Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19 (Nasal sinus congestion and drainage); Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Treatment of COVID-19 (Nasal sinus congestion and drainage)) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Prostate cancer (remission), Heart valve replacement and Aortic valve repair. Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 1 Batch No: Unknown. Location of injection: Arm Left Vaccine Administration Time: 12:00 PM) on 12-Feb-2021, Pfizer / BioNTech (Dose Number: 2 Batch No: Unknown. Location of injection: Arm Left Vaccine Administration Time: 12:00 PM) on 05-Mar-2021 and Pfizer / BioNTech (Dose Number: 3 Batch No: Unknown. Location of injection: Arm Left Vaccine Administration Time: 02:00 PM) on 01-Sep-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Allergy (Name of drug was not reported).    On 11-Apr-2022 at 1:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Treatment of COVID-19 (Nasal sinus congestion and drainage)) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, COVID-19 (Treatment of COVID-19 (Nasal sinus congestion and drainage)) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Co-suspect was reported as Pfizer for the indication of Treatment of COVID-19 with the administration start date 19-MAY-2022 and last administration date 24-MAY-2022. It was reported that patient was not taking other medications or products within 2 weeks of starting COVID-19 treatment.  Company comment: This spontaneous case concerns a 73-years-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Treatment of COVID-19 -Nasal sinus congestion and drainage) which occurred on unspecified day after the fourth dose of mRNA-1273 vaccine. It was noted that patient received 3 doses with Pfizer / BioNTech 7 months 10 days prior to current vaccination(Interchange of vaccine products).Ongoing Covid 19 pandemic and interchange of vaccine products 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.; Sender's Comments: This spontaneous case concerns a 73-years-old male patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Treatment of COVID-19 -Nasal sinus congestion and drainage) which occurred on unspecified day after the fourth dose of mRNA-1273 vaccine. It was noted that patient received 3 doses with Pfizer / BioNTech 7 months 10 days prior to current vaccination(Interchange of vaccine products).Ongoing Covid 19 pandemic and interchange of vaccine products 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.