Age: 62.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Interchange of vaccine products, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid on a home kit.; before the Moderna booster she only had one shot as a primary vaccine of the Johnson & Johnson vaccine; This spontaneous case was reported by a patient and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid on a home kit.) and INTERCHANGE OF VACCINE PRODUCTS (before the Moderna booster she only had one shot as a primary vaccine of the Johnson & Johnson vaccine) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011B221) for COVID-19 prophylaxis.    Co-suspect product included non-company product VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for Shingles.    Patient had no allergies. It was reported, patient had no acute illness or chronic or long-standing health conditions at the time of vaccination.  Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine. Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine. Concurrent medical conditions included Pain, Heartburn and Inflammation. Concomitant products included PANTOPRAZOLE for an unknown indication.   On 22-Jul-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (before the Moderna booster she only had one shot as a primary vaccine of the Johnson & Johnson vaccine). On 25-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid on a home kit.). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid on a home kit.) and INTERCHANGE OF VACCINE PRODUCTS (before the Moderna booster she only had one shot as a primary vaccine of the Johnson & Johnson vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jul-2022, SARS-CoV-2 test: (Positive) Positive.   The patient concomitantly took pain medicine, aromatase inhibitor, heart burn medication, inflammatory medication.  Patient received the first booster dose of Moderna on 22-Jul-2022. Patient wanted to know if the vaccine had antigens that could cause a false positive. The adverse event did not cause patient to seek medical care.  Treatment medication was not reported.  Company Comment: This is a spontaneous case of interchange of vaccine products for this 62-year-old, female patient with past drug history of administration of a dose of the Johnson & Johnson COVID-19 vaccine and history of co-suspect administration of a dose of a Shingles vaccine (unspecified brand), who experienced the unexpected, non-serious AESI of SARS-CoV-2 test positive. The event occurred 3 days after receiving a booster dose (second dose in the COVID-19 vaccination series) of the mRNA-1273 vaccine. It was reported that the patient tested positive for SARS-CoV-2 via a home kit. No symptoms were reported. No additional details were provided at the time of the report. The past drug history of administration of a dose of the Johnson & Johnson COVID-19 vaccine 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 62-year-old, female patient with past drug history of administration of a dose of the Johnson & Johnson COVID-19 vaccine and history of co-suspect administration of a dose of a Shingles vaccine (unspecified brand), who experienced the unexpected, non-serious AESI of SARS-CoV-2 test positive. The event occurred 3 days after receiving a booster dose (second dose in the COVID-19 vaccination series) of the mRNA-1273 vaccine. It was reported that the patient tested positive for SARS-CoV-2 via a home kit. No symptoms were reported. No additional details were provided at the time of the report. The past drug history of administration of a dose of the Johnson & Johnson COVID-19 vaccine remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.