- Staat
- IN
- Alter
- 17,0
- Geschlecht
- F
- Eingang
- 22.06.2021
- Impfdatum
- 21.06.2021
- Beginn
- 21.06.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Blood pressure measurement
Syncope
Symptomtext
Immediately after receiving the last vaccine patient had an episode of syncope. She regained consciousness quickly and was moved to our Trendelenburg chair. Vitals were checked within a few minutes (BP 108/62 P 70) and she was given water as well. She was accompanied by her mother and was able to leave after about 15 minutes.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- -
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- 14,0
- Geschlecht
- M
- Eingang
- 18.02.2021
- Impfdatum
- 16.02.2021
- Beginn
- 16.02.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: ja
Erholt: ja
Anaphylactic reaction
Chest pain
Dysphonia
Dyspnoea
Erythema
Headache
Hypoaesthesia
Malaise
Urticaria
Symptomtext
felt malaise, headaches and short of breath/raspy voice followed by red face and then red hives also on his chest. was determined to have anaphylaxis. given 0.3 ml of epinephrine. then had chest pain and felt like he couldn't feel his hands. oxygen dropped to 88% on pulse ox. was given an adult epi_pen oxygen returned to 97+%, still had increased work of breathing and accessory muscle usage.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Anaphylactic reaction
- Hospital-Tage
- -
- Labordaten
- pulse ox as above.
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- hypospadius s/p repair. tonsils and adenoids removed. adhd
- Andere Medikamente
- 18 mg Concerta po QAM for ADHD
- Allergien
- Rash with sulfa drugs and oxycodone.
- Vorherige Impfungen
- -
- Staat
- OR
- Alter
- 6,0
- Geschlecht
- M
- Eingang
- 11.02.2021
- Impfdatum
- 04.02.2021
- Beginn
- 04.02.2021
- Tage bis Beginn
- 0,0
- Dosis
- 3
- Route/Site
- IM / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Syncope
Symptomtext
10 minutes after vaccine were administered, patient had a syncopal episode.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Syncope
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- history of anemia d/t secondary iron deficiency in 2015
- Andere Medikamente
- none
- Allergien
- no known allergies
- Vorherige Impfungen
- -
- Staat
- ME
- Alter
- 1,0
- Geschlecht
- M
- Eingang
- 07.01.2021
- Impfdatum
- 18.12.2020
- Beginn
- 25.12.2020
- Tage bis Beginn
- 7,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: ja
Disable: unbekannt
ER: unbekannt
Erholt: ja
C-reactive protein
Differential white blood cell count
Dyskinesia
Electroencephalogram
Fall
Febrile convulsion
Full blood count
Metabolic function test
Muscle twitching
Pyrexia
SARS-CoV-2 test negative
Seizure
Symptomtext
Pt showed at the ER on 12/25/2020 after falling mid walk. Pt left hand was rhythmically opening and closing. Head was twitching and left arm and left leg twitching-sx lasted 10min. Fever of 103 documented by EMS, vaccines 1 wk prior to the ER visit. Sx resolved 2 hrs after seizure. Diagnosed with ? atypical febrile seizure. Patient then sent to Center where he had an EEG and neurology consult. Dx with complex febrile seizure- had felt possible febrile seizure vs epilepsy vs genetic predisposition secondary to TMPRSS3 genetic mutation.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Febrile convulsion
- Hospital-Tage
- 2,0
- Labordaten
- EEG, covid negative, crp, bmp, cbc w/diff
- Aktuelle Erkrankungen
- no- did have a fever
- Vorgeschichte
- Deaf- has cochlear implant
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 5,0
- Geschlecht
- F
- Eingang
- 30.08.2021
- Impfdatum
- 30.08.2021
- Beginn
- 30.08.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Asthenia
Nausea
Pallor
Vomiting
Symptomtext
15 min post Hepatitis A vaccination, Mother reported to Nurse that her daughter was feeling nauseas and vomited in the bathroom. Nurse further assessed patient who appeared alert and oriented, but looked pale in the face, weak, and felt nauseas. Nurse had patient lie down with feet elevated. Blood pressure, pulse, and respirations taken every 5 min -10 min until client was stable and began to feel better. Patient never fainted and was able to respond to all questions asked by nurse. 20 min post incident, client was able to sit up and reported feeling much better. Denied being short of breath, nauseas, or weak. Client complexion looked much better and patient was able to stand/walk without feeling light headed or dizzy. Nurse educated parent on vasovagal symptoms as well as adverse reaction signs/symptoms to report. Parent was instructed to dial EMS if any adverse reactions symptoms (itching, rash/hives, swelling of lips/face/throat, shortness of breath, light headed/fainting, nausea/vomiting/abdominal cramping, etc.) was to occur at home. Nurse advised parent to inform healthcare provider of incident as well. Parent (mom), verbalized understanding to all the above and denied further questions at this time. Client was able to leave clinic setting with no further concerns or acute reaction symptoms noted.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Nausea
- Hospital-Tage
- -
- Labordaten
- none at this time.
- Aktuelle Erkrankungen
- None noted by parent.
- Vorgeschichte
- None noted by parent.
- Andere Medikamente
- None
- Allergien
- NKDA - Patient does have Provider Exemption from Immunization completed for DTAP/TDAP vaccines due to history of mother having potentional hearing loss or seizure after receiving this particular vaccine. However, Child received the DTAP vaccine in the past, but has never had any reaction to it per mother's report. This Exemption for is taking out of precaution for the child due to the mother's experience.
