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Reporte zur Charge 5N259

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

34Reporte angezeigt
0Todesfaelle
2Hospitalisiert
1Lebensbedrohlich
0Bleibende Schaeden
NM 7 TX 7 OH 4 IL 3 TN 3 IN 2 CA 2 NY 1 GA 1 WA 1 WI 1 KY 1

VAERS 2474567

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

schwer
Staat
IN
Alter
0,5
Geschlecht
M
Eingang
11.10.2022
Impfdatum
15.09.2022
Beginn
19.09.2022
Tage bis Beginn
4,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: ja Hospital: ja Disable: unbekannt ER: ja Erholt: nein
Cerebrospinal fluid leakage Craniotomy Intensive care Iron deficiency anaemia Lumbar puncture Magnetic resonance imaging head abnormal Meningitis haemophilus Red blood cell transfusion Seizure

Symptomtext

H. Flu meningitis - PICU hospitalization -Spinal tap - IV antibiotics - ceftriaxone Seizures - Keppra Subdural fluid collection -MRI Burr Hole drilled - Hospital Iron Deficiency anemia - Packed RBC transfusion

Weitere VAERSDATA-Felder
Praegender Schweregrund
Intensive care
Hospital-Tage
14,0
Labordaten
Spinal Tap MRI
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2296436

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

schwer
Staat
IL
Alter
0,2
Geschlecht
M
Eingang
26.05.2022
Impfdatum
25.02.2022
Beginn
26.02.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: unbekannt Erholt: nein
Bacterial test Blood culture negative CSF glucose normal CSF protein normal CSF red blood cell count positive CSF white blood cell count negative Chest X-ray normal Computerised tomogram head normal Electroencephalogram abnormal Full blood count Haemoglobin decreased Lumbar puncture Lymphocyte percentage Neutrophil percentage Nitrite urine absent Platelet count increased Red blood cells urine positive SARS-CoV-2 test negative

Symptomtext

Patient reported to have seizure episode for 10 minutes. Seen at ED and then transferred to hospital and had CT, LP , labs and EEG completed. Required versed to resolve seizure episode. Since then has been evaluated in ED and hospital due to multiple episodes of seizure activity.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Seizure
Hospital-Tage
2,0
Labordaten
CBC ( 2/26/2022)--WBC of 13.8, HgB 9.3, Plt 517, 55% N, 35% L no bands UA (2/26/2022)--with negative leuks and nitrites, few bacteria, 2-5 RBC LP- (2/26/2022)--WBC 1, RBC 1, glucose 55, protein 31 Blood Culture-negative COVID ( 2/26/2022): negative CT (2/26/2022)IMPRESSION: No evidence of acute intracranial hemorrhage, significant intracranial mass effect, or displaced calvarial fracture. If there is clinical concern for an underlying seizure focus, MR brain imaging would be recommended for further characterization. CXR- (2/26/2022)-normal
Aktuelle Erkrankungen
None
Vorgeschichte
No previous history.
Andere Medikamente
Give 1 dose of acetaminophen after vaccines.
Allergien
No known allergies prior to vaccines given.
Vorherige Impfungen
-

VAERS 2639692

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

mild
Staat
OH
Alter
0,5
Geschlecht
F
Eingang
01.06.2023
Impfdatum
03.06.2022
Beginn
07.06.2022
Tage bis Beginn
4,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Post vaccination fever

Symptomtext

Postvaccination fever on 2022-06-07.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Post vaccination fever
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Encounter for routine child health examination NOS
Vorgeschichte
-
Andere Medikamente
ACETAMINOPHEN 160 MG/5ML ORAL SOLN
Allergien
-
Vorherige Impfungen
-

VAERS 2256682

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

mild
Staat
TN
Alter
0,3
Geschlecht
M
Eingang
28.04.2022
Impfdatum
19.04.2022
Beginn
19.04.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Rash erythematous

Symptomtext

Developed four red spots on forehead and on one cheek- not raised, noted after giving vaccines, No distress, exam normal except noted above baby was given Benadryl, Rash resolved within a few minutes. Observed here for 30 minutes awake no distress or rash at discharge

Weitere VAERSDATA-Felder
Praegender Schweregrund
Rash erythematous
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
Right Side Nasal Congestion
Vorgeschichte
Alpha Thalassemia, BW 2000-2500grams, Preemie 35wks
Andere Medikamente
Formula Neosure
Allergien
N/A
Vorherige Impfungen
-

