Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Overdose, Product preparation error, Pyrexia
Clinical narrative: fever 101.3; administered to a patient without being diluted; administered to a patient without being diluted; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician) from medical information team, Program ID.  A 2-year-old female patient received BNT162b2 (BNT162B2), on 23Aug2022 at 10:54 as dose 2 (maroon cap), 0.2 ml single (Lot number: FT9142, Expiration Date: 31Dec2022) at the age of 2 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "allergies" (unspecified if ongoing), notes: diagnosed allergies; "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic/chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities (including diabetes)" (unspecified if ongoing); "endocrine abnormalities (including diabetes)" (unspecified if ongoing); "obesity" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 23Aug2022 at 10:54, outcome "unknown" and all described as "administered to a patient without being diluted"; PYREXIA (non-serious) with onset 24Aug2022, outcome "recovered", described as "fever 101.3". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: patient age at time of vaccination in years: 2 years 9 months. This report is related to a study or programme. Vaccine name was unknown since not their patient. Concomitant drugs: drug name (trade and generic) was none. Patient(s) medical history: illness/ae was unknown. Reporter said the overdose event was the 2nd dose. The first dose was given in (withheld), so they don't have any information on the experience with prior dose. They are a walk in clinic, so the patient is not a regular patient. The patient has not reported any adverse events to them so far. Reporter clarified that she is a medical assistant who called on behalf of (withheld)-pediatrician, only provided by inbound transfer agent as unknown type of healthcare professional. She clarified that she did not call about the gray cap formulation; she called about the pfizer covid-19 vaccine, maroon cap 2-5 years of age formulation. She mentioned that this formulation is what they use for age 6 months to 4 years of age. She clarified that this patient was administered an undiluted dose of the product. She asked if they need to be aware if the patient could have any reactions relative to this event. Administered undiluted dose: there have been no associated adverse events or lasting effects with this event to caller's awareness. First dose, date of administration was unknown, reporter believes this suspect product dose was patient's second dose, but has no information to provide on what would have been her first dose. Vaccination facility type was clinic. Vaccine was not administered at military facility. History of all previous immunization with the pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) and reporter don't know about it. Additional vaccines administered on same date of the pfizer suspect-if applicable, list all vaccines administered on same date with the pfizer vaccine considered as suspect was none. Reporter was not aware of emergency room, physician office, 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), ae(s) following prior vaccinations, patient's medical history (including any illness at time of vaccination) provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, family medical history relevant to ae(s) and relevant tests. Other conditions, investigations and other products was given as no. It was reported that, the day after the vaccine the patient had a fever 101.3 and she gave her Motrin to lower the temperature and the fever resolved. She had been eating and sleeping well.  Follow-up (23Aug2022): This is a spontaneous follow-up report received from a contactable Other-HCP. Program Id. This Other-HCP reported for a 2 year old Female patient that:  Updated Information: Reporter information, patient details, suspect details, relevant medical history and additional information.  Follow-up (31Aug2022): This is a spontaneous follow-up report received from a contactable Other HCP. This Other HCP reported in response to HCP telephonic follow-up activity which included that:  Updated information included: Lab data, event details (new event of fever, start date and treatment received were added) and additional information updated.