Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Paranasal sinus discomfort, SARS-CoV-2 test
Clinical narrative: cough; COVID-19; sinus pressure; headache; This spontaneous case was reported by a consumer and describes the occurrence of PARANASAL SINUS DISCOMFORT (sinus pressure), HEADACHE (headache), COUGH (cough) and COVID-19 (COVID-19) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.     Previously administered products included for Prophylactic vaccination: JANSSEN COVID-19 VACCINE (Suspension for injection, batch number 1808982 and date of expiry was 21-Sep-2021. Patient received vaccine on left arm. Suspected covid-19 infection.) on 07-Apr-2021. Past adverse reactions to the above products included Vaccination failure with JANSSEN COVID-19 VACCINE.    On 06-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2022, the patient experienced PARANASAL SINUS DISCOMFORT (sinus pressure) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). On 24-Jan-2022, the patient experienced COVID-19 (COVID-19) (seriousness criterion medically significant). On 29-Jan-2022, the patient experienced COUGH (cough) (seriousness criterion medically significant). On 26-Jan-2022, PARANASAL SINUS DISCOMFORT (sinus pressure) and HEADACHE (headache) had resolved. On 30-Jan-2022, COUGH (cough) and COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.         No past medical history or concurrent condition was reported. No concomitant medications were reported. Treatment medication was not provided. Patient received booster vaccination with mRNA-1273. This report was associated with product quality complaint 90000216251.  Company comment: This case concerns a 40-year-old male patient with no medical history reported and interchange of vaccine products JANSSEN COVID-19 VACCINE with reported vaccination failure, who experienced the unexpected serious (medically significant according to authority report), event of COVID-19 (adverse event of special interest) 2 months 19 days after the second dose of mRNA-1273 vaccine. Additionally the patient experienced paranasal sinus discomfort, headache and cough. The patient received JANSSEN COVID-19 VACCINE (interchange of vaccine products) 7 months prior to mRNA-1273 vaccine. SARS-CoV-2 test: positive was Positive. Treatment  not reported.  Outcome reported as resolved. COVID-19 pandemic is a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 40-year-old male patient with no medical history reported and interchange of vaccine products JANSSEN COVID-19 VACCINE with reported vaccination failure, who experienced the unexpected serious (medically significant according to authority report), event of COVID-19 (adverse event of special interest) 2 months 19 days after the second dose of mRNA-1273 vaccine. Additionally the patient experienced paranasal sinus discomfort, headache and cough. The patient received JANSSEN COVID-19 VACCINE (interchange of vaccine products) 7 months prior to mRNA-1273 vaccine. SARS-CoV-2 test: positive was Positive. Treatment  not reported.  Outcome reported as resolved. COVID-19 pandemic is a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.