Zurueck zur Suche

Reporte zur Charge U035117

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

54Reporte angezeigt
0Todesfaelle
1Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
GA 6 NC 6 IL 5 FL 5 MA 4 MI 3 MD 3 TX 3 WA 3 NM 2 CA 2 MO 2

VAERS 2581601

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

schwer
Staat
MI
Alter
72,0
Geschlecht
F
Eingang
14.02.2023
Impfdatum
11.02.2023
Beginn
11.02.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Fall Loss of consciousness Rash pruritic

Symptomtext

Was contacted on 2-14-23 by family member patient had blacked out and fell at home between 3 to 4 hours after receiving vaccine. Patient currently has a rash that is not very itchy. Patient has contacted physician and was told to contact pharmacy. Pharmacy was contacted hence this report. Later from initial contact pharmacy was told she fell again today 11-14-23 Pharmacist has repeated twice patient needs to be seen by a physician.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Loss of consciousness
Hospital-Tage
-
Labordaten
none at this time
Aktuelle Erkrankungen
unknown
Vorgeschichte
diabetes, high blood pressure., high cholesterol
Andere Medikamente
isosorbide monohydrate 30mg Novolog Lantus Omeprazole 20mg Simvastatin 40mg atenolol 25mg metformin 500mg Amlodipine 10mg
Allergien
no allergies listed to medications
Vorherige Impfungen
-

VAERS 2453505

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

schwer
Staat
MI
Alter
20,0
Geschlecht
F
Eingang
21.09.2022
Impfdatum
18.09.2022
Beginn
18.09.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Hypotension Loss of consciousness Pallor

Symptomtext

Patient lost consciousness and came to within 30 seconds or less. Patient remained seated and upright the entire time. Patient was pale and her blood pressure was taken. It was low. Patient was advised to move to the floor and relax. We wanted to call emergency services for her but she refused and left within 10 minutes. Patient did not hit her head and said she was feeling fine when she left. Patient said that this had happened before with vaccines.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Loss of consciousness
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
None reported
Vorgeschichte
Mood disorder, Asthma
Andere Medikamente
Bupropion, Escitalopram, albuterol inhaler
Allergien
None reported
Vorherige Impfungen
she stated she had fainted before

VAERS 2619397

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

moderat
Staat
FL
Alter
69,0
Geschlecht
F
Eingang
22.04.2023
Impfdatum
06.04.2023
Beginn
07.04.2023
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Erythema Malaise Mobility decreased Pain in extremity Peripheral swelling Skin warm

Symptomtext

The patient reported the day after receiving her immunizations her right arm developed swelling, redness, pain and was warm to the touch; pt reported being in bed for 3 days feeling ill, her PCP prescribed Cephalexin 500mg capsules to take twice daily for 10 days, she came yesterday 04/21/23 to the pharmacy and informed us and she was feeling better and her arm had improved.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Mobility decreased
Hospital-Tage
-
Labordaten
None reported.
Aktuelle Erkrankungen
NONE REPORTED.
Vorgeschichte
DIABETES, HIGH BP, HIGH CHOLESTEROL, HYPOTHYROIDISM
Andere Medikamente
ATORVASTATIN 10MG, SYNJARDY XR 12.5-1000MG, OZEMPIC 8MG/3ML PEN, LEVOTHYROXINE 100MCG, CELECOXIB 200MG, LISINOPRIL 10MG, PREGABALIN 75MG,
Allergien
NONE.
Vorherige Impfungen
-

VAERS 2531045

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

moderat
Staat
MD
Alter
15,0
Geschlecht
F
Eingang
14.12.2022
Impfdatum
14.12.2022
Beginn
14.12.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Abdominal pain Dizziness Dyspnoea Immediate post-injection reaction

Symptomtext

Patient experienced shortness of breath, lightheadedness, and abdominal pain immediately after vaccine administered. Patient's vital signs remained stable, 100% oxygen saturation, and lung sounds were clear.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Dyspnoea
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
HIV disease
Andere Medikamente
Biktarvy, Cetirizine
Allergien
seasonal allergies
Vorherige Impfungen
-

VAERS 2464596

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

moderat
Staat
TX
Alter
59,0
Geschlecht
F
Eingang
29.09.2022
Impfdatum
31.08.2022
Beginn
31.08.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein
Dizziness Hypersensitivity Hypoaesthesia Paraesthesia Rash pruritic

Symptomtext

Pt reports feeling dizzy, numbness and tingling in face, and breaking out in a full body rash that was extremely itchy. The reaction started after she arrived home, days later she went to the ER where she was diagnosed with an allergic reaction and discharged, a few days later she returned to a different ER because the skin reaction was unbearable, again she was diagnosed with alergic reaction and discharged. Today 9/29/22 she came to our clinic for a blood pressure check and reported the above reactions.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Paraesthesia
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
hypertention, GERD, HepC, Morbid obesity, PTSD, hyperlipidemia, prediabetic and HIV
Andere Medikamente
Biktarvy 50-200-25, dicyclomine 10mg, esomeprazole 40mg, ezetimibe 10mg, fomatidine 20mg, hydroyzine HCl 25mg, hydroxyzine pamoate 25mg, loratadine 10mg, losartan-hydroCHLOROthiazide 100-25, metFORMIN 500MG, venlafaxine XR 150 mg
Allergien
Ace Inhibitors
Vorherige Impfungen
-

VAERS 2460898

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

moderat
Staat
NC
Alter
73,0
Geschlecht
M
Eingang
26.09.2022
Impfdatum
15.09.2022
Beginn
15.09.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Hypotension Joint swelling Peripheral swelling Skin warm

Symptomtext

PATIENT CALLED AND STATED HE HAD SWELLING IN HIS LEFT ARM AND IT WAS HOT TO THE TOUCH. HE ALSO STATED THE SWELLING AND HEAT HAD TRAVELED DOWN HIS ARM AND HE HAD SWELLING UNDER HIS ELBOW. I ADVISED HIM TO TAKE SOME ANTIHISTAMINES OTC SOME ZYRTEC OR BENADRYL. OVERALL HE STATED THE SWELLING WAS GOING DOWN AND IMPROVING. HE STATED THAT HIS BLOOD PRESSURE DROPPED LOW AND HE WOULD'VE SEEKEED MEDICAL CARE IF IT DIDNT COME BACK UP. I CHECKED ON HIM CALLED HIM TWICE AFTER HE REPORTED THIS TO ME. I TOLD HIM TO SEEK MEDICAL CARE IF THE REACTION/SWELLING/HEAT DIDNT SUBSIDE HE WAS ABLE TO MONITOR HIS BLOOD PRESSURE AND EVERTHING HAD IMPROVED AS THE DAY WENT ON. HE WAS NOT UPSET OR SEEKING ANYTHING FROM PHARMACY. I TOLD HIM FROM NOW ON NOT TO GET 2 SHOTS IN THE SAME ARM. PATIENT WAS VERY THANKFUL I CALLED TO CHECK ON HIM.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Hypotension
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
N/A
Vorgeschichte
HEART DISEASE/AFIB, COPD
Andere Medikamente
N/A
Allergien
NKA
Vorherige Impfungen
-