- Vorherige Impfungen
- -
- Staat
- MA
- Alter
- 1,0
- Geschlecht
- F
- Eingang
- 25.03.2021
- Impfdatum
- 11.12.2020
- Beginn
- 17.12.2020
- Tage bis Beginn
- 6,0
- Dosis
- 1
- Route/Site
- - / LA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Pallor
Rash
Rash erythematous
Rash maculo-papular
Symptomtext
erythematous maculopapular rash on trunk/neck non pruritic. Blanches. Received MMR 7 days prior,
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Rash
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 1,0
- Geschlecht
- M
- Eingang
- 26.01.2021
- Impfdatum
- 15.01.2021
- Beginn
- 23.01.2021
- Tage bis Beginn
- 8,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: unbekannt
Pyrexia
Rash erythematous
Rash maculo-papular
Symptomtext
Approximately 7 days after vaccines patient developed fever 101 and 1 cm erythematous maculopapular rash on Right arm that received Varicella vaccine
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Fever, Rash
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- MO
- Alter
- 1,5
- Geschlecht
- M
- Eingang
- 13.01.2021
- Impfdatum
- 11.01.2021
- Beginn
- 12.01.2021
- Tage bis Beginn
- 1,0
- Dosis
- 2
- Route/Site
- IM / RA
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Pyrexia
Vomiting
Symptomtext
Vomiting/fever - within 24 hours given zofran and tylenol satisfactory outcome
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Pyrexia
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- No
- Vorgeschichte
- No
- Andere Medikamente
- No
- Allergien
- No
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 1,8
- Geschlecht
- M
- Eingang
- 18.05.2022
- Impfdatum
- 20.04.2022
- Beginn
- 20.04.2022
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
No adverse event
Symptomtext
Caller did not provide any additional AE details; HCP reports that VAQTA that expired on 03-DEC-2021, was accidentally administered to a patient today, 20-APR-2022.; This spontaneous report has been received from a medical assistant referring to a 22-month-old male patient. The patient's pertinent medical history, and previous drugs reactions or allergies.Concomitant medications and historical vaccines included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 7v (crm197) (PREVENAR). On 20-APR-2022, the patient was accidentally vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, at a dose of 0.5 milliliter for prophylaxis lot number T013204, expiration date: 03-DEC-2021 (route of administration and anatomical location were not provided) . The reporter confirmed the product had been stored appropriately with no temperature excursions and did not provide any additional adverse event details(no adverse event). The patient's mom was notified about the expired vaccine and a re-vaccination was offered, nonetheless, the patient's mom did not want another vaccination.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- PENTACEL; PREVENAR
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- -
- Geschlecht
- U
- Eingang
- 08.01.2022
- Impfdatum
- -
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- 1
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Symptomtext
an expired VAQTA was given to a patient; No AEs were reported; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) syringe lot # T013204 with an expiration date on 03-DEC-2021, 0.5 milliliter once, for prophylaxis. No additional adverse events or product quality complaints were reported.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- -
- Geschlecht
- U
- Eingang
- 08.01.2022
- Impfdatum
- 15.12.2021
- Beginn
- 15.12.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Symptomtext
No additional AE reported.; an expired dose of VAQTA was administered.; This spontaneous report was received from a nurse concerning a patient of unknown age. No concurrent condition, medical history, or concomitant therapy was reported. On 15-DEC-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (0.5 mL, strength and route were unknown; lot # T013204 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 03-DEC-2021) for prophylaxis (expired product administered). The product had not experienced temperature excursion. There was no adverse event.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- -
- Geschlecht
- U
- Eingang
- 29.12.2021
- Impfdatum
- 15.12.2021
- Beginn
- 15.12.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Symptomtext
No additional AEs were reported; a patient received an expired VAQTA; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, drug reactions or allergies and concurrent conditions were not reported. On 15-DEC-2021, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) 0.5 milliliters (ml) as prophylaxis (vaccine scheme, route of administration and anatomical site of vaccination were not reported; lot number T013204 has been verified to be valid, expiration date reported and established as 03-DEC-2021) (expired product administered). No additional adverse events were reported (no adverse event).
