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VAERS ID: 665305 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:2016-05-11
Onset:0000-00-00
Submitted: 2016-11-10
Entered: 2016-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC72OA / 3 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M60561 / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Biopsy heart abnormal, Biopsy lung abnormal, Borrelia test negative, Bronchopulmonary disease, Cardiac disorder, Carditis, Circulatory collapse, Coronary artery occlusion, Cytomegalovirus test negative, Death, Dyspnoea, Epstein-Barr virus test negative, Erythema, Herpes simplex test negative, Human herpes virus 6 serology, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Livedo reticularis, Myocardial fibrosis, Polymerase chain reaction, Pyrexia, Rash, Restlessness, Rhinitis, Toxoplasma serology negative, Varicella virus test negative, Vasculitis, Viral infection, Viral test negative
SMQs:, Anaphylactic reaction (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Akathisia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (narrow), Vasculitis (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
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: 19.1;10016558~Vaccine not specified (no brand name)~~0.00~Patient|19.1;10039083~Vaccine not specified (no brand name)~~0.00~Pati
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Desquamation (desquamation of the left big toe); Redness (of the spaces between toes)
Allergies:
Diagnostic Lab Data: Test Name: Cardiac biopsy; Result Unstructured Data: Test Result: No cardiac or other malformation, closed foramen o; Comments: Heart examination (unknown date): pronounced abating round cell lymphocytoid pancarditis, pronounced postinflammatory fibrosis of the myocard, in particular perivascular, residual vasculitis, complete clogging of the anterior descending branch of the left coronary artery with intraluminar fibrin-rich parietal thrombus induced by inflammatory vessel changes; Lung biopsy (unknown date): moderate peri- and intrabronchial round cell infiltration in both lungs; Cardiac biopsy (unknown date): No cardiac or other malformation, closed foramen ovale, closed ductus arteriosus Botalli; Cardiac biopsy (27Jul2016): biopsy of the anterior and posterior left ventricular wall: pronounced small vessel disease (hyperplasia of the media, perivascular fibrosis) with pronounced ischemic myocardial damage, older and fresher ischemic lesions with macrophage-dominated clearance reaction, sudden cardiac death due to malignant cardiac arrythmias, no acute, chronic or eosinophilic myocarditis, no detection of EV, PVB19, HHV6 + 7, EBV, ADV, HCMV, HSV1 + 2, VZV, Influenza A + B, A subtype H1N1, Toxoplasma gondii, Borrelia burgdorferi or other bacterial causative organisms (nested PCR); no dilatative cardiomyopathy, no cardiomyopathy of other origin, in particular no desmino- or dystrophinopathy, no storage disease of the heart, in particular no glycogenosis. No evidence of atypical calcifications in the coronary arteries; Test Date: 20160727; Test Name: Cardiac biopsy; Result Unstructured Data: Test Result: biopsy of the anterior and posterior left ventricu; Comments: Heart examination (unknown date): pronounced abating round cell lymphocytoid pancarditis, pronounced postinflammatory fibrosis of the myocard, in particular perivascular, residual vasculitis, complete clogging of the anterior descending branch of the left coronary artery with intraluminar fibrin-rich parietal thrombus induced by inflammatory vessel changes; Lung biopsy (unknown date): moderate peri- and intrabronchial round cell infiltration in both lungs; Cardiac biopsy (unknown date): No cardiac or other malformation, closed foramen ovale, closed ductus arteriosus Botalli; Cardiac biopsy (27Jul2016): biopsy of the anterior and posterior left ventricular wall: pronounced small vessel disease (hyperplasia of the media, perivascular fibrosis) with pronounced ischemic myocardial damage, older and fresher ischemic lesions with macrophage-dominated clearance reaction, sudden cardiac death due to malignant cardiac arrythmias, no acute, chronic or eosinophilic myocarditis, no detection of EV, PVB19, HHV6 + 7, EBV, ADV, HCMV, HSV1 + 2, VZV, Influenza A + B, A subtype H1N1, Toxoplasma gondii, Borrelia burgdorferi or other bacterial causative organisms (nested PCR); no dilatative cardiomyopathy, no cardiomyopathy of other origin, in particular no desmino- or dystrophinopathy, no storage disease of the heart, in particular no glycogenosis. No evidence of atypical calcifications in the coronary arteries; Test Name: Lung biopsy; Result Unstructured Data: Test Result: moderate peri- and intrabronchial round cell; Comments: Heart examination (unknown date): pronounced abating round cell lymphocytoid pancarditis, pronounced postinflammatory fibrosis of the myocard, in particular perivascular, residual vasculitis, complete clogging of the anterior descending branch of the left coronary artery with intraluminar fibrin-rich parietal thrombus induced by inflammatory vessel changes; Lung biopsy (unknown date): moderate peri- and intrabronchial round cell infiltration in both lungs; Cardiac biopsy (unknown date): No cardiac or other malformation, closed foramen ovale, closed ductus arteriosus Botalli; Cardiac biopsy (27Jul2016): biopsy of the anterior and posterior left ventricular wall: pronounced small vessel disease (hyperplasia of the media, perivascular fibrosis) with pronounced ischemic myocardial damage, older and fresher ischemic lesions with macrophage-dominated clearance reaction, sudden cardiac death due to malignant cardiac arrythmias, no acute, chronic or eosinophilic myocarditis, no detection of EV, PVB19, HHV6 + 7, EBV, ADV, HCMV, HSV1 + 2, VZV, Influenza A + B, A subtype H1N1, Toxoplasma gondii, Borrelia burgdorferi or other bacterial causative organisms (nested PCR); no dilatative cardiomyopathy, no cardiomyopathy of other origin, in particular no desmino- or dystrophinopathy, no storage disease of the heart, in particular no glycogenosis. No evidence of atypical calcifications in the coronary arteries; Test Date: 20160513; Test Name: Body temperature; Result Unstructured Data: Test Result: 37.9, Test Result Unit: Centigrade; Comments: Heart examination (unknown date): pronounced abating round cell lymphocytoid pancarditis, pronounced postinflammatory fibrosis of the myocard, in particular perivascular, residual vasculitis, complete clogging of the anterior descending branch of the left coronary artery with intraluminar fibrin-rich parietal thrombus induced by inflammatory vessel changes; Lung biopsy (unknown date): moderate peri- and intrabronchial round cell infiltration in both lungs; Cardiac biopsy (unknown date): No cardiac or other malformation, closed foramen ovale, closed ductus arteriosus Botalli; Cardiac biopsy (27Jul2016): biopsy of the anterior and posterior left ventricular wall: pronounced small vessel disease (hyperplasia of the media, perivascular fibrosis) with pronounced ischemic myocardial damage, older and fresher ischemic lesions with macrophage-dominated clearance reaction, sudden cardiac death due to malignant cardiac arrythmias, no acute, chronic or eosinophilic myocarditis, no detection of EV, PVB19, HHV6 + 7, EBV, ADV, HCMV, HSV1 + 2, VZV, Influenza A + B, A subtype H1N1, Toxoplasma gondii, Borrelia burgdorferi or other bacterial causative organisms (nested PCR); no dilatative cardiomyopathy, no cardiomyopathy of other origin, in particular no desmino- or dystrophinopathy, no storage disease of the heart, in particular no glycogenosis. No evidence of atypical calcifications in the coronary arteries; Test Name: Pathology test; Result Unstructured Data: Test Result: pronounced abating round cell lymphocytoid pancardit; Comments: Heart examination (unknown date): pronounced abating round cell lymphocytoid pancarditis, pronounced postinflammatory fibrosis of the myocard, in particular perivascular, residual vasculitis, complete clogging of the anterior descending branch of the left coronary artery with intraluminar fibrin-rich parietal thrombus induced by inflammatory vessel changes; Lung biopsy (unknown date): moderate peri- and intrabronchial round cell infiltration in both lungs; Cardiac biopsy (unknown date): No cardiac or other malformation, closed foramen ovale, closed ductus arteriosus Botalli; Cardiac biopsy (27Jul2016): biopsy of the anterior and posterior left ventricular wall: pronounced small vessel disease (hyperplasia of the media, perivascular fibrosis) with pronounced ischemic myocardial damage, older and fresher ischemic lesions with macrophage-dominated clearance reaction, sudden cardiac death due to malignant cardiac arrythmias, no acute, chronic or eosinophilic myocarditis, no detection of EV, PVB19, HHV6 + 7, EBV, ADV, HCMV, HSV1 + 2, VZV, Influenza A + B, A subtype H1N1, Toxoplasma gondii, Borrelia burgdorferi or other bacterial causative organisms (nested PCR); no dilatative cardiomyopathy, no cardiomyopathy of other origin, in particular no desmino- or dystrophinopathy, no storage disease of the heart, in particular no glycogenosis. No evidence of atypical calcifications in the coronary arteries
CDC Split Type: DEPFIZERINC2016515963

Write-up: This is a spontaneous report received from the Health Authority. Regulatory Authority report number DE-PEI-PEI2016084906. A 4-month-old male patient received the third doses of PREVENAR 13 (batch no.: M60561) at 0.5ml single on 11May2016 and INFANRIX HEXA (batch no.: A21CC72OA) at single dose, route of administration not reported, both for prophylactic vaccination. Examination by the pediatrician on 11May2016 noted seborrhoeic dermatitis capitis, hydrocele testis right side, except from this was unremarkable. The patient''s medical history includes the beginning of April2016, the patient presented with intermittent reddening of the spaces between toes with periungual desquamation of the left big toe. Concomitant medications were not reported. According to the parents, clinical signs and symptoms included: After administration of the first doses, the patient developed fever (38.6 degree C), which was treated with a paracetamol (PCM) suppository, and rhinitis persisting for 8 hours. At the beginning of Apr2016, the patient presented with intermittent reddening of the spaces between toes with periungual desquamation of the left big toe. The patient received a local therapy with Clotrimazole in May2016. At the beginning of May2016, mild rash at the cheeks and retroauricular rash with spontaneous remission the subsequent day. Two days after administration of the third doses, restlessness, maximum body temperature 37.9 degree C. Three days after administration of the third doses, for a short time marbled skin at the hands when it was cold. Four days after administration of the third doses, 2 to 3 hours longer nighttime sleep and 1 hour longer daytime sleep, except from this the patient''s behavior was unremarkable. On 17May2016, slightly difficult respiration when breastfeeding around midday, rhinitis suspected; no further clinical abnormalities. On an unspecified date, the patient died. An autopsy was performed at the Institute for pathology and cytology. Examination of the heart and biopsy of the lungs: pronounced abating round cell lymphocytoid pancarditis, pronounced postinflammatory fibrosis of the myocard, in particular perivascular, residual vasculitis, complete clogging of the anterior descending branch of the left coronary artery with intraluminar fibrin-rich parietal thrombus induced by inflammatory vessel changes; moderate peri- and intrabronchial round cell infiltration in both lungs; suspicion of viral infection, differential diagnosis Kawasaki''s disease. Unclear etiology of reported pathologies. The following differential diagnoses were excluded: No cardiac or other malformation, closed foramen ovale, closed ductus arteriosus Botalli; Institute for Pathology and Neuropathology, 27Jul2016, biopsy of the anterior and posterior left ventricular wall: pronounced small vessel disease (hyperplasia of the media, perivascular fibrosis) with pronounced ischemic myocardial damage, older and fresher ischemic lesions with macrophage-dominated clearance reaction (CD68+, MHC II / HLA-DR alpha, CD3+ T lymphocytes), sudden cardiac death due to malignant cardiac arrythmias; no acute, chronic or eosinophilic myocarditis, in particular no detection of EV, PVB19, HHV6 + 7, EBV, ADV, HCMV, HSV1 + 2, VZV, Influenza A + B, A subtype H1N1, Toxoplasma gondii, Borrelia burgdorferi or other bacterial causative organisms (nested PCR); no dilatative cardiomyopathy, no cardiomyopathy of other origin, in particular no desmino- or dystrophinopathy, no storage disease of the heart, in particular no glycogenosis. No evidence of atypical calcifications in the coronary arteries. Reported causes of death: coronary artery disease, circulatory failure. Autopsy-determined causes of death: cardiac disorder, myocardial fibrosis. Follow-up information has been requested. Case closed. No follow-up attempts needed, follow-up automatically provided by Agency. Reported Cause(s) of Death: coronary artery disease; circulatory failure; Autopsy-determined Cause(s) of Death: cardiac disorder; myocardial fibrosis.


