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Reporte zur Charge UJ792AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

14Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
TX 3 PA 3 MO 2 NJ 2 MI 1 GA 1 IL 1 MA 1

VAERS 2652071

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ792AA

mild
Staat
TX
Alter
2,0
Geschlecht
M
Eingang
03.07.2023
Impfdatum
30.06.2023
Beginn
01.07.2023
Tage bis Beginn
1,0
Dosis
4
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Erythema Immunisation reaction Injection site warmth Nodule

Symptomtext

Patient came in on June 30,2023 and received the three vaccines listed above. Patient started experiencing symptoms on July 01,2023. The symptoms displayed were fever in the area of vaccination (left thigh) and a red knot on the patients thigh which was sensitive to touch. Over the weekend the symptoms progressed. On July 03,2023 mother called to have the patient seen in the clinic. Patient was seen by PA where he diagnosed adverse effect of vaccine. Patient was prescribed Benadryl allergy liquid and Cefdinir. Mother was also educated on the vaccine reaction. Follow up was scheduled for July 06,2023.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site warmth
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
During the visit patient was also seen for excess foreskin after circumcision and a head injury
Vorgeschichte
none listed
Andere Medikamente
Ibuprofen was be taken by the patient at the time of the vaccination. Ibuprofen Suspension, 100 MG/5ML, 6.5 mL, Orally, Three times a day, 2 days, 39 ML, Refills 0
Allergien
No known allergies
Vorherige Impfungen
-

VAERS 2714038

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ792AA

gering
Staat
MI
Alter
3,0
Geschlecht
F
Eingang
15.11.2023
Impfdatum
14.11.2023
Beginn
14.11.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered

Symptomtext

When entering vaccine into our EMR system I got an alert the vaccine had expired 10/6/2023. No treatment performed for this. Pt mother who brought her to the appointment was informed of the mishap and that the dose would need to be re administered as an expired dose does not count. Pt mother was understanding of having to repeat the Hib vaccine. I also informed one of our office's vaccine leads so they could pull the expired Hib vaccine from our stock to ensure this did not happen again.

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 2705779

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ792AA

gering
Staat
MO
Alter
0,2
Geschlecht
M
Eingang
30.10.2023
Impfdatum
30.10.2023
Beginn
30.10.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered

Symptomtext

Expired

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 2698866

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ792AA

gering
Staat
PA
Alter
-
Geschlecht
U
Eingang
19.10.2023
Impfdatum
11.10.2023
Beginn
11.10.2023
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 No adverse event

Symptomtext

administration of expired ACTHIB to a patient with no adverse event; Initial information received on 11-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and unknown gender patient who got administration of expired to a vaccine HIB (PRP/T) VACCINE [ACT-HIB] to patient with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 11-Oct-2023, the patient received a dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection (lot- UJ792AA and expiration date- 06-Oct-23) via unknown route in unknown administration site (dose, frequency, route, strength,: not provided) for Immunisation (expired product administered) (latency- same day). Action taken- 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.

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

VAERS 2696300

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ792AA

gering
Staat
NJ
Alter
1,8
Geschlecht
U
Eingang
16.10.2023
Impfdatum
09.10.2023
Beginn
09.10.2023
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 No adverse event

Symptomtext

expired ACT-HIB dose was administered to a patient with no adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 21-months-old and unknown gender patient who was administered expired HIB (PRP/T) vaccine [ACT-HIB] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Oct-2023, the patient received an unknown expired dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (batch number: UJ792AA; expiry date: 06-Oct-2023) (Strength: standard; Frequency: Once) via unknown route in unknown administration site for Immunization with no adverse event (expired product administered) (same day latency). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event. No additional information available at time of call; caller declined to respond to questions and has accepted follow-up. 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
-
Allergien
-
Vorherige Impfungen
-

