VAERS Reports UJ634AA

VAERS 2332394

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ634AA

mild

Staat: NE
Alter: 0,3
Geschlecht: F
Eingang: 24.06.2022
Impfdatum: 10.06.2022
Beginn: 10.06.2022
Tage bis Beginn: 0,0
Dosis: 2
Route/Site: IM / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: unbekannt Erholt: ja

Abscess Abscess drainage Blood culture negative C-reactive protein increased CSF glucose normal CSF protein normal CSF virus no organisms observed CSF white blood cell count Central venous catheterisation Ear tube insertion Enterovirus test positive Gastrointestinal pathogen panel Haemoglobin decreased Human rhinovirus test positive Immunoglobulins normal Influenza virus test negative Irritability Lumbar puncture normal

Symptomtext

Infant with onset of high fever (103-104) within 8 hours of her second round of vaccinations. No other symptoms. By the next morning not only had high fever but was extremely irritable especially if she was moved or lay down. Had persistent high fever of 102-104 all weekend and presented to my office on 6/13/2022 for evaluation of irritability and high fever. Still did not have any other symptoms other than irritability. Exam did not reveal source of infection. Had a negative COVID and influenza test in the office and then sent to the hospital for further work-up with concern of possible meningitis. Initial evaluation at the local hospital was negative until she had a MRI of her brain due to persistent irritability that showed evidence of a periauricular abscess/mastoiditis. Due to her young age she was sent to Hospital for ear nose and throat evaluation who elected to drain this abscess and to place bilateral ear tubes due to the presence of bilateral otitis media with mastoiditis. She was managed with a PICC line and infusions of Rocephin and oral dosing of metronidazole. She has improved and is in good clinical condition upon follow-up today 6/24/2020

Weitere VAERSDATA-Felder

Praegender Schweregrund: Pyrexia
Hospital-Tage: 7,0
Labordaten: 6/13/2022: Lumbar puncture?negative 6/14/2022: MRI of brain normal other than periauricular inflammation and possible small abscess 6/13/2022: White blood count 21,000, hemoglobin 8.8, platelet count 509,000 6/14/2022: White blood count 27,000, hemoglobin 9.1, platelet count 604,000 6/13/2022 procalcitonin 0.89 6/14/2022 procalcitonin 0.71 6/13/2022 blood culture negative 6/14/2022 CRP 9.7 6/14/2022 sed rate 81 6/13/2022 complete metabolic panel normal 6/14/2022 complete metabolic panel normal 6/13/2022 respiratory viral panel rhinovirus/ enterovirus detected 6/13/2022 White blood count CSF 8, glucose 67, protein 30, no growth after day 1 and all viral studies on CSF negative 6/14/2020 2 GI pathogen panel negative 6/20/2022 White blood count 8.97, hemoglobin 8.9, platelet count 1,028,000 6/20/2022 quantitative immunoglobulins within normal limits
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: none
Allergien: none
Vorherige Impfungen: -

VAERS 2313413

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ634AA

mild

Staat: TX
Alter: 0,3
Geschlecht: F
Eingang: 08.06.2022
Impfdatum: 31.05.2022
Beginn: 04.06.2022
Tage bis Beginn: 4,0
Dosis: 2
Route/Site: IM / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja

Abdominal pain Barium enema Intussusception Irritability Metabolic function test SARS-CoV-2 test Ultrasound abdomen abnormal Vomiting

Symptomtext

Patient was seen in office 05/31/22 for 4 month well child exam. Rotavirus vaccine was given at time of visit, 4 days later (06/04/22) she was seen in ER for intussusception. Symptoms included abdominal pain, vomiting, fussiness. She is now s/p successful reduction of intussusception with barium enema.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Abdominal pain
Hospital-Tage: -
Labordaten: ED work up included BMP, Covid PCR, US Bowel showing intussusception.
Aktuelle Erkrankungen: -
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2256797

