Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; Lack of drug effect; patient received 3rd full dose, unknown immunocompromised status; after getting the third dose of vaccine she experienced allergic reaction from shoulder to elbow; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19), DRUG INEFFECTIVE (Lack of drug effect), ACCIDENTAL OVERDOSE (patient received 3rd full dose, unknown immunocompromised status) and HYPERSENSITIVITY (after getting the third dose of vaccine she experienced allergic reaction from shoulder to elbow) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 028l20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (patient received 3rd full dose, unknown immunocompromised status) and HYPERSENSITIVITY (after getting the third dose of vaccine she experienced allergic reaction from shoulder to elbow). On 15-Dec-2021, the patient experienced COVID-19 (tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (tested positive for COVID-19), DRUG INEFFECTIVE (Lack of drug effect), ACCIDENTAL OVERDOSE (patient received 3rd full dose, unknown immunocompromised status) and HYPERSENSITIVITY (after getting the third dose of vaccine she experienced allergic reaction from shoulder to elbow) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2021, SARS-CoV-2 test: positive (Positive) positive. On 17-Dec-2021, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, Allergy test: penicillin penicillin.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not mention any immunocompromised disease or diagnosis.   No concomitant medication was reported by the patient.   The patient also mentioned about getting a treatment of unknown infusion on 15-Oct-2021. The patient received monoclonal antibodies because of COVID-19 (last was on 22-Dec-2021).  The patient's rheumatologist recommended that she should get 4 shots of the Moderna COVID-19 vaccine.  Company Comment: This spontaneous case of Accidental overdose and Drug ineffective, concerns a 67-year-old female patient, with relevant medical history of Penicillin allergy and previous vaccinations of mRNA-1273, who experienced the unexpected AESI of COVID-19, approximately 11 months 3 days after receiving the third dose of mRNA-1273, while the expected event of Hypersensitivity occurred on the same day of the third dose. The outcome of the events was unknown. It was reported that the patient received monoclonal antibodies because of COVID-19 (last was on 22-Dec-2021). The patient's immunocompromised status was not reported however, her rheumatologist recommended that she should get 4 shots of the Moderna COVID-19 vaccine. The patient's medical history of Penicillin allergy and previous vaccinations of mRNA-1273, remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case of Accidental overdose and Drug ineffective, concerns a 67-year-old female patient, with relevant medical history of Penicillin allergy and previous vaccinations of mRNA-1273, who experienced the unexpected AESI of COVID-19, approximately 11 months 3 days after receiving the third dose of mRNA-1273, while the expected event of Hypersensitivity occurred on the same day of the third dose. The outcome of the events was unknown. It was reported that the patient received monoclonal antibodies because of COVID-19 (last was on 22-Dec-2021). The patient's immunocompromised status was not reported however, her rheumatologist recommended that she should get 4 shots of the Moderna COVID-19 vaccine. The patient's medical history of Penicillin allergy and previous vaccinations of mRNA-1273, remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.