VAERS 2245675

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

mild
Staat
TN
Alter
-
Geschlecht
M
Eingang
21.04.2022
Impfdatum
21.04.2022
Beginn
21.04.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Rash erythematous

Symptomtext

Developed four red spots on forehead and one on cheek- not raised, noted after giving vaccines. NO distress, exam normal, except for noted above, Baby was given Benadryl. Rash resolved within a few minutes. Observed for 30 minutes awake and no distress or rash before discharged.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Rash erythematous
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
Righ Side Nasal Congestion
Vorgeschichte
Alpha Thalassemia, Birth Weight 2000-2500grams, Preemie 35wks
Andere Medikamente
Formula: Neosure
Allergien
N/A
Vorherige Impfungen
-

VAERS 2165562

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

mild
Staat
CA
Alter
5,0
Geschlecht
F
Eingang
08.03.2022
Impfdatum
07.03.2022
Beginn
08.03.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product preparation issue Pyrexia

Symptomtext

Patient reports fever. The adverse event was that Pfizer was not diluted and patient was administered non diluted Pfizer. Mother informed and follow up revealed a fever today, will treat, no other major adverse reactions.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
NKA
Aktuelle Erkrankungen
NKA
Vorgeschichte
NKA
Andere Medikamente
None
Allergien
NKA
Vorherige Impfungen
-

VAERS 2131522

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

mild
Staat
CA
Alter
0,4
Geschlecht
F
Eingang
22.02.2022
Impfdatum
17.02.2022
Beginn
17.02.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Diarrhoea Pyrexia Rash erythematous Respiration abnormal Urticaria

Symptomtext

103 fever and urticaria, given tylenol for infants At 8am 02/18/2022 had 'hives' on back, stomach, and arms; red spots; unknown if itchy Seems resolved now Breathing 'looked a little funny yesterday'-no wheezing 'or anything like that' but later mom said she seemed like trying to catch her breath but breathing fine Diarrhea on 02/17/2022 after vaccines

Weitere VAERSDATA-Felder
Praegender Schweregrund
Diarrhoea
Hospital-Tage
-
Labordaten
None.
Aktuelle Erkrankungen
Acute URI of multiple sites.
Vorgeschichte
None.
Andere Medikamente
Vitamin D3.
Allergien
Dairy.
Vorherige Impfungen
-

VAERS 2717686

GLAXOSMITHKLINE BIOLOGICALS · DTAP (INFANRIX) · Charge 5N259

gering
Staat
OH
Alter
0,2
Geschlecht
M
Eingang
24.11.2023
Impfdatum
14.11.2023
Beginn
14.11.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

Administration of an expired Infanrix dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old male patient who received DTPa (Infanrix) (batch number 5N259, expiry date 05-OCT-2023) for prophylaxis. On 14-NOV-2023, the patient received Infanrix. On 14-NOV-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Administration of an expired Infanrix dose). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 15-Nov-2023 The reporter reported that the 2 month old patient received an expired dose of Infanrix vaccine, which led to which led to expired vaccine used. The reporter wanted to know if the dose was considered valid. The reporter did consent to follow up.

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

VAERS 2701150

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
OH
Alter
0,2
Geschlecht
F
Eingang
24.10.2023
Impfdatum
13.10.2023
Beginn
13.10.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered

Symptomtext

expired drug used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 9-week-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 5N259, expiry date 05-OCT-2023) for prophylaxis. On 13-OCT-2023, the patient received Pediarix. On 13-OCT-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: expired drug used). The outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 16-OCT-2023 The registered nurse reported that an expired dose of Pediarix was administered to a patient which led to expired vaccine used. The reporter to consented to follow up. The vaccine administration facility is the same as primary reporter.

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

VAERS 2637280

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
IN
Alter
0,2
Geschlecht
F
Eingang
26.05.2023
Impfdatum
08.05.2023
Beginn
08.05.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
SC / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect route of product administration

Symptomtext

Vaccine given SQ instead of IM

Weitere VAERSDATA-Felder
Praegender Schweregrund
Incorrect route of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2610465

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
IL
Alter
0,2
Geschlecht
U
Eingang
06.04.2023
Impfdatum
13.02.2023
Beginn
13.02.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Accidental overdose

Symptomtext

Pediarix and Engerix given on the same day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 2-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number 5N259) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number FB9RH) for prophylaxis. On 13-FEB-2023, the patient received Pediarix and Engerix B. On 13-FEB-2023, an unknown time after receiving Pediarix and Engerix B, the patient experienced accidental overdose (Verbatim: Pediarix and Engerix given on the same day). The outcome of the accidental overdose was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 23-MAR-2023 The reporter was a medical assistant. The reporter consented to follow up. The patient received Engerix B and Pediarix on same day, which led to overdose.

