- Staat
- FL
- Alter
- 1,1
- Geschlecht
- F
- Eingang
- 11.08.2022
- Impfdatum
- 11.07.2022
- Beginn
- 11.07.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No additional AE reported.; VARIVAX that had undergone temperature excursion was administered to a patient; This spontaneous report was received from a Medical Assistant referringand refers to a 13-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included cardiac murmur, cafe au lait spots, clubfoot, and congenital valgus foot deformity. She had no known allergies. Concomitant medications included measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (manufacturer unknown) and hepatitis a vaccine (+) inactivated (manufacturer unknown). On 11-JUL-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis, lot #U025790, expiration date: 19-AUG-2023, administered subcutaneously in the right arm for prophylaxis (strength was not provided). The varicella virus vaccine live (oka/merck)(VARIVAX) was stored in temperature of 6.4 degree Fahrenheit (F) for 1 hours 45 minutes. There was no previous temperature excursion reported. It was reported that the patient came in for a recheck of her heart murmur and to catch up on the vaccines. Measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine (+) live (manufacturer unknown), hepatitis a vaccine (+) inactivated (manufacturer unknown), varicella virus vaccine live (oka/merck) (VARIVAX) were ordered by the physician. The vaccines were drawn up and given to the patient. Later, when checking the data logger from the freezer, it was discovered that the vaccines had gone through the excursion. The manufacturer was called and it was determined that the vaccine (varicella virus vaccine live (oka/merck) (VARIVAX)) was still viable. The excursion was reported to the state system. The patient did not have an adverse reaction to the vaccine. The vaccine (varicella virus vaccine live (oka/merck) (VARIVAX)) that was kept in a freezer went under excursion because of a move to a new building. The excursion was minimal.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Cafe au lait spots; Cardiac murmur; Clubfoot; Congenital valgus foot deformity
- Vorgeschichte
- -
- Andere Medikamente
- M-M-R II; VAQTA
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- SC
- Alter
- 1,3
- Geschlecht
- M
- Eingang
- 04.07.2022
- Impfdatum
- 26.05.2022
- Beginn
- 26.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No additional AE reported; temperature excursion VARIVAX has been administered; This spontaneous report was received from a medical assistant referring to a 15-month-old male patient. The patient's illness at vaccination was reported as none. The patient was allergy to peanuts, strawberries, tomatoes, lactose. The birth weight was 8 lbs and 12 oz. The patient had 1 sister and 1 brother. Concomitant therapy included sterile diluent (manufacturer unknown) and hib vaccine conj (tet tox) (HIBERIX). On 26-MAY-2022, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U025790, expiration date: 19-AUG-2023) (The vaccine underwent a temperature excursion of 5.5 Celsius degree for 5 hours and 6 minutes on 26-MAY-2022 (vaccine was moved to refrigerator to deforest freezer at 07:49, returned to freezer at 12:55, min temperature in fridge: 4.46 Celsius degree, max temperature in fridge: 5.55 Celsius degree, the excursion occurred as a result of digital data logger)) 0.5 ml subcutaneously at right thigh for prophylaxis (product storage error) at a private doctor's office. The vaccine was purchased with public funds. No adverse event was reported (no adverse event). The vaccine was no longer in office and no longer available for return or evaluation. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2206USA007524: US-009507513-2206USA007508: US-009507513-2206USA007509: US-009507513-2206USA007510: US-009507513-2206USA007511: US-009507513-2206USA007513: US-009507513-2206USA001254:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Food allergy; Lactose intolerance
- Vorgeschichte
- -
- Andere Medikamente
- STERILE DILUENT; HIBERIX
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- SC
- Alter
- 1,3
- Geschlecht
- F
- Eingang
- 04.07.2022
- Impfdatum
- 26.05.2022
- Beginn
- 26.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE reported; temperature excursion VARIVAX has been administered; This spontaneous report was received from a medical assistant referring to a 16-month-old (also reported as 14-month old) female patient. The patient's illness at vaccination and pre-existing allergies, birth defects and medical conditions were reported as none. The birth weight was 9 lbs. The patient had 1 sister. Concomitant therapy included sterile diluent (manufacturer unknown) and hib vaccine conj (tet tox) (HIBERIX). On 26-MAY-2022, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number U025790 (also reported as U02590), expiration date: 19-AUG-2023) (The vaccine underwent a temperature excursion of 5.5 Celsius degree for 5 hours and 6 minutes on 26-MAY-2022 (vaccine was moved to refrigerator to deforest freezer at 07:49, returned to freezer at 12:55, min temperature in fridge: 4.46 Celsius degree, max temperature in fridge: 5.55 Celsius degree, the excursion occurred as a result of digital data logger)) 0.5 ml subcutaneously at right thigh for prophylaxis (product storage error) at a private doctor's office. No adverse event was reported (no adverse event). The vaccine was used according to the instruction leaflet. The vaccine was no longer in office and no longer available for return or evaluation. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2206USA007524:MSD US-009507513-2206USA007508:MSD US-009507513-2206USA007509:MSD US-009507513-2206USA007511:MSD US-009507513-2206USA007512:MSD US-009507513-2206USA007513:MSD US-009507513-2206USA001254:MSD
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- STERILE DILUENT; HIBERIX
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 1,2
- Geschlecht
- M
- Eingang
- 25.06.2022
- Impfdatum
- 29.03.2022
- Beginn
- 29.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No adverse event; TE evaluation states vaccines had been administered to multiple patients; This spontaneous report was received from a medical assistance and refers to a 14-month-old male patient. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided. On 29-MAR-2022, the patient was vaccinated with the first dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not reported) administered subcutaneous route, lot # U025790 and expiration date 19-AUG-2023 administered as prophylaxis. The improperly stored dose of the suspect vaccine experienced a temperature excursion of -14 degree celscius (C) up to -10 C for 3 hours and -10 C up to 8 C for 1 hour and 30 minutes on 23-MAR-2022; no previous temperature excursions were reported. The call was made due to a digital data logger. No adverse symptoms were reported.; Sender's Comments: US-009507513-2205USA008004: US-009507513-2205USA008051: US-009507513-2205USA007852: US-009507513-2205USA007821:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 4,0
- Geschlecht
- M
- Eingang
- 25.06.2022
- Impfdatum
- 26.04.2022
- Beginn
- 26.04.2022
- 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 AE etails; improper storage of product in use; This spontaneous report was received from Other Health Professional and refers to a 4-year-old male patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 26-APR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U025790, expiration date: 19-AUG-2023, administered subcutaneously for prophylaxis (strength was not provided). The temperature excursion occurred on 23-MAR-2022, the vaccine was stored in a temperature of -14 degree Celsius (C) up to 10 C for 3 hours; -10 C up to 8 C for 1 hour 30 minutes as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse event details.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- F
- Eingang
- 25.06.2022
- Impfdatum
- 22.04.2022
- Beginn
- 22.04.2022
- 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 AE details; improper storage of product in use; This spontaneous report was received from Other Health Professional and refers to a 5-year-old female patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 22-APR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U025790, expiration date: 19-AUG-2023, administered subcutaneously for prophylaxis (strength was not provided). The temperature excursion occurred on 23-MAR-2022, the vaccine was stored in a temperature of -14 degree Celsius (C) up to 10 C for 3 hours; -10 C up to 8 C for 1 hour 30 minutes as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse event details.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 4,0
- Geschlecht
- M
- Eingang
- 25.06.2022
- Impfdatum
- 11.04.2022
- Beginn
- 11.04.2022
- 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 AE details; improper storage of product in use; This spontaneous report was received from Other Health Professional and refers to a 4-year-old male patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported. On 11-APR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U025790, expiration date: 19-AUG-2023, administered subcutaneously for prophylaxis (strength was not provided). The temperature excursion occurred on 23-MAR-2022, the vaccine was stored in a temperature of -14 degree Celsius (C) up to 10 C for 3 hours; -10 C up to 8 C for 1 hour 30 minutes as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse event details.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 1,0
- Geschlecht
- M
- Eingang
- 23.06.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
E evaluation states vaccines have been administered to multiple patients. Customer has a list of patients but states it would take too long to read each patient name. States 39 patients total received vaccines.; No additional AE details; This spontaneous report has been received from a medical assistant, concerning a 1-years-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided. On 22-APR-2022, the patient was administered vaccine varicella virus vaccine live (oka/merck) (VARIVAX) first dose, subcutaneously (valid lot number U025790 [expiration date 19-AUG-2023]) for prophylaxis, after a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours (h), 0 minutes (min) and 0 seconds (sec); -10 degrees C up to 8 degrees C for 1 h, 30 min, 0 sec. The time frame of 3 h, 0 min, 0 sec; 1 h, 30, min 0 sec (product storage error) and a device component malfunction was reported (dose, vaccination scheme frequency, and anatomical location of vaccination were not provided). No previous temperature excursion was reported. No additional adverse events (AE) were reported. This is one of several reports received from the same reporter. As recorded by data digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2204USA009330: US-009507513-2205USA008004: US-009507513-2205USA007821: US-009507513-2205USA007852:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 1,8
- Geschlecht
- M
- Eingang
- 22.06.2022
- Impfdatum
- 18.04.2022
- Beginn
- 18.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE details; TE evaluation states vaccines have been administered; This spontaneous report was received from a certified medical assistant and referring to a 22 months old male patient (also reported as 1-year-old). The patient's medical history, concomitant therapies and concurrent conditions were not provided. On 23-MAR-2022, the suspect vaccine underwent temperature excursion of -14 degrees Celsius (C) up to - 10C for 3 hours and -10C up to 8C for 1 hour and 30 minutes. On 18-APR-2022, the patient was vaccinated with the first dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously (lot # U025790 with expiration date: 19-AUG-2023; dose and strength were unknown) for prophylaxis (product storage error). No additional adverse event was reported (no adverse event). There were no previous temperature excursions. It was an initial use of vaccine/vaccine-device. The operator of the vaccine/vaccine-device was healthcare professional. The vaccine/vaccine-device was not available for return/evaluation as it was given to the patient. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-2205USA003614: US-009507513-2205USA007821: US-009507513-2205USA007847: US-009507513-2205USA007852: US-009507513-2204USA009330: US-009507513-2205USA008004: US-009507513-2205USA008051: US-009507513-2205USA008008: US-009507513-2205USA008028: US-009507513-2205USA007982: US-009507513-2205USA008105: US-009507513-2205USA008106:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 4,0
- Geschlecht
- M
- Eingang
- 22.06.2022
- Impfdatum
- 31.03.2022
- Beginn
- 31.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report has been received from a medical assistant, concerning a 4-years-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided. On 31-MAR-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), subcutaneous injection, first dose, administered subcutaneously, for prophylaxis (strength, dose, , vaccination scheme frequency and anatomical location were not provided; lot number U025790 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported and upon internal validation established as 19-AUG-2023) (product storage error). The administered dose of the varicella virus vaccine live (oka/merck) (VARIVAX) was stored in a temperature between -14 degrees Celsius (C) up to -10 degrees C for 3 hours (h) 0 minutes (min) and 0 seconds (sec) and between -10 degrees C up to 8 degrees C for 1 h 30 min 0 sec, on 23-MAR-2022 as recorded by a data logger. There was no previous temperature excursion reported. It was stated that the event was attributable to a device or device component malfunction, however, there was no device involved. No adverse events were reported. No additional