VAERS Reports U002540

VAERS 1553701

MERCK & CO. INC. · MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) · Charge U002540

mild

Staat: TN
Alter: 4,0
Geschlecht: F
Eingang: 13.08.2021
Impfdatum: 10.08.2021
Beginn: 11.08.2021
Tage bis Beginn: 1,0
Dosis: 2
Route/Site: SC / RA

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

Injection site erythema Injection site pain Injection site swelling Injection site warmth

Symptomtext

8/10/21 evening, patient began to c/o pain to left arm. On the morning of 8/11/21, patient c/o severe left arm pain and there was redness and swelling to injection site. Later on 8/11/21 caretaker noticed tactile warmth at injection site. Mom was advised to apply cold compress in 10 minute increments and monitor for fever. By 8/12/21, the redness and tactile warmth had worsened and patient was seen in our office. Caretaker also noticed on 8/12/21 that the right arm had some tactile warmth but no swelling or redness.

Weitere VAERSDATA-Felder

Praegender Schweregrund: Injection site erythema
Hospital-Tage: -
Labordaten: none
Aktuelle Erkrankungen: UTI, constipation
Vorgeschichte: childhood obesity
Andere Medikamente: polyethylene glycol
Allergien: PCN
Vorherige Impfungen: -

VAERS 1398627

MERCK & CO. INC. · MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) · Charge U002540

gering

Staat: TN
Alter: -
Geschlecht: U
Eingang: 15.06.2021
Impfdatum: -
Beginn: -
Tage bis Beginn: -
Dosis: UNK
Route/Site: - / -

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

No adverse event Product storage error

Symptomtext

a temperature excursion for PROQUAD, VARlVAX, and MMR II; products may have been administered; No additional AE's/PQC's noted.; This spontaneous report as received from an other reporter and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients might have been vaccinated with improperly stored doses of: - Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot # U002540, expiration date 24-JUL-2022, - Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), lot # S020161, expiration date 30-JUN-2021, albumin status rHA and lot # T007230, expiration date 27-FEB-2022, albumin status rHA, - varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # S033953, expiration date 24-OCT-2021 and lot # T027305, expiration date 12-AUG-2022. Doses and routes of administration were not reported. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 9 to 25 (13.1) degrees Celsius for 4 hours and 26 minutes. There was no previous excursion of -10 to 8 (8.1) degrees Celsius for 1 hour and 37 minutes reported. Data logger was involved.

Weitere VAERSDATA-Felder

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

VAERS 1387429

MERCK & CO. INC. · MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) · Charge U002540

gering

Staat: TX
Alter: -
Geschlecht: U
Eingang: 10.06.2021
Impfdatum: 12.05.2021
Beginn: 12.05.2021
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 dose omission issue Product quality issue

Symptomtext

No additional AEs.; Since the patient did not receive the varicella portion of what would have been PROQU AD received, a missed dose AE is being filed; a different color than normal. It was off in color and reported to be slightly tannish.; Product foaming; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported. The reporter received 20 vials of new measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) and on 12-MAY-2021, when a nurse reconstituted a vial she noticed a different color than normal. It was off in color and slightly tannish. The lyophilized powder appeared as it normally did and the sterile diluent (indication: prophylaxis, dose, strength, route were not reported, lot# T008475, expiration date 19-NOV-2022) was the same as usual. The reporter also reported that there was foam in the vial. The patient did not receive measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) 0.5 ml (lot# U002540, expiration date 24-JUL-2022, dose, route and anatomical location were not reported) for prophylaxis on that day (missed dose) as the reporter did not want to use any of the 20 vials. The patient instead received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The reporter did not have a varicella vaccine on site to give the patient as a complete replacement for the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD). No additional adverse events were reported.

Weitere VAERSDATA-Felder

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