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IL
- Alter
- 1,0
- Geschlecht
- M
- Eingang
- 15.12.2021
- Impfdatum
- 15.12.2021
- Beginn
- 15.12.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Symptomtext
Expired Hepatitis A (12/3/21)
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- No Known Allergies
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 20.11.2021
- Impfdatum
- 13.10.2021
- Beginn
- 13.10.2021
- 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
She denied further AE; administered to a patient after experiencing a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On 13-OCT-2021, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter (ml), lot # T013204, expiration date: 13-DEC-2021 (dose number and route of administration were not reported) for prophylaxis (product storage error). The vaccine was stored improperly for the time frame of 30 minutes in the temperature of 50.5 Fahrenheit (F). There was no previous temperature excursion. The reporter denied further adverse event (no adverse event). This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-2110USA007269:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 17.11.2021
- Impfdatum
- 11.10.2021
- Beginn
- 11.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
She denied further AE.; VAQTA was administered to a patient after experiencing a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-OCT-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter, lot # T013204, expiration date reported as 13-DEC-2021 but under internal validation established as 03-DEC-2021 for prophylaxis (anatomical location and route of administration were not reported). The vaccine was stored at the temperature that was reported as 50.5 degrees of Fahrenheit for 0 hours and 30 minutes. There was no previous temperature excursion reported. The reporter denied further adverse events. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-2110USA007275: US-009507513-2110USA007269: US-009507513-2110USA007379: US-009507513-2110USA007310: US-009507513-2110USA007288: US-009507513-2110USA006972: US-009507513-2110USA007007: US-009507513-2110USA007272:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 17.11.2021
- Impfdatum
- 13.10.2021
- Beginn
- 13.10.2021
- 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
She denied further AE; VAQTA was administered to a patient after experiencing a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 13-OCT-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 milliliter, lot # T013204, expiration date 13-DEC-2021 for prophylaxis (anatomical location and route of administration were not reported). The vaccine was stored at the temperature that was reported as 50.5 degrees of Fahrenheit for 0 hours and 30 minutes. There was no previous temperature excursion reported. The reporter denied further adverse events. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-2110USA007269: US-009507513-2110USA007275: US-009507513-2110USA007379: US-009507513-2110USA007316: US-009507513-2110USA007310: US-009507513-2110USA007288: US-009507513-2110USA006972: US-009507513-2110USA007007: US-009507513-2110USA007272:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 04.11.2021
- Impfdatum
- 03.10.2021
- Beginn
- 03.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
she denied further AE; VAQTA was administered to a patient after experiencing a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 03-OCT-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date on 03-DEC-2021 (conflicting information also reported as 13-DEC-2021) 0.5 milliliter, for prophylaxis (strength, route of administration and anatomical location were not reported); after experiencing a temperature excursion (product storage error). Vaccine was improperly stored at 50?F during a time frame of 0 hours and 30 minutes. No previous temperature excursion were reported and medical assistant denied further Adverse Event (AE) (no adverse event). ; Sender's Comments: US-009507513-2110USA007288: US-009507513-2110USA007310: US-009507513-2110USA007316: US-009507513-2110USA007379: US-009507513-2110USA007269: US-009507513-2110USA007272: US-009507513-2110USA006972:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.11.2021
- Impfdatum
- 13.10.2021
- Beginn
- 13.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
She denied further AE.; administered to a patient after experiencing a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 13OCT2021 the patient was vaccinated with with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 ml, lot # T013204 was confirmed to be valid with expiration date 03-DEC-2021 (route of administration, anatomical location were not reported) for prophylaxis. The administered dose underwent a temperature excursion of 50.5 degrees Fahrenheit for 30 minutes. There were no previous temperature excursions. No additional adverse effect was reported. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-2110USA007269: US-009507513-2110USA007288: US-009507513-2110USA007316:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 03.11.2021
- Impfdatum
- 05.10.2021
- Beginn
- 05.10.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
she denied further AE; She reported that VAQTA was administered to a patiient after experiencing a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 05-OCT-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date on 03-DEC-2021 (conflicting information also reported as 13-DEC-2021) 0.5 milliliter, for prophylaxis (strength, route of administration and anatomical location were not reported). Vaccine was administered after experiencing a temperature excursion (product storage error); it was stored at 50.5?F during a time frame of 0 hours and 30 minutes. There was no previous temperature excursions and further Adverse Event (AE) were denied (no adverse event). This one of several reports received from the same reporter. ; Sender's Comments: US-009507513-2110USA007288: US-009507513-2110USA007310: US-009507513-2110USA007316: US-009507513-2110USA007379: US-009507513-2110USA007269: US-009507513-2110USA007007: US-009507513-2110USA007272:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 29.10.2021
- Impfdatum
- 04.10.2021
- Beginn
- 04.10.2021
- 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
She denied further AE.; administered to a patient after experiencing a temperature excursion.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 04-OCT-2021 the patient was vaccinated with with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 ml, lot # T013204 was confirmed to be valid with expiration date 03-DEC-2021 (route of administration, anatomical location were not reported) for prophylaxis. The administered dose underwent a temperature excursion of 50.5 degrees Fahrenheit for 30 minutes. There were no previous temperature excursions. No additional adverse effect was reported. This is one of several reports received from the same reporter. ; Sender's Comments: US-009507513-2110USA007288: US-009507513-2110USA007310: US-009507513-2110USA007316:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 1,0
