Age: 76.0
Sex: F
Vaccine: HIBV, MEN, PNC
Symptoms: Hypersensitivity, Paraesthesia oral, Swollen tongue
Clinical narrative: tingling lips and swollen tongue; tingling lips and swollen tongue; Hypersensitivity; Initial information regarding this unsolicited valid non-serious courtesy case was received on 27-Feb-2024  from a Other Health Care Professional via Novartis (Reference number: NVSC2024US017078).  This case involves a 76 years old female patient (41.7 kg) who experienced tingling lips and swollen tongue, tingling lips and swollen tongue and hypersensitivity after receiving Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] and HIB Vaccine [HIB], Pneumococcal Vaccine CONJ 7V (CRM197) [Prevnar]  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Asthma, Open angle glaucoma, Hypersensitivity on 01-Jan-1998, Osteoporosis on 03-Mar-1998, Thyroid disorder on 01-Jan-2001, Tremor on 01-Jan-2013, Glaucoma on 04-Jun-2022, Dry age-related macular degeneration on 02-Nov-2022, Neovascular age-related macular degeneration on 02-Nov-2022 and Seizure on 01-Nov-2023.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) for Product used for unknown indication; FLUTICASONE (FLUTICASONE); ALENDRONATE SODIUM (ALENDRONATE); LEVOTHYROXINE (LEVOTHYROXINE); PRIMIDONE (PRIMIDONE); FOLIC ACID (FOLIC ACID); and TIMOLOL MALEATE (TIMOLOL MALEATE  On 20-Dec-2023, the patient received unknown dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine (Solution for injection) (lot number, expiry date and strength not reported) on same day,  the patient received unknown dose of sus pect Prevnar not produced by Sanofi Pasteur (lot number, expiry date and strength not reported) and the patient received unknown  dose of suspect HIB not produced by Sanofi Pasteur (lot number, expiry date and strength not reported) via unknown route in unknown administration site all for Product used for unknown indication.  On 08-Feb-2024, the patient received Unknown dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine (Solution for injection) (lot number, expiry date and strength not reported) in unknown administration site for Product used for unknown indication.  On 20-Dec-2023 the patient developed hypersensitivity (Latency: same day).  On 08-Feb- 2024 the patient developed tingling lips and swollen tongue (swollen tongue), (paraesthesia oral) (Latency: same day).   Action taken: Not applicable.  The patient was treated with Diphenhydramine Hydrochloride (Benadryl a) for (swollen tongue), (paraesthesia oral).  It was not reported that the patient received a corrective treatment for the event (Hypersensitivity).  At time of reporting, the outcome was Recovered / Resolved on 20-Dec-2023  for the event hypersensitivity, and Recovered / Resolved on 08-Feb-2024  swollen tongue, paraesthesia oral.  Seriousness Criteria: These events were assessed as medically significant.; Sender's Comments: Sanofi Company Comment dated 05-Mar-2024:This case involves a 76 years old female patient (41.7 kg) who experienced tingling lips and swollen tongue, tingling lips and swollen tongue and hypersensitivity after receiving Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] and HIB Vaccine [HIB], Pneumococcal Vaccine CONJ 7V (CRM197) [Prevnar]. Further information on allergy history, patient's medical history or concurrent conditions, concomitant medications, laboratory investigations excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of the vaccines cannot be assessed.