Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Overdose, SARS-CoV-2 test
Clinical narrative: She got sick on 28Dec2021 with covid; Inappropriate schedule of vaccine administered (3rd dose was not approved On 02 OCT 2021); 3rd dose was same as the 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of OVERDOSE (3rd dose was same as the 2nd dose), COVID-19 (She got sick on 28Dec2021 with covid) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (3rd dose was not approved On 02 OCT 2021)) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A, 031M20A and 030M20A) for COVID-19 vaccination.     The patient was not an immunocompromised. The patient had no allergies.  Concurrent medical conditions included Blood pressure high and Cholesterol. Concomitant products included LOSARTAN for Blood pressure high, ATORVASTATIN for Cholesterol.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced OVERDOSE (3rd dose was same as the 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (3rd dose was not approved On 02 OCT 2021)). On 28-Dec-2021, the patient experienced COVID-19 (She got sick on 28Dec2021 with covid). At the time of the report, OVERDOSE (3rd dose was same as the 2nd dose), COVID-19 (She got sick on 28Dec2021 with covid) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (3rd dose was not approved On 02 OCT 2021)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: (Positive) Positive.         No treatment information was provided.  Company comment- This spontaneous case concerns an 87-year-old female patient with no reported medical history, who experienced the unexpected, non-serious AESI COVID-19 (with a positive SARS-CoV-2 test) that occurred 2 months and 26 days after receiving the third dose of mRNA-1273 Vaccine. The interval between the first and second doses of mRNA was noted to be 28 days. Additionally, Inappropriate schedule of product administration was captured since the patient was given a booster dose prior to approval of booster dose administration and she was given the same dose as her second dose, hence Overdose was also captured.  Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-609541 (Linked Report).; Sender's Comments: This spontaneous case concerns an 87-year-old female patient with no reported medical history, who experienced the unexpected, non-serious AESI COVID-19 (with a positive SARS-CoV-2 test) that occurred 2 months and 26 days after receiving the third dose of mRNA-1273 Vaccine. The interval between the first and second doses of mRNA was noted to be 28 days. Additionally, Inappropriate schedule of product administration was captured since the patient was given a booster dose prior to approval of booster dose administration and she was given the same dose as her second dose, hence Overdose was also captured.  Outcome of the events was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. MOD-2022-609541:Other People Case