- Geschlecht
- F
- Eingang
- 04.06.2021
- Impfdatum
- 10.05.2021
- Beginn
- 10.05.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Symptomtext
Expired vaccine given. No treatment. no need for revaccination. As per call to Merck these are supported through 6 months after date of expiration. Potency remains unchanged
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- none
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 1,0
- Geschlecht
- M
- Eingang
- 04.06.2021
- Impfdatum
- 10.05.2021
- Beginn
- 10.05.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Symptomtext
Expired vaccine given. No treatment. No need for revaccination. As per call to Merck these are supported through 6 months after date of expiration. Potency remains unchanged.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none
- Andere Medikamente
- nystatin
- Allergien
- none
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 1,0
- Geschlecht
- F
- Eingang
- 04.06.2021
- Impfdatum
- 20.05.2021
- Beginn
- 20.05.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / RL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Expired product administered
Symptomtext
Expired vaccine given. No treatment. No need for revaccination. As per call to Merck these are supported through 6 months after the date of expiration. Potency remains unchanged.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- none
- Aktuelle Erkrankungen
- none
- Vorgeschichte
- none known
- Andere Medikamente
- Nystatin
- Allergien
- no known allergies
- Vorherige Impfungen
- -
- Staat
- PA
- Alter
- 1,0
- Geschlecht
- M
- Eingang
- 11.05.2021
- Impfdatum
- 22.04.2021
- Beginn
- 22.04.2021
- Tage bis Beginn
- 0,0
- Dosis
- 1
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Inappropriate schedule of product administration
Symptomtext
There are no adverse reactions but the PA gave 6 month vaccines instead of 12 month vaccines. We will catch the child up on MMR and Varicella at his 15 month appointment.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Inappropriate schedule of product administration
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.04.2021
- Impfdatum
- 25.03.2021
- Beginn
- 25.03.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported. On 25-MAR-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot #: T013204, expiration date: 03-DEC-2021 or lot #: T013546, expiration date: 28-OCT-2021 (two lot# of vaccines have been reported, no information of which one was administrated to the patient); dose, strength and route were not reported) for prophylaxis. The vaccines underwent temperature excursions and were stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported. This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2104USA002970: US-009507513-2104USA002944: US-009507513-2104USA002974: US-009507513-2104USA002975: US-009507513-2104USA002973: US-009507513-2104USA002971: US-009507513-2104USA002963: US-009507513-2104USA002972: US-009507513-2104USA002978: US-009507513-2104USA002980: US-009507513-2104USA002981: US-009507513-2104USA002982: US-009507513-2104USA002983: US-009507513-2104USA002984: US-009507513-2104USA002985: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE); VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.04.2021
- Impfdatum
- 23.03.2021
- Beginn
- 23.03.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported. On 23-MAR-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot #: T013204, expiration date: 03-DEC-2021 or lot #: T013546, expiration date: 28-OCT-2021 (two lot# of vaccines have been reported, no information of which one was administrated to the patient); dose, strength and route were not reported) for prophylaxis. The vaccines underwent temperature excursions and were stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported. This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2104USA002970: US-009507513-2104USA002944: US-009507513-2104USA002974: US-009507513-2104USA002973: US-009507513-2104USA002971: US-009507513-2104USA002963: US-009507513-2104USA002972: US-009507513-2104USA002976: US-009507513-2104USA002978: US-009507513-2104USA002980: US-009507513-2104USA002981: US-009507513-2104USA002982: US-009507513-2104USA002983: US-009507513-2104USA002984: US-009507513-2104USA002985: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE); VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.04.2021
- Impfdatum
- 23.03.2021
- Beginn
- 23.03.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported. On 23-MAR-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot #: T013204, expiration date: 03-DEC-2021 or lot #: T013546, expiration date: 28-OCT-2021 (two lot# of vaccines have been reported, no information of which one was administrated to the patient); dose, strength and route were not reported) for prophylaxis. The vaccines underwent temperature excursions and were stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported. This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2104USA002970: US-009507513-2104USA002944: US-009507513-2104USA002973: US-009507513-2104USA002971: US-009507513-2104USA002963: US-009507513-2104USA002972: US-009507513-2104USA002975: US-009507513-2104USA002976: US-009507513-2104USA002978: US-009507513-2104USA002980: US-009507513-2104USA002981: US-009507513-2104USA002982: US-009507513-2104USA002983: US-009507513-2104USA002984: US-009507513-2104USA002985: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE); VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.04.2021
- Impfdatum
- 17.02.2021
- Beginn
- 17.02.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported. On 17-FEB-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot #: T013204, expiration date: 03-DEC-2021 or lot #: T013546, expiration date: 28-OCT-2021 (two lot# of vaccines have been reported, no information of which one was administrated to the patient); dose, strength and route were not reported) for prophylaxis. The vaccines underwent temperature excursions and were stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported. This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2104USA002970: US-009507513-2104USA002944: US-009507513-2104USA002971: US-009507513-2104USA002963: US-009507513-2104USA002972: US-009507513-2104USA002974: US-009507513-2104USA002975: US-009507513-2104USA002976: US-009507513-2104USA002978: US-009507513-2104USA002980: US-009507513-2104USA002981: US-009507513-2104USA002982: US-009507513-2104USA002983: US-009507513-2104USA002984: US-009507513-2104USA002985: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE); VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.04.2021
- Impfdatum
- 10.02.2021
- Beginn
- 10.02.2021
