Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Incorrect dose administered, Laboratory test
Clinical narrative: positive for 12 days, having COVID,dizzy for a month and a half,coughed,a germ ball came out, It was like a boba ball.; Patient received primary series of Pizer and Moderna as fourth dose; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (positive for 12 days, having COVID,dizzy for a month and a half,coughed,a germ ball came out, It was like a boba ball.) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose), Pfizer (3rd dose) and Pfizer (2nd dose). Past adverse reactions to the above products included No adverse reaction with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Rheumatoid arthritis and Lupus syndrome.    On 22-Jan-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received primary series of Pizer and Moderna as fourth dose). On 24-Jan-2022, the patient experienced COVID-19 (positive for 12 days, having COVID,dizzy for a month and a half,coughed,a germ ball came out, It was like a boba ball.) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to COVID-19. At the time of the report, COVID-19 (positive for 12 days, having COVID,dizzy for a month and a half,coughed,a germ ball came out, It was like a boba ball.) had resolved and INTERCHANGE OF VACCINE PRODUCTS (Patient received primary series of Pizer and Moderna as fourth dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2022, SARS-CoV-2 test: negative (Negative) Negative. On 24-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. The patient reported as patient was in the hospital for 3 days and was seen by a neurologist, who cannot figure out what was wrong. No treatment medication were provided. Company comment: This spontaneous case concerns a 45-year-old female patient with no medical history reported, who experienced the unexpected serious adverse events of special interest COVID-19  (seriousness criteria hospitalization)which occurred 2 days after fourth dose of mRNA-1273 vaccine .It was noted that patient received 3 doses of Pfizer  prior to current vaccination(interchange of vaccine product). SARS-CoV-2 test was positive on 24-Jan-2022. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 45-year-old female patient with no medical history reported, who experienced the unexpected serious adverse events of special interest COVID-19  (seriousness criteria hospitalization)which occurred 2 days after fourth dose of mRNA-1273 vaccine .It was noted that patient received 3 doses of Pfizer  prior to current vaccination(interchange of vaccine product). SARS-CoV-2 test was positive on 24-Jan-2022. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.