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From the 4/23/2021 release of VAERS data:

Found 208 cases where Vaccine targets Varicella (MMRV or VARCEL) and Patient Died and Vaccination Date on/before '2019-05-31'



Case Details

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VAERS ID: 631457 (history)  
Form: Version 1.0  
Age: 1.7  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-11
Entered: 2016-03-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Encephalitis, Pyrexia, Somnolence, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1603AUS004063

Write-up: This literature report was obtained from the published literature article that refers to a report that summarizes national passive surveillance data for adverse events following immunization (AEFI) reported to the Therapeutic Goods Administration (TGA) to 28 February 2013. The report focuses on AEFI reported for vaccines administered during 2012 and trends in AEFI reporting over the 13-year period 1 January 2000 to 31 December 2012. AEFI were notified to the TGA by state and territory health departments, health professionals, vaccine manufacturers and members of the public. Records contained in the ADRS database were eligible for inclusion in the analysis -if a vaccine was recorded as ''suspected of involvement in the reported adverse event and either the vaccination occurred between 01-JAN-2000 and 31-DEC-2012, -or for records where the vaccination date was not recorded, the date of onset of symptoms or signs occurred between 01-JAN-2000 and 31-DEC-2012. This case refers to a 19-month old child who had received vaccination with varicella vaccine live (Merck) (manufacturer unknown) (route, dose, frequency were not reported). On unknown date 7 weeks after vaccination, the patient presented with vomiting, fever and drowsiness. On an unspecified date the patient died. The cause of death was recorded as encephalitis. The death was investigated by the TGA and no clear causal relationship with vaccine was found. The authors reported that in many instances a causal association between vaccines administered to an individual and events that subsequently occurred cannot be clearly ruled in or out. Upon internal review, the event encephalitis was determined to be medically significant. This case is one of the several reports from the same literature article. Additional information has been requested.


VAERS ID: 636165 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Male  
Location: Foreign  
Vaccinated:2016-03-30
Onset:2016-03-31
   Days after vaccination:1
Submitted: 2016-05-13
   Days after onset:43
Entered: 2016-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Blood HIV RNA decreased, Body temperature increased, Brain oedema, CSF test abnormal, Chest X-ray abnormal, Computerised tomogram head abnormal, Congestive cardiomyopathy, Coxsackie virus test negative, Death, Encephalitis, Enterococcal infection, Enterovirus test positive, HIV test negative, Hyponatraemia, Incomplete course of vaccination, Intensive care, Laboratory test normal, Pneumonia, Seizure, Status epilepticus
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-04-06
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature (31-MAR-2016): 39.1 Celsius degree, increased; body temperature (31-MAR-2016): 37 Celsius degree, increased; cranial computed tomography (03-APR-2016): widespread brain edema, not discarded effects of ground left thalamus region; serology human immunodeficiency virus (HIV) (05-APR-2016): negative/indeterminated; Coxsackie virus (05-APR-2016): negative/indeterminated; 04/04/2016, CSF test, enterovirus
CDC Split Type: WAES1605MEX005351

