Received May 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | Z005055 | LA |
Caller stated after leaving the office the patient lost feeling from her left elbow to her fingers, patient tried to open the car door and could not feel the handle prior to returning back in the office; This spontaneous report was received from a Nurse and refers to an 11-year-old female patient. The patient's medical history, concurrent conditions past drug reactions and allergies were reported as no. Concomitant medications included Meningococcal vaccine A/C/Y/W conj (tet tox) (MENQUADFI) and Diphtheria vaccine toxoid (+) Pertussis vaccine acellular (+) Tetanus vaccine toxoid (TDAP). On 08-MAY-2025, the patient visited the doctor´s office for a physical and was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) prefilled syringe, 1 dosage form, administered in the left deltoid as prophylaxis (lot number Z005055 has been verified to be valid for Human Papillomavirus 9-valent Vaccine, Recombinant [GARDASIL 9], expiration date 27-FEB-2026; route of administration, exact dose and vaccination scheme frequency were not reported). On that same date, after leaving the office, the patient lost feeling from her left elbow to her fingers. Patient tried to open the car door and could not feel the handle prior to returning back in the office (Sensory loss). The patient was seen by the doctor and was given two tablets of 200mg ibuprofen as treatment for the event. Approximately 20 minutes later, there was no change; doctor then recommended hot and cold compress during the night. At approximately 19:00 on that same date, the patient´s father contacted the office and stated that hot and cold compresses were applied, and patient was able to feel a little bit. On 09-MAY-2025, approximately at 6:00, the patient´s father contacted the office again and stated the patient fully recovered from the event. No additional information provided. The causal relationship between Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) and the event of Sensory loss was not reported.
MenQuadfi; T-dap vaccine