Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Interchange of vaccine products, Malaise, Nasal congestion
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MALAISE (Not feeling well), PRODUCTIVE COUGH (Wet Cough), NASAL CONGESTION (Congestion), OROPHARYNGEAL PAIN (Sore throat), VACCINATION FAILURE (Suspected clinical vaccination failure) and COVID-19 (Suspected Covid-19 infection) in a 51-year-old female 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) (COVID-19 VACCINE JANSSEN) for Prophylactic vaccination. No Medical History information was reported. On 23-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) (unknown route) 1 dosage form. On 29-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2022, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and COVID-19 (Suspected Covid-19 infection) (seriousness criterion medically significant). On 22-Mar-2022, the patient experienced MALAISE (Not feeling well) (seriousness criterion medically significant), PRODUCTIVE COUGH (Wet Cough) (seriousness criterion medically significant), NASAL CONGESTION (Congestion) (seriousness criterion medically significant) and OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant). On 24-Mar-2022, the patient experienced VACCINATION FAILURE (Suspected clinical vaccination failure) (seriousness criterion medically significant). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, HEADACHE (Headache), MALAISE (Not feeling well), PRODUCTIVE COUGH (Wet Cough), NASAL CONGESTION (Congestion), OROPHARYNGEAL PAIN (Sore throat), VACCINATION FAILURE (Suspected clinical vaccination failure) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown and COVID-19 (Suspected Covid-19 infection) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2022, SARS-CoV-2 test: positive (Positive) Positive. The patient had no known drug allergies. There was no drug abuse or Illicit drug usage. The Patient was not pregnant at the time of reporting. No concomitant medications were reported. No treatment drug information was provided. The patient had not taken any medication for symptoms. Planned for consult a doctor virtually for symptoms, didn't want to visit the doctor's office at that point. This report was associated with a product quality complaint for COVID-19 VACCINE JANSSEN as 90000223502. Company Comment: This spontaneous case concerns a 51-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) AESI of COVID-19, unexpected serious (medically significant) events of Headache, Malaise, Productive cough, Nasal congestion, and Oropharyngeal pain. Vaccination failure was also reported. The events Headache and COVID-19 occurred approximately 4 months 22 days after receiving the mRNA-1273 vaccine as 2nd dose. The next day, patient experienced Malaise, Productive cough, Nasal congestion, and Oropharyngeal pain and condition was getting worse. No medications taken. SARS-COV-2 test reported positive. The patient had previously received COVID-19 VACCINE JANSSEN as a primary series approximately 1 year prior to the events onset. Patient received heterologous vaccines (Interchange of vaccine products), therefore lack of efficacy cannot be concluded for this case. At the time of reporting, the outcome of event COVID-19 was not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2022-535314. Sender's Comments: This spontaneous case concerns a 51-year-old female patient, with no reported medical history, who experienced the unexpected serious (medically significant) AESI of COVID-19, unexpected serious (medically significant) events of Headache, Malaise, Productive cough, Nasal congestion, and Oropharyngeal pain. Vaccination failure was also reported. The events Headache and COVID-19 occurred approximately 4 months 22 days after receiving the mRNA-1273 vaccine as 2nd dose. The next day, patient experienced Malaise, Productive cough, Nasal congestion, and Oropharyngeal pain and condition was getting worse. No medications taken. SARS-COV-2 test reported positive. The patient had previously received COVID-19 VACCINE JANSSEN as a primary series approximately 1 year prior to the events onset. Patient received heterologous vaccines (Interchange of vaccine products), therefore lack of efficacy cannot be concluded for this case. At the time of reporting, the outcome of event COVID-19 was not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-535314:20220353513 (Crosslinked IDs for same reporter).