VAERS 2422777

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

moderat
Staat
SC
Alter
66,0
Geschlecht
M
Eingang
29.08.2022
Impfdatum
29.08.2022
Beginn
29.08.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Dyspnoea Erythema Hyperhidrosis Muscle tightness

Symptomtext

Patient walked away from pharmacy after receiving vaccine and about 2 minutes later came back and was profusely sweating, was very red in the face, and was having trouble breathing. He reported muscle tensing as well. EMS was called. I administered 0.3 mg of epinephrine and he immediately started feeling better. EMS arrived about 10 minutes later and did a full workup. At this point, he was feeling much better and talking normally. He chose not to be taken to hospital and EMS walked him out to his car.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Dyspnoea
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
None
Vorgeschichte
Diabetes and high blood pressure
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2394985

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

moderat
Staat
GA
Alter
78,0
Geschlecht
M
Eingang
28.07.2022
Impfdatum
07.06.2022
Beginn
07.06.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injected limb mobility decreased Pain in extremity

Symptomtext

Limited active and passive ROM secondary to pain in left arm

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injected limb mobility decreased
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2362722

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

moderat
Staat
MI
Alter
69,0
Geschlecht
F
Eingang
08.07.2022
Impfdatum
06.06.2022
Beginn
07.06.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Asthenia Chills Decreased appetite Diarrhoea Feeling abnormal Mobility decreased Nausea Nervousness Pain in extremity Pyrexia Swelling Urticaria Weight decreased

Symptomtext

She got her vaccines, her arm became sore with the Shingrix vaccine. She got it in the evening and felt bad and went to bed, she had nauseated, chills, fever, loss of appetite and weak, and felt so bad that she stayed in bed most of the next day except to feed her cat. On 6/8/22 she felt better, weak and shaky, diarrhea and had lost some weight. She had to take the cat to the vet so she got up and did that. She then noticed 4" x 3" hives on her arm, and had taken a picture but they had gone down in size, so probably had them the initial day. She did not go to the doctor, and just relaxed and did not take anything for it. The reaction finally went away, 2 days after the swelling was not as bad. The symptoms finally went away. The following week she had loose stools for a few days and lost more weight 3#. She is never sick and does not know what this is all about. She is not back to full speed. She is never getting 2 vaccines at the same time again. She feels that she was forced to get the vaccine. She read an article that the efficacy was not as good if she got it with another vaccine and wonders in about 5 months if she needs to get another Shingrix. She would like to be contacted if she got a bad lot#, and if it is a wise idea for her to get another Shingrix in about 6 months since she waited 8 months.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Mobility decreased
Hospital-Tage
-
Labordaten
None.
Aktuelle Erkrankungen
None.
Vorgeschichte
None.
Andere Medikamente
None.
Allergien
Erythromycin, Sulfa, Doxycycline, Minocycline, Tetracycline, Bee venom, latex, Terramycin , wasp venom.
Vorherige Impfungen
-

VAERS 2637415

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

mild
Staat
FL
Alter
7,0
Geschlecht
F
Eingang
26.05.2023
Impfdatum
22.05.2023
Beginn
01.05.2023
Tage bis Beginn
-
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Erythema Pain in extremity Peripheral swelling Tenderness

Symptomtext

Patient with swelling, pain, tenderness, and erythema on the left arm. Benadryl, Clindamycin, and Ibuprofen were prescribed. Advise applying cool compresses

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pain in extremity
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
fever and dysuria 2 days prior
Vorgeschichte
-
Andere Medikamente
-
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2624629

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

mild
Staat
FL
Alter
7,0
Geschlecht
M
Eingang
11.05.2023
Impfdatum
24.04.2023
Beginn
26.04.2023
Tage bis Beginn
2,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: ja Erholt: nein
Aspiration bone marrow normal Basophil percentage Blood culture negative Culture negative Discharge Cellulitis Injection site reaction Peripheral swelling Tenderness Drainage Eosinophil count normal Eosinophil percentage decreased Erythema Fluid retention Gram stain positive Granulocyte percentage Haematocrit normal Haemoglobin normal

Symptomtext

2 days after administration had local pain, malaise, 3 days after injection fevers, local swelling down to elbow and redness with induration. 7 days after administration mother noticed a large knot, redness, swelling and very painful. ER visit, treated with clindamycin tabs, not tolerated, used after that Keflex. 3rd visit to ER and others to urgent care, an ultrasound is performed, pocket of 2.4 ml with fluid noticed. Draine, obtained about 12-14 ml of purulent discharge. Culture negative. Treated with IV Ancef, then completed orally Keflex. 10 days. Assessed again 5.10.24 still 5 cm induration, redness, tender and still serosanguineous discharge. Started Clindamycin. Pain control.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site reaction
Hospital-Tage
7,0
Labordaten
No visits with results within 1 Day(s) from this visit. Latest known visit with results is: Admission on 05/06/2023, Discharged on 05/07/2023 Component Date Value Ref Range Status ? Blood/Bone Marrow Culture 05/06/2023 No growth at 72 hours Preliminary ? MRSA SSTI PCR 05/06/2023 Negative - Final Negative for Methicillin Resistant Staphylococcus aureus by Nucleic Acid Testing. ? S. aureus SSTI PCR 05/06/2023 Negative - Final Negative for Staphylococcus aureus by Nucleic Acid Testing. ? White Blood Cell Count 05/06/2023 8.52 5.50 - 15.50 K/cu mm Final ? Red Blood Cell Count 05/06/2023 4.62 4.00 - 5.20 M/cu mm Final ? Hemoglobin 05/06/2023 12.3 11.7 - 13.8 g/dL Final ? Hematocrit 05/06/2023 36.4 35.0 - 45.0 % Final ? Mean Corpuscular Volume 05/06/2023 78.8 77.0 - 95.0 fL Final ? Mean Corpus Hgb 05/06/2023 26.6 25.0 - 33.0 pg Final ? Mean Corpus Hgb Conc 05/06/2023 33.8 31.0 - 37.0 g/dL Final ? RBC Distribution Width 05/06/2023 12.5 11.5 - 14.5 % Final ? Platelet Count 05/06/2023 437 (H) 150 - 350 K/cu mm Final ? Mean Platelet Volume 05/06/2023 9.0 (L) 9.2 - 12.7 fL Final ? Nucleated RBC Number 05/06/2023 0.00 0.00 - 0.01 K/cu mm Final ? Neutrophil % 05/06/2023 47.7 33.0 - 59.0 % Final ? Lymphocytes % 05/06/2023 43.5 30.0 - 65.0 % Final ? Monocyte % 05/06/2023 6.7 3.0 - 9.0 % Final ? Eosinophil % 05/06/2023 0.7 (L) 1.0 - 4.0 % Final ? Basophil % 05/06/2023 0.7 0.0 - 2.0 % Final ? Immature Gran % 05/06/2023 0.7 0.0 - 1.0 % Final Immature Grans = Promyelocytes + Myleocytes + Metamyelocytes ? ANC-Neutrophil Absolute 05/06/2023 4.06 1.50 - 8.00 K/cu mm Final ? Lymphocytes Absolute 05/06/2023 3.71 1.30 - 10.10 K/cu mm Final ? Monocyte Absolute 05/06/2023 0.57 0.20 - 1.40 K/cu mm Final ? Eosinophil Absolute 05/06/2023 0.06 (L) 0.12 - 0.30 K/cu mm Final ? Immature Granulocytes Abs 05/06/2023 0.06 (H) 0.00 - 0.05 K/cu mm Final Immature Grans = Promyelocytes + Myleocytes + Metamyelocytes ? Aerobic/Anaerobic Misc Culture 05/06/2023 No growth to date Preliminary ? Gram stain 05/06/2023 Very Light Polymorphonuclear leukocytes Preliminary ? Gram stain 05/06/2023 No Squamous epithelial cells Preliminary ? Gram stain 05/06/2023 No organisms seen Preliminary US EXTREMITY LIMITED: 5/6/2023 13:50 Technique: Limited ultrasound of the lateral arm was performed. Findings: Anechoic avascular fluid measuring 3.5 x 0.8 x 1.6 cm (volume 2.4 mL) with partially collapsed morphology and thin hyperechoic non shadowing capsule located in the subcutaneous adipose tissue. Cine images demonstrate compressible/collapsible nature of the fluid collection. Increased echogenicity of the surrounding fat with blurring of the architecture and hyperemia overall measuring 5.5 x 1.3 x 2.6 cm. No involvement of the underlying musculature.
Aktuelle Erkrankungen
Sinusitis
Vorgeschichte
Oligoarticular juvenile idiopathic arthritis; moderate persistent asthma
Andere Medikamente
Albuterol, Symbicort, melatonin, MiraLAX
Allergien
Montelukast, essential oils
Vorherige Impfungen
-

