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Reporte zur Charge UJ678AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

15Reporte angezeigt
0Todesfaelle
1Hospitalisiert
1Lebensbedrohlich
0Bleibende Schaeden
MA 4 ID 2 CA 1 WA 1 OH 1 ME 1 VA 1

VAERS 2584766

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ678AAA

mild
Staat
CA
Alter
0,3
Geschlecht
M
Eingang
21.02.2023
Impfdatum
15.02.2023
Beginn
15.02.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Infant irritability Injection site rash Pyrexia Rash Skin warm

Symptomtext

Bumps all over body, crying and fever, received immunizations 2/15 Patient at home with mom.Patient had 4 mos vaccines ( 2nd series, OK last time) on 2/15/23.That afternoon , patient given bath with new soap with oat exract, and lotion with oatmilk and dimethicone. That night patient had fever " 105F" forehead temp , only forehead is hot , body not flushed or hot . Rx Tylenol, fever went down to 102F after 1 hr . Next day 12/16/23, no more fever , but noted rash on legs, then spreads to body today 2/17/23, few rashes on face, Slight fussy but eats OK . No other symptoms . Assessments 1. Rash and other nonspecific skin eruption - R21 (Primary) 2. Postvaccination fever - R50.83 Treatment 1. Rash and other nonspecific skin eruption Start Benadryl Allergy Liquid, 12.5 MG/5ML, 2.5 ml, Orally, every 6 hrs as needed, 7 days, 100 Notes: stop all products with dimethicone and oat extract. OK sensitive soap/ wash. ________________________________________________________ Date: 02/21/2023 Time: 08:48 AM spoke to mom to follow up on Fever/rash dicussed through video visit on 2/17 mom stated patients sxs are completely resolved picked up Benadryl rx sent on 2/17 the next day on 2/18 states fever stopped since then Rash looked better on Sunday 2/19 and woke up Monday 2/20 with rash completely resolved Mother offered no further concerns at this time.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site rash
Hospital-Tage
-
Labordaten
NONE
Aktuelle Erkrankungen
The patient was brought in by mom and grandma. Parental concerns runny nose/phlegm x 4 days. Reports with cough "little bit, not hard". Denies fever. No known sick exposure. Dry forhead. Reports bathing q 2 das with products.
Vorgeschichte
NONE
Andere Medikamente
NONE
Allergien
NONE
Vorherige Impfungen
-

VAERS 2573898

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ678AAA

mild
Staat
WA
Alter
0,3
Geschlecht
F
Eingang
01.02.2023
Impfdatum
12.01.2023
Beginn
23.01.2023
Tage bis Beginn
11,0
Dosis
UNK
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: ja Hospital: ja Disable: unbekannt ER: ja Erholt: nein
Blood culture C-reactive protein Coagulation test Full blood count Kawasaki's disease Metabolic function test Pyrexia Red blood cell sedimentation rate Urine analysis

Symptomtext

developed kawaski disease in the 2 weeks following, fevers started day of vaccination

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
2,0
Labordaten
CBC 1/30/23 BMP 1/30/23 coagulation studies 1/30/23 UA 1/30/23 ESR 1/30/23 CRP 1/30/23 Blood cultures 1/30/23
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2562194

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ678AAA

mild
Staat
OH
Alter
0,8
Geschlecht
M
Eingang
18.01.2023
Impfdatum
17.01.2023
Beginn
17.01.2023
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Rash Rash macular Urticaria

Symptomtext

Last night had some light-colored spots before bed. This morning there are red spots/rash that look like hives all over body - not on forehead or scalp. No fever or other symptoms.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Rash
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
milk allergy - vomiting
Vorherige Impfungen
-

VAERS 2562985

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ678AAA

gering
Staat
-
Alter
1,3
Geschlecht
M
Eingang
19.01.2023
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 Product preparation error

Symptomtext

product preparation error with no adverse event; Initial information received on 12-Jan-2023 regarding an unsolicited valid non-serious case received from a health professional. This case involves a 16 months old male patient who experienced product preparation error, with no adverse event after 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 an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot: UJ678AAA, Expiry date: 09-Sep-2023) via unknown route in unknown administration site (form, Strength: unknown) for Childhood vaccination. On an unknown date the patient had a product preparation error with no adverse event (product preparation error) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) 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 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
-

VAERS 2562984

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ678AAA

gering
Staat
-
Alter
0,5
Geschlecht
M
Eingang
19.01.2023
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 Product preparation issue

Symptomtext

vaccine [Pentacel] reconstituted with an unknown diluent, without the dtap-ipv component with no adverse event.; Initial information received on 12-Jan-2023 regarding an unsolicited valid non-serious case received via other health professional. This case involves a 6-month-old male patient (76 cm and 16 kg) who experienced vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] reconstituted with an unknown diluent, without the dtap-ipv component with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine suspension for injection (strength, expiry date: unknown) (lot: UJ678AAA) via unknown route in unknown administration site for Childhood vaccination. On an unknown date the patient had a non-serious event vaccine [pentacel] reconstituted with an unknown diluent, without the dtap-ipv component with no adverse event (product preparation issue) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine. Action taken with diphtheria, tetanus, AC pertussis, IPV AND HIB vaccine (pentacel) 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
Medication error
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2548567

