Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: had a positive test; received booster instead of primary third dose; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had a positive test) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received booster instead of primary third dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised and CLL (Due to the nature of this type of cancer, CLL is a chronic type  that could not have just occurred after mRNA-1273 vaccination). Concomitant products included ALPRAZOLAM (XANAX) for Insomnia.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (had a positive test) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received booster instead of primary third dose). At the time of the report, COVID-19 (had a positive test) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received booster instead of primary third dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Reported that patient was taking cancer medication. Reported that Xanax was the only reason she sleeps.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This spontaneous case concerns a female patient of an unknown age with concurrent Chronic lymphocytic leukaemia, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 on an unknown date after receiving a booster dose of mRNA-1273 vaccine given as third in the COVID-19 vaccination series.  Onset latency could not be determined as date of event onset was not reported. SARS-CoV-2 test was positive on an unknown date.  Patient previously received a 2-dose primary series of mRNA-1273 vaccine given at unknown dates and interval. The concurrent Chronic lymphocytic leukaemia  remains a confounder due to the immunocompromised status that could predispose to  infections such as COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age with concurrent Chronic lymphocytic leukaemia, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 on an unknown date after receiving a booster dose of mRNA-1273 vaccine given as third in the COVID-19 vaccination series.  Onset latency could not be determined as date of event onset was not reported. SARS-CoV-2 test was positive on an unknown date.  Patient previously received a 2-dose primary series of mRNA-1273 vaccine given at unknown dates and interval. The concurrent Chronic lymphocytic leukaemia  remains a confounder due to the immunocompromised status that could predispose to  infections such as COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.