VAERS ID: 665310 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:2016-10-24
Onset:0000-00-00
Submitted: 2016-11-10
Entered: 2016-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20BC328D / 2 LG / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M37097 / 2 LG / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Agitation, Death, Injection site haemorrhage, Injection site induration
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 19.1;10067482~Vaccine not specified (no brand name)~~0.00~Patient|19.1;10067482~Pneumo (Prevnar13)~~0.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none, Comment:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2016517760

Write-up: This is a spontaneous report from a contactable pharmacist via Medical Information team. A 4-month-old male patient received on 24Oct2016 the second dose of PREVENAR 13, lot M37097 Expiry date May2018, at 0.5ml single, and of INFANRIX QUINTA lot unknown, at single dose form, both for immunization. Injections were performed by a nurse on different sites on the two thighs. The patient had no relevant personal or family medical history. Concomitant medications, if any, were not reported. The patient received the first dose of pneumococcal 13-valent conjugate vaccine, lot N34834, on 22Aug2016, without any adverse event. On the day after vaccination (estimated date 25Oct2016), the patient experienced bleeding and subcutaneous induration at one of the injection sites. The patient also presented with agitation. He had no fever. He was brought to the emergency unit "in the next days". It was reported that the patient probably scratched him because there were scratch lesions and subcutaneous induration. The patient also presented with agitation but no fever. A pressure dressing (bandage) was put and the site treated with povidone iodine (BETADINE). The baby stayed in emergency room for 3 hours then he went back to home. On 30Oct2016 the baby died. An autopsy was planned. As the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) administered was well tolerated but was from a different lot, the reporter would like to know whether the lot M37097 is related with more important events.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the absence of autopsy results does not allow a meaningful causality assessment. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death.


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: 675960 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-11
Entered: 2016-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Death
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: No other medications
Current Illness: Tobacco user
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1611JPN005602

Write-up: Initial information has been received from a patient''s friend concerning a patient (gender and age unknown). It was reported that the patient was a smoker. On an unspecified date, the patient was vaccinated with PNEUMOVAX NP injection drug (lot number, dose and indication not reported) subcutaneously. There was no concomitant medication reported. On an unspecified date, the patient died. Information on whether or not an autopsy was performed that was not obtained. Reporter''s comment: It seems like the smoking was to blame. The reporter considered that the death was serious. The reporter did not assess the relationship of death to PNEUMOVAX NP. Follow-up attempts was not made because the reporter did not wish to be contacted.


VAERS ID: 676157 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-11
Entered: 2016-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Laboratory test abnormal, Lung disorder, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Lung disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unspecified test (unknown date): Water accumulated in the lung.
CDC Split Type: WAES1611JPN005609

Write-up: Initial information has been received from a patient''s friend concerning a patient of unknown gender and age. The patient''s concurrent conditions included an unspecified lung condition. On an unspecified date, the patient was subcutaneously vaccinated with a dose of PNEUMOVAX NP injection (lot number, dose and anatomical place of vaccination were not reported). There was no concomitant medication reported. On an unspecified date, the lung condition (lung disorder) of the patient who received the vaccination on time got aggravated after vaccination and was hospitalized. Subsequently, (in three weeks after hospitalization), water accumulated in the lung and the patient died. The cause of death was "water accumulated in the lung". Information on whether autopsy was performed or not was not obtained. At the time of reporting, the outcome of lung disorder was unknown. The reporter did not assess the relationship of lung disorder and pulmonary oedema to PNEUMOVAX NP. Upon internal review the pulmonary oedema was considered as medically significant. Additional information is not expected, as follow-up attempt was not made because the reporter did not wish to be contacted.


VAERS ID: 676160 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-11
Entered: 2016-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: 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: 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: WAES1611JPN004798

Write-up: Initial information has been received from patient''s friend via Customer Support Center, concerning an elderly male patient. The patient''s medical history and concurrent conditions were not reported. There was no concomitant medication reported. On an unspecified date, the patient was vaccinated with PNEUMOVAX NP Syringe (subcutaneously; dose, Lot # and expiration date were not reported). On an unspecified date, the patient developed pneumonia. On an unspecified date, the patient died. The cause of death was pneumonia. Information on whether or not autopsy was performed was not obtained. Reporter''s comment: not provided. The reporter considered that pneumonia was serious due to death. The reporter did not assess the relationship of pneumonia to PNEUMOVAX NP Syringe. Additional information is not expected because the reporter did not wish to be contacted.


VAERS ID: 676206 (history)  
Form: Version 1.0  
Age: 1.2  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-11
Entered: 2016-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Agitation, Ataxia, Biopsy brain abnormal, Blindness, Blindness cortical, CSF cell count normal, CSF lymphocyte count, CSF oligoclonal band absent, CSF protein, CSF protein decreased, Combined immunodeficiency, Cytopenia, Death, Diarrhoea, Disorientation, Hemiparesis, Hypoacusis, Immunoglobulin therapy, Lethargy, Mumps antibody test positive, Neurological decompensation, Nuclear magnetic resonance imaging brain abnormal, Panencephalitis, Polymerase chain reaction, Pyrexia, Rash, Seizure, Speech disorder developmental, Stem cell transplant, Stool analysis normal, Urine analysis normal, Viral test negative
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Dementia (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Myelodysplastic syndrome (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (broad), Opportunistic infections (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Parental consanguinity
Allergies:
Diagnostic Lab Data: Brain biopsy (unknown date) result: 110 million 81 base pair. CSF (cerebrospinal fluid) cell count (unknown date): result-negative. Lymphocyte count (unknown date): result - 11 (units not reported). MRI (magnetic resonance imaging) (unknown date): showed abnormalities of grey and white matter. MRI (unknown date): no new lesions. PCR (Polymerase chain reaction) (unknown date): Poloma JC virus detected; CSF protein increased, 1.35 g/l; Protein total decreased, 0.12 g/l
CDC Split Type: WAES1611GBR005404

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # GB-1577272925-2016011283) on 10-NOV-2016. Case retrieved from unsolicited literature on 03-NOV-2016. A 18-month-old male child patient received MMR vaccine, live (manufacturer unknown, batch number unknown) on an unknown date at the age of 14 months. The article describes neurological complications associated with the detection of live-attenuated mumps virus Jeryl Lynn (MuVJL5) in the brain of a child who had undergone successful allogeneic transplantation for severe combined immunodeficiency (SCID). This is the first confirmed report of MuVJL5 associated with chronic encephalitis and highlights the need to exclude immunodeficient individuals from immunisation with live-attenuated vaccines. The diagnosis was only possible by deep sequencing of the brain biopsy. This is a case of chronic panencephalitis in a child who had undergone successful allogeneic haematopoietic stem cell transplantation (allo-SCT) for severe combined immunodeficiency (SCID) in whom neither measles nor other pathogens could be detected. Using deep sequencing of fresh brain biopsy material, we identified the Jeryl Lynn 5 mumps virus (MuVJL5), a component of the MMR vaccine that had been administered to the child before the diagnosis of SCID. Similar to findings in measles viruses recovered from cases of SSPE, the mumps virus genome from the brain showed evidence of biased hypermutation, particularly in the matrix (M) gene. Comparison with sequence data from the original vaccine batch used to immunise this child identified the expansion of variants present at low frequency in the vaccine as well as de novo fixed missense substitutions. This case represents the first conclusive demonstration of chronic panencephalitis due to mumps virus. Case report: A male infant of consanguineous parents was diagnosed with SCID at the age of 18 months due to recombinase activating gene 1 (RAG1) deficiency 4 months after MMR vaccination. The infant received a CD34-selected haploidentical allo-SCT. Full donor chimerism was rapidly achieved, with recovery of a diverse T cell repertoire and excellent thymopoiesis. Post-transplant autoimmune cytopenias necessitated rituximab therapy, following which immunoglobulin replacement therapy was administered. Six months post-allo-SCT the child developed a febrile illness with rash, diarrhoea, lethargy and seizures, with evidence of encephalitis on magnetic resonance imaging (MRI) with raised CSF protein (1.35 g/L) and 11 lymphocytes. Despite extensive screening for neurotropic viruses and bacteria, no pathogen was detected. He was treated with antimicrobials, antivirals and steroids, making a good recovery, and was discharged on anticonvulsant therapy. Over the next few months, the child was noted to have behavioural problems, hearing impairment and speech and language delay. One year after discharge, the seizures recurred with only partial response to antiepileptic treatment, but he remained stable for another 9 months. Repeat MRI scan 2 years after initial encephalitic illness showed no new lesions. Over the next few months, the child''s neurological condition deteriorated, with increasing seizures together with episodes of lethargy, disorientation, agitation, ataxic gait, visual loss and eventual hospitalisation. Repeat MRI of the brain at 40 months post-allo-SCT revealed abnormalities of grey and white matter, involving both cerebral hemispheres with multiple foci of contrast enhancement, including the basal ganglia, temporal and parieto-occipital cortices. In the absence of a firm diagnosis, a brain biopsy was taken. Broad-spectrum antibiotics, aciclovir, ganciclovir and antifungal therapy were administered, as well as intravenous immunoglobulin (IVIG) and high-dose methylprednisolone. Increasing seizures, left-sided weakness, cortical blindness and progressive global neurological deterioration over several weeks ended with the patient''s death 7 weeks following his last hospital admission, at the age of 69 month-old. PCR assays: The viruses listed were tested for using realtime PCR and found to be negative using specific primers and TaqMan probes on an ABI 7500 thermocycler. The CSF and urine samples collected during the patient''s last hospitalisation, as well as RNA re-extracted from the brain biopsy, were sent to the Laboratory for mumps and mumps vaccine-specific RT-PCR (targeting the SH and HN gene) as well as measles and rubella-specific RT-PCR. Results: CSF on last admission was acellular, but with oligoclonal bands, although total protein was low 0.12 g/L. The oligoclonal bands were negative for HSV and VZV antibodies. Polyoma JC virus was detected by PCR in blood and urine on one occasion each. CSF PCR was negative for 16S (bacterial) and 18S (fungal) rRNA and for a wide number of viral pathogens, including JC virus, mumps, measles and rubella viruses. No pathogens were detected in stool, urine or blood. CSF was negative for rubella and measles antibodies. In the absence of a firm diagnosis, a brain biopsy showed neuronal loss, astrocytic gliosis, reactive astrocytes, microglia and chronic inflammatory cells, but no viral inclusions or granulomata. Infiltrating T lymphocytes were identified by CD3 staining. RNA-Seq of the brain biopsy [5, 20] resulted in 110 million 81 base pair (bp) paired-end reads. Approximately, one million reads were identified as non-human and were subsequently used for potential pathogen identification by the metaMix method [21]. Mumps virus was the only potential pathogen detected, with 77,624 assigned reads. The remaining reads were either unclassified or mapped to human and bacteria that are either environmental, part of human flora, kit contaminants [23] or of unknown significance. No reads mapped to measles, rubella or polyoma JC viruses. Using de novo assembly, the full-length viral sequence was recovered (99.94% genome coverage, median coverage depth: 290). Maximum likelihood phylogenetic analysis showed that the consensus viral sequence clustered closely with the MuVJL5 vaccine strains and shared 99.6% identity with the publicly available sequence (GenBank: FJ211585) of the mumps component of the MMR preparation administered to the child. The sequence identified in this study is named MuVJL5 (GenBank: KX223397). PCR of RNA extracted from the brain biopsy confirmed the presence of MuVJL5 vaccine strain, but was negative for all other viruses, including polyoma JC. Immunohistochemistry showed the presence of MuV nucleocapsid (N) protein with a neuronal pattern of staining. Control cortex and white matter were negative. We observed no specific staining for other pathogens and no evidence of viral intracytoplasmic or intranuclear inclusion bodies. Retrospective testing showed weakly positive mumps antibody in the CSF. To investigate this finding further, three million 251 bp paired-end reads were generated from the MMR vaccine batch that was used to immunise the child, of which 82,000 reads mapped to the MuVJL5 vaccine strain (median coverage: 706). There were no fixed differences identified compared with the reference. Fifteen positions in the vaccine sequence were found to be polymorphic (variant allele frequency (VAF) 5% or greater). Of 55 fixed nucleotide differences between MuVJL5 and the vaccine, 12 had been present as a minority variant (10-24%) in the vaccine (VAF 75% or greater). Of the remaining 43 new mutations, 28 coded for missense amino acid substitutions, with nine (32%) located in the M protein, more than expected by chance (two-tailed exact binomial test p = 2.8e-0.4. Other than position 140 in the M protein, the missense mutations were unique to MuVJL5. The Tyr140His substitution in MuVJL5 is found in all wild-type strains as well as the more neurovirulent MuVur Urabe and the MuVJL2 Jeryl Lynn 2 vaccine strain, which is a minor component of some vaccines. Discussion: In this child, clinical deterioration occurred following good T cell reconstitution in the context of normal T cell receptor repertoire and good levels of thymopoiesis. One possibility is that the presence of mumps tolerised and dysregulated T cell responses, thus permitting long-term viral persistence and the accumulation of pathogenic mutations. The similar pattern of viral mutations in this case and those of measles SSPE suggest a common pathogenic process and further work is currently underway to determine the contribution of fixed mutations to the chronic encephalitic phenotype observed in the patient. This case highlights the importance of developing strategies such as newborn screening to exclude the very small proportion of infants at extremely high risk of complications from live-attenuated vaccines.


