Age: 14.0
Sex: F
Vaccine: COVID19, PNC
Symptoms: Blood glucose, Blood glucose increased, Blood ketone body, Blood ketone body increased, Body temperature
Clinical narrative: daughter's blood sugar started to increase; She had very big ketones; hand and arm started to get cold; inflammation at the injection site that was 4 inch wide and was raised and red; she developed a fever of 102F; She started throwing up/ the daughter was still throwing up; severe headache at the front of her head; inflammation in the arm turned into cellulitis and had travelled from the injection site all the way down to her elbow; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE CELLULITIS (inflammation in the arm turned into cellulitis and had travelled from the injection site all the way down to her elbow), VACCINATION SITE INFLAMMATION (inflammation at the injection site that was 4 inch wide and was raised and red), PYREXIA (she developed a fever of 102F), VOMITING (She started throwing up/ the daughter was still throwing up), HEADACHE (severe headache at the front of her head), BLOOD GLUCOSE INCREASED (daughter's blood sugar started to increase), BLOOD KETONE BODY INCREASED (She had very big ketones) and PERIPHERAL COLDNESS (hand and arm started to get cold) in a 14-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Pneumococcal vaccine conj 7v (CRM197) (Prevnar) for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer (she had only Pfizer in the past). Past adverse reactions to the above products included No adverse effect with Pfizer. Concurrent medical conditions included Type 1 diabetes mellitus, Asthma and Celiac disease.   On 18-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and dose of Pneumococcal vaccine conj 7v (CRM197) (Prevnar) (unknown route) 1 dosage form. In October 2024, the patient experienced VACCINATION SITE CELLULITIS (inflammation in the arm turned into cellulitis and had travelled from the injection site all the way down to her elbow) (seriousness criterion hospitalization) and PERIPHERAL COLDNESS (hand and arm started to get cold) (seriousness criterion hospitalization). On 18-Oct-2024, the patient experienced VACCINATION SITE INFLAMMATION (inflammation at the injection site that was 4 inch wide and was raised and red) (seriousness criterion hospitalization), PYREXIA (she developed a fever of 102F) (seriousness criterion hospitalization), VOMITING (She started throwing up/ the daughter was still throwing up) (seriousness criterion hospitalization), HEADACHE (severe headache at the front of her head) (seriousness criterion hospitalization), BLOOD GLUCOSE INCREASED (daughter's blood sugar started to increase) (seriousness criterion hospitalization) and BLOOD KETONE BODY INCREASED (She had very big ketones) (seriousness criterion hospitalization). The patient was hospitalized from 20-Oct-2024 to 23-Oct-2024 due to HEADACHE, PYREXIA, VACCINATION SITE CELLULITIS, VACCINATION SITE INFLAMMATION and VOMITING. The patient was treated with Paracetamol (Tylenol) in October 2024 for Fever, at an unspecified dose and frequency; Cefalexin (Keflex) (intravenous use) in October 2024 for Cellulitis, at an unspecified dose and frequency and Cefalexin (Keflex) (oral use) from October 2024 to 27-Oct-2024 for Cellulitis, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE CELLULITIS (inflammation in the arm turned into cellulitis and had travelled from the injection site all the way down to her elbow), VACCINATION SITE INFLAMMATION (inflammation at the injection site that was 4 inch wide and was raised and red), PYREXIA (she developed a fever of 102F), VOMITING (She started throwing up/ the daughter was still throwing up), HEADACHE (severe headache at the front of her head), BLOOD GLUCOSE INCREASED (daughter's blood sugar started to increase), BLOOD KETONE BODY INCREASED (She had very big ketones) and PERIPHERAL COLDNESS (hand and arm started to get cold) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2024, Blood ketone body: had very big ketones. On 18-Oct-2024, Blood glucose: blood sugar started to increase. On 18-Oct-2024, Body temperature: 102F.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Patient had no know drug allergies. No concomitant medication was reported.  Reporter stated that, her daughter had a pediatrician's appointment for asthma checkup and after that she received her Moderna COVID vaccine and Prevnar vaccine, the caller then stated that both the Prevnar and COVID vaccines were taken at the same arm and same spot exactly. Later in the afternoon the arm started to hurt, and she developed a fever of 102F, she also had an inflammation at the injection site that was 4 inch wide and was raised and red. She started throwing up after and had a severe headache at the front of her head. The reporter then stated that her daughter had type 1 diabetes and that the daughter's blood sugar started to increase. The reporter then stated that by 3 am the daughter was still throwing up, the severe headache still continued and the 102 fever was still ongoing and that it had never went down despite the use of Tylenol. She had very big ketones and the reporter tried to bring her blood sugar down.  On 20-Oct-2024, the reporter took her daughter to the hospital emergency, and they took the decision to admit her to prevent her from going into DKA. The caller then mentions that the inflammation in the arm turned into cellulitis and had travelled from the injection site all the way down to her elbow, patient was on IV fluids the whole time to try to get rid of the ketones, which they were able to deal with pretty quickly. But the cellulitis was really challenging. She mentioned that it was so painful. The caller said that the daughter got an IV Keflex treatment for the cellulitis, they then started to find that the hand and arm started to get cold, and they worried that the daughter was developing compartment syndrome but finally that was ruled out and it was confirmed that it was only cellulitis. The daughter then got discharged on 23-Oct-2024 and was prescribed oral Keflex which she finished on 27-Oct-2024.     The reporter said that the cellulitis had cleared but the area was still very tender and looks like a mild bruise. The reporter states that this was the first time her daughter took Moderna, and she had only Pfizer in the past. She was not sure, but this was probably the 4th series of vaccination.; Reporter's Comments: The concurrent condition of diabetes is a contributor for events blood ketone body increased and blood sugar increased; co-suspect Pneumococcal vaccine conj 7v remains a confounder for all the events. The benefit -risk relationship of product is not affected by this report.