Age: 76.0
Sex: F
Vaccine: HIBV, MEN, PNC13
Symptoms: Condition aggravated, Hypersensitivity
Clinical narrative: Hypersensitivity; This is a spontaneous report received from an Other HCP. Other Case identifier(s): 2024SA068179 (Sanofi), NVSC2024USO17078 (Novaritis).  A 76-year-old female patient (not pregnant) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 20Dec2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 76 years for immunisation; meningococcal vaccine a/c/y/w (MENINGOCOCCAL VACCINE A/C/Y/W), on 20Dec2023 as dose number unknown, single) for immunisation; hib vaccine (HIB VACCINE), as dose number unknown, single) for immunisation. The patient's relevant medical history included: "Asthma" (ongoing); "Open angle glaucoma" (unspecified if ongoing); "Hypersensitivity", start date: 01Jan1998 (unspecified if ongoing); "Osteoporosis", start date: 03Mar1998 (unspecified if ongoing); "Thyroid disorder", start date: 01Jan2001 (unspecified if ongoing); "Tremor", start date: 01Jan2013 (unspecified if ongoing); "Glaucoma", start date: 04Jun2022 (unspecified if ongoing); "Dry age-related macular degeneration", start date: 02Nov2022 (unspecified if ongoing); "Neovascular age-related macular degeneration", start date: 02Nov2022 (unspecified if ongoing); "seizure", start date: 01Nov2023 (unspecified if ongoing). Concomitant medication(s) included: BEXSERO; FLUTICASONE [FLUTICASONE PROPIONATE]; ALENDRONATE SODIUM; LEVOTHYROXINE; PRIMIDONE; FOLIC ACID; TIMOLOL MALEATE. The following information was reported: HYPERSENSITIVITY (medically significant) with onset 20Dec2023, outcome "recovered" (20Dec2023). Clinical course: On 20Dec2023, the patient received unknown dose of suspect Meningococcal A-C-Y- W 135 (T CONJ) Vaccine (Solution for injection) (lot number, expiry date and strength not reported); on same day, the patient received unknown dose of suspect 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. On 20Dec2023 the patient developed hypersensitivity (Latency: same day). It was not reported that the patient received a corrective treatment for the event (Hypersensitivity). These events were assessed as medically significant.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: A possibly contributory role of PREVNAR 13 in triggering the onset of hypersensitivity cannot be fully excluded, considering the temporal relationship and known adverse event profile of the suspect vaccine.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate