Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (High fever, cough, intense headache, runny nose/Confirmed Covid-19 infection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose Janssen and second dose of Moderna) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination. Concurrent medical conditions included Rheumatoid arthritis, Hashimoto's thyroiditis and Sulfonamide allergy (Sulfa drug allergy). Concomitant products included ETANERCEPT (ENBREL) from January 2014 to May 2022 and LEVOTHYROXINE from January 2000 to May 2022 for an unknown indication. In March 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 26-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose Janssen and second dose of Moderna). In May 2022, the patient experienced COVID-19 (High fever, cough, intense headache, runny nose/Confirmed Covid-19 infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 03-May-2022 to 08-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (High fever, cough, intense headache, runny nose/Confirmed Covid-19 infection) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose Janssen and second dose of Moderna) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 10-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 14-May-2022, SARS-CoV-2 test: positive (Positive) Received a strong positive result. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. Company comment: This is a regulatory authority case concerning a 65-year-old female patient with Rheumatoid arthritis, Hashimoto's thyroiditis and Sulfonamide allergy, who experienced the non-serious unexpected event of COVID-19 (AESI), more than 6 months after receiving a dose of mRNA-1273 vaccine. (previous COVID-19 vaccination with NRVV AD26 JANSSEN COVID-19 VACCINE). Patient had fever, cough, headache and fatigue. Patient was prescribed Paxlovid for 5 days following a SARS-CoV-2 positive test. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. It was reported that the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that the patient was prescribed Paxlovid following a positive Covid test after experiencing symptoms of high fever, cough and intense headache. The patient began taking Paxlovid on 03-May-2022 and completed the 5 day treatment on 08-May-2022 for Covid-19 treatment. The patient tested and received negative tests using the rapid tests on 08-May-2022 and 10-May-2022. On 14-May-2022, the patient had a runny nose, a slight cough and a mild headache and she tested again and received a strong positive result. The patient had no fever, nor the intense fatigue that she experienced previously when tested positive. Sender's Comments: Company comment: This is a regulatory authority case concerning a 65-year-old female patient with Rheumatoid arthritis, Hashimoto's thyroiditis and Sulfonamide allergy, who experienced the non-serious unexpected event of COVID-19 (AESI), more than 6 months after receiving a dose of mRNA-1273 vaccine. (previous COVID-19 vaccination with NRVV AD26 JANSSEN COVID-19 VACCINE). Patient had fever, cough, headache and fatigue. Patient was prescribed Paxlovid for 5 days following a SARS-CoV-2 positive test. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.