Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, Product label issue
Clinical narrative: Fatigue; rash on my front torso, left side.; patient accidently may have received the vaccine without being diluted/I was the victim of a medication error; patient accidently may have received the vaccine without being diluted/I was the victim of a medication error; arm sore/right arm soreness; Headache; This is a spontaneous report from a contactable pharmacist and nurse (patient) and consumer via Medical information team. A 39 year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142 and expiry date: 01Mar2021), via intramuscular in the right arm (deltoid) on 19Jan2021 09:30 at 1.8 mL, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose on 19Jan2021 and stated that she was a victim of a medication error and needed some guidance on how to move forward. An RN (registered nurse) injected her with a 1 ml syringe and then proceeded to say that she didn't give her the diluent and proceeded to give the patient a 3 ml syringe in the same deltoid. She was having some side effects including arm sore and a headache, so the patient was assuming that she at least got some medicine, but she was not sure how much or what was in either injection she received. She was not sure what kind of dose she received. The patient accidently may have received the vaccine without being diluted. The patient wanted to know what to do now for getting the correct dosage of the vaccine and if she should repeat the series or continue with the second dose and get antibody tests. The patient wanted to know what her options are. Upon follow up on 01Feb2021 and 10Feb2021, it was reported that COVID-19 vaccine was administered incorrectly to the patient and was reported as medically significant serious event. The patient reported that 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. The patient further clarified COVID 19 vaccine being administered incorrectly as they had an immunization nurse come to help with their vaccine clinic. For some unknown reason 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. The pharmacist considered the event initially as serious then later provided as medically significant. She feels this way as the patient did not get the full dose and may not fully be protected against COVID. The patient did not directly show the immunization nurse the process of how to administer. The pharmacist was informed by the patient that she got two shots in one setting. The patient received the diluent first the 1.8ml injected and then another injection, the actual vaccine. The diluent was sodium chloride 0.9%. The facility where the most recent COVID-19 vaccine was administered was in the Pharmacy/Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The nurse was given a vial of Pfizer COVID vaccine and a vial of sodium chloride 0.9% (2mL single dose vial, NDC 63323-186-04). It was explained to the nurse to dilute the active vaccine with 1.8 mL (using 3mL 23G x 1" syringe/needle) of diluent and draw shots from this mixture (using 1mL 25G x 1") vanish point syr/needle). 1.8mL of diluent was injected into the vaccine vial and the nurse was told to draw up vaccine with the smaller needles. She asked if the patients should expect 2 doses. Assuming she meant the two-dose COVID vaccine series (21 days apart), the reported said yes, each patient gets two shots. Based on the report, the nurse then drew up 0.3mL of diluted  vaccine into a new syringe/needle (23G) and filled up the other smaller syringe with  diluent. Since there were two vials of Pfizer COVID vaccine to be reconstituted, the original fear was that she used the undiluted Pfizer COVID vial to draw up the first dose,  but based on the volume in the second COVID vial (had not been used or added to), the only opened vial at the time was the vial already mixed with diluent. So the patient received 0.3mL of diluted vaccine in the 23G syringe and then received 0.3mL of diluent as a second injection. The patient was not admitted to the hospital. The patient provided information to the nurse regarding the reported adverse events with the use of BNT162B2. It was unknown if the nurse considered the Pfizer product had a causal effect to the adverse event. No treatment was given to the patient for the events. The patient stated, "I received my first dose of Pfizer COVID-19 vaccine on Tuesday, 19Jan2021. I was injected with a 1 mL syringe in the right deltoid by the Registered Nurse administering the vaccine. I was then injected with a 3 mL syringe in the right deltoid by the Registered Nurse administering the vaccine. I am unable to validate the dose because it was not administered according to Pfizer's instructions and because there are discrepancies in the documentation. These discrepancies include, order of the injections and the amount of fluid present in the 3mL syringe. Since the injections received on 19Jan2021, I have experienced the following symptoms: headache, fatigue, right arm soreness and a 1" x 0.5" rash on my front torso, left side. I contacted Pfizer on Thursday, 21Jan2021. Pfizer had no previous record of a medication error of this nature and was unable to offer guidance since the medications administered could not be verified. Pfizer was not able to provide guidance on an invalid dose because there was no recommendations for an invalid dose of Pfizer COVID-19 vaccine at this time. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Amendment: This follow-up report is being submitted to amend previously reported information: suspect product data (lot number was unknown).  Follow-up (28Jan2021 and 28Jan2021): New information received from contactable pharmacist and consumer in response to HCP telephonic follow up activity includes: reporter's fax number added and clinical information updated.  Information about lot and batch number was requested.  Follow-up (06Mar2021): This follow up report contains no new safety information.  Follow-up (15Mar2021): This is a follow-up report combining information from duplicate reports 2021057789 and 2021045475. The current and all subsequent information will be reported under manufacturer report number 2021045475. New information included: new reporter, product details, upgrade the case to serious (patient accidently may have received the vaccine without being diluted upgraded from non-serious to serious), new events (arm sore/right arm soreness, Headache, Fatigue, rash on my front torso, left side.).; Sender's Comments: The patient accidently may have received the vaccine without being diluted. It was noted that "An RN (registered nurse) injected her with a 1 ml syringe and then proceeded to say that she didn't give her the diluent and proceeded to give the patient a 3 ml syringe in the same deltoid."