adverse events (AE) were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2204USA009330: US-009507513-2205USA008004: US-009507513-2205USA007861: US-009507513-2205USA007749: US-009507513-2205USA007739: US-009507513-2205USA003614: US-009507513-2205USA008830: US-009507513-2205USA008800: US-009507513-2205USA008795: US-009507513-2205USA008064: US-009507513-2205USA008189: US-009507513-2205USA008100: US-009507513-2205USA008069: US-009507513-2205USA008066: US-009507513-2205USA007957: US-009507513-2205USA008028: US-009507513-2205USA008008: US-009507513-2205USA008002: US-009507513-2205USA008000: US-009507513-2205USA007871: US-009507513-2205USA007860: US-009507513-2205USA007852: US-009507513-2205USA007809: US-009507513-2205USA007723: US-009507513-2205USA007704: US-009507513-2205USA007703: US-009507513-2205USA007978: US-009507513-2205USA008006: US-009507513-2205USA007982: US-009507513-2205USA008106: US-009507513-2205USA008105: US-009507513-2205USA007748: US-009507513-2205USA007821:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 6,0
- Geschlecht
- F
- Eingang
- 21.06.2022
- Impfdatum
- 25.04.2022
- Beginn
- 25.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE details/ What was the patient's response?: None; temp excursion/ TE evaluation states vaccines have been administered; This spontaneous report as received from a certified medial assistant refers to a 6-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. The patient did not have any illness at the time of vaccination. On 23-MAR-2022, a virus vaccine live (oka/merck) (VARIVAX), lot # U025790, expiry date 19-AUG-2023, experienced a temperature excursions of -14 degrees Celsius (C) up to -10 degrees C for 3 hours, and -10 degrees C up to 8 degrees C for 1 hours 30 minutes. There was not previous excursion. On 25-APR-2022, the patient was vaccinated by a healthcare professional at the private doctor's office/hospital with the second dose of varicella virus vaccine live (oka/merck) (VARIVAX), which experienced above mentioned temperature excursion (product storage error), lot # and expiry date as above, subcutaneously (SQ) for prophylaxis. It was reported that there was no patient's response. No additional adverse event details were reported (no adverse event). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2204USA009330: US-009507513-2205USA008051: US-009507513-2205USA008004: US-009507513-2205USA007852: US-009507513-2205USA007821:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 1,0
- Geschlecht
- M
- Eingang
- 21.06.2022
- Impfdatum
- 25.04.2022
- Beginn
- 25.04.2022
- 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 adverse event; the temperate excuration occurred, vaccines have been administered; This spontaneous report was received from a medical assistant and referred to 1-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-MAR-2022, the temperate excursion occurred to varicella virus vaccine live (oka/merck) (VARIVAX). The vaccines underwent temperature excursion of -14 degrees Celsius up to -10 degrees Celsius during a time frame of 3 hours; -10 degrees Celsius up to 8 degrees Celsius during a time frame of 1 hour and 30 minutes. There was no previous temperature excursion. On 25-APR-2022, at a private doctor's officer/hospital, the patient was vaccinated by a healthcare professional with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (valid lot # U025790 with expiration date: 19-AUG-2023; dose not provided) administered subcutaneously for prophylaxis (product storage error). This initially used vaccine was not available for return/evaluation due to being given to the patient. There was no prescription drug treatment for the experience required. No adverse event was reported (no adverse event). This is one of several reports from the same reporter.; Sender's Comments: US-009507513-2204USA009330:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 1,0
- Geschlecht
- M
- Eingang
- 20.06.2022
- Impfdatum
- 27.04.2022
- Beginn
- 27.04.2022
- 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 adverse event; the temperate excuration occurred, vaccines have been administered; This spontaneous report was received from a medical assistant and referred to 1-year-old male patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On 23-MAR-2022, the temperate excursion occurred to verified viability vaccine varicella virus vaccine live (oka/merck) (VARIVAX). The vaccines underwent temperature excursion of -14 degrees Celsius up to -10 degrees Celsius during a time frame of 3 hours; -10 degrees Celsius up to 8 degrees Celsius during a time frame of 1 hour and 30 minutes. There was no previous temperature excursion. The digital data logger was involved. On 27-APR-2022, at a private doctor's officer/hospital, the patient was vaccinated by a healthcare professional with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (valid lot # U025790 with expiration date: 19-AUG-2023; strength and dose not provided) administered subcutaneously for prophylaxis (product storage error). This initially used vaccine was not available for return/evaluation due to being given to the patient. There was no prescription drug treatment for the experience required. No additional adverse event details (no adverse event). This is one of several reports from the same reporter.; Sender's Comments: US-009507513-2204USA009330:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 1,0
- Geschlecht
- M
- Eingang
- 18.06.2022
- Impfdatum
- 20.04.2022
- Beginn
- 20.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
device or device component malfunction; no additional AE details; TE vaccine administered; This spontaneous report was received from a medical assistant and refers to a 12-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-APR-2022, the patient was vaccinated with an improperly stored first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, lot #U025790, expiration date reported and established as 19-AUG-2023, administered subcutaneously (dose and site of administration not provided) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of -14 degrees Celsius to -10 degrees Celsius for a total of 3 hours and a temperature excursion of -10 degrees Celsius up to 8 degrees Celsius for 1 hour 30 minutes. There were no previous temperature excursions. Additionally, a device or device component malfunction was reported (unspecified, conflicting information, varicella virus vaccine live [Oka/Merck] [VARIVAX] is not manufactured/ provided with a device component). The patient experienced no additional adverse event (AE). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2205USA008004: US-009507513-2205USA008051: US-009507513-2205USA007852: US-009507513-2205USA007821:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 5,0
- Geschlecht
- F
- Eingang
- 17.06.2022
- Impfdatum
- 25.04.2022
- Beginn
