Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; revaccination with different Covid-19 vaccine; Confirmed Covid-19 infection; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Confirmed Covid-19 infection) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A and 017F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 26-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced COVID-19 (Confirmed Covid-19 infection) (seriousness criterion medically significant). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different Covid-19 vaccine). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 27-Jun-2022 to 01-Jul-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Confirmed Covid-19 infection) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (revaccination with different Covid-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: (Positive) Positive. In July 2022, SARS-CoV-2 test: (Negative) Negative and (Positive) Positive.         No concomitant medications were provided by the reporter.  The patient felt better after receiving Paxlovid for about 5 days and tested negative. On an unspecified date in Jul-2022, patient started to have worse symptoms than original and tested positive again.  Action taken with Paxlovid was reported as withdrawn.  Company comment: This spontaneous case concerns a 55-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) adverse event of special interest COVID-19 that occurred on an unspecified date after receiving the mRNA-1273 vaccine as 3rd dose. Approximately 2 months after receiving the mRNA-1273 vaccine as 3rd dose, patient had Covid-19. Took Nirmatrelvir (Paxlovid) as treatment regimen. After completion of treatment, patient felt better for 5 days and tested negative. On an unspecified date (same month after treatment) patient had worse symptoms and tested positive again. The outcome of event COVID-19 was reported as not resolved. Patient initially received COVID-19 vaccine Ad26.COV2.S as 1st dose, then mRNA-1273 vaccine as 2nd dose 7 months later.  Another dose of mRNA-1273 vaccine was given as 3rd dose after 6 months (Interchange of vaccine products noted). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a 55-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) adverse event of special interest COVID-19 that occurred on an unspecified date after receiving the mRNA-1273 vaccine as 3rd dose. Approximately 2 months after receiving the mRNA-1273 vaccine as 3rd dose, patient had Covid-19. Took Nirmatrelvir,Ritonavir (Paxlovid) as treatment regimen. After completion of treatment, patient felt better for 5 days and tested negative. On an unspecified date (same month after treatment) patient had worse symptoms and tested positive again. The outcome of event COVID-19 was reported as not resolved. Patient initially received COVID-19 vaccine Ad26.COV2.S as 1st dose, then mRNA-1273 vaccine as 2nd dose 7 months later.  Another dose of mRNA-1273 vaccine was given as 3rd dose after 6 months (Interchange of vaccine products noted). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.