Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for covid on 5/24/2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for covid on 5/24/2022) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 004F21A, 030A21A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Blepharitis, Neck surgery (2 cervical neck fusion surgeries), Bariatric surgery ((type II diabetes in the past-ended with bariatric surgery in 2015); may be back now) in 2015 and Thyroidectomy (thyroid cancer (still current after  thyroidectomy)). Concurrent medical conditions included Blood pressure high, BPH, High cholesterol, Thyroid cancer (still current after thyroidectomy), Left inguinal hernia, Type II diabetes mellitus and Drug allergy. Concomitant products included ATORVASTATIN from 01-May-1986 to 25-May-2022, GABAPENTIN from 01-Mar-2021 to an unknown date, FISH OIL, RAMIPRIL, FINASTERIDE, LEVOTHYROXINE SODIUM (SYNTHROID) from 01-Sep-2021 to 25-May-2022, VITAMINS NOS (FLINTSTONES), KIRKLAND SIGNATURE SUPER B COMPLEX, CYANOCOBALAMIN (NATURE MADE VITAMIN B-12), CALCIUM CITRATE (SOLARAY CALCIUM CITRATE), TAMSULOSIN from 25-May-2022 to an unknown date, ACETYLSALICYLIC ACID (BABY ASPIRIN) from 25-May-2022 to 04-Jun-2022, POLYVINYL ALCOHOL, POVIDONE (REFRESH CLASSIC LUBRICANT EYE DROPS), IPRATROPIUM BROMIDE and PARACETAMOL (TYLENOL) from 25-May-2022 to 01-Jun-2022 for an unknown indication.   On 06-Feb-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021 at 2:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2022 at 8:00 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested positive for covid on 5/24/2022). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 25-May-2022 to 30-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for covid on 5/24/2022) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2022, SARS-CoV-2 test: positive (Positive) positive. On 05-Jun-2022, SARS-CoV-2 test: positive (Positive) positive.         Patient was tested positive for COVID on 24-May-2022 with symptoms runny nose, sneezing, fatigue and very sore throat. Patient was tested positive for COVID again on 05-Jun-2022 With symptoms runny nose, sneezing and fatigue.  Company comment: This is a spontaneous case concerning a 61-year-old, male patient with no relevant medical history and with concurrent medical conditions of thyroid cancer and type II diabetes mellitus and with vaccine history of receiving first, second and third dose of mRNA-1273 vaccine with appropriate dosage intervals, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred approximately 52 days after the fourth dose of mRNA-1273 vaccine administration. The event was described as, patient was tested positive with Covid-19 with symptoms of runny nose, sneezing, fatigue and sore throat. The next day, patient took Nirmatrelvir + Ritonavir (Paxlovid) for treatment of Covid-19. Approximately 6 days after the last dose of Nirmatrelvir + Ritonavir (Paxlovid), patient was tested positive again with Covid-19. Patient experienced symptoms of runny nose, sneezing and fatigue. No other information surrounding the event was reported. The outcome of the event was reported as not resolved. The concurrent medical conditions of thyroid cancer and type II diabetes mellitus remain confounders for the immune response to vaccine. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 61-year-old, male patient with no relevant medical history and with concurrent medical conditions of thyroid cancer and type II diabetes mellitus and with vaccine history of receiving first, second and third dose of mRNA-1273 vaccine with appropriate dosage intervals, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred approximately 52 days after the fourth dose of mRNA-1273 vaccine administration. The event was described as, patient was tested positive with Covid-19 with symptoms of runny nose, sneezing, fatigue and sore throat. The next day, patient took Nirmatrelvir + Ritonavir (Paxlovid) for treatment of Covid-19. Approximately 6 days after the last dose of Nirmatrelvir + Ritonavir (Paxlovid), patient was tested positive again with Covid-19. Patient experienced symptoms of runny nose, sneezing and fatigue. No other information surrounding the event was reported. The outcome of the event was reported as not resolved. The concurrent medical conditions of thyroid cancer and type II diabetes mellitus remain confounders for the immune response to vaccine. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.