Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Tenderness, Vaccine breakthrough infection
Clinical narrative: Tenderness in arm; sore throat; cough; lack of efficacy; I tested positive for COVID-19 on 01DEC2021; breakthrough infection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (breakthrough infection) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AZATHIOPRINE and INFLIXIMAB (INFLECTRA [INFLIXIMAB]) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced VACCINE BREAKTHROUGH INFECTION (breakthrough infection) (seriousness criterion medically significant). 01-Dec-2021, the patient experienced DRUG INEFFECTIVE (lack of efficacy) and COVID-19 (I tested positive for COVID-19 on 01DEC2021). On an unknown date, the patient experienced TENDERNESS (Tenderness in arm), OROPHARYNGEAL PAIN (sore throat) and COUGH (cough). At the time of the report, VACCINE BREAKTHROUGH INFECTION (breakthrough infection), TENDERNESS (Tenderness in arm), OROPHARYNGEAL PAIN (sore throat), COUGH (cough) and COVID-19 (I tested positive for COVID-19 on 01DEC2021) had not resolved and DRUG INEFFECTIVE (lack of efficacy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Dec-2021, SARS-CoV-2 test: positive (Positive) positive.         Treatment medications were not provided.  It was reported the symptoms are ongoing  Company Comment includes This spontaneous case concerns a 64-year-old male patient with medical history of Concomitant medication AZATHIOPRINE and INFLIXIMAB, who experienced non-serious unexpected event of special interest (AESI) COVID-19 on 01-Dec-2021.  The event occurred more than eight months after the second dose of properly scheduled second dose of mRNA-1273 vaccine and unexpected nonserious events of Infection, Tenderness, Oropharyngeal pain and Cough. Drug ineffective is also noted in this case. The interval between the first two doses of vaccines was of 28 days. Concomitant medication AZATHIOPRINE and INFLIXIMAB from the patient's medical history remains confounder for the case. The rechallenge is not applicable, as the event happened only after the second dose. The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case concerns a 64-year-old male patient with medical history of Concomitant medication AZATHIOPRINE and INFLIXIMAB, who experienced non-serious unexpected event of special interest (AESI) COVID-19 on 01-Dec-2021.  The event occurred more than eight months after the second dose of properly scheduled second dose of mRNA-1273 vaccine and unexpected nonserious events of Infection, Tenderness, Oropharyngeal pain and Cough. Drug ineffective is also noted in this case. The interval between the first two doses of vaccines was of 28 days. Concomitant medication AZATHIOPRINE and INFLIXIMAB from the patient's medical history remains confounder for the case. The rechallenge is not applicable, as the event happened only after the second dose. The benefit-risk relationship of drug is not affected by this report.