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Reporte zur Charge UJ635AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

10Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
MA 2 MD 1 WV 1 GA 1 VA 1 WI 1 PA 1 NM 1 OH 1

VAERS 2366292

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ635AA

mild
Staat
MD
Alter
0,5
Geschlecht
F
Eingang
12.07.2022
Impfdatum
11.07.2022
Beginn
11.07.2022
Tage bis Beginn
0,0
Dosis
7+
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Influenza virus test Pyrexia Respiratory syncytial virus test SARS-CoV-2 test

Symptomtext

Child developed high fevers several hours after vaccines were given.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
Child checked for covid, flu and RSV at follow up visit.
Aktuelle Erkrankungen
6/10/2022 URI
Vorgeschichte
none
Andere Medikamente
-
Allergien
No known allergies
Vorherige Impfungen
-

VAERS 2320587

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ635AA

mild
Staat
WV
Alter
49,0
Geschlecht
F
Eingang
15.06.2022
Impfdatum
09.06.2022
Beginn
09.06.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Chills Injection site erythema Myalgia Pain Pain in extremity Pyrexia

Symptomtext

Client contacted clinic on 6/13/2022 to report symptoms. States the evening she received her vaccines, she experienced fever, chills, pain, muscle aches. By Saturday, June 11, her left arm began to hurt and she noticed one thick, red streak from her shot site moving up toward her shoulder. Over the weekend, she took hot showers and used the heating pad to assist with the body aches. States no relief; states Monday morning (6/13/22) took Tylenol (states, even though I'm not supposed to, I took a dose of Tylenol). States she reviewed the VIS statement that were provided during the vaccine visit. Reviewed again during phone call. Explained that most of the symptoms she was explaining are common, even the sore arm, however, a red streak is not and instructed client to contact her PMD for evaluation and guidance. Voiced understanding. Client is receiving vaccines for pre-liver transplant needs.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Chills
Hospital-Tage
-
Labordaten
Is to contact her PMD for appointment.
Aktuelle Erkrankungen
None
Vorgeschichte
NASH Cirrhosis
Andere Medikamente
Unknown
Allergien
Naprosyn - vomiting
Vorherige Impfungen
-

VAERS 2298557

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ635AA

mild
Staat
GA
Alter
1,0
Geschlecht
M
Eingang
25.05.2022
Impfdatum
24.05.2022
Beginn
24.05.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Injection site erythema Injection site warmth

Symptomtext

Patient left facility with mother after about 2 hours returned with redness to back of left thigh. Thigh was a little warm to touch but not hot. Patient was not in any pain or distress. Dr. examined the area push on the leg no sign of pain in patient. Dr advise to put cold compress on sight and to com back for observation.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site erythema
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2544172

UNKNOWN MANUFACTURER · HIB (NO BRAND NAME) · Charge UJ635AA

gering
Staat
MA
Alter
-
Geschlecht
M
Eingang
28.12.2022
Impfdatum
06.07.2022
Beginn
06.07.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered

Symptomtext

Had given Vaxelis and had also given a dose on HIB that did not need to be given; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2359757-1. The original narrative from the sender is the following: When I was documenting the vaccines given I then realize that I had given Vaxelis and had also given a dose on HIB that did not need to be given. The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Had given Vaxelis and had also given a dose on HIB that did not need to be given". No further information is expected.

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

VAERS 2539142

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ635AA

gering
Staat
VA
Alter
0,2
Geschlecht
M
Eingang
21.12.2022
Impfdatum
19.12.2022
Beginn
19.12.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Expired product administered

Symptomtext

Patient received HIB vaccine in office that had a good expiration date on the actual vaccine and an expired date on the diluent. Manufacturer contacted and HIB vaccine is invalid due to diluent beyond use date. Patients mother contacted and is aware of the expired vaccine that was given and that the dose given is therefore invalid.

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

VAERS 2529457

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ635AA

gering
Staat
WI
Alter
0,3
Geschlecht
M
Eingang
13.12.2022
Impfdatum
07.12.2022
Beginn
07.12.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error No adverse event

Symptomtext

an expired diluent was used to reconstitute ACTHIB and administered to a patient with no adverse event; an expired diluent was used to reconstitute ACTHIB and administered to a patient with no adverse event; Initial information was received on 07-Dec-2022 regarding an unsolicited valid non-serious case received from a healthcare professional. This case involves a 3 months old male patient and reporter reported that an expired diluent was used to reconstitute HIB (PRP/T) vaccine [ACT-HIB] and administered to a patient with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Dec-2022, an expired diluent (lot number: U7178AA; Expiry date: 30-Nov-2022) was used to reconstitute 0.5 ml of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection (lot UJ635AA, expiry date for product: 27-Jan-2023) via intramuscular route in the right leg for immunization and administered to a patient with no adverse event (expired product administered) and (product preparation error) (latency: same day). Action taken: Not applicable. Corrective treatment: Not reported for both the events. Outcome: Unknown for both the events. 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2359757

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ635AA

gering
Staat
MA
Alter
0,5
Geschlecht
M
Eingang
06.07.2022
Impfdatum
06.07.2022
Beginn
06.07.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered

Symptomtext

When I was documenting the vaccines given I then realize that I had given Vaxelis and had also given a dose on HIB that did not need to be given.

