Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Rebound/ Four days later, symptoms returned even worse than first time/Tested positive again and continue with symptoms; Rebound/ Four days later, symptoms returned even worse than first time/Tested positive again and continue with symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound/ Four days later, symptoms returned even worse than first time/Tested positive again and continue with symptoms) and DRUG INEFFECTIVE (Rebound/ Four days later, symptoms returned even worse than first time/Tested positive again and continue with symptoms) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A, 006D1A, 015M20A and 041L20A) for COVID-19 vaccination.     The patient's past medical history included Depression. Previously administered products included for Drug use for unknown indication: SULFA [SULFANILAMIDE] and Penicillin. Past adverse reactions to the above products included Allergy with Penicillin and SULFA [SULFANILAMIDE]. Concurrent medical conditions included Asthma, Hypertension, Osteoporosis and Spinal stenosis. Concomitant products included LOSARTAN, AMLODIPINE, BUPROPION, ATENOLOL, VENLAFAXINE, BECLOMETASONE DIPROPIONATE (QVAR), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and VITAMIN D NOS for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DRUG INEFFECTIVE (Rebound/ Four days later, symptoms returned even worse than first time/Tested positive again and continue with symptoms). In May 2022, the patient experienced COVID-19 (Rebound/ Four days later, symptoms returned even worse than first time/Tested positive again and continue with symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 06-May-2022 to 10-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound/ Four days later, symptoms returned even worse than first time/Tested positive again and continue with symptoms) had not resolved and DRUG INEFFECTIVE (Rebound/ Four days later, symptoms returned even worse than first time/Tested positive again and continue with symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, SARS-CoV-2 test: negative (Negative) Tested negative (PCR) after taking Paxlovid for the 5 days. On 14-May-2022, SARS-CoV-2 test: positive (Positive) The symptoms returned even worse than first time. Tested positive again and continue with symptoms.. In May 2022, SARS-CoV-2 test: positive (Positive) positive (Prior starting Paxlovid).         It was reported that, the patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Additionally it was reported as, it was the rebound effect. The patient was tested negative (PCR) after taking Paxlovid for the 5 days. On an unknown date, the symptoms returned even worse than first time. She was tested positive again and continue with symptoms. The device date was reported as 20-May-2022.  Company comment: This is a spontaneous case concerning a 68-year-old female  patient with asthma and hypertension, who experienced the non-serious unexpected event of COVID-19 (AESI), more than 3 months after the fourth dose of mRNA-1273 vaccine. Patient describes that after taking paxlovid for COVID-19 treatment her symptoms rebound and tested positive again 4 days after completing the course. Drug ineffective was also captured as an event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 68-year-old female  patient with asthma and hypertension, who experienced the non-serious unexpected event of COVID-19 (AESI), more than 3 months after the fourth dose of mRNA-1273 vaccine. Patient describes that after taking paxlovid for COVID-19 treatment her symptoms rebound and tested positive again 4 days after completing the course. Drug ineffective was also captured as an event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.