- 25.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No adverse event; Product storage error; This spontaneous report was received from a medical assistant referring to a 5-year-old female patient. The patient's pertinent medical history, current conditions, drugs reactions or allergies and concomitant medication were not provided. On 25-APR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis, lot number U025790, has been verified to be a valid lot number with expiration date on 19-AUG-2023, administered subcutaneously (strength, dose, scheme frequency and anatomical location were not provided). The vaccines underwent temperature excursion of -14 degrees Celsius up to -10 degrees Celsius during a time frame of 3 hours; -10 degrees Celsius up to 8 degrees Celsius during a time frame of 1 hour and 30 minutes. No adverse event was reported. There was no previous temperature excursion. It was stated that temperature was recorded by digital data logger. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-2205USA008051: US-009507513-2205USA008004: US-009507513-2204USA009330:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 0,9
- Geschlecht
- F
- Eingang
- 16.06.2022
- Impfdatum
- 25.04.2022
- Beginn
- 25.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE details; TE evaluation states vaccine had been administered; This spontaneous report was received from a medical assistant referring to an 11-month-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 23-MAR-2022, the varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, underwent temperature excursion from -14 degrees Celsius to -10 degrees Celsius for 3 hours and from -10 degrees Celsius to 8 degrees Celsius for 1 hour and 30 minutes. No previous temperature excursions were reported. Digital Data Logger was used. On 25-APR-2022, the patient was vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), administered subcutaneously (strength and exact dose were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2205USA008051: US-009507513-2205USA008004: US-009507513-2205USA007821: US-009507513-2205USA007852:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 1,2
- Geschlecht
- M
- Eingang
- 16.06.2022
- Impfdatum
- 14.04.2022
- Beginn
- 14.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE details; TE evaluation states vaccine had been administered; This spontaneous report was received from a medical assistant referring to a 14-month-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 23-MAR-2022, the varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, underwent temperature excursion from -14 degrees Celsius to -10 degrees Celsius for 3 hours and from -10 degrees Celsius to 8 degrees Celsius for 1 hour and 30 minutes. No previous temperature excursions were reported. Digital Data Logger was used. On 14-APR-2022, the patient was vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), administered subcutaneously (strength and exact dose were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2205USA008051: US-009507513-2205USA007821: US-009507513-2205USA007852:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 4,0
- Geschlecht
- F
- Eingang
- 14.06.2022
- Impfdatum
- 28.03.2022
- Beginn
- 28.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
Device or device component malfunction; No adverse event; Temperature excursion occurred 23-MAR-2022/given to patient; This spontaneous report was received from a medical assistant and refers to a 4-year-old female patient. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided. On 28-MAR-2022, the patient was vaccinated with the second, improperly stored (product storage error) dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #: U025790, expiration date: 19-AUG-2023, administered subcutaneously(sq) (exact dose, site of administration were not provided) for prophylaxis. Malfunction of device or device component was reported (device malfunction), however no device was involved. Temperature excursion information: -14 degree Celsius up to -10 degrees Celsius for 3 hours. There was no previous temperature excursion. Temperature excursion occurred as a result of a reading from a Data Logger. No additional adverse event was reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2204USA009330:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 4,0
- Geschlecht
- F
- Eingang
- 10.06.2022
- Impfdatum
- 27.04.2022
- Beginn
- 27.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a medical assistant and refers to a 4-years-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided. On 27-APR-2022, the patient was vaccinated with improperly stored second dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U025790, expiration date: 19-AUG-2023 (exact dose, vaccination scheme frequency and anatomical location were not provided) administered subcutaneously for prophylaxis, after the vaccine underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours; -10 degrees C up to 8 degrees C for 1 h, 30 min on 23-MAR-2022 (product storage error). No previous temperature excursion was reported. No additional adverse events were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2204USA009330: US-009507513-2205USA008051: US-009507513-2205USA008004: US-009507513-2205USA007852: US-009507513-2205USA003614: US-009507513-2205USA007703: US-009507513-2205USA007704: US-009507513-2205USA007723: US-009507513-2205USA007739: US-009507513-2205USA007809: US-009507513-2205USA007957: US-009507513-2205USA007860: US-009507513-2205USA007871: US-009507513-2205USA007978: US-009507513-2205USA007982: US-009507513-2205USA008000: US-009507513-2205USA008002: US-009507513-2205USA008008: US-009507513-2205USA008028: US-009507513-2205USA008064: US-009507513-2205USA008066: US-009507513-2205USA008100: US-009507513-2205USA008105: US-009507513-2205USA008189: US-009507513-2205USA008795: US-009507513-2205USA008800: US-009507513-2205USA008830:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 1,0
- Geschlecht
- F
- Eingang
- 10.06.2022
- Impfdatum
- 27.04.2022
- Beginn
- 27.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a medical assistant and referred to a 1-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-MAR-2022, the temperature excursion (-14 degree Celsius up to -10 degree Celsius for 3 hours) occurred of varicella virus vaccine live (oka/merck) (VARIVAX). On 27-APR-2022, the patient was vaccinated with the varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection for prophylaxis (lot #U025790, expiration date: 19-AUG-2023; strength and dose were not provided) (product storage error). No additional adverse event (no adverse event) was reported. The reporter contacted company and verified the viability of vaccine; the vaccine was not available for return or evaluation because it was given to the patient. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-2204USA009330:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 5,0
- Geschlecht
- F
- Eingang
- 09.06.2022