VAERS ID: 665958 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2016-10-19
Onset:0000-00-00
Submitted: 2016-11-14
Entered: 2016-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R46401 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2016525519

Write-up: This is a spontaneous report received from a non-contactable healthcare professional through the regulatory authority and via local product quality group. Regulatory authority report number: FR-AFSSAPS-PB20161242. A patient of an unspecified age, race and gender received a single dose of PREVENAR 13; (lot R46401), via an unspecified route of administration, on an unspecified date, for immunisation. The patient''s medical history was not reported. The patient''s concomitant medications were not reported. The patient died on an unspecified date due to unknown cause of death. It was not reported if an autopsy was performed. Reported Cause(s) of Death: death.


VAERS ID: 666136 (history)  
Form: Version 1.0  
Age: 28.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-14
Entered: 2016-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Malaise, Thrombotic thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, arterial (narrow), Renovascular disorders (broad), Immune-mediated/autoimmune disorders (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU2016GSK167951

Write-up: This case was reported in a literature article and described the occurrence of thrombotic thrombocytopenic purpura in a 28-year-old subject who received Flu seasonal TIV Dresden. On an unknown date, 4 days after receiving Flu seasonal TIV Dresden, the subject developed thrombotic thrombocytopenic purpura. Serious criteria included death and GSK medically significant. Additional event(s) included unwell. The outcome of thrombotic thrombocytopenic purpura was fatal. The outcome(s) of the additional event(s) included unwell (unknown). The reported cause of death was thrombotic thrombocytopenic purpura. The investigator considered that there was a reasonable possibility that the thrombotic thrombocytopenic purpura and unwell may have been caused by Flu seasonal TIV Dresden. Additional information was provided. This case was reported in a literature article and described the occurrence of thrombotic thrombocytopenic purpura (TTP) in a 28-year-old patient of unspecified gender who was vaccinated with unspecified influenza vaccine (manufacturer unknown). The patient was a part of the report that summarised national passive surveillance data for adverse events following immunisation (AEFI) reported to the Administration to 28 February 2013. The report focused on AEFI reported for vaccines administered during 2012 and trends in AEFI reporting over a 13-year period 1 January 2000 to 31 December 2012. AEFI were notified to the Administration by state and territory health departments, health professionals, vaccine manufacturers and members of the public. All reports are assessed using internationally consistent criteria entered into the Adverse Drug Reactions System (ADRS) database. No information on patient''s family history or concurrent condition or concomitant medication was provided. On an unspecified date between 1 January 2012 and 31 December 2012, the patient received unspecified influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date, 2-3 days post vaccination, the patient became unwell. Subsequently, the patient developed TTP. 2 days after onset of symptoms, the patient died. The cause of death was documented as TTP. It was not reported if an autopsy was performed. This case has been considered serious due to death. The author stated that the death was temporally associated with receipt of vaccines. The death was investigated by the Administration and no clear causal relationship with vaccination was found. Treatment was unknown. The authors suspected the event of TTP related to unspecified influenza vaccine. The authors concluded that "The total number of reported AEFI in 2012 was reduced by 22% compared with 2011. Reports of ISR following DTPa-IPV at 4 years decreased in 2012 compared with 2011 but remained higher than in previous years. Reporting rates for most of the vaccines were similar to 2011 or lower in 2012, particularly in the 2 to less than 7 year age group. The majority of AEFIs reported to the Administration were mild transient events and the data reported here are consistent with an overall high level of safety for vaccines included in the NIP schedule". This is 1 of the 6 valid cases reported in the same literature article.


VAERS ID: 666794 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-17
Entered: 2016-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F82154 / 4 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pneumococcal bacteraemia, Streptococcus test positive
SMQs:, Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (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:
Current Illness: Immune disorder (NOS)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood culture; Result Unstructured Data: Test Result: pneumococcal bacteremia without focus serotype 24F
CDC Split Type: DEPFIZER INC2016534855

Write-up: This is a spontaneous report from a contactable physician. A 60-month-old male patient of an unspecified race received PREVENAR 13 at the age of 2 months, 4 months, 7 months and 14 months (Lot No of the last administered vaccine: F82154), each at 0.5 ml single, for immunisation. The patient was not a preterm baby, had no chronic diseases and had an immune deficiency (not specified). The patient''s concomitant medications were not reported. The patient experienced pneumococcal bacteremia without focus on an unspecified date. The patient underwent blood culture on an unspecified date which detected serotype 24F. The patient died on an unspecified date. It was not reported if an autopsy was performed.No follow-up attempts possible. No further information expected.; Sender''s Comments: Serotype 24F is not contained in PREVENAR 13, therefore a lack of efficacy in this patient can be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: pneumococcal bacteremia without focus, serotype 24F.


VAERS ID: 666962 (history)  
Form: Version 1.0  
Age: 28.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-18
Entered: 2016-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Malaise, Thrombotic thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, arterial (narrow), Renovascular disorders (broad), Immune-mediated/autoimmune disorders (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: AUSA2016SA207728

Write-up: Initial unsolicited report received from the literature on 11 November 2016. The following is verbatim from the article: Abstract: This report summarises passive surveillance data for adverse events following immunisation (AEFI) reported to the Therapeutic Goods Administration (TGA) for 2012. It also describes reporting trends over the 13-year period 1 January 2000 to 31 December 2012. There were 1,897 AEFI records for vaccines administered in 2012, a decrease of 22 percent from 2,417 in 2011. The decrease in 2012 compared with 2011 was mainly attributable to a drop in the reports following receipt of the 23-valent pneumococcal polysaccharide vaccine (405 reduced to 133). However, reporting rates for some other vaccines such as rotavirus and varicella vaccines were higher in 2012 than 2011. Although an increase was observed in estimated reporting rates for rotavirus and varicella in children aged less than 7 years in 2012 compared with 2011, it was not statistically significant. There were 370 AEFI records (37.2 per 100,000 doses) for the pneumococcal conjugate vaccine in 2012, which was fewer than in 2011 (43.4 per 100,000 doses). The most commonly reported reactions were injection site reactions (40 percent), fever (22 percent), allergic reactions (19 percent) and rash (10 percent). Only 7 percent of all the reported adverse events were categorized as serious. There were 2 reports of death, which were investigated by the TGA and no clear causal relationship with vaccination was found. This case involves a 28 year old patient (gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiration date, dose, site and route of administration were not reported for all vaccines) on an unspecified date. Patient''s medical history and concomitant medications were not reported. On an unspecified date, two to three day following the vaccination patient felt unwell. On unspecified day, following the vaccination patient developed thrombotic thrombocytopenic purpura. Patient''s lab data and corrective treatment were not reported. The outcome for unwell was not reported. On unspecified date, patient was died due to thrombotic thrombocytopenic purpura after 2 days of symptoms onset. It was unknown if autopsy was done. Documents held by sender: none. Sender''s Comments: This case is extract from literature Surveillance of adverse events following immunization, 2012. This is a poorly documented death case of 28 years (gender not specified) who became unwell 2-3 days post vaccination with SEASONAL INFLUENZA VACCINE and developed thrombotic thrombocytopenic purpura (TTP) (on an unspecified date after receiving the vaccine) and died 2 days after onset of symptoms. The cause of the death was reported as TTP. This case is also investigated by the Therapeutic Goods Administration (TGA) and no clear causal relationship with vaccination was found. However details regarding patient''s medical history, previous vaccination history, time to onset of TTP, autopsy and results of investigations are deficit to complete assessment of this case. Reported Cause(s) of Death: thrombotic thrombocytopenic purpura.


VAERS ID: 667121 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-18
Entered: 2016-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure acute, Death
SMQs:, Cardiac failure (narrow), Cardiomyopathy (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: RUPFIZER INC2016533894

Write-up: This is a spontaneous report from contactable physician supplied to safety via Pfizer Regional Medical Adviser and from a regional immunologist. A 60-year-old male patient of an unspecified race received PREVENAR 13 intramuscular on an unspecified date in 2016 at 0.5 ml single for immunisation. Concomitant medication included influenza vaccine (unknown manufacturer) given on the same unspecified date in 2016 for influenza vaccination. The patient medical history was not reported. The patient died due to acute cardiac failure on an unspecified date in 2016 (on the second day after vaccinations with pneumococcal 13-val conj vac (dipht crm197 protein) and influenza vaccine). It was not reported if an autopsy was performed. The first reporting physician assessed the causality between the event and pneumococcal 13-val conj vac (dipht crm197 protein) as unknown. The reporting regional immunologist considered there was not a reasonable possibility that acute cardiac failure was related to pneumococcal 13-val conj vac (dipht crm197 protein). Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: patient medical history and autopsy results. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: acute cardiac failure.


VAERS ID: 676163 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-18
Entered: 2016-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Death
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: No other medications
Current Illness: Tobacco user
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1611JPN008925

Write-up: Initial information has been received from a patient''s friend concerning a patient (gender and age unknown) who on an unspecified date was subcutaneously vaccinated with PNEUMOVAX NP injection drug, (lot number, dose and indication not reported). The patient was a smoker. There was no concomitant medication reported. On an unspecified date, the patient was vaccinated with pneumococcal vaccine (above-mentioned). On an unspecified date, the patient died. Information on whether or not an autopsy was performed that was not obtained. Reporter''s comment: It seems like the smoking was to blame. The reporter considered that the death was serious. Upon internal review, the event was determined to be medically significant. The reporter did not assess the relationship of death to pneumococcal vaccine. Follow-up attempt was not made because the reporter did not wish to be contacted.


VAERS ID: 676223 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-18
Entered: 2016-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK AR / SYR
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK AR / SYR

Administered by: Other       Purchased by: Other
Symptoms: Blood bilirubin increased, Death, Haemoglobin decreased, Injection site haemorrhage, Injection site necrosis, Injection site vesicles, Irregular breathing, Leukocytosis, Lymphocyte count normal, Mechanical ventilation, Metabolic acidosis, Myelofibrosis, Necrotising soft tissue infection, Neutrophil count increased, Platelet count, Renal function test abnormal, Sepsis, Urine output decreased, White blood cell count increased
SMQs:, Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Haematopoietic erythropenia (broad), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Blood premalignant disorders (narrow), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (narrow), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (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: No other medications
Current Illness: Splenectomy; Primary myelofibrosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests were performed on unknown date. No growth was detected on culture tests; Blood bilirubin, elevated; Haemoglobin, 7.6 g/dL; Lymphocyte count, 2,000 K/uL; Neutrophil count, 129,000 K/uL; Platelet count, 142,000 K/uL; Renal function test, elevated; White blood cell count, 133,000 K/uL
CDC Split Type: TR2016GSK169333

