Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bone density abnormal, Off label use, Product administration error, Wrong product administered
Clinical narrative: Pfizer COVID-19 vaccine orange caps was given as adult dose, 0.3ml; Pfizer COVID-19 vaccine orange caps was given as adult dose, 0.3ml; Pfizer COVID-19 vaccine orange caps was given as adult dose, 0.3ml; Bone mass; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  An 83-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2022 as dose 4 (booster), 0.3 ml single (Lot number: FL8095, Expiration Date: 12May2022) at the age of 83 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Diverticulosis of colon", start date: 23Apr2012 (ongoing), notes: Diverticulosis of colon; "Radical prostatectomy", start date: 15Jul2017 (ongoing), notes: History of radical prostatectomy; "Hypertension", start date: 03Nov2011 (ongoing); "Nodule of parotid gland", start date: 06Sep2013 (ongoing), notes: Nodule of parotid gland; "Malignant neoplasm of prostate (HCC)", start date: 03Nov2011 (ongoing), notes: Malignant neoplasm of prostate (HCC); "Pure hypercholesterolemia", start date: 03Nov2011 (ongoing); "Venous stasis", start date: 03Nov2011 (ongoing); "Villous adenoma of colon", start date: 01May2012 (unspecified if ongoing), notes: Villous adenoma of colon; "Arthritis pain" (unspecified if ongoing), notes: Arthritis pain. Concomitant medication(s) included: TYLENOL ARTHRITIS PAIN oral taken for arthralgia; LIPITOR oral, start date: 08Mar2022; EFUDEX topical, start date: 12Jan2022; MOVE FREE JOINT HEALTH oral; ALDARA topical; MAXZIDE oral, start date: 08Mar2022; VIT C oral. Vaccination history included: BNT162b2 (Caller says the patient's first dose of Pfizer COVID-19 vaccine was given 01Mar2021, for which she only has LOT: EN6202 to provide since it was not given there.), administration date: 01Mar2021, when the patient was 82-year-old, for Covid-19 Immunization, reaction(s): "None"; BNT162b2 (She says his second dose was 27Mar2021 of LOT: ER8733, which she only has LOT to provide for this dose), administration date: 27Mar2021, when the patient was 82-year-old, for Covid-19 immunization, reaction(s): "None"; BNT162b2 (She says his third dose/first booster was given 28Sep2021, NDC/LOT/EXCP: Unknown.), administration date: 28Sep2021, when the patient was 82-year-old, for Covid-19 immunization, reaction(s): "None"; Flu shot (Caller says the patient got a flu shot in Aug, but that was not recent. No further details provided about unspecified flu shot.), administration date: Aug2021, when the patient was 82 years old, for immunization. The following information was reported: BONE DENSITY ABNORMAL (non-serious) with onset 05Apr2022, outcome "not recovered", described as "Bone mass"; OFF LABEL USE (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), WRONG PRODUCT ADMINISTERED (non-serious) all with onset 05Apr2022, outcome "unknown" and all described as "Pfizer COVID-19 vaccine orange caps was given as adult dose, 0.3ml". Therapeutic measures were not taken as a result of bone density abnormal.  Additional Information: Patient did not provide information regarding the reported adverse event(s) with the use of the product. Vaccination facility type was Doctor's office/Urgent care. No history of Prior Vaccinations. No Family medical history relevant to AE. Follow-Up (07Apr2022): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are needed. No further information is expected.   Follow-up (20Apr2022) Follow-Up (22Apr2022): This is a follow-up spontaneous report received from a same contactable Nurse. This Nurse reported for a Male patient in response to HCP letter sent via follow-up letter which included that: Updated Information: Patient's full name added, RMH added, Route of administration added, Vaccination facility Name, Address, City, State, Postal code, Phone number added, Concomitant drugs added, AE 'Bone mass' added.  Follow-up attempts are completed. No further information is expected.