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Reporte zur Charge UJ091AA

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

2Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
NC 1 TX 1

VAERS 991229

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge UJ091AA

gering
Staat
NC
Alter
35,0
Geschlecht
M
Eingang
01.02.2021
Impfdatum
02.11.2020
Beginn
04.11.2020
Tage bis Beginn
2,0
Dosis
1
Route/Site
SC / LA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: ja Erholt: ja
Dermatitis Skin lesion

Symptomtext

The patient is a healthy 35 yo male with a history of GERD with Barrett's esophagus who experienced an adverse reaction after receipt of two vaccines on 02 NOV 20. He reports these as typhoid and YF-VAX but Agency documentation is rabies (Rabavert SKB ArBA731B) and YF-VAX (PMC UJ091AA-1/21). Facility has a progress note documentation YF-VAX and typhoid (Typhoid Vaccine Vi Capsular Polysaccharide, Lot # R1F781M Expiration date 09/2021). He reports he received IIV 3 days later, although he thought receipt dates were Friday and following Monday. The IIV is documented as 10 NOV, but the other elements are incomplete and may be a late entry. He reports he experienced no immediate adverse reaction after either vaccine receipt episode and denies oral/face/throat/tongue swelling/ urticaria, pruritis, Chest pain, cough, wheezing, SOB, n/v/d. He reports several days later he developed a pruritic fine papular erythematous dermatitis with discrete lesions initially to his arms then his abdomen. He denies vesicles, bruising, or tenderness. He was post op from his laparoscopic surgery and all the incision sites all developed similar peripheral dermatitis, but much more pronounced symptoms at incisional sites. He was seen in surgery clinic for post op 13 NOV 20 who submitted an allergy consult (photo of dermatitis in note) and ER 16 NOV who cultured the site which was negative and prescribed hydroxyzine. The rash fully resolved in 7-10 days. He denies any associated systemic symptoms (fever, headache, myalgias, arthralgias, n//v/d). He has no history of AE to any vaccines.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Dermatitis
Hospital-Tage
-
Labordaten
wound culture rare gram positive rods
Aktuelle Erkrankungen
GERD with Barrets esophogus. lap hiatal hernia repair with fundoplication 10/2020
Vorgeschichte
GERD with Barrets esophogus
Andere Medikamente
none
Allergien
none
Vorherige Impfungen
-

VAERS 960483

SANOFI PASTEUR · YELLOW FEVER (YF-VAX) · Charge UJ091AA

gering
Staat
TX
Alter
24,0
Geschlecht
M
Eingang
21.01.2021
Impfdatum
17.12.2020
Beginn
17.12.2020
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
- / RA
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
No adverse event Product preparation issue

Symptomtext

administered the YF-Vax vaccine mixed with sterile diluent water instead of sodium chloride with no adverse event; Initial information regarding an unsolicited valid non-serious case received from the other health professional. This case involved a 24-year old male patient who experienced administered the YELLOW FEVER VACCINE - US [YF-VAX] mixed with sterile diluent water instead of sodium chloride with no adverse event (Product preparation issue). Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. At the time of the event, the patient had ongoing typhoid. On 17-Dec-2020, the patient received a dose of suspect YELLOW FEVER VACCINE - US (lot number: UJ091AA, expiry date: unknown) via an unknown route of administration in the right arm for prophylactic vaccination. It was an actual medication error due to inappropriate reconstitution technique. On an unknown date, it was reported that reporter noticed that there was a vial of the diluent saline from the Yellow Fever Vaccine. Reporter became aware that the sterile water was used as a diluent with the Yellow Fever instead of the normal saline and yellow fever (Product preparation issue). No adverse events were reported. No treatments were needed. Prescriptions were not written in these cases. At the time of reporting, 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 holders 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
No adverse event
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Typhoid
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-