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Reporte zur Charge U026802

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

12Reporte angezeigt
0Todesfaelle
2Hospitalisiert
1Lebensbedrohlich
1Bleibende Schaeden
NY 3 CA 2 OR 1 IL 1 AK 1 TN 1 ID 1 MD 1 WA 1

VAERS 2446292

MERCK & CO. INC. · HIB (PEDVAXHIB) · Charge U026802

mild
Staat
OR
Alter
0,3
Geschlecht
F
Eingang
15.09.2022
Impfdatum
12.09.2022
Beginn
12.09.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Decreased appetite Lethargy Pyrexia Rash

Symptomtext

full body rash, fever 101.5 not relieved by tylenol, lethargy, decreased appetite. resolved within 2 days. pt better as of 9/15/2022

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

VAERS 2309632

MERCK & CO. INC. · HIB (PEDVAXHIB) · Charge U026802

mild
Staat
CA
Alter
0,2
Geschlecht
F
Eingang
04.06.2022
Impfdatum
25.04.2022
Beginn
09.05.2022
Tage bis Beginn
14,0
Dosis
1
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: ja Hospital: ja Disable: ja ER: ja Erholt: ja
Blood culture negative Blood magnesium normal Blood phosphorus abnormal Chest X-ray Full blood count Haematochezia Hypokalaemia Hypophosphataemia Intestinal resection Intussusception Metabolic function test abnormal Pathology test Respiratory viral panel Treatment failure Ultrasound abdomen abnormal Vomiting X-ray

Symptomtext

Patient started having emesis and bloody bowel movements 5/9/22, family called EMS 5/11/22 and patient was taken to the local hospital and found to have intussusception. She was transferred to Hospital where an attempt at air enema reduction was unsuccessful and patient required emergent surgery and bowel resection for incarceration ileocolic intussusception 5/11/2022.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Vomiting
Hospital-Tage
7,0
Labordaten
5/11/22: Abdominal ultrasound showing ileocolic intussusception 5/11/22: fluoroscopic guidance of air enema reduction of intussusception 5/11/22: CBC 5/11/22: BMP 5/11/22: type and screen 5/11/22: RVP (negative) 5/12/22: CXR 5/12/22: BMP showing mild hypokalemia 5/12/22: serum magnesium (normal) 5/12/22: serum phosphorus showing mild hypophosphatemia 5/12/22: surgical pathology: intussusception with marked acute ischemic injury of terminal ileum and cecum, appendix with mild acute ischemic changes. 5/14/22: blood culture (negative)
Aktuelle Erkrankungen
History of RSV Bronchiolitis requiring hospitalization 3/31/22-4/4/22
Vorgeschichte
-
Andere Medikamente
Vitamin D
Allergien
-
Vorherige Impfungen
-

VAERS 2225377

MERCK & CO. INC. · HIB (PEDVAXHIB) · Charge U026802

mild
Staat
IL
Alter
0,2
Geschlecht
M
Eingang
09.04.2022
Impfdatum
08.04.2022
Beginn
08.04.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: ja Erholt: nein
Blood test CSF culture Electroencephalogram Laboratory test Musculoskeletal stiffness Pyrexia Somnolence Urine analysis

Symptomtext

Patient received vaccines on 4/8 in AM. On 4/8 in PM patient had fever to 101, body stiffening episodes, and increased sleepiness. Patient taken to ED for evaluation.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
After arrival to ED patient had septic workup initiated including urine, blood, and CSF cultures and rapid meningitis panel. Continuous 24 hour video EEG started to capture any seizure activity.
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2629476

SANOFI PASTEUR · HIB (ACTHIB) · Charge U026802

gering
Staat
NY
Alter
1,0
Geschlecht
F
Eingang
10.05.2023
Impfdatum
18.04.2023
Beginn
18.04.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product storage error

Symptomtext

temperature excursion as temperature reached: negative -40f degrees for 8 hours and 25 minutes with no reported adverse event; received both Daptacel and Acthib post-temperature excursion where the vaccines were not suitable for use with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 1 years old female patient and reporter reported temperature excursion as temperature reached: negative -40f degrees for 8 hours and 25 minutes with no reported adverse event and received both haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] and diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] post-temperature excursion where the vaccines were not suitable for use with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Apr-2023, the patient received a dose of suspect haemophilus type B (HIB) (PRP/T) vaccine Powder and solvent for solution for injection at a dose of 0.5 ml total (lot U026802, expiry date- 03-NOV-2023) via intramuscular route in the left arm for Immunization and also received a dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection at a dose of 0.5 ml total (lot C5969AD, expiry date- 17-FEB-2024) via intramuscular route in the left arm for Immunization. Caller reported that temperature excursion for haemophilus type B (HIB) (PRP/T) vaccine and diphtheria-15/tetanus/5 AC pertussis vaccine as temperature reached: negative -40f degrees for 8 hours and 25 minutes with no reported adverse event (product storage error) (unknown latency) and received both daptacel and acthib post-temperature excursion where the vaccines were not suitable for use with no reported adverse event (poor quality product administered) (latency- same day). Action taken was not applicable. At time of reporting, the outcome was Unknown for both the events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: US-SA-2023SA137908:01597142 US-SA-2023SA138048:01597145 US-SA-2023SA137832:01597167 US-SA-2023SA136956:01597157

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

VAERS 2627818

SANOFI PASTEUR · HIB (ACTHIB) · Charge U026802

gering
Staat
NY
Alter
1,0
Geschlecht
F
Eingang
06.05.2023
Impfdatum
04.04.2023
Beginn
04.04.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Poor quality product administered Product storage error

Symptomtext

temperature excursion where the temperature reached negative -40F degrees for 8 hours and 25 minutes with no reported adverse event; received the vaccine post-temperature excursion where the vaccine were not suitable for use with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2023SA137832, 2023SA137908, 2023SA137832, 2023SA136956 and 2023SA137832. This case involves a 1 years old female patient who received HIB (PRP/T) vaccine [ACT-HIB] post temperature excursion where the temperature reached negative -40f degrees for 8 hours and 25 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Prophylactic vaccination. On 04-Apr-2023, the patient received 0.5 ml dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot: U026802; expiry date: 03-Nov-2023) via intramuscular route in the left arm for Immunization post temperature excursion where the temperature reached negative -40f degrees for 8 hours and 25 minutes with no reported adverse event (product storage error) (poor quality product administered) (same day latency). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event received the vaccine post-temperature excursion where the vaccine were not suitable for use with no reported adverse event and was Unknown for the event temperature excursion where the temperature reached negative -40f degrees for 8 hours and 25 minutes with no reported adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

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

VAERS 2627002

SANOFI PASTEUR · HIB (ACTHIB) · Charge U026802

gering
Staat
NY
Alter
1,0
Geschlecht
F
Eingang
05.05.2023
Impfdatum
18.04.2023
Beginn
18.04.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product storage error

Symptomtext

temperature excursion of negative -40f degrees or 8 hours and 25 minutes with no reported adverse events; receiving the vaccines post-temperature excursion with no adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 1 years old female patient who received the HIB (PRP/T) vaccine [ACT-HIB] post temperature excursion of negative -40f degrees or 8 hours and 25 minutes with no reported adverse events. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Immunisation. On 18-Apr-2023, the patient received an unknown dose of suspect HIB (PRP/T) vaccine (lot: U026802; exp: 03-Nov-2023) via intramuscular route in left arm for prophylactic vaccination post temperature excursion of negative -40f degrees or 8 hours and 25 minutes with no reported adverse events (product storage error) (poor quality product administered) (same day latency). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event temperature excursion of negative -40f degrees or 8 hours and 25 minutes with no reported adverse events and was Unknown for the event receiving the vaccines post-temperature excursion with no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

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

VAERS 2590332

MERCK & CO. INC. · HIB (PEDVAXHIB) · Charge U026802

gering
Staat
AK
Alter
1,0
Geschlecht
F
Eingang
02.03.2023
Impfdatum
27.01.2023
Beginn
27.01.2023
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Inappropriate schedule of product administration No adverse event

Symptomtext

Infanrix vaccine administered prior to four to six month interval. Administered at 3mo, 1weeks. No adverse reaction from patient.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Inappropriate schedule of product administration
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
NKA
Vorherige Impfungen
-

VAERS 2582928

MERCK & CO. INC. · HIB (PEDVAXHIB) · Charge U026802

gering
Staat
TN
Alter
0,6
Geschlecht
F
Eingang
16.02.2023
Impfdatum
07.02.2023
Beginn
07.02.2023
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event Product administered to patient of inappropriate age

Symptomtext

Administered Afluria Influenza Vaccine (licensed for ages 3yrs and up) to this patient (age 7 months). Notified mother 3 hours later. Mother reported that patient had not exhibited any signs or symptoms of adverse reaction.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None reported
Vorgeschichte
None reported
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 2429172

MERCK & CO. INC. · HIB (PEDVAXHIB) · Charge U026802

gering
Staat
ID
Alter
-
Geschlecht
U
Eingang
06.09.2022
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
No adverse event Product storage error

Symptomtext

no adverse event; an imroperly stored dose of PEDVAX HIB was administered to a patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, or drug reactions or allergies was provided. On 08-AUG-2022, the patient started therapy with an improperly stored dose of haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot #U026802, expiration date: 03-NOV-2023; strength, route of administration, vaccination scheme frequency, anatomical location, and dose were not reported) administered to prevent haemophilis influenza B infection (product storage error). No additional adverse event was reported (no adverse event).

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

VAERS 2386653

MERCK & CO. INC. · HIB (PEDVAXHIB) · Charge U026802

gering
Staat
MD
Alter
-
Geschlecht
U
Eingang
23.07.2022
Impfdatum
-
Beginn
23.06.2022
Tage bis Beginn
-
Dosis
1
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Vaccination error

Symptomtext

No other AE; Caller reported an AE for PEDVAX HIB. The caller said they have a patient who received PENTACEL and PEDVAX HIB on the same day, 23JUN2022. Confirmed with caller no other AE occurred. AE letter sent to prescriber. No other AE. No PQC.; This spontaneous report was received from nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. Caller reported an adverse event for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB). The caller reported that have a patient who received first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # U026802 and expiration date: 03-SEP-2021 (dose, indication and route were not reported), and first dose of diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), lot # UJ529AAA expiration date: 22-JUL-2022 (dose, route of administration and indication were not provided), on the same date, on 23-JUN-2022. No other adverse event occurred.

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

VAERS 2327291

MERCK & CO. INC. · HIB (PEDVAXHIB) · Charge U026802

gering
Staat
WA
Alter
3,0
Geschlecht
F
Eingang
22.06.2022
Impfdatum
15.06.2022
Beginn
15.06.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Extra dose administered No adverse event

Symptomtext

No adverse reaction, however the patient was given an additional dose that was not necessary. It would appear that the patient has had 7 DTaP doses to date. And additional dose of IPV

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

VAERS 2296733

MERCK & CO. INC. · HIB (PEDVAXHIB) · Charge U026802

gering
Staat
CA
Alter
0,7
Geschlecht
M
Eingang
26.05.2022
Impfdatum
26.05.2022
Beginn
26.05.2022
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Off label use Product administered to patient of inappropriate age Vaccination error Wrong product administered

Symptomtext

Off label use: Kinrix is supposed to be given at the earliest age of 4 years (here given to an 8 month old). Immunizations due: DTap, Hib, Polio. In order to minimize shots to be given, and not give immunization with Hep B( not needed), I administered Kinrix (DTap + polio), not noticing until after administration that it was not age appropriate. these does should be OK as long as they are within the proper catch up schedule frequency, which both DTap and Polio were. This was not the correct vaccination, however, and is reportable as an error.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Off label use
Hospital-Tage
-
Labordaten
NA
Aktuelle Erkrankungen
NA
Vorgeschichte
NA
Andere Medikamente
NA
Allergien
NA
Vorherige Impfungen
-