- Impfdatum
- 12.04.2022
- Beginn
- 12.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE details; Product storage error; This spontaneous report has been received from a medical assistant, regarding a 5-year-old female patient. The patient's pertinent medical history, previous drugs reactions or allergies and concomitant medications were not reported. On 23-MAR-2022, a varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U025790, which was determined to be valid, with an expiration date of 19-AUG-2023) underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours and -10 degrees C up to 8 degrees C for 1 hour 30 minutes. It was stated that a data logger was involved. There was no previous temperature excursion reported. Then, on 12-APR-2022, the patient was vaccinated with the second dose of the aforementioned improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneously (sq) as prophylaxis (dose and anatomical location were not reported) (product storage error). It was stated that the event was attributable to the device component malfunction, however there is no device involved. No additional adverse event was reported. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-2204USA009330: US-009507513-2205USA003614: US-009507513-2205USA007821: US-009507513-2205USA007847: US-009507513-2205USA007852: US-009507513-2205USA008008: US-009507513-2205USA008028: US-009507513-2205USA008051: US-009507513-2205USA007982: US-009507513-2205USA008105: US-009507513-2205USA008189: US-009507513-2205USA008004:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 4,0
- Geschlecht
- F
- Eingang
- 09.06.2022
- Impfdatum
- 12.04.2022
- Beginn
- 12.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE details; TE evaluation states vaccines have been administered to multiple patients/temp ezcursion occured March 23; This spontaneous report was received from a medical assistant and refers to a 4-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-APR-2022, the patient was vaccinated with an improperly stored dose of with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # U025790, expiration date: 19-AUG-2023, administered subcutaneously for prophylaxis (strength, exact dose, and anatomical location of administration were not provided) (product storage error). There was no adverse effect reported (no adverse event). Administered dose of vaccine experienced the temperature excursion of -14 degrees Celsius for 3 hours. There were no previous temperature excursions. The viability of the vaccine was verified at Merck hotline. The reporter also stated that there was a device or device component malfunction (discrepant information, as varicella virus vaccine live [oka/merck] [VARIVAX] is not a medical device or medical device component product).; Sender's Comments: US-009507513-2205USA008051: US-009507513-2205USA008004:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 8,0
- Geschlecht
- M
- Eingang
- 09.06.2022
- Impfdatum
- 25.04.2022
- Beginn
- 24.04.2022
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE deatils; improperly stored vaccine administered to a patient; This spontaneous report was received from a certified medical assistant and refers to a 8-year-old male patient. The patient's medical history, concomitant therapies and concurrent conditions were not provided. On 25-APR-2022, the patient was vaccinated with first dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered subcutaneously, lot # U025790, expiration date 19-AUG-2023 (dose and anatomical location) for prophylaxis (product storage error). No treatment for the event was required. On 23-MAR-2022, the administered vaccine underwent temperature excursion of -14 Celsius degrees up to - 10 Celsius degrees for 3 hours and -10 Celsius degrees up to 8 Celsius degrees for 1 hour and 30 minutes. There were no previous temperature excursions. No additional adverse event was reported (no adverse event). It was an initial use of vaccine/vaccine-device. The operator of the vaccine/vaccine-device was healthcare professional. The vaccine/vaccine-device was not available for return/evaluation as it was given to the patient. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-2204USA009330: US-009507513-2205USA008004: US-009507513-2205USA008051: US-009507513-2205USA003614: US-009507513-2205USA007703: US-009507513-2205USA007704: US-009507513-2205USA007723: US-009507513-2205USA007739: US-009507513-2205USA007809: US-009507513-2205USA007821: US-009507513-2205USA007852: US-009507513-2205USA007860: US-009507513-2205USA007871: US-009507513-2205USA008830: US-009507513-2205USA007957: US-009507513-2205USA008069: US-009507513-2205USA008800: US-009507513-2205USA008100: US-009507513-2205USA008105: US-009507513-2205USA008189: US-009507513-2205USA007978: US-009507513-2205USA008795: US-009507513-2205USA008066: US-009507513-2205USA007982: US-009507513-2205USA008064: US-009507513-2205USA008028: US-009507513-2205USA008000: US-009507513-2205USA008008: US-009507513-2205USA008004: US-009507513-2205USA007852: US-009507513-2205USA008002:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 5,0
- Geschlecht
- F
- Eingang
- 08.06.2022
- Impfdatum
- -
- Beginn
- 30.03.2022
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE details; Temperature excusion occurred on 23-MAR-2022; This spontaneous report has been received from a medical assistant, concerning a 5-years-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided. On 30-MAR-2022, the patient was administered vaccine varicella virus vaccine live (oka/merck) (VARIVAX) first dose, subcutaneously (valid lot number U025790 [expiration date 19-AUG-2023]) for prophylaxis, after a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours (h), 0 minutes (min) and 0 seconds (sec); -10 degrees C up to 8 degrees C for 1 h, 30 min, 0 sec. The time frame of 3 h, 0 min, 0 sec; 1 h, 30, min 0 sec (product storage error) and a device component malfunction was reported (dose, vaccination scheme frequency, and anatomical location of vaccination were not provided). No previous temperature excursion was reported. No additional adverse events (AE) were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2205USA007978: US-009507513-2205USA007982: US-009507513-2205USA008006: US-009507513-2205USA008105: US-009507513-2205USA007703: US-009507513-2205USA007704: US-009507513-2205USA007723: US-009507513-2205USA007809: US-009507513-2205USA007821: US-009507513-2205USA007852: US-009507513-2205USA007860: US-009507513-2205USA007871: US-009507513-2205USA007957: US-009507513-2205USA008000: US-009507513-2205USA008002: US-009507513-2205USA008008: US-009507513-2205USA008028: US-009507513-2205USA008051: US-009507513-2205USA008066: US-009507513-2205USA008069: US-009507513-2205USA008100: US-009507513-2205USA008189: US-009507513-2205USA008064: US-009507513-2205USA008795: US-009507513-2205USA008800: US-009507513-2205USA008830: US-009507513-2204USA009330: US-009507513-2205USA003614: US-009507513-2205USA007739: US-009507513-2205USA007748: US-009507513-2205USA007749: US-009507513-2205USA007861:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 1,0