VAERS 2606295

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

mild
Staat
MA
Alter
67,0
Geschlecht
F
Eingang
29.03.2023
Impfdatum
29.03.2023
Beginn
29.03.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Erythema Pruritus Swelling

Symptomtext

PATIENT CALLED AND REPORT REDNESS, SWELLING AND A LITTLE ITCHY

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pruritus
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2583970

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

mild
Staat
WA
Alter
67,0
Geschlecht
F
Eingang
17.02.2023
Impfdatum
13.02.2023
Beginn
14.02.2023
Tage bis Beginn
1,0
Dosis
2
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Erythema Myalgia Peripheral swelling

Symptomtext

severe pain and swelling in entire deltoid, redness lasting through today, which is 4 days

Weitere VAERSDATA-Felder
Praegender Schweregrund
Myalgia
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
recent cold , recent genital herpes outbreak
Vorgeschichte
chronic pain syndrome, peripheral neuropathy
Andere Medikamente
acyclovir, buspirone, calcium/magnesium, cyclobenzaprine, D3, fish oil, gabapentin, ibuprofen, multivitamin, oxycodone, red rice yeast, sertraline, ambien,
Allergien
morphine, lexapro, codeine
Vorherige Impfungen
-

VAERS 2550365

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

mild
Staat
MA
Alter
60,0
Geschlecht
M
Eingang
04.01.2023
Impfdatum
13.12.2022
Beginn
23.12.2022
Tage bis Beginn
10,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
C-reactive protein Differential white blood cell count Full blood count Injection site erosion Injection site erythema Injection site scab Laboratory test Rash Rash macular Rash maculo-papular Red blood cell sedimentation rate Skin lesion Treponema test

Symptomtext

The patient was noted to have "red circular spots" on the left arm, darkened scab area on the left upper arm, and "circle-like red spots" in the abdominal area. No pain or itching was reported. No respiratory distress was noted or reported." Maculopapular rash concentrated on the trunk (abd/chest/back) with a few scattered similar lesions on Bilat UE. LUE with 1 solitary lesion that appears larger excoriated with central dark scab & Minimal surrounding erythema.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erosion
Hospital-Tage
-
Labordaten
C-reactive Protein CBC auto differential RPR (Diagnosis) with Reflex to Titer and Confirmatory Testing Sedimentation Rate by Modified Westergren
Aktuelle Erkrankungen
N/A
Vorgeschichte
Alcohol use disorder HTN
Andere Medikamente
hydrochlorothiazide thiamine multivitamin
Allergien
No known drug allergies
Vorherige Impfungen
-

VAERS 2513009

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

mild
Staat
MO
Alter
65,0
Geschlecht
F
Eingang
21.11.2022
Impfdatum
27.10.2022
Beginn
31.10.2022
Tage bis Beginn
4,0
Dosis
N/A
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site erythema Injection site vesicles Pain in extremity Peripheral swelling

Symptomtext

REPROTED BY PATIENT: I have a blister where I received the Covid booster and Pneumonia shot on Thursday 10/27. There is a red ring around it. My arm feels better today as it was very sore and swollen the last 3days. The blister started Saturday. Just checking if I should do anything special. I am being careful no to break it

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
NONE
Aktuelle Erkrankungen
10/26/2022 VIRAL GASTROENTERITIS
Vorgeschichte
CKD (chronic kidney disease) stage 3, GFR 30-59 ml/min (CMS/HCC) Mild non proliferative diabetic retinopathy (CMS/HCC) M obesity BMI 50.0-59.9, adult (CMS/HCC) Well controlled type 2 diabetes mellitus (CMS/HCC) Recurrent major depressive disorder, in full remission (CMS/HCC) Dyspepsia Essential hypertension Pure hypercholesterolemia Uric acid stone in urine AK (actinic keratosis) History of gastroenteritis
Andere Medikamente
allopurinol (ZYLOPRIM) 100 MG tablet Take 1 (one) tablet by mouth 2 times daily aspirin (ASPIRIN) 325 MG tablet Take 325 mg by mouth once daily Blood Glucose Monitoring Suppl (ONE TOUCH ULTRA SMART) W/DEVICE KIT Use 1 Device once daily.
Allergien
ERTHROMYCIN
Vorherige Impfungen
-

VAERS 2510792

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

mild
Staat
NC
Alter
67,0
Geschlecht
F
Eingang
17.11.2022
Impfdatum
14.09.2022
Beginn
15.09.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Arthralgia Pain Pain in extremity Ultrasound scan X-ray limb

Symptomtext

Patient received Vaccine on 9/14/22 and staed she started to experience arm pain radiating to Elbow on 9/15/22 , reported to provider on 11/7/22 and seen in office on 11/16/22 fo rright arm pain.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Arthralgia
Hospital-Tage
-
Labordaten
X-ray of righ arm, Ultrasound of right arm, Meloxicam 7.5 mg , and prednisone taper given.
Aktuelle Erkrankungen
None
Vorgeschichte
Diabetes, Hypertension
Andere Medikamente
Tylenol, Albuterol, aspirin, Atorvastatin, Buspar, Trulicity, Cymbalta, Enalapril, Gabapentin, Metformin.
Allergien
No Known allergies
Vorherige Impfungen
-

