VAERS Reports U036156

VAERS 2575053

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge U036156

schwer

Staat: MI
Alter: 52,0
Geschlecht: F
Eingang: 03.02.2023
Impfdatum: 07.07.2022
Beginn: 30.01.2023
Tage bis Beginn: 207,0
Dosis: 1
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: unbekannt Erholt: ja

Blood bicarbonate decreased Blood glucose increased Blood ketone body increased Blood pH decreased COVID-19 Condition aggravated Device malfunction Device power source issue Diabetic ketoacidosis Electrolyte substitution therapy Intensive care Respiratory symptom SARS-CoV-2 test positive Type 1 diabetes mellitus Upper respiratory tract infection

Symptomtext

Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 1/30/2023 Discharge Date: ?2/1/2023 PRESENTING PROBLEM: DKA, type 1, not at goal Diabetic ketoacidosis without coma associated with type 1 diabetes mellitus COVID-19 HOSPITAL COURSE: Patient is a 53-year-old woman with complex past medical history including type 1 diabetes with insulin pump, combined heart failure, hypertension, atrial fibrillation, coronary artery disease status post stenting who presented with 2 weeks of upper respiratory infection symptoms and difficulty monitoring her blood sugars. Patient's Dexcom meter malfunctioned and she did not have any more sensors at home. She was unable to refill the sensors early. She still continued to use her insulin pump, but was unable to check sugars at all because her home fingerstick glucometer was out of batteries. She stated that life was busy lately and she did not have time to get batteries for the glucometer. When she presented to the emergency department her blood glucose was 525, pH was 7.07, beta hydroxybutyrate greater than 9, and bicarbonate of 7. She was found to be COVID positive. Patient was admitted to the intensive care unit for insulin drip. She required electrolyte replacement on the drip and was also given IV fluids. Patient was taken off the insulin drip and transitioned to subcutaneous Lantus 15 units in the early afternoon on 01/31. Her blood sugars remained well controlled and by the following day she was feeling well. She was set up with a new glucometer and discharged on basal bolus insulin. She has an appointment with her endocrinologist next week and was encouraged to keep that appointment and to follow up with her PCP after discharge. The patient verbalized understanding of these instructions and discharged home in stable condition.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Intensive care
Hospital-Tage: 2,0
Labordaten: -
Aktuelle Erkrankungen: None
Vorgeschichte: Hypertension Chronic depression Subclinical hypothyroidism Insulin pump status Lipoma Nonalcoholic steatohepatitis Allergy to latex Nonproliferative diabetic retinopathy Terrien's marginal degeneration of cornea Myopia Vitamin D deficiency Calculus of kidney Carpal tunnel syndrome Hydronephrosis right - RGP/RT URS w/ ureteral biopsy pathology negative Collagen disorder OSA treated with BiPAP Terrien's marginal degeneration of cornea, bilateral HTN, goal below 130/80 Dyslipidemia, goal LDL below 70 Presbyopia of both eyes Type 1 diabetes mellitus with mild nonproliferative retinopathy of both eyes without macular edema Irritable bowel syndrome Hypothyroidism due to acquired atrophy of thyroid S/P gastric bypass Steroid-induced osteoporosis Mixed anxiety depressive disorder Type 1 diabetes mellitus RLS (restless legs syndrome) Humeral surgical neck fracture Osteoporosis Difficulty with CPAP use At risk for falls Atrial fibrillation Diabetic neuropathy Gastroesophageal reflux disease Psoriasis Right lower lobe pneumonia Celiac sprue Apical variant hypertrophic cardiomyopathy Major depressive disorder in partial remission, unspecified whether recurrent Coronary artery disease involving native heart, unspecified vessel or lesion type, unspecified whether angina present Diabetic polyneuropathy associated with type 1 diabetes mellitus Gastroparesis Loss of hypoglycemic warning symptoms Hypoferremia COVID CHF (congestive heart failure), NYHA class I, chronic, combined
Andere Medikamente: acetaminophen (TYLENOL) 500 MG tablet aspirin 81 MG tablet B Complex Vitamins (VITAMIN B COMPLEX) tablet cpap doxycycline (VIBRAMYCIN) 50 MG capsule EPINEPHrine 0.3 MG/0.3ML auto-injector escitalopram (LEXAPRO) 5 MG tablet fenofibrate (TRIG
Allergien: Contrast Dye [Ivp Dye, Iodine Containing]Shortness of Breath Peanuts [Nuts]Shortness of Breath Shellfish AllergyAnaphylaxis GlutenDiarrhea Indomethacin LatexRash Plastics Povidone Iodine SoyJoint Pain Brassica Oleracea ItalicaNausea/Vomiting/Diarrhea
Vorherige Impfungen: -

VAERS 2531039

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge U036156

mild

Staat: NC
Alter: 61,0
Geschlecht: F
Eingang: 14.12.2022
Impfdatum: 30.11.2022
Beginn: 01.12.2022
Tage bis Beginn: 1,0
Dosis: 3
Route/Site: IM / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: ja Erholt: ja

Angiogram cerebral normal Atrial fibrillation Blood creatinine normal Blood glucose increased Blood potassium decreased Blood sodium decreased Blood urea decreased Computerised tomogram head normal Dizziness Drug interaction Dysarthria Echocardiogram normal Electrocardiogram abnormal Full blood count normal Headache International normalised ratio increased Magnetic resonance imaging head normal Metabolic function test

