Received Nov 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | HR3650 | OT / LL |
Patient possibly had hand foot and mouth; Administered expired dose of Prevnar 20- to 15-month-old patient/was administered vaccine that expired 31Oct2025; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 14-month-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 11Nov2025 as dose number unknown, 0.5 ml single (Lot number: HR3650, Expiration Date: 31Oct2025) intramuscular, in left anterolateral thigh for immunisation, Device Lot Number: HR3650, Device Expiration Date: 31Oct2025. The patient's relevant medical history included: "Otitis media" (unspecified if ongoing); "ear infection" (unspecified if ongoing). Concomitant medication(s) included: AMOXICILLIN taken for otitis media, start date: 27Oct2025, stop date: 06Nov2025; HAVRIX intramuscular, on 11Nov2025 as 0.5 ml, single (right anterolateral thigh); PEDVAXHIB intramuscular, on 11Nov2025 as 0.5 ml, single (left anterolateral thigh); MMRVAXPRO subcutaneous, on 11Nov2025 as 0.5 ml, single. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 11Nov2025, outcome "unknown", described as "Administered expired dose of Prevnar 20- to 15-month-old patient/was administered vaccine that expired 31Oct2025"; HAND-FOOT-AND-MOUTH DISEASE (non-serious), outcome "unknown", described as "Patient possibly had hand foot and mouth". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter needed to know of any adverse reactions to go over with patient's parents. NDC clarified as 0005-2000-01. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. There are no allergies documented in patient's chart, no previous reactions to any previous vaccinations. Test results: Patient possibly had hand foot and mouth, nothing came of that and, patient did have the Otitis media. The AE did not require a visit to the Emergency Room. Not see any calls or requests, or any ER visits. AE did not require a visit to a Physician's Office. Follow-up (12Nov2025): This is a spontaneous follow-up report received from a Consumer or other non HCP from medical information team, Program ID. Updated information: patient age, lab data, product data (product dosage details, lot number and expiration date, vaccination location), concomitant medications, new event "hand foot and mouth" added and event expired vaccine used detail added and clinical course added.
Medical History/Concurrent Conditions: Ear infection; Otitis media
AMOXICILLIN; HAVRIX; PEDVAXHIB; MMRVAXPRO
Test Date: 20251027; Test Name: BMI; Result Unstructured Data: Test Result:17.26; Test Name: Test results; Result Unstructured Data: Test Result:Patient possibly had hand foot and mouth