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Reporte zur Charge UJ840AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

14Reporte angezeigt
1Todesfaelle
1Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
NJ 4 NY 3 TX 2 MI 2 NC 1 AZ 1 IN 1

VAERS 2646937

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ840AA

kritisch
Staat
NC
Alter
0,3
Geschlecht
F
Eingang
19.06.2023
Impfdatum
17.05.2023
Beginn
18.05.2023
Tage bis Beginn
1,0
Dosis
UNK
Route/Site
IM / RL
Tod: ja Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Death Respiratory arrest Resuscitation Unresponsive to stimuli

Symptomtext

PCP office notified of deceased patient on 5/18/2023. Per ED documents, patient was brought in unresponsive, CPR in progress. Also noted, 2-year-old found lying on top of the patient and patient was not breathing. PCP office instructed by Risk Management department to file VAERS report on 6/19/2023.

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

VAERS 2661303

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ840AA

mild
Staat
AZ
Alter
0,4
Geschlecht
F
Eingang
26.07.2023
Impfdatum
24.07.2023
Beginn
25.07.2023
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Erythema Injection site mass Injection site warmth Pyrexia Urticaria

Symptomtext

At time of visit after waiting 5 minutes pt appeared to not have any adverse reactions. Parent states about 24 hours later pt began to have hives, low grade fever, and redness on both cheeks but more red on left side. Left thigh were PCV13 was given is warm to touch and has small lump. PT came in office to have provider look at reaction. provider plan of treatment is to apply cool compresses to thigh and face, gave instructions on what signs to look out for in case pt needs to be seen at an ER . parents agree w plan of care.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site mass
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
N/A
Vorgeschichte
N/A
Andere Medikamente
N/A
Allergien
no known allergies
Vorherige Impfungen
-

VAERS 2654774

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ840AA

mild
Staat
NY
Alter
1,3
Geschlecht
M
Eingang
11.07.2023
Impfdatum
29.06.2023
Beginn
30.06.2023
Tage bis Beginn
1,0
Dosis
4
Route/Site
- / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site erythema Injection site swelling Injection site warmth

Symptomtext

Patient presented with 9cm x 4cm of warmth, swelling, erythema at site of Pentacel injection about 48 hours prior

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
Encephaloceple, Chiari Type 1 malformation
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2637545

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge uj840AA

mild
Staat
TX
Alter
-
Geschlecht
F
Eingang
26.05.2023
Impfdatum
24.05.2023
Beginn
25.05.2023
Tage bis Beginn
1,0
Dosis
UNK
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site cellulitis

Symptomtext

The day following immunization administration, the patient developed cellulitis to bilateral thighs at injections sites.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site cellulitis
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
No known allergies
Vorherige Impfungen
-

VAERS 2620292

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ840AA

mild
Staat
NJ
Alter
0,2
Geschlecht
M
Eingang
24.04.2023
Impfdatum
17.04.2023
Beginn
22.04.2023
Tage bis Beginn
5,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: ja Erholt: ja
Crying Diarrhoea Faeces discoloured Food refusal Infant irritability Infantile spitting up Intestinal operation Intussusception Musculoskeletal stiffness Occult blood positive Procedural failure Ultrasound abdomen abnormal

Symptomtext

Patient was fussy starting Saturday, April 22, 2023, spitting up, has diarrhea and is refusing to eat; patient was crying intermittently, fussy and stiffening at 4/23/2023 visit; patient has been afebrile. Viewed the patient's diaper - there was urine in the front and red/pink in the back and the stool was positive for occult blood (POCT done in office 4/23/2023). Patient was referred to emergency room - was diagnosed with intussusception; failed reduction by radiology, successfully reduced in OR.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Diarrhoea
Hospital-Tage
-
Labordaten
POCT OCCULT BLOOD STOOL; ABDOMINAL ULTRASOUND
Aktuelle Erkrankungen
None reflected on file.
Vorgeschichte
None reflected on file.
Andere Medikamente
Vitamin D3 400 Units 1ml once a day.
Allergien
None reflected on file.
Vorherige Impfungen
-

