Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: I initially had COVID symptoms on the evening of May 08; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I initially had COVID symptoms on the evening of May 08) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy.   On 25-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-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 18-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 08-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (I initially had COVID symptoms on the evening of May 08). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 14-May-2022 for COVID-19 treatment, at an unspecified dose and frequency and CHLORPHENAMINE MALEATE, PARACETAMOL (CORICIDIN HBP COLD AND FLU) on 21-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (I initially had COVID symptoms on the evening of May 08) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medication were reported.  Pfizer had permission to contact patient about this report.  It was reported that the patient did not take any other medications or products within 2 weeks of starting COVID-19 treatment. The patient reported having a rebound of COVID-19 and still testing positive and initially had COVID symptoms on the evening of May 08. Device date was reported as 21-May-2022.  Company Comment: This is a spontaneous case concerning a 46-year-old male patient with no relevant medical history, who experienced the unexpected non-serious, adverse event of special interest, COVID-19 which occurred approximately 2 months after receiving the second dose of mRNA-1273 Vaccine. This is also a case of Inappropriate Schedule of Vaccination since the interval between the two doses was 52 days. As reported, the patient reported having a rebound of COVID-19 and still testing positive and initially had COVID symptoms on the evening of May 08. The patient was treated with Paxlovid and Corricidin HBP. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The events were considered related to the product per the reporter's assessment.   This case was linked to MOD-2022-574859 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 46-year-old male patient with no relevant medical history, who experienced the unexpected non-serious, adverse event of special interest, COVID-19 which occurred approximately 2 months after receiving the second dose of mRNA-1273 Vaccine. This is also a case of Inappropriate Schedule of Vaccination since the interval between the two doses was 52 days. As reported, the patient reported having a rebound of COVID-19 and still testing positive and initially had COVID symptoms on the evening of May 08. The patient was treated with Paxlovid and Corricidin HBP. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The events were considered related to the product per the reporter's assessment.