Age: 80.0
Sex: F
Vaccine: PNC20
Symptoms: Antinuclear antibody positive, CREST syndrome, Computerised tomogram abnormal, Extra dose administered, Magnetic resonance imaging spinal abnormal
Clinical narrative: Primary Open angle glaucoma (POAG) of right eye; Myopia; receiving two doses instead of one; This is a spontaneous report received from a Nurse from medical information team.  An 80-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 12Dec2023 at 10:19 as dose 2, 0.5 ml single (Lot number: HE6172, Expiration Date: 28Feb2025) at the age of 80 years intramuscular, in right deltoid for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Lymphoma" (unspecified if ongoing); "autoimmune diseases" (unspecified if ongoing); "cancer/ skin cancer" (unspecified if ongoing); "hypertensive kidney disease" (unspecified if ongoing); "Mild aortic regurgitation" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing); "Age-related macular degeneration", start date: 27Sep2023 (unspecified if ongoing); "Dry right eye", start date: 27Sep2023 (unspecified if ongoing); "Parkinson disease", start date: 27Sep2023 (unspecified if ongoing); "Actinic keratosis" (unspecified if ongoing); "Acute right-sided low back pain with right-sided sciatica" (unspecified if ongoing); "Anemia in CKD (chronic kidney disease)" (unspecified if ongoing); "Angioma of skin" (unspecified if ongoing); "Anxiety disorder" (unspecified if ongoing); "Aortic atherosclerosis" (unspecified if ongoing), notes: Cholesterol risk factor management with Lovastatin; "Arthritis of hand" (unspecified if ongoing), notes: Arthritis of hand, right; "Axillary lymphadenopathy" (unspecified if ongoing); "Back pain" (unspecified if ongoing), notes: unspecified back location, unspecified back pain laterality, Chronic low back pain; "unspecified chronicity Basal cell carcinoma (BCC)" (unspecified if ongoing), notes: unspecified chronicity Basal cell carcinoma (BCC) of skin Of left upper extremity including shoulder; "Biceps tendinitis" (unspecified if ongoing), notes: Biceps tendinitis of left upper extremity; "edema" (unspecified if ongoing), notes: Bilateral lower extremity edema; "Bilateral pseudophakia" (unspecified if ongoing); "Bradycardia" (unspecified if ongoing); "Chronic depression" (unspecified if ongoing); "Chronic diarrhea" (unspecified if ongoing); "Chronic headache" (unspecified if ongoing); "Chronic kidney disease, stage 3" (unspecified if ongoing); "Crest syndrome" (unspecified if ongoing), notes: Description: Hydroxychloroquine tx and follow with rheum; "Degenerative joint disease" (unspecified if ongoing), notes: Degenerative joint disease (DJD) of lumbar spine; "Dyschromia" (unspecified if ongoing); "Dyspnea on exertion" (unspecified if ongoing); "Edema of foot" (unspecified if ongoing); "Emphysema" (unspecified if ongoing); "COPD" (unspecified if ongoing), notes: Description: Visible radiographically by CT scan with borderline PFT'S. See Aug2017 (Withheld) consult. Reassurance. Avoid smoke 2nd hand and other toxins.; "Fatigue" (unspecified if ongoing), notes: Fatigue, unspecified type; "Foot pain", start date: Mar2022 (unspecified if ongoing); "Foot trauma" (unspecified if ongoing); "Foraminal stenosis of lumbosacral region" (unspecified if ongoing), notes: MRI 11Jun2020 multilevel bill foraminal stenosis severe on the right L5-S1 and L4-L5; "Gait instability" (unspecified if ongoing); "Gastroesophageal reflux disease" (unspecified if ongoing), notes: Gastroesophageal reflux disease, unspecified whether esophagitis present; "Heart palpitations" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "Hypertensive kidney disease" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "Iritis of right eye" (unspecified if ongoing); "Itching" (unspecified if ongoing); "Left arm pain" (unspecified if ongoing); "Left flank pain" (unspecified if ongoing), notes: Description: and upper and mid back pain; "Left shoulder pain" (unspecified if ongoing); "Left upper quadrant pain" (unspecified if ongoing); "Left-sided chest pain" (unspecified