Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: COVID Positive about 2 months after first booster; First Booster dose after first 2 doses/ patient with autoimmune disease and history of cancer; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID Positive about 2 months after first booster) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Booster dose after first 2 doses/ patient with autoimmune disease and history of cancer) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 012A21A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Autoimmune disorder.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Booster dose after first 2 doses/ patient with autoimmune disease and history of cancer). In January 2022, the patient experienced COVID-19 (COVID Positive about 2 months after first booster). At the time of the report, COVID-19 (COVID Positive about 2 months after first booster) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First Booster dose after first 2 doses/ patient with autoimmune disease and history of cancer) outcome was unknown.            Concomitant products were not reported.  Treatment medications were not reported.  Company Comment: This is a spontaneous  case concerning  a  43-year-old, male patient with past medical history included Cancer and Concurrent medical conditions of Autoimmune disorder, who experienced the unexpected non-serious (AESI) Covid-19  and Inappropriate schedule of product administration. The event Inappropriate schedule of product administration  occurred on the same day after the third dose of mRNA-1273 Vaccine. The exact date of the onset of the event COVID-19 was not specified, hence latency could not be assessed.  No further details on clinical course, lab test results and treatment received were reported. Outcome of the events was unknown, at the time of report. The past medical history included Cancer and Concurrent medical conditions of Autoimmune disorder remains a confounder for event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.    This case was linked to MOD-2022-630572 (Patient Link).; Sender's Comments: This is a spontaneous  case concerning  a  43-year-old, male patient with past medical history included Cancer and Concurrent medical conditions of Autoimmune disorder, who experienced the unexpected non-serious (AESI) Covid-19  and Inappropriate schedule of product administration. The event Inappropriate schedule of product administration  occurred on the same day after the third dose of mRNA-1273 Vaccine. The exact date of the onset of the event COVID-19 was not specified, hence latency could not be assessed.  No further details on clinical course, lab test results and treatment received were reported. Outcome of the events was unknown, at the time of report. The past medical history included Cancer and Concurrent medical conditions of Autoimmune disorder remains a confounder for event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine, is not affected by this report.