Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Overdose, Pain in extremity, Product preparation error
Clinical narrative: Fever; Fatigue; Headache; Arm Pain; They did not dilute and gave my daughter the entire vial\about 5 times the correct dose/Patient received an entire vial of the Pfizer vaccine 29Jul2021 in error instead of a single dose.; They did not dilute and gave my daughter the entire vial/Patient received an entire vial of the Pfizer vaccine 29Jul2021 in error instead of a single dose.; This is a spontaneous report from a contactable consumer (parent). A 14-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, lot: EW0198) via an unspecified route of administration in right arm on 29Jul2021 at 11:30 (at the age of 14-years-old) as dose 1, single for covid-19 immunization.The patient's medical history was reported as unknown. Concomitant medication(s) included: JUNEL taken for acne (ongoing); CLINDAMYCIN taken for acne (ongoing); EPIDUO taken for acne (ongoing); FLUTICASONE taken for hypersensitivity (ongoing). It was reported that the reporter was an employee of Pfizer for 23 years. She works in the Hospital in Sterile Injectables. Her daughter (patient) was given her first vaccine that day around 11:30 AM. The reporter received a call later from the clinic supervisor and an infectious disease doctor stating that they did not dilute and gave her daughter (patient) the entire vial. They stated that was about 5 times the correct dose. The reporter would like to talk to someone in Medical who knows the information on doses used in the trials and side effects that were found. She was very concerned and worried if someone from Medical can please call her. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. Patient received an entire vial of the Pfizer vaccine 29Jul2021 in error instead of a single dose, PYREXIA (non-serious) with onset 01Aug2021, described as "Fever"; FATIGUE (non-serious) with onset 01Aug2021, described as "Fatigue"; HEADACHE (non-serious) with onset 01Aug2021, described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 01Aug2021, described as "Arm Pain". Mother (Withheld) who is a Pfizer employee was informed of this two hour after the dose. She reported this through (Withheld) and asked in (Withheld) for Pfizer Medical to call her. Contacted me today (03Aug2021) when no one from Pfizer Medical had called her. Reports patient is ok as of today but concerned about long term effects. For more complete information please contact her. It was unknown whether the patient received any other medications as a treatment medication. The outcome of the events was unknown.  Additional Information: No prior vaccinations. No relevant test.  Follow-up (03Aug2021): New information reported from a contactable consumer includes : patient details updated, no new AE added, Narrative was added.   Follow-up (09Aug2021): Follow-up attempts are completed. No further information is expected.  Follow-up (31Aug2021): This is a follow-up Spontaneous report received from a contactable consumer. This Consumer (mother) reported for a patient (daughter) in response to Non-HCP letter sent that included: New information included: Vaccine information updated, concomitant added and events added.  Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected.