VAERS Reports U002397

VAERS 1684729

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U002397

schwer

Staat: AL
Alter: 15,0
Geschlecht: F
Eingang: 09.09.2021
Impfdatum: 08.09.2021
Beginn: 08.09.2021
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: SC / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Seizure like phenomena Syncope

Symptomtext

Event occurred 09/08/2021: Pt had syncopal vs seizure like episode after vaccines. Patient received TDAP, MMR, Varicella, Hep A, HPV 9 and MCV4. Last vaccine given at approx 11:41am. Patient was scared and upset while receiving vaccines. As soon as last vaccine (HPV 9) was given patient had syncopal episode, but also appeared to have a seizure. The seizure like activity only lasted for approx 10 seconds. Patient didn't appear to have a post-ictal period. 911 called at 11:45am. VS at 11:45am BP 110/64, HR 96 and O2sat 99. Fire Dept arrived at 11:52am. Patient evaluated. Mother refused for patient to to hospital. Fire Dept also believes that patient had a seizure based on the way patient was acting. Heavily educated mother on the need for child to go to the doctor to be evaluated. Fire Dept escorted patient to vehicle. 09/09/2021 Called mother this morning to check on patient. Mother states that patient is fine, and she did not take her to the doctor. Mother says that patient is at school this morning.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Seizure like phenomena
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: none
Allergien: NKDA
Vorherige Impfungen: -

VAERS 1864544

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U002397

mild

Staat: TN
Alter: 5,0
Geschlecht: F
Eingang: 12.11.2021
Impfdatum: 09.11.2021
Beginn: 10.11.2021
Tage bis Beginn: 1,0
Dosis: 2
Route/Site: - / RL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Injection site swelling

Symptomtext

3cm pink , slightly swollen areas around injection sites. Hydroxyzine oral . Triamcinolone 0/1% cream

Weitere VAERSDATA-Felder

Praegender Schweregrund: Injection site swelling
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: none
Allergien: -
Vorherige Impfungen: -

VAERS 1757276

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U002397

mild

Staat: SC
Alter: 1,0
Geschlecht: F
Eingang: 03.10.2021
Impfdatum: 27.09.2021
Beginn: 28.09.2021
Tage bis Beginn: 1,0
Dosis: UNK
Route/Site: SC / RA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Abnormal behaviour Autism spectrum disorder Eating disorder Gait disturbance Genital rash Pyrexia Rash Speech disorder

Symptomtext

Loss of milestones and change in behavior x 1 day. Self resolved. Mother describing that child would not eat, drink, talk, walk or crawl. Would just stand there and do nothing. Did not describe any staring or anything to suggest seizure activity. Rash in genitalia and backs of legs x 1 day. Hive like, as described by mother. Also fever x 3 days. Tmax 104 but mostly low grade. At time of visit, mother stating that fever still present but behavior was starting to return to normal. Mainly tried to reassure mother, but she was very upset and wanting report of vaccine event documented

Weitere VAERSDATA-Felder

Praegender Schweregrund: Genital rash
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: None
Vorgeschichte: None
Andere Medikamente: Tylenol at or after vaccine administration
Allergien: None
Vorherige Impfungen: -

VAERS 2569528

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U002397

gering

Staat: TN
Alter: 11,0
Geschlecht: M
Eingang: 27.01.2023
Impfdatum: 23.01.2023
Beginn: 23.01.2023
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: SC / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Expired product administered

Symptomtext

PRESENTS FOR VARICELLA VACCINE #1. VACCINE WAS SCANNED AND ISSUED FOR ADMINISTRATNION TO PATIENT. VACCINE WAS ADMINISTRED AND PATIENT TOLERATED WELL. REQUESTED PATIENT REMAIN IN CLINIC FOR 20 MINUTES AFTER VACCINE GIVEN TO MONITOR FOR REACTIONS. AFTER VACCINE WAS ADMINISTERED, I WAS UNABLE TO DOCUMENT THE ADMINISTRATION AND REALIZED THAT THE VACCINE HAD, IN FACT, EXPIRED THE PREVIOUS DAY. THE EXPIRATION DATE WAS ON A WEEKEND DAY AND THE CLINIC WAS CLOSED, AND THE VACCINE WAS NOT PULLED TO PREVENT USEAGE.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: N/A
Aktuelle Erkrankungen: UNKOWN
Vorgeschichte: NONE KNOWN
Andere Medikamente: UNKOWN
Allergien: NO KNOWN ALLERGIES
Vorherige Impfungen: -

VAERS 2569522

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U002397

gering

Staat: TN
Alter: 14,0
Geschlecht: F
Eingang: 27.01.2023
Impfdatum: 23.01.2023
Beginn: 23.01.2023
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: SC / LA

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: ja

Expired product administered

Symptomtext

PRESENTS FOR VARICELLA VACCINE #1. VACCINE WAS SCANNED AND ISSUED FOR ADMINISTRATNION TO PATIENT. VACCINE WAS ADMINISTRED AND PATIENT TOLERATED WELL. REQUESTED PATIENT REMAIN IN CLINIC FOR 20 MINUTES AFTER VACCINE GIVEN TO MONITOR FOR REACTIONS. AFTER VACCINE WAS ADMINISTERED, I WAS UNABLE TO DOCUMENT THE ADMINISTRATION AND REALIZED THAT THE VACCINE HAD, IN FACT, EXPIRED THE PREVIOUS DAY. THE EXPIRATION DATE WAS ON A WEEKEND DAY AND THE CLINIC WAS CLOSED, AND THE VACCINE WAS NOT PULLED TO PREVENT USEAGE.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Expired product administered
Hospital-Tage: -
Labordaten: N/A
Aktuelle Erkrankungen: UNKOWN
Vorgeschichte: NONE KNOWN
Andere Medikamente: UNKOWN
Allergien: NO KNOWN ALLERGIES
Vorherige Impfungen: -