Write-up: This spontaneous report as received from a physician refers to a 1 year old male patient. The patient''s concurrent conditions and medical history were not reported. The patient was born by Caesarean section, Apgar 8/9, weight born: 3800kg, height 52 cm. An incomplete vaccination scheme for lack of the third (3rd) dose of rotavirus was reported for the infant. It was reported that the patient had not been sick and did not receive any medication in the last 15 days. The patient was fed with a chicken and vegetables. On 30-MAR-2016 at 12:00, the patient was vaccinated with the first 0.5 ml dose of VARIVAX subcutaneously (batch # were reported as L003047 and as L009047, expiration date: December 2016). On 31-MAR-2016, at approximately 18:00, his body temperature was 39.1 Celsius degree and was controlled by physical means within the day care, to achieve down to 37 Celsius degree. The patient was giving in these conditions to authorized person (paternal grandmother) at 18:35, also it was given medical assessment request. On 01-APR-2016 at approximately 8:30, the mother''s child requested the change to format medical assessment, signing the letter of responsibility, leaving as a commitment that she would call to give diagnosis, situation that did not happen so far. The physician prescribed DENVAR, MOTRIN, FEBRAX and TEGO. On 04-APR-2016, to verify that the child not reached as usual time, the daycare proceeded to call to obtain information. The father replied that on 01-APR-2016 (Friday) and on 02-APR-2016 (Saturday), the child had been found in a good condition. On 03-APR-2016 (Sunday) about at noon, the child convulsed on right side without submitting fever, so they went to the emergency room of the hospital at 12:30, where was channeled and was hospitalized immediately into intensive care to do tests. On the same date, an x-ray thoracoabdominal showed pneumonia of multiple foci; cranial computed tomography showed widespread brain edema, not discarded effects of ground left thalamus region. The hospital admission diagnosis was convulsion in studio, status epilepticus and hyponatremia. The patient was treated with parenteral solutions, electrolytes, anticonvulsants, aciclovir, vancomycin, ceftriaxone, midazolam and general care routine in Pediatric Intensive Care Unit (PICU). On 04-APR-2016, it was conducted a study of cerebrospinal fluid (CSF), which revealed enterovirus. A molecular profile of meningitis detected enterovirus, varicella zoster was not detected. A molecular profile respiratory virus detected Enterococcus. On 05-APR-2016, a serology human immunodeficiency virus (HIV)/ Coxsackie virus was negative/indeterminated. On 06-APR-2016, an enterococcal infection was diagnosed. The child continued in intensive care until that day, where the parent notified that her son had died. The discharge diagnosis was reported as encephalitis by enterovirus, seizure secondary, state postarrest, dilated cardiomyopathy and death. The outcome of enterococcal infection was reported as fatal. It was unknown if an autopsy was performed. The cause of death was not reported. The relationship between the event and the vaccine was reported as: inconsistent causal association with vaccination (coinciden). No more information was provided. Additional information has been requested.


VAERS ID: 642441 (history)  
Form: Version 1.0  
Age: 1.0  
Sex: Female  
Location: Foreign  
Vaccinated:2016-04-12
Onset:0000-00-00
Submitted: 2016-06-03
Entered: 2016-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. L045239 / UNK AR / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. K003383 / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Death, Meningococcal sepsis
SMQs:, Sepsis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-04-18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1606DEU000515

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer number# DE-1577272925-2016005670) on 01-JUN-2016. Case received from a physician on 27-May-2016. A female patient of unknown age received M-M-RVAXPRO (batch/lot number L045239, rHA) via intramuscular route in Arm site on 12-Apr-2016. The patient received concomitant administration of VARIVAX/06643101/, batch/lot number# K003383 on 12-Apr-2016. The patient experienced Meningococcal sepsis on an unknown date. The patient''s outcome was reported as Fatal. The patient died on 18-Apr-2016.


