Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Immunisation, Poor quality product administered, Product administered to patient of inappropriate age, Product temperature excursion issue
Clinical narrative: Booster; Inadvertent administration of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) to a patient (13 years old) as booster dose/ vaccines have been stored in the refrigerator for 30 days; Patient is 13 years old and received the adult dose of the booster dose of the Pfizer BioNTech Covid-19 vaccine; Anxiety; Inadvertent administration of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) to a patient (13 years old) as booster dose/ vaccines have been stored in the refrigerator for 30 days; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 13 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 02Dec2021 (Lot number: FH8030, Expiration Date: 14Dec2021) at the age of 13 years as dose 3 (booster), 0.3 ml single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]. Vaccination history included: Bnt162b2 (Dose:1, Lot Number / Expiry Date: EW0178/unknown, Route, Anatomical Location: intramuscular, unknown which arm), administration date: 20May2021, when the patient was 12 years old, for COVID-19 immunization; Bnt162b2 (Dose:2, Lot Number / Expiry Date: EW0178/unknown, Route, Anatomical Location: intramuscular, unknown which arm), administration date: 12Jun2021, when the patient was 12 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021, outcome "unknown", described as "Booster"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 02Dec2021, outcome "unknown", PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 2021, outcome "unknown" and all described as "Inadvertent administration of the Pfizer BioNTech COVID-19 vaccine adult formulation (purple cap) to a patient (13 years old) as booster dose/ vaccines have been stored in the refrigerator for 30 days"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 02Dec2021, outcome "unknown", described as "Patient is 13 years old and received the adult dose of the booster dose of the Pfizer BioNTech Covid-19 vaccine"; ANXIETY (non-serious) with onset 02Dec2021, outcome "unknown", described as "Anxiety".  Additional information: Inadvertent Excursions to the Labelled Storage Condition for Frozen or Thawed, Undiluted Vaccine. Informed caller: At a temperature range of 2C to 8C (35F to 46F) there is total time: 32 days = 31 days labelled time described in the Prescribing Information plus 1 day excursion time. Time used for transportation at this condition counts against total time at this temperature. Not more than 12 hours are permitted for transportation. As of 27Nov2021 the vaccines had been stored in the refrigerator for 30 days. The reporter clarified that it was not the pediatric formulation of the booster dose of the BioNTech Covid-19 vaccine that was administered to the 13 year old female patient. The caller states that the patient is 13 years old and received the adult dose of the booster dose of the Pfizer BioNTech Covid-19 vaccine. The stated this event was an unrelated to the event that she had reported on prior to her transfer to USMI. this event happened today, 02Dec2021. Received the adult dose of the booster dose of the BioNTech Covid-19 vaccine and was not eligible for the booster: Seriousness Criteria reported as Caller states not serious but does not really know if it is serious, she does not know for sure. The events did not required visit in emergency Room or physician Office. Patient did not received any vaccination within 4 weeks and patient had no reaction at the clinic after receiving the dose. Any AE(s) did not require a visit to Emergency Room and Physician Office. Patient's Medical History (including any illness at time of vaccination)? No. Family Medical History Relevant to AE reported as No, not that she knows of. Caller stated she does not see anything on there. She states the patient has anxiety and that is all she sees. Relevant Tests reported as None.   Follow-up attempts are completed. No further information is expected.