Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, SARS-CoV-2 test, Tinnitus
Clinical narrative: Got COVID-19; Lack of drug effect; Immunocompromised but got booster for third dose; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Got COVID-19), DRUG INEFFECTIVE (Lack of drug effect) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Immunocompromised but got booster for third dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 030M20A and 026L20A) for COVID-19 vaccination.     The patient's past medical history included Vertigo. Concurrent medical conditions included Immunocompromised (she has been receiving IgG for many years.), Latex allergy, Drug allergy (NSAIDs allergy), Iodine allergy, Food allergy, Migraine and Tinnitus (Mild Tinnitus for close to 10 yrs, recent change in status reported as worse tinnitus).   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Immunocompromised but got booster for third dose). On 12-Jan-2022, the patient experienced COVID-19 (Got COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Got COVID-19), DRUG INEFFECTIVE (Lack of drug effect) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Immunocompromised but got booster for third dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient administered Influenza vaccine in September 2021 for unknown indication.  No concomitant medication information was provided. No treatment medication were provided.  Company Comment:  This spontaneous case concerns a 64-year-old female patient in Immunocompromised state (she has been receiving IgG for many years), who experienced the unexpected non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test), that occurred 4 months and 29 days after receiving the first booster dose of mRNA-1273 vaccine (third in the COVID-19 vaccine schedule). Additionally, Drug ineffective was also reported. Patient previously received 2 doses of Moderna COVID-19 vaccines given at an interval of 28 days. Patient is immunocompromised but has reported the current mRNA-1273 vaccine as the first booster dose (not as third dose in the primary series) which was administered 6 months and 10 days after the second dose of mRNA-1273 vaccine. The concurrent Immunocompromised state (she has been receiving IgG for many years) remains a confounder.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-560521 (Patient Link).; Sender's Comments: This spontaneous case concerns a 64-year-old female patient in Immunocompromised state (she has been receiving IgG for many years), who experienced the unexpected non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test), that occurred 4 months and 29 days after receiving the first booster dose of mRNA-1273 vaccine (third in the COVID-19 vaccine schedule). Additionally, Drug ineffective was also reported. Patient previously received 2 doses of Moderna COVID-19 vaccines given at an interval of 28 days. Patient is immunocompromised but has reported the current mRNA-1273 vaccine as the first booster dose (not as third dose in the primary series) which was administered 6 months and 10 days after the second dose of mRNA-1273 vaccine. The concurrent Immunocompromised state (she has been receiving IgG for many years) remains as a confounder.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.