Symptomtext
male patient that was inadvertently administered by a nurse with an undiluted vial; Received six times the dose; undiluted; left foot went numb; chest pain; BP was high; This is a spontaneous report from a contactable pharmacist. A 41-years-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Deltoid Left on 22Oct2021 (Batch/Lot Number: UJ711AB) as single dose for covid-19 immunisation (Age at vaccination 41 years) . The patient medical history was not reported. Concomitant medications included influenza vaccine inact sag 3v (FLUCELVAX) taken for an unspecified indication from 22Oct2021 to 25Oct2021. The patient experienced left foot went numb (medically significant) on 27Oct2021 with outcome of not recovered , chest pain (medically significant) on 27Oct2021 with outcome of not recovered , BP was high (medically significant) on 27Oct2021 with outcome of unknown , male patient was inadvertently administered by a nurse with an undiluted vial (non-serious) on 22Oct2021 with outcome of unknown , received six times the dose; undiluted (non-serious) on 22Oct2021 with outcome of unknown. The patient underwent lab tests and procedures which included electrocardiogram: WNL on 28Oct2021 Comment: Normal. The patient visited the ER because of the event. Course of the event. The patient was administered an undiluted vial of Pfizer Covid-19 vaccine on 22Oct2021. No ADE reported on day of event. Flu was done on 23Oct, 24Oct and on 25Oct and no ADEs were reported. He was kept for observation for an hour on 22Oct before he was released. On 27Oct2021 patient stated his left foot went numb while in the shower that night. He also started having chest pains that radiated down his left arm. He reports his BP was high. He awoke on 28Oct2021 and still had some numbness in the left foot and pain down his arm so he went to our clinic for follow up. He had an EKG and it was normal. He had not gone to pick up his BP meds that was sent at his last visit. He was going to pick up when he left the clinic. We will follow up with patient in a week.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events hypoaesthesia, chest pain and hypertension cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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.