Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: first shot on 1March2021, second shot on 9Nov2021 (unknown lot) and booster on; COVID-19 after booster dose/she was diagnosed with COVID-19; she went to a birthday party and was exposed to COVID. On 12-Nov-2021 she was diagnosed; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 after booster dose/she was diagnosed with COVID-19), EXPOSURE TO SARS-COV-2 (she went to a birthday party and was exposed to COVID. On 12-Nov-2021 she was diagnosed) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first shot on 1March2021, second shot on 9Nov2021 (unknown lot) and booster on) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.  Concomitant products included AMLODIPINE BESILATE (NORVASC), LOSARTAN, BUPROPION HYDROCHLORIDE (WELLBUTRIN), LAMOTRIGINE (LAMICTAL), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), BUPROPION, ATORVASTATIN, ALPRAZOLAM, METFORMIN, LURASIDONE HYDROCHLORIDE (LATUDA), LANSOPRAZOLE, LISINOPRIL, MODAFINIL, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ), CETIRIZINE, HYDROMORPHONE HYDROCHLORIDE (DILAUDID) and IBUPROFEN for an unknown indication.  On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced COVID-19 (COVID-19 after booster dose/she was diagnosed with COVID-19) and EXPOSURE TO SARS-COV-2 (she went to a birthday party and was exposed to COVID. On 12-Nov-2021 she was diagnosed). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first shot on 1March2021, second shot on 9Nov2021 (unknown lot) and booster on). At the time of the report, COVID-19 (COVID-19 after booster dose/she was diagnosed with COVID-19) and EXPOSURE TO SARS-COV-2 (she went to a birthday party and was exposed to COVID. On 12-Nov-2021 she was diagnosed) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first shot on 1March2021, second shot on 9Nov2021 (unknown lot) and booster on) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2021, SARS-CoV-2 test: diagnosed with covid-19 (Positive) diagnosed with COVID-19.     The concomitant modafinil was discontinued. Treatment medication use was not provided by the reporter.  This is a spontaneous case concerning a 72-year-old female patient with no reported medical history, who experienced the non-serious unexpected AESI event of COVID-19. The event occurred 4 days after the second dose of mRNA-1273 vaccine administration. Causality for the event of COVID-19 was not applicable to the product administration. The rechallenge was not applicable since the event occurred after the second dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 72-year-old female patient with no reported medical history, who experienced the non-serious unexpected AESI event of COVID-19. The event occurred 4 days after the second dose of mRNA-1273 vaccine administration. Causality for the event of COVID-19 was not applicable to the product administration. The rechallenge was not applicable since the event occurred after the second dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.