Received Feb 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8122AA | OT |
prediabetic and now the diabetes is worse; mouth with numbness; Both backs of my arms were burning; back was burning; From my knees down to my feet I had redness but no itching; I became really sensitive to all medications; does not feel well with blurry vision; sick to his stomach; having Covid; very ill and cannot work; condition aggaravated; mast cells are upside down; face with numbness; Initial information received on 16-Feb-2026 regarding an unsolicited valid serious case received from a consumer/non-hcp (healthcare professional). This case involves a 68 years old male patient who had prediabetic and now the diabetes is worse, face with numbness, mouth with numbness, both backs of my arms were burning, back was burning, from my knees down to my feet i had redness but no itching, i became really sensitive to all medications, does not feel well with blurry vision, sick to his stomach, having covid, very ill and cannot work, condition aggaravated and mast cells are upside down while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. 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 Glucose tolerance impaired. Concomitant medications included Cyanocobalamin (B 12); Magnesium (Magnesium); and Docosahexaenoic acid, Eicosapentaenoic acid (Omega-3). On an unknown date in 2025, the patient received a dose of 0.5ml of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (strength unknown) (lot U8122AA and expiry date- 30-APR-2026) via unknown route in unknown administration site for Immunization. On an unknown date in 2025 the patient developed prediabetic and now the diabetes is worse (diabetes mellitus), face with numbness (hypoaesthesia), mouth with numbness (hypoaesthesia oral), both backs of my arms were burning (pain in extremity), back was burning (back pain), from my knees down to my feet i had redness but no itching (erythema), i became really sensitive to all medications (multiple drug hypersensitivity), does not feel well with blurry vision (vision blurred), sick to his stomach (abdominal discomfort), covid (covid-19), very ill and cannot work (illness) and mast cells are upside down (mastocytosis) (unknown latency). Action taken was not applicable. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome was Not Recovered / Not Resolved for the events. Seriousness Criteria- The event of diabetes mellitus was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 20-Feb-2025: This case involves a 68 years old male patient who had prediabetic and now the diabetes is worse, face with numbness, mouth with numbness, both backs of my arms were burning, back was burning, from my knees down to my feet i had redness but no itching, i became really sensitive to all medications, does not feel well with blurry vision, sick to his stomach, having covid, very ill and cannot work, condition aggaravated and mast cells are upside down while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The temporal relationship shows event onset in 2025, with most events remaining unresolved or with unknown outcomes. The patient had a significant underlying medical history including prediabetes and developed COVID-19 during the reporting period, which represents an important confounding factor. However, critical information is lacking including detailed event chronology, specific onset dates for individual events, laboratory investigations, complete medical history, concomitant medications, family history, patient compliance, allergy history, and clinical course details that would help exclude alternative etiologies. The confounding role of concurrent COVID-19 infection and pre-existing prediabetic condition cannot be overlooked. Based on the limited available information, the causal role of the suspect vaccine cannot be definitively assessed. Comprehensive follow-up information would facilitate proper causality evaluation.
Prediabetes
B 12; Magnesium; Omega-3