Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: 3 patients that received the Pfizer Covid 19 vaccine that was diluted with less than the recommended 1.8ml/three patients were administered a more concentrated dose of the COVID-19 Vaccine; 3 patients that received the Pfizer Covid 19 vaccine that was diluted with less than the recommended 1.8ml/Received first dose of COVID-19 vaccine that was more concentrated; diluted with only half the amount of diluent; This is a follow-up spontaneous report from a sponsored Program, from a contactable pharmacist reported for a 15-year-old male consumer (patient).  This is a spontaneous report from a contactable pharmacist. A patient of 15-year-old male consumer received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0180, Expiration Date:20 Aug 2021), via intramuscular, administered in left arm on 03Jun2021 as 0.3 ml First dose, single dose for covid-19 immunisation. Time the Vaccination Was Given is Between 11:30 - 12:00 and NDC number of COVID-19 Vaccine is 59267100001. The patient medical history was none and concomitant medications were not reported. On 03Jun2021 the patient experienced 3 patients that received the Pfizer covid 19 vaccine that was diluted with less than the recommended 1.8ml on an unspecified. Consumer stated that asking for guidance on how to treat 3 patients that received the Pfizer Covid 19 vaccine that was diluted with less than the recommended 1.8ml as per EUA. Incorrect diluent volume (i.e., the vial contents were diluted with a diluent volume other than 1.8 ml, but a 0.3 ml dose was still administered). For doses administered with diluent volume less than 1.8 ml, Inform the recipient of the potential for local and systemic adverse events. patient came to get vaccinated since they are eligible. Verbatim event relatedness: COVID-19 Vaccine: Received first dose of COVID-19 vaccine that was more concentrated; diluted with only half the amount of diluent is unrelated. Pfizer COVID-19 Vaccine was diluted with half the amount of diluent. Three patients were administered a more concentrated dose of the COVID-19 Vaccine. Clarified Consumer wants to know what information Pfizer has. Wants to know what to expect, if patients are going to experience more serious side effects. Is the arm going to be more sore than usual? Wants to make sure the patients aren't going to be harmed. Print on label is new and tiny. Clarified it was the first dose of the COVID-19 Vaccine for all three patients. Same NDC/LOT/EXP for all three patients. All three patients received 0.3ml injected intramuscularly into the left arm. Consumer clarifies the age of this patient as 15years old. Initially provided age of 12 years. Clarified and documented as provided. Patient Age at Time of Vaccination in Months: or Years was reported as 13 years old. Patient did not visit emergency Room or physician Office. Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Seriousness is reported as wouldn't say Medically significant but would describe as Serious. The outcome for events was unknown.  Information about batch/lot number has been requested.  Follow-up: (03Jun2021) This is a follow-up spontaneous report from a sponsored Program, from a contactable pharmacist reported for a 15-year-old male consumer (patient). Additional information received was as follows: Product (Start date: 03Jun2021, Expiry date: 20 Aug 2021, Lot number: EW0180, Dose: First dose, Dosage: 0.3ml, Route of administration: intramuscularly, anatomical location: left arm), Event (Received first dose of COVID-19 vaccine that was more concentrated; diluted with only half the amount of diluent merged with 3 patients that received the Pfizer Covid 19 vaccine that was diluted with less than the recommended 1.8ml and Three patients were administered a more concentrated dose of the COVID-19 Vaccine merged with 3 patients that received the Pfizer Covid 19 vaccine that was diluted with less than the recommended 1.8ml)   No follow-up attempts are needed. No further information is expected ; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event overdose, Inappropriate dilution of medication and the suspect drug BNT162B2.,Linked Report(s) : US-PFIZER INC-2021650089 same reporter/product/event, different patient;US-PFIZER INC-2021651198 same reporter/product/event, different patient