Age: 0.17
Sex: F
Vaccine: PNC20
Symptoms: Laryngomalacia, Poor quality product administered, Product storage error
Clinical narrative: Laryngomalacia; Temperature excursion; it was given to a patient; Temperature excursion; it was given to a patient; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A 9-week-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 05Feb2024 at 10:02 as dose number unknown, 0.5 ml single (Lot number: HA2258, Expiration Date: 31Jan2025) at the age of 9 weeks intramuscular, in vastus lateral.right for immunisation. The patient's relevant medical history included: "congestion" (unspecified if ongoing). Concomitant medication(s) included: SODIUM CHLORIDE resp inhalation taken for nasal congestion; PEDIARIX intramuscular as dose number unknown, single; ACT HIB intramuscular as dose number unknown, single; ROTATEQ oral. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset Feb2024, outcome "unknown", POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 05Feb2024, outcome "unknown" and all described as "Temperature excursion; it was given to a patient"; LARYNGOMALACIA (medically significant) with onset 05Feb2024, outcome "unknown". The patient underwent the following laboratory tests and procedures: Body height: 56.5 cm; Weight: 10 lbs.  Clinical information: Reporter reported that before she did not provide the exact date or month but she mentioned on the first they got experience temperature excursion for Prevenar 20, and it was given to a patient. The date of the excursion was 04Feb2024 and the temperature was 58.9 and that lasts for 6 hours and 25 minutes. Upon follow-up on 01Apr2024, Lot Number and Expiration Date of Prevnar 20 were reported as HA2258, 31Jan2025 (previously provided as lot number: GY1933, expiration date: 31Dec2024, in right thigh, pending further clarification). The medication error was described as Vaccine administered after temperature excursion, called manufacturer received clearance to give vaccine. The medication error occurred when vaccine administered after temperature excursion. The error was not noticed and intercepted before the product was supplied to the patient. The factor considered to be responsible for the medication error was Vaccine administered after temperature excursion, without clearance from manufacturer. The product was prescribed by a healthcare professional and was taken as prescribed. The patient didn't experience any adverse event(s) as a consequence of the error. Patient's age at immunization of vaccines Pediarix, ACT H1B and RotaTeq was 2 months old. No AE required a visit to emergency Room or physician Office. Reported Illness/AE: Laryngomalacia with onset date 05Feb2024. No relevant Tests.  Follow-up (25Mar2024): Follow-up attempts are completed.  Follow-up (01Apr2024): This is a spontaneous follow-up report received from a same consumer in response to Non-HCP letter. Updated Information: reporter information, patient's details, lab data added, suspect vaccine data (lot number, expiration date, anatomical location updated), Vaccine Facility and HCP information added, concomitant vaccines added, new event (Laryngomalacia), case upgraded to serious.