VAERS ID: 665312 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Female  
Location: Foreign  
Vaccinated:2016-01-12
Onset:2016-01-17
   Days after vaccination:5
Submitted: 2016-11-10
   Days after onset:298
Entered: 2016-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. K019920 / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M27705 / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Cardiac monitoring abnormal, Cough, Death, Loss of consciousness, Mechanical ventilation, Mydriasis, Pyrexia, Restlessness, Resuscitation, Rhinorrhoea
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-01-20
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Craniosynostosis; Familial risk factor (Mother history of Developmental Dysplasia of Hip. Other children underwent hip ultrasound (normal)); Microcephaly
Allergies:
Diagnostic Lab Data: Test Date: 20160120; Test Name: Cardiac monitoring; Result Unstructured Data: Test Result: asystole in three leads; Comments: examination at a neurosurgeon (22Feb2015): examination at a neurosurgeon due to a suspicion of microcephalus. She was referred after a suspicion of small head circumference and a closed fontanel. Pregnancy and birth were normal. Head circumference at birth was 38. To the physician''s opinion the enlargement was reasonable according to the age. There was no problem with the development of the head. The parents were recommended to follow up the baby by the treating physician, and to follow up head circumferences at the baby clinic according to scheduled visits. In case there was a disturbance in head growth they should turn to a neurosurgery consultation; examination at a neurosurgeon (02Jun2015): there was a suspicion of craniosynostosis. Development was normal. Growth was fine - she was short but also the parents and other children were short. Head circumference was raising nicely and the development was normal. The fontanel was a bit open, without overriding sutures and with a normal head circumference, without a concern at the time of the examination, but the clinic would keep following up. Folds were asymmetrical.; Test Date: 20141208; Test Name: Head circumference; Result Unstructured Data: Test Result: 38; Comments: examination at a neurosurgeon (22Feb2015): examination at a neurosurgeon due to a suspicion of microcephalus. She was referred after a suspicion of small head circumference and a closed fontanel. Pregnancy and birth were normal. Head circumference at birth was 38. To the physician''s opinion the enlargement was reasonable according to the age. There was no problem with the development of the head. The parents were recommended to follow up the baby by the treating physician, and to follow up head circumferences at the baby clinic according to scheduled visits. In case there was a disturbance in head growth they should turn to a neurosurgery consultation; examination at a neurosurgeon (02Jun2015): there was a suspicion of craniosynostosis. Development was normal. Growth was fine - she was short but also the parents and other children were short. Head circumference was raising nicely and the development was normal. The fontanel was a bit open, without overriding sutures and with a normal head circumference, without a concern at the time of the examination, but the clinic would keep following up. Folds were asymmetrical.; Test Date: 20150222; Test Name: Neurological examination; Result Unstructured Data: Test Result: no problem with the development of the head; Comments: examination at a neurosurgeon (22Feb2015): examination at a neurosurgeon due to a suspicion of microcephalus. She was referred after a suspicion of small head circumference and a closed fontanel. Pregnancy and birth were normal. Head circumference at birth was 38. To the physician''s opinion the enlargement was reasonable according to the age. There was no problem with the development of the head. The parents were recommended to follow up the baby by the treating physician, and to follow up head circumferences at the baby clinic according to scheduled visits. In case there was a disturbance in head growth they should turn to a neurosurgery consultation; examination at a neurosurgeon (02Jun2015): there was a suspicion of craniosynostosis. Development was normal. Growth was fine - she was short but also the parents and other children were short. Head circumference was raising nicely and the development was normal. The fontanel was a bit open, without overriding sutures and with a normal head circumference, without a concern at the time of the examination, but the clinic would keep following up. Folds were asymmetrical.; Test Date: 20150602; Test Name: Neurological examination; Result Unstructured Data: Test Result: The fontanel was a bit open; Comments: examination at a neurosurgeon (22Feb2015): examination at a neurosurgeon due to a suspicion of microcephalus. She was referred after a suspicion of small head circumference and a closed fontanel. Pregnancy and birth were normal. Head circumference at birth was 38. To the physician''s opinion the enlargement was reasonable according to the age. There was no problem with the development of the head. The parents were recommended to follow up the baby by the treating physician, and to follow up head circumferences at the baby clinic according to scheduled visits. In case there was a disturbance in head growth they should turn to a neurosurgery consultation; examination at a neurosurgeon (02Jun2015): there was a suspicion of craniosynostosis. Development was normal. Growth was fine - she was short but also the parents and other children were short. Head circumference was raising nicely and the development was normal. The fontanel was a bit open, without overriding sutures and with a normal head circumference, without a concern at the time of the examination, but the clinic would keep following up. Folds were asymmetrical.; Test Date: 20160120; Test Name: Physical examination; Result Unstructured Data: Test Result: death stains and extended pupils; Comments: examination at a neurosurgeon (22Feb2015): examination at a neurosurgeon due to a suspicion of microcephalus. She was referred after a suspicion of small head circumference and a closed fontanel. Pregnancy and birth were normal. Head circumference at birth was 38. To the physician''s opinion the enlargement was reasonable according to the age. There was no problem with the development of the head. The parents were recommended to follow up the baby by the treating physician, and to follow up head circumferences at the baby clinic according to scheduled visits. In case there was a disturbance in head growth they should turn to a neurosurgery consultation; examination at a neurosurgeon (02Jun2015): there was a suspicion of craniosynostosis. Development was normal. Growth was fine - she was short but also the parents and other children were short. Head circumference was raising nicely and the development was normal. The fontanel was a bit open, without overriding sutures and with a normal head circumference, without a concern at the time of the examination, but the clinic would keep following up. Folds were asymmetrical.
CDC Split Type: ILPFIZER INC2016421878