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

VAERS 2607565

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge 5N259

gering
Staat
OH
Alter
5,0
Geschlecht
M
Eingang
31.03.2023
Impfdatum
23.03.2022
Beginn
25.03.2022
Tage bis Beginn
2,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Adverse reaction

Symptomtext

Adverse effect of other vaccines and biological substances, initial encounter on 2022-03-25.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Adverse reaction
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Iron deficiency anemia, unspecified; Overweight; Elevated blood-pressure reading, without diagnosis of hypertension; Encounter for routine child health examination NOS; Immunization not carried out for unspecified reason
Vorgeschichte
-
Andere Medikamente
CETIRIZINE HCL 1 MG/ML ORAL SOLN
Allergien
-
Vorherige Impfungen
-

VAERS 2454835

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
NY
Alter
0,2
Geschlecht
F
Eingang
22.09.2022
Impfdatum
12.08.2022
Beginn
12.08.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Administration site nodule

Symptomtext

Patient received routine vaccines as above. Mom noted a few days later a small subcutaneous nodule in right thigh at administration site that has persisted at her 4 month visit

Weitere VAERSDATA-Felder
Praegender Schweregrund
Administration site nodule
Hospital-Tage
-
Labordaten
n/a
Aktuelle Erkrankungen
nystagmu
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2318885

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
NM
Alter
-
Geschlecht
F
Eingang
14.06.2022
Impfdatum
25.03.2022
Beginn
25.03.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Inappropriate schedule of product administration

Symptomtext

Patient was seen 3 weeks prior for routine vaccinations which she received. Patient had another visit in which the same routine vaccines were pended, ordered and given again by RN. Inapproporate interval of vaccines given too close together which will require the patient to be revaccinated again at the proper interval. Vaccines- Dtap, Hep B, Polio, Prevnar 13, Hib, Rotavirus

Weitere VAERSDATA-Felder
Praegender Schweregrund
Inappropriate schedule of product administration
Hospital-Tage
-
Labordaten
NA
Aktuelle Erkrankungen
Vaccination received 3 weeks too soon on 3/25/22. Received Dtap, Hep B, Polio, Prevnar 13, Hib, and Rotavirus and will require revaccination
Vorgeschichte
NA
Andere Medikamente
NA
Allergien
NKA
Vorherige Impfungen
-

VAERS 2297545

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5n259

gering
Staat
TX
Alter
0,3
Geschlecht
M
Eingang
27.05.2022
Impfdatum
17.05.2022
Beginn
17.05.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect dose administered

Symptomtext

Patient was administrated with Pediarix an extra dose of Sanofi IPV; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 3-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 5n259, expiry date 5th October 2023) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and POLIOMYELITIS VACCINE INACTIVATED (IPV VACCINE) for prophylaxis. On 17th May 2022, the patient received the 1st dose of Pediarix, Pediarix Pre-Filled Syringe Device and IPV VACCINE. On 17th May 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 17-May-2022 Reporter's comments: Medical assistance reported that the patient was administrated with Pediarix and an extra dose of Sanofi IPV vaccine on same day. No adverse event was reported. The vaccine administration facility was the same as primary reporter. The consent to follow up was given. Additional Supportive Information: The patient received Pediarix and an extra dose of Sanofi IPV vaccine on same day, which led to overdose.

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

VAERS 2287405

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
IL
Alter
-
Geschlecht
M
Eingang
20.05.2022
Impfdatum
20.05.2022
Beginn
20.05.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Circumstance or information capable of leading to medication error No adverse event Product administered to patient of inappropriate age

Symptomtext

Patient's date of birth was entered incorrected upon being registered in the computer. Patient was brought in for newborn check and was administered vaccines appropriate for a 2 month old child due to the date of birth being incorrect. At this time, patient has no side effects reported.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Circumstance or information capable of leading to medication error
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 2207109

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
TX
Alter
0,4
Geschlecht
M
Eingang
30.03.2022
Impfdatum
30.03.2022
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Extra dose administered

Symptomtext

None in office

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
N/A
Vorgeschichte
N/A
Andere Medikamente
N/a
Allergien
N/A
Vorherige Impfungen
-