Symptomtext

Diagnosed with stroke-like syndrome. Received COVID Bivalent booster and PCV15 vaccines on 11/30/22 with no observed adverse events immediately following the vaccines. Called PCP on 12/1/22 reporting headache with 6/10 pain with nausea and dizziness for the last 1.5 days with suicidal ideation. Was told to go to the ED immediately. When to ED on 12/1/22 presenting with mild headache, blurred vision, and slurred speech. Tests were negative for stroke but was found to be in Afib with RVR and was given digoxin, metoprolol PO and IV for rate control, and IV fluids then admitted and consulted by cardiology. Was then placed on amiodarone and converted back to sinus rhythm then transitioned to PO propafenone and metoprolol. Ramipril was stopped due to low BP and trazodone and tizanidine were stopped due to drug interactions. Was seen by cardiologist and PCP post discharge and her condition has resolved.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Dizziness
Hospital-Tage: 1,0
Labordaten: CBC ? unremarkable; CMP ? Na 135, K 2.5, BUN 6, SCr 0.86, glucose 248; troponin 7; INR 1.27; ECG ? afib with RVR; CT head ? negative for acute infarct; MRI & MRA ? negative for acute infarct, stable AVM; 2D echo - unremarkable
Aktuelle Erkrankungen: no acute illness present
Vorgeschichte: Hyperlipidemia, Obesity, Osteoporosis, Gastroesophageal Reflux Disease, Atrial Fibrillation: paroxysmal--S/P Watchman Procedure 2/2022, Carotid Artery Stenosis, OSA, leg cramps, Type 2 Diabetes, basal ganglia AVM-MRA Stable, Hypertensive retinopathy, chronic low back pain, osteoarthritis, pulmonary nodule, chronic bronchitis, anxiety, migraines
Andere Medikamente: hydroxyzine HCL, docusate sodium, trazodone, zinc sulfate, potassium gluconate, aspirin, promethazine, Farxiga, oxycodone-acetaminophen, Levemir, Bydureon, pantoprazole, venlafaxine, atorvastatin, cranberry, ondansetron, famotidine, Ramipri
Allergien: sulfonamides (rash), Nucynta (insomnia, vivid dreams), metformin (diarrhea, fatigue), Bactrim (rash, shakiness), contrast dye (hives), gabapentin (sleep disturbances)
Vorherige Impfungen: Experienced dehydration after the 1st Pfizer COVID vaccine dose in 6/9/2021, but tolerated the 2nd dose on 6/30/21 with no repor

VAERS 2516235

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge U036156

mild

Staat: FL
Alter: -
Geschlecht: F
Eingang: 25.11.2022
Impfdatum: 19.10.2022
Beginn: 20.10.2022
Tage bis Beginn: 1,0
Dosis: UNK
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Product design confusion Product label confusion Product preparation issue Product use complaint Vaccination site erythema Vaccination site induration Vaccination site pain Vaccination site swelling Wrong technique in product usage process

Symptomtext

Patient instructions for use in label confusing; induration, the grape size; swelling at vaccination site; redness at vaccination site; painful at the injection site (very painful per patient); do not know how to use the syringe due to two caps at the end and there were no directions in the PI on how to use it; Practice keep moving vaccine pre-filled syringe while it was in the pt's arm / vaccine admin did not know how to remove cap of "leur-lok pre-filled syringe and attach a needle; didn't know that vaccine had to been shaken vigorously prior adminis; Vaccine administer had troubles prepping the vaccination/ medical assistant complained VAXNEUVANCE during previous administrations and reemphasized that drug preparation and administration was not intuitive like other pre-filled syringe; Vaccine administrator did not know how to remove cap of eur-lok pre-filled syringe and attach a needle; additionally, they did not know that the vaccine had to been shaken vigorously prior to administration; This spontaneous report was received from a nurse prescriber and refers to a 67-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-OCT-2022, the patient started therapy with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, pre-filled syringe, 0.5 milliliter, lot #U036156, expiration date: 25-MAY-2023, administered for prophylaxis (anatomical location, and route of administration were not provided). The vaccination was administered by medical assistant at practice who kept moving the vaccine pre-filled syringe while it was in the patient's arm. The lead nurse practitioner mentioned that the person who administered the vaccine had troubles prepping the vaccination (vaccine administrator did not know how to remove cap of leur-lok pre-filled syringe and attach a needle (Product preparation issue); additionally, they did not know that the vaccine had to been shaken vigorously prior to administration) and administering the injection (Wrong technique in product usage process). According to lead nurse practitioner, the medical assistant has complained pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) during previous administrations and reemphasized that drug preparation and administration was not intuitive like other pre-filled syringe vaccines on the market (Product use complaint). On 20-OCT-2022 (reported also as: next after received), the patient experienced vaccination site induration, vaccination site swelling, vaccination site erythema, vaccination site pain. The patient reported that the next day she had induration (it was the size grape) the next after received. It was painful at the injection site (very painful per patient). Redness, swelling like the size of a grape (the site very hard). The Patient was a registered nurse who reported a red grape size painful induration at injection site. The patient was very upset she had never had any issues with any vaccine. Nurse practitioner (NP) reported that they did not know how to use the pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE). That no one in the facility could figure out how to correctly use the product. NP reported that it was confusing to use since it looks like it had two caps the rubber one at the very end then you pull the rubber one off and it looked like it has another cap on the end. The Employee reported that she was not even sure how to use the product and that it was very confusing to her as well. The NP and employee made it seem like at the begging of the call that they had not been able to use the product due to no one at the facility understanding how to use the syringe. Towards the end of the call before the employee hung up she mentions that she would call back later to report an adverse event (AE). NP reported that no one in the facility knows how to use pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE). No products actually messed up per caller they do not know how to use the syringe due two the two caps at the end and there are no directions in the prescribing information (PI) on how to use it. Caller did not under why there are two caps and if they need to remove both. Caller thinks there should be something in the PI stating how to use the syringe or what the two caps are for per caller. Customer had issues that their was not something in the PI to tell how to use the syringe (Product design confusion). Customer reported they were all confused since it looked to have two caps on the syringe. Caller states there is nothing to tell them how to use the syringe (Product label confusion). No stating how to use the syringe it was confusing to them since it looked like there are two caps the rubber on and clear one. The reporter stated the healthcare provider feels like there needs to be direction on how to utilized the pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) pre-filled syringe and picture directions for administration should be included in the PI as you don't normally had to shake a pre-filled syringe vigorously until it was cloudy. The reporter stated that none of the nurses in the office realized it should be shaken in that manner. At the time of reporting, the outcome of the events vaccination site induration, vaccination site swelling, vaccination site erythema, vaccination site pain was unknown. The causal relationship between the events vaccination site induration, vaccination site swelling, vaccination site erythema, vaccination site pain and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was unknown.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Vaccination site pain
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2403326

