diagnostic tests and treatment details were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per medical judgement.; Sender's Comments: This is a spontaneous case reported by a consumer, concerning a female patient of unknown age, with no relevant medical history reported, who experienced the unexpected, non- serious AESI of COVID-19 (Contracted Covid-19 or Omicron/ Sore throat/ headache/ ill/ occassional cough) on an unknown date after receiving a dose of mRNA-1273 vaccine in the covid 19 vaccination series. It was reported that the patient received 2 previous doses with Moderna vaccines on unknown dates, a dose of p[fizer covid 19 vaccine on an unknown date also received Paxlovid, which could be considered as a confounding factor. Interchange of vaccine products was noted. On an unknown date, SARS-CoV-2 test was positive. No details on risk factors, comorbidities, labs, diagnostic tests and treatment details were provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per medical judgement.