Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rapid test positive for COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccines) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The patient's past medical history included COVID-19 (Before vaccines were out there) in 2020. Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (Dose-1) on 04-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE (Dose-2) on 02-May-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. In 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2022, the patient experienced COVID-19 (Rapid test positive for COVID-19). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccines). At the time of the report, COVID-19 (Rapid test positive for COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccines) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2022, SARS-CoV-2 test: (Positive) Positive. On 19-Aug-2022, SARS-CoV-2 test: (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Patient went to doctor to had lungs checked and stated patient could breathe, voice was hoarser and had more phlegm. On Tuesday afternoon 16-Aug-2022 patient began to feel unwell, had fever at work. When got home around 7:00 patient did a rapid test which came positive for COVID-19. On Friday 19-Aug-2022 patient made appointment in pharmacy and there they did other test (PCR) and got the results on Sunday night which was confirmed as positive. Patient requested information about Paxlovid for emergency use. Patient had not started Paxlovid yet. No treatment medications were reported. Company Comment: This spontaneous case concerns a 62-year-old, female patient with medical history of COVID-19 who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with positive SARS-CoV-2 test) which occurred on the same year of administration of mRNA-1273 vaccine taken as booster dose of COVID-19 vaccination series. Interchange of vaccine products and COVID-19 immunization reported as Revaccination with different COVID-19 vaccines were noted in the case as patient received Tozinameran as primary series of vaccination prior to the booster dose. There was no adverse event reported after the first two doses of COVID-19 vaccines. The patient tested positive for SARS-CoV-2 test twice after presenting with hoarseness and sputum production. She consulted a physician and was prescribed with Paxlovid but was not taken at the time of report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 62-year-old, female patient with medical history of COVID-19 who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with positive SARS-CoV-2 test) which occurred on the same year of administration of mRNA-1273 vaccine taken as booster dose of COVID-19 vaccination series. Interchange of vaccine products and COVID-19 immunization reported as Revaccination with different COVID-19 vaccines were noted in the case as patient received Tozinameran as primary series of vaccination prior to the booster dose. There was no adverse event reported after the first two doses of COVID-19 vaccines. The patient tested positive for SARS-CoV-2 test twice after presenting with hoarseness and sputum production. She consulted a physician and was prescribed with Paxlovid but was not taken at the time of report. The benefit-risk relationship of mRNA-1273 is not affected by this report.