VAERS 2512064

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U002397

gering

Staat: PA
Alter: 1,3
Geschlecht: U
Eingang: 18.11.2022
Impfdatum: 30.06.2022
Beginn: 04.11.2022
Tage bis Beginn: 127,0
Dosis: UNK
Route/Site: OT / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

No adverse event Product administration error

Symptomtext

no adverse event; patient inadvertently received HAVRIX, MMR II and VARIVAX on 11/4/2022. The same vaccines- HAVRIX, MMR Iand VARIVAX had been administered on 6/30/2022; This spontaneous report was received from a nurse and refers to a 16-month-old patient of an unspecified gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 30-JUN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, recombinant Human albumin (rHa), dose 0.5 ml, lot #T029550, expiration date: 01-SEP-2022, administered subcutaneously (anatomical location was not provided), varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, dose 0.5 ml, lot #U002397, expiration date: 22-JAN-2023, administered subcutaneously for prophylaxis (anatomical location was not provided) and hepatitis a vaccine inactivated (HAVRIX), administered for prophylaxis (dose, route of administration, lot #, expiry date, and anatomical location were not provided). On 04-NOV-2022, the patient inadvertently received (product administration error) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, recombinant Human albumin (rHa), dose 0.5 ml, lot #U029619, expiration date: 22-SEP-2023, administered subcutaneously (anatomical location was not provided), varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, dose 0.5 ml, lot #U008182, expiration date: 04-NOV-2023, administered subcutaneously for prophylaxis (anatomical location was not provided) and hepatitis a vaccine inactivated (HAVRIX), administered for prophylaxis (dose, route of administration, lot #, expiry date, and anatomical location were not provided). No additional adverse events reported.

Weitere VAERSDATA-Felder

Praegender Schweregrund: No adverse event
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 2480476

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U002397

gering

Staat: VA
Alter: 1,3
Geschlecht: M
Eingang: 17.10.2022
Impfdatum: 14.10.2022
Beginn: 14.10.2022
Tage bis Beginn: 0,0
Dosis: 1
Route/Site: SC / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Extra dose administered

Symptomtext

unable to reach mom to discuss 3 attempts

Weitere VAERSDATA-Felder

Praegender Schweregrund: Extra dose administered
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: none
Vorgeschichte: none
Andere Medikamente: none
Allergien: none
Vorherige Impfungen: -

VAERS 1817128

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U002397

gering

Staat: FL
Alter: -
Geschlecht: U
Eingang: 26.10.2021
Impfdatum: 13.10.2021
Beginn: 13.10.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: - / LL

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

Incorrect product formulation administered

Symptomtext

No additional AE; PROQUAD and VARlVAX instead of VARlVAX and MMR II.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 13-OCT-2021, the patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (lot# U010742, expiration date was reported as 03-OCT-2022, but upon internal validation established as 02-OCT-2022, 0.5 milliliter in the right thigh) and varicella virus vaccine live (oka/merck) (VARIVAX) (lot# U002397, expiration date 22-JAN-2023, 0.5 ml into left thigh) (formulations, concentrations, dose numbers, frequencies and routes of administration were not reported) for prophylaxis. The measles (+) mumps (+) rubella (+) varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was administered (instead of measles (+) mumps (+) rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II)) (overdose). Both of administered vaccines were dissolved in sterile diluent lot# T013004, expiration date 13-NOV-2022, 0.7 ml (formulation , strength, route of administration, frequency were not reported). No additional adverse event was reported (no adverse event).

Weitere VAERSDATA-Felder

Praegender Schweregrund: Incorrect product formulation administered
Hospital-Tage: -
Labordaten: -
Aktuelle Erkrankungen: Prophylaxis
Vorgeschichte: -
Andere Medikamente: -
Allergien: -
Vorherige Impfungen: -

VAERS 1794403

MERCK & CO. INC. · VARICELLA (VARIVAX) · Charge U002397

gering

Staat: MD
Alter: -
Geschlecht: U
Eingang: 18.10.2021
Impfdatum: 28.09.2021
Beginn: 28.09.2021
Tage bis Beginn: 0,0
Dosis: UNK
Route/Site: - / -

Tod: unbekannt Lebensbedrohlich: unbekannt Hospital: unbekannt Disable: unbekannt ER: unbekannt Erholt: nein

No adverse event Product storage error

Symptomtext

No further AE reported / No additional AEs reported; VARIVAX underwent a temperature excursion and was then administered to a patient; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 28-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliters (ml) (route of administration, anatomical site of vaccination, and vaccine scheme were not reported; lot number U002397 has been verified to be valid, expiration date reported and established as 22-JAN-2023) as prophylaxis. The vaccine underwent a temperature excursion of minus 14 degrees Celsius (-14 C) to minus 10 degrees Celsius (-10 C) during a time frame of 1 hour and 30 minutes; minus 10 degrees Celsius (-10 C) to 8 degrees Celsius (-9.68 C) for 15 minutes. There was no previous temperature excursion (product storage error). No further adverse event reported (no adverse event).

Weitere VAERSDATA-Felder

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