Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: On day 11 I tested positive again; Inappropriate Schedule of Product Administration; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (On day 11 I tested positive again) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of Product Administration) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045b21a, 037b21a and 016b21a) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol (Use meds), Blood pressure abnormal (Use meds) and Penicillin allergy.   On 30-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021 at 12:45 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of Product Administration). In May 2022, the patient experienced COVID-19 (On day 11 I tested positive again). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (On day 11 I tested positive again) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of Product Administration) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive. On 16-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. It was reported that patient took Paxlovid and it eased symptoms of chest pressure, coughing, headache and fever within 24 hours. After 5 days patient tested negative for 3 days. On day 11 patient tested positive again with mild cold symptoms. Device Date was reported as 28-May-2022. Company comment This is a spontaneous case concerning a 65-year-old male patient with no relevant medical history reported, who experienced the non-serious, unexpected AESI event of COVID-19, which occurred approximately 5 months after the 3rd dose of mRNA-1273. Inappropriate Schedule of Product Administration was considered an additional event. It was reported that the patient experienced COVID-19, was treated with Paxlovid for 4 days and relieved the symptoms of chest pressure, coughing, headache and fever within 24 hs. After 5 days the patient tested negative for 3 days. On day 11 the patient tested positive again with mild cold symptoms. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-579911 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 65-year-old male patient with no relevant medical history reported, who experienced the non-serious, unexpected AESI event of COVID-19, which occurred approximately 5 months after the 3rd dose of mRNA-1273. Inappropriate Schedule of Product Administration was considered an additional event. It was reported that the patient experienced COVID-19, was treated with Paxlovid for 4 days and relieved the symptoms of chest pressure, coughing, headache and fever within 24 hs. After 5 days the patient tested negative for 3 days. On day 11 the patient tested positive again with mild cold symptoms. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.