VAERS 2496857

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

mild
Staat
GA
Alter
72,0
Geschlecht
F
Eingang
02.11.2022
Impfdatum
29.10.2022
Beginn
31.10.2022
Tage bis Beginn
2,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site erythema Injection site swelling Injection site warmth

Symptomtext

Shots given in same arm at patient request, 1 inch apart. Arm is swollen from shoulder down to elbow, red, and warm to the touch.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2491469

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

mild
Staat
MS
Alter
65,0
Geschlecht
F
Eingang
27.10.2022
Impfdatum
22.10.2022
Beginn
23.10.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site erythema Peripheral swelling Skin warm

Symptomtext

Patient came back to the pharmacy with redness/swelling/fever in her right arm. There was a red line going around her arm near injection site.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
Patient went to the doctor 10/25/22 and was prescribed zyrtec and medrol dose pack.
Aktuelle Erkrankungen
Cancer
Vorgeschichte
Cancer
Andere Medikamente
Cymbalta, Femara, Elocon cream, Neurontin, Atorvastatin, Lisinopril/HCTZ,
Allergien
penicillins
Vorherige Impfungen
-

VAERS 2472899

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

mild
Staat
IA
Alter
67,0
Geschlecht
F
Eingang
09.10.2022
Impfdatum
05.10.2022
Beginn
06.10.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein
Injection site erythema Injection site pain Injection site swelling

Symptomtext

Patient developed soreness, swelling, and redness in the left arm from the top of the shoulder down to the elbow at least 24 hours after receiving 2 immunizations in the left arm. She sought care in the ER, where she was prescribed an antibiotic and a steroid and instructed to use OTC Benadryl if needed.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
Unknown.
Aktuelle Erkrankungen
Unknown.
Vorgeschichte
High cholesterol; Restless legs; High blood pressure; Pain.
Andere Medikamente
Meloxicam; Atorvastatin; Duloxetine; Ropinirole; Hydrochlorothiazide; Losartan; Omeprazole.
Allergien
Tetanus Toxoid.
Vorherige Impfungen
-

VAERS 2467758

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge u035117

mild
Staat
GA
Alter
70,0
Geschlecht
F
Eingang
03.10.2022
Impfdatum
29.09.2022
Beginn
29.09.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Haemorrhage Impaired work ability Joint range of motion decreased Musculoskeletal stiffness Pain in extremity Product administered at inappropriate site

Symptomtext

Patient states that following the injection she had bleeding and stiffness in her left arm. Her arm became so sore she was unable to lift her arm at the shoulder and had to stay home for work for two days. She presented to the dr on 10/3/22 and was prescribed diclofenac and baclofen. Pt states that the doctor believed the injection was given too close to the shoulder joint.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pain in extremity
Hospital-Tage
-
Labordaten
Unsure, patient saw PCP 10/3/22
Aktuelle Erkrankungen
unknown
Vorgeschichte
Diabetic, hypercholesterolemia
Andere Medikamente
Metformin, Atorvastatin, Meclizine, dicyclomine
Allergien
NKA
Vorherige Impfungen
-

VAERS 2445070

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

mild
Staat
-
Alter
66,0
Geschlecht
M
Eingang
15.09.2022
Impfdatum
30.08.2022
Beginn
31.08.2022
Tage bis Beginn
1,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Rash Rash pruritic

Symptomtext

Red rash over most of my body; no blisters but itchy. Treated with hydrocortisone and antihistamine. Resolved after about 6 days.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Rash
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
no
Vorgeschichte
no
Andere Medikamente
multi vitamin, Lipitor
Allergien
no
Vorherige Impfungen
-

VAERS 2430835

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

mild
Staat
HI
Alter
72,0
Geschlecht
F
Eingang
07.09.2022
Impfdatum
01.09.2022
Beginn
01.09.2022
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site bruising Injection site erythema Injection site pain Injection site swelling Pain Pyrexia Skin warm

Symptomtext

Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Mild, Additional Details: Pt received Fluzone HD 2022-23 and Pneumovax 23 on 9/1/22 at 9am. Began experiencing fever-like symptoms (low grade fever, slight body aches) that night around 6-7pm. Woke up in morning on 9/2 and had bruising at injection site and redness/swelling on bicep/deltoid area. Area was hot to the touch, swollen and moderately painful. Adverse effects are resolving on 9/3/22, pt doesn't request follow up with MD.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site bruising
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2422661

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

mild
Staat
IL
Alter
71,0
Geschlecht
F
Eingang
29.08.2022
Impfdatum
23.08.2022
Beginn
24.08.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site bruising Injection site erythema Injection site pain Injection site swelling

Symptomtext

Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site bruising
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2419322

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

mild
Staat
WA
Alter
68,0
Geschlecht
M
Eingang
24.08.2022
Impfdatum
22.08.2022
Beginn
23.08.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site erythema Injection site swelling Pyrexia

Symptomtext

Patient reports that redness and swelling at injection site began 1 day after receiving vaccine. Also notes feeling feverish. Presents to clinic for evaluation today and redness and swelling is noted lower in bicep. Area is not warm to the touch and no fever is noted.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
none
Vorgeschichte
Hyperlipidemia, arthralgia, pulmonary emphysema, colonic polyps - benign, palpitations, abnormal liver function, alcohol dependence - remission, ADHD, cannabis use, tobacco use, eczema, depression, BPH, erectile dysfunction
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2412386

MERCK & CO. INC. · PNEUMO (VAXNEUVANCE) · Charge u035117

mild
Staat
GA
Alter
82,0
Geschlecht
M
Eingang
16.08.2022
Impfdatum
15.08.2022
Beginn
16.08.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Axillary pain Erythema Induration Oedema peripheral

Symptomtext

erythema, edema, tenderness with induration of tissue from left axilla extending distal to left medial epicondyle

Weitere VAERSDATA-Felder
Praegender Schweregrund
Axillary pain
Hospital-Tage
-
Labordaten
ordered CBC
Aktuelle Erkrankungen
-
Vorgeschichte
OA, COPD, BPH, allergic rhinitis, prediabetes, obesity
Andere Medikamente
finasteride, lisinopril, tamsulosin, vitamin D
Allergien
None
Vorherige Impfungen
-

VAERS 2403519

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

mild
Staat
FL
Alter
74,0
Geschlecht
M
Eingang
05.08.2022
Impfdatum
03.08.2022
Beginn
04.08.2022
Tage bis Beginn
1,0
Dosis
2
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Blood creatinine Blood glucose Blood urea Differential white blood cell count Electrocardiogram Full blood count Laboratory test Pruritus Rash Urticaria Vitamin B12 White blood cell count

Symptomtext

Symptoms:: Rash developed at first on the left eye lid and then spread over to stomach and lower abdomen , groin and thighs and hand area. A few hours later to the neck area and also on the back side. Itching all over the body at various places Treatment at ER: diphenhydrAMINE (BENADRYL) , Famotidine (PEPCID) and methylPREDNISolone Sod Succ (PF) ( SOLU-Medrol PF) and Sodium Chloride 0.9 % all given Intravenously Diagnosis: URTICARIA (HIVES)

