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Reporte zur Charge UJ649AAA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

14Reporte angezeigt
1Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
TX 2 FL 2 SC 2 ME 1 WV 1 AL 1 TN 1 NC 1

VAERS 2514034

MERCK & CO. INC. · HIB (PEDVAXHIB) · Charge UJ649AAA

kritisch
Staat
ME
Alter
0,2
Geschlecht
M
Eingang
10.12.2022
Impfdatum
27.10.2022
Beginn
28.10.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
IM / LG
Tod: ja Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Autopsy Breath sounds abnormal Death Discomfort Livedo reticularis Cardiac arrest Cardiac monitoring abnormal Life support Loss of consciousness Pallor Pulse absent Respiratory arrest Unresponsive to stimuli Peripheral coldness Restlessness Resuscitation Screaming

Symptomtext

Patient was born. He was born without any issues and was perfectly healthy. On October 20, 2022 we took him to his Pediatrician?s office because he had had a rash over his torso for 2 weeks and had now developed cold symptoms (runny nose, dry cough and sneezing). He saw a traveling Pediatrician that day and was diagnosed with a virus and viral rash. We were told to put Eucerin cream on the rash. We had stopped breastmilk a few weeks prior and were trying to introduce Nutramigen formula however at this time we started giving breast milk again and giving patient daily baths. One week later, on October 27, 2022, patient was due for his 2 month vaccinations. He had been given the Hep B at birth with no complications. His rash was better but he did still have cold symptoms, which did not seem to concern the Pediatrician. His temperature was 98.6. He was given 4 shots that day, Pediarix (DTap, IPV and Hep B), Prevnar #13, Hib and Rotateq. He seemed to do fine the rest of the day. He did have a screaming fit when he was being changed, like he was uncomfortable so we gave him 1.25 mL of Tylenol. He was restless and wouldn?t lay on either side but after the Tylenol he slept well all night. The next day, October 28, 2022 patient did well. He did seem uncomfortable in the morning so I gave him 1 mL of Tylenol and he fell asleep in my arms. I needed to start getting ready for work at 4 (from home) and his Dad got him at 3. He fed Patient (5 oz which he ate well) and walked around with him until he fell asleep, around 4:30. He laid him down in the bassinet in our room. Around 4:50 patients dad left to go get supper and I was making coffee, getting ready to start work. I watched the monitor from the kitchen (right next to the bedroom) and listened to him. At 5:15 patients dad got bak home and Patient woke up. It was normal for him to wake up every 45 min or so, and Patient fell back asleep. Between 5-6 he woke up again so Dad fed him another 2 oz and rocked him back to sleep then laid him down on his left side in the bassinet, where he slept for another hour. Patient started to stir again and seemed uncomfortable so Dad went in and moved him to his belly, which seemed to calm him down. There were not blankets in the crib other than the one he laid on and he had no pacifier. Patient was laying peacefully with his head turned to the side, one arm kind of underneath him and the other up by his face. Dad could tell he was asleep by his breathing so he left the room, leaving the door cracked open. He was outside on the deck cooking. 7:30 was the last time he checked in on Patient and could see everything was fine. At 9:00pm I finished work, pumped for about 15 minutes then went online for a few minutes. I saw the second green light on the monitor go on, which indicates noise so I went into the bedroom thinking Patient was stirring. (Our home is small, so the monitor picks up all noises). The fans were on and it felt a bit cool, so I went over and touched Patients right leg and it was freezing cold. He was face down, so I picked him up. I don?t know where the light was coming from, but I could see that he was already mottled. I went outside to patients dad saying, ?He?s gone, he?s dead?. I was trying to rouse him but he was already gone. While on the phone with EMT we put him on the new rug on the floor and started CPR. As we were giving him breaths I could hear the fluid. When the EMT?s arrived I had to go outside because I just couldn?t look at him like that. Just 34 hours after receiving his 2 month vaccinations my baby was gone.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Cardiac arrest
Hospital-Tage
-
Labordaten
Autopsy
Aktuelle Erkrankungen
Viral rash
Vorgeschichte
None
Andere Medikamente
None
Allergien
None known
Vorherige Impfungen
-

VAERS 2608856

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ649AAA

gering
Staat
WV
Alter
60,0
Geschlecht
M
Eingang
04.04.2023
Impfdatum
17.03.2023
Beginn
17.03.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error No adverse event