VAERS 2696298

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ792AA

gering
Staat
MO
Alter
0,2
Geschlecht
M
Eingang
16.10.2023
Impfdatum
09.10.2023
Beginn
09.10.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

expired dose of ACTHIB was inadvertently administered with no adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves 2 months old male patient who was administered expired dose of HIB (PRP/T) vaccine [ACT-HIB] inadvertently with no 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); and Diphtheria vaccine Toxoid, Hepatitis B vaccine RHBSAG (YEAST), Pertussis vaccine Acellular 3-Component, Polio vaccine INACT 3V (VERO), Tetanus vaccine toxoid (PEDIARIX) for Immunisation. On 09-Oct-2023, the patient received 0.5 ml expired dose (dose 1) (frequency: once; strength: Standard) of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of lot UJ792AA and expiry: 06-Oct-2023 via intramuscular route in the left thigh for immunization, with no reported adverse event (expired product administered) (Latency: same day). No lab data was reported. Action taken was not applicable. At time of reporting, the outcome 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PREVNAR 13; PEDIARIX
Allergien
-
Vorherige Impfungen
-

VAERS 2693972

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ792AA

gering
Staat
NJ
Alter
1,8
Geschlecht
M
Eingang
11.10.2023
Impfdatum
09.10.2023
Beginn
09.10.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Expired product administered

Symptomtext

Vaccine given had expired on 10/6/2023

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

VAERS 2632257

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ792AA

gering
Staat
PA
Alter
-
Geschlecht
F
Eingang
02.10.2023
Impfdatum
10.05.2023
Beginn
10.05.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Wrong product administered

Symptomtext

On 10-May-2023 the patient administered VAXELIS instead of giving act-hib as a stand-alone vaccine with no adverse event; On 10-May-2023 the patient administered VAXELIS instead of giving act-hib as a stand-alone vaccine with no adverse event; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2632257-1. The original narrative from the sender is the following: using vaxelis instead of giving act-hib as a stand-alone vaccine with no adverse event; Initial information received on 10-May-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 2 months old female patient who had been administered VAXELIS instead of giving HIB (PRP/T) VACCINE [ACT-HIB] as a stand-alone vaccine with no 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) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination. On 10-May-2023, the patient received a dose 1 at a dose of 0.5 ml suspect HIB (PRP/T) VACCINE for Powder and solvent for solution for injection (with an unknown frequency, strength, expiry date, lot UJ792AA) via intramuscular route in unknown administration site for immunization (immunisation). On an unknown date, the patient received suspect VAXELIS not produced by Sanofi Pasteur (with an unknown dosage, formulation, frequency, strength, expiry date, lot number) via unknown route in unknown administration site for prophylactic vaccination (immunization). On 10-May-2023 the patient administered VAXELIS instead of giving act-hib as a stand-alone vaccine with no adverse event (wrong product administered) (latency: same day) . Action taken: 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 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. The causal relationship between Vaxelis and the event "On 10-May-2023 the patient administered VAXELIS instead of giving act-hib as a stand-alone vaccine with no adverse event" was assessed as not applicable due to the nature of the reported event. No further information is expected. NI not working. Added state to Reporter State and Vaccine facility information.

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

VAERS 2632257

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ792AA

gering
Staat
PA
Alter
-
Geschlecht
F
Eingang
02.10.2023
Impfdatum
10.05.2023
Beginn
10.05.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Wrong product administered

Symptomtext

On 10-May-2023 the patient administered VAXELIS instead of giving act-hib as a stand-alone vaccine with no adverse event; On 10-May-2023 the patient administered VAXELIS instead of giving act-hib as a stand-alone vaccine with no adverse event; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2023 with the following VAERS Primary ID 2632257-1. The original narrative from the sender is the following: using vaxelis instead of giving act-hib as a stand-alone vaccine with no adverse event; Initial information received on 10-May-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 2 months old female patient who had been administered VAXELIS instead of giving HIB (PRP/T) VACCINE [ACT-HIB] as a stand-alone vaccine with no 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) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination. On 10-May-2023, the patient received a dose 1 at a dose of 0.5 ml suspect HIB (PRP/T) VACCINE for Powder and solvent for solution for injection (with an unknown frequency, strength, expiry date, lot UJ792AA) via intramuscular route in unknown administration site for immunization (immunisation). On an unknown date, the patient received suspect VAXELIS not produced by Sanofi Pasteur (with an unknown dosage, formulation, frequency, strength, expiry date, lot number) via unknown route in unknown administration site for prophylactic vaccination (immunization). On 10-May-2023 the patient administered VAXELIS instead of giving act-hib as a stand-alone vaccine with no adverse event (wrong product administered) (latency: same day) . Action taken: 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 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. The causal relationship between Vaxelis and the event "On 10-May-2023 the patient administered VAXELIS instead of giving act-hib as a stand-alone vaccine with no adverse event" was assessed as not applicable due to the nature of the reported event. No further information is expected. NI not working. Added state to Reporter State and Vaccine facility information.

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

VAERS 2669304

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ792AA

gering
Staat
GA
Alter
0,7
Geschlecht
M
Eingang
10.08.2023
Impfdatum
18.07.2023
Beginn
18.07.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Product preparation error

Symptomtext

The Hib vaccine needs to be reconstituted. However, after finding the hib powder vaccine in the box, we realized the saline was only given and the vaccine was never reconstituted.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product preparation error
Hospital-Tage
-
Labordaten
patient has not experienced any adverse effects
Aktuelle Erkrankungen
cradle cap, hydrocele, low weight percentile
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2658924

GLAXOSMITHKLINE BIOLOGICALS · HIB (HIBERIX) · Charge UJ792AA

gering
Staat
TX
Alter
0,8
Geschlecht
M
Eingang
20.07.2023
Impfdatum
07.06.2023
Beginn
07.06.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Extra dose administered

Symptomtext

Mom came in for an acute visit and brought in a hard copy of the patients immunization to be filled out with the previous vaccines that the patient received on 06/07/2023. As MA was looking over the immunization card, she noticed some previous vaccines that were not added to System. Those vaccines were given by facility on 11/01/2022. The hard copy was scanned in by our clinic to patient docs on 05/01/2023 prior or receiving 06/07/2023 vaccines. With putting in the missing vaccines it showed the patient was given double the vaccines on 06/07/2023 by MA. The vaccines are DTap, Hib, PCV and IPV. Provider spoke with mom and let her know what happened and any affects. Notes were added to the visit as well. Mom seemed to take the information as well.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
-
Andere Medikamente
none
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2657740

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ792AA

gering
Staat
IL
Alter
8,0
Geschlecht
F
Eingang
18.07.2023
Impfdatum
06.07.2023
Beginn
06.07.2023
Tage bis Beginn
0,0
Dosis
5
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Wrong product administered

Symptomtext

Patient was administered incorrect vaccine by medical assistant staff from what was ordered by doctor. No adverse events have been reported by patient's mother.

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

VAERS 2651124

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ792AA

gering
Staat
MA
Alter
0,6
Geschlecht
F
Eingang
29.06.2023
Impfdatum
27.06.2023
Beginn
27.06.2023
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event Product preparation issue

Symptomtext

HIB vaccine was not properly reconstituted, only the sterile diluent was administered. No adverse reaction for the patient.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
NA
Aktuelle Erkrankungen
NA
Vorgeschichte
NA
Andere Medikamente
Vitamin D
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2646149

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ792AA

gering
Staat
TX
Alter
2,0
Geschlecht
F
Eingang
16.06.2023
Impfdatum
09.06.2023
Beginn
09.06.2023
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 error

Symptomtext

used the recommended diluent but was not able to administer it together with the lyophilized powder with no reported adverse event; Initial information received on 12-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 years old female patient and reporter reported that she used the recommended HIB (PRP/T) VACCINE [ACT-HIB] (diluent) but was not able to administer it together with the lyophilized powder, 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 1 at a dose of 0.5 ml of suspect HIB (PRP/T) VACCINE (frequency: once, Strength: standard, expiry date: 06-Oct-2023 and lot: UJ792AA) via intramuscular route in the right thigh for immunization. On 09-Jun-2023 the patient used the recommended diluent but was not able to administer it together with the lyophilized powder, with no reported adverse event (product preparation error) (unknown latency). Action taken: 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 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
-