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Reporte zur Charge UJ574AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
WA 1 MD 1 IA 1 CO 1

VAERS 2331885

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ574AA

mild
Staat
WA
Alter
1,3
Geschlecht
F
Eingang
24.06.2022
Impfdatum
13.06.2022
Beginn
22.06.2022
Tage bis Beginn
9,0
Dosis
4
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site erythema Injection site induration Injection site warmth Lymphadenopathy Nodule

Symptomtext

Left thigh day after vaccination had two areas of redness which resolved over a few days. Then 9 days after vaccination (6/22/2022) right thigh (site of varicella) developed 3 nodules, worsening and red the next day, then today (6/24/2022) a 6 cm x 3 cm area of erythema, warmth, and induration surrounding the nodules, with enlarged right inguinal lymph nodes. No fluctuance, vesicles, or discharge.

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

VAERS 2509275

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ574AA

gering
Staat
MD
Alter
0,6
Geschlecht
F
Eingang
16.11.2022
Impfdatum
04.11.2022
Beginn
04.11.2022
Tage bis Beginn
0,0
Dosis
3
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

patient was administered expired ActHIB with no reported adverse event; Initial information received on 09-Nov-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 7 months old female patient was administered expired HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation; and POLIO VACCINE INACT (IPV) for Immunisation. On 04-Nov-2022, the patient received a third dose 0.5 ml of suspect HIB (PRP/T) VACCINE once (lot UJ574AA; expiry date: 24-SEP-2022) via intramuscular route in the right thigh for prophylactic vaccination. On 04-NOV-2022 the patient reported a non-serious event patient was administered expired HIB (PRP/T) VACCINE [ACT-HIB] with no reported adverse event (expired product administered). 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
DTAP; PREVNAR 13; HEPATITIS A; ROTAVIRUS VACCINE; IPV
Allergien
-
Vorherige Impfungen
-

VAERS 2466578

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ574AA

gering
Staat
IA
Alter
1,6
Geschlecht
F
Eingang
01.10.2022
Impfdatum
-
Beginn
22.09.2022
Tage bis Beginn
-
Dosis
4
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

product ACTHIB was expired and was administered to a patient with no reported adverse event; Initial information received on 22-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 19 months old female patient who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] and the product acthib was expired and was administered to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation; INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL) for Immunisation; and HEPATITIS A VACCINE INACT (HAVRIX) for Immunisation. On an unknown date, the patient received a fourth series dose of 0.5 ml of suspect HIB (PRP/T) VACCINE (formulation: powder, strength: unknown) (LOT UJ574AA Expiration: 24Sep2022 Diluent-Lot U7114AA Expiration: 20Sep2022 Carton-Lot UJ574AAA Expiration: 20Sep2022) via intramuscular route in left leg as Immunization. On an unknown date the product acthib was expired and was administered to a patient with no reported adverse event (expired product administered) same day following the administration of HIB (PRP/T) VACCINE. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (product ACTHIB was expired and was administered to a patient with no reported adverse 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.

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

VAERS 2408966

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ574AA

gering
Staat
CO
Alter
1,0
Geschlecht
M
Eingang
11.08.2022
Impfdatum
01.08.2022
Beginn
01.08.2022
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered Wrong product administered

Symptomtext

On 08/01/2022 at approximately 01:45 PM, RN administered MMRV (Measles, Mumps, Rubella and Varicella) vaccine in error to pt. in left upper arm subcutaneously in the child clinic room. Pt. was scheduled to receive five vaccines today which included pediatric Hepatitis A (Hep A), Pneumococcal conjugate (PVC-13), Haemophilus Influenza type B (Hib), Measles, mumps, rubella (MMR), and Varicella (VAR-Varivax). RN misread the vaccination label when pulling MMR out of the freezer. RN believed at the time of pulling the vaccine, that MMR is in the freezer with VAR. The vaccine in the freezer was actually measles, mumps, rubella and varicella (MMRV-Proquad) Both MMRV and VAR were labeled as state vaccines. Which at the time, I believed the patient to be eligible. RN did not complete one of my six rights of administration by double checking the vial on the vaccine to make sure it was the right medication. I believe if I had completely turned the vaccine vial, I would have read the entire label. RN made a telephone call to parent at approximately 03:10 PM to notify her that her son received a double dose of the VAR which is a live vaccine, I relayed side effects of vaccines and what to watch out such as increase in fever, redness, soreness and pain at injection site and irritability. Parent asked RN "is my son going to come down with chicken pox later and possibly give it to my other son?", and RN replied, "he is not likely to come down with chicken pox and become contagious" Parent had no further question and she was given my name and the name of my immediate supervisor to call if she had additional questions. Parent did not notice any adverse effects of vaccine at this time but stated to the effect "I will keep an eye on him" At 05:02 RN made call to Merck, the vaccine manufacturer to get additional information on other adverse effects. RN spoke with Merck. Rep relayed that Merck showed no other adverse effects than those side effects listed for each vaccine as Fever, Irritability, redness, soreness or pain at the injection site, and that contracting chicken pox was not listed as an adverse event, side effect when the two vaccines MMRV (Proquad) and Var (Varivax) were given together. Rep at Merck is to provide information via email on findings with RN. At 05:21 PM, RN made additional call to parent on MERCK findings on adverse events, side effects when taking Proquad and Varivax together and that there were no findings to support that patients contracted chicken pox after vaccination. RN to email copy of findings from Merck to parent once received. RN asked parent how her son was doing now and she replied "he is resting now as he typically does after vaccination, I gave him pediatric Tylenol before resting, but I have not noticed any adverse effects at this time". She thanked me for the information and stated she would call if she had questions. On 8/2/2022 at 9:20 AM Information was sent to parent at the email provided from parent, she stated to the effect that this was an old work email she had kept and had been using and never changed it. Parent was given information provided in attachments from Merck. On 8/2/2022 at 3:46 PM, RN made a call to parent, I received her voice mail and a voice mail message was left by me asking parent is she had received my email with the information and to call if she had any questions, in addition RN asked parent on the well being of her son. On 8/3/2022 RN's supervisor made follow up telephone call to parent to inquire on well being of her son, There was no answer, a message was left for parent to return call. No call back known to be received and no return messages were left. Result of outcome of adverse event(s) is unknown due to no follow up response from Patient's parent.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Extra dose administered
Hospital-Tage
-
Labordaten
Unkown
Aktuelle Erkrankungen
Parent denies current illness, unkown up to one month prior.
Vorgeschichte
None reported by parent at time of vaccination.
Andere Medikamente
Unkown
Allergien
Parent denies allergies to medication or foods.
Vorherige Impfungen
-