Received Mar 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TD | TETANUS DIPHTHERIA (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8021BA | OT |
syncope; constellation of atypical symptoms after the reaction chest vibrations; tachycardia; hypermetabolism; phonophobia; insomnia; severe anxiety; weight loss; hypoglycemic symptoms; Initial information received on 06-Mar-2025 regarding an unsolicited valid serious case received from Health Care Professional. This case involves Adult female patient who experienced syncope, constellation of atypical symptoms after the reaction chest vibrations, tachycardia, hypermetabolism, phonophobia, insomnia, severe anxiety, weight loss and hypoglycemic symptoms after receiving Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult. The patient's past medical history included Post-traumatic stress disorder as she describes as PTSD and general anxiety at one point history consistent with agoraphobia, (Anxiety and Agoraphobia). The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 07-Jul-2024, the patient received unknown dose of suspect Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult, Suspension for injection (lot U8021BA; strength and expiry date not reported) via unknown route in unknown administration site for vaccination. On 07-Jul-2024 (15 mins after vaccination) the patient developed a serious syncope. This event was assessed as medically significant. She went to ED and emergency room physician felt she had vasovagal reaction. She had on 07-Jul-2024 constellation of atypical symptoms after the reaction chest vibrations (chest discomfort), tachycardia, hypermetabolism, phonophobia, insomnia, severe anxiety (anxiety), weight loss (weight decreased) and hypoglycemic symptoms (hypoglycaemia) on same day. Action taken: Not applicable. It was not reported if the patient received a corrective treatment for all the events. At time of reporting, the outcome was Recovered / Resolved on an unknown date for all the events. These symptoms slowly resolved over 2 months. She feels she is better now. No other information was able to be gathered from the HCP.; Sender's Comments: Sanofi Company Comment dated 11-MAR-2025: This case involves Adult female patient who experienced syncope, constellation of atypical symptoms after the reaction chest vibrations, tachycardia, hypermetabolism, phonophobia, insomnia, severe anxiety, weight loss and hypoglycemic symptoms after receiving Diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult. Post-traumatic stress disorder and general anxiety at one point history consistent with agoraphobia could also paly confounding role Further information regarding concurrent condition during vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Medical History/Concurrent Conditions: Agoraphobia; Anxiety; Post-traumatic stress disorder (She was left with what she describes as PTSD and general anxiety at one point history consistent with agoraphobia)