- Staat
- CA
- Alter
- 5,0
- Geschlecht
- M
- Eingang
- 02.08.2022
- Impfdatum
- 02.08.2022
- Beginn
- 02.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- SC / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: nein
Dyspnoea
Oxygen saturation decreased
Symptomtext
Shortness of breath, low O2 saturation.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Dyspnoea
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- UT
- Alter
- 1,0
- Geschlecht
- M
- Eingang
- 26.10.2022
- Impfdatum
- 08.06.2022
- Beginn
- 08.10.2022
- Tage bis Beginn
- 122,0
- Dosis
- 1
- Route/Site
- SC / UN
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: nein
Blister
Haemorrhage
Herpes zoster
Pain
Polymerase chain reaction positive
Pustule
Rash erythematous
Skin lesion
Varicella virus test positive
Symptomtext
Developed lesions on the right leg that started 10/8/22 or 10/9/22. Grouped pustules and hemorrhagic vesicles on an erythematous base in a dermatomal distribution with viral PCR positive for VZV consistent with herpes zoster infection. No history of chickenpox but did receive first dose of varicella vaccine approximately 4 months prior. Was given IV acyclovir, treated for aggressive pain control with ice packs/cool compresses and systemic analgesics.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pain
- Hospital-Tage
- -
- Labordaten
- 10/10/2022 - lesion positive for varicella zoster virus (VZV) by PCR
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- PCP concern for immunodeficiency. Congenital dermal melanocytosis. Third admission in a year (febrile UTI, COVID, PNA).
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- -
- Alter
- 22,0
- Geschlecht
- F
- Eingang
- 03.08.2022
- Impfdatum
- 01.08.2022
- Beginn
- 02.08.2022
- Tage bis Beginn
- 1,0
- Dosis
- UNK
- Route/Site
- SC / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Rash
Symptomtext
Patient received varicella vaccine on 8/1/2022 and developed a rash on 8/2/2022. No fever, swelling, or respiratory symptoms.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- -
- Geschlecht
- U
- Eingang
- 02.02.2023
- Impfdatum
- 25.01.2023
- Beginn
- 25.01.2023
- 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 additional AE details available; Caller is a HBP in charge of vaccine storage. She reports one dose of VARIVAX that had experienced multiple excursions throughout the month of January was administered to one patient. Product was administered 1/25/2023; This spontaneous report has been received from an office Manager, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported. On 25-JAN-2023, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection as prophylaxis (lot number: U039949, which was determined to be valid, with an expiration date on 16-DEC-2023) (strength, dose, schemer, route and anatomical location of administration were not reported) (product storage error). The administered dose underwent a temperature excursion, but as they did not use a data logger, they did not have cumulative data to know at what temperature and during which period of time it was improperly storage, but after completing temperature check it was noted the temperature excursion happened multiple times throughout the month of January. The highest temperature noted was 12.9 degrees Fahrenheit (F). It was reported that there was not any previous temperature excursion. No additional adverse event was reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CA
- Alter
- 29,0
- Geschlecht
- F
- Eingang
- 06.10.2022
- Impfdatum
- 01.09.2022
- Beginn
- 01.09.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- SC / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Incorrect product formulation administered
No adverse event
Symptomtext
no symptoms at time of administration. Given monovalent Moderna for booster inadvertently.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect product formulation administered
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- None
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- 0,9
- Geschlecht
- M
- Eingang
- 16.08.2022
- Impfdatum
- 16.08.2022
- Beginn
- 16.08.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- SC / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Inappropriate schedule of product administration
No adverse event
Symptomtext
No adverse symptoms noted. Vaccines were administered five days earlier than minimum valid date. Provider in office was notified. Father was also notified while in office and advised vaccines will need to be given again. Father educated to monitor for signs of adverse reactions and advised to report them. Father verbalized understanding.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- NM
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.07.2022
- Impfdatum
- 14.06.2022
- Beginn
- 14.06.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Incorrect dose administered
Symptomtext