- 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 adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported. On 10-FEB-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot #: T013204, expiration date: 03-DEC-2021 or lot #: T013546, expiration date: 28-OCT-2021 (two lot# of vaccines have been reported, no information of which one was administrated to the patient); dose, strength and route were not reported) for prophylaxis. The vaccines underwent temperature excursions and were stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported. This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2104USA002971: US-009507513-2104USA002970: US-009507513-2104USA002944: US-009507513-2104USA002963: US-009507513-2104USA002973: US-009507513-2104USA002974: US-009507513-2104USA002975: US-009507513-2104USA002976: US-009507513-2104USA002978: US-009507513-2104USA002980: US-009507513-2104USA002981: US-009507513-2104USA002982: US-009507513-2104USA002983: US-009507513-2104USA002984: US-009507513-2104USA002985: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE); VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.04.2021
- Impfdatum
- 09.02.2021
- Beginn
- 09.02.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported. On 09-FEB-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot #: T013204, expiration date: 03-DEC-2021 or lot #: T013546, expiration date: 28-OCT-2021 (two lot# of vaccines have been reported, no information of which one was administrated to the patient); dose, strength and route were not reported) for prophylaxis. The vaccines underwent temperature excursions and were stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported. This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2104USA002970: US-009507513-2104USA002944: US-009507513-2104USA002963: US-009507513-2104USA002972: US-009507513-2104USA002973: US-009507513-2104USA002974: US-009507513-2104USA002975: US-009507513-2104USA002976: US-009507513-2104USA002978: US-009507513-2104USA002980: US-009507513-2104USA002981: US-009507513-2104USA002982: US-009507513-2104USA002983: US-009507513-2104USA002984: US-009507513-2104USA002985: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE); VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.04.2021
- Impfdatum
- 08.02.2021
- Beginn
- 08.02.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported. On 08-FEB-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot #: T013204, expiration date: 03-DEC-2021 or lot #: T013546, expiration date: 28-OCT-2021 (two lot# of vaccines have been reported, no information of which one was administrated to the patient); dose, strength and route were not reported) for prophylaxis. The vaccines underwent temperature excursions and were stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported. This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2104USA002963: US-009507513-2104USA002944: US-009507513-2104USA002971: US-009507513-2104USA002972: US-009507513-2104USA002973: US-009507513-2104USA002974: US-009507513-2104USA002975: US-009507513-2104USA002976: US-009507513-2104USA002978: US-009507513-2104USA002980: US-009507513-2104USA002981: US-009507513-2104USA002982: US-009507513-2104USA002983: US-009507513-2104USA002984: US-009507513-2104USA002985: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE); VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- WA
- Alter
- -
- Geschlecht
- U
- Eingang
- 27.04.2021
- Impfdatum
- 03.02.2021
- Beginn
- 03.02.2021
- 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 adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported. On 03-FEB-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot #: T013204, expiration date: 03-DEC-2021 or lot #: T013546, expiration date: 28-OCT-2021 (two lot# of vaccines have been reported, no information of which one was administrated to the patient); dose, strength and route were not reported) for prophylaxis. The vaccines underwent temperature excursions and were stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported. This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2104USA002944: US-009507513-2104USA002970: US-009507513-2104USA002971: US-009507513-2104USA002972: US-009507513-2104USA002973: US-009507513-2104USA002974: US-009507513-2104USA002975: US-009507513-2104USA002976: US-009507513-2104USA002978: US-009507513-2104USA002980: US-009507513-2104USA002981: US-009507513-2104USA002982: US-009507513-2104USA002983: US-009507513-2104USA002984: US-009507513-2104USA002985: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE); VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- IN
- Alter
- 29,0
- Geschlecht
- U
- Eingang
- 13.04.2021
- Impfdatum
- 22.03.2021
- Beginn
- 22.03.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Incorrect dose administered
No adverse event
Product administered to patient of inappropriate age
Symptomtext
No additional adverse events reported; a 29 year old patient received 0.5 milliliters of pediatric VAQTA; a 29 year old patient received 0.5 milliliters of pediatric VAQTA; This spontaneous report was received from a physician referring to a 29 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 22-MAR-2021, the patient was vaccinated with pediatric hepatitis a vaccine, inactivated(VAQTA) (0.5 milliliters, one time dose, lot # T013204, expiration date 03-DEC-2021; strength and route were not reported) for prophylaxis (product administered to patient of inappropriate age and incorrect dose administered). No additional adverse events or product quality complaints were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Incorrect dose administered
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- 1,9
- Geschlecht
- F
- Eingang
- 05.04.2021
- Impfdatum
- 08.03.2021
- Beginn
- 08.03.2021
- Tage bis Beginn
- 0,0
- Dosis
- 2
- Route/Site
- IM / LL
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: ja
Expired product administered
No adverse event
Symptomtext
This patient was given a dose that was expired. The ActHib vaccine had expired on 3/7/21 and it was administered on 3/8/21. There were no adverse symptoms observed. The patient has been notified and scheduled for a new ActHib vaccination.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Expired product administered
- Hospital-Tage
- -
- Labordaten
- NONE
- Aktuelle Erkrankungen
- NONE
- Vorgeschichte
- NONE
- Andere Medikamente
- NONE
- Allergien
- NKA
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,3
- Geschlecht
- U
- Eingang
- 08.03.2021
- Impfdatum
- 22.01.2021
- Beginn
- 22.01.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 15-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 22-JAN-2021, the patient was vaccinated with improperly stored doses of hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S037500 has been verified to be a valid lot number, with expiration date reported as 20-NOV-2021 (strengths, exact doses, doses #, anatomical locations and routes of administration were not reported) as prophylaxis. Administered doses of vaccines experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original cases # 2102USA004059 and 2102USA003923). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA003923: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,0
- Geschlecht
- U
- Eingang
- 05.03.2021
- Impfdatum
- 21.01.2021
- Beginn