Symptomtext

administered ActHIB on 17MAR2023 that had diluent expiration date of 05MAR2023, with no adverse event; Initial information received on 29-Mar-2023 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 60 years old male patient and reporter reported that he was administered HIB (PRP/T) vaccine [ACT-HIB] on 17-Mar-2023 that had diluent expiration date of 05-Mar-2023 with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (DIP TOX) (menactra) for Immunisation. On 17-Mar-2023, the patient received 0.5 ml (milliliter) (1x) (once) of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection, (lot number: UJ649AAA, expiry date for powder: 03-Apr-2023 and expiry date for diluent: 05-Mar-2023) via intramuscular route in the left deltoid for immunization. On 17-Mar-2023 the patient was administered HIB (PRP/T) vaccine that had diluent expiration date of 05-Mar-2023, with no 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 an 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
MENACTRA
Allergien
-
Vorherige Impfungen
-

VAERS 2607948

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ649AAA

gering
Staat
TX
Alter
0,5
Geschlecht
F
Eingang
01.04.2023
Impfdatum
20.03.2023
Beginn
20.03.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error No adverse event

Symptomtext

that expired ACTHIB had been administered twice with no reported adverse event; Initial information received on 24-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case involves a 5 months old female patient who received expired HIB (PRP/T) vaccine [ACT-HIB] twice with no reported adverse event. The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided. On 20-Mar-2023, the patient received 0.5ml dose of suspect HIB (PRP/T) vaccine (frequency- once, strength - standard, lot - UJ649AAA, expiry date - 03-Mar-2023) via intramuscular route in the thigh nos for prophylactic vaccine. On 20-Mar-2023 the patient received expired acthib twice with no reported adverse event (expired product administered) (latency: same day). 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
-
Allergien
-
Vorherige Impfungen
-

VAERS 2606382

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ649AAA

gering
Staat
TX
Alter
0,3
Geschlecht
M
Eingang
30.03.2023
Impfdatum
20.03.2023
Beginn
20.03.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

Expired ACT-HIB was administered to a patient with no reported adverse event; Initial information received on 24-Mar-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional. This case is linked to case 2023SA096953. This case involves a 3 months old male patient and reporter reported that an expired HIB (PRP/T) vaccine [ACT-HIB] was administered to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided. On 20-Mar-2023, caller reported that 0.5 ml (milliliter) (1x) (once) of an expired HIB (PRP/T) vaccine, powder and solvent for solution for injection (lot UJ649AAA, expiry date: 05-Mar-2023) (Strength: standard) via intramuscular route in the thigh NOS for immunization was administered to a patient with no reported adverse event (expired product administered) (latency: 1 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 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 2603575

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ649AAA

gering
Staat
-
Alter
0,8
Geschlecht
F
Eingang
24.03.2023
Impfdatum
23.03.2023
Beginn
23.03.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
SYR / UN
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Expired product administered No adverse event

Symptomtext

Patient received expired dose of ACtHIB that expired on 3/5/2023. Patient has had no known adverse events until this point.

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

VAERS 2603573

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ649AAA

gering
Staat
-
Alter
-
Geschlecht
F
Eingang
24.03.2023
Impfdatum
20.03.2023
Beginn
20.03.2023
Tage bis Beginn
0,0
Dosis
3
Route/Site
SYR / UN
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Expired product administered No adverse event

Symptomtext

Patient received an expired dose of ActHIB that expired on 3/5/2023. There have been no adverse events until this point.

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

VAERS 2603569

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ649AAA

gering
Staat
-
Alter
0,2
Geschlecht
M
Eingang
24.03.2023
Impfdatum
17.03.2023
Beginn
17.03.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
SYR / UN
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Expired product administered No adverse event

Symptomtext

Patient received expired ActHIB vaccine that expired on 3/5/2023. Patient has no adverse reaction at this point.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
-
Allergien
None
Vorherige Impfungen
-

VAERS 2603134

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ649AAA

gering
Staat
FL
Alter
1,0
Geschlecht
M
Eingang
24.03.2023
Impfdatum
14.03.2023
Beginn
14.03.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered Medication error No adverse event

Symptomtext

received an ACT-HIB vaccine on 14Mar2023 that expired on 05Mar2023 with no reported adverse event; Initial information received on 16-Mar-2023 regarding an unsolicited valid non-serious case from a consumer/non-hcp. This case involves a 1-year-old male patient who received HIB (PRP/T) VACCINE [ACT-HIB] on 14-Mar-2023 that expired on 05-Mar-2023 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant: PCV 13. On 14-Mar-2023, the patient received suspect HIB (PRP/T) VACCINE powder and solvent for solution for injection at an unknown dose (lot UJ649AAA, expiry date: 05-Mar-2023) via intramuscular route in the thigh nos for immunisation. On 14-Mar-2023 the patient received an act-hib vaccine that expired on 05-Mar-2023 with no reported adverse event (expired product administered, same day latency). The caller asks if the dose is valid, if he should be revaccinated, and if so, when. Action taken: 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2599719

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ649AAA

gering
Staat
AL
Alter
1,3
Geschlecht
F
Eingang
20.03.2023
Impfdatum
14.03.2023
Beginn
14.03.2023
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

Symptomtext

expired dose of ACTHIB with an expired diluent were administered with no reported adverse event; Initial information received on 15-Mar-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 15 months old female patient who was administered expired dose of HIB (PRP/T) vaccine [ACT-HIB] with an expired diluent with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Mar-2023, the patient received an expired Booster dose of 0.5 mL of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (Strength: standard) (lot: UJ649AAA; expiry date: 05-Mar-2023 ) via intramuscular route in the right thigh with an expired diluent with no reported adverse event (expired product administered) (same day latency). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event expired dose of acthib with an expired diluent were administered 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 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.; Sender's Comments: US-SA-2023SA085856:01533896

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

VAERS 2599718

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ649AAA

gering
Staat
SC
Alter
-
Geschlecht
F
Eingang
20.03.2023
Impfdatum
-
Beginn
13.03.2023
Tage bis Beginn
-
Dosis
UNK
Route/Site
- / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Expired product administered No adverse event

Symptomtext

expired dose of ACTHIB being administered to a patient with no reported advesre event; Initial information received on 14-Mar-2023 regarding an unsolicited valid non-serious case received via other health professional. This case involves a 12 months old female patient who used expired dose of acthib being administered to a patient with no reported advesre event after receiving vaccine hib (prp/t) vaccine [Act-Hib]. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination. On an unknown date, the patient received suspect hib (prp/t) vaccine (strength, dose, frequency, formulation, route, : unknown) (lot UJ649AAA, Expiry date: 05-Mar-2023) in unknown administration site for prophylactic vaccination (immunization). On 13-MAR-2023 the patient diagnosed with a non-serious expired dose of acthib being administered to a patient with no reported advesre event (expired product administered) (unknown latency) following the administration of hib (prp/t) vaccine. Action taken was not applicable. At time of reporting, the outcome was 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
Expired product administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2598506

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ649AAA

gering
Staat
FL
Alter
1,0
Geschlecht
M
Eingang
17.03.2023
Impfdatum
14.03.2023
Beginn
14.03.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Expired product administered No adverse event

Symptomtext

Expiration date on Hib vaccine was misread as 03/15/23 instead of 03/05/23. Pt was given the vaccine on his LT on 03/14/23 (9 days after expiration). Pt is not experiencing any adverse side effects at this time.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
N/A
Aktuelle Erkrankungen
N/A
Vorgeschichte
N/A
Andere Medikamente
N/A
Allergien
N/A
Vorherige Impfungen
Red and swollen leg. DTaP-Hib-IPV given IM on LT at 2 months on 05/02/2022. Sanofi Pasteur.

VAERS 2596018

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ649AAA

gering
Staat
SC
Alter
1,0
Geschlecht
F
Eingang
14.03.2023
Impfdatum
13.03.2023
Beginn
13.03.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered No adverse event

Symptomtext

Patient was administered on 03/13/2023 reconstituted ActHIB with an expiration date of 03/05/2023. No current reactions. Manufacture (Sanofi Pasteur) contacted for guidance. ActHIB is a non-live virus which should not be counted as a valid dose per CDC guidelines. Patient may be revaccinated as soon as possible with no wait period. Patient's mother notified and made aware of vaccination error and manfacture recommendations. Request to wait on repeat vaccine at this time due to child feeling under the weather from vaccines received yesterday so she will wait a week or so. Will followup with mother in 48hours, to maintain no adverse reactions and schedule followup appointment

Weitere VAERSDATA-Felder
Praegender Schweregrund
Expired product administered
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
NKDA
Vorherige Impfungen
-

VAERS 2591779

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ649AAA

gering
Staat
TN
Alter
1,3
Geschlecht
M
Eingang
06.03.2023
Impfdatum
06.03.2023
Beginn
06.03.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered

Symptomtext

Patient received expired ActHIB, will repeat dose.

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

VAERS 2588554

SANOFI PASTEUR · HIB (ACTHIB) · Charge UJ649AAA

gering
Staat
NC
Alter
0,3
Geschlecht
F
Eingang
28.02.2023
Impfdatum
28.02.2023
Beginn
28.02.2023
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Wrong product administered

Symptomtext

Hib only vaccine was given instead of Pentacel. Parents notified.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Wrong product administered
Hospital-Tage
-
Labordaten
None
Aktuelle Erkrankungen
None
Vorgeschichte
none
Andere Medikamente
Famotidine, nystatin, d-vi-sol, simethicone, baby probiotic
Allergien
NKA
Vorherige Impfungen
-