No additional AE details provided.; Medical assistant calling reported he inadvertently administered PROQUAD and VARIVAX concomitantly to a patient.; This spontaneous report has been received from a medical assistant concerning to a patient of unknown age and gender. The patient's concomitant medications included sterile diluent. The medical history, drug reactions or allergies and concurrent conditions were not reported. On 14-JUN-2022, the patient was administered inadvertently a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) lot # W004030, expiration date 02-AUG-2023 (dose, route of administration and anatomical location were not provided) and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039949, expiration date 16-DEC-2023 (dose, route of administration and anatomical location were not provided) (accidental overdose). No additional events were reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- STERILE DILUENT
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- U
- Eingang
- 25.06.2022
- Impfdatum
- -
- Beginn
- 01.05.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No further Adverse event details; they just found out they had another TE 1 week ago/-14?C up to-10?C (-12C) for 0 hours 50 minutes 0 seconds; This spontaneous report was received from a pharmacist regarding a patient of an unknown age and unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. Between 11-MAY-2022 and 24-MAY-2022, varicella virus vaccine live (oka/merck) (VARIVAX) lot #U039949, expiration date: 16-DEC-2023 (strength, and route of administration were not provided) was administered, following a temperature excursion (product storage error). The temperature was reported as -14 degree Celsius (C) up to-10 C for 2 hours 5 minutes 0 seconds; -10 C up to 8 C (-0.4 C) for 1 hour 25 minutes 0 seconds, there was a previous temperature excursion, reported as -14 C up to-10 C (-12 C) for 0 hours 50 minutes 0 seconds. No additional adverse events had been reported (no adverse event). No additional information was provided.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- STERILE DILUENT
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- U
- Eingang
- 25.06.2022
- Impfdatum
- 01.05.2022
- Beginn
- 01.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE details; Customer calling for TE evaluation of VARIVAX/ Temperature -14?C up to-10?C for 2 hours 5 minutes 0 seconds ; -10?C up to 8?C (-0.4C) for 1 hour 25 minutes 0 seconds; they just found out they had another TE 1 week ago/-14?C up to-10?C (-12C) for 0 hours 50 minutes 0 seconds; This spontaneous report was received from other unspecified reporter, regarding to a patient of unknown age, gender and race. The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported. On an unspecified date in May 2022 (also reported as "a week ago and between 11-MAY-2022 and 24-MAY-2022") they reported that varicella virus vaccine live (oka/merck) (VARIVAX) with the lot number U039949 that has been verified to be valid (expiration date: 16-DEC-2022) underwent a temperature excursion at about 14 degrees Celsius (?C) up to 10?C (-12C) for 50 minutes; 14?C up to-10?C for 2 hours and 5 minutes; and finally from-10?C up to 8?C (-0.4C) for 1 hour and 25 minutes; then on an unspecified date in May 2022 (also reported as between 11-MAY-2022 and 24-MAY-2022), the patient was vaccinated with one of this doses of varicella virus vaccine live (oka/merck) (VARIVAX) and sterile diluent (dose, frequency, strength, and route of administration were not provided) for prophylaxis. No further adverse event (AE) details were available.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- U
- Eingang
- 23.06.2022
- Impfdatum
- 01.05.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
VARIVAX has been administered with an inappropriate storage; No adverse event; This spontaneous report was received from a customer and referring to a patient of unknown age and gender. The patient's medical history, drug reactions, allergies, concurrent conditions were not reported. Concomitant medication included sterile diluent (MERCK STERILE DILUENT). On an unknown date in May 2022 (between 11-MAY-2022 and 24-MAY-2022), the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U039949 with expiration date: 16-DEC-2023, for prophylaxis (strength, dose and route of administration were not provided) (product storage error). The vaccine underwent temperature excursion of -14 Celsius degree up to-10 Celsius degree for 2 hours 5 minutes; -10 Celsius degree up to 8 Celsius degree (-0.4C) for 1 hour 25 minutes. Previous temperature excursion was -14 Celsius degree up to-10 Celsius degree (-12C) for 50 minutes; 8.1 degrees Fahrenheit for 17 minutes and 9.5 degrees Fahrenheit for 21 minutes. No additional adverse event details was reported. This is one of 13 reports received from the same reporter.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- MERCK STERILE DILUENT
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- U
- Eingang
- 23.06.2022
- Impfdatum
- 01.05.2022
- Beginn
- 01.05.2022
- 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 adverse event; Customer states she called yesterday 5/24/2022 to report a TE but they just found out they had another TE 1 week ago and they need to report that at this time.; This spontaneous report was received from a costumer referring to an unknown age and gender patient. The patient's concurrent conditions and medical history were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT). On an unknown date in May 2022 (between 11-MAY-2022 and 24-MAY-2022), the patient was vaccinated with a varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U039949 has been verified to be valid, expiration date 16-DEC-2023) (dose regimen, route of administration and anatomical location were not reported), for prophylaxis that underwent a temperature excursion (TE) (Product storage error). The time frame of the temperature excursion was -14 degree Celsius (C) up to -10C for 2 hours 5 minutes 0 seconds; -10C up to 8C (-0.4C) for 1 hour 25 minutes 0 seconds. A previous temperature excursion occurred with temperatures of -14C up to -10C (-12C) for 0 hours 50 minutes 0 seconds. No adverse event occurred. This is one of 13 reports received from the same reporter.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- MERCK STERILE DILUENT