Write-up: This case was reported in a literature article and described the occurrence of sepsis in a 63-year-old male patient who received Pneumococcal vaccine. Co-suspect products included Hib vaccine. Concurrent medical conditions included primary myelofibrosis and splenectomy. On an unknown date, the patient received Pneumococcal vaccine and Hib vaccine. On an unknown date, 21 days after receiving Pneumococcal vaccine and Hib vaccine, the patient experienced sepsis (serious criteria death, hospitalization and GSK medically significant), metabolic acidosis (serious criteria death and hospitalization), necrotizing soft tissue infection (serious criteria hospitalization and GSK medically significant), leukocytosis (serious criteria hospitalization), urine output decreased (serious criteria hospitalization), irregular breathing (serious criteria hospitalization), bullous eruption at injection site (serious criteria hospitalization), injection site hemorrhage (serious criteria hospitalization) and injection site necrosis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the sepsis and metabolic acidosis were fatal and the outcome of the necrotizing soft tissue infection, leukocytosis, urine output decreased, irregular breathing, bullous eruption at injection site, injection site hemorrhage and injection site necrosis were unknown. The reported cause of death was metabolic acidosis. It was unknown if the reporter considered the sepsis, metabolic acidosis, leukocytosis, urine output decreased and irregular breathing to be related to Pneumococcal vaccine and Hib vaccine. The reporter considered the necrotizing soft tissue infection, bullous eruption at injection site, injection site hemorrhage and injection site necrosis to be related to Pneumococcal vaccine and Hib vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of post-splenectomy sepsis (PSS) in a 63-years-old male who was vaccinated with unspecified pneumococcal vaccine, Hib and meningococcal vaccines (manufacturer unknown for all). The patient had primary myelofibrosis. The patient''s concomitant medication included preoperative prophylactic antibiotic. No information on patient''s family history or concurrent condition was provided. On an unspecified date, the patient received unspecified pneumococcal vaccine, Hib and meningococcal vaccines (administration site and route unspecified; dosages unknown; batch number not provided). On an unspecified date, 3 weeks after vaccination, the patient was admitted to general surgery department for splenectomy. The patient had hyper-leukocytosis following surgery and was consulted to the department. On the physical examination, it was seen that there was bullous haemorrhagic necrotizing lesion at injection site at both arms. The patient was treated with various antibiotic combinations respectively. The patient was admitted to intensive care unit (ICU) due to lacking of bilateral breathing, decreased urinary output, elevated bilirubin values and renal function tests. The patient needed mechanical ventilation (MV) support during follow-up. The patient underwent haemodia-filtration and inotrope support was initiated. On the day 3 after admission, the patient died due to refractory metabolic acidosis. It was unknown if an autopsy was performed. Laboratory investigation revealed: leukocyte count: 133,000 K/uL, (neutrophil: 129,000, lymphocyte: 2,000) (normal range not provided for both), haemoglobin: 7.6 g/dL, platelet count: 142,000 K/uL (normal range not provided for both). No growth was detected on culture tests. This case has been considered serious due to death/hospitalisation. The authors did not comment on the relationship between the event of post-splenectomy sepsis with unspecified pneumococcal vaccine, Hib and meningococcal vaccines. The authors concluded that "Necrotizing soft tissue infection is/are broad category of bacterial and fungal skin infections. Descriptive terms vary based on location, depth and extent of infection. NSTI could cause PSS in high risk patients underwent splenectomy".


VAERS ID: 676237 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-18
Entered: 2016-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA2016GSK169039

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of unknown cause of death in a infant patient who received ROTARIX. Co-suspect products included dTpa vaccine, Hib vaccine, Poliomyelitis vaccine and PREVNAR 13. On an unknown date, the patient received ROTARIX (oral), dTpa vaccine at an unknown dose, Hib vaccine at an unknown dose. Poliomyelitis vaccine at an unknown dose and PREVNAR 13 at an unknown dose. On an unknown date, an unknown time after receiving ROTARIX, dTpa vaccine, Hib vaccine and Poliomyelitis vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to ROTARIX, dTpa vaccine, Hib vaccine and Poliomyelitis vaccine. Additional details were provided as follows: This case derived from physician via Health line listing report. No consent to follow up was reported. No additional details regarding the death were available.


VAERS ID: 667237 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-19
Entered: 2016-11-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Unknown
Symptoms: Asthma, Death
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBAstraZeneca2016SF14292

Write-up: The report had been received from a physician. The report concerns a 6 years old patient. The patient''s medical history included asthmatic. Concurrent disease and concomitant products were not reported. The patient received Fluenz (intranasal). Shortly after receiving LAIV, the patient died. The immediate cause of death was acute asthma. Underlying cause continued to be investigated by authorities. Evidence suggested respiratory infection. It was unknown if autopsy was performed. The event of respiratory infection had been identified from the source document nad added as ana dverse event by the company physician. According to the reporter the event was considered as serious with the serious criteria of death, the company physician consdiered the event of respiratory infection as serious with the serious criteria of important medical event. Sender''s Comments: Respiratory tract infection and fatal event of asthma are not listed in company core data sheet of Fluenz tetra. Patient''s relevant condition of asthma as risk factor along with respiratory tract infection could be contributory for asthma. There is limited information on patient''s concurrent conditions, personal hygiene, autopsy report, and aetiologic and diagnostic workup which facts makes individual causal assessment difficult. Reported Cause(s) of Death: ACUTE ASTHMA; RESPIRATORY INFECTION.


VAERS ID: 676300 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-21
Entered: 2016-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Brain neoplasm malignant, Death, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1611ECU009202

Write-up: This spontaneous report was received from a physician via company representative regarding a 15 year old female patient. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patient received the first and second dose of GARDASIL (Lot#, dose and route unknown). On an unknown date, after the second dose, the patient had a syncope, and then she completed the scheme (on an unknown date received the third dose). Then on an unknown date, the patient was diagnosed with a malignant neoplasm of cerebellum, this tumor was difficult to localize and on an unknown date she died. The cause of death was unknown. The outcome of the syncope was not provided. The patient''s mother reported to the physician she believed that somehow or coincidently the events were related to GARDASIL. The physician did not report causality assessment for the events. Upon internal review, the malignant neoplasm of cerebellum was considered serious as an other important medical event. Additional information has been requested.


VAERS ID: 676449 (history)  
Form: Version 1.0  
Age: 0.13  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-22
Entered: 2016-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Sudden infant death syndrome
SMQs:, Neonatal disorders (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SE2016GSK170439

Write-up: This case was reported by a physician via sales rep and described the occurrence of sudden infant death in a 9-week-old female patient who received ROTARIX. On an unknown date, the patient received the 1st dose of ROTARIX (oral). On an unknown date, 14 days after receiving ROTARIX, the patient experienced sudden infant death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the sudden infant death was fatal. The reported cause of death was sudden infant death. The reporter considered the sudden infant death to be related to ROTARIX. Additional details were provided as follows: The patient received ROTARIX at the age of 7 weeks. At the age of 9 weeks, approximately 2 weeks after vaccination, the patient was found to be death (sudden infant death). No further information was available, but a follow up would be performed. The physician had also reported the case to the Agency.


VAERS ID: 676595 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-11-01
Submitted: 2016-11-23
   Days after onset:22
Entered: 2016-11-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Chest X-ray abnormal, Chest discomfort, Death, Dyspnoea, Pneumonia
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), 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: 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: No other medications
Current Illness: Unknown
Preexisting Conditions: Cardiac operation, The operation was underwent more than 10 years ago.
Allergies:
Diagnostic Lab Data: In approximately November 2016, there was a shadow in patient''s lung on the X-ray.
CDC Split Type: WAES1611JPN009825

Write-up: Initial information has been received from a patient''s family concerning a 77-year-old male patient who in approximately 2014 was subcutaneously vaccinated with PNEUMOVAX NP injection (Lot number and dose not reported). The patient''s history included cardiac operation (more than ten years ago). There was no concomitant medication reported. On an unspecified date (more than 10 years ago), the patient underwent cardiac operation. In approximately 2014 (2 years ago), the patient was vaccinated with PNEUMOVAX NP for periodical inoculation at the age of 75 (as described above). In approximately November 2016, the patient appeared to have trouble breathing and also experienced distressed feeling in chest. The patient was hospitalized by emergency ambulance. It was told that there was no problem with the patient''s heart, but there was a shadow in his lung on the X-ray indeed, and he had pneumonia. In approximately November 2016 (the next day), the patient stabilized and felt better. In approximately November 2016 (the day after), the patient became worse again. In approximately November 2016, upon inquiring physician, it was told that the medicine was weak and that if the patient was switched to stronger medicine, he would get better. But the patient did not improve, and died. The cause of death was pneumonia. Autopsy information was not obtained. Reporter''s comment: not provided. The reporter considered the pneumonia to be serious due to death and hospitalization. Upon internal review, the pneumonia was determined to be serious as an other important medical event. The reporter did not assess the causal relationship of pneumonia to PNEUMOVAX NP. Follow-up attempt was not made because the reporter did not wish to be contacted.


VAERS ID: 676347 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-11-24
Entered: 2016-11-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, 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: 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: WAES1611JPN009836

Write-up: Initial information has been received from a patient''s family concerning an elderly patient (gender unknown) who on an unspecified date was vaccinated with PNEUMOVAX NP (Lot Number and dose not reported). There was no other concomitant medication reported. On an unspecified date, the patient was vaccinated with PNEUMOVAX NP (as mentioned above). On an unspecified date (about three years after vaccination), the patient developed pneumonia. The patient died on an unknown date. The cause of death was pneumonia. Information on autopsy was not reported. Reporter''s comments: not provided. The reporter considered the pneumonia was serious due to death. Upon internal review, the pneumonia was determined to be serious as an other important medical event. The reporter did not assess the relationship of pneumonia to PNEUMOVAX NP. Follow-up attempt was not made because the reporter did not wish to be contacted.


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: 676634 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2016-01-18
Onset:0000-00-00
Submitted: 2016-11-23
Entered: 2016-11-28
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Anuria, Bacterial infection, Capillary nail refill test, Cerebral hypoperfusion, Death, Dehydration, Diarrhoea, Dyspnoea, Fontanelle bulging, General physical health deterioration, Haemoptysis, Hepatomegaly, Hypotension, Irregular breathing, Irritability, Oedema, Poor peripheral circulation, Rales, Respiratory distress, Respiratory rate increased, Shock, Ultrasound skull abnormal, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-01-22
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 01/22/2016, Heart rate, 200; 01/21/2016, Ultrasound skull, very poor cerebral perfusion
CDC Split Type: ZA2016GSK172707

Write-up: This case was reported by a regulatory authority via licensee and described the occurrence of diarrhea in a 6-week-old male patient who received SYNFLORIX. Co-suspect products included ENGERIX B pediatric. On 18th January 2016, the patient received SYNFLORIX and ENGERIX B pediatric. In January 2016, less than a week after receiving SYNFLORIX and ENGERIX B pediatric, the patient experienced diarrhea (serious criteria death and hospitalization), vomiting, bacterial infection and fontanel bulging. The patient was treated with LASIX. On an unknown date, the outcome of the diarrhea was fatal and the outcome of the vomiting, bacterial infection and fontanel bulging were unknown. The patient died on 22nd January 2016. The reported cause of death was diarrhea. The reporter considered the diarrhea and vomiting to be possibly related to SYNFLORIX. It was unknown if the reporter considered the bacterial infection and fontanel bulging to be related to SYNFLORIX and ENGERIX B pediatric. It was unknown if the reporter considered the diarrhea and vomiting to be related to ENGERIX B pediatric. Additional details were provided as follows: The patient had possible severe bacterial infection (bulging fontanelle). The patient was found to be more than 10 percent dehydrated and shocked with poor peripheral perfusion, had respiratory distress with irregular respiration, bilateral creps and pink frothy hemoptysis, good peripheral pulses and cap refill less than 2 seconds. The patient had distended abdomen with a 3 cm hepatomegaly, soft sunken fontanelle and irritability. On an unknown date, at 17:05 hours, the patient was clinically deteriorated with pulse of 200 and gasping respiration, poor peripheral perfusion and persistent hypotension. The patient become anuric with worsening oedema despite a LASIX infusion and poor cerebral perfusion. The patient was died on 22nd January 2016.


