Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Overdose, Pain in extremity, Product preparation error
Clinical narrative: nausea; arm soreness; fatigue; Patient Received Undiluted Pfizer Vaccine At Hospital Clinic. Nurse Was Not Appropriately Trained On Pfizer Vaccine Administration; Patient Received Undiluted Pfizer Vaccine At Hospital Clinic. Nurse Was Not Appropriately Trained On Pfizer Vaccine Administration; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 30Nov2021 at 13:30 as dose 1, 0.3 ml single (Lot number: EW0217) at the age of 46 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hypertension", start date: 2016 (ongoing), notes: Mild. There were no concomitant medications. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 30Nov2021 at 13:30, outcome "unknown" and all described as "Patient Received Undiluted Pfizer Vaccine At Hospital Clinic. Nurse Was Not Appropriately Trained On Pfizer Vaccine Administration"; FATIGUE (non-serious) with onset 30Nov2021 at 21:30, outcome "recovered" (01Dec2021 at 21:30); PAIN IN EXTREMITY (non-serious) with onset 01Dec2021, outcome "recovered", described as "arm soreness"; NAUSEA (non-serious) with onset 01Dec2021, outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue.  Additional information: On 30Nov2021 patient received undiluted pfizer vaccine at hospital clinic. Nurse was not appropriately trained on pfizer vaccine administration; up until that point she had only given moderna which does not need to be diluted. Patient did not experience any significant known untoward effects. It was also reported that patient provided information regarding the reported adverse events with the use of the product and considered the Pfizer product had a causal effect to the adverse event. There was no specific relevant test for thromboembolic events with thrombocytopenia. Patients wife (who was also a pharmacist) was in the vaccine room with him, she was getting her booster at the same time. She realized about 2 seconds too late that the vaccine was not diluted by the nurse. The nurse opened the vial and aspirated 0.3 ml of straight undiluted vaccine and administered it to him. The error was realized immediately after injection. He had only mild symptoms- fatigue starting about 8 hours after the injection which lasted about 24 hours total. Upon waking the next day, he had arm soreness and some nausea but that resolved eventually.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (31Aug2022): This is a spontaneous follow-up report from a contactable pharmacist. This pharmacist (patient) reported in response to HCP letter sent which included.  Updated Information included: Reporter's complete address, patient details (address, age and age at vaccination) added, vaccine information( Dose, route of administration, lot no. and anatomical loc.) added, Conmed therapy added. Relevant medical history, Lab data added, New adverse events (Fatigue, pain in extremity and nausea) added, Product name changed, Product Concentration Updated and additional information updated in narrative.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200055034 same reporter/drug, different patient and event;