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Reporte zur Charge UJ678AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

8Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
SC 2 CA 2 UT 1 HI 1 MI 1 WA 1

VAERS 2675271

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ678AA

mild
Staat
SC
Alter
1,3
Geschlecht
F
Eingang
22.08.2023
Impfdatum
15.08.2023
Beginn
15.08.2023
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Hypersensitivity Laboratory test Pyrexia Swelling face Urticaria

Symptomtext

fever of 101.4?F; facial swelling; hives all over the body/welts all over the body; allergic reaction with the PENTACEL; Initial information received on 18-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Non-healthcare professional). This case involves a 1 years old female patient who experienced facial swelling, hives all over the body/welts all over the body, allergic reaction with the pentacel and fever of 101.4?f 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) and family history were not provided. On 15-Aug-2023, the patient received 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: UJ678AA) (Strength: Standard) (Frequency: Once) (1 X) (with an unknown expiry date) via intramuscular (Left Vastus Lateralis Intramuscular) route in unknown administration site for immunization. On 15-Aug-2023, the patient developed events of facial swelling (swelling face), hives all over the body/welts all over the body (urticaria) and allergic reaction with the pentacel (hypersensitivity) (Latency: same day). On 16-Aug-2023, the patient developed an event of fever of 101.4?f (pyrexia) (latency: 1 day). Relevant laboratory test results included: Body temperature - On 16-Aug-2023: 101 F It was reported, Patient's mother reporting an adverse event on behalf of her daughter. Patient's mother reported that her daughter had a sever allergic reaction to PENTACEL. Patient's mother reported that her daughter was given PENTACEL last 15Aug2023. Patient experienced facial swelling, hives and welts all over the body 2 hours after the vaccine was given. Patient was given IBUPROFEN and BENADRYL for the fever and hives as per the advise of her nurse. On 16Aug2023, patient's full body was covered with hives and had a fever of 101.4?F. Patient was rushed to the ER as per the HCP's advice. After a few hours that the patient was the patient was sent home from the ER, the patient had the hives again and patient's mother called back their doctor and the patient was given PREDNISONE and BENADRYL. Patient's mother reported that the patient's hives will re-appear if BENADRYL's effect would run out. Patient went back to the doctor and HCP confirmed that the patient had an allergic reaction with the PENTACEL. Patient's mother reported that the patient will undergo testing as per HCPs advice. Patient's mother was asking compensation for the laboratory tests and treatment that was done on her daughter. Customer relations number was given to the patient's mother. Case number was given to the patient's mother for reference Action taken: not applicable. The patient was treated with PREDNISONE (PREDNISONE) for Urticaria, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Urticaria and IBUPROFEN (IBUPROFEN) for Pyrexia. Outcome: Not Recovered / Not Resolved for the reported events

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
Test Date: 20230816; Test Name: Body temperature; Test Result: 101 {DF}
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2672761

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ678AA

mild
Staat
SC
Alter
1,3
Geschlecht
F
Eingang
17.08.2023
Impfdatum
15.08.2023
Beginn
15.08.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: nein
Breath holding Confusional state Decreased appetite Feeling abnormal Irritability Pyrexia Rash Swelling face Urticaria