- Geschlecht
- M
- Eingang
- 08.06.2022
- Impfdatum
- 04.04.2022
- Beginn
- 04.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
no adverse event; Product storage error; This spontaneous report has been received from the medical assistant referring a 1-year-old male patient. The patient's pertinent medical history, previous drugs reactions or allergies and concomitant medications were not provided. On 04-APR-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, administered subcutaneously as prophylaxis (strength was not provided) following a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours and -10 degrees C up to 8 degrees C for 1 hour 30 minutes, it was stated that a data logger was involved (product storage error). There was no previous temperature excursion reported. It was stated that the event was attributable to the device component malfunction, however there is no device involved. No additional adverse event was reported.; Sender's Comments: US-009507513-2205USA008004:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 4,0
- Geschlecht
- F
- Eingang
- 07.06.2022
- Impfdatum
- 24.03.2022
- Beginn
- 24.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a certified medical assistant and refers to a 4-years-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 23-MAR-2022, the varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, underwent temperature excursion from -14 Celsius degrees (?C) to -10?C for 3 hours and from -10?C to 8?C for 1 hour and 30 minutes. No previous temperature excursions were reported. Digital Data Logger was used. On 24-MAR-2022, the patient was vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), administered subcutaneously (strength and exact dose were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event). ; Sender's Comments: US-009507513-2205USA008004: US-009507513- 2204USA009330: US-009507513-2205USA003614: US-009507513-2205USA007821: US-009507513-2205USA007847: US-009507513-2205USA007852:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 4,0
- Geschlecht
- M
- Eingang
- 07.06.2022
- Impfdatum
- 26.04.2022
- Beginn
- 24.03.2022
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a certified medical assistant and refers to a 4-years-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 23-MAR-2022, the varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, underwent temperature excursion from -14 Celsius degrees (?C) to -10?C for 3 hours and from -10?C to 8?C for 1 hour and 30 minutes. No previous temperature excursions were reported. Digital Data Logger was used. On 24-MAR-2022, the patient was vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), administered subcutaneously (strength and exact dose were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event).; Sender's Comments: US-009507513-2205USA008004: US-009507513- 2204USA009330: US-009507513-2205USA003614: US-009507513-2205USA007821: US-009507513-2205USA007847: US-009507513-2205USA007852:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 7,0
- Geschlecht
- M
- Eingang
- 07.06.2022
- Impfdatum
- -
- Beginn
- 24.04.2022
- Tage bis Beginn
- -
- Dosis
- 2
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a certified medical assistant and refers to a 7 year old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 23-MAR-2022, the varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, underwent temperature excursion from -14 Celsius degrees (?C) to -10?C for 3 hours and from -10?C to 8?C for 1 hour and 30 minutes. No previous temperature excursions were reported. Digital Data Logger was used. On 24-MAR-2022, the patient was vaccinated with the improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot number U025790, expiration date: 19-AUG-2023, administered subcutaneously (strength and exact dose were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event). This is one of several reports from the same reporter.; Sender's Comments: US-009507513- 2204USA009330:Original Case : 2204USA009330 US-009507513-2205USA003614: US-009507513-2205USA007821: US-009507513-2205USA007847: US-009507513-2205USA007852: US-009507513-2205USA008028: US-009507513-2205USA008004:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 1,0
- Geschlecht
- M
- Eingang
- 07.06.2022
- Impfdatum
- 15.04.2022
- Beginn
- 15.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a medical assistant, concerning a 1-year-old male patient. His pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided. On 15-APR-2022, the patient was vaccinated with improperly stored first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U025790, expiration date: 19-AUG-2023 (exact dose and anatomical location were not provided) administered subcutaneously for prophylaxis, after the vaccine underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours (h), 0 minutes (min) and 0 seconds (sec); -10 degrees C up to 8 degrees C for 1 h, 30 min, 0 sec on 23-MAR-2022 (Product storage error). No previous temperature excursion was reported. No additional adverse events were reported. The reporter verified viability of the vaccine on the Company hotline. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2205USA008004: US-009507513-2205USA003614: US-009507513-2205USA007703: US-009507513-2205USA007704: US-009507513-2205USA007723: US-009507513-2205USA007809: US-009507513-2205USA007821: US-009507513-2205USA007847: US-009507513-2205USA007852: US-009507513-2205USA007860: US-009507513-2205USA007871: US-009507513-2205USA007957: US-009507513-2205USA007978: US-009507513-2205USA007982: US-009507513-2205USA008006: US-009507513-2205USA008008: US-009507513-2205USA008028: US-009507513-2205USA008051: US-009507513-2205USA008105: US-009507513-2205USA008189:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- F
- Eingang
- 04.06.2022
- Impfdatum
- 31.03.2022
- Beginn
- 31.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
no additional AE details; Improperly stored VARIVAX administered; This spontaneous report has been received from a certified medical assistant, concerning a 1-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided. The patient's birth weight was reported as 7 pounds. On 31-MAR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (first dose) subcutaneous injection, lot #U025790, expiration date: 19-AUG-2023 (dose, vaccination scheme frequency and anatomical location were not provided) administered subcutaneously for prophylaxis. The vaccine underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours (h), 0 minutes (min) and 0 seconds (sec); -10 degrees C up to 8 degrees C for 1 h, 30 min, 0 sec on 23-MAR-2022. No previous temperature excursion was reported. No additional adverse events were reported. It was also mentioned that the patient experienced a "device or device component malfunction" (Discrepant information). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2205USA008004:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 6,0
