Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Confirmed covid-19 infection; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Confirmed covid-19 infection) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. LGH022887060) for Prophylactic vaccination. 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 Prophylactic vaccination.    Previously administered products included for Prophylactic vaccination: Pfizer vaccine (dose number in series 2) in August 2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine. Concurrent medical conditions included Asthma (Mild occasional asthma) and Allergy.   On 08-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2022, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 08-Jan-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 25-Apr-2022, the patient experienced COVID-19 (Confirmed covid-19 infection) (seriousness criterion medically significant). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-Apr-2022 to 21-Apr-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 30-Apr-2022, COVID-19 (Confirmed covid-19 infection) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2022, SARS-CoV-2 test: positive (Positive) positive. On 26-Apr-2022, SARS-CoV-2 test: positive (Positive) positive. On 27-Apr-2022, SARS-CoV-2 test: positive (Positive) positive. On 28-Apr-2022, SARS-CoV-2 test: positive (Positive) positive. On 29-Apr-2022, SARS-CoV-2 test: positive (Positive) positive. On 30-Apr-2022, SARS-CoV-2 test: negative (Negative) negative. On an unknown date, SARS-CoV-2 test: negative (Negative) negative.         No concomitant medication has been provided.  On an unspecified date in 2022 the patient experienced COVID-19. it was reported as five days after completing a five days treatment with Paxlovid ( nirmatrelvir and ritonavir) all symptoms disappeared. The patient continued to test positive for COVID-19 and lastly tested negative on 30th April 2022. This report was associated with product quality complaint: 90000230235. Company comment This is a spontaneous case concerning a 68-year-old female patient with no relevant medical history reported, previously received Janssen COVID-19 Vaccine, Pfizer COVID-19 Vaccine, who experienced the serious, unexpected ADR event of COVID-19, which occurred approximately 3 months after the 3rd dose of mRNA-1273. Interchange of vaccine products was considered an additional event. It was reported that the patient experienced COVID-19 five days after completing a 5-days treatment with Paxlovid. All symptoms disappeared and patient was tested negative. On the next day the symptoms reappeared and the patient was tested positive. The patient continued to test positive for over 4 days and finally tested negative. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 68-year-old female patient with no relevant medical history reported, previously received Janssen COVID-19 Vaccine, Pfizer COVID-19 Vaccine, who experienced the serious, unexpected ADR event of COVID-19, which occurred approximately 3 months after the 3rd dose of mRNA-1273. Interchange of vaccine products was considered an additional event. It was reported that the patient experienced COVID-19 five days after completing a 5-days treatment with Paxlovid. All symptoms disappeared and patient was tested negative. On the next day the symptoms reappeared and the patient was tested positive. The patient continued to test positive for over 4 days and finally tested negative. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.