Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Nausea, Vaccination failure
Clinical narrative: vaccination failure; nauseous; headache; Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19), VACCINATION FAILURE (vaccination failure), NAUSEA (nauseous) and HEADACHE (headache) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A, 083J21A and 048A21A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 respiratory infection in February 2021. Concurrent medical conditions included Rheumatoid arthritis, Hyperkalemia and Immunocompromised.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid-19). On an unknown date, the patient experienced VACCINATION FAILURE (vaccination failure), NAUSEA (nauseous) and HEADACHE (headache). The patient was treated with PREDNISONE at an unspecified dose and frequency; DEXLANSOPRAZOLE (DEXILANT) at an unspecified dose and frequency; VENLAFAXINE HYDROCHLORIDE (EFFEXOR) at an unspecified dose and frequency; LAMOTRIGINE (LAMICTAL) at an unspecified dose and frequency; POTASSIUM CHLORIDE at a dose of 40 meq three times daily and MOLNUPIRAVIR (LAGEVRIO) at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) and VACCINATION FAILURE (vaccination failure) outcome was unknown and NAUSEA (nauseous) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, COVID-19: second Moderna Covid-19 infection in mid February 2021. On 01-Dec-2022, COVID-19: third Covid-19 infection on December 1, 2022.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant products reported.  It was reported that patient received her first Moderna Covid 19 vaccine primary series and had no adverse reactions. The patient received her second Moderna Covid 19 vaccine primary series and felt nauseous and had a bad headache The patient was immunocompromised and received her third full dose of Moderna Covid 19 vaccine booster dose and had no adverse reactions. The patient caught Covid-19 on 28 Dec 2021. The patient had a second Moderna Covid-19 infection in mid February 2021. The patient had a third Covid-19 infection on 01 Dec 2022.  Company Comment: This spontaneous case concerns a 45-year-old female patient with a medical history of immunocompromised, who experienced the unexpected, non-serious event of COVID-19 which occurred approximately 8 months 16 days after second dose of mRNA-1273 vaccine. Vaccination failure is also noted in this case as the interval between the first and second doses was approximately 28 days. Patient also experienced non-serious events of Nausea and Headache after the second dose of mRNA-1273 vaccine. No further information on clinical course, investigations and treatment received was available in the report. The current pandemic of Covid-19 and patients' medical history could be confounding for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 45-year-old female patient with a medical history of immunocompromised, who experienced the unexpected, non-serious event of COVID-19 which occurred approximately 8 months 16 days after second dose of mRNA-1273 vaccine. Vaccination failure is also noted in this case as the interval between the first and second doses was approximately 28 days. Patient also experienced non-serious events of Nausea and Headache after the second dose of mRNA-1273 vaccine. No further information on clinical course, investigations and treatment received was available in the report. The current pandemic of Covid-19 and patients' medical history could be confounding for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.