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (OTHER) · Charge U036156

mild

Staat: CA
Alter: 67,0
Geschlecht: F
Eingang: 05.08.2022
Impfdatum: 27.07.2022
Beginn: 27.07.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Erythema Mass Pruritus Swelling

Symptomtext

REDNESS, SIGNIFICANT SWELLING A LARGE LUMP, ITCHINESS

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pruritus
Hospital-Tage: -
Labordaten: NONE
Aktuelle Erkrankungen: -
Vorgeschichte: DM2 ULCERATIVE COLITIS RHEUMATOID ARTHRITIS
Andere Medikamente: OMEPRAZOLE 20MG LANTUS 20IU FOLIC ACID 1mg PREDNISONE 5mg METFORMIN 500mg AMLODIPINE LOSARTAN 100MG SULFA SALAZINE 500MG CALCIUM D3 METOPROLOL ER 25 MG ADK METHOTREXATE 2.5MG
Allergien: NKDA
Vorherige Impfungen: -

VAERS 2386828

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge U036156

mild

Staat: CA
Alter: 64,0
Geschlecht: F
Eingang: 23.07.2022
Impfdatum: 17.07.2022
Beginn: 23.07.2022
Tage bis Beginn: 6,0
Dosis: 2
Route/Site: IM / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Injection site swelling

Symptomtext

Slight swelling on the injection site. Patient did not take any medications for the swelling nor seek medical attention.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Injection site swelling
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: N/A
Vorgeschichte: N/A
Andere Medikamente: Aspirin, Losartan, Atorvastatin , Metformin, Montelukast, Symbicort, Albuterol
Allergien: NKA
Vorherige Impfungen: -

VAERS 2259926

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge u036156

mild

Staat: GA
Alter: 66,0
Geschlecht: F
Eingang: 01.05.2022
Impfdatum: 27.04.2022
Beginn: 28.04.2022
Tage bis Beginn: 1,0
Dosis: 1
Route/Site: IM / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Burning sensation Peripheral swelling Pruritus

Symptomtext

the patient has swollen arm and it says it burns and itches

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pruritus
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: NOT KNOWN
Vorgeschichte: NOT KNOWN
Andere Medikamente: NOT KNOWN
Allergien: NOT KNOWN
Vorherige Impfungen: -

VAERS 2228531

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge U036156

mild

Staat: KS
Alter: 61,0
Geschlecht: F
Eingang: 12.04.2022
Impfdatum: 08.04.2022
Beginn: 09.04.2022
Tage bis Beginn: 1,0
Dosis: 1
Route/Site: IM / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Fatigue Injection site erythema Injection site induration Injection site mass Injection site pain Injection site swelling Injection site warmth Malaise

Symptomtext

Redness, swelling, and tender/hard lump on L deltoid/upper arm. Area around injection site warm to touch. Red/swollen area reached approximately 4.5" x 3" in diameter. Patient also experienced significant fatigue/malaise.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Fatigue
Hospital-Tage: -
Labordaten: N/A
Aktuelle Erkrankungen: unknown - pneumonia in January 2022
Vorgeschichte: Asthma, restless leg syndrome
Andere Medikamente: Cymbalta, Astmacort inhaler, Requip
Allergien: Penicillin, all cephalosporin antibiotics
Vorherige Impfungen: -

VAERS 2656745

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge U036156

gering

Staat: OR
Alter: -
Geschlecht: U
Eingang: 17.07.2023
Impfdatum: 30.05.2023
Beginn: 30.05.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Expired product administered No adverse event

Symptomtext

no adverse event; Inbound call transferred from specialist received. called to report expired administered VAXNEUVANCE. Caller was on delayed hold while sought guidance; agreed to returned call with additional guidance for expired administered vaccine. ; This spontaneous report was received from a nurse referring to an unknown age and gender patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 30-MAY-2023, the patient started therapy with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dose, lot #U036156, expiration date: 25-MAY-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event (AE) or product quality compliant (PQC). Inbound call transferred from specialist received and called to report that expired administered pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE). Caller was on delayed hold while employee sought guidance; agreed to returned call with additional guidance for expired administered vaccine. Complete AE details not received at the reporting time. The causality between the event and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was not reported.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2650008

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge U036156

gering

Staat: WA
Alter: 25,0
Geschlecht: U
Eingang: 27.06.2023
Impfdatum: 14.06.2023
Beginn: 14.06.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Expired product administered No adverse event

Symptomtext

No symptoms or side effects reported by the patient; Medical Assistant called to report that a Patient received an expired dose of VAXNEUVANCE yesterday, 6/14/2023. HCP denies known temperature excursions on product. No symptoms or side effects reported by the patient. Operator of the device is a healt; This spontaneous report was received from a medical assistant referring to a 25-year-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported. On 14-JUN-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) lot number U036156, expiration date 23-MAY-2023, 0.5 milliliter (route of administration) for prophylaxis (expired product administered). No adverse event was reported. The vaccine did not underwent any temperature excursion.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2531186

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge U036156

gering

Staat: MI
Alter: 59,0
Geschlecht: F
Eingang: 14.12.2022
Impfdatum: 13.12.2022
Beginn: 13.12.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: IM / RA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Incorrect product formulation administered

