Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: interchange of vaccine products (primary series with Pfizer and booster with Moderna); COVID-19 test positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 test positive) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products (primary series with Pfizer and booster with Moderna)) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 1  Batch/Lot No: EN6202  Location of injection: Arm Right  Vaccine Administration Time: 11:30 AM) on 28-Feb-2021 and Pfizer / BioNTech (Dose Number: 2  Batch/Lot No: Er8727  Location of injection: Arm Left  Vaccine Administration Time: 03:00 PM) on 22-Mar-2021; for Drug use for unknown indication: Gluten. Past adverse reactions to the above products included Celiac disease with Gluten; and No adverse event with Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Sarcoidosis, Pre-diabetic (Prediabetic taking Metformin to control A1C) and Shellfish allergy. Concomitant products included METFORMIN for Pre-diabetic, EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), ROSUVASTATIN CALCIUM (CRESTOR) from an unknown date to 29-Apr-2022 and EZETIMIBE (ZETIA) from an unknown date to 29-Apr-2022 for an unknown indication.    On 13-Nov-2021 at 12:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2022, the patient experienced COVID-19 (COVID-19 test positive). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products (primary series with Pfizer and booster with Moderna)). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 29-Apr-2022 to 04-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 test positive) was resolving and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products (primary series with Pfizer and booster with Moderna)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 04-May-2022, SARS-CoV-2 test: positive (Positive) Pcr positive and negative (Negative) Negative. On 09-May-2022, SARS-CoV-2 test: positive (Positive) Remained negative until 5/9/22. I tested daily. Symptoms reappeared 5/9/22 stuffy nose and mild sore throat. RAT positive on 5/9/22.. On 17-May-2022, SARS-CoV-2 test: positive (Positive) I have been RAT tested every day and tests have remained positive through today 5/17/22. So 5 days RAT positive, 5 days RAT negative, now 9 days. positive. After the rebound, the RAT's became instantly positive with very heavy bright line..         Patient's symptoms were fairly mild, stuffy nose but very severe sore throat. The symptoms abated on day 4. Rapid antigen test negative starting from day 6, but on 04-May-2022 but PCR was positive. Rapid antigen test remained negative until 09-May-2022. Patient tested daily. Symptoms reappeared 09-May-2022, stuffy nose and mild sore throat.  Patient tested positive with rapid antigen test on 09-May-2022. Patient had rapid antigen test every day and tests remained positive through 17-May-2022.  In total 5 days rapid antigen test positive and 5 days rapid antigen test negative, at the time of report 9 days, positive.  After the rebound, the rapid antigen tests became instantly positive with very heavy bright line. The day reporter reported was the first day line appeared softer. Device Date reported as 18-May-2022. Company comment This spontaneous case reported by a 60 year old male patient, with relevant medical history of sarcoidosis, pre diabetes and coeliac disease , who experienced the unexpected, non-serious AESI of covid 19 Infection about 05 months after receiving the 3 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Patient previously received 2 primary doses with Pfizer vaccines with the last dose taken about 07 months prior to the 3 dose. Interchange of Vaccine products was noted. On 28 Apr 2022, patient tested positive for SARS-CoV-2 test and was started on Paxlovid for Covid 19 Infection for 6 days from 29 Apr 2022 till 04 May 2022. On 04-May-2022, SARS-CoV-2 test was positive and it remained negative until 09 May 2022. Symptoms started on 09 May 2022 with stuffy nose and mild sore throat. RAT test was positive on 5/9/22 and remained positive through 5/17/22. The event was resolving. Age of the patient, medical history of pre diabetes and coeliac disease are risk factors and the Ongoing Covid 19 pandemia could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 23-May-2022: Follow-up received include no new information.; Sender's Comments: This spontaneous case reported by a 60 year old male patient, with relevant medical history of sarcoidosis, pre diabetes and coeliac disease , who experienced the unexpected, non-serious AESI of covid 19 Infection about 05 months after receiving the 3 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Patient previously received 2 primary doses with Pfizer vaccines with the last dose taken about 07 months prior to the 3 dose. Interchange of Vaccine products was noted. On 28 Apr 2022, patient tested positive for SARS-CoV-2 test and was started on Paxlovid for Covid 19 Infection for 6 days from 29 Apr 2022 till 04 May 2022. On 04-May-2022, SARS-CoV-2 test was positive and it remained negative until 09 May 2022. Symptoms started on 09 May 2022 with stuffy nose and mild sore throat. RAT test was positive on 5/9/22 and remained positive through 5/17/22. The event was resolving. Age of the patient, medical history of pre diabetes and coeliac disease are risk factors and the Ongoing Covid 19 pandemia could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.