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pruritus
Hospital-Tage
-
Labordaten
Lab Test conducted 08/4/2022 at 9:49 PM BLOOD UREA CBC CREATININE ELECTROLYTE PANEL GLUCOSE WHITE BLOOD CELL DIFFERENTIAL VITAMIN B12 and EKG
Aktuelle Erkrankungen
NONE
Vorgeschichte
NONE
Andere Medikamente
NONE
Allergien
NONE
Vorherige Impfungen
-

VAERS 2401346

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

mild
Staat
MA
Alter
4,0
Geschlecht
F
Eingang
04.08.2022
Impfdatum
02.08.2022
Beginn
04.08.2022
Tage bis Beginn
2,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Cellulitis Erythema Injection site swelling

Symptomtext

Patient presented with arm redness and red streak along with arm swelling at injection site, two days after administration of routine 4 year old vaccine. Patient is being treated for cellulitis of left arm with Clindamycin 225 mg orally 3 times a day.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site swelling
Hospital-Tage
-
Labordaten
Examination of left arm by provider. No lab test performed.
Aktuelle Erkrankungen
Congenital hear Disease, Congestive Heart Failure, Tricuspid atresia, Pulmonary Hypertension
Vorgeschichte
Congenital hear Disease, Congestive Heart Failure, Tricuspid atresia, Pulmonary Hypertension
Andere Medikamente
None
Allergien
No known allergies
Vorherige Impfungen
-

VAERS 2379145

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

mild
Staat
TX
Alter
57,0
Geschlecht
M
Eingang
22.07.2022
Impfdatum
19.07.2022
Beginn
20.07.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Erythema Insomnia Pain in extremity Peripheral swelling Skin warm

Symptomtext

Patient reported swollen (from top of the shoulder to the wrist), red, and hot on the left arm. Patient reported that it was painful, and he couln't sleep on it. Treatment consisted of medrol pack and a z-pack and the time course was for six days.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pain in extremity
Hospital-Tage
-
Labordaten
No tests and labs
Aktuelle Erkrankungen
Not reported
Vorgeschichte
Type II Diabetes Mellitus
Andere Medikamente
Sildenafil 100mg tablet
Allergien
NKA
Vorherige Impfungen
-

VAERS 2318592

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

mild
Staat
OH
Alter
3,0
Geschlecht
M
Eingang
14.06.2022
Impfdatum
10.06.2022
Beginn
11.06.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Erythema Induration Local reaction Pyrexia

Symptomtext

14 cm local reaction with induration and erythema. Fever of 105 degrees F, 24 hours after immunization with temps resolving after 48 hours.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
viral URI May 19, 2022
Vorgeschichte
Anti-pneumococcal antibody deficiency. asthma
Andere Medikamente
Dulera 110-5 Mcg/ACT 2 puffs twice daily
Allergien
none
Vorherige Impfungen
-

VAERS 2713882

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
CA
Alter
-
Geschlecht
U
Eingang
14.11.2023
Impfdatum
04.11.2023
Beginn
04.11.2023
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 additional AEs or PQC; expired dose of PNEUMOVAX 23 was administered.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 04-NOV-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe lot #U035117, expiration date: 18-AUG-2023 (strength, anatomical location, and route of administration were not provided) as prophylaxis. No adverse event was reported.

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

VAERS 2710288

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
-
Alter
71,0
Geschlecht
F
Eingang
06.11.2023
Impfdatum
04.11.2023
Beginn
04.11.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Expired product administered

Symptomtext

Expired vaccine was accidentally administered (expiration: 8/18/23; administration: 11/4/23) to patient, pt did not experience any adverse event. Consulted manufacturer regarding vaccine administration beyond expiration date, advised to repeat vaccination as soon as possible.

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

VAERS 2695811

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
IL
Alter
-
Geschlecht
U
Eingang
13.10.2023
Impfdatum
11.10.2023
Beginn
11.10.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

No additional AE; adverse event regarding an expired dose of PNEUMOVAX 23 that was administered to a patient; This spontaneous report as received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided. On 11-OCT-2023, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection (0.5 mL, lot #U035117 was valid for formulation prefilled syringe, expiration date 18-AUG-2023, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used). Nurse confirmed that the patient involved had not reported any symptoms or medical concerns related to the administration of the expired dose. No additional information provided regarding this adverse event. No additional adverse event (AE)/product quality complaint (PQC) reported (No adverse event).

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

VAERS 2694206

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
IL
Alter
72,0
Geschlecht
M
Eingang
11.10.2023
Impfdatum
11.10.2023
Beginn
11.10.2023
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event

Symptomtext

No adverse effects

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
viral uri with cough
Vorgeschichte
hypertension, ckd
Andere Medikamente
Vitamin D, Torsemide, Viagra, Lisinopril, Flonase, spironolactone, farxiga, doxazosin, allopurinal, eliquis, lipitor, benzonate
Allergien
n/a
Vorherige Impfungen
-

VAERS 2686907

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge u035117

gering
Staat
MD
Alter
-
Geschlecht
U
Eingang
26.09.2023
Impfdatum
-
Beginn
07.09.2023
Tage bis Beginn
-
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

Medical assistant calls to report PNEUMOVAX 23 lot#u035117 8/18/2023 administered after expiration date. See AE case 02467053 No further AE. No PQC MIR request case 02467042.; Medical assistant calls to report PNEUMOVAX 23 lot#u035117 8/18/2023 administered after expiration date. See AE case 02467053 No further AE. No PQC MIR request case 02467042.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 07-SEP-2023, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, one time, lot #u035117, expiration date: 18-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided). On 07-SEP-2023, medical assistant called to report pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was administered after expiration date. See adverse event (AE) case 02467053. No further AE. No product quality complain (PQC). Request case 02467042.

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

VAERS 2683487

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
NM
Alter
37,0
Geschlecht
F
Eingang
19.09.2023
Impfdatum
12.09.2023
Beginn
12.09.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered

Symptomtext

Expired Pneumovax-23 administered to patient. Will get repeat dose at next follow up appointment in October 2023.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
NA
Aktuelle Erkrankungen
NA
Vorgeschichte
Hodgkins Lymphoma (in remission)
Andere Medikamente
Acyclovir, gabapentin, Lipase-protease-amylase, folic acid, omeprazole
Allergien
NKA
Vorherige Impfungen
-

VAERS 2677206

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
GA
Alter
-
Geschlecht
U
Eingang
19.09.2023
Impfdatum
24.08.2023
Beginn
24.08.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

Caller reporting that a dose of PNEUMOVAX 23 was given to patient after its expiration date. Date of expiration: 8/18/2023, date of administration: 8/24/2023. Confirmed that the vaccine had never undergone temperature excursion.; This spontaneous report was received from a registered nurse concerning an unknown age and gender patient. The patient's concurrent condition, medical history, and concomitant medications were not provided. On 24-AUG-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection 0.5 mL as prophylaxis (lot#: U035117, expiry date: 18-AUG-2023, route of administration, and anatomical location not provided) (expired product administered). It was confirmed that vaccine had never undergone temperature excursion.