Write-up: This is a spontaneous report from a contactable other healthcare professional received from the Ministry of Health. The Regulatory authority report number was not provided. A 13 month-old female patient of an unspecified ethnicity received the third single dose of PREVENAR 13, lot M27705 and an unspecified dose of PROQUAD (lot K019920), both via an unspecified route of administration on 12Jan2016 for immunization. Medical history included a suspected microcephalus and a suspected craniosynostosis. It was reported that when the patient was 2 month and 2 week-old on 22Feb2015 there was an examination at a neurosurgeon due to a suspicion of microcephalus. She was referred after a suspicion of small head circumference and a closed fontanel. Pregnancy and birth were normal. Head circumference at birth was 38. To the physician''s opinion the enlargement was reasonable according to the age. There was no problem with the development of the head. The parents were recommended to follow up the baby by the treating physician, and to follow up head circumferences at the baby clinic according to scheduled visits. In case there was a disturbance in head growth they should turn to a neurosurgery consultation. Follow up at a neurosurgeon at a hospital: suspicion of craniosynostosis, in an examination which was performed in a baby clinic on 02Jun2015 it was written that there was a suspicion of craniosynostosis. Development was normal. Growth was fine - she was short but also the parents and other children were short. Head circumference was raising nicely and the development was normal. The fontanel was a bit open, without overriding sutures and with a normal head circumference, without a concern at the time of the examination, but the clinic would keep following up. Folds were asymmetrical. The mother had a history of developmental dislocation of hip (DDH). Other children underwent hip joints ultrasound which was normal - for the patient she did not receive a recommendation, it was recommended to be advised by an orthopedic. The patient''s concomitant medications were not reported. The patient died on 20Jan2016, about 8 days after she had received the vaccines. The patient was found unconscious in her bed about 8 days after receipt of the vaccines. In a letter from 20Jan2016 at 15:58 it was written: at the morning of 20Jan2016 hospital was called for unconscious child. According to the father, he found her unconscious in her bed, he carried her out and ran to the neighbor. The neighbor started cardiopulmonary resuscitation (CPR) steps until the persons on-call arrived. The persons on-call continued with artificial respiration and massage until arrival. On arrival at hospital they connected a monitor which showed asystole in three leads. The child already had death stains and extended pupils. Thus, with the approval of the medical service center CPR steps were not continued. The child didn''t have any signs of violence. As far as the father said the child was health without disease. In a letter from 20Jan2016 at 19:52 it was written: in the evening of 20Jan2016 the mother had stated that on 12Jan2016 the child was vaccinated with the vaccines. Since 19Jan2016 the patient had a fever which was not high, she lowered the fever with ACAMOL and NUROFEN. The mother attributed the fever to the vaccines. There was no rash on the body. In the death certificate it was written that the death was called by a paramedic. At the epidemiology department reporting form it was indicated that 5 days after the vaccines, on 17Jan2016, fever appeared (it was not mentioned how much), the patient was unrest, and she had runny nose and cough. Cough lasted 2 days, outcome of the other events was unknown. Product quality complaint investigational results as follows: customer complaint investigation conclusions from 07Oct2016: "The batch records were reviewed and there were no relevant comments or planned deviations that may have caused this type of complaint. This batch met all the criteria for the market and was Q.P. released. The cold chain temperature control data for the bulk stock received and the packed stock stored were all satisfactory, confirming suitable storage conditions maintained at all times with no impact to product quality, safety or efficacy. During its journey to the markets distribution center an excursion occurred for a maximum of 10 hours, with a low of 1.2C and high of 9.5C (Reference PR# 1257511). There was no quality impact as stability data supports the excursion. PCOM Lot History Report identified no other complaints for adverse events for this packed lot. The complaint is unconfirmed as no root cause has been identified and no trend has been identified by the Global Safety Team." Evaluation of the manufacturing process conclusions from 02Nov2016: "This summarized the technical evaluation conducted for the bulk conjugate batches and associated activated saccharide batches (as detailed above) in support of this reported Adverse Event. All investigations associated with these batches were reviewed from a manufacturing and technical perspective and all investigations were appropriately addressed and closed. Based on the review of the Batch Records, CoA and investigations associated with the batches, the release results were deemed satisfactory. These technical evaluations did not indicate any issues that would have contributed to this complaint. An evaluation of the reserve sample and complaint sample was not applicable to under this Adverse Event as the Adverse Event was reported for the bulk drug product lot." PREVENAR 13 drug substance summary report conclusions from 04Nov2016: "This summarises the technical evaluation conducted for the bulk conjugate batches and associated activated saccharide batches (as detailed above) in support of this reported Adverse Event complaint. All investigations associated with these batches were reviewed from a manufacturing and technical perspective and all investigations were appropriately addressed and closed. Batch Records and testing results were reviewed prior to Product Release and were deemed satisfactory. Based on the review of associated investigations there was no requirement to repeat these reviews for the Drug Substance manufacture. An evaluation of the reserve sample and complaint sample was not applicable to this Drug Substance investigation and this will be carried out as part of the Drug Product investigation. No issues impacting the identity, strength, purity or quality of the product were identified during the technical evaluation therefore no regulatory notification was required. An evaluation of the complaint history for this interim Drug product Lot on 02Nov2016 confirmed that two Drug Substance adverse event-FDA 15 day reportable events were received for investigation for this interim drug product Lot. Agency will continue to monitor adverse events for this interim Lot L77846. No further action is required at this time." "An evaluation of the complaint history confirmed that two complaints were received for Filled Batch L77846 for complaint Class/ Subclass; External Cause Investigation/ Adverse Event Safety Request for Investigation. A lot specific trend was not identified. The reserve sample review for Fill Lot L77846 found no defects. The batch record and manufacturing investigation review found no evidence to suggest that this complaint was related to manufacturing activity at Pfizer therefore it was determined that a regulatory notification was not required. No evidence was found to indicate this complaint occurred as a result of activities conducted at Pfizer. Agency will continue to monitor complaints for this Fill lot." Follow up (04Nov2016): New information included product quality complaint investigational results for Filled Batch/fill lot L77846. Sender''s Comments: Linked Report(s): 2016421878 Legacy paper report number; Reported Cause(s) of Death: The patient was found unconscious in her bed about 8 days after receipt of the vaccines, in the death report reason of death was unknown; The patient was found unconciuos in her bed about 8 days after receipt of the vaccines, in the death report reason.


VAERS ID: 676370 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Foreign  
Vaccinated:2016-11-15
Onset:2016-11-16
   Days after vaccination:1
Submitted: 2016-11-24
   Days after onset:8
Entered: 2016-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. M012946 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 08/2016, VARIVAX, 06643101, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1611ESP010234

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # ES-1577272925-2016011766) on 21-NOV-2016. Case received from a physician on 16-Nov-2016. Additional information received from a physician via the Health Authorities on 17-Nov-2016 under the reference number ES-AGEMED-805536238. The HA gained the information from the same primary physician. A 39-month-old male child patient received VARIVAX, (batch number M012946, Dose 2) (lot/batch #M012946, expiration date 28-FEB-2018) via intramuscular route on 15-Nov-2016. The first dose of VARIVAX, (batch number not reported) had been administered on an unspecified date 3 months before the second dose. The patient was found dead on 16-Nov-2016 1 day Post Administration. The patient''s outcome was reported as Fatal. The patient died on 16-Nov-2016. The reporter assessed the causal relationship between Unknown cause of death and VARIVAX as Reasonable Possibility. According to the HAs they reported the causal relationship as "Conditional". According to the narrative from the Health Authorities: 3 years-old male child was vaccinated with second dose against varicella, VARIVAX (batch number M012946, EXP: 28/02/2018) via intramuscular route of administration, according to the official vaccination calendar schedule, on 15/11/2016. The first dose was administered three months ago, unknown day. In the morning of the following day after his second dose vaccination, the mother found him dead. Currently results from autopsy are pending.


VAERS ID: 682425 (history)  
Form: Version 1.0  
Age: 1.33  
Sex: Male  
Location: Foreign  
Vaccinated:2017-01-26
Onset:2017-02-02
   Days after vaccination:7
Submitted: 2017-02-13
   Days after onset:11
Entered: 2017-02-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER A71CA941A / UNK LA / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R45142 / UNK LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Computerised tomogram, Death, Depressed mood, Pyrexia, Restlessness, Resuscitation, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-04
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 201702; Test Name: CT scan
CDC Split Type: ILPFIZER INC2017060234

Write-up: This is a spontaneous report from a contactable other healthcare professional received from the Health Authority. A 16-month-old male patient of an unspecified race and ethnicity received for immunization on 26Jan2017 PREVENAR 13 (Lot R45142) at single dose and PRIORIX TETRA (Lot A71CA941A) at single dose. The patient medical history and concomitant medications were not reported. Based on the grandmother and mother he was a healthy toddler without significant side effects after previous unspecified vaccines. One week after having received the vaccine, on 02Feb2017, the patient developed a tremor, high fever and restlessness, he received antipyretic drugs and calmed down. The next day he felt good but looked sad, that same evening the fever rose again and he was treated with antipyretics again. After he fell asleep in the stroller he was moved to his bed and in the morning he was found in his bed not alive. An ambulance team arrived and resuscitated, including defibrillation and the paramedic that arrived in the place determined his death. The family refused the autopsy but agreed to perform a computerised tomogram (CT) with results not received yet. The legal medical institute reported that according to the body temperature, it seemed that the toddler died in the evening (it was possible that when they moved him from the stroller to the bed he was already not alive). Death occurred on 04Feb2017. Fatal outcome was reported for the events high fever, restlessness, tremor and the next day he felt good but looked sad.; Reported Cause(s) of Death: High fever; Restlessness; The next day he felt good but looked sad; Tremor.


VAERS ID: 685991 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Female  
Location: Foreign  
Vaccinated:2017-02-22
Onset:0000-00-00
Submitted: 2017-03-15
Entered: 2017-03-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. M026438 / 1 RL / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Death, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Bronchopulmonary dysplasia; Premature baby 26 to 32 weeks; Symptomatic epilepsy
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131703DEU003028

Write-up: This spontaneous report was received from a physician referring to a 15 month old female premature baby (28th pregnancy weeks) with epilepsy and bronchopulmonary dysplasia. The patient''s medical history included a cerebral hemorrhage on an unknown date. No information about the patient''s concomitant medications was provided. On 22-FEB-2017, the patient was vaccinated with a dose of VARIVAX in her left upper leg, (lot # M026438 with an expiration date in 30-APR-2018), for prophylaxis (dose, frequency, route and strength were not provided) in an unspecified stable domestic environment. On an unspecified date in February 2017, the patient experienced pneumonia and subsequently died on 24-FEB-2017 in a hospital ("two days after the vaccination") probably due to pneumonia. At the time of reporting, the outcome of pneumonia was reported as fatal. The cause of death was reported as "probably due to" pneumonia. The primary reporter did not provide the causal relationship between VARIVAX and pneumonia. Upon internal review, pneumonia was determined to be medically significant. Additional information has been requested. Reported Cause(s) of Death: Propbably due to pneumonia.


VAERS ID: 736311 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131802DEU001356

Write-up: Information has been downloaded from Regulatory Authority (DE-GLAXOSMITHKLINE-DE2018GSK007466). This spontaneous report as received from a physician refers to a 1 year old patient. Information on medical history, past drugs, concurrent conditions and concomitant medications were not provided. On an unknown date, the patient was vaccinated with VARIVAX for prophylaxis (dose, frequency, route were not provided). Other suspect therapy included PRIORIX for prophylaxis (dose, frequency, route were not provided). On an unknown date, the patient had pyrexia and died on an unknown date due to an unknown cause (the outcome of pyrexia was also reported as unknown). It was unknown if an autopsy was performed. The causality assessment was not provided by the reporter.The events were considered serious due to hospitalization and death. The Agency considered the events to be medically significant.


VAERS ID: 738610 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Death, Measles, Morbillivirus test positive, Pneumonia
SMQs:, Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GR0095075131802GRC009987

Write-up: This spontaneous report was received from a physician (Medical Lead Vaccines) regarding a 35 year old female patient, which was posted at the website of Agency. Information on medical history, current condition and concomitant medication was not reported. On an unknown date, the patient was vaccinated with an unspecified measles vaccine: either with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) or with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(manufacturer unknown) for prophylaxis (dosage and lot # unspecified). On an unknown date, the patient was diagnosed with pneumonia and acute respiratory distress syndrome (ARDS). On an unknown date, the patient underwent an unspecified laboratory test and was tested positive for measles. The outcome of the events was reported as fatal. The cause of death was reported as acute respiratory distress syndrome and pneumonia. It was unknown if an autopsy was performed. Causality assessment was not reported. Upon internal review, the events pneumonia, measles and acute respiratory distress syndrome were determined to be medically significant. Reported Cause(s) of Death: Acute Respiratory Distress Syndrome; Pneumonia.


VAERS ID: 763958 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunocompromised
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU0095075131808AUS001414

Write-up: Information was received from a doctor, and refers to a 26 year old male patient with immunocompromised. The patient medical history and concomitant therapy were not reported. In 2017 (reported as last year), the patient was seronegative when tested. On an unknown date in 2017, the patient received his primary vaccination with varicella virus vaccine live (oka/merck) (manufacturer unknown) (dose, route, lot# and expiration date unknown) against chickenpox. After vaccination, the patient developed an infection and died. The cause of death was not provided. The outcome of unspecified infection was unknown. The causality assessment was not provided by the reporter.


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