Zurueck zur Suche

Reporte zur Charge U024504

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

26Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
MI 5 KS 3 WA 2 MD 2 CA 2 IL 2 NV 2 UT 1 NY 1 NC 1 TX 1 VA 1

VAERS 2252043

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

schwer
Staat
MI
Alter
1,1
Geschlecht
M
Eingang
26.04.2022
Impfdatum
22.04.2022
Beginn
22.04.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Febrile convulsion Injection site rash Pyrexia

Symptomtext

Certified medical assistant was getting vaccines ready and she accidentally drew up a ProQuad instead of an MMR. Patient tolerated vaccines well, and parent was informed of what to watch for: Fevers/ febrile seizures/ and rash around the injection site.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Febrile convulsion
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
Left OM/ URI on 4/11/2022 (finished abx)
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2430006

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

mild
Staat
WA
Alter
-
Geschlecht
M
Eingang
06.09.2022
Impfdatum
30.08.2022
Beginn
30.08.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Gait disturbance Incorrect dose administered Injection site erythema Injection site mass Injection site pain Injection site swelling Overdose

Symptomtext

A Medical Assistant administered 9 doses of IPV in one injection. Poison Control, Provider, and Medical Director provider notified. Poison Control states patient should be fine, just watch for abnormal reactions. They state nothing else can be done. Provider assessed the injection site when parent noticed some swelling and lump form around the injection site. There was no other known symptoms around administration. Patient came in for a follow up visit on 9/2/22. Provider evaluated patient's injection sites in his legs. His left leg where the IPV was given did not show any type of reaction. But his right leg was present with a basball sized area of erythema with some swelling, tender with touch, and came into clinic Limping on the right leg. Patient does not have any other symptoms. Patient's symptoms from his reaction is improving. Provider advised to continue watching for any abnormal symptoms, use ice packs, and Ibu for pain. If this does not resolve or worsens, patient needs to come back in for evaluation. The Medical Assistant who administered the vaccines on that day has been discharged from the clinic.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Epistaxis days before event
Vorgeschichte
None
Andere Medikamente
No
Allergien
Lactose
Vorherige Impfungen
-

VAERS 2361582

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

mild
Staat
MD
Alter
15,0
Geschlecht
F
Eingang
07.07.2022
Impfdatum
11.04.2022
Beginn
11.04.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered Rash Rash pruritic

Symptomtext

COVID 19 Pfizer dose given beyond use date. Pt developed itchy bumps over her arms one week after receiving vaccine. Pt was given Benadryl. Bumps resolved after one week. Pt recovered and is back to baseline

Weitere VAERSDATA-Felder
Praegender Schweregrund
Rash
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
Pfizer COVID 19 2nd dose on 10/18/21. Developed itchy bumps over arms one week after receiving vaccine. Resolved after one week.

VAERS 2263315

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

mild
Staat
MI
Alter
1,0
Geschlecht
F
Eingang
04.05.2022
Impfdatum
22.04.2022
Beginn
01.05.2022
Tage bis Beginn
9,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site rash Injection site reaction Irritability Pallor Pyrexia Rash papular Skin lesion

Symptomtext

patient received MMR, VAR and HAV on 4/22/22. Patient had rash / lesion on right lateral upper thigh at injection site for VARIVAX- noted 5/1/22. Fever to 103 noted 5/1/22 after the rash / lesion started. Patient with significant fussiness during this. Lesion was darker in redness, almost purple with 2 non vesicular papules on either side of the injection site. Patient continued with fever to 101 x 36 hours and defervesced. Injection site lesion improving 5/4/22 at office visit. 5/4/22 evaluation with mild pink, flat blanching 2.5 x 1.5 cm lesion on upper lateral right thigh. No tenderness, no vesicles or papules. No subcutaneous tissue changes. No streaking or warmth. No other skin rashes or change.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site rash
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
possible teething syndrome
Vorgeschichte
none
Andere Medikamente
none
Allergien
NKMA
Vorherige Impfungen
-

VAERS 2647643

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

mild
Staat
UT
Alter
1,0
Geschlecht
F
Eingang
04.04.2022
Impfdatum
22.03.2022
Beginn
25.03.2022
Tage bis Beginn
3,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Rash morbilliform

Symptomtext

Developed a morbilliform rash 3 days after receiving vaccine.

