Received Feb 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | LM7786 | OT |
bilateral acute otitis media; cough; congestion; diarrhea; sneezing; rsv bronchiolitis; more tired; febrile; fussied; a 12 and plus was given to a 15 month old/Given Covid-19 vaccine for ages 12 and older; a 12 and plus was given to a 15 month old/Given Covid-19 vaccine for ages 12 and older; This is a spontaneous report received from an Other HCP and Physicians from medical information team. A 15-month-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 18Dec2024 at 09:52 as dose 1, 0.3 ml single (Lot number: LM7786, Expiration Date: 07Apr2025) at the age of 15 months intramuscular, in thigh for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 18Dec2024 at 09:52, outcome "unknown" and all described as "a 12 and plus was given to a 15 month old/Given Covid-19 vaccine for ages 12 and older"; PYREXIA (non-serious) with onset 19Dec2024, outcome "unknown", described as "febrile"; IRRITABILITY (non-serious) with onset 19Dec2024, outcome "unknown", described as "fussied"; FATIGUE (non-serious) with onset 19Dec2024, outcome "unknown", described as "more tired"; RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS (medically significant), outcome "recovering", described as "rsv bronchiolitis"; OTITIS MEDIA ACUTE (non-serious), outcome "recovering", described as "bilateral acute otitis media"; COUGH (non-serious), outcome "unknown"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; SNEEZING (non-serious), outcome "unknown". The events "cough", "congestion", "diarrhea" and "sneezing" required physician office visit. Therapeutic measures were taken as a result of respiratory syncytial virus bronchiolitis, otitis media acute. Clinical course: No prior vaccinations since Aug2024. Difficult to say as patient got dose 18Dec2024. Became febrile 19Dec2024 and was more tired and fussied. Seen in office 20Dec2024 for cough, congestion, sneezing and diarrhea. No Acute findings. Start again 23Dec2024 for similar symptoms, diagnosed with RSV bronchiolitis and bilateral acute otitis media, started an amoxicillin. Defervesced and improved by 24Dec2024. The medication error occurred when the product was dispensed. The medication error occurred when the product was administered to / taken by the patient. Misunderstanding of instructions by the individual administering the medication Checked. Follow-up (18Dec2024): This is a spontaneous follow-up report received from an Other HCP from medical information team. Updated information: dosing information, event (added vaccine overdose), and narrative. Follow-up (26Jan2025): Follow-up attempts are completed. Follow-up (19Feb2025): This is a spontaneous follow-up report received from the Physician. This Physician reported for a patient in response to HCP letter sent which included that: Updated information: Classification removed. Reporter details(New true reporter added), product details(Best Doctor / Health Care Professional Information added. product indication removed from device subtab), event details(new events added, Physician Office Visit checked. Event onset date added. Event outcome added).; Sender's Comments: Based on known disease pathophysiology, the event respiratory syncytial virus bronchiolitis is assessed as not related to BNT162B2 OMICRON (KP.2), and more likely an intercurrent medical condition of respiratory syncytial virus infection.
Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE