Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: breakthrough case of COVID-19/ Patient had COVID-19 infection 10 days ago; patient received second dose 8 months after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (breakthrough case of COVID-19/ Patient had COVID-19 infection 10 days ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received second dose 8 months after first dose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A, 001C21A and 025120-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concomitant products included ESTRADIOL, CALCIUM, ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN A NOS, VITAMIN B NOS, VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received second dose 8 months after first dose). In February 2022, the patient experienced COVID-19 (breakthrough case of COVID-19/ Patient had COVID-19 infection 10 days ago). In February 2022, COVID-19 (breakthrough case of COVID-19/ Patient had COVID-19 infection 10 days ago) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received second dose 8 months after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, Body temperature: 101 (High) 101° F. In February 2022, SARS-CoV-2 test: positive (Positive) positive.         Patient had no allergy.   It was reported that patient had symptoms as fever for 2 days of 101° F and sore throat. She was already recovered  Treatment: patient did not take aspirin a couple of days while she had fever. She took no medication for COVID, it was not that bad.  Company Comment: This spontaneous case concerns an 81-year-old female patient with no medical history reported, who experienced the non-serious unexpected event of COVID-19. The event occurred in an unknown date during the same month of the administration of a booster dose of mRNA-1273 and the outcome at the time of the report was Recovered/Resolved. Also, Inappropriate schedule of product administration was added as an event in this case (time between dose number 1 and 2 was 7 months and 23 days and the booster dose was administered 4 months and 3 days after the second dose of the vaccine). The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-500125.; Sender's Comments: This spontaneous case concerns an 81-year-old female patient with no medical history reported, who experienced the non-serious unexpected event of COVID-19. The event occurred in an unknown date during the same month of the administration of a booster dose of mRNA-1273 and the outcome at the time of the report was Recovered/Resolved. Also, Inappropriate schedule of product administration was added as an event in this case (time between dose number 1 and 2 was 7 months and 23 days and the booster dose was administered 4 months and 3 days after the second dose of the vaccine). The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.