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ678AAA

gering
Staat
MA
Alter
-
Geschlecht
U
Eingang
03.01.2023
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 Product preparation error Single component of a two-component product administered

Symptomtext

was administered the separate Hib component of the Pentacel vaccine reconstituted with an unknown diluent, without the DTaP-IPV component with no AE; was administered the separate Hib component of the Pentacel vaccine reconstituted with an unknown diluent, without the DTaP-IPV component with no AE; Initial information received on 29-Dec-2022 regarding an unsolicited non-valid non-serious case received from a other health professional. This case involves a patient of unknown age and gender who was administered the separate hib component of the diphtheria/tetanus/5 hybrid AC pertussis /IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel] reconstituted with an unknown diluent, without the dtap-ipv component with no adverse event. The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided. On an unknown date, the patient was administered an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis /IPV(MRC5)/HIB(PRP/T) vaccine, suspension for injection (strength - unknown, frequency - once, lot - UJ678AAA and expiry date -09-Sep-2023) via unknown route in unknown administration site for immunization. On an unknown date the patient was administered the separate hib component of the pentacel vaccine reconstituted with an unknown diluent, without the dtap-ipv component with no adverse event (product preparation error) (single component of a two-component product administered) (unknown latency) Reportedly, HCP stated that they discovered a box of Pentacel that still had the DTaP-IPV component, but the Hib component had been removed and administered to a patient. HCP stated that they do not know the date this happened, and they do not know which child was administered the separate Hib component of the Pentacel vaccine, without the DTaP-IPV component. They also do not know with what type of diluent the Hib component of the Pentacel vaccine was reconstituted with, prior to administration. HCP stated that they do not know which child received the Hib component of the Pentacel vaccine, but they have narrowed it down to five children, any one of whom may be the one that received the Hib component of the Pentacel vaccine, mixed with an unknown diluent. These five candidates range in age from 6 months old to 4 years old. Action taken was not applicable. At time of reporting, the outcome was 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 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 2545740

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ678AAA

gering
Staat
MA
Alter
0,5
Geschlecht
M
Eingang
29.12.2022
Impfdatum
19.12.2022
Beginn
22.12.2022
Tage bis Beginn
3,0
Dosis
UNK
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product preparation issue Single component of a two-component product administered

Symptomtext

Pentacel comes in a 2 vial dose that needs to be constituted together for single administration. Once green cap vial (HIB) and one blue cap vial (DTaP-IPV). It was discovered on 12/22/2022 that there was one blue cap vial in the box missing it?s companion green cap vial. It is assumed that this is one of 5 patients did not receive the blue vial (DTaP-IPV)

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

VAERS 2545734

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ678AAA

gering
Staat
MA
Alter
1,3
Geschlecht
M
Eingang
29.12.2022
Impfdatum
28.11.2022
Beginn
22.12.2022
Tage bis Beginn
24,0
Dosis
UNK
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product preparation issue Single component of a two-component product administered

Symptomtext

Pentacel comes in a 2 vial dose that needs to be constituted together for single administration. Once green cap vial (HIB) and one blue cap vial (DTaP-IPV). It was discovered on 12/22/2022 that there was one blue cap vial in the box missing it?s companion green cap vial. It is assumed that this is one of 5 patients did not receive the blue vial (DTaP-IPV)

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

VAERS 2545729

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ678AAA

gering
Staat
-
Alter
4,0
Geschlecht
M
Eingang
29.12.2022
Impfdatum
14.11.2022
Beginn
22.12.2022
Tage bis Beginn
38,0
Dosis
UNK
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product preparation issue Single component of a two-component product administered

Symptomtext

Pentacel comes in a 2 vial dose that needs to be constituted together for single administration. Once green cap vial (HIB) and one blue cap vial (DTaP-IPV). It was discovered on 12/22/2022 that there was one blue cap vial in the box missing it?s companion green cap vial. It is assumed that this is one of 5 patients did not receive the blue vial (DTaP-IPV)

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

VAERS 2545722

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ678AAA

gering
Staat
-
Alter
1,3
Geschlecht
M
Eingang
29.12.2022
Impfdatum
14.11.2022
Beginn
22.12.2022
Tage bis Beginn
38,0
Dosis
UNK
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product preparation issue Single component of a two-component product administered

Symptomtext

Pentacel comes in a 2 vial dose that needs to be constituted together for single administration. Once green cap vial (HIB) and one blue cap vial (DTaP-IPV). It was discovered on 12/22/2022 that there was one blue cap vial in the box missing it?s companion green cap vial. It is assumed that this is one of 5 patients did not receive the blue vial (DTaP-IPV)

