Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Overdose, Pain in extremity, Product preparation error
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team. A 65-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2022 at 12:30 as dose 3 (booster), single (Lot number: FJ8757) at the age of 65 years intramuscular, in right deltoid for Covid-19 immunisation. The patient's relevant medical history included: "Prevention of ASCVD" (unspecified if ongoing); "Lipids" (unspecified if ongoing); "Chronic pain leg, back" (unspecified if ongoing), notes: Chronic pain leg, back; "Low back, leg pain", start date: 2010 (ongoing), notes: Total knee Aug2011 plus 2 previous procedure; "Hyperlipidemia", start date: 2015 (ongoing); "Irregular heart beat" (unspecified if ongoing), notes: Irregular heart beat; "Memory impairment" (ongoing); "urinary hesitancy" (ongoing); "OCC. Atrial Bigeminy" (unspecified if ongoing), notes: Onset Date: Episode 2. The patient's family history included: "Former smoker" (ongoing), notes: Father died age 62- MI smoker; Brother aged 66 bypass. Concomitant medication(s) included: ASPIRIN 81 oral taken for arteriosclerosis (ongoing); ATORVASTATIN oral taken for lipids, start date: 2016 (ongoing); HYDROCODONE oral taken for pain in extremity, start date: 2016 (ongoing). Vaccination history included: BNT162b2 (Dose 1, single, Route of administration: Intramuscular, Batch/Lot number: Pharmacy dose-unknown,), administration date: 02Mar2021, when the patient was 65-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, single, Anatomical Site of injection: Right deltoid, Route of administration: Intramuscular, Batch/Lot number: FF2593), administration date: 25Oct2021, when the patient was 65-year-old, for Covid-19 immunization. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 20Apr2022, outcome "unknown" and all described as "Medication error with third dose/booster dose: patient was administered undiluted dose"; PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious), outcome "recovering", and all described as "aches/pain in legs/arms". Therapeutic measures were taken as a result of pain in extremity, pain in extremity. Additional information: Dose 1 Batch/Lot number: Pharmacy dose-unknown, patient state she had a 2nd dose at pharmacy-no information to corroborate. Prior Vaccinations within 4 weeks was None. Relevant Tests was None. Specific relevant test for thromboembolic events with thrombocytopenia was reported as None. Comment/Narrative: Patient did not have strong reaction to previous doses. Need for dilution of vaccine- patient received unknown dose but layer than normal. Decreasing frequency of doses given at clinic. Confirm in reading chart in med room. Long time nurse- no concerns frequent changes in vaccine administration and vials. Nurse was up to date in competency and training. The patient did not have an unusual reaction- 1st night was usual aches/pain in legs/arms. Took an extra hydrocodone and did normal activities the next day. Followed for 5 day and is doing fine. No follow up attempts are possible. No further information is expected. Follow-up (20Apr2022): This is a follow-up spontaneous report from a contactable physician. This physician reported for a 65-year-male patient that: Updated information included: Reporter slider 01 mail id added. Follow-up (03May2022): This is a spontaneous follow-up report from same contactable Physician. This Physician reported in response to HCP letter sent which included that: Updated information included: Institution name, Historical vaccine batch/lot information added, vaccine facility information added, concomitant drug added. RMH added. Patient medical history added, new event added. Primary reporter middle initial added. No follow up attempts are possible. No further information is expected.