Sex: M
Vaccine: TDAP
Symptoms: Anaphylactic shock, Dysstasia, Fall, Feeling cold, Loss of consciousness
Clinical narrative: suffered anaphylactic shock; big fall white attempted riding my bicycle in town during family visit; could not stand on my feet; felt extremely cold; i woke up, felt pain all over my body; passed out; Initial information received on 31-Oct-2024 regarding an unsolicited valid serious Courtesy case received from a other health professional.  This case involves an unknown age male patient (14.732 cm and 101.9 kg) who passed out, suffered anaphylactic shock, big fall while attempted riding my bicycle in town during family visit, woke up, felt pain all over body, could not stand on feet and felt extremely cold after receiving 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 Drug hypersensitivity with bupivacaine, COVID-19 vaccine, mRNA-1273, LNP-S (moderna), Covid-19 vaccine, mRNA, cx-024414, LNP-S (Moderna), dapagliflozin, fentanyl, influenza a (H1N1) virus vaccine monovalent 2009, methylprednisolone, Opioids-Meperidine and Related, Polyethylene Glycol Analogues, preservative free, Tdap.   On an unknown date in Jun-2021, the patient received a dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine (lot number, strength, dose and expiry not reported) via unknown route in unknown administration site as prophylactic vaccination.  On 14-JUN-2021 the patient suffered anaphylactic shock (anaphylactic shock) ,big fall white attempted riding his bicycle in town during family visit (fall) (latency: few days approximately) following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine. On an unknown date in 2021 the patient passed out while talking to his son (loss of consciousness) and when he woke up, felt pain all over his body (pain), could not stand on his feet (dysstasia) and quickly layed down on floor where he could not get up for almost 2 hours and felt extremely cold (feeling cold) as if he was experiencing thyroid disorder (unknown latency) following the administration of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the events.  Seriousness: Medically significant for loss of consciousness and anaphylactic shock .; Sender's Comments: Sanofi company comment for information received on 05-NOV-2024: This case involves an unknown age male patient (14.732 cm and 101.9 kg) who passed out and suffered anaphylactic shock after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel]. Further information regarding medical history, concomitant medication and tolerance,  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. Additionally previous history of drug hypersensitivity to many products could be confounding factor.