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Reporte zur Charge UJ425AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

8Reporte angezeigt
1Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
WA 2 PA 1 MA 1 NM 1 OK 1 IN 1 MI 1

VAERS 1414392

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ425AAA

kritisch
Staat
PA
Alter
0,2
Geschlecht
M
Eingang
21.06.2021
Impfdatum
08.06.2021
Beginn
11.06.2021
Tage bis Beginn
3,0
Dosis
1
Route/Site
IM / RL
Tod: ja Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Respiratory arrest

Symptomtext

Ceased to breathe on 6/11/21

Weitere VAERSDATA-Felder
Praegender Schweregrund
Respiratory arrest
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
unknown
Allergien
nka
Vorherige Impfungen
-

VAERS 2602062

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge UJ425AAA

mild
Staat
MA
Alter
0,2
Geschlecht
M
Eingang
25.10.2021
Impfdatum
13.08.2021
Beginn
13.08.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LG
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: unbekannt
Crying Hypersensitivity Injection site reaction Injection site swelling Pyrexia Vaccination site swelling Vomiting

Symptomtext

After being vaccinated, he was crying a lot for almost 2 hrs. He developed fever, started vomiting, and his left leg was swollen like a potato, from thigh down the leg. He was taken to the ED and were informed that he had an "allergic reaction" more than expected. REVIEW-> He was seen at ED on 8/13. Found to have left more than right thigh swelling, status post getting his 2-month vaccine today. No change in breathing and no body rash. On PE, vitals were normal. Mild localized swelling around the vaccination site on both thighs. Assessment was "No concern for allergic reaction, as expected post vaccine reaction," and discharged. In addition, there is a discrepancy in the chart in terms of where the vaccines were administered. On chart review- received PCV and Td/HIB/IPV L thigh, R thigh HBV. However, parents recall and provide photos for me to review which demonstrate that he received 2 vaccines on his right thigh and 1 vaccine on his left. Discrepancy in chart vs parent report regarding which vaccines were received in which thigh, however given that this was likely a site reaction and not an allergic reaction, largely reassured parents and will follow up regarding discrepancy of documentation of 2mo vaccines.

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

VAERS 1490703

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ425AAA

mild
Staat
WA
Alter
1,5
Geschlecht
F
Eingang
21.07.2021
Impfdatum
16.07.2021
Beginn
16.07.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Erythema Injection site erythema Pyrexia Skin warm Swelling

Symptomtext

7/19/21 EHR visit note Immunization Reaction pt here with mom for a reaction to imms from friday. friday evening fevers til saturday now redness warm to touch and swelling. it has improved. patient did not die unable to uncheck the box Mother noted redness on the left anterior thigh where Patient had 2 vaccines on Friday evening 7/16/21. He spiked a 101 degree on Friday night to Saturday. The fever has resolved. The redness is still present. Hurts when it is touched. No other symptoms. He is walking well. Patient had fever and he had redness around the vaccine shot on the left anterior thigh. Discussed that this is due to a local reaction to vaccine-most likely due to the Pentacel . He had Pentacel and Hep A on the left thigh and Varivax on the right thigh. Give Benadryl 12.5 mg q 6-8 hrs until the redness is gone.Recheck if with worsening symptoms. Tylenol 1 tsp q 4 hours as needed for fever or pain. Has not returned to clinic appointment 7/20/21 canceled

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
EHR note from 7/16/21 visit: Parental concerns: Denies acute concerns; but wants to mention has been gagging, and clearing of the throat- just questioning if allergies or something else. Lately, he seems to be clearing his throat. No fever or cough. His brother has allergies. Mother wants him tested for allergies
Vorgeschichte
-
Andere Medikamente
-
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2356761

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ425AAA

gering
Staat
WA
Alter
2,0
Geschlecht
M
Eingang
03.07.2022
Impfdatum
21.06.2022
Beginn
21.06.2022
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

Symptomtext

calling in regards to expired pentacel/therapy date: 21Jun2022 with no other reported adverse event; Initial information received on 22-Jun-2022 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 2 years old male patient who was administered expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] with no other reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation. On 21-Jun-2022, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (lot number: UJ425AAA, expiry date: 21-May-2022; formulation, strength and route not reported) for immunization. On 21-JUN-2022 the patient was administered expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] with no other reported (expired product administered). Action taken was not applicable. Outcome: Unknown 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
MMR
Allergien
-
Vorherige Impfungen
-

VAERS 1824760

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ425AAA

gering
Staat
NM
Alter
-
Geschlecht
U
Eingang
28.10.2021
Impfdatum
19.10.2021
Beginn
19.10.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error Product preparation error Product preparation issue

Symptomtext

administered the DTAP-IPV liquid separately from the HIB component, HIB Component was reconstituted with Merck live virus sterile water, then administered to the patient with no AE; Initial information was received on 20-Oct-2021 regarding an unsolicited valid non-serious case received from pharmacist and physician via the Medical Information under reference number- 00821046. This case involves a patient of (unknown demographics) who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] that was reconstituted with dtap-ipv liquid separately from the hib component, hib component was reconstituted with merck live virus sterile water (Product preparation issue). The patient's medical history, past medical treatment(s), vaccination(s), concomitant therapy(s) and family history were not provided. Concomitant medications included WATER FOR INJECTION (STERILE WATER). On 19-Oct-2021, the patient received a 0.5ml {total} dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number UJ425AAA and expiry date 21-May-2022 was reported) via an unknown route at an unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to wrong solution used in drug reconstitution (latency was on same day). At the time of report, no adverse event reported. Outcome of event was unknown. 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
STERILE WATER
Allergien
-
Vorherige Impfungen
-

VAERS 1553734

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ425AAA

gering
Staat
OK
Alter
4,0
Geschlecht
F
Eingang
13.08.2021
Impfdatum
12.08.2021
Beginn
12.08.2021
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Extra dose administered Wrong product administered

Symptomtext

PATIENT ACCIDENTLY GIVEN PENTACEL INSTEAD OF ACTHIB - THEREFORE PATIENT RECEIVED AN EXTRA DTAP AND AN EXTRA IPV THAT DAY. PARENT NOTIFIED VIA SPANISH TRANSLATION.

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

VAERS 1440130

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ425AAA

gering
Staat
IN
Alter
0,3
Geschlecht
F
Eingang
01.07.2021
Impfdatum
09.06.2021
Beginn
09.06.2021
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Inappropriate schedule of product administration No adverse event

Symptomtext

baby was received a PENTACEL vaccine, medical assistant administered the DTaP-IPV portion only due to misunderstanding/ no AE; DTaP-IPV portion twice within 2 days/ no AE; Initial information was received on 23-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Agency (Reference number- 00653789) and transmitted to Sanofi on 23-Jun-2021. This case involves a four-month-old female patient who was vaccinated with 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number UJ425AAA, expiry date not reported) via intramuscular route in left thigh on 09-Jun-2021 for prophylactic vaccination and DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE [lot number not reported and expiry date not reported] via unknown route on an administration site on an unknown date for prophylactic vaccination and reported that baby was received a PENTACEL vaccine, medical assistant administered the DTaP-IPV portion only due to misunderstanding with no adverse event (product preparation issue) and DTaP-IPV portion twice within 2 days with no adverse event (Inappropriate schedule of product administration). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for prophylactic vaccination and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination. Caller stated PENTACEL was ordered DTAP and IPV was given not the ACTHIB. Caller stated there was a misunderstanding at the office as for the mixing, nursing staff believed that the MA had administered 0.4% saline (diluent for ActHIB) only, so a dose of PENTACEL was reconstituted appropriately and administered. Caller stated the patient came back and received the correct PENTACEL. Caller wanted to verify safety for the patient. It was a case of actual medication error due to product preparation issue and inappropriate schedule of product administration (latency was on same day). At the time of reporting, patient had 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
Inappropriate schedule of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 1371299

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ425AAA

gering
Staat
MI
Alter
1,3
Geschlecht
F
Eingang
03.06.2021
Impfdatum
02.06.2021
Beginn
03.06.2021
Tage bis Beginn
1,0
Dosis
4
Route/Site
IM / UN
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event

Symptomtext

NO ADVERSE EVENTS OCCURED AS OF NOW

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