Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: redness, swelling, hot to touch, the area was 15 cm in diameter at the injection site; a circular bubble in the middle, the area was 15 cm in diameter at the injection site; itching at the injection site, the area was 15 cm in diameter at the injection site; redness, swelling, itching, a circular bubble in the middle, hot to touch, the area was 15 cm in diameter at the injection site; Initial and additional information received on 27-May-2021 regarding an unsolicited valid non-serious case received from a physician (Contact specialty Pediatrics) via Medical Information  (Reference number- 00618803).  This case involves a five year old female patient who experienced redness, swelling, hot to touch, the area was 15 cm in diameter at the injection site (inflammation), circular bubble in the middle, the area was 15 cm in diameter at the injection site (blister), itching at the injection site, the area was 15 cm in diameter at the injection site (pruritus) and redness, swelling, itching, a circular bubble in the middle, hot to touch, the area was 15 cm in diameter at the injection site (vaccination site reaction), while receiving vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included POLIO VACCINE for prophylactic vaccination on 25-May-2021 at the same visit.  On 25-May-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5765BA and expiry date: 28-Aug-2022) (Injection) via an unknown route in the left thigh for prophylactic vaccination.  On 25-MAY-2021, the patient developed a non-serious redness, swelling, hot to touch, the area was 15 cm in diameter at the injection site (inflammation), circular bubble in the middle, the area was 15 cm in diameter at the injection site (blister), itching at the injection site, the area was 15 cm in diameter at the injection site (pruritus) and redness, swelling, itching, a circular bubble in the middle, hot to touch, the area was 15 cm in diameter at the injection site (vaccination site reaction), on same day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  It was also reported description: Health Care Professional called to report DAPTACEL has been causing chemical reaction in four patients. The caller stated that she has had four patients that developed the same injection site reaction after a vaccination with Daptacel and Doctors nurse called back stating they would like a replacement. Three of the patient received the same lot number for sure, the caller was not sure about the fourth patient. She will send pictures of the reaction areas of all of these patients. Product used, Still using product: No  No laboratories details reported.  The patient was treated with BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE] and cool compresses for all the events.  On an unknown date, the patient recovered from all the events after five days.