Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID/ Chills/ Muscle ache/ Headache/ Nasal congestion/runny nose/ Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID/ Chills/ Muscle ache/ Headache/ Nasal congestion/runny nose/ Fatigue) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.    Co-suspect product included non-company product  (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 24-Jan-2021, received second dose of  (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced COVID-19 (tested positive for COVID/ Chills/ Muscle ache/ Headache/ Nasal congestion/runny nose/ Fatigue). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) (oral) from 19-Nov-2021 to 24-Nov-2021 for SARS-CoV-2 infection, at a dose of 500 mg and IBUPROFEN (oral) from 19-Nov-2021 to 24-Nov-2021 for SARS-CoV-2 infection, at a dose of 200 mg. At the time of the report, COVID-19 (tested positive for COVID/ Chills/ Muscle ache/ Headache/ Nasal congestion/runny nose/ Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID Source of Sample: Nasopharyngeal.         No concomitant medications were reported  No treatment medications were reported.  Patient experienced the COVID-19 symptoms such as, chills for 1 day, muscle aches for 3 days, headache for 5 days, nasal congestion/runny nose for 3 days and fatigue for 3 days.  Company comment: This case concerns a 53-year-old female, with no reported medical history, who experienced the non-serious, unexpected AESI event of COVID-19, 28 days after the third dose of mRNA 1273 vaccine. Patient received the first two dose of Pfizer BIONTECH COVID-19 vaccine 9 months prior to the booster of mRNA 1273 vaccine. The patient experienced chills, muscle aches, headache, nasal congestion, and fatigue during the period that he had Covid-19. She took Tylenol and ibuprofen for her symptoms. The patient receiving Pfizer BIONTECH COVID-19 vaccine as her primary series remain as confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2021: Significant Follow up included updated information's of  event details and treatment medication; Sender's Comments: This case concerns a 53-year-old female, with no reported medical history, who experienced the non-serious, unexpected AESI event of COVID-19, 28 days after the third dose of mRNA 1273 vaccine. Patient received the first two dose of Pfizer BIONTECH COVID-19 vaccine 9 months prior to the booster of mRNA 1273 vaccine. The patient experienced chills, muscle aches, headache, nasal congestion, and fatigue during the period that he had Covid-19. She took Tylenol and ibuprofen for her symptoms. The patient receiving Pfizer BIONTECH COVID-19 vaccine as her primary series remain as confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.