VAERS ID: 669339 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2016-10-06
Onset:2016-10-06
   Days after vaccination:0
Submitted: 2016-11-29
   Days after onset:54
Entered: 2016-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LA / SYR

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-10-06
   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: Blood disorder, exclusively liquid black corpse blood, blood richness of the inner organs; Hypertension; Pulmonary hypertension; Coronary artery disease; Angiosclerosis, high-grade; generalised; Nephroangiosclerosis, beginning; both sides; Emphysema, age-related; Benign prostatic hyperplasia; Cholelithiasis; Inguinal hernia, with displacement of
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2016GSK171887

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of sudden arrhythmic death syndrome in a 77-year-old male patient who received Influenza vaccine. Concurrent medical conditions included hypertension, pulmonary hypertension, triple vessel disease, angiosclerosis (high-grade; generalised), nephroangiosclerosis (beginning; both sides), emphysema (age-related), hyperplasia of prostate, cholelithiasis, inguinal hernia (with displacement of) and blood disorder (exclusively liquid black corpse blood, blood richness of the inner organs). On 6th October 2016, the patient received the 1st dose of Influenza vaccine .5 ml. On 6th October 2016, several hours after receiving Influenza vaccine, the patient experienced sudden arrhythmic death syndrome (serious criteria death and GSK medically significant). On 6th October 2016, the outcome of the sudden arrhythmic death syndrome was fatal. The patient died on 6th October 2016. The reported cause of death was sudden arrhythmic death syndrome. An autopsy was performed. It was unknown if the reporter considered the sudden arrhythmic death syndrome to be related to Influenza vaccine. Additional details were reported as follows: The patient received the Influenza vaccine on the left deltoid. It was unknown that the patient had been suffering from hypertension. Concomitant medication was not provided. In the morning, the patient received Influenza vaccine (manufacturer unspecified; trade name and batch number were not known or not reported). On the very same day, after vaccination, during the noon hours, the patient was found lifeless in the stairwell of the multifamily house. An emergency physician was called who could only determine the patient''s death. No cardiopulmonary resuscitation was done. An autopsy was performed. Significant findings were found in the autopsy. It was found that anterior wall of the heart was spotted callus and brightened areas in the posterior wall of the heart. The patient had triple vessel disease, severe generalised angiosclerosis, signs of pulmonary hypertension, suspicion of emphysema of old age, exclusively liquid black corpse blood and blood richness of the inner organs. The beginning nephroangiosclerosis of both sides, nodular hyperplasia of the prostate, cholelithiasis was observed. No signs of recent bone fractures, and recent injection site at the left upper arm without signs of inflammation were noted. No signs of external force by a third party were found. On the basis of the autopsy findings and regarding the patient''s pre-existing cardiac disease it could be assumed that the patient died from sudden arrhythmic death syndrome. Autopsy determined and reported cause of death was sudden arrhythmic death syndrome. The physicians performing autopsy reported that death from sudden arrhythmic death syndrome was temporally related to vaccination but considered that a causal relationship could not be easily established. The regulatory authority requested further information.


VAERS ID: 677096 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:2016-08-19
Onset:2016-08-24
   Days after vaccination:5
Submitted: 2016-11-29
   Days after onset:97
Entered: 2016-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER M7140 / 1 LL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER L5348 / 1 MO / PO
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M35866 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB445BA / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-08-24
   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:
Preexisting Conditions: Congenital urethral anomaly, the patient was born with suspected no urethral opening
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZA2016GSK172725

Write-up: This case was reported by a other health professional via licensee and described the occurrence of unknown cause of death in a 6-week-old patient who received ROTARIX (batch number AROLB445BA, expiry date unknown). Co-suspect products included Oral polio vaccine (batch number L5348 ?, expiry date unknown), DTaP-HepB-IPV-Hib (batch number M7140 ?, expiry date unknown) and PCV 13 vaccine (batch number M35866, expiry date unknown) The patient''s past medical history included congenital urethral anomaly (the patient was born with suspected no urethral opening). On 19th August 2016, the patient received the 1st dose of ROTATEQ (oral), the 1st dose of Oral polio vaccine (oral) and the 1st dose of DTaP-HepB-IPV-Hib (intramuscular). On 24th August 2016, 5 days after receiving ROTARIX, Oral polio vaccine and DTaP-HepB-IPV-Hib, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 24th August 2016. The reported cause of death was unknown cause of death. An autopsy was performed. It was unknown if the reporter considered the unknown cause of death to be related to ROTARIX, Oral polio vaccine and DTaP-HepB-IPV-Hib. Additional details were provided as follows: The age at vaccination was not provided. The patient was born with suspected no urethral opening. The condition of the patient before vaccination was not established as the vaccinator was on the night shift on the day of adverse event following immunization investigation. The patient received the hexavalent vaccine on the left thigh and the PCV 13 on right thigh. On 24th August 2016, an electronic message was received from the district coordinator about the adverse event following immunization. Investigation on event was conducted on 30th August 2016. The post-mortem was already arranged and the patient''s mortal remains were collected for procedure. The investigational team visited the clinic and interviewed the clinic persons. The interviewed professional nurse''s skills on vaccination was found to be up to the required standard. The observer observed some finding as vaccine storage fridge temperature was (0 to 8 degree C) and conditioning of ice pac after removal from the freezer. The autopsy was performed but the results were not available. It was unknown if the reporter considered the unknown cause of death to be related to PCV 13 vaccine as well. The reported batch numbers for hexavalent vaccine and Oral polio vaccine were not in accordance with GSK lot number.


VAERS ID: 676983 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2016-05-31
Onset:2016-06-01
   Days after vaccination:1
Submitted: 2016-12-02
   Days after onset:184
Entered: 2016-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER M8099 / UNK UN / UN
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER O37G5099 / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER M5103 / UNK UN / UN
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS L20075 / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB293AA / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Pneumonia, Pulse absent, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: 2016-06-01
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZA2016GSK172863

Write-up: This case was reported by a other health professional via licensee and described the occurrence of bronchopneumonia in a 6-week-old male patient who received ROTARIX (batch number AROLB293AA, expiry date unknown). Co-suspect products included SYNFLORIX (batch number L20075 ?, expiry date unknown), BCG vaccine (batch number O37G5099, expiry date unknown), OPV (batch number M5103, expiry date unknown) and HEXAXIM (batch number M8099-1, expiry date unknown). On 31st May 2016, the patient received ROTARIX (oral), SYNFLORIX .5 ml, BCG .5 ml, OPV 2 drop(s) and HEXAXIM .5 ml. On 1st June 2016, 1 days after receiving ROTARIX and SYNFLORIX, the patient experienced bronchopneumonia (serious criteria death and GSK medically significant). On an unknown date, the outcome of the bronchopneumonia was fatal. The patient died on 1st June 2016. An autopsy was performed. The autopsy determined cause of death was bronchopneumonia. It was unknown if the reporter considered the bronchopneumonia to be related to ROTARIX and SYNFLORIX. Additional details were provided as follows: Following vaccination the patient did not present with any signs of adverse reaction. Also, the patient was well and received feeds at home after immunization. The patient was last breastfed at 2:30 hours on 1st June 2016. On 1st June 2016, at 4:30 hours, the patient''s mother realized that the patient was not breathing at when changing the patient''s position. At 5:35 hours, the patient was taken to clinic. Then patient was not breathing and had no pulse. The emergency medical service (EMS) certified the death and requested the forensic department to collect the deceased patient for autopsy to confirm cause of death. No adverse events were reported from the clinic for the patients who received vaccines from the above batch numbers. On 12th July2016, a final verbal autopsy report was provided by the forensic pathologist. The final autopsy report was that the patient died of bronchopneumonia and not related to the vaccinations that was provided. The clarification was requested for consideration of suspect vaccine as SYNFLORIX and correct batch numbers for SYNFLORIX and BCG vaccine, but no clarification could be received.


VAERS ID: 669694 (history)  
Form: Version 1.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2016-11-18
Onset:2016-11-19
   Days after vaccination:1
Submitted: 2016-12-02
   Days after onset:13
Entered: 2016-12-04
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 167202 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Death
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-22
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Nodal arrhythmia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2016IT165868

Write-up: Case number PHHY2016IT165868, is an initial spontaneous report received from a healthcare professional via company (reference number 385768) on 30 Nov 2016. This report refers to a 76-years-old male patient. Past medical history was not reported. Current condition included nodal hypertensive tachycardia. Concomitant medications were not reported. The patient was vaccinated with FLUAD (batch number: 167202) at a dose of 0.5 ml intramuscularly on 18 Nov 2016. On 19 Nov 2016, due to acute epigastric pain the patient went to emergency room (ER). On 21 Nov 2016, the patient went to emergency room again due to condition worsening. On 22 Nov 2016, the patient died. The cause of death was unknown. It was unknown whether autopsy was done or not. The causality of the event was reported as suspected.


VAERS ID: 669599 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:2016-11-23
Onset:2016-11-23
   Days after vaccination:0
Submitted: 2016-12-05
   Days after onset:12
Entered: 2016-12-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR M74631M / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Feeling abnormal, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-24
   Days after onset: 1
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: CNSA2016SA217794

Write-up: Initial unsolicited report received from health authority (CDC) via company representative on 28 November 2016. This case involves 02-month-old patient (Gender not reported) who was vaccinated with a 0.5 ml primary first dose of IMOVAX (batch number: M74631M, expiry date was not reported) intramuscularly in left arm on 23 November 2016. Patient''s medical history and concomitant medication were not reported. On 23 November 2016, same day following the vaccination, patient had drowsiness and low spirits. On 24 November 2016 at 06:00 A.M, one day following vaccination, the patient died. Lab data and corrective treatment were not reported. Outcome of events drowsiness and low spirits was not reported and cause of death was not reported. Upon internal review, the company decided to code the event drowsiness and low spirits which was mentioned in the narrative but was not coded by HA. It was not reported whether autopsy was performed. List of documents held by sender: none. Sender''s Comments: This is a poorly documented death case, of a 2 months old child, who received first dose of IPV (VERO) and on same day developed drowsiness and low spirits. On next day child died. Time to onset is compatible with the role of vaccine. Information about autopsy was not provided. Further information about investigations performed, etiological workup, reaction to previous vaccination, concurrent condition, concomitant medication, and detailed autopsy result will be needed. The cause of this death remains unknown according to available data. This case lacks of information to make a full assessment; Reported Cause(s) of Death: Death NOS.


VAERS ID: 676836 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2016-06-20
Onset:2016-06-21
   Days after vaccination:1
Submitted: 2016-12-07
   Days after onset:169
Entered: 2016-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER M5103 / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER M57603 / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB446AA / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Cough, Death, Dyspnoea, Endotracheal intubation, Influenza, Malaise
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-06-21
   Days after onset: 0
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: No other medications
Current Illness: Cough
Preexisting Conditions: Jaundice neonatal; Apnoea; Hypoglycaemia; Influenza like illness; Low birth weight baby, the patient''s birth weight was recorded as 1.56kg
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZA2016GSK173439