- Geschlecht
- F
- Eingang
- 03.06.2022
- Impfdatum
- 31.03.2022
- Beginn
- 31.03.2022
- 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 AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a health professional and refers to a 6-year-old female patient. The patients' pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported. On 31-MAR-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number U025790, expiration date reported as 19-AUG-2023, and lot number U029496, expiration date reported as 21-SEP-2023, administered for prophylaxis (strength were not provided) (product storage error). The temperature excursion was -14 degrees Celsius (?C) up to -10?C for 3 hours 0 minutes, and -10?C up to 8?C for 1 hour 30 minutes 0 seconds. No previous temperature excursion was reported. No adverse event was reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-2204USA009330: US-009507513-2205USA008004:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- F
- Eingang
- 03.06.2022
- Impfdatum
- 14.04.2022
- Beginn
- 14.04.2022
- 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 AE details; Improperly stored VARIVAX administered; This spontaneous report has been received from a certified medical assistant, concerning a 4-years-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided. The patient's birth weight was reported as 6 pounds and 11 oz. On 14-APR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (second dose) subcutaneous injection, lot #U025790, expiration date: 19-AUG-2023 (dose, vaccination scheme frequency and anatomical location were not provided) administered subcutaneously for prophylaxis. The vaccine underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours (h), 0 minutes (min) and 0 seconds (sec); -10 degrees C up to 8 degrees C for 1 h, 30 min, 0 sec on 23-MAR-2022. No previous temperature excursion was reported. No additional adverse events were reported. It was also mentioned that the patient experienced a "device or device component malfunction" (Discrepant information). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2205USA008004:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 5,0
- Geschlecht
- F
- Eingang
- 03.06.2022
- Impfdatum
- 05.04.2022
- Beginn
- 05.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report has been received from a medical assistant, concerning a 5-years-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided. On 05-APR-2022, the patient was vaccinated with improperly stored second dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U025790, expiration date: 19-AUG-2023 (exact dose, vaccination scheme frequency and anatomical location were not provided) administered subcutaneously for prophylaxis, after the vaccine underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours (h), 0 minutes (min) and 0 seconds (sec); -10 degrees C up to 8 degrees C for 1 h, 30 min, 0 sec on 23-MAR-2022 (Product storage error). No previous temperature excursion was reported. No additional adverse events were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2205USA008004: US-009507513-2205USA007978: US-009507513-2205USA007982: US-009507513-2205USA008006: US-009507513-2205USA008105: US-009507513-2205USA007703: US-009507513-2205USA007704: US-009507513-2205USA007723: US-009507513-2205USA007809: US-009507513-2205USA007821: US-009507513-2205USA007852: US-009507513-2205USA007871: US-009507513-2205USA007957: US-009507513-2205USA008000: US-009507513-2205USA008002: US-009507513-2205USA008008: US-009507513-2205USA008028: US-009507513-2205USA008051: US-009507513-2205USA008066: US-009507513-2205USA008069: US-009507513-2205USA008100: US-009507513-2205USA008189: US-009507513-2205USA007739: US-009507513-2204USA009330:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- M
- Eingang
- 03.06.2022
- Impfdatum
- 24.03.2022
- Beginn
- 24.03.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a certified medical assistant and refers to an 1-year-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 24-MAR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U025790, expiration date: 19-AUG-2023, administered subcutaneously (strength and exact dose were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event). On 23-MAR-2022, the vaccine underwent temperature excursion from -14 Celsius degrees (C) to -10C for 3 hours and from -10C to 8C for 1 hour and 30 minutes. No previous temperature excursions were reported. Digital Data Logger was used. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-2204USA009330:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- M
- Eingang
- 02.06.2022
- Impfdatum
- 20.04.2022
- Beginn
- 23.03.2022
- Tage bis Beginn
- -
- 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 AE details; Temperature excrusion/TE evaluation states vaccines have been administered to multiple patients; Device or device component malfunction; This spontaneous report was received from a medical assistant and an other non-health care professional referring to a 5 year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. No illness at time of vaccination nor vaccine within 4 weeks prior to vaccination date was reported. On 23-MAR-2022, the temperature excursion occurred of varicella virus vaccine live (oka/merck) (VARIVAX). The storage temperature was -14 degree Celsius up to -10 degree Celsius for 3 hours and -10 degree Celsius up to 8 degree Celsius for 1 hour 30 minutes. There was no previous temperature excursion. The temperature excursion occurred as a result of a reading from a digital data logger. On 20-APR-2022, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection by a healthcare professional for prophylaxis (subcutaneous, lot #U025790, expiration date: 19-AUG-2023; strength and dose were not provided) (product storage error). No additional adverse event (no adverse event) was reported. After administration, the reporter contacted company and verified the viability of vaccine. The vaccine was not available for return or evaluation because it was given to the patient. Additionally, it was reported device or device component malfunction. This is one of several reports from the same reporter.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- M
- Eingang
- 02.06.2022
- Impfdatum
- 28.03.2022
- Beginn
- 23.03.2022
- Tage bis Beginn
- -