VAERS 2708643

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ840AA

gering
Staat
MI
Alter
4,0
Geschlecht
M
Eingang
02.11.2023
Impfdatum
19.10.2023
Beginn
19.10.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Product preparation error Underdose

Symptomtext

patient only received half of the vaccine. Was not mixed properly.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product preparation error
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2700599

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ840AA

gering
Staat
IN
Alter
0,3
Geschlecht
M
Eingang
24.10.2023
Impfdatum
12.10.2023
Beginn
12.10.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect dose administered No adverse event Product preparation error Product storage error

Symptomtext

nurse only gave the DTaP-IPV portion of Pentacel with no reported adverse event; Initial information received on 13-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 4 months old male patient for whom nurse only gave the DTAP-IPV portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] 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 rotavirus vaccine and pneumococcal vaccine for Prophylactic vaccination (Immunisation). On 12-Oct-2023, the patient received a standard dose 2 of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection at a dose of 0.5 ml total (lot UJ840AA, expiry date- 16-FEB-2024) via intramuscular route in the left thigh for Immunization. On 12-OCT-2023, the nurse only gave the DTAP-IPV portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine with no reported adverse event (single component of a two-component product administered) (latency- same day). Reportedly, Site manager reports that a nurse grabbed PENTACEL, and she did not reconstituted the DTaP-IPV portion into the HIB portion; reports that the nurse only gave the DTaP-IPV portion. She asks what they should do? She asks how much 0.4% NaCl (sodium chloride) should be used to dilute the HIB portion of Pentacel? Site manager reports that the HIB portion of the PENTACEL has been left out of the refrigerator since yesterday around 3:30PM; reports that excursion lasted around 17 hours and reached a maximum temperature of 70F; she asks for stability information. This excursion is covered by the extended stability data. Site manager asks if she can order just the 0.4% NaCl saline diluent. Treatment -no treatment Action taken was not applicable. 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 and Regulatory Authority 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
Incorrect dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
ROTAVIRUS VACCINE; PNEUMOCOCCAL VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2683523

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ840AA

gering
Staat
NY
Alter
1,5
Geschlecht
F
Eingang
19.09.2023
Impfdatum
23.08.2023
Beginn
23.08.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Unevaluable event

Symptomtext

n/a

Weitere VAERSDATA-Felder
Praegender Schweregrund
Unevaluable event
Hospital-Tage
-
Labordaten
n/a
Aktuelle Erkrankungen
n/a
Vorgeschichte
n/a
Andere Medikamente
n/a
Allergien
n/a
Vorherige Impfungen
-

VAERS 2683490

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ840AA

gering
Staat
NY
Alter
0,4
Geschlecht
M
Eingang
19.09.2023
Impfdatum
23.08.2023
Beginn
23.08.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Unevaluable event

Symptomtext

n/a

Weitere VAERSDATA-Felder
Praegender Schweregrund
Unevaluable event
Hospital-Tage
-
Labordaten
n/a
Aktuelle Erkrankungen
n/a
Vorgeschichte
n/a
Andere Medikamente
n/a
Allergien
n/a
Vorherige Impfungen
-

VAERS 2677500

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ840AA

gering
Staat
NJ
Alter
0,5
Geschlecht
M
Eingang
29.08.2023
Impfdatum
01.05.2023
Beginn
01.05.2023
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Expired product administered No adverse event

Symptomtext

Vaccine was administered after the BUD. Parent has not reported any adverse reactions

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2652507

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ840AA

gering
Staat
NJ
Alter
1,0
Geschlecht
M
Eingang
05.07.2023
Impfdatum
30.06.2023
Beginn
30.06.2023
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 Single component of a two-component product administered