Write-up: This case was reported by a other health professional via licensee and described the occurrence of unknown cause of death in a 8-week-old male patient who received ROTARIX liquid formulation (batch number AROLB446AA, expiry date unknown). Co-suspect products included BIVALENT OPV1 (batch number M5103, expiry date unknown) and Pneumococcal vaccine (batch number M57603 ?, expiry date unknown). The patient''s past medical history included neonatal jaundice, apnea, hypoglycemia, birth weight low and influenza-like symptoms. Concurrent medical conditions included cough. On 20th June 2016, the patient received ROTARIX liquid formulation (oral), BIVALENT OPV 1 Plus 3 and Pneumococcal vaccine. On 20th June 2016, less than a day after receiving ROTARIX liquid formulation and BIVALENT OPV1 Plus 3 and pneumococcal vaccine, the patient experienced cough and difficulty breathing. On 21st June 2016, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On 21st June 2016, the outcome of the unknown cause of death was fatal. On an unknown date, the outcome of the cough and difficulty breathing were unknown. The patient died on 21st June 2016. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, cough and difficulty breathing to be related to ROTARIX liquid formulation, BIVALENT OPV 1 Plus 3 and Pneumococcal vaccine. Additional details were provided as follows: The patient was born preterm and via Caesarean section. Before discharge from the hospital, at birth, the patient received BCG and oral polio vaccine and there were no any associated reactions with these vaccines. The patient was subsequently discharged on sound clinical grounds. On 20th June 2016, on Monday, the patient was brought in by his mother to the clinic with a one day history of cough. She had not brought the patient for immunization. The patient''s mother was therefore referred to the Integrated Management of childhood illness or Primary Health Care (IMCI/PHC) room or Room number 3 of the facility consultation. The professional nurse in charge of the clinic, she realized that the patient had missed his 6 weeks immunization, immediately referred patient and mother to the vaccination room (room 3) to get bookings for the patient''s overdue immunizations. The nurse did not check the patient vitals before this referral. She had expected mother and patient to return after the immunization bookings for continuations of the patient clinical consultations and perhaps for possible treatments. Unfortunately, the mother and the patient never returned. The other nurse who was in charge of the room 2, noticed that the patient had already missed his 6 weeks immunization schedule had to have him immunized for that age. She however did not realize that after the due immunizations, mother and the patient had to go back to the IMCI/PHC room (Room 3) for continuation of clinical consultations. The nurse did not check for temperature readings or any other vitals. She only noticed that the patient looked neglected and had to make the mother to be aware of that. The nurse said that she only realized that the patient might have a cough after he started coughing after being administered his oral polio drops. The patients did not receive HEXAXIM vaccine that day because it was out of stock in the clinic. There were no immediate untoward developments immediately after the administrations of the available vaccines. But according to story from the mother, the patient had started developing difficulty in breathing after she had walked about two streets away from the clinic. She subsequently noticed that the patient was looking like a dead baby. She further went on to admit that she was aware she should have taken the patient back to clinic. However, she was afraid to get back to that nurse who had told her that her patient might die. The patient''s mother instead went home with the patient whose condition as expected worsened. They had to stay awake to nurse him the entire night. On 21st June 2016 on Tuesday, around 6:00 am, the patient was still not improving; they had to take him to a nearby Private General Practitioner. The physician immediately referred the patient to the hospital. The patient was urgently attended to the hospital where he was intubated and a transfer to another hospital. The patient was died whilst waiting to be transferred to the other hospital. For some reasons not yet made clear at the time of this report, there was no post mortem that was carried out on the body of the patient. It was also understood that the patient was buried the same day of his death at the cemetery. The nurse, who administered the vaccine, was a retired Professional nurse who had some experienced. The patient''s mother stated that, she came to the clinic with the patient because he was sick of flu and was coughing, when she reached to the clinic they send her to room 3. The nurse at room 3 told the patient''s mother that they did not have pills for him so they send her to the room 2 for a booking for 6 week. When the patient''s mother was reached there the nurse started checking the patient. The patient''s mother stated that she did not know why because they sent her to the nurse to give her a booking for 6 week. The nurse said no she gave the patient an injection in the leg. After that the nurse start going with the patient. After 2 street, the patient was started breathing badly and she was down like a dead body. the patient''s mother did not understand but she said no maybe the patient was just fed-up but she was worried when she arrived at home, the patient''s condition got worst. All night it was a disaster til the morning. We went to the private hospital, the patient was very sick. They give us a letter and transfer us to another hospital. The patient''s mother went there straight. The patient''s mother arrived there at 7.00 and they checked the patient and told her that the patient was very sick and in bad condition. But the patient''s mother said that the patient was fine, since from that clinic. They tried and tried but it never works till 9.00, at night the patient passed away. Upon internal QC check: The suspect vaccine BIVALENT OPV 1 had been changed by BIVALENT poliomyelitis 1 and 3.


VAERS ID: 676851 (history)  
Form: Version 1.0  
Age: 0.1  
Sex: Female  
Location: Foreign  
Vaccinated:2016-10-20
Onset:0000-00-00
Submitted: 2016-12-05
Entered: 2016-12-07
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB511BA / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Apathy, Autopsy, Crying, Death, Diarrhoea, Faeces discoloured, Haematochezia, Muscle tightness, Poor quality sleep, Screaming, Strabismus
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal haemorrhage (narrow), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-03
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: Neonatal infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: SE2016175894

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of crying in a 7-week-old female patient who received ROTARIX (batch number AROLB511BA, expiry date unknown). The patient''s past medical history included neonatal infection. On 20th October 2016, the patient received the 1st dose of ROTARIX (oral). In 2016, less than a year after receiving ROTARIX, the patient experienced apathy (serious criteria other). In October 2016, the patient experienced crying (serious criteria other), muscle tension (serious criteria other) and squint (serious criteria other). On 2nd November 2016, the patient experienced greenish stool (serious criteria other), stools watery (serious criteria other) and blood in stool (serious criteria GSK medically significant and other). On an unknown date, the outcome of the crying, muscle tension, squint, apathy, greenish stool, stools watery and blood in stool were unknown. The reporter considered the crying, muscle tension, squint, apathy, greenish stool, stools watery and blood in stool to be possibly related to ROTARIX. Additional details: Date of death of patient was reported as 03 November 2016 and cause of death was not provided. Initial information was received from physician via regulatory authority on 28 November 2016: Report from a physician regarding a 7 weeks old girl who was born at full term, had transient neonatal infection but then been healthy. The girl grew normally, was a quiet child who slept six hours a night. The child was vaccinated at 7 weeks of age, with the first dose ROTARIX. After the vaccination, she was more screaming and slept poorly. "Was tensed in her body as if she had a stomach ache. Different glanse in the eyes with some squinting." Absent and somewhat apathetic the last days. She had green watery faeces with blood streak the day before she was found lifeless. The girl died about two weeks after vaccination with ROTARIX, but the cause of death is unknown when the autopsy report is not ready yet. According to the reporter "macroscopic examination at autopsy did not show injury or illness." Further information is sought.


VAERS ID: 676982 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2013-01-08
Onset:0000-00-00
Submitted: 2016-12-06
Entered: 2016-12-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood test, Death, Meningococcal sepsis, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Sepsis (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: No other medications
Current Illness: Unknown
Preexisting Conditions: Sickle cell anaemia; Asplenia, to treat Sickle-cell anemia; Stem cell transplant; Splenectomy
Allergies:
Diagnostic Lab Data: On an unknown date, the blood sample was analyzed to identify the meningococcal C strain involved in the infection the results were not available.
CDC Split Type: IT2016GSK177803

Write-up: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 22-year-old male patient who received MENJUGATE. Co-suspect products included Meningococcal ACWY Vaccine (potential MENVEO). The patient''s past medical history included splenectomy. On an unknown date, the patient received Meningococcal C Vaccine and Meningococcal ACWY Vaccine (potential MENVEO). On an unknown date, an unknown time after receiving Meningococcal C Vaccine and Meningococcal ACWY Vaccine (potential MENVEO), the patient experienced vaccination failure (serious criteria GSK medically significant) and meningococcal sepsis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure and the outcome of the meningococcal sepsis was fatal. The reported cause of death was meningococcal sepsis. The reporter considered the vaccination failure and meningococcal sepsis to be possibly related to Meningococcal C Vaccine and Meningococcal ACWY Vaccine (potential MENVEO). Additional details were provided as follows: The age at vaccination was not reported. This case was considered as suspected vaccination failure as information regarding time to onset was unknown. The patient received Meningococcal C in 2007 and Meningococcal ACWY in 2013. Follow up information was received by a physician via sales rep on 1st December 2016: The patient''s initial was updated. The patient''s past medical history included sickle-cell anemia and asplenia (to treat sickle-cell anemia) and underwent stem cell transplant. The suspect vaccine Meningococcal C Vaccine was updated to MENJUGATE KIT and Meningococcal ACWY Vaccine was updated to MENVEO. The patient received MENJUGATE KIT on 4th May 2007 and MENVEO on 8th January 2013 and experienced sepsis which caused the patient''s death in about 4 to 5 hours. The blood sample was analyzed to identify the meningococcal C strain involved in the infection of which the results were not available. The patient was treated with an unspecified long lasting (although discontinuously) therapy. The physician did not believe that it was a vaccines lack of efficacy, since in such patients, the immune response to vaccination was very poor, therefore they should follow a different and more appropriate vaccination protocol.


VAERS ID: 671066 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-12-09
Entered: 2016-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 1 UN / SYR

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: 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: JP0095075131612JPN004747

Write-up: Initial information has been received from a patient''s family concerning an elderly male patient who on an unspecified date was subcutaneously vaccinated for the first time with PNEUMOVAX NP for prophylaxis (lot number, and dose not reported). There was no concomitant medication reported. On an unknown date (at around age 90), the patient was vaccinated with pneumococcal vaccine for the first time (as described above). On an unknown date (after vaccination), the patient developed pneumonia. On an unknown date, the patient died. The cause of death was pneumonia. At the time of the report, no information regarding autopsy was reported. Reporter''s comment: Not provided. The reporter did not assess the relationship of pneumonia to pneumococcal vaccine. The reporter considered pneumonia to be serious due to death. Upon internal review, pneumonia was determined to be serious as an other important medical event. This is one of several reports received from the same source. Follow-up attempt was not performed because the reporter did not wish to be contacted.; Reported Cause(s) of Death: Pneumonia.


VAERS ID: 671557 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:2016-12-02
Onset:2016-12-03
   Days after vaccination:1
Submitted: 2016-12-12
   Days after onset:9
Entered: 2016-12-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER L02606V / 2 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R65641 / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-12-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2016567340

Write-up: This is a spontaneous report received from the Regulatory Authority. Regulatory Authority report number 386312. A physician (contactable through Regulatory Authority only) referred that a 4-month-old male patient received on 02Dec2016 at 10:00 the second dose of PREVENAR 13 (Lot n. R65641 expiration date 30Oct2018) 0.5ml single intramuscular and the second dose of HEXYON (Lot n. L02606V expiration date 10Jul2017) intramuscular, for immunization. The patient medical history and concomitant medications were not reported. The patient died of unknown cause on 03Dec2016 at 06:59 at the emergency room. It was reported that no reaction occurred in the first 30 minutes after vaccination. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Death.


VAERS ID: 671975 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2016-05-18
Onset:2016-11-20
   Days after vaccination:186
Submitted: 2016-12-13
   Days after onset:23
Entered: 2016-12-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 3 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Diarrhoea, Dry mouth, Gastroenteritis, Lid sulcus deepened, Malnutrition, Pyrexia, Skin turgor decreased, Thirst, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Periorbital and eyelid disorders (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-27
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Malnutrition
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20161124; Test Name: Body temperature; Result Unstructured Data: Lab result: 38.1 ?C; Test Date: 20161124; Test Name: Respiratory rate; Result Unstructured Data: Lab result: 42 /min; Test Date: 20161124; Test Name: Weight; Test Result: 6.7 kg
CDC Split Type: ML0095075131612MLI006019

Write-up: This spontaneous report has been received from a physician concerning a 9-month-old male patient enrolled in a Post Marketing Active Surveillance Program. The patient''s concurrent condition included malnutrition. The patient''s medical history and concomitant therapies were not reported. On 10-MAR-2016, the patient was vaccinated with the first dose of ROTATEQ orally (dose and Lot/Batch# were not reported), once, for prevention. On 11-APR-2016 and 18-MAY-2016, the patient was vaccinated orally with the second and third dose of ROTATEQ (dose and Lot/Batch# were not reported), once, for prevention, respectively. According to the mother, the infant had fever and diarrhea that began on 20-NOV-2016. In the presence of these symptoms, the child received a traditional treatment based on herbal tea. Without success, the aunt brought the infant to a community health association on 24-NOV-2016. The infant presented: liquid stool without blood or mucus (6-10 times a day), vomiting (2-4 times a day), intense thirst, normal consciousness. An examination showed dry mouth, sunken eyes with loss of skin turgor, weight 6.7kg, height 70.0 cm, arm circumference 12.5 cm, temperature 38.1 Celsius degree, respiratory rate 42 cycles/min. The infant was diagnosed with moderate diarrhea and malnutrition and then included in the VIDA-Merck study and the following treatment (SRO, Cotrimoxazole 240 mg (5ml 2 times/day), metronidazole 125 mg ( 5ml 2times/day), artesunate (+) lumefantrine (1cp 2times/day), zinc (unspecified) (1cpd/day), paracetamol 125mg syrup (5 times/day) was prescribed for administration at home. The event was diagnosed as gastroenteritis. According to the aunt, diarrhea and fever continued with lack of financial meant she did not return to the center and the child died on 27-NOV-2016 at home around 12:00. Of note, the mother of the child had died. Action taken with ROTATEQ was not applicable. The reporter considered gastroenteritis to be not related to ROTATEQ. Additional information has been requested. Reported Cause(s) of Death: Gastroenteritis.


VAERS ID: 672278 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2016-09-01
Onset:0000-00-00
Submitted: 2016-12-14
Entered: 2016-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis pneumococcal
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-12-01
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: FRPFIZER INC2016576944

Write-up: This is a spontaneous report from a contactable physician via a sales representative. An infant male patient (aged 6 or 7 months) received a single dose of PREVENAR 13 on an unknown date for immunization. Number of doses received was not specified. The patient''s medical history and concomitant medications, if any, were not reported. In 2016 the patient experienced pneumococcal meningitis, leading to patient''s death on 01Dec2016. It was not reported if an autopsy was performed.; Sender''s Comments: Based on the information provided in the case, a lack of efficacy with PREVENAR 13 in this patient cannot be excluded. Further information like serotyping results is needed for a full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: pneumococcal meningitis; pneumococcal meningitis.


