Received May 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 8080748 | OT |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8459MA | OT |
type 1 diabetes mellitus; Diabetic ketoacidosis; low back pain; excessive vomiting; Fatigue; Initial information received on 29-Apr-2025 (Live follow-up processed together) regarding an unsolicited valid serious (courtesy) case received from a consumer/non-healthcare professional. This case involves an unknown age and unknown gender patient who had type 1 diabetes mellitus, diabetic ketoacidosis after receiving Elasomeran [Spikevax] and Influenza USP Trival A-B Subvirion no Preservative Vaccine [Fluzone]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Cleft palate on 13-Jun-2008 and attention deficit hyperactivity disorder on 12-Feb-2020. Concomitant medications included Methylphenidate Hydrochloride (Concerta); Melatonin (Melatonin) and Escitalopram Oxalate (Lexapro) all for attention deficit hyperactivity disorder. On 26-Dec-2024, the patient received 1DF (Dosage form) dose of suspect Influenza Quadrival A-B Multidose Vaccine Preserved, Suspension for injection, lot UT8459MA, for prophylactic vaccination (immunisation) and received 50ug dose of suspect Spikevax, Injection not produced by Sanofi Pasteur lot 8080748 (unknown strength and expiry date) via intramuscular route in unknown administration site for COVID-19 prophylaxis. On 07-Jan-2025 the patient developed fatigue (Latency 12 days). On 08-Jan-2025 the patient developed a non-serious excessive vomiting (vomiting) (Latency 13 days). On 09-Jan-2025 at 02:00 hours, the patient developed low back pain (back pain) and at 03:00 hours, the patient developed type 1 diabetes mellitus and diabetic ketoacidosis (Latency 14 days). Relevant laboratory test results included: Laboratory test - On 09-Jan-2025: [revealed diabetic ketoacidosis] Reportedly, patient was taken to emergency room. Testing revealed DKA (diabetic ketoacidosis) and patient took life flight to health center with concern for brain swelling. Patient received treatment of DKA from 11-Jan-2025 with ongoing type 1 diabetes. Action taken was not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for the event (type 1 diabetes mellitus) and (diabetic ketoacidosis), was Unknown for rest of the events. Seriousness criteria: Both event were assessed as medically significant and The patient was hospitalized for both the events. The patient was discharged on 12-Jan-2025 (hospitalization for 3 days).; Sender's Comments: Sanofi Company Comment dated 06-May-2025,This case involves an unknown age and unknown gender patient who had type 1 diabetes mellitus, diabetic ketoacidosis after receiving Elasomeran [Spikevax] and Influenza USP Trival A-B Subvirion no Preservative Vaccine [Fluzone]. Further information regarding tolerance, allergic history, medical history, and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Concomitant medications included Methylphenidate Hydrochloride (Concerta); Melatonin (Melatonin) and Escitalopram Oxalate (Lexapro) all for attention deficit hyperactivity disorder. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Attention deficit hyperactivity disorder; Cleft palate
CONCERTA; MELATONIN; LEXAPRO
Test Date: 20250109; Test Name: Laboratory test; Result Unstructured Data: revealed DKA