- 21.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 21-JAN-2021, the patient was vaccinated with improperly stored doses of hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S037500 has been verified to be a valid lot number, with expiration date reported as 20-NOV-2021 (strengths, exact doses, doses #, anatomical locations and routes of administration were not reported) as prophylaxis. Administered doses of vaccines experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original cases # 2102USA004059 and 2102USA003923). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA003923: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,0
- Geschlecht
- U
- Eingang
- 05.03.2021
- Impfdatum
- 20.01.2021
- Beginn
- 20.01.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 20-JAN-2021, the patient was vaccinated with improperly stored doses of hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S037500 has been verified to be a valid lot number, with expiration date reported as 20-NOV-2021 (strengths, exact doses, doses #, anatomical locations and routes of administration were not reported) as prophylaxis. Administered doses of vaccines experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original cases # 2102USA004059 and 2102USA003923). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ;devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA003923: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,0
- Geschlecht
- U
- Eingang
- 05.03.2021
- Impfdatum
- 16.01.2021
- Beginn
- 16.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 16-JAN-2021, the patient was vaccinated with improperly stored doses of hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S037500 has been verified to be a valid lot number, with expiration date reported as 20-NOV-2021 (strengths, exact doses, doses #, anatomical locations and routes of administration were not reported) as prophylaxis. Administered doses of vaccines experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original cases # 2102USA004059 and 2102USA003923). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA003923: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,0
- Geschlecht
- U
- Eingang
- 05.03.2021
- Impfdatum
- 27.01.2021
- Beginn
- 27.01.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 27-JAN-2021, the patient was vaccinated with improperly stored doses of hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S037500 has been verified to be a valid lot number, with expiration date reported as 20-NOV-2021 (strengths, exact doses, doses #, anatomical locations and routes of administration were not reported) as prophylaxis. Administered doses of vaccines experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original cases # 2102USA004059 and 2102USA003923). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA003923: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,0
- Geschlecht
- U
- Eingang
- 05.03.2021
- Impfdatum
- 16.01.2021
- Beginn
- 16.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 16-JAN-2021, the patient was vaccinated with improperly stored doses of hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S037500 has been verified to be a valid lot number, with expiration date reported as 20-NOV-2021 (strengths, exact doses, doses #, anatomical locations and routes of administration were not reported) as prophylaxis. Administered doses of vaccines experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original cases # 2102USA004059 and 2102USA003923). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA003923: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,0
- Geschlecht
- U
- Eingang
- 05.03.2021
- Impfdatum
- 04.01.2021
- Beginn
- 04.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 04-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA003923: US-009507513-2102USA005233: US-009507513-2102USA005234: US-009507513-2102USA005235: US-009507513-2102USA005236: US-009507513-2102USA005237: US-009507513-2102USA005238: US-009507513-2102USA005239: US-009507513-2102USA005240: US-009507513-2102USA005241: US-009507513-2102USA005242: US-009507513-2102USA005243: US-009507513-2102USA005244: US-009507513-2102USA005245: US-009507513-2102USA005246: US-009507513-2102USA005247: US-009507513-2102USA005248: US-009507513-2102USA005249: US-009507513-2102USA005250: US-009507513-2102USA005251: US-009507513-2102USA005252: US-009507513-2102USA005253: US-009507513-2102USA005254: US-009507513-2102USA005255: US-009507513-2102USA005256: US-009507513-2102USA005257: US-009507513-2102USA005258: US-009507513-2102USA005227: US-009507513-2102USA005228: US-009507513-2102USA005229: US-009507513-2102USA005230: US-009507513-2102USA005231: US-009507513-2102USA005232:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TN
- Alter
- 1,2
- Geschlecht
- U
- Eingang
- 03.03.2021
- Impfdatum
- 29.01.2021
- 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
incorrect product storage; No additional adverse events reported; This spontaneous report was received from an administrator via a Nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On 29-JAN-2021, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) which had a lot # T013204 with expiration date on 03-DEC-2021 (dose, frequency and route of administration were not reported) for prophylaxis. Other dose of hepatitis a vaccine, inactivated (VAQTA) with lot # T013204 and expiration date on 03-DEC-2021 was also improperly stored. However no adverse events were mentioned. It was reported that the vaccines were exposed to temperature of -7.9 Centigrade range for a time frame of 52 minutes and -10.5 for 52 minutes The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE); VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 2,0
- Geschlecht
- U
- Eingang
- 01.03.2021
- Impfdatum
- 22.01.2021
- Beginn
- 22.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to an 2-year-old patient of unknown gender. Their concurrent conditions, medical history and concomitant therapies were not provided. On 22-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA003923: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,0
- Geschlecht
- U
- Eingang
- 01.03.2021
- Impfdatum
- 20.01.2021
- Beginn
- 20.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-mont-old patient of unknown gender. Their concurrent conditions, medical history and concomitant therapies were not provided. On 20-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA003923: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 2,0
- Geschlecht
- U
- Eingang
- 26.02.2021
- Impfdatum
- 26.01.2021
- Beginn
- 26.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. Their concurrent conditions, medical history and concomitant therapies were not provided. On 26-JAN-2021 , the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA003923: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 4,0
- Geschlecht
- U
- Eingang
- 26.02.2021
- Impfdatum
- 05.01.2021
- Beginn
- 05.01.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 05-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 2,0
- Geschlecht
- U
- Eingang
- 26.02.2021
- Impfdatum
- 05.01.2021
- Beginn
- 05.01.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 05-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,3
- Geschlecht
- U
- Eingang
- 24.02.2021