VAERS ID: 677287 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2016-11-22
Onset:2016-11-25
   Days after vaccination:3
Submitted: 2016-12-13
   Days after onset:18
Entered: 2016-12-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-25
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2016GSK183242

Write-up: This case was reported by a physician via sales rep and described the occurrence of sudden infant death syndrome in a 22-week-old patient who received ROTARIX. Co-suspect products included HEXYON. On 22nd November 2016, the patient received the 2nd dose of ROTARIX (oral) 1.5 ml and the 2nd dose of HEXYON .5 ml. On 25th November 2016, 3 days after receiving ROTARIX, the patient experienced sudden infant death syndrome (serious criteria death and GSK medically significant). On 25th November 2016, the outcome of the sudden infant death syndrome was fatal. The patient died on 25th November 2016. The reported cause of death was sudden infant death syndrome. An autopsy was performed. It was unknown if the reporter considered the sudden infant death syndrome to be related to ROTARIX. Additional details were provided as follows: The age at vaccination was not reported. On the day of vaccination, the patient was completely healthy. The patient showed no signs of an infection or fever or other pathologic medical conditions. No concomitant medication was reported. Post vaccination the patient did not experience any postvaccinal adverse reaction or complication. Approximately three days later, on 25th November 2016, the patient was found dead in bed. Sudden infant death syndrome (SIDS) was considered. An autopsy was performed but the report was not provided. Autopsy showed no conspicuous findings, especially no finding concerning possible complications post vaccination with ROTARIX involving the gastrointestinal tract. It was unknown if the reporter considered the infant death syndrome to be related to HEXYON as well.


VAERS ID: 673666 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-12-19
Entered: 2016-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU2016GSK187737

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 5-year-old subject who received Flu seasonal TIV Dresden. On an unknown date, 2 days after receiving Flu seasonal TIV Dresden, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. The investigator considered the unknown cause of death to be possibly related to Flu seasonal TIV Dresden. Additional information was provided. This case was reported in a literature article and described the occurrence of death NOS in a 5-year-old child of unspecified gender who was vaccinated with FLUARIX (GlaxoSmithKline). The patient was a part of the report that summarized data for adverse events following immunisation (AEFI) reported to the Administration for 2013. The report focused on AEFI reported for vaccines administered during 2013 and trends in AEFI reporting over the 14-year period 1 January 2000 to 31 December 2013. AEFI were notified to the Administration by state and territory health departments, health professionals, vaccine manufacturers and members of the public. All reports are assessed using internationally consistent criteria entered into the Adverse Drug Reactions System (ADRS) database. The patient had multiple unspecified underlying medical problems. No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 1 January 2013 and 31 December 2013, the patient received FLUARIX (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date, 2 days after vaccination, the patient died. It was not reported if the autopsy was performed. The cause of death was unknown. This case has been considered serious due to death. The authors commented that "All deaths were investigated by the Administration and no clear causal relationship with vaccination was found. The death NOS was temporally associated with the receipt of vaccine." The authors concluded that "The total number of reported AEFI in 2013 increased by 59% compared with 2012, due to an increasing trend in propensity to report. The higher reporting rates may also be in response to the activities undertaken by the Administration and the state and territory health departments to encourage and facilitate reporting of AEFI. Reporting rates for the majority of the vaccines were higher than 2012. Increases were most marked in the 7 to under 20 year age group following extension of HPV to boys and associated enhanced surveillance. The majority of AEFIs reported to the Administration were mild transient events. The data reported here are consistent with an overall high level of safety for vaccines included in the schedule". This is 1 of the 9 valid cases reported in the same literature article.


VAERS ID: 677131 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-12-20
Entered: 2016-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU2016GSK187789

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 2-month-old subject who received DTPa-HBV-IPV+Hib vaccine. Co-suspect products included Pneumococcal 13 serotypes vaccine. On an unknown date, 1 day after receivng DTPa-HBV-IPV+Hib vaccine and Rotavirus vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. The investigator considered the unknown cause of death to be possibly related to DTPa-HBV-IPV+Hib vaccine and Rotavirus vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of death NOS in a 2-month-old child who was vaccinated with unspecified rotavirus vaccine, unspecified hexavalent vaccine and unspecified 13 valent pneumococcal conjugate vaccine (13vPCV) (manufacturer unknown for both). The patient was a part of the report that summarized national passive surveillance data for adverse events following immunisation (AEFI) reported to the Administration for 2013. The report focused on AEFI reported for vaccines administered during 2013 and trends in AEFI reporting over the 14-year period 1 January 2000 to 31 December 2013. AEFI were notified to the Administration by state and territory health departments, health professionals, vaccine manufacturers and members of the public. All reports are assessed using internationally consistent criteria entered into the Adverse Drug Reactions System (ADRS) database. No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 1 January 2013 and 31 December 2013, the patient received unspecified rotavirus vaccine, unspecified hexavalent vaccine (administration route and site unspecified; dosages unknown; batch number not provided) co-administered with 13vPCV. On an unspecified date, 1 day after vaccination, the patient died. It was not reported if the autopsy was performed. The cause of death was unknown. This case has been considered serious due to death. The authors commented that "All deaths were investigated by the Administration and no clear causal relationship with vaccination was found. The death NOS was temporally associated with the receipt of vaccine." The authors concluded that "The total number of reported AEFI in 2013 increased by 59% compared with 2012, due to an increasing trend in propensity to report. The higher reporting rates may also be in response to the activities undertaken by the Administration and the state and territory health departments to encourage and facilitate reporting of AEFI. Reporting rates for the majority of the vaccines were higher than 2012. Increases were most marked in the 7 to under 20 year age group following extension of HPV to boys and associated enhanced surveillance. The majority of AEFIs reported to the Administration were mild transient events. The data reported here are consistent with an overall high level of safety for vaccines included in the NIP schedule." This is 1 of the 9 valid cases reported in the same literature article.


VAERS ID: 677036 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-12-21
Entered: 2016-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU2016GSK187788

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 1-year-old subject who received Haemophilus influenzae type B vaccine (UNK). On an unknown date, 5 days after receiving Haemophilus influenzae type B vaccine (UNK), Meningococcal C vaccine and MMR vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. The investigator considered the unknown cause of death to be possibly related to Haemophilus influenzae type B vaccine (UNK), Meningococcal C vaccine and MMR vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of death NOS in a 1-year-old child who was vaccinated with unspecified Hib vaccine; unspecified meningococcal C (Men C) vaccine and unspecified MMR vaccine (manufacturer unknown for all). The patient was a part of the report that summarized national passive surveillance data for adverse events following immunisation (AEFI) reported to the Administration for 2013. The report focused on AEFI reported for vaccines administered during 2013 and trends in AEFI reporting over the 14-year period 1 January 2000 to 31 December 2013. AEFI were notified to the Administration by state and territory health departments, health professionals, vaccine manufacturers and members of the public. All reports are assessed using internationally consistent criteria entered into the Adverse Drug Reactions System (ADRS) database. No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 1 January 2013 and 31 December 2013, the patient received unspecified Hib, Men C and MMR vaccines (administration route and site unspecified; dosages unknown; batch number not provided for all). On an unspecified date, 5 days after vaccination, the patient died. It was not reported if the autopsy was performed. The cause of death was unknown. This case has been considered serious due to death. The authors commented that "All deaths were investigated by the Administration and no clear causal relationship with vaccination was found. The death NOS was temporally associated with the receipt of vaccine". The authors concluded that "The total number of reported AEFI in 2013 increased by 59% compared with 2012, due to an increasing trend in propensity to report. The higher reporting rates may also be in response to the activities undertaken by the Administration and the state and territory health departments to encourage and facilitate reporting of AEFI. Reporting rates for the majority of the vaccines were higher than 2012. Increases were most marked in the 7 to under 20 year age group following extension of HPV to boys and associated enhanced surveillance. The majority of AEFIs reported to the Administration were mild transient events. The data reported here are consistent with an overall high level of safety for vaccines included in the NIP schedule". This is 1 of the 9 valid cases reported in the same literature article. This article is not available for regulatory submission due to copyright restriction.


VAERS ID: 677538 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-12-20
Entered: 2016-12-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU2016GSK187787

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 15-month-old subject who received Haemophilus influenzae type B vaccine (UNK). On an unknown date, 9 days after receiving Haemophilus influenzae type B vaccine (UNK), Meningococcal C vaccine and MMR vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. The investigator considered the unknown cause of death to be possibly related to Haemophilus influenzae type B vaccine (UNK), Meningococcal C vaccine and MMR vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of death NOS in a 15-month-old child who was vaccinated with unspecified Hib vaccine; unspecified meningococcal C (Men C) vaccine and unspecified MMR vaccine (manufacturer unknown for all). The patient was a part of the report that summarized national passive surveillance data for adverse events following immunisation (AEFI) reported to the Administration for 2013. The report focused on AEFI reported for vaccines administered during 2013 and trends in AEFI reporting over the 14-year period 1 January 2000 to 31 December 2013. AEFI were notified to the Administration by state and territory health departments, health professionals, vaccine manufacturers and members of the public. All reports are assessed using internationally consistent criteria entered into the Adverse Drug Reactions System (ADRS) database. No information on patient''s medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 1 January 2013 and 31 December 2013, the patient received unspecified Hib, Men C and MMR vaccines (administration route and site unspecified; dosages unknown; batch number not provided for all). On an unspecified date, 9 days after vaccination, the patient died. It was not reported if the autopsy was performed. The cause of death was unknown. This case has been considered serious due to death. The authors commented that "All deaths were investigated by the Administration and no clear causal relationship with vaccination was found. The death NOS was temporally associated with the receipt of vaccine". The authors concluded that "The total number of reported AEFI in 2013 increased by 59% compared with 2012, due to an increasing trend in propensity to report. The higher reporting rates may also be in response to the activities undertaken by the Administration and the state and territory health departments to encourage and facilitate reporting of AEFI. Reporting rates for the majority of the vaccines were higher than 2012. Increases were most marked in the 7 to under 20 year age group following extension of HPV to boys and associated enhanced surveillance. The majority of AEFIs reported to the Administration were mild transient events. The data reported here are consistent with an overall high level of safety for vaccines included in the NIP schedule". This is 1 of the 9 valid cases reported in the same literature article. This article is not available for regulatory submission due to copyright restriction.


VAERS ID: 674075 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2016-12-12
Onset:2016-12-19
   Days after vaccination:7
Submitted: 2016-12-21
   Days after onset:2
Entered: 2016-12-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER DM020A / 1 LA / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 9KS08R / 2 RA / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR M1049 / 2 LA / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 15L01A / 2 RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Death, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-12-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 19.1;10016558~Vaccine not specified (no brand name)~~0.00~Patient|19.1;10016558~Hib (ActHIB)~~0.00~Patient|19.1;10016558~Pneumo
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20161212; Test Name: Body temperature; Result Unstructured Data: Test Result: 36.9, Test Result Unit: Centigrade
CDC Split Type: JPPFIZER INC2016588352

Write-up: This is a spontaneous report received from Pharmaceuticals and Medical Devices Agency (PMDA)/Ministry of Health, Labor and Welfare (MHLW). Regulatory authority report is number v16100933. A contactable physician reported that a 3-month-old male patient received second dose of subcutaneous PREVENAR 13 (Lot # 15L01A, Exp. Date 31Oct2018) at 0.5 ml single dose in the right arm, first dose of SQUAREKIDS(Lot # DM020A) at 1 DF single in the left arm, second dose of subcutaneous HEPTAVAX (Lot # 9KS08R) at 1 DF single in the right arm, and second dose of subcutaneous ACT-HIB (Lot # M1049) at 1 DF single in the left arm, all in the afternoon of 12Dec2016 for immunisation. The patient had no significant family history. The patient had pyrexia after receiving the first vaccination with pneumococcal 13-val conj vac (dipht crm197 protein), hepatitis b vaccine and haemophilus influenza type b vaccine on 14Nov2016. The patient''s body temperature immediately before the vaccination on 12Dec2016 was 36.9 centigrade. After receiving vaccination on 12Dec2016, the patient had no problem and he was alive at 10:00 p.m. on 18Dec2016 at the latest. However, on 19Dec2016 at 3:32 am, the patient presented to the reporting hospital in a state of cardiopulmonary arrest on arrival (CPAOA). The patient died on 19Dec2016. The patient died on 19Dec2016. It was not reported if an autopsy was performed. The reporting physician classified this case as serious due to the patient''s death. The reporting physician considered that the causal relationship between the event and the vaccinations was unassessable, and provided other etiology of suffocation or sudden infant death syndrome (SIDS) for the unexplained abnormal death. The reporting physician commented that the causal relationship to the vaccinations was completely unknown.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-2016589900 same patient and product, different event; Reported Cause(s) of Death: Cardio-respiratory arrest.


