Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound after taking Paxlovid - Rebound started on day 11 after positive test and on day zero, patient had rapid onset of symptoms and tested with PCR test lab showing immediate positive results; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound after taking Paxlovid - Rebound started on day 11 after positive test and on day zero, patient had rapid onset of symptoms and tested with PCR test lab showing immediate positive results) and COVID-19 (COVID-19) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no drug allergy.  Concurrent medical conditions included Asthma (this is the reason why the patient took Paxlovid at patient's age group).   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, the patient experienced COVID-19 (COVID-19). On 15-May-2022, the patient experienced COVID-19 (Rebound after taking Paxlovid - Rebound started on day 11 after positive test and on day zero, patient had rapid onset of symptoms and tested with PCR test lab showing immediate positive results). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 09-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound after taking Paxlovid - Rebound started on day 11 after positive test and on day zero, patient had rapid onset of symptoms and tested with PCR test lab showing immediate positive results) and COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 15-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported.  The patient received Moderna booster dose on 17-Nov-2021.  The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that the patient had undergone PCR test for COVID-19 positive diagnosis and not antigen test. The patient was prescribed Paxlovid on day 0 and continued full course. The symptoms abated by end of 30 hours of treatment with Paxlovid.  On day 11 (15-May-2022) after first symptoms, after the first PCR test and administration of first dose of Paxlovid, the patient had experienced rapid onset of symptoms again that included fever, headache, aches, stuffy nose, cough, extreme fatigue and upset stomach.  The patient felt only a little better on day 12 (second rebound day).  Symptoms of rebound infection were worse than day zero when the patient felt extreme aches and fever. The device date was reported as 14-May-2022.  Company Comment: This spontaneous case concerns a 37 year old female patient with underlying medical history of asthma who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (reported twice- 1. LLT of COVID-19 and 2. LLT of COVID-19 Recurrent). The event COVID-19 (LLT COVID-19) occurred approximately 5 months and 17 days after receiving a dose of mRNA1273 as third dose of COVID-19 vaccine, the second event of COVID-19 (LLT COVID-19 recurrent) started 5 months and 28 days post vaccination. The patient experienced COVID-19 (LLT COVID-19) 5 months 17 days after vaccination of mRNA1273, she tested positive on the COVID-19 PCR test and was treated with Nirmatrelvir and Ritonavir (Paxlovid) for 5 days at an unspecified dose and frequency. On day 11 (after the first postive PCR test and first dose of treatment) the patient had rapid rapid onset of symptoms again including fever, headache, aches, stuffy nose, cough, extreme fatigue, upset stomach, she has undergone COVID-19 PCR test- which showed immediate positive results(LLT: COVID-19 Recurrent). The patient claims that she was a little better the next day ( 12th day after first positive PCR test). The patients underlying medical history of asthma may be considered as a risk factor for the event COVID-19 in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 37 year old female patient with underlying medical history of asthma who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (reported twice- 1. LLT of COVID-19 and 2. LLT of COVID-19 Recurrent). The event COVID-19 (LLT COVID-19) occurred approximately 5 months and 17 days after receiving a dose of mRNA1273 as third dose of COVID-19 vaccine, the second event of COVID-19 (LLT COVID-19 recurrent) started 5 months and 28 days post vaccination. The patient experienced COVID-19 (LLT COVID-19) 5 months 17 days after vaccination of mRNA1273, she tested positive on the COVID-19 PCR test and was treated with Nirmatrelvir and Ritonavir (Paxlovid) for 5 days at an unspecified dose and frequency. On day 11 (after the first postive PCR test and first dose of treatment) the patient had rapid rapid onset of symptoms again including fever, headache, aches, stuffy nose, cough, extreme fatigue, upset stomach, she has undergone COVID-19 PCR test- which showed immediate positive results(LLT: COVID-19 Recurrent). The patient claims that she was a little better the next day ( 12th day after first positive PCR test). The patients underlying medical history of asthma may be considered as a risk factor for the event COVID-19 in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report.