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Reporte zur Charge U006165

Verknuepft ueber VAERS_ID mit VAERSDATA, Vax und Symptoms

8Reporte angezeigt
0Todesfaelle
0Hospitalisiert
0Lebensbedrohlich
0Bleibende Schaeden
DE 4 NC 1 TN 1 WV 1 OH 1

VAERS 2228679

MERCK & CO. INC. · ROTAVIRUS (ROTATEQ) · Charge U006165

mild
Staat
NC
Alter
0,4
Geschlecht
F
Eingang
12.04.2022
Impfdatum
30.03.2022
Beginn
31.03.2022
Tage bis Beginn
1,0
Dosis
UNK
Route/Site
PO / MO
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: unbekannt
Injection site bruising Injection site erythema Injection site induration Injection site swelling Pain Product administered at inappropriate site Pyrexia

Symptomtext

6 month old infant presented on 3/30 for well-visit and was prescribed to receive DTaP HepB IPV combined vaccine IM (PEDIARIX), HiB PRP-OMP conjugate vaccine 3 dose IM (PedvaxHIB), Pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13), and Rotavirus vaccine pentavalent 3 dose oral (ROTATEQ) by MD. CMA prepared vaccines and administered DtaP/HepB/IPV IM in patient's right thigh (LOT# 552F4), Hib (PRP-OMP, PedvaxHIB) IM in patient's left thigh (LOT # U024489), Pneumococcal conjugate 13-valent (Prevnar 13) IM in patient's left thigh (LOT # EX1981) and Rotavirus Pentavalent orally (LOT # U006165). CMA documented "pt tolerated well". On 4/2, parent sent message noting patient had fever (102) day after injections and s On 4/2, parent sent message noting patient had fever (102) day after injections and still in pain. RN responded noting fever post injection indicated muscle administration and immune response triggered. RN did note "we could definitely give vaccines in different part of the leg in the future (upper, lateral thigh would be preferable". RN sent communication to MD noting "Vaccines look like they were given low and more central on the thighs? Maybe an inservice/refresher on giving vaccines for potentially less side effects?" MD agree with RN's recommendation. Follow up on 4/4 noted patient's "leg less red?more like bruises and very swollen if you feel it, it's super hard". MD recommended to continue to monitor, use cool compresses, and contact provider if fever reoccurs, red streak or warmth to skin is noted. System lists the following as adverse reactions for PedvaxHIB include irritability, pain, swelling, tenderness at injection sites, and fever. Patient's symptoms are likely and not unusual reaction for vaccine administration. Possible contributing cause could be if vaccine given in suboptimal location (preferred upper, lateral thigh).

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

VAERS 2555786

MERCK & CO. INC. · ROTAVIRUS (ROTATEQ) · Charge U006165

gering
Staat
TN
Alter
0,2
Geschlecht
F
Eingang
10.01.2023
Impfdatum
05.01.2023
Beginn
05.01.2023
Tage bis Beginn
0,0
Dosis
1
Route/Site
PO / MO
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja
Expired product administered No adverse event

Symptomtext

Infant was at the health department for 2 month immunizations. Vaccines were taken from the state refrigerator and scanned in to system prior to administration. Pediarix, Hib, Prevnar, and Rotateq. Vaccines were ordered and scanned prior to administration with no flags noted. Vaccines were administered per protocol. During completion of the administration section of system, it was noted that the Rotateq was expired. RN supervisor notified. Follow up with the infant's mother after the event. Mother reported that child had no adverse effects and was doing well. Per recommendation of Immunization program- Rotateq is to be repeated in 1 month.

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

VAERS 2493599

MERCK & CO. INC. · ROTAVIRUS (ROTATEQ) · Charge U006165

gering
Staat
WV
Alter
0,2
Geschlecht
F
Eingang
31.10.2022
Impfdatum
25.10.2022
Beginn
25.10.2022
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

No additional adverse event; RN calling to report that expired lot of ROTATEQ was administered to patient. Per caller, product expired on 10/18/22 and was administered on 10/25/22. No additional AEs, no PQCs.; This spontaneous report has been received from a nurse, concerning a 2-months-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not mentioned. On 25-OCT-2022, the patient was vaccinated with expired Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 ml once orally for prophylaxis (lot#U006165 has been verified to be a valid lot, expiration date: 18-OCT-2022) (strength, dose regimen and frequency was not reported) (expired product administered). No additional adverse event.

