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Reporte zur Charge UJ473AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

16Reporte angezeigt
1Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
NY 9 IL 1 WA 1 VA 1 AR 1 ME 1 TX 1 NC 1

VAERS 1959021

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ473AAA

kritisch
Staat
IL
Alter
0,3
Geschlecht
M
Eingang
17.12.2021
Impfdatum
13.12.2021
Beginn
16.12.2021
Tage bis Beginn
3,0
Dosis
1
Route/Site
IM / LL
Tod: ja Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Cardiac arrest Death Echocardiogram Resuscitation Unresponsive to stimuli Vomiting

Symptomtext

Morning of 12/16 family found him unresponsive in bed and noted emesis in bed. Parents started CPR. Paramedics arrived and in full arrest. Resuscitation attempted in ER for 1 hour. No cardiac activity, and resuscitation attempts stopped.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Cardiac arrest
Hospital-Tage
-
Labordaten
Discussed with coroner and cause of death still pending. Autopsy had not been performed yet.
Aktuelle Erkrankungen
RSV diagnosed on 11/24/21 in the ER. He was seen twice in the ER, and admitted on 11/26 to the hospital. Required HFNC initially and discharged home 11/29/21.
Vorgeschichte
none
Andere Medikamente
Vitamin D 400 IU drops
Allergien
none
Vorherige Impfungen
-

VAERS 2453636

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ473AAA

gering
Staat
WA
Alter
3,0
Geschlecht
M
Eingang
21.09.2022
Impfdatum
13.07.2022
Beginn
01.07.2022
Tage bis Beginn
-
Dosis
UNK
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered No adverse event

Symptomtext

Vaccine administered to patient on 7/13/2022 was expired on 7/9/2022. This error was noted when patient returned on 9/6/2022 for catch up vaccines. Patient was administered DTAP/IPV vaccine at this visit to correct the error. ( Parent declined the HIB) Parent did not report any adverse reactions to the expired vaccine.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
No additional testing was performed.
Aktuelle Erkrankungen
None noted
Vorgeschichte
None noted
Andere Medikamente
None Noted
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2372135

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ473AAA

gering
Staat
VA
Alter
1,3
Geschlecht
M
Eingang
18.07.2022
Impfdatum
12.07.2022
Beginn
12.07.2022
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error No adverse event

Symptomtext

administered an expired PENTACEL to a 15-month-old patient with no reported adverse event; Initial information received on 12-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 15 months old male patient who was administered with expired Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] 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 Pneumococcal Vaccine Conj 13V (CRM197) (Prevnar 13) for prophylactic vaccination (immunization). On 12-Jul-2022, the patient received a 0.5 ml dose (4th dose) once total of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine Suspension for injection (lot: UJ473AAA; expiry date: 09Jul2022; strength not reported) via intramuscular route in the left thigh for prophylactic vaccination (immunization). On 12-Jul-2022 the patient developed a non-serious event administered an expired pentacel to a 15-month-old patient with no reported adverse event (expired product administered) (latency: same day) following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine. Action taken with Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine (Pentacel) was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PREVNAR 13
Allergien
-
Vorherige Impfungen
-

VAERS 2238754

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ473AAA

gering
Staat
AR
Alter
1,1
Geschlecht
F
Eingang
18.04.2022
Impfdatum
07.04.2022
Beginn
07.04.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Incorrect dose administered No adverse event

Symptomtext

Adult dose 1ml instead of the peds dose of 0.5 ml -no adverse effects noted from the adult dose given mom has not reported any adverse effects. Call has been p[laced to om x2 to check on patient. Message left mom has not returned my call.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect dose administered
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
Mother report no illness
Vorgeschichte
Mother reports no history
Andere Medikamente
None
Allergien
NIKSA
Vorherige Impfungen
-

VAERS 1997092

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ473AAA

gering
Staat
ME
Alter
0,7
Geschlecht
F
Eingang
01.01.2022
Impfdatum
20.12.2021
Beginn
20.12.2021
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 preparation issue

Symptomtext

This case involves a 8 months old female patient who had experienced an event was only given the liquid portion of the vaccine and HCP would like to know if he powder portion of the vaccine can be reconstituted and given as a separate injection with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Dec-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE injection (strength: unknown) at the dose of 0.6 ml once via route intramuscular (batch number: UJ473AAA, expiry date: 09-jul-2022) via unknown administration site for indication prophylactic indication. On 20-DEC-2021 the patient developed a non-serious event "was only given the liquid portion of the vaccine and HCP would like to know if he powder portion of the vaccine can be reconstituted and given as a separate injection with no reported adverse event" (product preparation issue) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) /HIB(PRP/T) VACCINE. Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable. At time of reporting, the outcome was Unknown for the event was only gave the liquid portion of the vaccine and HCP would like to know if he powder portion of the vaccine can be reconstituted and given as a separate injection 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. 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 1941974

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ473AAA

gering
Staat
TX
Alter
15,0
Geschlecht
M
Eingang
11.12.2021
Impfdatum
02.12.2021
Beginn
02.12.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product administered to patient of inappropriate age

Symptomtext

PENTACEL was administered to a 15-year old patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician via Agency (Reference number- 00882537) and transmitted to Sanofi on 02-Dec-2021. This case involves a 15-year-old male patient was administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (product administered to patient of inappropriate age) Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and MENINGOCOCCAL VACCINE CONJ (MENINGOCOCCAL VACCINE CONJ) for prophylactic vaccination. On 02-Dec-2021, 15-year-old male patient received first 0.5ml total dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot: UJ473AAA and expiry date: 09-Jul-2022) (Frequency = once) (Strength = standard) (Form: solution) via intramuscular route in the right deltoid for prophylactic vaccination (product administered to patient of inappropriate age). It was reported "Nurse asks what adverse events they should look out for; asks if the vaccine would be considered valid? Nurse states that the patient was receiving PENTACEL because he has no immunization record, so he was supposed to be getting a catch-up series. Nurse states they thought they could administer PENTACEL so that the patient did not have to receive as many shots. Nurse states after they realized that PENTACEL is not approved for patients his age, they called the patient and his mother at home; states when they called the patient and his mother, no adverse events were reported to them. Nurse states that the patient did not experience any adverse events that required treatment while he was at their office; states the patient also reported no adverse events that required treatment when they contacted the patient at home. No further information provided by the reporter". This case was an actual medication error due to inappropriate age at vaccine administration (latency: same day). At the time of reporting, 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1858217

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UJ473AAA

gering
Staat
NY
Alter
16,0
Geschlecht
U
Eingang
10.11.2021
Impfdatum
19.10.2021
Beginn
19.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product storage error

Symptomtext

VACCINE EXPOSED TO TEMP OUTSIDE OF REC. STORAGE RANGE. UNKNOWN VIABILITY/POTENCY PER MANUFACTURER.

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

VAERS 1858199

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ473AAA

gering
Staat
NY
Alter
0,2
Geschlecht
U
Eingang
10.11.2021
Impfdatum
19.10.2021
Beginn
19.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product storage error

Symptomtext

VACCINES EXPOSED TO TEMP. OUTSIDE OF REC. STORAGE RANGE. UNKNOWN VIABILITY/POTENCY PER MANUFACTURER.

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

VAERS 1858184

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ473AAA

gering
Staat
NY
Alter
0,5
Geschlecht
U
Eingang
10.11.2021
Impfdatum
19.10.2021
Beginn
19.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product storage error

Symptomtext

Vaccine exposed to temperature outside recommended storage range. Unknown viability potency per manufacturer.

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

VAERS 1858163

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ473AAA

gering
Staat
NY
Alter
1,3
Geschlecht
U
Eingang
10.11.2021
Impfdatum
19.10.2021
Beginn
19.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product storage error

Symptomtext

VACCINES EXPOSED TO TEMP OUT OF REC. STORAGE RANGE. UNKNOWN VIABILITY/POTENCY PER MANUFACTURER

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

VAERS 1858137

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ473AAA

gering
Staat
NY
Alter
1,3
Geschlecht
U
Eingang
10.11.2021
Impfdatum
19.10.2021
Beginn
19.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product storage error

Symptomtext

Vaccine exposed to temperature outside recommended storage range. Unknown viability potency per manufacturer.

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

VAERS 1858120

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ473AAA

gering
Staat
NY
Alter
1,7
Geschlecht
U
Eingang
10.11.2021
Impfdatum
19.10.2021
Beginn
19.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product storage error

Symptomtext

Vaccine exposed to temperature outside recommended storage range. Unknown viability potency per manufacturer.

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

VAERS 1857843

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ473AAA

gering
Staat
NY
Alter
0,2
Geschlecht
U
Eingang
10.11.2021
Impfdatum
18.10.2021
Beginn
18.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product storage error

Symptomtext

VACCINE EXPOSED TO TEMP. OUTSIDE OF REC. STORAGE RANGE. UNKNOWN VIABILITY/POTENCY PER MANUFACTURER.

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

VAERS 1857833

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ473AAA

gering
Staat
NY
Alter
0,3
Geschlecht
U
Eingang
10.11.2021
Impfdatum
18.10.2021
Beginn
18.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product storage error

Symptomtext

VACCINE EXPOSED TO TEMP. OUTSIDE REC. STORAGE RANGE. UNKNOWN VIABILITY/POTENCY PER MANUFACTURER.

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

VAERS 1857826

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ473AAA

gering
Staat
NY
Alter
0,7
Geschlecht
U
Eingang
10.11.2021
Impfdatum
18.10.2021
Beginn
18.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product storage error

Symptomtext

VACCINE EXPOSED TO TEMPERATURE OUTSIDE OF RECOMMENDED STORAGE RANGE. UNKNOWN POTENCY/VIABILITY PER MANUFACTURER.

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

VAERS 1718511

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ473AAA

gering
Staat
NC
Alter
4,0
Geschlecht
M
Eingang
21.09.2021
Impfdatum
08.09.2021
Beginn
08.09.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered Wrong product administered

Symptomtext

Patient given PENTACEL instead of DAPTACELwith no reported adverse event; given an extra IPOL dose with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- 00759904) and transmitted to Sanofi on 08-Sep-2021. This case involved 4 year-5-month-old male patient given DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and given an extra IPV (VERO) [IPOL] dose (wrong product administered and extra dose administered) Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE; MUMPS VACCINE; RUBELLA VACCINE; VARICELLA ZOSTER VACCINE in the right for prophylactic vaccination. On 08-Sep-2021, the patient received 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot number: UJ473AAA and expiry date: 09-Jul-2022) (Frequency = once) (Strength = standard) via intramuscular route in the left thigh for prophylactic vaccination instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and given an extra 0.5ml dose of suspect IPV (VERO) [IPOL] (lot number: T1E871M and expiry date: 10-Oct-2022) (Frequency = once) (Strength = standard) via subcutaneous route in the left thigh for prophylactic vaccination. It was reported, "What should they do now? The Medical Information agent confirmed the spelling of demographics with the caller for accuracy. The patient is doing fine and the provider is aware". This case was an actual medication error due to wrong vaccine administered and extra dose administered. At the time of reporting, 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
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
MEASLES VACCINE;MUMPS VACCINE;RUBELLA VACCINE;VARICELLA ZOSTER VACCINE
Allergien
-
Vorherige Impfungen
-