if ongoing), notes: Left-sided chest wall pain; "Leg swelling" (unspecified if ongoing); "Lentigo" (unspecified if ongoing); "Lumbar radiculopathy" (unspecified if ongoing); "Lumbar Spondylosis" (unspecified if ongoing); "Lymphadenopathy of right cervical region" (unspecified if ongoing); "Mild aortic regurgitation" (unspecified if ongoing); "Milia" (unspecified if ongoing); "Mixed incontinence" (unspecified if ongoing); "influenza" (unspecified if ongoing); "Neurogenic Claudication" (unspecified if ongoing), notes: Neurogenic Claudication due to lumbar spinal stenosis; "lumbar spinal stenosis" (unspecified if ongoing), notes: Neurogenic Claudication due to lumbar spinal stenosis; "Night sweats" (unspecified if ongoing); "Non ulcer dyspepsia" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing), notes: Description: intolerant to Bisphosphonates and then placed on Prolia She did not continue it. only 2 shots AMA paresthesia; "Peripheral neuropathy" (unspecified if ongoing); "Posterior Capsular opacification", start date: 27Sep2023 (unspecified if ongoing), notes: Posterior Capsular opacification visually significant of right eye; "Primary localized osteoarthritis of right knee" (unspecified if ongoing); "Proteinuria" (unspecified if ongoing); "Raynauds phenomenon" (unspecified if ongoing); "Renal insufficiency" (unspecified if ongoing); "Rheumatoid factor positive" (unspecified if ongoing); "Right ankle swelling" (unspecified if ongoing); "Right foot injury" (unspecified if ongoing); "knee pain" (unspecified if ongoing), notes: Right knee pain; "Right Wrist pain" (unspecified if ongoing); "Scar" (unspecified if ongoing); "Seborrhea" (unspecified if ongoing); "Seborrheic keratosis" (unspecified if ongoing); "Senile osteoporosis" (unspecified if ongoing); "Shortness of breath" (unspecified if ongoing); "Skin neoplasm" (unspecified if ongoing); "Sprain of right foot" (unspecified if ongoing); "Squamous cell carcinoma" (unspecified if ongoing); "Squamous cell carcinoma of skin of cheek" (unspecified if ongoing), notes: Squamous cell carcinoma of skin of scalp and neck; "Subacromial bursitis of left shoulder joint" (unspecified if ongoing); "Thoracic radiculopathy" (unspecified if ongoing), notes: Thoracic radiculopathy due to degenerative joint disease of spine; "Thoracic spondylosis" (unspecified if ongoing); "Venous stasis dermatitis" (unspecified if ongoing), notes: Venous stasis dermatitis of both lower extremities; "Vertigo" (unspecified if ongoing); "Xerosis cutis" (unspecified if ongoing); "Xerosis cutis" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM 600 + D; COLESEVELAM HCL oral, start date: 13Feb2024; TRAMADOL HCL oral, start date: 27Mar2024; VITAMIN D [COLECALCIFEROL]. Past drug history included: Diltiazem hcl, start date: 22Feb2022, notes: Medication: Diltiazem HCL- 120 mg oral tablet, Take one tablet by mouth one time daily, Days: 30, Qty: 30 tablet, Refills: 5, Status provider: active (name); Furosemide, start date: 04Feb2022, notes: Medication: Furosemide 20 mg oral tablet, Take 1 tablet by mouth daily, Days: 90, Qty: 90 tablet, Refills: 3, Status provider: active (name); Gabapentin, start date: 16Oct2012, notes: Medication: Gabapentin 100 mg oral capsule, Take 1 capsule PO QAM, 1 capsule PO at noon and 3 capsules PO QHS, Days: 30, Qty: 150 capsule, Refills: 5, Status provider: active (name); Hydroxychloroquine sulphate, start date: 04May2017, notes: Medication: Hydroxychloroquine sulfate 200 mg oral tablet, Take 1 tablet daily, Days: 0, Qty: 90 tablet, Refills: 1, Status provider: active (name); Hydroxyzine hcl, start date: 11Mar2016, notes: Medication: Hydroxyzine HCL - 25 mg oral tablet, Take 1 to 2 tablets at bedtime as needed, Days: 90, Qty: 180 tablet, Refills: 3, Status provider: active (name); Latanoprost, start date: 17Feb2023, notes: Medication: Latanoprost 0.005% ophthalmic solution, Use 1 drop right eye every night, Days: 0, Qty: 1 * 2.5 ml bottle , Refills: 3, Status provider: active (name); Lovastatin, start date: 27May2014, notes: Medication: Lovastatin 10 mg oral tablet, Take one tablet by mouth one time daily as directed, Days: 90, Qty: 90 tablet, Refills: 1, Status provider: active (name); Omeprazole, start date: 12Jul2021, notes: Medication:Omeprazole 20 mg oral capsule delayed release, Days: 30, Qty: 30 capsule, Refills: 5, Status provider: active; Oxybutynin, start date: 22Feb2022, notes: Medication: Take one capsule by mouth one time daily; Oxybutynin chloride 5 mg oral tablet, Days: 30, Qty: 60 tablet, Refills: 5, Status: Active; Sucralfate, start date: 16Sep2021, notes: Medication: Take one tablet by mouth twice a day; Sucralfate 1 gm oral tablet, Days: 30, Qty: 30 tablet, Refills: 5, Status: Active; Timolol, start date: 10Jan2022, notes: Medication: Take one tablet by mouth one time daily; Timolol maleate 0.5% Ophthalmic solution, Days: 0, Qty: 1*15 ml Bottle, Refills: 3, Status: Active; Valsartan, start date: 01Feb2022, notes: Medication: Take 1 tablet 3 times daily PRN; Valsartan 320 mg oral tablet, Days: 30, Qty: 30 tablet, Refills: 5, Status: Active; Plaquenil, start date: 19Feb2019, notes: Long term use of plaquenil. Vaccination history included: prevnar 20 (DOSE 1, SINGLE, lot: gm9409 exp 31Aug2024), administration date: 30May2023, when the patient was 80-year-old, for Immunization; flu (dose number unknown, manufacturer unknown), administration date: 01Oct2018, when the patient was 75-year-old, for Immunization; fluzone high dose (dose number unknown, manufacturer unknown), administration date: 01Oct2021, when the patient was 78-year-old, for Immunization; fluzone high dose (dose number unknown, manufacturer unknown), administration date: 05Oct2022, when the patient was 79-year-old, for Immunization; fluzone high dose (dose number unknown, manufacturer unknown), administration date: 13Sep2023, when the patient was 80-year-old, for Immunization; influenza (dose number unknown, manufacturer unknown), administration date: 06Oct2009, when the patient was 66-year-old, for Immunization; influenza (dose number unknown, manufacturer unknown), administration date: 25Jan2010, when the patient was 67-year-old, for Immunization; influenza (dose number unknown, manufacturer unknown), administration date: 28Sep2010, when the patient was 67-year-old, for Immunization; influenza (dose number unknown, manufacturer unknown), administration date: 07Oct2011, when the patient was 68-year-old, for Immunization; influenza (dose number unknown, manufacturer unknown), administration date: 27Dec2012, when the patient was 69-year-old, for Immunization; influenza (dose number unknown, manufacturer unknown), administration date: 16Sep2013, when the patient was 70-year-old, for Immunization; influenza (dose number unknown, manufacturer unknown), administration date: 22Sep2013, when the patient was 70-year-old, for Immunization; influenza (dose number unknown, manufacturer unknown), administration date: 06Oct2014, when the patient was 71-year-old, for Immunization; influenza (dose number unknown, manufacturer unknown), administration date: 05Oct2015, when the patient was 72-year-old, for Immunization; influenza (dose number unknown, manufacturer unknown), administration date: 14Sep2016, when the patient was 73-year-old, for Immunization; influenza (dose number unknown, manufacturer unknown), administration date: 22Sep2017, when the patient was 74-year-old, for Immunization; influenza (dose number unknown, manufacturer unknown), administration date: 27Aug2018, when the patient was 75-year-old, for Immunization; influenza (dose number unknown, manufacturer unknown), administration date: 21Aug2019, when the patient was 76-year-old, for Immunization; influenza (dose number unknown, manufacturer unknown), administration date: 01Oct2019, when the patient was 76-year-old, for Immunization; influenza (dose number unknown, manufacturer unknown), administration date: 01Oct2020, when the patient was 77-year-old, for Immunization; influenza (dose number unknown, manufacturer unknown), administration date: 08Oct2020, when the patient was 