Symptomtext

My daughter received pentacel for the first time along with Prevnar 13(which she previously had several doses of) for her 15 month check up. She was administered the vaccine at 3:30 p.m. on 08/15/2023. We stopped to pick up a few groceries on the way home and by the time I got her home at 5:30 to put her in the bath, I took of her diaper and saw huge whelts and hives localized to the lower left side of her back. We knew she had not been bit or strung, and that she had not had any new foods so we could rules out any of those things and knew it was a reaction to the new vaccine. She had a breath-holding spell upon adminsitration of the vaccine, was fussy in between the doctor's office and home. Once we identified the reaction, we sent photos to the after hours triage nurse and were told at first that itt probably wasn't a reaction since it was localized, however, then they asked us about the vaccines they did send the photos to the doctor and they advised ibuprofen, we also gave pt. benadryl because we knew she was having an allergic reaction based on other family member's history of anaphylaxis due to other sources. Pt. would not drink her milk that evening before bed. The next morning she seemd okay, but upon waking up from her nap at 11:45 a.m. Pt. seemed very dazed and confused, and her whole body was covered with hives, whelts and her face swollen. I called the doctor's office and they advised that I give her benadryl and take her to the ER since they could not see her right away. I gave her 6mg of benadryl. Upon arrival to the hospital her symptoms were subsiding however she had a 101.4 fever. They took her vitals and gave her the appropriate dose of ibuprofen. The ER doctor was able to rule out any other causes of the reaction and said that it was from the vaccine. However, he kept saying that she had a rash to us and in his notes even though the photos indicate hives and whelts, as well as a high fever. Upon discharging from the ER and returning home at 3:30 p.m., I took pt. out of the car and she was having an outbreak of welts and hives again on her legs and arms. I called the doctor's office again and they told me to give her another dose of benadryl since itw as almost 4 hours since she had it. The doctor then prescribed prednison to take for 6 days to help alleviate pt.'s symptoms.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
-Well-Check and Vaccines Administered (08/15/2023 -Triage Nurse After hours call (08/15/2023) -Several calls with doctor's office over phone before and after ER (08/16/2023) -ER visit where they checked vitals and adminsitered medicine. (08/16/2023)
Aktuelle Erkrankungen
None
Vorgeschichte
None
Andere Medikamente
Vitamin D Drops
Allergien
None
Vorherige Impfungen
-

VAERS 2573902

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ678AA

mild
Staat
UT
Alter
1,3
Geschlecht
F
Eingang
01.02.2023
Impfdatum
23.01.2023
Beginn
31.01.2023
Tage bis Beginn
8,0
Dosis
3
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site erythema Vaccination site pain Vaccination site swelling Vaccination site warmth

Symptomtext

1/31/2023 - redness at vaccine site 2/1/2023 - red, swollen, hot to touch, bigger in size at vaccine site

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

VAERS 2491574

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge uj678aa

mild
Staat
CA
Alter
0,3
Geschlecht
F
Eingang
27.10.2022
Impfdatum
11.10.2022
Beginn
11.10.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Eye movement disorder Eyelid ptosis Fatigue Immunisation reaction Posture abnormal Pyrexia Unresponsive to stimuli

Symptomtext

Spoke to Mom about pt.'s immunization reaction. Pt. received Dtap/IPV/HIB, Hep B, and Rotavirus at 9:30 AM on 10/11. Mom reported that she first noticed pt.'s fever around 7:30 PM on 10/11, temperature of 101.7 F. Mom went work and Grandma was watching pt., when about 30 minutes she was unresponsive. Grandma reported that her head was tilted back, her eyes rolled back, and unresponsive. The timing of this episode is unclear because Grandma had stepped away for about a minute and realized this once coming back. Mom reported they then took pt. to Urgent Care where she appeared exhausted, with droopy eyes, and had a temp of 100.7 F. Mom stated that they administered Tylenol and advised her to continue the Tylenol for the next 24 hours. Later that night pt.'s fever broke. Mom stated that the next morning, 10/12, pt. appeared to be behaving normally. She since has not had any symptoms. Mom reports no concerns, she has been feeding well and has plenty of wet diapers.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Fatigue
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none known
Vorherige Impfungen
-

VAERS 2652510

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ678AA

gering
Staat
HI
Alter
2,0
Geschlecht
M
Eingang
05.07.2023
Impfdatum
30.06.2023
Beginn
30.06.2023
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 error

Symptomtext

giving the liquid component of the Pentacel to a child/lyophilized component wasn't mixed with the liquid component, with no reported adverse event; Initial information received on 30-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 2 years old male patient who was given the liquid component of the diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV(vero)/ HIB(PRP/T) vaccine [Pentacel (Vero)] / lyophilized component wasn't mixed with the liquid component, 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 pneumococcal vaccine conj 13V (CRM197) (Prevnar 13) for Prophylactic vaccination (immunization). On 30-Jun-2023, the patient received 0.5 mL dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV (vero)/HIB(PRP/T) vaccine, suspension for injection (batch number: UJ678AA (Act-Hib); Expiry date: 09-sep- 2023; Batch number: U7311AA (DTAP-IPV), Expiry date: 09-sep- 2023) via intramuscular route in left leg for Immunization, only given the liquid component of the pentacel to a child/ lyophilized component wasn't mixed with the liquid component, with no reported adverse event (product preparation error) (same day latency). Action taken: not applicable. At time of reporting, the outcome was Unknown for the event giving the liquid component of the pentacel to a child/ lyophilized component wasn't mixed with the liquid component, 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.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PREVNAR 13
Allergien
-
Vorherige Impfungen
-

VAERS 2619642

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ678AA

gering
Staat
CA
Alter
0,3
Geschlecht
F
Eingang
21.04.2023
Impfdatum
13.04.2023
Beginn
13.04.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Hypotonia Unresponsive to stimuli

Symptomtext

On 4/13/2023 child had Immunizations (Pentacel, Prevnar, Rotateq) after 7 to 10 minutes that Immunizations were given child became limp, not responding (parent already in the car with infant on carseat) episode lasted 5-10 minutes child's color was good, breathing, during episode

Weitere VAERSDATA-Felder
Praegender Schweregrund
Hypotonia
Hospital-Tage
-
Labordaten
Physical exam after event, child was active normal vital signs
Aktuelle Erkrankungen
None (HAD COVID infection 1/19/2023
Vorgeschichte
Capilar venous malformation (cheeck/Face
Andere Medikamente
Propanolol 4.28mg/mL Takes 1.7 ml TID
Allergien
None
Vorherige Impfungen
-

VAERS 2612254

SANOFI PASTEUR · DTAP + IPV + HIB (PENTACEL) · Charge UJ678AA

gering
Staat
MI
Alter
2,0
Geschlecht
F
Eingang
10.04.2023
Impfdatum
03.04.2023
Beginn
03.04.2023
Tage bis Beginn
0,0
Dosis
4
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
No adverse event Product preparation issue

Symptomtext

Patient was only vaccinated with the Pentacel diluent. The nurse did not mix the diluent with the powder vial to compound the vaccine. The dose was not a valid and needs to be repeated. No adverse signs or symptoms.

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

VAERS 2603135

UNKNOWN MANUFACTURER · VACCINE NOT SPECIFIED (NO BRAND NAME) · Charge UJ678AA

gering
Staat
WA
Alter
0,2
Geschlecht
M
Eingang
24.03.2023
Impfdatum
13.03.2023
Beginn
13.03.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
OT / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Medication error No adverse event Product preparation error

Symptomtext

patient was administered the Hib portion of PENTACEL that was mixed with a sterile water diluent rather than the DTaP-IPV diluent,with no reported adverse event; Initial information received on 16-Mar-2023 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 2 months old male patient and reporter reported that he was administered the hib portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (VERO)] was mixed with a sterile water diluent rather than the dtap-ipv diluent,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 hepatitis B vaccine for Immunisation; pneumococcal vaccine CONJ (pneumococcal conjugate vaccine) for Immunisation; and rotavirus vaccine (rotavirus vaccine) for Immunisation. On 13-Mar-2023, the patient received 0.5 ml (milliliter) (dose 1) (once) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection, (strength: standard) (lot UJ678AA, expiry date: 09-Sep-2023) via intramuscular route in the right vastus lateralis for immunization. On 13-Mar-2023, the patient was administered the hib portion of pentacel that was mixed with a sterile water diluent rather than the dtap-ipv diluent with no reported adverse event (product preparation error) (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 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
-