Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administration error
Clinical narrative: COVID 19 Vaccine being administered incorrectly; This is a spontaneous report from a contactable pharmacist. This Pharmacist reported for a 53-year-old female patient that:  Contact Details Patient Details Is the patient also the reporter: No Age: 53 Years   Reporter Details Reporter type: Pharmacist  Primary / Prescribing Healthcare Professional Info  Event Details COVID 19 Vaccine Administered incorrectly Dates of adverse event: 19Jan2021- Seriousness criteria: Medically significant  Products Suspect products: COVID 19 Vaccine Therapy dates: 19Jan2021- Is this a Pfizer product: Yes NDC number: 59267-1000-01 Lot Number: EL0142 Expiry date: 01Mar2021 What was the dose, dosage units, formulation, route of administration and frequency when the adverse event occurred: Administered in left arm  Sodium Chloride Therapy dates: 19Jan2021 - NDC number: 63323018604 Lot Number: 6022719 Expiry date: Sep2022  History Concomitant Products Other Products: Unknown Other conditions Other Conditions: Unknown  Investigations Investigations: Unknown  Additional Context The report is cross referenced to report ID: # Report 2 of 2 Caller on the line calling about the COVID 19 Vaccine. She stated she tried to place a report a couple of weeks ago regarding the vaccine potentially being administered incorrectly. She was not able to reach anyone when she contacted us previously. She reached medical information, but she is unsure if she was able to make a report. She stated she spoke to someone in medical information and was sent information about her question. She was told she would receive a fax from us requesting additional information, but she has not received it yet. She provided these details, but unsure if a report was completed. Therefore, calling to follow-up to provide details. Caller does not have a reference number to provide. Height and Weight: Unknown Ethnicity: Unknown Caller further clarified COVID 19 Vaccine being administered incorrectly as they had an immunization nurse come to the (Institute name) to help with their vaccine clinic. For some reason unknown the nurse was giving people two shots at that vaccine administration. Nurse administered one shot that was of the diluted vaccine and one was of the diluent. Caller stated she does not know why the nurse did it this way. The patient has had no side effects from this occurrence that she is aware of. Seriousness Criteria: Medically Significant. She feels this way as the patient did not get the full dose and may not fully be protected against COVID 19. Caller stated she did not directly show the immunization nurse the process of how to administer. The caller was informed by the patient that she got two shots in one setting. Caller explained the 0.3ml of the diluted vaccine was administered with a 23G needle first and then the diluent was administered as a second shot. This patient got two separate shots. Exact diluent amount administered unknown. Stated it would make since for it to be 1.8ml because that is what is remaining in the vial. Nurse was not (Institute name) trained. Caller stated the nurse questioned if patients should get two shots as this is what she had been doing. Caller stated she informed the nurse yes, as she thought she was referencing the two different doses, first vaccine and then the second vaccine three weeks later. However, nurse was giving two different shots on the same day, the diluted vaccine and the diluent. Caller clarified the diluent to be Sodium Chloride 0.9%.  Vaccine Supplemental Form Patient Last Name: (Name) Patient First Name: (Name) Address: # City: # State: # Zip code: # Phone: # Patient age at time of the vaccination: 53 Years Old Time the Vaccination was Given: Around 9:30AM Vaccine Lot Number: EL0142 Vaccine Lot Expire Date: 01Mar2021 Anatomical Location of Administration of Pfizer Vaccine considered as suspect: Left arm Vaccination Facility Type- Pharmacy/Drug Store Vaccination: Facility Address: Facility Name: See reporter details Address: See reporter details City: See reporter details State: See reporter details Zip Code: See reporter details Phone: See reporter details History of all previous immunization with the Pfizer Vaccine considered as suspect: None, first dose. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None  AE Details AE: COVID 19 Vaccine Administered incorrectly Time of onset: Around 9:30AM Did any of the AEs require a visit to: Emergency Room- No Physician Office- No Prior Vaccinations within 4 weeks: None Patient's Medical History: Unknown Relevant: Unknown; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of  Product administration error due to temporal relationship.  There is very  limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.