Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (ADACEL) | SANOFI PASTEUR | UNK | U8115AA | OT |
it was a fluid filled blister; it got to be the size of a grapefruit, and it was hot; had a swollen hard knot the size of a baseball; ad a swollen hard knot the size of a baseball and it was red; itching; Initial information received on 01-May-2025 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 59 years old female patient who had itching, had a swollen hard knot the size of a baseball, ad a swollen hard knot the size of a baseball and it was red, it got to be the size of a grapefruit, and it was hot and it was a fluid filled blister 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 28-Apr-2025, the patient received 0.5 ml dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine, Suspension for injection, lot U8115AA, unknown expiry date and strength, frequency: once, via unknown route in the right shoulder for immunisation. On 28-Apr-2025 the patient had itching (vaccination site pruritus) (latency: same day). On 29-Apr-2025 the patient had a swollen hard knot the size of a baseball (vaccination site swelling) and ad a swollen hard knot the size of a baseball and it was red (vaccination site erythema) (latency: 1 day). On 30-Apr-2025 the patient developed it got to be the size of a grapefruit, and it was hot (vaccination site warmth) and it was a fluid filled blister (vaccination site vesicles) (latency: 2 days). Action taken was not applicable. The patient was treated with Diphenhydramine hydrochloride, Diphenhydramine hydrochloride (Benadryl), Cetirizine hydrochloride, Cetirizine hydrochloride (Zyrtec), Famotidine, Famotidine (Pepcid) and Doxycycline, Doxycycline (Doxycycline) for all the events. At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.