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ634AA

mild

Staat: NC
Alter: 0,5
Geschlecht: M
Eingang: 28.04.2022
Impfdatum: 28.04.2022
Beginn: 28.04.2022
Tage bis Beginn: 0,0
Dosis: 3
Route/Site: IM / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Rash erythematous

Symptomtext

Patient was administered vaccines at 10:50am on 4/28/2022. A red rash appeared at 11am on patient/'s forehead, right shoulder, bottom of bilateral feet on the plantar surface, bilateral shins, right hand and posterior neck. Rash appeared red and in patches. No visible difficulty breathing, restlessness, itching, fever although patient is warm to the touch, absence of any other symptoms. No reaction at injection sites. Patient was monitored for 40 minutes after vaccine administration, patient was discharged at 11:30am with almost complete resolution of rash. Remaining rash was observed on the plantar surface of the right foot. Benadryl was offered at 11:20am, parents declined Benadryl at this time.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Rash erythematous
Hospital-Tage: -
Labordaten: None
Aktuelle Erkrankungen: COVID-19 diagnosed on 4/20/2022, symptoms started 4/16/2022.
Vorgeschichte: None
Andere Medikamente: None
Allergien: None
Vorherige Impfungen: -

VAERS 2576878

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ634AA

gering

Staat: -
Alter: 1,0
Geschlecht: M
Eingang: 07.02.2023
Impfdatum: 01.02.2023
Beginn: 01.02.2023
Tage bis Beginn: 0,0
Dosis: 4
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

receiving an expired dose of pentacel yesterday with no reported adverse event; Initial information received on 02-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 1-year-old male patient and it reported that he received an expired dose of Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] yesterday with no reported adverse event. The patient's past vaccination(s) included Pediarix on 30-Jun-2021, Pentacel on 22-Sep-2021, HIB on 30-Jun-2021, HIB on 22-Sep-2021 and HIB on 30-Nov-2021. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included hepatitis A vaccine, measles vaccine, mumps vaccine, rubella vaccine (MMR) and varicella zoster vaccine (varicella vaccine) all for Prophylactic vaccination. On 01-Feb-2023, the patient received 0.5 ml (milliliter) (dose 4), 1x (once) of suspect Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot number: UJ634AA, expiry date: 28-Jan-2023) (with unknown strength and route) in the right thigh for prophylactic vaccination (immunization). On 01-Feb-2023, the reporter reported that patient received an expired dose of pentacel yesterday with no reported adverse event (expired product administered) (latency; same day). No lab data were reported. 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: HEPATITIS A VACCINE; MMR; VARICELLA VACCINE
Allergien: -
Vorherige Impfungen: -

VAERS 2576192

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ634AA

gering

Staat: -
Alter: 1,8
Geschlecht: M
Eingang: 02.02.2023
Impfdatum: 01.02.2023
Beginn: 01.02.2023
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: IM / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt

Expired product administered

Symptomtext

Patient was given expired Pentacel. Expiration date was in the following form: 28Jan23, so the MA thought this was 1-23-28 because the other vaccines had exp dates in this form: YYYY-MO-DATE. Sanofi was notified today and the expiration date was confirmed to be 1-28-23. Adverse event was filed with Sanofi as well. Sanofi is going to send this to their Quality and Safety division to see about having the dates written in a different form so as to not be confusing.

Weitere VAERSDATA-Felder

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

VAERS 2211416

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ634AA

gering

Staat: MI
Alter: 4,0
Geschlecht: M
Eingang: 01.04.2022
Impfdatum: 30.03.2022
Beginn: 30.03.2022
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 Wrong product administered

Symptomtext

Dr. ordered patient to have a Dtap-IPV injection. MA drew up Dtap-IPV-Hib vaccine instead and gave to the patient. MA did have a co-signer who missed that the incorrect vaccine was drawn up. MA gave the patient the injection with no adverse reaction.

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: Pharmacy and patient's mom were notified that incorrect vaccine was given.
Aktuelle Erkrankungen: None
Vorgeschichte: None
Andere Medikamente: None
Allergien: No allergies
Vorherige Impfungen: -