Symptomtext

I administered a Monovalent Moderna Vaccine vs Moderna Bivalent vaccine as a booster dose.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Incorrect product formulation administered
Hospital-Tage: -
Labordaten: None
Aktuelle Erkrankungen: N/A
Vorgeschichte: Hypertension and High cholesterol.
Andere Medikamente: Metformin and high blood pressure medicine
Allergien: None
Vorherige Impfungen: -

VAERS 2509118

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge U036156

gering

Staat: IN
Alter: 81,0
Geschlecht: U
Eingang: 16.11.2022
Impfdatum: 10.11.2022
Beginn: 10.11.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

No adverse event Wrong product administered

Symptomtext

patient was accidently administered VAXNEUVANCE instead of a flu vaccine; No additional AE; This spontaneous report was received from a registered nurse concerning an 81-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided. On 10-NOV-2022, the patient was administered accidentally a dose of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) 0.5 ml/once, administered as prophylaxis, lot number U036156 with expiration date 25-MAY-2023 (route of administration was not provided), instead of a flu vaccine (unspecified) (Wrong product administered). No additional adverse events were reported (No adverse event).

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2480978

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge U036156

gering

Staat: CA
Alter: -
Geschlecht: U
Eingang: 18.10.2022
Impfdatum: 28.09.2022
Beginn: 28.09.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

No adverse event Product storage error

Symptomtext

no additional adverse event; Medical assistant reporting a vaccine was administered after a temperature excursion. No additional AE. No PQC. ? Names of vaccines involved (including lot/exp) VAXNEUVANCE U036156 5/25/2023 ? Temperature 9.2C for 3 hours; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-SEP-2022, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) prefilled syringe, 0.5 milliliter, lot #U036156, expiration date: 25-MAY-2023, administered as prophylaxis (strength, and route of administration were not provided). It was reported that the vaccine was administered after a temperature excursion at a temperature of 9.2 Celsius degrees (C) for 3 hours (product storage error). A previous temperature excursion was reported at a temperature of 15C for 1 hour. No additional adverse events were reported.

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2427298

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge U036156

gering

Staat: CA
Alter: -
Geschlecht: U
Eingang: 02.09.2022
Impfdatum: 01.08.2022
Beginn: 01.08.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

No adverse event Syringe issue

Symptomtext

NO ADVERSE EVENT; Caller reports 2 broken VAXNEUVANCE PFS, One PFS has leur-lock broken off and the other one has the finger flange broken; She drew medication out of a broken PFS and administered the dose to a patient.; She drew medication out of a broken PFS and administered the dose to a patient.; Caller reports 2 broken pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) PFS. One PFS had leur-lock broken off and the other one had the finger flange broken. Caller declined to send pictures. Caller stated, "you can take all the pictures you want once I send them back". Caller would hold product for return. No adverse event (AE) reported. No additional Product Quality Complaint (PQC) reported. Question section: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes for DPOC: A cracked syringe has a line or chip in the glass, but the syringe is essentially intact in one piece. A syringe is considered broken when the syringe is in 2 or more pieces. A syringe is also considered "cracked" if it appears to be intact with evidence of a chip or crack OR appears to be intact initially but then breaks into 2 or more pieces during use (such as while attaching a needle or injecting diluent). Please provide a detailed description of the defect using the questions below: Is there a crack? No If yes, describe the size, shape & depth of the crack: NA Provide the exact location of the crack on the syringe: NA Is the syringe broken into 2 or more pieces? Yes If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) Broken into several pieces Provide the exact location of the breakage on the syringe? 1 syringe is broken at leur-lock and another syring is broken at finger flange. Does the syringe have a broken component? Yes (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange). If yes, describe in detail how it is broken. Leur-lock is off completley - finger flange is broken off. Provide the exact location of the breakage on the syringe? By the leur lock for one syringe and by the finger flange for the other. Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? Yes (if yes describe) broken off of the one syringe. Was there difficulty trying to attach the syringe needle to the syringe? NA If yes, describe If yes, was it supplied by MERCK: NA If not supplied by MERCK, what type & brand, needle size & gauge was used? NA Under what situation was this defect noticed: (select one) While the syringe was still in the tray? Yes If yes, is there product (liquid or dried residue) in the tray? Yes Is there any broken glass or other separated component in the tray? (if yes specify) yes broken glass in tray. After removing the syringe from the tray? No While trying to attach the needle to the syringe? No While giving the injection? No Immediately after giving the injection? No Was the syringe tip cap attached properly prior to use? Yes If no, describe issue: Was the syringe tray intact and undamaged on receipt? Yes If no, describe damage. If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? See below. Yes If no, describe damage Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) No. If yes, describe Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? No If complaint sample is not/cannot be returned, please provide reason: will hold for return If photos are available, ask the customer to send them, HCP refuses to send photos Retrieval Information: Obtain product (& tray if possible) Expedite return for cracked syringes. If there is a doubt whether it is cracked or broken, please expedite. Note: Vaccine Prefilled Syringes may be returned even if biohazardous. Sample Tracking Number: User's Experience: Repeat User Insertion Difficulty: Insertion Difficulty Details: Doubt About Presence: Doubt Details: Migration: Migration Details: Removal Problem: Removal Problem Details: 19-AUG-2022 15:30 PM: Attachment added. 19-AUG-2022 15:30 PM: Waiting for Retrieval Site from Quality-- See attachments 19-AUG-2022 15:30 PM: Attachment added. 19-AUG-2022 Requested DPOC to confirm with the reporter if the 2 defected syringes are from the same lot. 19-AUG-2022: Second person review performed. 19-AUG-2022 17:30 PM: Attachment added. 19-AUG-2022 17:30 PM: Email received on 19-AUG-2022 at 4:05 pm with the following message from quality: "Can you please confirm with the reporter, if the 2 defected syringes are from the same lot?" See attachment. Will forward to case owner for follow up. 19-AUG-2022 17:30 PM: PQC clarification: Can you please confirm with the reporter, if the 2 defected syringes are from the same lot? It was confirmed during initial call that both syringes were from the same lot and in the same tray. 19-AUG-2022 17:30 PM: Attachment added. 19-AUG-2022 17:30 PM: Labels created 19-AUG-2022 22-AUG-2022 Based upon further review, has also been added as a lead for the syringe hub defect - broken, as they are the manufacturing site. 22-AUG-2022 The reported and investigative PQC has been updated for the second PFS to Syringe hub defect- broken, since the leur-lock was broken.

