Received Mar 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MEN | MENINGOCOCCAL (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8369AA | OT / LA |
| MENB | MENINGOCOCCAL B (BEXSERO) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | — | OT / LA |
rash was red, hot to the touch, very tender, and slightly outside circle drawn the night before; rash was red, hot to the touch, very tender, and slightly outside circle drawn the night before; diagnosed with cellulitis; Significant pain started in left arm <5 hours after shot; rash was red/on arm approximately 2cm below the injection site; Initial information received on 15-Mar-2025 regarding an unsolicited valid non-serious case received from a consumer/ Non-Healthcare Professional. This case involves a 16 years old female patient who was diagnosed with cellulitis after receiving meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi]. The patient's past medical history included Pharyngitis streptococcal on 14-FEB-2025. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 13-Mar-2025, the patient received an unknown dose of Bexsero not produced by Sanofi Pasteur (formulation, strength, expiry date and lot number not reported) via unknown route in the left arm and received a dose of meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (strength, expiry date- unknown and lot U8369AA) via intramuscular route in the left arm for Routine vaccination (Immunization). On 13-Mar-2025 the patient developed a significant pain started in left arm <5 hours after shot (pain) (latency- approximately few hours) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine and Bexsero. On 14-Mar-2025 the patient was diagnosed with cellulitis (cellulitis) (latency- 1 day) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine and Bexsero. On 15-Mar-2025 the patient developed rash was red, hot to the touch, very tender, and slightly outside circle drawn the night before (rash) (condition aggravated) (latency- 2 days) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine and Bexsero. On an unknown date in MAR-2025 the patient developed rash was red/on arm approximately 2cm below the injection site (rash erythematous) (unknown latency) following the administration of meningococcal A-C-Y-W135 (T CONJ) vaccine and Bexsero. Reportedly, Pain continued on 16-MAR-2025. Touching/bumping arm caused significantly more pain. Rash, that was swollen, pink, and hot to the touch noted on arm around 8pm approximately 2cm below the injection site. Circle drawn around the rash. Oral cephalexin prescribed Action taken was not applicable. The patient was treated with IBUPROFEN (ADVIL 12 HOUR), NAPROXEN and PARACETAMOL (TYLENOL) for Symptomatic treatment. At time of reporting, the outcome was Not Recovered / Not Resolved for the events.
Medical History/Concurrent Conditions: Streptococcal sore throat