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

VAERS 2355669

MERCK & CO. INC. · ROTAVIRUS (ROTATEQ) · Charge U006165

gering
Staat
DE
Alter
-
Geschlecht
U
Eingang
03.07.2022
Impfdatum
20.06.2022
Beginn
20.06.2022
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 storage error

Symptomtext

No additional AEs; ROTATEQ administered after temperature excursion.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, concomitant medications, pertinent medical history or drug reactions/allergies was not provided. On an unspecified date, there was a temperature excursion reported for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) which was improperly stored at 49.8 Fahrenheit degrees, for 2 hours. There was no previous temperature excursion. On 20-JUN-2022, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #U006165, expiration date 18-OCT-2022, administered orally for prophylaxis (product storage error). No additional adverse events were reported.

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

VAERS 2335496

MERCK & CO. INC. · ROTAVIRUS (ROTATEQ) · Charge U006165

gering
Staat
DE
Alter
-
Geschlecht
U
Eingang
27.06.2022
Impfdatum
20.06.2022
Beginn
20.06.2022
Tage bis Beginn
0,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Product storage error

Symptomtext

No additional AEs or PQC reported; ROTATEQ administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided. On an unknown date, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced temperature excursion with 49.8 Fahrenheit degrees for 2 hours. There was no previous temperature excursion. On 20-JUN-2022, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (2 ml, lot# U006165, expiration date 18-OCT-2022; strength was not reported) orally for prophylaxis (product storage error). No additional adverse events (AEs) or product quality complaint (PQC) was reported.

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

VAERS 2334824

MERCK & CO. INC. · ROTAVIRUS (ROTATEQ) · Charge U006165

gering
Staat
DE
Alter
-
Geschlecht
U
Eingang
25.06.2022
Impfdatum
20.06.2022
Beginn
20.06.2022
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 storage error

Symptomtext

No additional AEs; ROTATEQ administered after temperature excursion; Information has been received from a medical assistant referring to a patient of unknown ages and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 20-JUN-2022, the patient were vaccinated with temperature excursion Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (2ml, lot # U006165, expiration date on 18-OCT-2022) orally for prophylaxis. No additional adverse events was reported. The vaccines had a temperature excursion of 49.8 Fahrenheit (F) for 2 hours. It was also confirmed that no previous temperature excursions occurred.

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

VAERS 2334820

MERCK & CO. INC. · ROTAVIRUS (ROTATEQ) · Charge U006165

gering
Staat
DE
Alter
-
Geschlecht
U
Eingang
25.06.2022
Impfdatum
20.06.2022
Beginn
20.06.2022
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 storage error

Symptomtext

No additional adverse event; ROTATEQ administered after temperature excursion. Temperature 49.8F; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 20-JUN-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #U006165, expiration date: 18-OCT-2022, administered for prophylaxis (strength was not provided). Administered dose of vaccine experienced the temperature excursion of 49.8 degrees Fahrenheit for 2 hours (Product storage error). There was no additional adverse event or product quality complaint reported.

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

VAERS 2219682

MERCK & CO. INC. · ROTAVIRUS (ROTATEQ) · Charge U006165

gering
Staat
OH
Alter
0,2
Geschlecht
F
Eingang
07.04.2022
Impfdatum
01.11.2021
Beginn
22.03.2022
Tage bis Beginn
141,0
Dosis
UNK
Route/Site
OT / -
Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein
Interchange of vaccine products No adverse event

Symptomtext

No additional information provided; she received a dose of ROT ATEQ after ROTARlX; This spontaneous report as received from a medical assistant, referring to a 6 months old female patient. The patient's concurrent conditions, medical history or concomitant medications were not provided. On unspecified dates in November in 2021 and January in 2022 (also reported at 2 months old and 4 months old), the patient received two doses of rotavirus vaccine live oral 1v(ROTARIX) (dose regimen details, lot #, expiration date and indication were not provided) separately. On 22-MAR-2022 (also reported as at 6-months old), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ), oral for prophylaxis (interchange of vaccine products). No additional adverse events were reported.

Weitere VAERSDATA-Felder
Praegender Schweregrund
Interchange of vaccine products
Hospital-Tage
-
Labordaten
-
Aktuelle Erkrankungen
-
Vorgeschichte
-
Andere Medikamente
-
Allergien
-
Vorherige Impfungen
-