Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Illness, Nausea, SARS-CoV-2 test, Vomiting
Clinical narrative: Her 2 home tests were both positive for the virus; started feeling sick/she felt like she was too sick to take the next dose; Nauseous; Vomiting; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Her 2 home tests were both positive for the virus), ILLNESS (started feeling sick/she felt like she was too sick to take the next dose), NAUSEA (Nauseous) and VOMITING (Vomiting) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A, 036B21A, 958E21A and 022J21A) for COVID-19 prophylaxis. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for COVID-19.No Medical History information was reported. On an unknown date, the patient received first 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, third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Her 2 home tests were both positive for the virus), ILLNESS (started feeling sick/she felt like she was too sick to take the next dose), NAUSEA (Nauseous) and VOMITING (Vomiting). The patient was treated with FRUCTOSE, GLUCOSE, PHOSPHORIC ACID (EMETROL [FRUCTOSE;GLUCOSE;PHOSPHORIC ACID]) for Nausea, at a dose of 15 milliliter, at 15 minutes intervals. At the time of the report, COVID-19 (Her 2 home tests were both positive for the virus), ILLNESS (started feeling sick/she felt like she was too sick to take the next dose), NAUSEA (Nauseous) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive and (Positive) Positive. Race of the patient was reported . No concomitant medications was reported. Reporter stated, reporter and his wife both were vaccinated and double boosted with vaccine Moderna. reporter's wife (patient) started feeling sick on an unknown date on Tuesday and yesterday reporter gave the patient 2 home tests and they were both positive for the virus. Reporter called her doctor who was on vacation and the doctor that was on duty ordered the Paxlovid for the patient. Th patient  took the first dose of Paxlovid last night, that was the first 3 tablets and within an hour and a half patient started to get nauseous and was nauseous all night long and in the morning patient was vomiting. Patient felt like too sick to take the next dose. The reporter got some antinausea medication which eased the patient a bit. The reporter does not know if they suppose to skip any doses. Company comment- This spontaneous case concerns a 64-year-old female patient receiving PAXLOVID (ritonavir/nirmatrelvir), who experienced the unexpected AESI COVID-19 along with the non-serious events of illness, vomiting and nausea. First, second and 2 booster doses of mRNA-1273 vaccine were administered on unknown dates, hence latency cannot be assessed. It was reported patient started feeling sick and tested positive for 2 COVID-19 home tests. PAXLOVID was prescribed. Within an hour and a half of taking PAXLOVID patient started to get nauseous and was nauseous all night long and, in the morning, patient was vomiting. Patient felt like too sick to take the next dose. She got some anti nausea medication which eased the patient a bit. Treatment with PAXLOVID remains as a confounder for the events of illness, vomiting and nausea.  The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 64-year-old female patient receiving PAXLOVID (ritonavir/nirmatrelvir), who experienced the unexpected  COVID-19 along with the non-serious events of illness, vomiting and nausea. First, second and 2 booster doses of mRNA-1273 vaccine were administered on unknown dates, hence latency cannot be assessed. It was reported patient started feeling sick and tested positive for 2 COVID-19 home tests. PAXLOVID was prescribed. Within an hour and a half of taking PAXLOVID patient started to get nauseous and was nauseous all night long and, in the morning, patient was vomiting. Patient felt like too sick to take the next dose. She got some anti nausea medication which eased the patient a bit. Treatment with PAXLOVID remains as a confounder for the events of illness, vomiting and nausea.  The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.