Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Device malfunction, Exposure via eye contact, Fatigue, Malaise
Clinical narrative: had fever; chills; fatigue; she did not feel well; HCP stated she was administering the Spikevax vaccine from a SDV to a   patient but due to syringe malfunction (clarified it is not a PFS) the vaccine leaked out and the   patient did not get the full dose; Vaccine splashed in HCP's eye. The HCP flushed her eye   with water for a while; HCP stated she was administering the Spikevax vaccine from a SDV to a   patient but due to syringe malfunction (clarified it is not a PFS) the vaccine leaked out and the   patient did not get the full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (had fever), CHILLS (chills), FATIGUE (fatigue), MALAISE (she did not feel well) and SYRINGE ISSUE (HCP stated she was administering the Spikevax vaccine from a SDV to a   patient but due to syringe malfunction (clarified it is not a PFS) the vaccine leaked out and the   patient did not get the full dose) in a 38-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included Pre-filled Syringe injection for COVID-19 vaccination.    Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:No listed conditions. Caller got COVID-19 a week after getting her last COVID-19 Moderna shot.  Previously administered products included for Drug use for unknown indication: J and J COVID-19 Vaccine (First Dose) in 2021; for COVID-19 vaccination: Moderna (shot during the fall 2021 and another Moderna on fall next year and last Moderna dose on 29-Sep-2023) in 2021. Past adverse reactions to the above products included No adverse event with J and J COVID-19 Vaccine and Moderna.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On 17-Oct-2023, the patient experienced PYREXIA (had fever), CHILLS (chills), FATIGUE (fatigue), MALAISE (she did not feel well), SYRINGE ISSUE (HCP stated she was administering the Spikevax vaccine from a SDV to a   patient but due to syringe malfunction (clarified it is not a PFS) the vaccine leaked out and the   patient did not get the full dose), ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine splashed in HCP's eye. The HCP flushed her eye   with water for a while) and ACCIDENTAL UNDERDOSE (HCP stated she was administering the Spikevax vaccine from a SDV to a   patient but due to syringe malfunction (clarified it is not a PFS) the vaccine leaked out and the   patient did not get the full dose). On 17-Oct-2023, PYREXIA (had fever), CHILLS (chills) and FATIGUE (fatigue) had resolved. At the time of the report, MALAISE (she did not feel well) had resolved and SYRINGE ISSUE (HCP stated she was administering the Spikevax vaccine from a SDV to a   patient but due to syringe malfunction (clarified it is not a PFS) the vaccine leaked out and the   patient did not get the full dose), ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine splashed in HCP's eye. The HCP flushed her eye   with water for a while) and ACCIDENTAL UNDERDOSE (HCP stated she was administering the Spikevax vaccine from a SDV to a   patient but due to syringe malfunction (clarified it is not a PFS) the vaccine leaked out and the   patient did not get the full dose) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter considered PYREXIA (had fever), CHILLS (chills), FATIGUE (fatigue), MALAISE (she did not feel well), SYRINGE ISSUE (HCP stated she was administering the Spikevax vaccine from a SDV to a   patient but due to syringe malfunction (clarified it is not a PFS) the vaccine leaked out and the   patient did not get the full dose), ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine splashed in HCP's eye. The HCP flushed her eye   with water for a while) and ACCIDENTAL UNDERDOSE (HCP stated she was administering the Spikevax vaccine from a SDV to a   patient but due to syringe malfunction (clarified it is not a PFS) the vaccine leaked out and the   patient did not get the full dose) to be not related.    The pharmacist was administered with the Spikevax vaccine from a SDV to a patient but due to syringe malfunction (clarified it is not a PFS) the vaccine leaked out and the patient did not get the full dose, also vaccine splashed in HCP's eye. The HCP flushed her eye with water for a while and she was currently not reporting AES so far, no irritation or red eye. It was reported that for all the shots, the patient had side effects during approximately 24 hours and did not feel well, had fever, chills and fatigue.  No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745970, US-MODERNATX, INC.-MOD-2023-745984 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745970:Different patient same vaccine US-MODERNATX, INC.-MOD-2023-745984:same patient Spikevax NOS