- 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 AE details; Temperature excrusion/TE evaluation states vaccines have been administered to multiple patients; Device or device component malfunction; This spontaneous report was received from a medical assistant and an other non-health care professional referring to a 4year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. No illness at time of vaccination nor vaccine within 4 weeks prior to vaccination date was reported. On 23-MAR-2022, the temperature excursion occurred of varicella virus vaccine live (oka/merck) (VARIVAX). The storage temperature was -14 degree Celsius up to -10 degree Celsius for 3 hours and -10 degree Celsius up to 8 degree Celsius for 1 hour 30 minutes. There was no previous temperature excursion. The temperature excursion occurred as a result of a reading from a digital data logger. On 28-MAR-2022, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection by a healthcare professional for prophylaxis (subcutaneous, lot #U025790, expiration date: 19-AUG-2023; strength and dose were not provided) (product storage error). No additional adverse event (no adverse event) was reported. After administration, the reporter contacted company and verified the viability of vaccine. The vaccine was not available for return or evaluation because it was given to the patient. Additionally, it was reported device or device component malfunction. This is one of several reports from the same reporter.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- CT
- Alter
- 2,0
- Geschlecht
- M
- Eingang
- 01.06.2022
- Impfdatum
- 25.05.2022
- Beginn
- 25.05.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- SC / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
No adverse event
Wrong product administered
Symptomtext
Pediatrician ordered Dtap, PCV13, HepA, MMR, and Varicella vaccines for child visiting the clinic. During preparation the wrong vaccine was taken out, prepared, and administered. Instead of Dtap by itself, Pedarix (Dtap, HepB, IPV combo) was given in it's place by this RN. Child had NO adverse reaction, and had already received Hep B and IPV vaccines on a prior date. Pediatrician was notified within 10 minutes of administration mistake and mom was called immediately but was not able to talk to her until the next morning. Mom was notified of the incorrect vaccine given and mom reported child had no adverse reactions overnight and child slept well, drank, and ate as usual.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- Autism Spectrum Disorder
- Andere Medikamente
- Loratadine 5MG/5ML
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 1,0
- Geschlecht
- F
- Eingang
- 31.05.2022
- Impfdatum
- 04.04.2022
- Beginn
- 04.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from a medical assistant and an other non-health care professional referring to a 1-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. No illness at time of vaccination nor vaccine within 4 weeks prior to vaccination date was reported. On 23-MAR-2022, the temperature excursion occurred of varicella virus vaccine live (oka/merck) (VARIVAX). The storage temperature was -14 degree Celsius up to -10 degree Celsius for 3 hours and -10 degree Celsius up to 8 degree Celsius for 1 hour 30 minutes. There was no previous temperature excursion. The temperature excursion occurred as a result of a reading from a digital data logger. On 04-APR-2022, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection by a healthcare professional for prophylaxis (subcutaneous, lot #U025790, expiration date: 19-AUG-2023; strength and dose were not provided) (product storage error). No additional adverse event (no adverse event) was reported. After administration, the reporter contacted company and verified the viability of vaccine. The vaccine was not available for return or evaluation because it was given to the patient. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-2205USA008004: US-009507513-2204USA009330:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- M
- Eingang
- 28.05.2022
- Impfdatum
- 11.04.2022
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- OT / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Product storage error
Symptomtext
No additional AE details; TE evaluation states vaccines have been administered to multiple patients; This spontaneous report was received from Other Health Professional and refers to unspecified number of patients. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, unk, lot #U025790, expiration date: 19-AUG-2023 or U029496 with expiration date on 21-SEP-2023, administered for prophylaxis (strength, and route of administration were not provided). The vaccines underwent temperature excursion of -14?C up to-10 degrees C for 3 hours 0 and -10 degrees C up to 8 degrees C for 1 hour 30 minutes. No adverse event was reported. This is one of several reports from the same reporter. This case in non-valid due to the lack of the patients' identifiers. Follow up information has been received from the physician's office, on 24-MAY-2022, referring to a 5 year old male patient. On 11-APR-2022, the patient was vaccinated with an improperly storage dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U025790 expiration date: 19-AUG-2023, subcutaneous (SQ), for prophylaxis (no previous vaccine administered) product storage error. Temperature excursion occurred on 23-MAR-2022. No further clarify. ; Sender's Comments: US-009507513-2205USA003614: US-009507513-2205USA007821: US-009507513-2205USA007847:Original Case : 2204USA009330 US-009507513-2205USA007852:Original Case : 2204USA009330
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 4,0
- Geschlecht
- F
- Eingang
- 28.05.2022
- Impfdatum
- 25.03.2022
- Beginn
- 25.03.2022
- 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 AE details; TE evaluation states vaccines have been administered; This spontaneous report was received from a medical assistant and refers to unspecified number of patients. The patients' medical history, concurrent conditions were not reported and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot # U025790, expiration date: 19-AUG-2023, lot # U029496 with expiration date on 21-SEP-2023) administered for prophylaxis (dose and route of administration were not provided). The vaccines underwent temperature excursion of -14 degrees Celsius up to -10 degrees Celsius during a time frame of 3 hours; -10 degrees Celsius up to 8 degrees Celsius during a time frame of 1 hour and 30 minutes. No adverse event was reported. This is one of several reports from the same reporter. Follow-up information has been received from the medical assistant on 24-MAY-2022, referring to a 4-year-old (also reported as 5-year-old, discrepant information) female patient. On 25-MAR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) administered subcutaneously (SQ) as prophylaxis (dose and anatomical site of vaccination were not reported; lot number U025790 has been verified to be valid, expiration date reported and established as 19-AUG-2023). The patient's identifiers were missing in the initial report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2205USA003614: US-009507513-2205USA007821: US-009507513-2205USA007847: US-009507513-2205USA007852:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -