Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive Covid test after experiencing symptoms of high fever, cough and intense headache) and DRUG INEFFECTIVE (Lack of drug effect) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for Drug use for unknown indication: Jansen (Dose number 01, unknown batch number and Location of injection: Arm Right) in March 2021. Past adverse reactions to the above products included No adverse event with Jansen. Concurrent medical conditions included Rheumatoid arthritis, Hashimoto's thyroiditis and Sulfonamide allergy. Concomitant products included ETANERCEPT (ENBREL) and LEVOTHYROXINE from January 2000 to May 2022 for an unknown indication. On 26-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive Covid test after experiencing symptoms of high fever, cough and intense headache) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 03-May-2022 to 08-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Positive Covid test after experiencing symptoms of high fever, cough and intense headache) and DRUG INEFFECTIVE (Lack of drug effect) 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) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. Date of birth was reported as Jun-1955. Patient received booster dose of Moderna Covid-19 Vaccine. It was reported as the patient had a runny nose, a slight cough and a mild headache. Patient tested again and received a strong positive result. Patient did not have fever and the intense fatigue that she experienced previously when she tested positive. Device date was reported as 15-May-2022. Company comment: This spontaneous case reported by a consumer, concerns a 66 year old female patient having concurrent illness with Rheumatoid arthritis and Hashimoto's Thyroiditis, who experienced the unexpected, non-serious AESI of Covid-19 Infection about 6 months later on an unknown date, after receiving a booster dose of Modena mRNA1273 vaccine. Patient previously received a dose of Janssen vaccine 6 months prior to Moderna vaccine. Interchange of vaccine products was noted. She had symptoms of high fever, cough, and intense headache and was treated with Paxlovid for 5 days. The event had resolved with negative Covid-19 tests done twice. Concomitant use of Etanercept could be considered as a a confounder to the event. It was reported that she again had a runny nose, slight cough, and mild headache and tested strongly positive for Covid-19, about 01 week after stopping Paxlovid. 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 reported by a consumer, concerns a 66 year old female patient having concurrent illness with Rheumatoid arthritis and Hashimoto's Thyroiditis, who experienced the unexpected, non-serious AESI of Covid-19 Infection about 6 months later on an unknown date, after receiving a booster dose of Modena mRNA1273 vaccine. Patient previously received a dose of Janssen vaccine 6 months prior to Moderna vaccine. Interchange of vaccine products was noted. She had symptoms of high fever, cough and intense headache and was treated with Paxlovid for 5 days. The event had resolved with negative Covid-19 tests done twice. Concomitant use of Etanercept could be considered as a a confounder to the event. It was reported that she again had a runny nose, slight cough, and mild headache and tested strongly positive for Covid-19, about 01 week after stopping Paxlovid. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.