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2423732

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge U036156

gering

Staat: AZ
Alter: -
Geschlecht: U
Eingang: 30.08.2022
Impfdatum: -
Beginn: 16.08.2022
Tage bis Beginn: -
Dosis: UNK
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Syringe issue

Symptomtext

no adverse event; Sterile Injectable;N/A;Broken Syringe; Office manager reports at least 2 broken finger flanges on pre-filled syringes of VAXENUVANCE. Office manager states medical assistant heard something in the unopened box moving around and opened the box to discover at least 2 broken finger flanges with glass pieces in the box. Product is available for retrieval. See CR request case 02227250 for replacement. No AE reported. No additional PQC. QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes for DPOC: *A cracked syringe has a line or chip in the glass, but the syringe is essentially intact in one piece. A syringe is considered broken when the syringe is in 2 or more pieces. *A syringe is also considered "cracked" if it appears to be intact with evidence of a chip or crack OR appears to be intact initially but then breaks into 2 or more pieces during use (such as while attaching a needle or injecting diluent). *Please provide a detailed description of the defect using the questions below: Is there a crack? NO If yes, describe the size, shape & depth of the crack: Provide the exact location of the crack on the syringe: Is the syringe broken into 2 or more pieces? YES If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) FINGER FLANGE IS BROKEN Provide the exact location of the breakage on the syringe? FINGER FLANGE Does the syringe have a broken component? YES/NO/NA/UNSPECIFIED (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) YES. BROKEN FINGER FLANGE If yes, describe in detail how it is broken. FINGER FLANGE IS BROKEN OFF Provide the exact location of the breakage on the syringe? FINGER FLANGE Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? YES/NO/NA/UNSPECIFIED (if yes describe) NO Was there difficulty trying to attach the syringe needle to the syringe? NO. THIS WAS NOT ATTEMPTED If yes, describe N/A If yes, was it supplied by MERCK: N/A If not supplied by MERCK, what type & brand, needle size & gauge was used? N/A Under what situation was this defect noticed: (select one) While the syringe was still in the tray? YES If yes, is there product (liquid or dried residue) in the tray? UNKNOWN Is there any broken glass or other separated component in the tray? (if yes specify) YES. PART OF THE BROKEN FINGER FLANGE IS IN THE TRAY. IT WAS NOTICED BECAUSE MEDICAL ASSISTANT HEARD SOMETHING MOVING AROUND LOOSE IN THE TRAY AND OPENED IT TO FIND GLASS PEICES After removing the syringe from the tray? NO. THIS WAS NOTICED WHILE THE SYRINGES WERE IN THE TRAY. BECAUSE THEY WERE BROKEN, NO SYTRINGES WERE REMOVED FROM THE TRAY While trying to attach the needle to the syringe? NO While giving the injection? NO Immediately after giving the injection? NO Was the syringe tip cap attached properly prior to use? N/A If no, describe issue: Was the syringe tray intact and undamaged on receipt? YES If no, describe damage. N/A If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *See below. YES If no, describe damage Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO If yes, describe Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? NO If complaint sample is not/cannot be returned, please provide reason: If photos are available, ask the customer to send them Retrieval Information: Obtain product (& tray if possible) Expedite return for cracked syringes. If there is a doubt whether it is cracked or broken, please expedite. NOTE: Vaccine Prefilled Syringes may be returned even if biohazardous. Sample Tracking Number: User's Experience: Repeat User Insertion Difficulty: Insertion Difficulty Details: Doubt About Presence: Doubt Details: Migration: Migration Details: Removal Problem: Removal Problem Details: 16-Aug-2022 19:30: Attachment added. 17Aug2022: Second person review performed by Company employee 1 17-Aug-2022 12:30: Waiting for Retrieval Site from Quality--See attachments 17-Aug-2022 12:30: Attachment added. 17-Aug-2022 13:30: Attachment added. 17-Aug-2022 13:30: Labels created 08/17/2022 17-Aug-2022 13:30:******CORRECTION TO N-793646*******

Weitere VAERSDATA-Felder

Praegender Schweregrund: Syringe issue
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2419492

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge U036156

gering

Staat: CA
Alter: 67,0
Geschlecht: F
Eingang: 24.08.2022
Impfdatum: 05.08.2022
Beginn: 07.08.2022
Tage bis Beginn: 2,0
Dosis: UNK
Route/Site: IM / RA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja

Lumbar puncture Meningitis aseptic

Symptomtext

Aseptic meningitis.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Lumbar puncture
Hospital-Tage: -
Labordaten: Lumbar puncture.
Aktuelle Erkrankungen: obesity
Vorgeschichte: obesity.
Andere Medikamente: estrace vaginal cream, multi vitamins
Allergien: sulfa rugs
Vorherige Impfungen: -

VAERS 2416617

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge U036156

gering

Staat: CA
Alter: -
Geschlecht: U
Eingang: 20.08.2022
Impfdatum: 22.07.2022
Beginn: 22.07.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

No adverse event Poor quality product administered

Symptomtext

No additional AE reported.; a syringe of VAXNUVANCE broke when the needle was attached.; the patient was administered the full dose of VAXNUVANACE from the syringe involved in the product compliant; This spontaneous report was received from an office manager and referred to a patient of unknown age and gender. The medical history, current conditions and concomitant medications were not provided. On 22-JUL-2022, awhen the needle was attached to pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), the interior portion of the syringe where the luer-lock was located broke (Syringe issue). The syringe did not broken into 2 or more pieces. The tip of the syringe or Luer lock adaptor did not loose or broken off of the syringe tip. There was no difficulty to attach the syringe needle to the syringe and the needle was 25Dx1 inch eclipse needle. The syringe tip cap attached properly prior to use. The syringe tray intact and undamaged on receipt. The cellophane covered the syringe tray intact and was completely sealed. The syringe carton did not damage prior to use. Although the luer-lock broke, the vaccine was still able to be administered. Then, on the same day (22-JUL-2022), the patient was vaccinated with the full dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (dose: 0.5 milliliter, lot #U036156, expiration date: 25-MAY-2023; route and strength were unknown) for prophylaxis (Poor quality product administered). A biohazard mailer for retrieval of the pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was arranged. On 28-JUL-2022, the product was returned. The pictures of the defective syringe were submitted. No additional information provided. No additional AE reported.

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2413280

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge U036156

gering

Staat: GA
Alter: -
Geschlecht: U
Eingang: 17.08.2022
Impfdatum: -
Beginn: 04.08.2022
Tage bis Beginn: -
Dosis: UNK
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Syringe issue

Symptomtext

no adverse event; Sterile Injectable;Broken;Syringe Hub Defect; the medication was leaked into the carton; Medical Assistant called stating they received an order of pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) (10 count) which they order through their Merck Representative. When initially opening the shipment and prior to removing vaccines from carton, it was found that 2 of the 10 prefilled syringes were broken and the medication was leaked into the carton. Caller states that the needle hub tip of the pre-filled syringe was completely broken off of 2 syringes and loose in the carton. Caller stated that there appeared to be no damage to the cellophane wrap, the carton or the box they arrived in. The 2 syringes were found broken prior to removing them from the carton. No patient's involved. No AE reported. PQC filed. Caller requested replacement and sent pictures which are attached to case. Caller stated their was no rush on replacement and will hold onto the broken syringes and carton to return to Merck. Reemphasized to caller to only return the damaged products and the carton and to keep the undamaged products. QUESTION SECTION: Medium Risk: Broken Syringe Barrel. High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes for DPOC: o A cracked syringe had a line or chip in the glass, but the syringe is essentially intact in one piece. A syringe is considered broken when the syringe is in 2 or more pieces. o A syringe is also considered "cracked" if it appears to be intact with evidence of a chip or crack OR appears to be intact initially but then breaks into 2 or more pieces during use (such as while attaching a needle or injecting diluent). o Please provide a detailed description of the defect using the questions below: o Is there a crack? NO o If yes, describe the size, shape & depth of the crack: o Provide the exact location of the crack on the syringe: o Is the syringe broken into 2 or more pieces? YES o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) THE TIP WHERE THE NEEDLE IS PLACED IS COMPLETELY SNAPPED OFF o Provide the exact location of the breakage on the syringe? NEEDLE HUB WHERE NEEDLE ATTACHES TO SYRINGE o Does the syringe have a broken component? YES (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) o If yes, describe in detail how it is broken. NEEDLE HUB IS COMPLETELY BROKEN/SNAPPED OFF o Provide the exact location of the breakage on the syringe? NEEDLE HUB WHERE NEEDLE ATTACHES o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? YES (if yes describe) COMPLETELY BROKEN OFF o Was there difficulty trying to attach the syringe needle to the syringe? N/A. WE NEVER TRIED TO ATTACH A NEEDLE BECAUSE IT WAS COMPLETELY BROKEN OFF AND MOST OF LIQUID LEAKED OUT o If yes, describe o If yes, was it supplied by MERCK: N/A o If not supplied by MERCK, what type & brand, needle size & gauge was used?' N/A o Under what situation was this defect noticed: (select one) o While the syringe was still in the tray? YES o If yes, is there product (liquid or dried residue) in the tray? YES o Is there any broken glass or other separated component in the tray? (if yes specify) YES; BROKEN NEEDLE HUB OF SYRINGE LOOSE IN THE TRAY o After removing the syringe from the tray? N/A o While trying to attach the needle to the syringe? N/A o While giving the injection? N/A o Immediately after giving the injection? N/A o Was the syringe tip cap attached properly prior to use? NO o If no, describe issue: NEVER USED o Was the syringe tray intact and undamaged on receipt? YES o If no, describe damage. o If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *See below. YES o If no, describe damage o Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO o If yes, describe o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? NO o If complaint sample is not/cannot be returned, please provide reason: N/A *If photos are available, ask the customer to send them Retrieval Information: o Obtain product (& tray if possible) o Expedite return for cracked syringes. If there is a doubt whether it is cracked or broken, please expedite. NOTE: Vaccine Prefilled Syringes may be returned even if biohazardous. Sample Tracking Number: User's Experience: Repeat User Insertion Difficulty: Insertion Difficulty Details: Doubt About Presence: Doubt Details: Migration: Migration Details: Removal Problem: Removal Problem Details: 04-AUG-2022 17:30: Attachment added. 04-AUG-2022 17:30: Email received in the mailbox on 04-AUG-2022 at 15:04 with pictures associated with this case. See attachment. 04-AUG-2022 17:30: Attachment added. 04-AUG-2022 17:30: Attachment added. 04-AUG-2022: reviewer A; Attached PHOTO and AE Correspondence. 05-AUG-2022: Second person review performed by reviewer B. 05-AUG-2022 14:30: Waiting for Retrieval Site from Quality-- See attachments 05-AUG-2022 14:30: Attachment added. 05-AUG-2022 15:30: Attachment added. 05-AUG-2022 15:30: 05-AUG-2022 10-AUG-2022; reviewer A; Patient code was changed to correct field; "No Health Consequence or Impact; C50675; F26 (Medical Device Reportable PQC). 10-AUG-2022: Second person review performed by reviewer B 10-AUG-2022; reviewer A; Updated Medical Device Reporting Rationale to "Based on the Reportability Matrix for this Product, a Reportability Assessment is needed." 10-AUG-2022: Second person review performed by reviewer B 10-AUG-2022 17:30: Attachment added. 10-AUG-2022 17:30: Email received in the Mailbox on 10-AUG-2022 at 16:09 reporting the mailer was received. Product return date updated and case closed. See attachment.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Syringe issue
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2407142

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge u036156

gering

Staat: PA
Alter: 12,0
Geschlecht: F
Eingang: 10.08.2022
Impfdatum: 09.08.2022
Beginn: 09.08.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: IM / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Product administered to patient of inappropriate age Product administration error Wrong product administered

Symptomtext

patient was administered vaxneuvance instead of fluarix in error. reported error to family and pediatrician office. vaccine is indicated for pediatric use but was not requested in this situation. monitoring for potential adverse reactions

Weitere VAERSDATA-Felder

Praegender Schweregrund: Product administered to patient of inappropriate age
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: N/A
Vorgeschichte: ADD/ADHD
Andere Medikamente: dextroamphetamine-amphetamine ER 20mg capsules
Allergien: N/A
Vorherige Impfungen: -

VAERS 2407137

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge u036156

gering

Staat: PA
Alter: 8,0
Geschlecht: F
Eingang: 10.08.2022
Impfdatum: 09.08.2022
Beginn: 09.08.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: IM / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Product administered to patient of inappropriate age Product administration error Wrong product administered

Symptomtext

patient was administered vaxneuvance instead of fluarix in error. reported error to family and pediatrician office. vaccine is indicated for pediatric use but was not requested in this situation. monitoring for potential adverse reactions

Weitere VAERSDATA-Felder

Praegender Schweregrund: Product administered to patient of inappropriate age
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: N/A
Vorgeschichte: N/A
Andere Medikamente: N/A
Allergien: N/A
Vorherige Impfungen: -

VAERS 2395706

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge U036156

gering

Staat: CT
Alter: -
Geschlecht: U
Eingang: 29.07.2022
Impfdatum: -
Beginn: 15.07.2022
Tage bis Beginn: -
Dosis: UNK
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Syringe issue

Symptomtext

no adverse event; 2 VAXNEUVANCE PFS found broken when tray opened; Caller reported 2 pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE PFS) found broken when tray opened. No AE reported. No additional PQC reported. Caller will send picture and will hold product and tray for return. QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes: o A cracked syringe has a line or chip in the glass, but the syringe is essentially intact in one piece. A syringe is considered broken when the syringe is in 2 or more pieces. o A syringe is also considered "cracked" if it appears to be intact with evidence of a chip or crack OR appears to be intact initially but then breaks into 2 or more pieces during use (such as while attaching a needle or injecting diluent). o Please provide a detailed description of the defect using the questions below: o Is there a crack? NO o If yes, describe the size, shape & depth of the crack: NA o Provide the exact location of the crack on the syringe: NA o Is the syringe broken into 2 or more pieces? YES o If yes, describe in detail how it is broken: (e.g. shattered, broken in half etc.) Leur-lock is broken off o Provide the exact location of the breakage on the syringe? Leur-lock o Does the syringe have a broken component? YES (e.g. broken syringe tip; loose or detached luer lock, or broken finger flange) o If yes, describe in detail how it is broken. Leur-lock is broken off o Provide the exact location of the breakage on the syringe? Leur-lock o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? YES (if yes describe) o Was there difficulty trying to attach the syringe needle to the syringe? NA o If yes, describe NA o If yes, was it supplied by MERCK: NA o If not supplied by MERCK, what type & brand, needle size & gauge was used?'NA o Under what situation was this defect noticed: (select one) o While the syringe was still in the tray? YES o If yes, is there product (liquid or dried residue) in the tray? NO o Is there any broken glass or other separated component in the tray? (if yes specify) Yes- Leur-lock is separated o After removing the syringe from the tray? NO o While trying to attach the needle to the syringe? NO o While giving the injection? NO o Immediately after giving the injection? NO o Was the syringe tip cap attached properly prior to use? YES o If no, describe issue: NA o Was the syringe tray intact and undamaged on receipt? YES o If no, describe damage. NA o If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? *See below. YES o If no, describe damage NA o Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO o If yes, describe NA o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? NO o If complaint sample is not/cannot be returned, please provide reason: NA *If photos are available, ask the customer to send them Retrieval Information: o Obtain product (& tray if possible) o Expedite return for cracked syringes. If there is a doubt whether it is cracked or broken, please expedite. NOTE: Vaccine Prefilled Syringes may be returned even if biohazardous. Sample Tracking Number: User's Experience: Repeat User Insertion Difficulty: Insertion Difficulty Details: Doubt About Presence: Doubt Details: Migration: Migration Details: Removal Problem: Removal Problem Details: 20-JUL-2022 15:30 PM :Attachment added to Service Cloud. 20-JUL-2022 15:30 PM :Attachment added to Service Cloud. 20-JUL-2022 15:30 PM :Email received on 20-JUL-2022 at 2:26pm with pictures related to this case. See attached. 20-JUL-2022: The priority for this record has been changed per Product Quality Complaint, Complaint Category and Risk Priority Table. 20-JUL-2022: PHOTOS received & attached 20-JUL-2022; Second person reviewed 20-JUL-2022 16:30 PM :Waiting for Retrieval Site from Quality---See attachments 20-JUL-2022 16:30 PM :Attachment added to Service Cloud. 20-JUL-2022 17:30 PM :Attachment added to Service Cloud. 20-JUL-2022 17:30 PM : Labels created 20-JUL-2022 21-JUL-2022 09:30 AM :Attachment added to Service Cloud. 21-JUL-2022: Lead was updated 21-JUL-2022; Second reviewed 21-JUL-2022: Requested reroute return mailer 21-JUL-2022 13:30 PM :Attachment added to Service Cloud. 21-JUL-2022 13:30 PM :Email received on 21-JUL-2022 at 12:05pm with the following request from quality: "Please reroute return mailer." Forwarded to mail team for follow up. See attached. 21-JUL-2022 15:30 PM :Attachment added 21-JUL-2022 15:30 PM : Labels created

Weitere VAERSDATA-Felder

Praegender Schweregrund: Syringe issue
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2386663

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge U036156

gering

Staat: MO
Alter: -
Geschlecht: U
Eingang: 23.07.2022
Impfdatum: -
Beginn: 06.07.2022
Tage bis Beginn: -
Dosis: UNK
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Syringe issue

Symptomtext

no adverse event; Sterile Injectable;N/A;Broken Syringe; Complaint Description Detail Office manager reported that her facility received a carton of ten pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) prefilled syringes. Immediately upon opening carton, office manager noticed that one of the pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) prefilled syringes was damaged. The pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) prefilled syringe was intact, but the finger flange was broken and sliding up and down the lime green plunger. Office manager confirmed that product had not been administered to patient. Office manager confirmed that syringe itself was not broken, and no product had leaked. One of the ten pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) prefilled syringes were effected. Office manager confirmed that the other nine were undamaged. See request case: 02199095. No AE reported. No additional PQC reported. QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Immediately upon opening carton, office manager noticed that one of the pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) prefilled syringes was damaged. The pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) prefilled syringe was intact, but the finger flange was broken and sliding up and down the lime green plunger. Notes for DPOC: o A cracked syringe had a line or chip in the glass, but the syringe was essentially intact in one piece. A syringe was considered broken when the syringe was in 2 or more pieces. o A syringe was also considered "cracked" if it appeared to be intact with evidence of a chip or crack or appeared to be intact initially but then broke into 2 or more pieces during use (such as while attaching a needle or injecting diluent). o Please provide a detailed description of the defect using the questions below: o Was there a crack? No. o If yes, describe the size, shape & depth of the crack. N/A o Provide the exact location of the crack on the syringe. N/A o Was the syringe broken into 2 or more pieces? No. The syringe was intact, the finger flange was broken and sliding up and down the lime green plunger. o If yes, describe in detail how it was broken: (e.g. shattered, broken in half etc.) N/A o Provide the exact location of the breakage on the syringe? N/A o Does the syringe have a broken component? Yes. Loose/broken finger flange. o If yes, describe in detail how it was broken. The finger flange broke off, and was sliding up and down the lime green plunger. o Provide the exact location of the breakage on the syringe? The plastic ring broke and was separated from the pre filled syringe vaccine. It broke right at the bottom of the body of the pre filled syringe. o Is the tip of the syringe or Luer lock adaptor loose or broken off of the syringe tip? No. o Was there difficulty trying to attach the syringe needle to the syringe? N/A. A needle had not been attached. o If yes, describe. N/A. o If yes, was it supplied by MERCK: N/A. o If not supplied by MERCK, what type & brand, needle size & gauge was used?' N/A. o Under what situation was this defect noticed: (select one) o While the syringe was still in the tray? YES. o If yes, was there product (liquid or dried residue) in the tray? No. o Was there any broken glass or other separated component in the tray? (if yes specify) No. o After removing the syringe from the tray? N/A o While trying to attach the needle to the syringe? N/A o While giving the injection? N/A o Immediately after giving the injection? N/A o Was the syringe tip cap attached properly prior to use? N/A o Was the syringe tray intact and undamaged on receipt? Yes. o If the product came with a cellophane cover, was the cellophane covering the syringe tray intact and completely sealed? Yes. o Was the syringe carton damaged prior to use? No. o Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? No. o If complaint sample was not/could not be returned, please provide reason. 06-JUL-2022 16:30 PM: Attachment added. 06-JUL-2022 16:30 PM: Email received in the Mailbox on 06JUL2022 at 12:46pm with pictures for this case. See attached. 06-JUL-2022 16:30 PM: Attachment added. 07-JUL-2022: Received & attached Photos. 07-JUL-2022: Second person review. 07-JUL-2022 13:30 PM: Attachment added. 07-JUL-2022 13:30 PM: Email received in the Mailbox on 7-JUL-2022 at 9:29am from quality stating: "Route return expediated mailer to manufacturing site". See attached. Email forwarded to the mail team. 07-JUL-2022 15:30 PM: Labels created for manufacturing site. 07-JUL-2022

Weitere VAERSDATA-Felder

Praegender Schweregrund: Syringe issue
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2360821

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge U036156

gering

Staat: NY
Alter: 77,0
Geschlecht: F
Eingang: 07.07.2022
Impfdatum: 22.06.2022
Beginn: 22.06.2022
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

No adverse event Wrong product administered

Symptomtext

No additional AEs; patient was supposed to received PNEUMOVAX 23 today, but was administered VAXNEUVANCE today by mistake; This spontaneous report was received from a pharmacist and concerns a 77-year-old female patient. Her historical vaccinations included Pneumococcal vaccine polysacch 23V (PNEUMOVAX 23) administered on 14-APR-2009. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-JUN-2022, the patient was supposed to receive the second dose of Pneumococcal vaccine polysacch 23V (PNEUMOVAX 23), however she was administered with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection in dose of 0.5 ml once, lot number U036156, expiration date: 25-MAY-2023 (route and anatomical site of administration were not provided) for prophylaxis (wrong product administered). The patient experienced no side effects from administration and no additional adverse events were reported (no adverse event).

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -