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Reporte zur Charge U037808

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

4Reporte angezeigt
0Todesfaelle
1Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
CA 4

VAERS 2464147

UNKNOWN MANUFACTURER · ROTAVIRUS (NO BRAND NAME) · Charge U037808

mild
Staat
CA
Alter
0,3
Geschlecht
F
Eingang
29.09.2022
Impfdatum
19.04.2022
Beginn
19.04.2022
Tage bis Beginn
0,0
Dosis
2
Route/Site
PO / MO
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Pyrexia Vomiting

Symptomtext

Fever 105F after VAXELIS vaccine and vomiting; Fever 105F after VAXELIS vaccine + vomiting; This non-serious spontaneous Safety Report, with reference numbers 02208144/02208142, was received on 19-JUL-2022 and forwarded on 20-JUL-2022 from a physician. The reporter did not provide an assessment of the causal relationship between VAXELIS and the reported event "fever". No further information is expected. FOLLOW-UP INFORMATION was received by a partner on 07-SEP-2022 and forwarded on 09-SEP-202. Additional information was received on 12-SEP-2022. The case is maintained as non-serious. The reporter assessed the causal relationship between Vaxelis and the reported events "Fever 105F after Vaxelis vaccine and vomiting" as related. Further information is expected to clarify patient's duration of hospitalization.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Pyrexia
Hospital-Tage
-
Labordaten
Test Date: 20211203; Test Name: Birth weight; Result Unstructured Data: 6 pounds 10 oz
Aktuelle Erkrankungen
Prophylaxis
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2440227

MERCK & CO. INC. · ROTAVIRUS (ROTATEQ) · Charge U037808

mild
Staat
CA
Alter
0,3
Geschlecht
F
Eingang
12.09.2022
Impfdatum
19.04.2022
Beginn
19.04.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: ja Disable: unbekannt ER: unbekannt Erholt: ja
Pyrexia Vomiting

Symptomtext

fever; vomiting; This spontaneous report was received from a physician via a company representative, referring to a 4-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-APR-2022, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) oral liquid, orally, lot #U037808, expiration date: 26-MAR-2023, (strength was not provided); the patient also was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection, lot number reported as "EW2019", expiration date: 15-APR-2024, (strength and route of administration were not provided) and with a dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, 0.5 milliliter, lot #U7125AA, expiration date: 15-JUL-2024 (strength and route of administration were not provided); all vaccines administered for prophylaxis. On the same date (19-APR-2022), the patient was taken to emergency room due to fever (body temperature showed 105 (units not provided)) and vomiting. It was reported that the patient was hospitalized on an unspecified date due to the events. On an unknown date in 2022, the patient recovered from the events. No treatment was given for fever or the vomiting. The causal relationship between fever and vomiting with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was unknown and the causal relationship between the aforementioned events and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) was reported as related.

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

VAERS 2428340

MERCK & CO. INC. · ROTAVIRUS (ROTATEQ) · Charge U037808

gering
Staat
CA
Alter
0,2
Geschlecht
M
Eingang
03.09.2022
Impfdatum
14.06.2022
Beginn
15.06.2022
Tage bis Beginn
1,0
Dosis
1
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Haematochezia Mucous stools

Symptomtext

bloody and mucus stools; bloody and mucus stools; This spontaneous report was received from a physician and refers to a 8-week-old (discrepant information, also reported as 4-month-old) male patient. The patient was delivered via cesarean section however it was challenging to take him out during the process. When the baby was finally delivered, he was dark blue and only had a heart beat. The patient stayed after birth in the neonatal intensive care unit. He had a significant medical history including birth asphyxia, brain damage and seizures. Concomitant therapies were not reported. On 14-JUN-2022, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #U037808, expiration date: 26-MAR-2023 (both confirmed to be valid), administered orally for prophylaxis (strength was not provided). On 15-JUN-2022, also reported as 1 day after the dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), the patient experienced bloody and mucus stools (haematochezia). The patient was seen by a pediatric gastroenterologist and no treatment was given. The patent was observed and on 17-JUN-2022, the patient recovered from the events. The causal relationship between the events and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown. Upon internal review, the event bloody and mucus stools (haematochezia) was determined to be medically significant.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Haematochezia
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
Brain damage
Vorgeschichte
Medical History/Concurrent Conditions: Birth asphyxia; intensive care; Seizure
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-

VAERS 2424206

MERCK & CO. INC. · ROTAVIRUS (ROTATEQ) · Charge U037808

gering
Staat
CA
Alter
0,2
Geschlecht
F
Eingang
30.08.2022
Impfdatum
24.03.2022
Beginn
24.03.2022
Tage bis Beginn
0,0
Dosis
1
Route/Site
PO / MO
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Aphasia

Symptomtext

Mom states that infant no longer could say "hi", "hair", and "I love you" which she could say before (meaningfully) which happened "immediately" after those shots. I told her that since we don't expect infants at that age to say actual words with intention, I did not believe it was an adverse event. Mom was adamant that I complete a VAERS report. I told her to complete a form also. NO TREATMENT. Mom has refused any more Rotateq after first dose. She received 2 PCV13 doses but has not returned for more. She has had 3 doses of pentacel. Otherwise growing/developing well.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Aphasia
Hospital-Tage
-
Labordaten
none
Aktuelle Erkrankungen
none
Vorgeschichte
none
Andere Medikamente
vit D 400 units/day
Allergien
none known
Vorherige Impfungen
-