VAERS 2192056

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
TX
Alter
0,8
Geschlecht
F
Eingang
22.03.2022
Impfdatum
22.03.2022
Beginn
22.03.2022
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

Extra dose given

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

VAERS 2191639

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
TX
Alter
0,8
Geschlecht
F
Eingang
22.03.2022
Impfdatum
09.03.2022
Beginn
09.03.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered

Symptomtext

administered a fourth dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 9-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 5N259, expiry date 5th October 2023) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Pediarix (received 1st dose on 25 August 2021), Pediarix (received 2nd dose on 20th October 2021) and pediatrix (received 3rd dose on 16th December 2021). On 9th March 2022, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 9th March 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient received Pediarix series and the patient was then inadvertently administered a fourth dose which led to extra dose administered. The reporter consented to follow up. The health care professional gave permission for follow-up.

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

VAERS 2189980

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
-
Alter
2,0
Geschlecht
F
Eingang
21.03.2022
Impfdatum
05.03.2022
Beginn
05.03.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Extra dose administered

Symptomtext

N/A

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

VAERS 2182859

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
TX
Alter
11,0
Geschlecht
M
Eingang
16.03.2022
Impfdatum
15.03.2022
Beginn
-
Tage bis Beginn
-
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Drug dispensed to wrong patient Product administered to patient of inappropriate age Wrong product administered

Symptomtext

Doctor circle the wrong vaccines in chart and medical assistant administered them to the wrong patient that was meant for the younger sibling.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Drug dispensed to wrong patient
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
-
Vorgeschichte
NONE
Andere Medikamente
NONE
Allergien
NONE
Vorherige Impfungen
-

VAERS 2182232

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5n259

gering
Staat
GA
Alter
0,1
Geschlecht
M
Eingang
16.03.2022
Impfdatum
28.12.2021
Beginn
29.12.2021
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Eye swelling Stridor

Symptomtext

Swollen eyes, ? stridor the following morning after vaccine administration. Resolved spontaneously.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Eye swelling
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
Reflux/Spitting up; mainly physiologic
Andere Medikamente
Vit D drops
Allergien
None known
Vorherige Impfungen
-

VAERS 2170724

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
NM
Alter
0,4
Geschlecht
M
Eingang
10.03.2022
Impfdatum
01.03.2022
Beginn
01.03.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product storage error

Symptomtext

Vaccine administered experienced a low temperature excursion and data did not support it' s use. Patient has not reported adverse reaction. Revaccination plan being organized.

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

VAERS 2168680

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
NM
Alter
0,2
Geschlecht
F
Eingang
09.03.2022
Impfdatum
01.03.2022
Beginn
01.03.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Incorrect dose administered Product storage error

Symptomtext

Vaccine administered was exposed to low temperatures and is considered an invalid dose. Patient has not reported negative reactions. Revaccination plan is being planned.

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

VAERS 2168597

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
NM
Alter
0,5
Geschlecht
M
Eingang
09.03.2022
Impfdatum
01.03.2022
Beginn
01.03.2022
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

Vaccine administered was exposed to a low temperature and not supported for administration. Patient has not reported any reactions. Revaccination plan to be initiated.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product storage error
Hospital-Tage
-
Labordaten
n/a
Aktuelle Erkrankungen
n/a
Vorgeschichte
n/a
Andere Medikamente
N/a
Allergien
n/a
Vorherige Impfungen
-

VAERS 2168388

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
NM
Alter
0,3
Geschlecht
M
Eingang
09.03.2022
Impfdatum
28.02.2022
Beginn
01.03.2022
Tage bis Beginn
1,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

Vaccine administered was exposed to a low temperature and not supported for administration. Patient has not reported any reactions. Revaccination plan to be initiated.

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

VAERS 2168377

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
NM
Alter
1,3
Geschlecht
M
Eingang
09.03.2022
Impfdatum
28.02.2022
Beginn
01.03.2022
Tage bis Beginn
1,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

Vaccine administered was exposed to a low temperature and not supported for administration. Patient has not reported any reactions. Revaccination plan to be initiated.

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

VAERS 2168375

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
NM
Alter
0,5
Geschlecht
F
Eingang
09.03.2022
Impfdatum
28.02.2022
Beginn
01.03.2022
Tage bis Beginn
1,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

Vaccine administered was exposed to a low temperature and not supported for administration. Patient has not reported any reactions. Revaccination plan to be initiated.

