Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I tested positive last week/ sore throat/ a low-grade temp/ Diarrhea/ lethargic/ had no energy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 prophylaxis. Concurrent medical conditions included Supraventricular tachycardia, Cardiac disorder NOS (Intent history) and Heart rate. Concomitant products included METOPROLOL for Supraventricular tachycardia and Heart rate. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced COVID-19 (I tested positive last week/ sore throat/  a low-grade temp/ Diarrhea/ lethargic/ had no energy). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in July 2022 for COVID-19 treatment, at an unspecified dose and frequency; LOPERAMIDE for Diarrhea, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, COVID-19 (I tested positive last week/ sore throat/ a low-grade temp/ Diarrhea/ lethargic/ had no energy) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-1 test: (Positive) I tested positive last week Tuesday. Patient ethnicity reported as Asian. Patient reported that she had got the COVID shot (Covid-19 vaccine) she had got the booster the third booster and thought to be fourth one. Patient reported that she was calling because she needed to report side effects because she took the Paxlovid. She took the medication because she tested positive. It worked for a couple of days and then she was like symptomatic again and running a low-grade temp and it gave her really bad side effects from the medication. So the medication did not work like it worked for first two days because when she tested positive, she had no energy nothing like that and then after wards it gave her some energy. But then when she finished her five days it did not work no more. She had symptoms again like her throat felt like she was swallowing glass. She was not feel good and very lethargic. Consumer further stated she was the one who requested Paxlovid from her physician because when she had symptoms and everything she saw that they had for COVID. So requested the Paxlovid from her Doctor and thought it was going to work but it did not, it worked for a couple of days and then she again went back to her sore throat, her throat was hurting. She continued to have a low grade temperature. She had to take Tylenol (Treatment) for her temperature. Company Comment: This is a regulatory case concerning a 32 year-old female patient with no significant reported medical history, who experienced the unexpected AESI of COVID-19, unknown days after the third dose of mRNA-1273 vaccine. The outcome was reported as unknown. COVID-19 PCR test result was positive. She took Paxlovid medication because she tested positive; it worked for a couple of days and then she was like symptomatic again. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reported. Sender's Comments: Company Comment: This is a regulatory case concerning a 32 year-old  female patient with no significant reported medical history, who experienced the unexpected AESI of COVID-19, unknown days after the third dose of mRNA-1273 vaccine. The outcome was reported as unknown. COVID-19 PCR test result was positive. She took Paxlovid medication because she tested positive; it worked for a couple of days and then she was like symptomatic again. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event´s seriousness assessed as reported.