Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | — | OT |
sick; pain radiates to the chest when sleeping; pain in the joint of the arm; sleeping a lot; pain in the arm of administration and pain in the injection site/pain started at the injection site of the left shoulder; that soon after the injection the arm felt like it was burning like being on fire; fever; chills; Initial information received on 20-Feb-2025 regarding an unsolicited valid non-serious case received from a Patient. This case involves a 24 years old female patient who experienced sick, pain radiates to the chest when sleeping, pain in the joint of the arm, sleeping a lot, pain in the arm of administration and pain in the injection site/pain started at the injection site of the left shoulder; that soon after the injection the arm felt like it was burning like being on fire, fever and chills 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. On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, frequency, strength, lot/batch number and expiration date: not provided) for Prophylactic vaccination (immunization). On an unknown date the patient developed sick (illness), pain radiates to the chest when sleeping (chest pain), pain in the joint of the arm (pain in extremity), sleeping a lot (hypersomnia), pain in the arm of administration and pain in the injection site/pain started at the injection site of the left shoulder; that soon after the injection the arm felt like it was burning like being on fire (vaccination site pain), fever (pyrexia) and chills (unknown latency). 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 Not Recovered / Not Resolved for the event pain in the arm of administration and pain in the injection site/pain started at the injection site of the left shoulder; that soon after the injection the arm felt like it was burning like being on fire, pain radiates to the chest when sleeping, sleeping a lot, pain in the joint of the arm was Unknown for the event fever, sick, chills.