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

VAERS 2141936

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
TX
Alter
10,0
Geschlecht
F
Eingang
26.02.2022
Impfdatum
17.02.2022
Beginn
17.02.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age

Symptomtext

10 year old was administered PEDIARIX; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 5N259, expiry date 5th October 2023) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 17th February 2022, the patient received Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 17th February 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient received Pediarix in left deltoid. The patient received Pediarix at the age of 10 years, which led to inappropriate age at vaccine administration. The reporter consented to follow up.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2129082

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
TX
Alter
10,0
Geschlecht
F
Eingang
21.02.2022
Impfdatum
17.02.2022
Beginn
18.02.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
No adverse event Product administered to patient of inappropriate age

Symptomtext

Patient did not had symptoms.

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

VAERS 2103887

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
TN
Alter
0,5
Geschlecht
M
Eingang
11.02.2022
Impfdatum
02.02.2022
Beginn
02.02.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Overdose

Symptomtext

Engerix-B - Pediarix administered on same day; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 6-month-old male patient who received HBV (Engerix B pediatric) (batch number 2H575, expiry date 12th September 2022) for prophylaxis. Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number 5N259, expiry date 5th October 2023) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 2nd February 2022, the patient received Engerix B pediatric, Pediarix and Pediarix Pre-Filled Syringe Device. On 2nd February 2022, unknown after receiving Engerix B pediatric, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: The reporter was a nurse. The patient received a dose of Engerix B and Pediarix on the same day, which led to overdose of hepatitis B vaccine. Consent to follow up was granted.

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

VAERS 2098696

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
WA
Alter
0,6
Geschlecht
F
Eingang
09.02.2022
Impfdatum
19.01.2022
Beginn
19.01.2022
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Inappropriate schedule of product administration

Symptomtext

This patient came in on 01.19.2022 to see Dr. and got her second dose of primary vaccines (Pediarix - DTaP, hep B, IPV, hib, PCV, and flu). First dose of primary vaccines was given at 6mo0days on 12.03.2021. The CDC recommends if the vaccine was given more than four days before the recommended minimum due date (01.28.22 per system), then you will repeat dosage at the recommended interval. I spoke with MDs for their recommendations as pediatricians in clinic. Dr. believes that this is not a true error, as children receive an extra hep B dosage with the normal intervals. Due to this patient being late to receiving the first primary dose of vaccines, this is what is equating the "error". Also, the human body can tolerate an additional hep B vaccine dose. Dr. stated that due to patient needing to come in within the next four weeks for their second flu shot, that when they come in for that they could get the next series dosage. This needs to happen AFTER February 19th. After the date February 19th, this patient can receive her second flu shot, third pediarix dosage, third PCV, and third HIB. This patient has an appointment on February 18th where doctor has okayed the patient to receive her next dose at that appointment.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Inappropriate schedule of product administration
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2098155

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5N259

gering
Staat
WI
Alter
0,6
Geschlecht
U
Eingang
09.02.2022
Impfdatum
28.01.2022
Beginn
28.01.2022
Tage bis Beginn
0,0
Dosis
3
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product administered to patient of inappropriate age Underdose

Symptomtext

did not received the full dose, partial dose was administered; 7 months old was administered Pediarix; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 7-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number 5N259, expiry date 5th October 2023) for prophylaxis. Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Pediarix (received 1st and 2nd dose on an unknown date). On 28th January 2022, the patient received the 3rd dose of Pediarix (intramuscular) and Pediarix Pre-Filled Syringe Device. On 28th January 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the underdose and inappropriate age at vaccine administration were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: Reporter was a nurse manager at the health care facility. The nurse reported that, the patient did not receive the full dose of their Pediarix injection, which led to underdose. The partial dose that was administered was the 3rd dose in the Pediarix series and was administered into the right thigh. The nurse also reported the seven months old patient received dose of Pediarix, which led to inappropriate age at vaccine administration. The reporter consented to follow-up.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Product administered to patient of inappropriate age
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2076012

GLAXOSMITHKLINE BIOLOGICALS · DTAP + HEPB + IPV (PEDIARIX) · Charge 5n259

gering
Staat
KY
Alter
0,6
Geschlecht
M
Eingang
31.01.2022
Impfdatum
31.01.2022
Beginn
31.01.2022
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

Symptomtext

No adverse events

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
Ear infection
Vorgeschichte
N/A
Andere Medikamente
Famotidine and Cefdinir
Allergien
N/A
Vorherige Impfungen
-