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Reporte zur Charge UJ336AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

9Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
NC 2 OK 2 IN 2 NY 1 WI 1 VA 1

VAERS 1410830

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ336AAA

kritisch
Staat
NC
Alter
0,7
Geschlecht
F
Eingang
18.06.2021
Impfdatum
18.06.2021
Beginn
18.06.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Crying Cyanosis Hyperhidrosis Pallor Respiratory arrest

Symptomtext

After administering the third vaccine which was Prevnar on to her right thigh, the infant had cried to a point where she started turning blue and seemed to have stopped breathing. Infant taken from parent and rubbed on chest and infant started crying though she was sweaty and appeared bluish pale. Per parent, while recovering infant, her energy level is back to baseline. Called Dr. and left message for callback. Infant assessed by Dr., MD on site and spoke to parents regarding infant reaction to vaccinations.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Respiratory arrest
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 1101704

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ336AAA

mild
Staat
NY
Alter
1,5
Geschlecht
F
Eingang
15.03.2021
Impfdatum
12.03.2021
Beginn
12.03.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Urticaria

Symptomtext

Hives starting evening of vaccination and progressing until time of visit 3/15. Has not yet been treated. Recommended today to start treatment with benadryl.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Urticaria
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
Yes. 2/25/2021 Vomiting, Temp to tmax 100.2F, COVID antigen and PCR testing negative. Also teething at the time.
Vorgeschichte
None
Andere Medikamente
None
Allergien
None
Vorherige Impfungen
-

VAERS 1483673

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ336AAA

gering
Staat
WI
Alter
1,5
Geschlecht
F
Eingang
18.07.2021
Impfdatum
07.07.2021
Beginn
07.07.2021
Tage bis Beginn
0,0
Dosis
4
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event

Symptomtext

expired pentacel was administered to patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional (nurse) and physician via global medical information (GMI) (Reference number- 00674667) and transmitted to Sanofi on 08-Jul-2021. This case involves a 19-month-old female patient who received an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered). Medical history, medical treatment, vaccination and family history were not reported. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13),MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) and HEPATITIS A VACCINE. On 07-Jul-2021, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB [Pentacel] VACCINE (total, lot UJ336AAA and Expiry date- 05-Jul-2021) via an unknown route at the right vastus lateralus site for prophylactic vaccination (expired product administered) (latency: on the same day). It was a case of actual medication error due to expired vaccine used. At the time of report, reporter was asked for any adverse event to watch for and what should they do. At the time of report, no adverse event was reported. 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
PREVNAR 13; MMRVAXPRO; HEPATITIS A VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1483672

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ336AAA

gering
Staat
VA
Alter
0,2
Geschlecht
M
Eingang
18.07.2021
Impfdatum
08.07.2021
Beginn
08.07.2021
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 Medication error

Symptomtext

expired dose of PENTACEL was administered with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00674627) and transmitted to Sanofi on 08-Jul-2021. This case involves a 2-month-old male patient who administered expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (VERO)/HIB (PRP/T) VACCINE [PENTACEL (VERO)] vaccine. The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE. On 08-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [lot UJ336AAA and expiry date: 05-Jul-2021] via an unknown route in unknown administration site for prophylactic vaccination. It was a case of actual medication error due to expired product administered [Latency: on the same day]. No adverse effects have been reported. Details of laboratory data not reported. It was not reported if the patient received any 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
HEPATITIS B VACCINE; PREVNAR 13; ROTAVIRUS VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1381428

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ336AAA

gering
Staat
OK
Alter
0,2
Geschlecht
F
Eingang
08.06.2021
Impfdatum
10.12.2020
Beginn
10.12.2020
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

patient was given the Dtap/IPV portion of PENTACEL and did not get the ActHIB part, no AE; Upon Internal review a signification amendment was performed on 04-Jun-2021, to change the product code of Pentacel from 242 to 520. Initial information received on 14-Dec-2020 regarding an unsolicited valid non-serious case from a physician. This case involves a 2 months old female patient who was given the first dose of DTAP/IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Lot number UJ336AAA and expiration date 05-Jul-2021) and did not get the ACT-HIB part, via intramuscular route in the right thigh for prophylactic vaccination on 10-Dec-2020 (Product preparation issue). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE for prophylactic vaccination. It was a case of actual medication error due to inappropriate reconstitution technique (same day latency). Physician stated that an employee gave the DTAP/IPV portion of PENTACEL. She wanted to know how to proceed, to give them just an ActHIB or another Pentacel. The physician stated that an employee at the office gave the DTaP/IPV portion of Pentacel on 10-Dec-2020. At the time of report, no adverse event was reported. 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 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
HEPATITIS B VACCINE; ROTAVIRUS VACCINE; PNEUMOCOCCAL VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1230976

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ336AAA

gering
Staat
NC
Alter
0,2
Geschlecht
M
Eingang
19.04.2021
Impfdatum
23.03.2021
Beginn
23.03.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation issue

Symptomtext

2 month-old male was administered a Pentacel vaccine, but it was not reconstituted with the HIB portion of the vaccine with no adverse event.; Initial information regarding an unsolicited valid non-serious was received from other health professional via Medical Information (Reference number- 00537382) and transmitted to Sanofi on 26-Mar-2021. This case involves a 2 months old male patient who was administered with a 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], but it was not reconstituted with the HIB portion of the vaccine (lot UJ336AAA and expiry date: 05-Jul-2021) via intramuscular route at an unknown administration site for prophylactic vaccination on 23-Mar-2021. Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ). It was actual medication error due to Inappropriate reconstitution technique (on same day). The reporter wanted to know if there was any other diluent that can be used on the Pentacel powder and inquire about ordering 0.4% (percent) sodium chloride solution. The error was discovered on the day of reporting. They reported that they will administer stand-alone ActHIB. At the time of report, the patients experienced 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 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
PREVNAR; ROTATEQ
Allergien
-
Vorherige Impfungen
-

VAERS 1030229

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ336AAA

gering
Staat
IN
Alter
1,7
Geschlecht
M
Eingang
15.02.2021
Impfdatum
22.01.2021
Beginn
22.01.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein
No adverse event Product preparation issue

Symptomtext

dose of PENTACEL was administered without reconstituting with the Hib portion of the vaccine, no ae; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Agency (Reference number- 00446341) and transmitted to Sanofi on 26-Jan-2021. This case involves an one year old male patient who was vaccinated with 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot UJ336AAA and expiration date :05-Jul-2021) via intramuscular route (other dosing details were unknown) for prophylactic vaccination on 22-Jan-2021 and reported that a dose of PENTACEL was administered without reconstituting with the Hib portion of the vaccine (Product preparation issue). Also reported that Caller reported two patients were administered the vaccine but unsure of which patient was only administered the DTap-IPV portion of the vaccine and asked when to re-vaccinate both patients. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE. It was a case of actual medication error due to an inappropriate reconstitution technique (same day latency). It was not reported whether the patient had any 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 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
-
Allergien
-
Vorherige Impfungen
-

VAERS 1004657

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ336AAA

gering
Staat
IN
Alter
0,1
Geschlecht
F
Eingang
05.02.2021
Impfdatum
21.01.2021
Beginn
21.01.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation issue

Symptomtext

a dose of PENTACEL was administered without reconstituting with the Hib portion of the vaccine with no AE; Initial information received on 26-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 2 month old female patient who administered dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without reconstituting with the hib portion of the vaccine (Product preparation issue). Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCIN); PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE). On 21-Jan-2021, the patient received a 05mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ336AAA, Expiry date: 05-Jul-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination. It was a case of actual medication error due to inappropriate reconstitution technique (Product preparation issue) [latency: at the same time of vaccination]. It was reported that, caller reporting two patients were administered the vaccine but unsure of which patient was administered only the DTap-IPV portion of the vaccine. Caller with asked on when to re-vaccinate both patients. At the time of report no adverse event was reported. 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 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
HEPATITIS B VACCIN; PREVNAR; ROTAVIRUS VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 922404

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ336AAA

gering
Staat
OK
Alter
0,2
Geschlecht
F
Eingang
06.01.2021
Impfdatum
10.12.2020
Beginn
10.12.2020
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

patient was given the Dtap/IPV portion of PENTACEL and did not get the ActHIB part, no AE; Initial information received on 14-Dec-2020 regarding an unsolicited valid non-serious case from a physician in the united States. This case involves a 2 months old female patient who was given the first dose of dtap/ipv portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number UJ336AAA and expiration date 05-Jul-2021) and did not get the ACT-HIB part, via intramuscular route in the right thigh for prophylactic vaccination on 10-Dec-2020. Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) ; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for prophylactic vaccination. It was a case of actual medication error due to inappropriate reconstitution technique (product preparation issue, same day latency). At the time of report no adverse event was reported. 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 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
HEPATITIS B VACCINE; ROTAVIRUS VACCINE; PNEUMOCOCCAL VACCINE
Allergien
-
Vorherige Impfungen
-