- Impfdatum
- 19.01.2021
- Beginn
- 19.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 16-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On 19-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA003923: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 10,0
- Geschlecht
- U
- Eingang
- 23.02.2021
- Impfdatum
- 05.01.2021
- Beginn
- 05.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 10-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 05-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,9
- Geschlecht
- U
- Eingang
- 23.02.2021
- Impfdatum
- 19.01.2021
- Beginn
- 19.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 23-moths-old patient of unknown gender. Concurrent conditions, medical history and concomitant therapies were not provided. On 19-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA003923: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,2
- Geschlecht
- U
- Eingang
- 23.02.2021
- Impfdatum
- 05.01.2021
- Beginn
- 05.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 14-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 05-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,1
- Geschlecht
- U
- Eingang
- 23.02.2021
- Impfdatum
- 05.01.2021
- Beginn
- 05.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 13-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 05-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,7
- Geschlecht
- U
- Eingang
- 22.02.2021
- Impfdatum
- 13.01.2021
- Beginn
- 13.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 20-month-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-JAN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date was not provided, but upon internal validation process it was established as 03-DEC-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 47.01 Fahrenheit (F) for 1 minute 30 seconds. Data logger was involved. There were no previous excursions reported. No additional adverse events were reported. This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA003923: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,3
- Geschlecht
- U
- Eingang
- 22.02.2021
- Impfdatum
- 12.01.2021
- Beginn
- 12.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 15-month-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-JAN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date was not provided, but upon internal validation process it was established as 03-DEC-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 47.01 Fahrenheit (F) for 1 minute 30 seconds. Data logger was involved. There were no previous excursions reported. No additional adverse events were reported. This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA003923: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,9
- Geschlecht
- U
- Eingang
- 22.02.2021
- Impfdatum
- 08.01.2021
- Beginn
- 08.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 23-month-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-JAN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date was not provided, but upon internal validation process it was established as 03-DEC-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 47.01 Fahrenheit (F) for 1 minute 30 seconds. Data logger was involved. There were no previous excursions reported. No additional adverse events were reported. This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA003923: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 0,5
- Geschlecht
- U
- Eingang
- 22.02.2021
- Impfdatum
- 07.01.2021
- Beginn
- 07.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 6-month-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-JAN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date was not provided, but upon internal validation process it was established as 03-DEC-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 47.01 Fahrenheit (F) for 1 minute 30 seconds. Data logger was involved. There were no previous excursions reported. No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA003923: US-009507513-2102USA004059: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,4
- Geschlecht
- U
- Eingang
- 18.02.2021
- Impfdatum
- 07.01.2021
- Beginn
- 07.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 17-month-old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-JAN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date was not provided, but upon internal validation process it was established as 03-DEC-2021 (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 47.01 Fahrenheit (F) for 1 minute 30 secundes. Data logger was involved. There were no previous excursions reported. No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA003923: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 4,0
- Geschlecht
- U
- Eingang
- 18.02.2021
- Impfdatum
- 07.01.2021
- Beginn
- 07.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 07-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,0
- Geschlecht
- U
- Eingang
- 18.02.2021
- Impfdatum
- 05.01.2021
- Beginn
- 05.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 05-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,7
- Geschlecht
- U
- Eingang
- 17.02.2021
- Impfdatum
- 29.01.2021
- Beginn
- 29.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 20-month-old patient of unknown gender. Their concurrent conditions, medical history and concomitant therapies were not provided. On 29-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,0
- Geschlecht
- U
- Eingang
- 17.02.2021
- Impfdatum
- 29.01.2021
- Beginn
- 29.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. Their concurrent conditions, medical history and concomitant therapies were not provided. On 29-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 8,0
- Geschlecht
- U
- Eingang
- 17.02.2021
- Impfdatum
- 27.01.2021
- Beginn
- 27.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to an 8-year-old patient of unknown gender. Their concurrent conditions, medical history and concomitant therapies were not provided. On 27-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot number: T013204, expiration date: 03-DEC-2021 (strength, dose, frequency and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 2,0
- Geschlecht
- U
- Eingang
- 17.02.2021
- Impfdatum
- 18.01.2021
- Beginn
- 18.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 18-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 2,0
- Geschlecht
- U
- Eingang
- 17.02.2021
- Impfdatum
- 15.01.2021
- Beginn
- 15.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 15-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,3
- Geschlecht
- U
- Eingang
- 17.02.2021
- Impfdatum
- 14.01.2021
- Beginn
- 14.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 16-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 14-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 1,0
- Geschlecht
- U
- Eingang
- 17.02.2021
- Impfdatum
- 13.01.2021
- Beginn
- 13.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 13-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 2,0
- Geschlecht
- U
- Eingang
- 17.02.2021
- Impfdatum
- 13.01.2021
- Beginn