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

VAERS 2309783

SANOFI PASTEUR · HIB (ACTHIB) · Charge uj635aa

gering
Staat
PA
Alter
1,3
Geschlecht
F
Eingang
06.06.2022
Impfdatum
12.05.2022
Beginn
12.05.2022
Tage bis Beginn
0,0
Dosis
3
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation issue

Symptomtext

administered the vaccine but it was reconstituted with sterile water instead of the supplied diluent with no reported adverse event; Initial information received on 17-May-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 16 months old female patient who administered the vaccine but it was reconstituted with sterile water instead of the supplied diluent with no reported adverse event while receiving vaccines DTAP and HIB (PRP/T) vaccine [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-May-2022, the patient received a 3rd series of 0.5ml dose of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection (lot: uj635aa, expiry: 27-Jan-2023) via intramuscular route in the right thigh for Immunization. On an unknown date, the patient received a dose of suspect DTAP not produced by Sanofi Pasteur (strength, form, dose, route, lot number, expiry not reported) on an unknown administration site for Prophylactic vaccination. On 12-May-2022 the patient experienced administered the vaccine but it was reconstituted with sterile water instead of the supplied diluent with no reported adverse event (product preparation error) (Latency: same day with respect of HIB (PRP/T) vaccine and unknown for DTAP) Action taken: not applicable for both the suspects. 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
Product preparation issue
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2267197

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ635AA

gering
Staat
NM
Alter
-
Geschlecht
M
Eingang
09.05.2022
Impfdatum
02.05.2022
Beginn
02.05.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product packaging issue Product preparation error

Symptomtext

situation is reported as a medication error due to a stand alone Hib being reconstituted by the DTaP-IPV and administered with no adverse event; Initial information received on 02-May-2022 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 19 month old male patient who had medication error due to a stand-alone hib being reconstituted by the dtap-ipv and administered with no adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-May-2022, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (lot UJ635AA,Expiration Date :2023-01-27 Lot Number:UJ594ABA,Expiration Date :2022-12-18 Lot Number:U7054AA,Expiration Date :2022-12-18 expiry date: unknown) via intramuscular route in the left upper thigh as immunization. On 02-MAY-2022 the patient developed a non-serious "situation is reported as a medication error due to a stand alone hib being reconstituted by the dtap-ipv and administered with no adverse event (product preparation issue)". It was reported "The Nurse called regarding PENTACEL. She reconstituted the Hib lyophilized powder with the DTaP-IPV that was in the box, however when she checked the Lot Number of the Hib vial, it did not match the box or her inventory number and also didn't say "Part of Pentacel" as she has normally seen. The PENTACEL was administered to a patient this morning on 2MAY2022. Caller wants to know what to do. 2MAY2022 @ 1221: Caller had patient waiting and asked to be called back with information. 2MAY2022@ 1306pm: Outbound made to original caller (disclaimer given to receptionist and caller). AE and PTC information was gathered from caller. This situation is reported as a medication error due to a stand alone Hib being reconstituted by the DTaP-IPV and administered. Caller states this was a brand new unopened box and doesn't believe anyone switched the Hib portion out of the box for a stand alone vial. Caller states they have other unopened PENTACEL boxes that they will keep an eye out for this issue when opening. She did administer the PENTACEL to a patient. Number of units affected: This is the only they're aware of. They have all new boxes that are unopened. Information to be gathered on the type of needle that was used by the end-user (e.g. gauge size) 25 gauge 1 inch Different lots in same box." Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable. It was not reported if the patient received a corrective treatment for the event (situation is reported as a medication error due to a stand alone Hib being reconstituted by the DTaP-IPV and administered with no adverse event). At time of reporting, the outcome was Unknown for the event situation is reported as a medication error due to a stand alone hib being reconstituted by the dtap-ipv and administered with 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 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
-
Allergien
-
Vorherige Impfungen
-

VAERS 1963583

SANOFI PASTEUR · HIB (ACTHIB) · Charge uj635aa

gering
Staat
OH
Alter
1,3
Geschlecht
F
Eingang
20.12.2021
Impfdatum
13.12.2021
Beginn
13.12.2021
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered No adverse event

Symptomtext

No symptoms or reaction. Vaccine was expired

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
no
Allergien
NKDA
Vorherige Impfungen
-