Age: 3.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered, Product preparation issue, Pyrexia
Clinical narrative: night terrors; irritable; lethargic; High fevers; his eyes like a gooky something; received 0.2 mL of undiluted COVID-19 vaccine on 02Dec2022; received 0.2 mL of undiluted COVID-19 vaccine on 02Dec2022; decreased appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the parent.  A 3-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2022 at 10:15 as dose 2 (maroon cap), 0.2 ml single (Lot number: FT9142, Expiration Date: 31Dec2022) at the age of 3 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1; , Lot Number: FT9142), administration date: 11Nov2022, when the patient was 3-year-old, for COVID-19 immunization. The following information was reported: PRODUCT PREPARATION ERROR (non-serious) with onset 02Dec2022, outcome "recovered" (02Dec2022), OVERDOSE (non-serious) with onset 02Dec2022 at 10:15, outcome "recovered" (02Dec2022) and all described as "received 0.2 mL of undiluted COVID-19 vaccine on 02Dec2022"; PYREXIA (non-serious) with onset 02Dec2022 at 14:00, outcome "recovered" (03Dec2022), described as "High fevers"; EYE DISCHARGE (non-serious) with onset 02Dec2022 at 14:00, outcome "recovered" (04Dec2022), described as "his eyes like a gooky something"; LETHARGY (non-serious) with onset 02Dec2022 at 14:00, outcome "recovered" (06Dec2022), described as "lethargic"; IRRITABILITY (non-serious) with onset 03Dec2022 at 07:00, outcome "recovered" (06Dec2022), described as "irritable"; SLEEP TERROR (non-serious) with onset 04Dec2022, outcome "recovered" (07Dec2022), described as "night terrors"; DECREASED APPETITE (non-serious) with onset Dec2022, outcome "recovered" (08Dec2022). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Therapeutic measures were not taken as a result of decreased appetite, lethargy, irritability, sleep terror, eye discharge.  Additional information: Has a caregiver who reported that her 3 year old son received an undiluted dose of the Covid 19 vaccine. Information confirmed as provided. Color of the cap was unknown. Was for his second dose. Was trying to understand what amount of undiluted vaccine would be in what he received if it was appropriately diluted. Wanted to know how many times the actual dose of vaccine that he received. Later provided that he was sick having symptoms from Friday to yesterday. Provided symptoms of high fevers, decreased appetite, very lethargic, irritable and having night terrors and having discharge from his eyes like a gooky something. Patient details: Clarified age of onset was 3 years, 2 months approximately. Weight is 35 pounds, 6 ounces. Height is approximately 3 feet, 1 inch. Event details: High fevers: Started Friday afternoon at 2:00pm. Had high fevers on Friday and Saturday. Treatment: Gave Tylenol and fluids. Had him drink more water and stuff. Decreased appetite: Started Friday or Saturday and his appetite came back yesterday. Treatment: None. Very lethargic: Started Friday and he bounced back Tuesday. Treatment: None. Irritable: Started Friday and that kind of recovered by Tuesday; Treatment: None. Having night terrors: Last night was his first night without. Wednesday was his last night of night terrors. Treatment: None. Having discharge from his eyes like a gooky something: Started Friday evening 02Dec2022 through Sunday 04Dec2022. Treatment: None. Product details: Had his first dose of Pfizer Covid 19 vaccine on 11Nov2022 with a lot of FT9142 and unknown expiration date. Pfizer/BioNTech COVID-19 Vaccine Follow-up, Questionnaire 1. Patient Details: Patient Age at Time of Vaccination (Years): 3 years, 2 months 2.Pfizer/BioNtech COVID-19 Vaccine Details: 1st dose: Date: 11Nov2022 Time: Not provided. Anatomical Site of injection: Not provided, Route of Administration: if other, please specify: Not provided Batch/Lot number: FT9142 4. For Only: Vaccination Facility Type: Pharmacy. Vaccine Administered at Military Facility? No 5. Prior Vaccinations (within 4 weeks): If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None 6. Concomitant Drugs: List below concomitant drugs taken within two weeks before the event onset. Exclude all drugs only administered more than two weeks before the event, and any drug used to treat the event or taken after event onset: None 7. Patient's Medical History (including any illness at time of vaccination): None 8. Family Medical History Relevant to Adverse Events (AEs): None 9. Relevant Tests: None 10. Specific Relevant Test: For Thromboembolic events with Thrombocytopenia: Not applicable 11. Adverse Events: Note: For Thromboembolic Events with Thrombocytopenia Include specific relevant test above: AE Term: second dose: son received an undiluted dose of the Covid 19 vaccine. Onset Time: approximately 1015. AE required visit to: followed up with physician's office on 05Dec2022 for general check up, AE Term: high fevers, Onset Time: 1400. AE required visit to: None. AE Term: decreased appetite, Onset Time: 1400; caller clarified the start date for decreased appetite was 02Dec2022 or 03Dec2022. AE required visit to: None. AE Term: very lethargic, Onset Time: 1400, AE required visit to: None. AE Term: irritable, Onset Time: 0700, AE required visit to: None, AE Term: having discharge from his eyes like a gooky something, Onset Time: 1400, AE required visit to: None 12. Autopsy Information: In case of death, was an autopsy done? Not applicable 13. Comments/Narrative: provide clear narrative description of the sequence of event(s), diagnosis, treatment, and any other relevant details: Not applicable. Caller would like to know how much of the actual compound (RNA) his son received after he received an undiluted 0.2 mL dose of the COVID-19 vaccine. Question: Caller thinks we should provide this information and also that the company is withholding information. Question: Caller would like to know how much diluent is added to each vial. Question: Caller would like to know how many mcg of RNA her son was administered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (09Dec2022): New information received from a contactable consumer reported for a patient which included: reporter slider #02, patient details (Ethnicity, height, weight), relevant medical history, historical vaccine, lab data, product details (lot no., expiry date, anatomical location) vaccination information (best doctor, vaccine facility information), event onset date, stop date, outcome, new event and clinical information was added.