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- U
- Eingang
- 17.06.2022
- Impfdatum
- 01.05.2022
- Beginn
- 01.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No additional AE details; patient was vaccinated with VARIVAX after temperature excursion; This spontaneous report was received from a customer and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and drug reactions/allergies were not reported. Concomitant therapy was sterile diluent (manufacturer: Merck). On an unknown date in May 2022 (between 11-MAY-2022 and 24-MAY-2022), the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (valid lot #U039949 with expiration date: 16-DEC-2023; dose, and route of administration were not provided) for prophylaxis after temperature excursion -14 Celsius degrees up to -10 Celsius degrees for 2 hours 5 minutes 0 seconds; and -10 Celsius degrees up to 8 Celsius degrees (-0.4 Celsius degrees) for 1 hour 25 minutes 0 seconds (Product storage error). 1 week ago, this vaccine had another temperature excursion with -14 Celsius degrees up to-10 Celsius degrees (-12 Celsius degrees) for 0 hours 50 minutes 0 seconds. There were no additional adverse event details (no adverse event). This is one of 13 reports received from the same reporter.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- STERILE DILUENT
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- U
- Eingang
- 15.06.2022
- Impfdatum
- 01.05.2022
- Beginn
- 01.05.2022
- 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 adverse event; Customer calling for TE evaluation of VARIVAX. Customer states she called yesterday 5/24/2022 to report a TE but they just found out they had another TE 1 week ago and they need to report that at this time.; This spontaneous report was received from a costumer referring to an unknown age and gender patient. The patient's concurrent conditions and medical history were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT). On an unknown date in May 2022 (between 11-MAY-2022 and 24-MAY-2022), the patient was vaccinated with a varicella virus vaccine live (oka/merck) (VARIVAX) that underwent a temperature excursion (TE) (Product storage error). The time frame of the temperature excursion was -14 degree Celsius (C) up to -10C for 2 hours 5 minutes 0 seconds; -10C up to 8C (-0.4C) for 1 hour 25 minutes 0 seconds. A previous temperature excursion occurred with temperatures of -14C up to -10C (-12C) for 0 hours 50 minutes 0 seconds. No adverse event occurred. This is one of 13 reports received from the same reporter.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- STERILE DILUENT
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- U
- Eingang
- 08.06.2022
- Impfdatum
- 01.05.2022
- Beginn
- 01.05.2022
- 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 additional AE details; Just found out they had another TE / Varivax has been administered; This spontaneous report was received from an unspecified reporter (customer, reported as "Other") referring to a patient of unspecified age and gender. The patient's concurrent conditions, medical history, and concomitant therapies were not reported. The reporter informed about a temperature excursion (TE) "1 week ago" for vaccines of varicella virus vaccine live (Oka/Merck) (VARIVAX), as follows: temperature -14 Celsius degrees up to -10 Celsius degrees for 2 hours 5 minutes 0 seconds; -10 Celsius degrees up to 8 Celsius degrees (-0.4C) for 1 hour 25 minutes 0 seconds; previous temperature excursion: -14 Celsius degrees up to -10 Celsius degrees (-12C) for 0 hours 50 minutes 0 seconds. On an unknown date between 11-MAY-2022 and 24-MAY-2022, the patient was administered a dose of these varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccines (lot # U039949 has been verified to be a valid lot number, expiration date: 16-DEC-2023; dose and route of administration not reported) administered for prophylaxis (Product storage error); additional product reported included sterile diluent (MERCK STERILE DILUENT) (reported as "DILUENT MRK"). There were no additional adverse event (AE) details provided (No adverse event). There was no product quality complaint (PQC).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- U
- Eingang
- 08.06.2022
- Impfdatum
- 01.05.2022
- Beginn
- 01.05.2022