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

VAERS 2194667

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

mild
Staat
NY
Alter
1,0
Geschlecht
F
Eingang
23.03.2022
Impfdatum
11.03.2022
Beginn
21.03.2022
Tage bis Beginn
10,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Pyrexia Rash macular Respiratory tract congestion

Symptomtext

On 3/21/22, mother noticed small red spots on belly, which has spread to other parts of the body, did have fever today, Tmax 101.2 F. She is appearing well otherwise, No trouble breating, Maintianing at baseline. No expsoure to measles case as per mom. Likely post vaccine signs from measles vaccine.Advised to bring the child in for examination (child not with mother at the time of phone call) . seen in office 3/23/22 MMR,Varicella,Prevnar 13 and Hep A were done on 3/11. Reports rash started on Sunday and got some what difuse. No reports of contact to other kids with Measles or wild type exposure Positive for: mild congestion, mother states thats chronic for her. Fevers have now subsided. Last fever 2 days ago. Negative for: Nausea, Vomiting, Fever, Chills, Changes in Is and Os (No changes in Urine or bowel habits), Changes in activity levels (maintains activity levels at baseline), No difficulty breathing, Shortness of breath, or Chest pain. No specific sick contacts but goes to day care, No history of travelling. Per Providers assessment rash likely secondary to MMR vaccine- to seek medical treatment if emergency arises- no treatment needed.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
Pelviectasis
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2189858

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

mild
Staat
NC
Alter
1,0
Geschlecht
M
Eingang
21.03.2022
Impfdatum
01.03.2022
Beginn
01.03.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Pyrexia Rash

Symptomtext

fever and rash x 4 days after vaccines.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
n/a
Aktuelle Erkrankungen
n/a
Vorgeschichte
n/a
Andere Medikamente
n/a
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2163104

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

mild
Staat
WA
Alter
4,0
Geschlecht
M
Eingang
07.03.2022
Impfdatum
25.02.2022
Beginn
25.02.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Injection site bruising Injection site erythema Injury associated with device Local reaction Product administered at inappropriate site

Symptomtext

Patient developed large area of redness around what appears to be the injection location of either the MMR or the Hep A injections. Reaction is on the left otter/posterior leg above the knee. Although documented that 1 vaccine was on the left thigh and one on the right. Both injections sites appear to be on the left outer leg based on this reaction and another location of what appears to be a needle stick and bruise. This is a situation of an improperly placed injection and a localized site reaction.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site bruising
Hospital-Tage
-
Labordaten
none. Follow-up provided with family/patient. localized reaction resolved on it's own per mother's comments.
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2482004

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

gering
Staat
TX
Alter
2,0
Geschlecht
F
Eingang
18.10.2022
Impfdatum
17.10.2022
Beginn
17.10.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered

Symptomtext

Patient received Hep A vaccine, expiration date on 10/15/2022. Patient's mother notified by provider.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
NONE
Vorgeschichte
NONE
Andere Medikamente
N/A
Allergien
NONE
Vorherige Impfungen
-

VAERS 2481723

MERCK & CO. INC. · HEP A (VAQTA) · Charge u024504

gering
Staat
VA
Alter
6,0
Geschlecht
F
Eingang
18.10.2022
Impfdatum
17.10.2022
Beginn
17.10.2022
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 Product expiration date issue

Symptomtext

Vaccine exp date on syringe 10/15/22 and on box 10/2022; exp check on box administered when charted in computer exp 10/15/22 noted and adverse event found.

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

VAERS 2439333

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

gering
Staat
NM
Alter
-
Geschlecht
U
Eingang
10.09.2022
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

A HCP called and reported an AE where doses of improperly stored products were possibly administered to patient(s) on unknown dates.; No additional AE reported.; This spontaneous report was received from a medical assistant regarding an unknown number of patients of unspecified age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improper storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #U038854, expiration date: 20-APR-2023, taken orally (dosage regimen and strength were not provided) as prophylaxis; measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot #T039671, expiration date: 24-NOV-2022, lot #U017524, expiration date: 03-JUN-2023, (dosage regimen, strength, anatomical location, and route of administration were not provided) as prophylaxis; hepatitis a vaccine, inactivated (VAQTA) lot #W002889, expiration date: 06-MAR-2023, lot #U024504, expiration date: 15-OCT-2022, (dosage regimen, strength, anatomical location, and route of administration were not provided) as prophylaxis (Product storage error). No additional adverse events were reported. The improperly stored vaccines of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #T039671 and lot #U017524), and hepatitis a vaccine, inactivated (VAQTA) lot #W002889 underwent a temperature excursion of 48 degrees Fahrenheit (F) for 10 minutes without previous excursions. The improperly stored vaccines of hepatitis a vaccine, inactivated (VAQTA) lot #U024504 underwent a temperature excursion of 49 degrees Fahrenheit (F) for 10 minutes without previous excursions (This lot was stored in a second refrigerator). This is a non-valid report due to lack of patients' identifiers.

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

VAERS 2416621

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

gering
Staat
IN
Alter
33,0
Geschlecht
U
Eingang
20.08.2022
Impfdatum
08.08.2022
Beginn
08.08.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect dose administered No adverse event Product administered to patient of inappropriate age

Symptomtext

No additional AE; Patient was administered the pediatric dose of VAQTA instead of the adult dose.; Dose: 25 units/0.5 mL; This spontaneous report as received from a licensed practical nurse refers to a 33-year-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 08-AUG-2022, the patient was vaccinated with the pediatric dose (25 units/0.5 mL) of hepatitis a vaccine, inactivated (VAQTA) (lot number: U024504, expiration date: 15-OCT-2022; route of administration not provided) instead of the adult dose (product administered to patient of inappropriate age, incorrect dosage administered). No adverse event was reported.

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

VAERS 2361587

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

gering
Staat
MD
Alter
17,0
Geschlecht
F
Eingang
08.07.2022
Impfdatum
11.04.2022
Beginn
11.04.2022
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered No adverse event

Symptomtext

COVID 19 Pfizer dose given beyond use date. There were no signs or symptoms of side effects. There was no treatment necessary.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2313609

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

gering
Staat
MI
Alter
-
Geschlecht
U
Eingang
09.06.2022
Impfdatum
24.05.2022
Beginn
24.05.2022
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 administered to patient of inappropriate age Underdose

Symptomtext

No additional AEs were reported; A nurse reported that an adult patient received a pediatric dose of VAQTA; This spontaneous report was received from a licenced practical nurse concerning an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 24-MAY-2022, the adult patient was vaccinated with a paediatric dose (incorrect dose administered) of hepatitis a vaccine, inactivated (VAQTA), lot number U024504 with expiration date 15-OCT-2022, serial number reported as 101139666936, 0.5 millilitre (mL) dose, once for prophylaxis (route of administration and anatomical location were not provided). No adverse events (AEs) were reported. At the reporting time, the patient's outcome was unknown.

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

VAERS 2247899

GLAXOSMITHKLINE BIOLOGICALS · HEP A (HAVRIX) · Charge U024504

gering
Staat
MI
Alter
1,5
Geschlecht
M
Eingang
22.04.2022
Impfdatum
11.04.2022
Beginn
11.04.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Inappropriate schedule of product administration

Symptomtext

2nd Ped Hep A administered prior to the due date.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Inappropriate schedule of product administration
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
N/A
Vorgeschichte
N/A
Andere Medikamente
N/A
Allergien
N/A
Vorherige Impfungen
-

VAERS 2235799

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

gering
Staat
CA
Alter
-
Geschlecht
F
Eingang
15.04.2022
Impfdatum
-
Beginn
10.03.2022
Tage bis Beginn
-
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Syringe issue

Symptomtext

another Nurse was administering VAQTA to a patient and while pushing the plunger to the barrel flange, a piece of the barrel flange broke and a shard of glass broke through the administering Nurse's glove and cut her finger; another Nurse was administering VAQTA to a patient and while pushing the plunger to the barrel flange, a piece of the barrel flange broke and a shard of glass broke through the administering Nurse's glove and cut her finger; This spontaneous report has been received from a registered nurse, referring to another female administering nurse of unreported age. The administering nurse's relevant medical history was not reported. According to the reporting registered nurse, the other nurse was administering hepatitis A vaccine, inactivated (VAQTA) 0.5 milliliter (ml) syringe formulation to a patient on 10-MAR-2022 (valid lot number U024504 and expiration date 15-OCT-2022) (case # 2203USA006289). While pushing the plunger to the barrel flange, a piece of the barrel flange broke (syringe issue), and a shard of glass broke through the administering nurse's glove and cut her finger (wound). The administering nurse was seen by the facility's occupational health and was not hospitalized. The administering nurse's outcome from the wound was not provided. The reporting registered nurse did not provide a causality assessment for the wound. ; Sender's Comments: US-009507513-2203USA006289:

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

VAERS 2222515

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

gering
Staat
IL
Alter
47,0
Geschlecht
U
Eingang
08.04.2022
Impfdatum
08.03.2022
Beginn
08.03.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Heart transplant No adverse event Product administered to patient of inappropriate age

Symptomtext

No addittional adverse events; Adult patient received a pediatric dose of VAQTA by mistake on 08-MAR-2022. HCP stated the reason patient is receiving VAQTA is because the patient is going to have a heart transplant; This spontaneous report has been received from a registered nurse, concerning an 47-year-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies. On 08-MAR-2022, the patient was vaccinated by mistake with a pediatric hepatitis a vaccine, inactivated (VAQTA) syringe, administered once as the patient had to undergo a heart transplant (lot number reported and validated as U024504, expiration date reported and stablished as 15-OCT-2022) (strength, exact dose, vaccination scheme, route of administration and anatomical location were not provided) (product administered to patient of inappropriate age). No other adverse events (AE) reported (no adverse event).

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

VAERS 2210749

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

gering
Staat
CA
Alter
-
Geschlecht
U
Eingang
01.04.2022
Impfdatum
-
Beginn
10.03.2022
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; a piece of the barrel flange broke; Nurse reporting product quality complaint pertaining to hepatitis a vaccine, inactivated (VAQTA) along with adverse event. Nurse reports that another Nurse was administering hepatitis a vaccine, inactivated (VAQTA) to a patient and while pushing the plunger to the barrel flange, a piece of the barrel flange broke and a shard of glass broke through the administering Nurse's glove and cut her finger. Nurse reports that patient was not injured during the administration of hepatitis a vaccine, inactivated (VAQTA). Please reference case number 02129514 for adverse event documentation pertaining to the administering Nurse. Nurse reports that pictures were submitted to her quality department and she will will attempt to obtain pictures and submit them to Agency. No additional information provided. No additional adverse events reported. No additional product quality complaints reported. No further details provided. QUESTION SECTION: Medium Risk: Broken Syringe Barrel High Risk: Cracked or Broken Luer Lock (Needle Attachment Issues), Broken Finger Flange. Notes for Agency: 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: 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.) o Provide the exact location of the breakage on the syringe? Nurse was administering hepatitis a vaccine, inactivated (VAQTA) to a patient and while pushing the plunger to the barrel flange, a piece of the barrel flange broke and a shard of glass broke through the administering Nurse's glove and cut her finger. 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. Nurse reporting product quality complaint pertaining to hepatitis a vaccine, inactivated (VAQTA) along with adverse event. Nurse reports that another Nurse was administering hepatitis a vaccine, inactivated (VAQTA) to a patient and while pushing the plunger to the barrel flange, a piece of the barrel flange broke and a shard of glass broke through the administering Nurse's glove and cut her finger. Nurse reports that patient was not injured during the administration of hepatitis a vaccine, inactivated (VAQTA). o Provide the exact location of the breakage on the 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? NO o If yes, describe o If yes, was it supplied by MERCK: YES/NO/NA/UNSPECIFIED o If not supplied by MERCK, what type & brand, needle size and gauge was used?' o Under what situation was this defect noticed: (select one) o While the syringe was still in the tray? NO o If yes, is there product (liquid or dried residue) in the tray? YES/NO/NA/UNSPECIFIED o Is there any broken glass or other separated component in the tray? (if yes specify) 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? YES o Immediately after giving the injection? YES o Was the syringe tip cap attached properly prior to use? YES o If no, describe issue: 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. UNSPECIFIED 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)? YES o If complaint sample is not/cannot be returned, please provide reason: Nurse reports that syringe has been disposed of. *If photos are available, ask the customer to send them to email Retrieval Information: o Obtain product (and 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: Unknown 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 16-MAR-2022 18:30 PM: Agent placed outbound call to inquire if syringe can be obtained. Nurse stated that syringe has been dispose of. No further details provided. 16-MAR-2022 18:30 PM: Attachment added. 17-MAR-2022: Based on the review of the PQC the priority for this record has been changed per Product Quality Complaint, Complaint Category and Risk Priority Table. 17-MAR-2022: Second person reviewed ; Sender's Comments: US-009507513-2203USA007024:

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

VAERS 2208680

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

gering
Staat
KS
Alter
-
Geschlecht
U
Eingang
31.03.2022
Impfdatum
14.02.2022
Beginn
14.02.2022
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 AE reported; Patient was administered improperly stored VAQTA; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided. On 14-FEB-2022, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # U024504, expiration date 15-OCT-2022, doses, strengths and route were not provided) for prophylaxis (product storage error). The vaccines administered experienced temperature excursions of 0.8 Degree Celsius for 35 minutes on 05-FEB-2022. There was no previous temperature excursion. No additional adverse event reported. This is one of multiple cases received from the same reporter. ; Sender's Comments: US-009507513-2203USA003820: US-009507513-2203USA003814: US-009507513-2203USA003938: US-009507513-2203USA003853: US-009507513-2203USA003841: US-009507513-2203USA003951:

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

VAERS 2178990

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

gering
Staat
KS
Alter
-
Geschlecht
U
Eingang
15.03.2022
Impfdatum
22.02.2022
Beginn
22.02.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

No additional AE reported; patent was administered improperly storgae VAQTA; Spontaneous information had been received from a nurse, referring a patient of unknown age or gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and drug allergies or reactions were not provided. A dose of Hepatitis A Vaccine, Inactivated (VAQTA) (with a valid lot # U024504 with expiration date on 15-OCT-2022) experienced a temperature excursion at 0.8 degree Celsius on 05-FEB-2022 during 35 minutes. On 22-FEB-2022, the patient was vaccinated with the improper stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) (exact dose, formulation and route were not reported for prophylaxis. The vaccine had not experienced previous temperature excursion. No additional adverse event reported. This is one of several cases received from the same reporter. ; Sender's Comments: US-009507513-2203USA003814:

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

VAERS 2174757

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

gering
Staat
KS
Alter
-
Geschlecht
U
Eingang
12.03.2022
Impfdatum
10.02.2022
Beginn
10.02.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

no adverse event; Patient was administered improperly stored Vaqta; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant medications were not reported. On 05-FEB-2022, the hepatitis a vaccine, inactivated (VAQTA) (lot # U024504, expiration date 15-OCT-2022) was exposed to a temperature excursion of 0.8 degrees C for 35 minutes, and on 10-FEB-2022, the patient was vaccinated with it as prophylaxis (dose, route and anatomical location were not reported) (product storage error). There was not previous temperature excursion. This is one of multiple cases received from the same reporter.

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

VAERS 2158338

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

gering
Staat
NV
Alter
8,0
Geschlecht
F
Eingang
04.03.2022
Impfdatum
04.03.2022
Beginn
04.03.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Wrong product administered

Symptomtext

Pt Given Hep A vaccine meant for another pt. This Pt was not scheduled to receive this vaccine.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
adhd, allergies
Andere Medikamente
Focalin XR
Allergien
guanfacine
Vorherige Impfungen
-

VAERS 2151898

MERCK & CO. INC. · HEP A (VAQTA) · Charge u024504

gering
Staat
IL
Alter
1,0
Geschlecht
M
Eingang
02.03.2022
Impfdatum
16.02.2022
Beginn
02.03.2022
Tage bis Beginn
14,0
Dosis
1
Route/Site
SYR / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Lymphadenopathy

Symptomtext

Swollen lymph nodes in groin noted on 3/2/2022

Weitere VAERSDATA-Felder
Praegender Schweregrund
Lymphadenopathy
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
none
Vorgeschichte
Abnormal head circumference in relation to growth Slow weight gain in pediatric patient Feeding difficulties
Andere Medikamente
Cholecalciferol 10mcg/ml oral drops
Allergien
NKA
Vorherige Impfungen
-

VAERS 2141825

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

gering
Staat
OH
Alter
-
Geschlecht
U
Eingang
26.02.2022
Impfdatum
24.01.2022
Beginn
24.01.2022
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 AE reported; administered the RECOMBIVAX HB to a 17 year old patient instead of the VAQTA; patient was already fully vaccinated with the RECOMBIVAX HB; This spontaneous report was received from a medical assistant and refers to a 17-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 24-JAN-2022, the patient was vaccinated with hepatitis B vaccine (recombinant) thimerosal-free (RECOMBIVAX HB) 5 microgram (mcg)/0.5 ml, 0.5 ml, lot # U005271 with expiration date on 21-NOV-2022 (route of administration was not reported), for prophylaxis. The reporter stated that she administered the hepatitis B vaccine (recombinant) (RECOMBIVAX HB) instead of the hepatitis A vaccine, inactivated (VAQTA) (wrong product administered). The patient was already fully vaccinated with the hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (extra dose administered). On the same day, after the error was discovered, the hepatitis A vaccine, inactivated (VAQTA) (25 units (U)/0.5ml, 0.5 ml, lot # U024504 with expiration date on 15-OCT-2022, for prophylaxis; route of administration not reported) was administered in the patient's opposite arm. No additional adverse event was reported.

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

VAERS 2101569

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

gering
Staat
MI
Alter
5,0
Geschlecht
M
Eingang
10.02.2022
Impfdatum
07.02.2022
Beginn
07.02.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

Administered COVID vaccine past thaw expiration date.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product storage error
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2098067

MERCK & CO. INC. · HEP A (VAQTA) · Charge U024504

gering
Staat
NV
Alter
1,5
Geschlecht
F
Eingang
09.02.2022
Impfdatum
27.12.2021
Beginn
27.12.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Ill-defined disorder Inappropriate schedule of product administration Product storage error

Symptomtext

adverse experience; revaccinated; Temperature excursion involving VAQTA; This spontaneous report has been received from a medical assistant (also reported as a nurse), concerning 18-month-old of female patient. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 27-DEC-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # U024504, expiration date: 15-OCT-2022, which have been verified to be valid lot numbers for hepatitis a vaccine, inactivated (strength, exact dose and route of administration were not provided) in left thigh for prophylaxis. The vaccine was exposed to a temperature excursion of below 36?F (30.4?F) for 0 hours 35 minutes on 08-DEC-2021. Digital data logger was involved. On an unknown date, the patient experienced unspecified adverse reaction (ill-defined disorder). The patient's parents agreed to revaccination (inappropriate schedule of vaccine administered). The outcome of the event of ill-defined disorder was reported as resolved on an unknown date. The causality assessment between the event of ill-defined disorder and suspect vaccine was considered as unknown. The reporter considered the event of ill-defined disorder to be important medical event (medically significant). This is one of several cases received from the same reporter. ; Sender's Comments: US-009507513-2201USA000582:

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