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

VAERS 2677206

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
GA
Alter
-
Geschlecht
U
Eingang
19.09.2023
Impfdatum
24.08.2023
Beginn
24.08.2023
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

Caller reporting that a dose of PNEUMOVAX 23 was given to patient after its expiration date. Date of expiration: 8/18/2023, date of administration: 8/24/2023. Confirmed that the vaccine had never undergone temperature excursion.; This spontaneous report was received from a registered nurse concerning an unknown age and gender patient. The patient's concurrent condition, medical history, and concomitant medications were not provided. On 24-AUG-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection 0.5 mL as prophylaxis (lot#: U035117, expiry date: 18-AUG-2023, route of administration, and anatomical location not provided) (expired product administered). It was confirmed that vaccine had never undergone temperature excursion.

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

VAERS 2682647

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
MO
Alter
-
Geschlecht
U
Eingang
15.09.2023
Impfdatum
12.09.2023
Beginn
12.09.2023
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 further AE.; patient given PNEUMOVAX23 expiration 8/18/2023; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-SEP-2023, the patient was vaccinated with an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, one time, lot #U035117, expiration date: 18-AUG-2023, administered for prophylaxis (anatomical location, and route of administration were not provided) (expired product administered). There were no adverse events reported (no adverse event).

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

VAERS 2681001

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge u035117

gering
Staat
MD
Alter
-
Geschlecht
U
Eingang
11.09.2023
Impfdatum
07.09.2023
Beginn
07.09.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

No further AE.; Medical assistant calls to report PNEUMOVAX 23 lot#u035117 8/18/2023 administered after expiration date. See AE case. No further AE. No PQC. MIR request case; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 07-SEP-2023, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, one time, lot #u035117, expiration date: 18-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided). On 07-SEP-2023, medical assistant called to report PNEUMOVAX 23 was administered after expiration date. See AE case. No further AE. No PQC. MIR request case.

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

VAERS 2681000

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
FL
Alter
-
Geschlecht
U
Eingang
11.09.2023
Impfdatum
23.08.2023
Beginn
23.08.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

No additional AEs or PQC reported; Caller reports expired dose of PNEUMOVAX 23 was administered. No other information provided. No additional AEs or PQC reported.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history. On 23-AUG-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter, intramuscularly (IM), lot number U035117 with expiration date 18-AUG-2023 (anatomical location was not reported) for prophylaxis (expired product administered). No additional adverse events were reported.

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

VAERS 2679448

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
-
Alter
-
Geschlecht
M
Eingang
06.09.2023
Impfdatum
-
Beginn
30.08.2023
Tage bis Beginn
-
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; HCBP calling to report AE for patient that received dose of expired PNEUMOVAX 23. Vaccine expired on 8/18/2023. Per memo, data supports dosing. No additional AE or PQC.; This spontaneous report was received from Other Health Professional and refers to an 81-year-old male patient. The patient's medical, concurrent conditions and concomitant therapies were not reported. On 30-AUG-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) injection, single dose, lot #U035117, expiration date: 18-AUG-2023 (strength, route of administration, and indication were not provided). No additional adverse event was reported.

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

VAERS 2676112

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
WI
Alter
41,0
Geschlecht
M
Eingang
24.08.2023
Impfdatum
22.08.2023
Beginn
22.08.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Expired product administered

Symptomtext

Vaccine was expired when administered.

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

VAERS 2656661

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
WA
Alter
73,0
Geschlecht
F
Eingang
14.07.2023
Impfdatum
14.07.2023
Beginn
14.07.2023
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event

Symptomtext

No reaction or symptoms reported

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
No labs or test related to event. Separate Labs for other reasons done today 7/14/2023 were drawn today for other Lab studies.
Aktuelle Erkrankungen
-
Vorgeschichte
Asthma, Hypertension, Hyperlipidemia
Andere Medikamente
Atorastatin (Lipitor), Advair Diskus Inhaler, Amlodipine (Norvasc), Cholecalciferol, Olopatadine (Pataday) ophthalmic solution, Aspirin DR, Ascorbic acid Vitamin C, Multivitamin (OTC), Omega-3 fatty acids- fish oil (OTC)
Allergien
Adhesive Tape
Vorherige Impfungen
-

VAERS 2560298

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
TX
Alter
-
Geschlecht
U
Eingang
16.01.2023
Impfdatum
03.01.2023
Beginn
03.01.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product storage error

Symptomtext

No additional AE details were provided and no additional AE's were reported; The HCP reports that the patient received a dose of PNEUMOVAX 23 after it was involved in a temperature excursion. .; This spontaneous report was received from a medical assistant referred to a patient of unknown age and gender. The patient's medical history, pertinent medical history and drug reaction/allergies were not reported. On 03-JAN-2023, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 ml, lot #U035117, expiration date: 18-AUG-2023, administered intramuscularly for prophylaxis (strength was not provided) (product storage error). It was reported that the suspect vaccine was exposed to a temperature of minus 0.4 F for a time frame of 1 hour and 10 minutes, minus 14 F for a time frame of 5 minutes, minus 33 F for a time frame of 30 minutes, minus 27 F for a time frame of 25 minutes, minus 2 F for a time frame of 5 minutes, 16.7 F for a time frame of 5 minutes. The total time frame was 2 hours 20 minutes. There were no previous temperature excursions. No additional adverse event (AE) details and no additional AE were provided (no adverse event).

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

VAERS 2513110

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
NM
Alter
68,0
Geschlecht
M
Eingang
28.12.2022
Impfdatum
30.08.2022
Beginn
30.08.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Incorrect product formulation administered Wrong product administered

Symptomtext

Ordered Pneumococcal 20 and patient actually given Pneumococcal 23

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect product formulation administered
Hospital-Tage
-
Labordaten
na
Aktuelle Erkrankungen
-
Vorgeschichte
GERD, BPH, Diabetes Type 2, hyperlipidemia, Stage 3a CKD, hypertension, depression/anxiety
Andere Medikamente
lisinopril, meloxicam, metformin XR, fenofibrate, simvastatin, Singulair, sertraline, aspirin
Allergien
NKA
Vorherige Impfungen
-

VAERS 2466397

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
NC
Alter
65,0
Geschlecht
U
Eingang
01.10.2022
Impfdatum
27.09.2022
Beginn
27.09.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Underdose

Symptomtext

No additional AE reported; Patient received a smaller than recommended dose; This spontaneous report was received from a registered nurse referring to a 65-year-old patient of unspecified gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided. On 27-SEP-2022, the patient was vaccinated with a smaller than recommended dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (exact dose, route of administration, vaccine scheme, and anatomical site of vaccination were not reported; lot number U035117 has been verified to be valid, expiration date reported and established as 18-AUG-2023) (incorrect dose 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 2460910

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
NC
Alter
67,0
Geschlecht
F
Eingang
26.09.2022
Impfdatum
24.09.2022
Beginn
24.09.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Erythema Skin warm