- 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 additional AE details; Just fount out they had another TE / Varivax has been administered; This spontaneous report was received from an unspecified reporter (customer, reported as "Other") referring to a patient of unspecified age and gender. The patient's concurrent conditions, medical history, and concomitant therapies were not reported. The reporter informed about a temperature excursion (TE) "1 week ago" for vaccines of varicella virus vaccine live (Oka/Merck) (VARIVAX), as follows: temperature -14 Celsius degrees up to -10 Celsius degrees for 2 hours 5 minutes 0 seconds; -10 Celsius degrees up to 8 Celsius degrees (-0.4C) for 1 hour 25 minutes 0 seconds; previous temperature excursion: -14 Celsius degrees up to -10 Celsius degrees (-12C) for 0 hours 50 minutes 0 seconds. On an unknown date between 11-MAY-2022 and 24-MAY-2022, the patient was administered a dose of these varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccines (lot # U039949 has been verified to be a valid lot number, expiration date: 16-DEC-2023; dose and route of administration not reported) administered for prophylaxis (Product storage error); additional product reported included sterile diluent (MERCK STERILE DILUENT) (reported as "DILUENT MRK"). There were no additional adverse event (AE) details provided (No adverse event). There was no product quality complaint (PQC).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.06.2022
- Impfdatum
- 01.05.2022
- Beginn
- 01.05.2022
- 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 adverse event; VARIVAX has been administered to a total of 13 patients. Temperature excursion; This spontaneous report has been received from a consumer concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided. On an unspecified date between 11-MAY-2022 and 24-MAY-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U039949, expiration date: 16-DEC-2023 (dose, route, vaccination scheme frequency and anatomical location were not provided); along with an sterile diluent, for prophylaxis. The vaccine underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 2 hours (h), 5 minutes (min) and 0 seconds (sec); -10 degrees C up to 8 degrees C for 1 h, 25 min, 0 sec. The involved vaccine had a previous temperature excursion of -14?C up to-10?C (-12C) for 50 minutes 0 seconds. 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
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- U
- Eingang
- 31.05.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
VARIVAX has been administered to a total of 13 patients. Temperature -14?C up to-10?C for 2 hours 5 minutes 0 seconds ; -10?C up to 8?C (-0.4C) for 1 hour 25 minutes 0 seconds; No additional AE details; This spontaneous report was received from a costumer referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent. On an unknown date, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # U039949 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 16-DEC-2023) (strength, dose, route of administration and anatomical location were not provided). The temperature of storage and time frame of the excursion were -14? Celsius (C) up to -10?C for 2 hours and 5 minutes and -10?C up to 8?C for 1 hour and 25 minutes respectively. If a digital data logger was involved was not reported. The vaccines experienced a previous temperature excursion of -14?C up to -10?C for 0 hours 50 minutes. No adverse event reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- STERILE DILUENT
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- U
- Eingang
- 31.05.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
VARIVAX has been administered with an inappropiate storage; No additional AE details; This spontaneous report was received from a consumer referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent. On an unknown date, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # U039949 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 16-DEC-2023) (strength, dose, route of administration and anatomical location were not provided). The temperature of storage and time frame of the excursion were -14? Celsius (C) up to -10?C for 2 hours and 5 minutes and -10?C up to 8?C for 1 hour and 25 minutes respectively. If a digital data logger was involved was not reported. The vaccines experienced a previous temperature excursion of -14?C up to -10?C for 0 hours 50 minutes. No adverse event reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- STERILE DILUENT
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MI
- Alter
- -
- Geschlecht
- U
- Eingang
- 28.05.2022
- Impfdatum
- 01.05.2022
- Beginn
- 01.05.2022
- 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 additional AE details; Customer calling for TE evaluation of VARIVAX. Customer states she called yesterday 5/24/2022 to report a TE but they just found out they had another TE 1 week ago and they need to report that at this time. VARIVAX has been administered to a total of; This spontaneous report was received from a customer referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided. Between 11-MAY-2022 and 24-MAY-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number U039949, expiration date 12-DEC-2023 (dose and route of administration not provided) for prophylaxis and that was reconstituted with a sterile diluent (product storage error). No adverse event was reported. The excursion was between -14 degrees Celsius (?C) to 10 ?C for 2 hours and 5 minutes and between -10?C to 8?C with an average of -0.4?C for 1 hour and 25 minutes. A previous temperature excursion was deteceted and was between -14?C to -10?C with an average of -12?C for 50 minutes.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- STERILE DILUENT
- Allergien
- -
- Vorherige Impfungen
- -