Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound of symptoms and Covid positive antigen test after testing negative; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound of symptoms and Covid positive antigen test after testing negative) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 044B21A and 006B21A) for COVID-19 vaccination.     The patient's past medical history included Drug allergy (Name of Drug was not reported). Concurrent medical conditions included Blood pressure high (controlled). Concomitant products included LISINOPRIL from January 1985 to an unknown date, ATORVASTATIN from January 2021 to 12-May-2022, ZOLPIDEM TARTRATE from January 2021 to an unknown date, MELATONIN from January 2021 to an unknown date, VITAMIN D NOS from 01-Mar-2022 to an unknown date, VITAMIN C [ASCORBIC ACID] from 12-May-2022 to an unknown date and ZINC from 12-May-2022 to an unknown date for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Rebound of symptoms and Covid positive antigen test after testing negative). At the time of the report, COVID-19 (Rebound of symptoms and Covid positive antigen test after testing negative) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     The patient had Pfizer product as co-suspect taken from 12May2022 to 17May2022 for COVID-19 treatment.  Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 vaccine.  Device date was reported as 26May2022.  Company Comment: This spontaneous case concerns a 65-year-old, male patient with relevant medical history of Hypertension and history of co-suspect intake of a non-Company product for COVID-19 treatment, who experienced the unexpected, non-serious AESI of COVID-19 recurrent. The event occurred approximately 6 months after receiving the third dose of the mRNA-1273 vaccine. On an unspecified date, the patient developed COVID-19 symptoms (unspecified). He took and completed a 6-day course of COVID-19 treatment (unspecified) from 12May2022 to 17May2022. It was reported that the patient developed rebound of symptoms (unspecified) 4 days after COVID-19 treatment. The patient tested positive for SARS-CoV-2 via Antigen test after testing negative on an unspecified date. No treatment was provided for the event COVID-19 recurrent. The medical history of Hypertension, which is a known risk factor for COVID-19, remains a confounder. The patient's advanced age (high risk for infections) also remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65-year-old, male patient with relevant medical history of Hypertension and history of co-suspect intake of a non-Company product for COVID-19 treatment, who experienced the unexpected, non-serious AESI of COVID-19 recurrent. The event occurred approximately 6 months after receiving the third dose of the mRNA-1273 vaccine. On an unspecified date, the patient developed COVID-19 symptoms (unspecified). He took and completed a 6-day course of COVID-19 treatment (unspecified) from 12May2022 to 17May2022. It was reported that the patient developed rebound of symptoms (unspecified) 4 days after COVID-19 treatment. The patient tested positive for SARS-CoV-2 via Antigen test after testing negative on an unspecified date. No treatment was provided for the event COVID-19 recurrent. The medical history of Hypertension, which is a known risk factor for COVID-19, remains a confounder. The patient's advanced age (high risk for infections) also remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.