Symptomtext

PATIENT COMPLAINED HER ARM WAS HOT TO THE TOUCH AND HAD REDNESS.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Erythema
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
N/A
Vorgeschichte
N/A
Andere Medikamente
N/A
Allergien
N/A
Vorherige Impfungen
-

VAERS 2456066

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
MA
Alter
46,0
Geschlecht
F
Eingang
23.09.2022
Impfdatum
20.09.2022
Beginn
21.09.2022
Tage bis Beginn
1,0
Dosis
UNK
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Discomfort Erythema Peripheral swelling Skin warm

Symptomtext

Patient received Influenza and Pneumococcal 23 on 9/20/22, both to left deltoid. On 9/21/22 patient noticed arm to be red, warm, swollen. Patient came into clinic today on 9/23/22 with continued redness and warmth to left arm, below the deltoid and above the elbow, measuring 5 in width and 4 in height. No swelling noted. No fevers. Patient does admit to some improvement today since 9/21/22. Provider evaluated reaction and determined its a localized reaction to both vaccines given in the same deltoid. Patient was given ice pack and advised to apply ice to localized area, advised to take OTC pain relivers for discomfort. Advised to call or return to clinic if no improvement.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Discomfort
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
At the time of vaccination patient was treated for cervicitis
Vorgeschichte
Hypertension and Anxiety
Andere Medikamente
Norvasc 5 mg daily and Junel 1-20 mg-mcg daily
Allergien
Amoxicillin, Lisinopril and Losartan
Vorherige Impfungen
-

VAERS 2421794

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
NC
Alter
-
Geschlecht
U
Eingang
27.08.2022
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Needle issue

Symptomtext

Tip Cap AskewSterile Injectable;Needle Detached;Syringe Hub Defect; Sterile Injectable;Cannot Attach Needle;; Sterile Injectable;Cannot Attach Needle;Syringe Hub DefectSterile Injectable;N/A;Tip Cap AskewSterile Injectable;Needle Detached;Syringe Hub Defect; No adverse event; Complaint Description Detail Health care provider (HCP) calling to report product quality complain (PQC) associated with 2 lots of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) PFS. Caller reported that HCP users had had difficulty screwing safety needles into syringe hubs and needles do no securely stay in place. On 2 occasions, the needle dislodged from the syringe hub 1) while attempting to attach safety needle cap and 2) while preparing for administration. Caller also reported that tip caps do not securely thread on to luer-lock adaptor. Caller stated the issue could also be associated with 25g 1" safety needles and will file PQC for needle products as well. No AEs reported, no additional PQCs. QUESTIONS SECTION: IF REPORTED: PQC Prefilled Syringe: PQC Prefilled Syringe: Syringe Needle Defects Dull Bent Damaged Missing Syringe Needle Hub Defects Broken Wrong Color Syringe Needle Sheath Cover Defects Damaged Missing, Dislodged (High Risk). QUESTIONS SECTION: What was the lot number(s) on the product/carton? U035117 18-AUG-2023; U027357 25-MAR-2023 NOTE: This was needed to identify the needle supplied with the kit. NO NEEDLES SUPPLIED WITH KIT Please identify which part of the syringe needle was affected - NEEDLE ATTACHMENT, SYRINGE HUB Please provide a detailed description of the complaint defect. NEEDLES ATTACHED TO HUB SITE ARE FALLING OUT AND CAN NOT BE SECURELY ATTACHED; SYRINGE TIP DOES NOT SECURELY FASTEN TO HUB Under what situation was this defect noticed: (select one) If the syringe needle was not integrated into the syringe: Prior to removing the needle sheath? NO After removing the needle sheath? NO Prior to attaching the needle to the body of the syringe? NO While attaching the needle to the syringe? YES/NO/NA/UNSPECIFIED (if yes, describe) YES, UNABLE TO SECURE NEEDLE INTO HUB While giving the injection? YES/NO/NA/UNSPECIFIED (if yes, describe) NO After the injection was given? YES/NO/NA/UNSPECIFIED (if yes, describe) YES, NEEDLE DISLODGED OUT OF HUB WHILE ATTEMPTINT TO SECURE SAFETY CAP AFTER INJECTION. If Syringe needle was integrated into the body of the syringe: N/A Prior to removing the needle sheath? N/A After remove the needle sheath? N/A While giving the injection? N/A After the injection was given? N/A If the complaint was for a dull needle: N/A Did you/the patient allow at least one minute for the disinfectant (e.g. alcohol) to dry on your/the patient's skin before inserting the needle? N/A Did you/the patient use an alcohol swab on the syringe needle? N/A NOTE: An alcohol swab should not be used on the syringe needle as it removes the silicone. Did you/the patient use a "slightly" different injection site than the last injection? N/A Have you/the patient injected yourself/herself at this injection site before? N/A Did you/the patient insert the needle into the body at an angle of 45 to 90? N/A Did you/the patient draw blood into the syringe and need to reposition the needle without removing from the skin? N/A How many times did you/the patient try to inject the syringe? (Note: The patient should only inject the syringe once) - N/A Was the product dropped? NO 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 N/A Was the syringe carton damaged prior to use? (i.e. crushed, ripped, unglued) NO If yes, describe N/A 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: 1 SYRINGE CAN BE RETURNED FROM LOT #U027357 EXP. 25-MAR-2023. 2 SYRINGES FROM LOT #U035117 EXP 18-AUG-2023 WERE USED AND DISPOSED. *If photos were available, ask the customer to send them UNAVAILABLE Retrieval Information: Obtain product (& tray if possible). Ensure enough absorbent material was provided to prevent breakage. 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 14:30 PM: Attachment added. 16-AUG2022: Reported lot U027357 logged under 368614 16-AUG-2022: Second person reviewed. 16-AUG-2022 16:30 PM: Waiting for Retrieval Site from Quality-- See attachments 16-AUG-2022 16:30 PM: Attachment added. 17-AUG-2022 11: 30 AM: Attachment added. 17-AUG-2022 12:30 PM: Labels created 17-AUG-2022 18-AUG-2022: Upon review, both Patient Code & Device Code fields were updated. 18-AUG-2022: Second person review performed. Complaint Description Summary HCP users have had difficulty screwing safety needles into syringe hubs and needles do no securely stay in place and the needle dislodged from the syringe hub. ; Sender's Comments: US-009507513-2208USA007610:

Weitere VAERSDATA-Felder
Praegender Schweregrund
Needle issue
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2411673

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
CT
Alter
37,0
Geschlecht
F
Eingang
15.08.2022
Impfdatum
07.07.2022
Beginn
08.07.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Erythema Feeling hot Swelling

Symptomtext

Patient describes redness, swelling, warmth, and pain the day after her injection that lasted 3-4 days. She never notified the office until 1 month later.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Erythema
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
None
Vorgeschichte
Cigarette smoker, anxiety
Andere Medikamente
Wellbutrin
Allergien
Percocet
Vorherige Impfungen
-

VAERS 2401031

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
IL
Alter
-
Geschlecht
U
Eingang
04.08.2022
Impfdatum
16.07.2022
Beginn
16.07.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Accidental underdose Device use error No adverse event Syringe issue

Symptomtext

No Adverse Event; Due to the leaking the patient received a smaller than recommended dose; There was product leaking from where the needle attaches to the syringe.; There is a possibility the leaking was due to user error as there was no noticeable damage or issues; This spontaneous report was received from pharmacist and referring to a patient of an unknown age and gender. The patient's pertinent medical history, current conditions, drugs reactions or allergies and concomitant medication was not provided. On 16-JUL-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, for prophylaxis lot #U035117 validated upon internal review, expiration date: 18-AUG-2023 (strength, dose, frequency, anatomical location and route of administration were not provided). That day after the administration was completed the health care professional (HCP) noticed there was product leaking from where the needle attaches to the syringe (syringe issue) (also reported as between the syringe hub/luer lock and the syringe needle). Caller stated due to the leaking the patient received a smaller than recommended dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (accidental underdose). Additionally, it was reported there was a possibility the leaking was due to user error as there was no noticeable damage or issues with the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe (device use error), but it could not be confirmed as the HCP did not check the tightness of the needle after administration. The reported confirmed the syringe needle was attached securely to the syringe tip before the leaking occurred (conflicting information, also reported as the HCP possible did not properly ensure the needle was tightly secured to the syringe). Caller stated this product was not available for retrieval nor are pictures able to be taken as the product had already been disposed of. No adverse events (AE) were reported.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Accidental underdose
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2397080

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
IL
Alter
-
Geschlecht
U
Eingang
30.07.2022
Impfdatum
-
Beginn
16.07.2022
Tage bis Beginn
-
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Syringe issue Underdose

Symptomtext

no adverse event; Syringe leak; t he pati ent r eceiv ed a smaller than r ecornmended dose of PNEUMOVAX 23; Call er stated ther e is a possibility the leaking was due to user error; Pharmacist reporting an adv er se event and product quality complaint associated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23). Caller stated a patient was administered a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), but after the administration was complete the HCP noticed there was product leaking from where the needle attaches to the syringe. Caller stated due to the leaking the patient received a smaller than recommended dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23). Caller stated there is a possibility the leaking was due to user error as there was no noticeable damage or issues with the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) syringe, but it cannot be confirmed as the HCP did not check the tightness of the needle after administration. Caller stated this product is not available for retrieval nor are pictures able to be taken as the product has already been disposed of. No additional information provided. No additional AE or PQC reported. QUESTION SECTION: High Risk: Leaking Prior to Opening High Risk: Leaking during use from a site other than the product dispensing point Medium Risk: Leaking during use from the product dispensing point NOTE: Most MERCK prefilled syringes require a syringe needle to be attached to the hub or tip of the syringe using a Luer Lock attachment by the healthcare provider, which allows the needle to be twisted onto the tip and then locked in place. NOTE: Confirm that the syringe is not cracked or broken, including a broken or loose Luer Lock adaptor. If there is any sign of breakage, refer to the appropriate broken/ cracked syringe article. Additionally, if there was difficulty attaching the syringe needle, and the leakage occurred at the syringe tip and syringe needle area of attachment, a l so refer to the Prefilled Syringe: Broken/ Cracked Article. For syringes when the customer must attach a needle: Was the syringe needle attached to the syringe tip before the leaking occurred? YES If a needle was attached, was the needle able to be attached securely to the syringe? YES If no, describe what issue was encountered while attaching the needle? N/A From where did the leaking occur? (Select one) o From the tip of the Syringe Needle? NO o From the tip of the Syringe? NO o Between the syringe hub/ Luer lock and syringe needle? YES Base of syringe where the plunger rod/ stopper is located? NO Under what situation was this defect noticed: (select one) o While the syringe was still in the tray? NO o If yes, is there still product (liquid or residue) in the blister tray? NA After removing the syringe from the tray? NO While trying to attach the needle to the syringe? NO While pulling back on the plunger rod? NO While the plunger rod was being pushed forward? NO Did the plunger rod/ stopper come completely or partially out of the syringe barrel while pulling back on the plunger rod? NO While giving the injection? No After the injection was given. YES Is there anything that is visible that could explain why the leaking occurred? (e. g. cracked barrel, malformed stopper etc.?) NO DAMAGE TO THE SYR INGE. THE CALLER TH INKS IT MIGHT HAVE OCCURED DUE TO USER ERROR AND THE EMPLOYEE POSSIBILY DID NOT PROPERLY ENSURE THE NEEDLE \VAS TIGHTLY SECURED TO THE SYRINGE. CALLER STATED THE HCP DID NOT CHECK THE TIGHTNESS OF THE NEEDLE AFTER ADMINISTRATION TO CHECK IF THAT IS WHY THE LEAKING OCCURED Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES *If photos are available, ask the customer to send them Retrieval Information: Expedited Return Obtain product (& tray if possible) NOTE: Vaccine Prefill ed Syringes may be returned even if biohazardous. Sample Tracking Number: User's Experience: Repeat User Insertion Difficulty: Not Applicable Insertion Difficulty Details: Not Applicable Doubt About Presence: Not Applicable Doubt Details: Not Applicable Migration: Not Applicable Migration Details: Not Applicable Removal Problem: Not Applicable Removal Problem Details: Not Applicable 18-JUL-2022 20:30 PM: Attachment added to Service Cloud. 19-JUL-2022; Second person reviewed

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

VAERS 2387833

PFIZER\WYETH · PNEUMO (PREVNAR20) · Charge U035117

gering
Staat
NC
Alter
69,0
Geschlecht
M
Eingang
24.07.2022
Impfdatum
23.07.2022
Beginn
23.07.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Erythema Hypoaesthesia Peripheral swelling Skin warm

Symptomtext

Patient presented to pharmacy on 7/24 and showed a left arm that was swollen and red all the way down to the left elbow and all the way around the arm. Patient stated that he had feelings of numbness in his left hand the night before and his whole arm was very hot to the touch. He was instructed to take Benadryl and seek out medical help if the condition got any worse.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Erythema
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2317624

MERCK & CO. INC. · PNEUMO (PNEUMOVAX) · Charge U035117

gering
Staat
CA
Alter
65,0
Geschlecht
F
Eingang
13.06.2022
Impfdatum
25.05.2022
Beginn
13.06.2022
Tage bis Beginn
19,0
Dosis
UNK
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Wrong product administered

Symptomtext

Patient was given this vaccine in error. Patient was to have received PCV-23. Patient was given PCV-13 first in error, and then physician requested that PCV-23 still be given during the same visit.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
n/a
Aktuelle Erkrankungen
no acute complaints
Vorgeschichte
Hyperlipidemia, Hyperparathyroidism, Hypothyroidism, Vit D deficiency
Andere Medikamente
Levothyroxine, Naproxen, Excedrin Migraine, Sudafed, Allertec, Vit D3
Allergien
Hydrocodone Bitartrate
Vorherige Impfungen
-