- 13.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 13-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- TX
- Alter
- 12,0
- Geschlecht
- U
- Eingang
- 17.02.2021
- Impfdatum
- 13.01.2021
- Beginn
- 13.01.2021
- 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 reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 12-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided. On 13-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported. This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments: US-009507513-2102USA004059:
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- SC
- Alter
- 1,2
- Geschlecht
- F
- Eingang
- 16.02.2021
- Impfdatum
- 25.01.2021
- Beginn
- 09.02.2021
- Tage bis Beginn
- 15,0
- Dosis
- 1
- Route/Site
- IM / OT
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Erythema
Induration
Skin reaction
Symptomtext
Small reaction site, sore, red, and somewhat hard.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Erythema
- Hospital-Tage
- -
- Labordaten
- None
- Aktuelle Erkrankungen
- None
- Vorgeschichte
- None
- Andere Medikamente
- None
- Allergien
- None
- Vorherige Impfungen
- -
- Staat
- KY
- Alter
- 1,5
- Geschlecht
- U
- Eingang
- 03.02.2021
- Impfdatum
- 06.01.2021
- Beginn
- 06.01.2021
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
No adverse event
Product storage error
Symptomtext
No additional AE.; Improperly Stored VAQTA was administered to patient.; This spontaneous report was received from a nurse and refers to a 18-month-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 06-JAN-2021 between 9:30 AM and 12:00 PM, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # T013204, expiration date 03-DEC-2021 (exact dose, anatomical location and route of administration were not reported) for prophylaxis. Digital Data logger was involved. The temperature excursion occurred on 06-JAN-2021 at 1:30AM. The vaccine was stored at the temperature that was reported as 35.2 degrees of Fahrenheit for 45 minutes. There was no previous temperature excursion reported. No additional adverse event reported. This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- No adverse event
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- Prophylaxis
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- -
- Geschlecht
- U
- Eingang
- 14.01.2021
- Impfdatum
- 31.12.2020
- Beginn
- -
- Tage bis Beginn
- -
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Hepatitis A immunisation
Product storage error
Symptomtext
improperly stored vaccine administered; This spontaneous report has been received from a medical assistant referring to a patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not provided. On 31-DEC-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (strength, dose, route, frequency and anatomical location were not provided) lot # T013204 with expiration date of 03-DEC-2021 for prophylaxis. The vaccine was exposed to a temperature below 36 F for 5 hours and 40 minutes. There were no previous temperature excursions and the vaccines were back in range. Data logger was used (product storage error). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Hepatitis A immunisation
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- VA
- Alter
- -
- Geschlecht
- U
- Eingang
- 12.01.2021
- Impfdatum
- 28.12.2020
- Beginn
- 28.12.2020
- Tage bis Beginn
- 0,0
- Dosis
- UNK
- Route/Site
- - / -
Tod: unbekannt
Lebensbedrohlich: unbekannt
Hospital: unbekannt
Disable: unbekannt
ER: unbekannt
Erholt: nein
Hepatitis A immunisation
Product storage error
Prophylaxis
Symptomtext
a VAQTA vaccine which had been improperly stored was administered to a patient.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided. On 28-DEC-2020, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) (lot # T013204, expiration date 03-DEC-2021, 1 injection) for prophylaxis (product storage error). The temperature excursion was supported, at below 36 Fahrenheit degree (32.1 Fahrenheit degree) for 5 hours and 40 minutes. There were no previous excursions, and a data logger was used. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Hepatitis A immunisation
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- VAQTA SYRINGE (DEVICE)
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- 17,0
- Geschlecht
- U
- Eingang
- 06.01.2021
- Impfdatum
- 15.12.2020
- Beginn
- 15.12.2020
- 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
Nurse reported temperature excursion with GARDASIL 9 and VAQTA.; This spontaneous report as received from a Registered Nurse referring to a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 15-DEC-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter (strength, route, frequency, and anatomical location were unknown) with lot # 1637641 and expiration date on 16-FEB-2022; and finally with an improperly stored dose of Hepatitis A Vaccine, Inactivated(VAQTA) 0.5 milliliter (strength, route, frequency, and anatomical location were unknown) with lot # T013204 and expiration date on 03-DEC-2021 for prophylaxis. The administered doses of vaccines experienced temperature excursion (0.38 degrees Celsius) for 4 hours and 45 minutes and (11.09 degrees Celsius) for 1 hour and 30 minutes. There was a digital data logger invloved, but no previous temperature excursion for Hepatitis A Vaccine, Inactivated(VAQTA) but there was a previous temperature excursion with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (17.52 degrees Celsius) for 2 hours and 42 minutes.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -
- Staat
- NJ
- Alter
- -
- Geschlecht
- U
- Eingang
- 06.01.2021
- Impfdatum
- 15.12.2020
- Beginn
- 15.12.2020
- 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
Caller reporting temperature excursion, product was administered; This spontaneous report was received from a registered nurse referring to a 14-year-old patient. The patient's pertinent concurrent conditions, medical history and concomitant medications were not reported. On 15-DEC-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot number 1637641 and expiration date reported 16-FEB-2022) and hepatitis a vaccine, inactivated (VAQTA) (lot number T013204 and reported expiration date 03-DEC-2021) both as prophylaxis at a dose of 0.5 milliliter, concentrations, vaccination scheme frequency, routes of administration and anatomical locations were not reported. According to the reporter, the temperature excursion of both vaccines was 0.38 degrees Celsius for a time frame of four hours and 45 minutes and 11.09 degrees Celsius for 1 hour and 30 minutes on an unspecified date (product storage error), hepatitis a vaccine, inactivated (VAQTA) without any previous temperature excursion, however the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccine had a previous temperature of excursion of 17.52 degrees Celsius for 2 hours and 42 minutes; which were detected by a digital data logger.
Weitere VAERSDATA-Felder
- Praegender Schweregrund
- Product storage error
- Hospital-Tage
- -
- Labordaten
- -
- Aktuelle Erkrankungen
- -
- Vorgeschichte
- -
- Andere Medikamente
- -
- Allergien
- -
- Vorherige Impfungen
- -