Symptomtext

received only the lyophilized component,Hib portion of the PENTACEL product, with no reported adverse event; Initial information received on 30-Jun-2023 regarding an unsolicited valid non-serious case received via other health professional. This case involves a 1-year-old male patient who had received only the lyophilized component,hib portion of the pentacel product, with no reported adverse event after receiving diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)]. 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 Prophylactic vaccination. On 30-Jun-2023, the patient received a total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot: UJ840AA) via intramuscular route in unknown administration site for Immunization. On 30-Jun-2023 the patient had event of received only the lyophilized component,hib portion of the pentacel product, with no reported adverse event (single component of a two-component product administered) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine. It was unknown if any lab data/tests available. Action taken with diphtheria, tetanus, AC pertussis, IPV AND HIB vaccine (Pentacel (Vero)) 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 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 2652506

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ840AA

gering
Staat
NJ
Alter
1,3
Geschlecht
M
Eingang
05.07.2023
Impfdatum
30.06.2023
Beginn
30.06.2023
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 Single component of a two-component product administered

Symptomtext

received only the liquid, DTaP-IPV portion of the PENTACEL product with no reported adverse event; Initial information received on 30-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 15 months old male patient who had received only the liquid, DTAP-IPV portion of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] product 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 hepatitis A vaccine (Hepatitis A vaccine) for prophylactic vaccination; and measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination. On 30-Jun-2023, the patient received only the liquid, DTAP-IPV portion of a standard total dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ840AA, expiry date: 16-Feb-2024) via intramuscular route in left leg for Immunization with no reported adverse event (single component of a two-component product administered) (latency- same day). Reportedly, Caller asks what's the medication or ingredient in the PENTACEL's vial (diluent) and powder? Another staff member, stated the reason they ask is because it was administered separately instead of together and to 2 different patients. Should they repeat the dose? Should they wait? Is there any harm in the patient receiving a partial or inactive dose? Action taken was not applicable. 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.; Sender's Comments: US-SA-2023SA203212:01674842

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

VAERS 2644339

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ840AA

gering
Staat
TX
Alter
-
Geschlecht
U
Eingang
13.06.2023
Impfdatum
05.06.2023
Beginn
05.06.2023
Tage bis Beginn
0,0
Dosis
3
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

dose that was given only contained the liquid vaccine component without the lyophilized vaccine component, with no reported adverse event; Initial information was received on 06-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 6 months old and unknown gender patient who experienced dose that was given only contained the liquid vaccine component without the lyophilized vaccine component, with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (vero)]. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 05-Jun-2023, the patient received 0.5 ml once dose 3 of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(vero)/HIB(PRP/T) vaccine (lot number: UJ840AA, expiration date: 16-Feb-2024) via intramuscular route in the right thigh for Immunization (immunisation). On 05-Jun-2023 the patient developed a non-serious event of "dose that was given only contained the liquid vaccine component without the lyophilized vaccine component, with no reported adverse event" (product preparation error) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine. It was reported "about a PENTACEL that was administered by a nurse to a pediatric patient. The dose that was given only contained the liquid vaccine component (DTAP-IPV component) without the lyophilized vaccine component. She also wanted to know what to do next. Gender was unable to report during the call." No lab data reported. Action taken: not applicable. Outcome: Unknown for the event dose that was given only contained the liquid vaccine component without the lyophilized vaccine component, 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 2641860

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ840AA

gering
Staat
MI
Alter
-
Geschlecht
U
Eingang
06.06.2023
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Poor quality product administered Product storage error

Symptomtext

received vaccines after a temperature excursion with no reported adverse event; Initial information received on 02-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves at 6 patients received vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] temperature excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection expiry date not reported lot UJ840AA via unknown route in unknown administration site for prophylactic vaccination (immunization). On an unknown date the patient developed a non-serious received vaccines after a temperature excursion with no reported adverse event (poor quality product administered) on the same day following the administration of IPV (VERO). It was reported "The batteries went bad Max/low temperature reached: Negative 4.8C Human error? No Does extended stability data cover the excursion? No If negative advice, was the product administered to a patient? Yes". Action taken was not applicable. At time of reporting, the outcome was Unknown for the event received vaccines after a temperature excursion 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-