77-year-old, for Immunization; influenza (dose number unknown, manufacturer unknown), administration date: 09Oct2021, when the patient was 78-year-old, for Immunization; moderna COVID-19 (dose number unknown), administration date: 24Oct2022, when the patient was 79-year-old, for Covid-19 Immunization; moderna COVID-19 vaccine (dose number unknown), administration date: 03Mar2021, when the patient was 78-year-old, for Covid-19 Immunization; moderna COVID-19 vaccine (dose number unknown), administration date: 31Mar2021, when the patient was 78-year-old, for Covid-19 Immunization; moderna COVID-19 vaccine (dose number unknown), administration date: 30Oct2021, when the patient was 78-year-old, for Covid-19 Immunization; moderna COVID-19 vaccine (dose number unknown), administration date: 12Apr2022, when the patient was 79-year-old, for Covid-19 Immunization; pcv (dose number unknown, manufacturer unknown), administration date: 16Oct2015, when the patient was 72-year-old, for immunization; pneumococcal polysaccharide vaccine (dose number unknown, manufacturer unknown), administration date: 12Sep2008, when the patient was 65-year-old, for immunization; td/dt (dose number unknown, manufacturer unknown), administration date: 19Nov1998, when the patient was 55-year-old, for Immunization; td/dt (dose number unknown, manufacturer unknown), administration date: 12Sep2008, when the patient was 65-year-old, for Immunization; tetanus (dose number unknown, manufacturer unknown), administration date: 21Dec2012, when the patient was 69-year-old, for Immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset Dec2023, outcome "unknown", described as "receiving two doses instead of one"; MYOPIA (non-serious) with onset 16Apr2024, outcome "unknown"; OPEN ANGLE GLAUCOMA (medically significant) with onset 16Apr2024 at 12:00, outcome "unknown", described as "Primary Open angle glaucoma (POAG) of right eye". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: (unspecified date) positive, notes: Centromere patter suggestive of CREST syndrome; Computerised tomogram: (unspecified date) borderline PFT'S, notes: Visible radiographically by CT scan with borderline PFT'S; Magnetic resonance imaging: (11Jun2020) multilevel bill foraminal stenosis, notes: multilevel bill foraminal stenosis severe on the right L5-S1 and L4-L5; Mammogram: (unspecified date) Abnormal; Weight: (unspecified date) 155 lbs.  Clinical course: The provider accidentally ordered the Prevnar 20 vaccine twice for two patients; their billing office caught the error when they attempted to bill it, and the insurance said that the patients already had it. Upon reviewing the charts, they discovered that both patients had already received the vaccine resulting in both patients receiving two doses instead of one. Both patients received an additional dose in Dec2023 about 6 months apart from the initial dose. The reporter just wanted to know if there would be any kind of problem with that or if there were any studies related to the administration of more than one dose to adult patients. On 30Apr2024, the reporter considered the events (Primary open angle glaucoma, Myopia) were not caused by Pfizer drug.  Follow-up (30Apr2024): This is a spontaneous follow-up report received from a same Nurse. Upon received follow up information, this case now upgraded to serious.  Updated information: lab data added, medical history, past drug and historical vaccine added, suspect drug vaccination date updated, concomitant drugs added, new events (Primary open angle glaucoma, Myopia) added, causality assessment.; Sender's Comments: Based on the given information, the Company confirms that the events open angle glaucoma, and myopia unrelated to the suspected drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) and most likely due to the advanced age of the patient and other medical conditions such as age-related macular degeneration and dry eye may play a contributory role.,Linked Report(s) : US-PFIZER INC-202400063345 same reporter/drug/event for different patients;