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

VAERS 2545714

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ678AAA

gering
Staat
MA
Alter
0,3
Geschlecht
M
Eingang
29.12.2022
Impfdatum
11.11.2022
Beginn
22.12.2022
Tage bis Beginn
41,0
Dosis
UNK
Route/Site
IM / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Product preparation issue Single component of a two-component product administered

Symptomtext

Pentacel comes in a 2 vial dose that needs to be constituted together for single administration. Once green cap vial (HIB) and one blue cap vial (DTaP-IPV). It was discovered on 12/22/2022 that there was one blue cap vial in the box missing it?s companion green cap vial. It is assumed that one of 5 patients did not receive the blue vial (DTaP-IPV)

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

VAERS 2539291

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ678AAA

gering
Staat
ID
Alter
0,2
Geschlecht
F
Eingang
21.12.2022
Impfdatum
08.12.2022
Beginn
-
Tage bis Beginn
-
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
No adverse event Single component of a two-component product administered

Symptomtext

There were no known adverse events. However, the liquid form of Pentacel was only given (Dtap and Polio). The powder form (Hib) was never diluted with the liquid form (Dtap and Polio), so the Hib was never administered.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
None
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2535566

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ678AAA

gering
Staat
ME
Alter
3,0
Geschlecht
M
Eingang
16.12.2022
Impfdatum
13.12.2022
Beginn
13.12.2022
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 Product preparation issue Single component of a two-component product administered

Symptomtext

only the liquid part of the vaccine was given and the powder portion was not mixed in with it with no reported adverse event; Initial information received on 13-Dec-2022 regarding an unsolicited valid non-serious case via other health professional. This case involves a 3-year-old male patient and the reporter reported only the liquid part of the vaccine was given and the powder portion was not mixed in with it 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), concomitant(s) and family history were not provided. Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination; and varicella zoster vaccine (Varicella Vaccine) for Prophylactic vaccination. On 13-Dec-2022, the patient received 0.5 mL of suspect diphtheria/tetanus/5 HYBRID AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (batch lot: UJ678AAA) (strength: unknown) (expiry date: 09-Sep-2023) via intramuscular route in unknown administration site for immunization. On 13-Dec-2022 the patient had a non-serious event of only the liquid part of the vaccine was given and the powder portion was not mixed in with it with no reported adverse event (product preparation issue) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine. Action taken with diphtheria, tetanus, AC pertussis, IPV AND HIB vaccine was not applicable. It was not reported if the patient received a corrective treatment for the event. 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
MMR; VARICELLA VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 2530711

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ678AAA

gering
Staat
ID
Alter
0,2
Geschlecht
F
Eingang
14.12.2022
Impfdatum
08.12.2022
Beginn
08.12.2022
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 quality issue

Symptomtext

administered the liquid portion of pentacel without reconstituting with the powder portion with no reported adverse event; Initial information received on 09-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 months old female patient who was administered the liquid portion of pentacel without reconstituting with the powder portion with no reported adverse event after 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. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Prophylactic vaccination; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Prophylactic vaccination. On 08-Dec-2022, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE(strength: 0.5 ml) (lot UJ678AAA)(unknown expiry date) via unknown route in right leg for Immunization. On 08-Dec-2022 the patient had a non-serious event of administered the liquid portion of pentacel without reconstituting with the powder portion with no reported adverse event (product preparation issue) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Action taken: not applicable. Outcome was Unknown for the event administered the liquid portion of pentacel without reconstituting with the powder portion 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
-

VAERS 2516499

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ678AAA

gering
Staat
VA
Alter
-
Geschlecht
U
Eingang
25.11.2022
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

The excursion lasted for 33.0 minutes, and the temperature reached 1.5 degrees Celsius with no reported adverse event; The vaccines were given post excursion with no reported adverse event; Initial information was received on 09-Nov-2022 regarding an unsolicited valid non-serious case from a other health professional. This case involves an unknown age/gender patient to whom diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel] and tuberculin test [Tubersol] vaccine were given post excursion and the excursion lasted for 33.0 minutes, and the temperature reached 1.5 degrees celsius with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, it was reported that the excursion lasted for 33.0 minutes, and the temperature reached 1.5 degrees celsius with no reported adverse event (product storage error) for diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine and tuberculin test. On an unknown date, tuberculin test vaccine (lot number - C5994AA, expiry date: 26-Sep-2024) (route, dose, strength, formulation, administration site: unknown) for Immunization and diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (with lot number: UJ678AAA, expiration date: 09-Sep-2023) (route, dose, strength, formulation, administration site: unknown) for prophylactic vaccination (Immunisation) were given post excursion with no reported adverse event (poor quality product administered) No lab data reported. Action taken: not applicable. It was not reported if the patient received a corrective treatment 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 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
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Labordaten
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Aktuelle Erkrankungen
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Vorgeschichte
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Andere Medikamente
TUBERSOL
Allergien
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Vorherige Impfungen
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