Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; Covid-19 infection/ tested positive in covid-19 pcr; Headache; Congestion; Fatigue; Mild Fever; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 infection/ tested positive in covid-19 pcr), HEADACHE (Headache), NASAL CONGESTION (Congestion), FATIGUE (Fatigue) and PYREXIA (Mild Fever) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No medical history was reported.  The patient had no known allergies.    On 03-Apr-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 07-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced COVID-19 (Covid-19 infection/ tested positive in covid-19 pcr) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), NASAL CONGESTION (Congestion) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and PYREXIA (Mild Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 07-Jan-2022, COVID-19 (Covid-19 infection/ tested positive in covid-19 pcr) had resolved. At the time of the report, HEADACHE (Headache), NASAL CONGESTION (Congestion), FATIGUE (Fatigue), PYREXIA (Mild Fever) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2022, SARS-CoV-2 test: positive (Positive) confirmed covid-19 infection.         No concomitant medications were reported.  It was reported that on 07-Dec-2021, the patient received suspect vaccine MRNA 1273 (dose number in series: 2) (form of admin, route of admin, and batch number were not reported) dose was not reported.  On 05-Jan-2022, the patient visited urgent care clinic and had tested positive in covid-19 PCR (polymerase chain reaction) test which indicated confirmed covid-19 infection and confirmed clinical vaccination failure (dose number in series: 1).  No treatment details were reported.  The other Company (Janssen) company comment was reported as considered not related to their Vaccine. The event (s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event, than the drug. specifically: SPECIAL SITUATIONS.  Company Comment: This regulatory case concerns a 25-year old male patient, with no medical history reported, who experienced the unexpected, serious (Seriousness criterion Medically Significant), AESI event of COVID-19 and the unexpected, serious (Seriousness criterion Medically Significant) events of Headache, Nasal congestion, Fatigue and Pyrexia 28 days after the unknown dose of mRNA-1273. SARS-CoV-2 test was Positive. Patient had previously received COVID-19 VACCINE JANSSEN (Interchange of vaccine products noted). At the time of report, outcome of the event COVID-19 was Resolved and outcome of other events was Unknown. Current COVID-19 Pandemic can be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This regulatory case concerns a 25-year old male patient, with no medical history reported, who experienced the unexpected, serious (Seriousness criterion Medically Significant), AESI event of COVID-19 and the unexpected, serious (Seriousness criterion Medically Significant) events of Headache, Nasal congestion, Fatigue and Pyrexia 28 days after the unknown dose of mRNA-1273. SARS-CoV-2 test was Positive. Patient had previously received COVID-19 VACCINE JANSSEN (Interchange of vaccine products noted). At the time of report, outcome of the event COVID-19 was Resolved and outcome of other events was Unknown. Current COVID-19 Pandemic can be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.