Age: 65.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Positive for COVID; Interchange of vaccine products; This spontaneous case was reported by a patient and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for COVID) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 9344c4) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer vaccine (Anatomical site of injection-Arm, 0.3 ml Intramuscular, batch number-EL3248 EXP: 30-Apr-2021) on 26-Jan-2021, Pfizer vaccine (Anatomical site of injection-Arm, 0.3 ml Intramuscular and batch number-EL3248 EXP: 30-Apr-2021) on 12-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 25-Apr-2022, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for COVID). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) on 27-Apr-2022 for COVID-19 treatment, at a dose of 3 tablets by mouth 2 times a day. At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for COVID) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 26-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant products were not provided.  It was reported that Paxlovid working within 12hrs and didn't feel worse. Bitter/sour taste began at the back of throat and fade and would return after taking paxlovid.  Company Comment: This is a spontaneous case of interchange of vaccine products for this 65-year-old patient, of unknown gender, with past drug history of administration of two doses of the Pfizer/BioNTech COVID-19 mRNA vaccine, who experienced the unexpected, non-serious AESI of SARS-CoV-2 test positive. The event occurred approximately 5 months after receiving the third (booster) dose of the mRNA-1273 vaccine. The patient tested positive for SARS-CoV-2 twice (25Apr2022 & 26Apr2022) via home tests. No symptoms were reported. The patient reported the positive status to the doctor and asked to be prescribed with Paxlovid (nirmatrelvir, ritonavir). The patient took and completed a 5-day course of Paxlovid, 3 tablets twice daily, from 27Apr2022 to 01May2022. It was reported that the patient felt the medication was working within 12 hours and that the patient 'didn't feel worse'. However, the patient experienced a bitter/sour taste at the back of the throat which is a common side effect (altered sense of taste) of Paxlovid. No additional details were provided. The outcome of the event was unknown at the time of the report. The patient's advanced age (high risk for infections) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case of interchange of vaccine products for this 65-year-old patient, of unknown gender, with past drug history of administration of two doses of the Pfizer/BioNTech COVID-19 mRNA vaccine, who experienced the unexpected, non-serious AESI of SARS-CoV-2 test positive. The event occurred approximately 5 months after receiving the third (booster) dose of the mRNA-1273 vaccine. The patient tested positive for SARS-CoV-2 twice (25Apr2022 & 26Apr2022) via home tests. No symptoms were reported. The patient reported the positive status to the doctor and asked to be prescribed with Paxlovid (nirmatrelvir, ritonavir). The patient took and completed a 5-day course of Paxlovid, 3 tablets twice daily, from 27Apr2022 to 01May2022. It was reported that the patient felt the medication was working within 12 hours and that the patient 'didn't feel worse'. However, the patient experienced a bitter/sour taste at the back of the throat which is a common side effect (altered sense of taste) of Paxlovid. No additional details were provided. The outcome of the event was unknown at the time of the report. The patient's advanced age (high risk for infections) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.