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Reporte zur Charge U6842BA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

6Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
MS 1 MN 1 MD 1 NC 1 MA 1 NH 1

VAERS 1653320

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6842BA

gering
Staat
MS
Alter
4,0
Geschlecht
M
Eingang
29.08.2021
Impfdatum
03.08.2021
Beginn
03.08.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

recevied expired a dtap vaccine/ no AE;Initial information was received on 03-Aug-2021 regarding an unsolicited valid non-serious case from other healthcare professional and physician via call center via Medical Information (Reference number- 00708519). This case involves a 4-year-old male patient who was vaccinated with an expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (expired product administered). The patient's past medical history, medical treatments, vaccinations, concomitant vaccination and family history were not provided. Concomitant medications included MEASLES VACCINE LIVE, MUMPS VACCINE LIVE, RUBELLA VACCINE LIVE (WISTAR RA 27/3), PROQUAD; HEPATITIS A VACCINE; and PNEUMOCOCCAL 13 VALENT VACCINE for prophylactic vaccination. On 03-Aug-2021, the patient received a third dose of 0.5mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (diluent lot number: U6842BA, powder lot number: UJ335AA and expiry date: 05-Jul-2021) via intramuscular route in the right arm for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency: same day). It was reported that, "I gave a dtap vaccine but it expired last month. Does the person have to come and redo it?." At the time of reporting, 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PROQUAD; HEPATITIS A; PNEUMOCOCCAL 13 VALENT VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 1381432

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6842BA

gering
Staat
MN
Alter
1,3
Geschlecht
M
Eingang
08.06.2021
Impfdatum
17.05.2021
Beginn
17.05.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation error

Symptomtext

patient was administered a 0.5ml dose of the diluent of the Pentacel vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from the other healthcare professional via Medical Information inbound (reference number- 00608210) and transmitted to Sanofi on 19-May-2021. This case involves 16 month old male patient who was administered a 0.5ml dose of only the diluent of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: U6842BA; expiry date: 05-JUL-2021) via unknown route in the right thigh for prophylactic vaccination on 17-MAY-2021(product preparation error). Medical history, medical treatment(s), past vaccination(s), and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) for prophylactic vaccination on 17-MAY-2021. It was a case of an actual medication error due to active ingredient not added to diluent (latency same day). The reporter stated that a nurse administered the diluent only regarding the Pentacel. The reporter wanted to know what if a vaccination with just a stand alone vaccine for the components not given by just administering the diluent. Also, the reporter wanted to know if the powder component be given if diluted with something else. 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
MMR VACCIN
Allergien
-
Vorherige Impfungen
-

VAERS 1320383

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6842BA

gering
Staat
MD
Alter
0,2
Geschlecht
M
Eingang
15.05.2021
Impfdatum
06.04.2021
Beginn
06.04.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Inappropriate schedule of product administration Product preparation issue

Symptomtext

Patient received only received the IPV and DTAP and not the HIB portion, while patient received a first dose of PENTACEL with no AE; Initial information regarding an unsolicited valid non-serious case was received from the other health professional (nurse) via Agency (Reference number- 00577561) and transmitted to Sanofi on 26-Apr-2021. This case involves a 2 month old male patient who only received the IPV and DTAP and not the HIB portion, while patient received a first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [lot number: U6842BA, expiry date: 05-Jul-2021 and other dosing details were not reported] on 06-Apr-2021 for prophylactic vaccination (product preparation issue). Medical history, medical treatment, vaccination and family history were not reported. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE), PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE). It was a case of actual medication error due to inappropriate reconstitution technique. (Latency: same day) It was reported that, while doing inventory, reporter discovered an extra vial of Act HIB in a Pentacel box. It was also reported that, recently the have had vaccinated 2 children in last 2-3 weeks with Pentacel but they could not tell which child only got the IPV/DTaP vial and not the powder Act HIB vial. At the time of reporting, reporter was not sure that, the patient details reported for child that one if only IPV/DTAP portion and not the HIB portion of Pentacel or not. Reporter said one option was to do titer but not sure they will be accurate, but the patient was only 2 months old, so reporter prefer not to do a blood draw. 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
Inappropriate schedule of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1255766

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6842BA

gering
Staat
NC
Alter
0,2
Geschlecht
F
Eingang
25.04.2021
Impfdatum
23.03.2021
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

Patient adminstered Pentacel without mixing the Hib component powder with no AE; Initial information regarding an unsolicited valid non serious case was received from a other health professional via Agency (Reference number- 00537013) and transmitted to Sanofi on 26-Mar-2021. This case involves a 63 days old female patient who administered 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without mixing the Hib component (Lot U6842BA and UJ336AA expiry date 05-Jul-2021) once via Intramuscular in right thigh for prophylactic vaccination on 23-Mar-2021,(Product preparation issue). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and HEPATITIS B VACCINE (HEPATITIS B VACCINE) for prophylactic vaccination. It was a case of an actual medication error due to inappropriate reconstitution technique (latency same day). Health care professional reported that patient was given Pentacel without the Hib component. 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
-
Allergien
-
Vorherige Impfungen
-

VAERS 982052

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6842BA

gering
Staat
MA
Alter
0,5
Geschlecht
F
Eingang
28.01.2021
Impfdatum
04.01.2021
Beginn
04.01.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation issue

Symptomtext

patient was given the diluent DTaP-IPV portion of Pentacel in the left deltoid without mixing with the Hib powder portion/no AE; Initial information regarding an unsolicited valid non-serious case via Medical Information (Reference number- 00431824) was received from an other health professional and transmitted to Sanofi on 15-Jan-2021. This case involved a six-month-old female patient who was given 0.5 ml of the diluent dtap-ipv portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: U6842BA and expiry date: 05-Jul-2021) on 04-Jan-2021 via unknown route in the left deltoid for prophylactic vaccination without mixing with the Hib powder portion (Product preparation issue). Relevant medical history, past medical treatment, vaccination details and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) both for prophylactic vaccination. The patient did not receive the Hib portion at all. The practice is aware of the video and has their staff review it annually. The caller stated that in this case, the mistake was human error and they are reviewing details to determine the contributing causes. The caller stated that in addition to this event, the same situation happened once before, a few years ago. Details were not asked for the previous case, as it was a few years ago. The caller was not at the location of the office today and was not able to pull the actual product for the lots numbers from other components). Administering physician Vaccine was administered by a Medical Assistant. Product used : Used First time product used : No Still using product : No. It was an actual medication error case due to Inappropriate reconstitution technique (latency same day). At the time of reporting, 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 holders 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
Product preparation issue
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
ROTAVIRUS VACCINE; PREVNAR 13
Allergien
-
Vorherige Impfungen
-

VAERS 957469

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge U6842BA

gering
Staat
NH
Alter
0,2
Geschlecht
F
Eingang
20.01.2021
Impfdatum
12.01.2021
Beginn
12.01.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product administration error Product preparation error

Symptomtext

8 week old infant received the PENTACEL but it was not mixed, the liquid part was given and not the powder with no adverse event; 8 week old infant received the PENTACEL but it was not mixed, the liquid part was given and not the powder with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from a other health professional and transmitted to Sanofi on 12-Jan-2021. The case involved an 8 week old infant patient who received the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (DTap Lot Number: U6842BA, expiration Date: 05-Jul-2021, ACTHIB Lot Number: UJ336AA, expiration Date: 05-Jul-2021, Carton Lot Number: UJ336AAA, expiration Date :2021-07-05) via intramuscular route in the right thigh for prophylactic vaccination on 12-Jan-2021, but it was not mixed, the liquid part was given and not the powder (product administration error and product preparation issue). Relevant medical history, past medical treatment, vaccination details and family history were not provided. Concomitant medications included HEPATITIS B VACCINE; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE. It was a case of actual medication error due to product administration error and inappropriate reconstitution technique. At the time of reporting, no adverse event was reported. The reporter wanted to know the corrective measure to fix this and information about the patient next date to come. This suspected adverse reaction report was 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 was 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 had contributed to or was 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; PREVNAR 13; ROTAVIRUS VACCINE
Allergien
-
Vorherige Impfungen
-