Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product packaging quantity issue, Tremor, Vaccination site haemorrhage, Vomiting
Clinical narrative: bled from the site way more than other times; Experienced freezing, temperature of 103F; Caller says the HCP told them that they believe this happened because of the way the vaccine is labeled. Each vial is labeled as a single dose of 0.25mL but there is 0.5mL in the vial.; Caller says the HCP told them that they believe this happened because of the way the vaccine is labeled. Each vial is labeled as a single dose of 0.25mL but there is 0.5mL in the vial.; shaking uncontrollably; injected with a nearly adult dose; body pains; experienced puking, vomiting 5 or 6 times; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TREMOR (shaking uncontrollably) in a 10-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.     Patient had no known allergies. The reporter did not have the vaccination card at the time but reported that every available COVID-19 dose had been given to the patient.  Previously administered products included for Product used for unknown indication: FLU VACCINE VII (Flut shot). Past adverse reactions to the above products included No adverse event with FLU VACCINE VII. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for an unknown indication.   On 11-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 11-Oct-2023, the patient experienced TREMOR (shaking uncontrollably) (seriousness criterion medically significant), PAIN (body pains), VOMITING (experienced puking, vomiting 5 or 6 times) and OVERDOSE (injected with a nearly adult dose). On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (bled from the site way more than other times), PYREXIA (Experienced freezing, temperature of 103F), PRODUCT LABEL CONFUSION (Caller says the HCP told them that they believe this happened because of the way the vaccine is labeled. Each vial is labeled as a single dose of 0.25mL but there is 0.5mL in the vial.) and PRODUCT PACKAGING QUANTITY ISSUE (Caller says the HCP told them that they believe this happened because of the way the vaccine is labeled. Each vial is labeled as a single dose of 0.25mL but there is 0.5mL in the vial.). At the time of the report, TREMOR (shaking uncontrollably), VACCINATION SITE HAEMORRHAGE (bled from the site way more than other times), PAIN (body pains), VOMITING (experienced puking, vomiting 5 or 6 times), PYREXIA (Experienced freezing, temperature of 103F), OVERDOSE (injected with a nearly adult dose), PRODUCT LABEL CONFUSION (Caller says the HCP told them that they believe this happened because of the way the vaccine is labeled. Each vial is labeled as a single dose of 0.25mL but there is 0.5mL in the vial.) and PRODUCT PACKAGING QUANTITY ISSUE (Caller says the HCP told them that they believe this happened because of the way the vaccine is labeled. Each vial is labeled as a single dose of 0.25mL but there is 0.5mL in the vial.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 F.  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.   Concomitant medication details included dose of 44 mcg of Flovent steroid inhaler.  The patient experienced puking, freezing, temperature of 103-degree Fahrenheit, vomiting 5 or 6 times, body pains, aches, bled from the site way more than other times, might had nicked a vein and was shaking uncontrollably.  The HCP told the reporter that they believed this happened because of the way the vaccine was labeled. Each vial was labeled as a single dose of 0.25 mL dose but there was 0.5 mL dose in the vial.  The reporter's daughter (patient) was injected with a nearly adult dose. They were blaming Moderna for it.  No treatment medications were reported.  Rationale for no investigation was reported as: the paediatric Single Dose Vial (SDV) are filled to the same volume as the adult SDV. However, the final volume for administration varies between the population groups, with paediatrics receiving 0.25ml and adults receiving 0.5ml. In both cases, the final volume of the vial will have a slight overfill. In paediatrics, as only 0.25mL from the total volume is drawn for administration, it is expected to have roughly half the vial content remaining in the vial after drawing. As instructed in the Fact Sheet for Moderna covid-19 vaccine (2023-2024 formula), for individuals 6 months through 11 years of age, section 2 "Dosage and Administration", the vial is to be discarded after single use. Additionally, the Medical Information call center has updated their FAQs for inquiries around the remaining volume in the SDV after drawing the dose.  Company Comment: This is a spontaneous case concerning a 10-year-old female patient with no relevant medical history reported who experienced the unexpected and serious (medically significant) event tremor after a dose of SPIKEVAX 2023-2024 vaccine was administered, exact latency is unknown. It was reported that the caller's daughter was injected with a nearly adult dose.  After caller's daughter received the new Moderna vaccine she experienced puking, freezing, temperature of 103F, vomiting 5 or 6 times, body pains, aches, bled from the site way more than other times, they may have nicked a vein and shaking uncontrollably. It was also reported that caller says the HCP told them that they believe this happened because of the way the vaccine is labeled. Each vial is labeled as a single dose of 0.25mL but there is 0.5mL in the vial. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 30-Oct-2023: Live follow-up received: Closed investigation summary report received, narrative updated, reference numbers added.