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Reporte zur Charge UT7102JA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

9Reporte angezeigt
1Todesfaelle
1Hospitalisiert
1Lebensbedrohlich
0Bleibende Schaeden
WA 4 CA 3 AZ 2

VAERS 1499111

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7102JA

kritisch
Staat
CA
Alter
-
Geschlecht
M
Eingang
25.06.2022
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
2
Route/Site
IM / RL
Tod: ja Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Adenovirus test Anaemia Biopsy lung abnormal Bronchoalveolar lavage abnormal Cardiogenic shock Chemotherapy Coagulopathy Cytomegalovirus test negative Death Disease complication Gene sequencing Haemophagocytic lymphohistiocytosis Immunoglobulin therapy Measles Hepatosplenomegaly Herpes simplex test negative Histology Immunosuppressant drug therapy

Symptomtext

vaccine-strain measles; hemophagocytic lymphohistiocytosis; vaccine-strain measles/vaccine-strain varicella; Litarature report: This literature marketed report has been received from the authors of a published article, titled as stated above, and refers to a 19-month-old male was diagnosed with intermediate risk, PRETEXT Ill P+ hepatoblastoma at 14 months of age and treated per AHEP1531 (vincristine/cisplatin/doxorubicin/5-fluorouracil). On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, unk, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). On an unknown date, 11 days after receiving measles-mumps-rubella and varicella vaccines the patient treated per AHEP1531 with vincristine, cisplatin, oxorubicin and 5-fluorouracil for intermediate risk, PRETEXT Ill P+ hepatoblastoma. After two cycles of treatment, he developed skin lesions along his scalp, thigh, and groin with vaccine-strain varicella viremia, treated with acyclovir. The subsequent three months of chemotherapy were complicated by fevers and progressive lung infiltrates with no identified etiology. Despite broad anti-infective coverage and chemotherapy being withheld, progression of his nodules led to an extensive evaluation for bacterial, fungal and viral causes. A lung biopsy showed nodular histiocytic infiltrates with reactive multinucleate cells. Polymerase chain reaction testing and histopathology of the sample were negative for tuberculosis, varicella, adenovirus, herpes simplex and cytomegalovirus. Eventually, next-generation sequencing of a bronchoalveolar lavage sample revealed measles, later confirmed as vaccine-strain through the Center for Disease Control. He developed persistent fevers with worsening anemia, thrombocytopenia, coagulopathy, hepatosplenomegaly, and cardiogenic shock. Ferritin was elevated at 39 994 ng/mL and soluble IL-2R was 3544 U/ml. He was diagnosed with hemophagocytic lymphohistiocytosis (HLH) per HLH-2004 criteria. Rapid whole-genome sequencing was negative for primary HLH and other inborn errors of immunity. He began immunosuppressive therapy (dexamethasone and etoposide) for secondary HLH and Emapalumab-lzsg due to poor upfront response. Measles-directed therapy (ribavirin, IVIG and vitamin A) was initiated once measles was confirmed. Despite these interventions, he succumbed to complications from measles and secondary HLH two weeks after starting HLH-directed therapy. The reporter considered hemophagocytic lymphohistiocytosis to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The reporter considered vaccine-strain measles to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The reporter considered vaccine-strain measles/vaccine-strain varicella to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). Upon internal review, the events vaccine-strain measles and hemophagocytic lymphohistiocytosis were determined to be medically significant. A copy of the published article is attached as further documentation of the patient's experience. This is one of three cases derived from the same literature article.; Sender's Comments: US-009507513-2206USA006539: US-009507513-2206USA006540:; Reported Cause(s) of Death: vaccine-strain measles; hemophagocytic lymphohistiocytosis

Weitere VAERSDATA-Felder
Praegender Schweregrund
Death
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Hepatoblastoma (14 months of age)
Vorgeschichte
-
Andere Medikamente
VARIVAX; VINCRISTINE; CISPLATIN; DOXORUBICIN; FLUOROURACIL 5
Allergien
-
Vorherige Impfungen
-

VAERS 956905

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7102JA

schwer
Staat
WA
Alter
0,8
Geschlecht
M
Eingang
19.01.2021
Impfdatum
07.01.2021
Beginn
07.01.2021
Tage bis Beginn
0,0
Dosis
N/A
Route/Site
IM / LL
Tod: unbekannt Lebensbedrohlich: ja Hospital: ja Disable: unbekannt ER: unbekannt Erholt: ja
Agitation Barium swallow Breath sounds abnormal Bronchoscopy abnormal Condition aggravated Dysphagia Dysphonia Dyspnoea Endotracheal intubation Full blood count Increased upper airway secretion Intensive care Laryngoscopy abnormal Oxygen saturation decreased Respiration abnormal Respiratory distress Respiratory tract congestion Respiratory viral panel

Symptomtext

Patient is a 10-month-old male born at 37 weeks with a history of aortic coarctation s/p surgical repair and angioplasty, left vocal cord hypomobility, and prior episodes of stridor, who presented to ED on 1/7 with 1 day of progressive respiratory distress. He was found to have significant tracheal stenosis during this hospitalization. He presented with symptoms of progressively noisy breathing and muted voice which culminated in an episode of severe respiratory distress with increased secretions and work of breathing. He previously had been on a thickened diet but was cleared by OT to take un-thickened breastmilk after a swallow study had been reassuring against aspiration in June. In the week prior, he had also been transitioned from a preemie nipple to larger size nipple. On the day of presentation, he had also incidentally received his 2nd flu shot prior to respiratory decompensation. In the ED he had oxygen saturation in the low 70s, pronounced work of breathing with tracheal tugging, intercostal and subcostal retractions, and biphasic stridor. He had significant improvement after 1 dose of racemic epi, dexamethasone, and initiation of high-flow nasal cannula on 8 L at 40% FiO2. He was initially transitioned to the floor, but soon became significantly more agitated, tachycardic to the 180s, with recurrence of significant work of breathing, coarse lung sounds, intermittent stridor, self-resolving desaturation to the low 80s. He was given an additional dose of racemic epinephrine due to concern for possible atypical presentation of anaphylaxis. Vital signs improved but given recurrence of respiratory distress, he was transferred to the PICU. In the PICU he received 2 further doses of dexamethasone and two nighttime doses of racemic epinephrine for initial concern for croup. He did not have any further episodes of respiratory distress, continued to improve symptomatically, and vitals stabilized. ENT performed bedside laryngoscopy which revealed a posterior vocal fold notch concerning for glottic and/or subglottic stenosis. He was transferred to the floor on 1/10. Due to concern for aspiration, on 1/11 Pt underwent a video fluoroscopic swallow study, at which time he was found to have fatigue-related pharyngeal phase dysphagia, vocal fold hypomobility, and VF notch. He also had baseline chest rattle and congestion that increased during feeding. These findings were concerning for potential aspiration, so OT recommended returning to half nectar-thickened feeds. On 1/12 ENT performed an exam under anesthesia with micro laryngoscopy and bronchoscopy which revealed complete tracheal rings and severe tracheal narrowing to 2.9 mm. CT angiogram on 01/13 was consistent with complete tracheal rings and did not show evidence of vascular ring or extrinsic compression by a mediastinal mass. Pulmonology was consulted and recommended albuterol (for mucus clearance) and CPT/clapping twice daily, and recommended discharge with racemic epinephrine to be used only in case of respiratory emergency while concurrently calling 911. An EpiPen was also provided as an emergency precaution. After joint decision-making with ENT and family, Pt was discharged home on 01/15 for continued discussion of surgical planning for a slide tracheoplasty. Pt will also follow-up with pulmonology in 4-8 weeks after discharge. He will need pre-operative CHO and outpatient visit with his cardiologist. He will need a repeat VFSS in 4-6 months. He is already established for feeding therapy

Weitere VAERSDATA-Felder
Praegender Schweregrund
Intensive care
Hospital-Tage
8,0
Labordaten
1/7/21: CBCd, RVP-Long, intubation, sedated bronchoscopy
Aktuelle Erkrankungen
None
Vorgeschichte
H/o aortic coarctation s/p repair including repeat valvuloplasty Eczema Stridor Peanut/dairy allergy
Andere Medikamente
Ferrous sulfate, polyvitamin, hydrocortisone 2.5%
Allergien
peanuts, dairy
Vorherige Impfungen
-

VAERS 1066439

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7102JA

mild
Staat
WA
Alter
35,0
Geschlecht
F
Eingang
02.03.2021
Impfdatum
20.02.2021
Beginn
22.02.2021
Tage bis Beginn
2,0
Dosis
N/A
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Myalgia Pain Pain in extremity

Symptomtext

Muscle aches and pains , Arms and Legs

Weitere VAERSDATA-Felder
Praegender Schweregrund
Myalgia
Hospital-Tage
-
Labordaten
None known
Aktuelle Erkrankungen
Skin conditions, vitamin deficiency
Vorgeschichte
skin conditions , vitamin deficiency
Andere Medikamente
unknown
Allergien
NKA
Vorherige Impfungen
-

VAERS 1063431

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7102JA

mild
Staat
AZ
Alter
1,3
Geschlecht
F
Eingang
01.03.2021
Impfdatum
18.02.2021
Beginn
01.03.2021
Tage bis Beginn
11,0
Dosis
2
Route/Site
IM / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Rash

Symptomtext

Mom left message for triage nurse 03/01/2021 @ 1102 stating parents noted a small rash to bell and back today @ 1000. Per voicemail, child otherwise normal (eating well, drinking well, peeing, pooping, active). RN left mom a voicemail explaining that in about 5% of the population a mild, pink rash to the trunk is noted that lasts 2-3 days and occurs approximately 7-12 days after the MMR vaccine. RN advised via voicemail if rash lasts greater than 3 days or turns red to call back to discuss.

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

VAERS 1017753

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7102JA

mild
Staat
AZ
Alter
0,8
Geschlecht
F
Eingang
09.02.2021
Impfdatum
05.02.2021
Beginn
05.02.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Pyrexia Rash

Symptomtext

Fever for 2 days. Rash on leg and face intermittently from time of injection, lasted 3 days.

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

VAERS 929743

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7102JA

mild
Staat
CA
Alter
11,0
Geschlecht
F
Eingang
08.01.2021
Impfdatum
06.01.2021
Beginn
07.01.2021
Tage bis Beginn
1,0
Dosis
7+
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Vaccination site erythema Vaccination site pain Vaccination site vesicles

Symptomtext

Patient noted a blister like lesion in the area of the vaccination on the left upper arm. First noted a day after the vaccination. Did also have expected soreness and erythema to the area. Seen two days after the vaccination and a 0.5 cm flaccid blister noted lateral to the injection site but in the area of the part of the bandaid. Dad states blister is bigger today than it was last evening

Weitere VAERSDATA-Felder
Praegender Schweregrund
Vaccination site pain
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 927962

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7102JA

mild
Staat
WA
Alter
11,0
Geschlecht
M
Eingang
07.01.2021
Impfdatum
04.01.2021
Beginn
04.01.2021
Tage bis Beginn
0,0
Dosis
1
Route/Site
IM / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Injection site pain Injection site swelling Injection site warmth

Symptomtext

patient started having swelling right deltoid after having immunization. warm to touch & burning sensation. Area affected seems to be where he received the menactra

Weitere VAERSDATA-Felder
Praegender Schweregrund
Injection site pain
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
none
Allergien
NKDA
Vorherige Impfungen
-

VAERS 922406

UNKNOWN MANUFACTURER · INFLUENZA (SEASONAL) (NO BRAND NAME) · Charge UT7102JA

gering
Staat
WA
Alter
-
Geschlecht
M
Eingang
06.01.2021
Impfdatum
-
Beginn
-
Tage bis Beginn
-
Dosis
UNK
Route/Site
OT / LL
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product administered to patient of inappropriate age

Symptomtext

it is not recommended to give to a two month old, with no AE; Initial information regarding an unsolicited valid non-serious case received from a other health professional on 23-Dec-2020. This case involves a 2 months old male patient for whom it was reported that it was not recommended to give to a two month old, (product administered to patient of inappropriate age), while he received quadrivalent influenza vaccine (Influenza Quadrival A-B Vaccine). The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided. Concomitant medications included diphtheria vaccine toxoid, hib vaccine conj (Tet Tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (Pentacel); Hepatitis B Vaccine and Rotavirus Vaccine. On an unknown date, the patient received an unknown dose of suspect Influenza Quadrival A-B Vaccine (lot UT7102JA) via intramuscular route in the left vastus lateralis for prophylactic vaccination, who was 2 months old (product administered to patient of inappropriate age). It was a case of potential medication error due to inappropriate age at vaccine administration. At the time of report, no adverse event was reported. 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 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. There will be no information available on the batch number for this case.

Weitere VAERSDATA-Felder
Praegender Schweregrund
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
PENTACEL; HEPATITIS B VACCIN; ROTAVIRUS VACCINE
Allergien
-
Vorherige Impfungen
-

VAERS 918163

SANOFI PASTEUR · INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) · Charge UT7102JA

gering
Staat
CA
Alter
-
Geschlecht
F
Eingang
04.01.2021
Impfdatum
16.12.2020
Beginn
22.12.2020
Tage bis Beginn
6,0
Dosis
2
Route/Site
OT / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Extra dose administered No adverse event

Symptomtext

inadvertently received an additional dose of Fluzone quadrivalent today, with no ae; Initial information received on 22-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional. This case involves a 2 years old female patient who inadvertently received an additional dose of fluzone quadrivalent today (extra dose administered), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV]. The patients past medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided. On 16-Dec-2020, the patient was vaccinated with 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE (lot: UT7102JA; expiration date: 30-Jun-2021) via intramuscular route in the left deltoid. On 22-Dec-2020, 6 days after patient received the vaccine, patient inadvertently received an additional dose of Fluzone quadrivalent (extra dose administered). No adverse event reported at the time of reporting. 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 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
Extra dose administered
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-