VAERS ID: 674078 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Male  
Location: Foreign  
Vaccinated:2011-01-31
Onset:2011-02-04
   Days after vaccination:4
Submitted: 2016-12-22
   Days after onset:2148
Entered: 2016-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A72FA598A / UNK UN / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0793Y / UNK UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E83113 / UNK UN / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-02-04
   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:
Current Illness: Prophylactic
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ0095075131612NZL005945

Write-up: Information was obtained on a request by the Company from the agency (agency # not provided) via a Case Line Listing concerning a 15 month old male patient. The patient had no pre-existing renal disease, pre-existing hepatic disease, known allergy, other chemicals, nutritional supplements or other unspecified medical conditions. Information about recent therapy, transfusion, X-ray with contrast media and familial were unknown. On 31-JAN-2011, the patient was vaccinated with a dose of MMRII (rHA) (lot # 0793Y, batch# N2746, 0.5 ml) subcutaneously for immunization against measles-mumps-rubella. Other therapy included HIBERIX (batch# A72FA598A, 0.5 ml, intramuscular) as need for immunization against other specified single viral diseases and pneumococcal vaccine (unspecified) (batch# E83113, 0.5 ml, intramuscular) as need for immunization against other single bacterial diseases. On 04-FEB-2011, the patient experienced sudden death (severe). The cause of the death was unclassifiable. Dechallenge was reported as unknown and no rechallenge was performed. The reporter considered these the causality between the event and MMRII was unclassifiable. The original reporting source was not provided. Additional information is not expected as no further information can be obtained from the local regulatory authority.


VAERS ID: 677047 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-12-22
Entered: 2016-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Meningococcal infection, Neisseria test positive
SMQs:, Opportunistic infections (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: Lab tests were performed on an unspecified date between 1 September 2015 and 30 June 2016 and confirmed meningococcal B infection.
CDC Split Type: GB2016GSK189804

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a infant subject who received Meningococcal B Recom vaccine + AIOH + OMV. On an unknown date, less than a year after receiving Meningococcal B Recom vaccine + AIOH + OMV, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. Additional event(s) included meningococcal infection with serious criteria of GSK medically significant. Additional event(s) included meningococcal infection with serious criteria of GSK medically significant. The outcome of unknown cause of death was fatal. The outcome(s) of the additional event(s) included meningococcal infection (unknown). The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Meningococcal B Recom vaccine + AIOH + OMV. The investigator considered that there was a reasonable possibility that the meningococcal infection may have been caused by Meningococcal B Recom vaccine + AIOH + OMV. Relevant Tests: Lab tests were performed on an unspecified date between 1 September 2015 and 30 June 2016 and confirmed meningococcal B infection. Additional information was provided. This case was reported in a literature article and described the occurrence of invasive meningococcal disease in an infant of unspecified gender who was vaccinated with BEXSERO (GlaxoSmithKline). The patient was a part of the study that aimed to assess the effectiveness and impact of 4CMenB in vaccine-eligible infants. The patient was born on or after 1 May 2015. No information on patient''s medical history, family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received 1 dose of BEXSERO (administration route and site unspecified; batch number not provided). (In this study, a reduced 2-dose priming schedule was offered to infants at 2 months and 4 months, alongside an opportunistic catch-up for 3 month and 4 month olds). On an unspecified date between 1 September 2015 and 30 June 2016, 7 weeks after vaccination, the patient developed laboratory confirmed invasive meningococcal disease. At the age of 15 weeks, the patient died. The cause of death was unknown. It was not reported if the autopsy was performed. Treatment was unknown. This case has been considered serious due to death. The authors did not comment on the relationship between invasive meningococcal disease and BEXSERO. The authors concluded that "Our initial results show a significant reduction in cases of MenB among vaccine-eligible infants within 10 months of introduction of 4CMenB. Although the vaccine is licensed using a three-dose priming schedule in infancy, short-term vaccine effectiveness against MenB disease was high after two doses. Ongoing national surveillance will continue to monitor the long-term impact of the programme on disease burden alongside vaccine safety and disease severity in young children." This is 1 of the 6 valid cases reported in the same literature article.


VAERS ID: 675075 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2016-11-25
Onset:2016-11-26
   Days after vaccination:1
Submitted: 2016-12-22
   Days after onset:26
Entered: 2016-12-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Cardiac arrest, Feeling abnormal, Pyrexia, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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: 2016-12-01
   Days after onset: 5
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: No other medications
Current Illness: Multiple sclerosis; Paralysis; Respiratory disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2016IT176117

Write-up: Case number PHHY2016IT176117, is an initial spontaneous report from a physician (general practitioner) via company employee lay press (published on a local newspaper) through email received on 20 Dec 2016. This report refers to a 62 years old male patient. Past medical history was not reported. Current conditions included as multiple sclerosis that made his precarious condition and paralyzed for years with severe respiratory crisis. Concomitant medications were not reported. This 62 years old patient was vaccinated with FLUAD (batch number: not reported) on 25 Nov 2016. On 26 Nov 2016 the day after the vaccination the patient began to feel bad with high fever for two or three days. In the morning of the fourth day in Nov 2016 the patient did not respond to external stimuli and paramedical intervention was called. The patient''s condition did not improve also after the hospitalization (reason unspecified). The article reported also the suspect that the vaccine could have been defective. The family turned to a lawyer. On 01 Dec 2016 the patient died due to a fatal cardiac arrest at 11 AM. It was unknown whether autopsy was performed or not. The outcome of the events high fever and cardiac arrest was reported as fatal and for the events feeling abnormal and unresponsive to stimuli it was reported as condition unchanged for other events it was unknown. Seriousness of assessment of the events feeling abnormal and unresponsive to stimuli were upgraded to medically significant based on the information available in the source document. The general practitioner stated to rule out any relationship between the vaccine and the death of the patient (the patient was paralyzed for years with severe respiratory crisis). Causality for other events was not reported.


VAERS ID: 674732 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-12-26
Entered: 2016-12-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bordetella test positive, Death, Lymphocyte count, Pertussis, White blood cell count
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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZSA2016SA232941

Write-up: Initial unsolicited report received from literature on 15-Dec-2016. Background: Pertussis immunization programs aim to prevent severe infant disease. Investigation was carried out with respect to temporal trends in infant pertussis deaths and pediatric intensive care unit (PICU) admissions and associations of changes in disease detection and vaccines used with death and PICU admission rates. Methods: Using national data infant pertussis deaths and PICU admissions from 1991-2013 were described, over which time national immunization coverage at age two years increased from less than 80% to 92%. In the country, pertussis became a notifiable disease with polymerase chain reaction (PCR) diagnosis available in 1997 and acellular replaced whole-cell vaccine in 2000. Poisson regression was used to model temporal trends and compared rates in time intervals using rate ratios (RR) with 95% confidence intervals (CI). Results: There were 10 pertussis deaths and 159 infant PICU admissions with pertussis from 1991-2013. The annual number of infant pertussis PICU admissions increased from 1991 to 2013 (P=0.02) but the number of pertussis deaths did not (P=0.09). The risk of PICU admission during infancy with pertussis was increased in the notification/PCR versus the non-notification/PCR era (RR=1.12, 95%, CI 1.02-1.19) and when acellular replaced whole-cell vaccine (RR=1.19, 95%CI 1.06-1.31). Median pediatric index of mortality scores during 2001-2013 were lower than during 1991-1999 (P<0.001). Conclusion: Infant PICU pertussis admission rates have increased in the country despite improvements in immunization coverage. Higher rates have occurred since pertussis notification/PCR became available and since acellular replaced whole-cell vaccine. The severity of disease in infants admitted to PICU with pertussis has decreased in recent years. This case involves a group of 10 infant patients (onset age and gender not specified) who received a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (batch number, expiry date, dose form, route and site of administration not reported) on an unspecified date. Relevant medical history and concomitant medications were not reported. On an unspecified date and an unspecified time frame after vaccination it was reported that the patients developed pertussis which resulted in their death. Laboratory investigations included tests on an unspecified date that revealed confirmation of Bordetella pertussis infection, culture positive for Bordetella pertussis and also peripheral leukocyte count (median) and peripheral lymphocyte count (Median). Corrective treatment was not reported. It was unknown if the post mortem (Autopsy) was done. List of documents held by the sender: None. Sender''s Comments: A 53 days old infant died of pertussis approximately 11 days after receiving the first dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The infant was from the endemic region for pertussis. No information on the diagnostic tests or clinical records used to confirm pertussis were provided. It should be noted that one dose of pertussis vaccine administered at 6 weeks of age is not sufficient to provide protective immunity. The vaccine itself contains inactivated components and cannot lead to active pertussis infection. Detail regarding history of contact with any pertussis patient, medical history, sequence of event before death, autopsy report are needed to further assess the case. Reported Cause(s) of Death: pertussis.


VAERS ID: 675489 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2016-11-16
Onset:2016-11-17
   Days after vaccination:1
Submitted: 2016-12-26
   Days after onset:39
Entered: 2016-12-28
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLUA868AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chest X-ray abnormal, Condition aggravated, Cough, Death, General physical health deterioration, Histiocytosis haematophagic, Hypogammaglobulinaemia, Immunoglobulin therapy, Intensive care, Lung infiltration, Multiple organ dysfunction syndrome, Palliative care, Pneumonia, Pyrexia, Serum ferritin increased
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow), Sepsis (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-25
   Days after onset: 8
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: ZYDELIG; Aciclovir; BACTRIM FORTE; DENTAN; SYMBICORT TURBUHALER; ALVDEDON; Omeprazole; KIOVIG
Current Illness: Unknown
Preexisting Conditions: Hypogammaglobulinaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: SE2016190745

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of hemophagocytic lymphohistiocytosis in a 70-year-old male patient who received FLUARIX (batch number AFLUA868AA, expiry date unknown). Co-suspect products included ZYDELIG film-coated tablet for chronic lymphoid leukemia. The patient''s past medical history included hypogammaglobulinemia. Concomitant products included ACICLOVIR, BACTRIM FORTE, DENTAN, SYMBICORT TURBUHALER, ALVEDON, omeprazole and KIOVIG. On 16th November 2016, the patient received FLUARIX (intramuscular) .5 ml. On 12th January 2016, the patient started ZYDELIG (oral) 150 mg twice daily (300 mg daily). On 17th November 2016, 1 days after receiving FLUARIX, the patient experienced hemophagocytic lymphohistiocytosis (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the hemophagocytic lymphohistiocytosis was fatal. The patient died on 25th November 2016. The reported cause of death was hemophagocytic lymphohistiocytosis. The reporter considered the hemophagocytic lymphohistiocytosis to be possibly related to FLUARIX. The reporter considered the hemophagocytic lymphohistiocytosis to be possibly related to ZYDELIG. The batch number of FLUARIX was reported as AFLUA818AA. Based on a batch number review. The batch number was updated to AFLUA868AA. Initial received from a physician via regulatory authority on 23 December 2016: Report from a physician regarding a 70-year old man with advanced chronic lymphatic leukemia (CLL), previously transformed disease with 17p deletion. Treated initially with Ibrutinib, but due to progress exchanged to ZYDELIG 150 mg January 2016. Has been in stable remission and wellbeing. Receives FLUARIX 16-NOV-2016. That evening the man develops some cough and the day after, fever. Seeking emergency 18-Nov-2016 and is treated at hospital, at the medical clinic. Chest x-ray shows sparse infiltrates and pneumonia was suspected and investigating CMV, treated with CYMEVENE before the negative test results. Clinically, a rapid deterioration was seen. The man was moved to the intensive care unit and at the same time it was understood that this concerns hemophagocytic lymphohistiocytosis (HLH) with high values of Ferritin (about 57000) and soluble CD25. Multiple organ failure develops rapidly. Despite intensive care efforts and attempts to annul the progress with IVIg and steroids, the man further deteriorates and the treatment became palliative. The man deceases approximately one week after admission to hospital. Reporter suspects FLUARIX and ZYDELIG and says that "might affect modern treatment the risk of developing serious vaccine reactions? At least one event has been described with similar background". The reporter said that the man over the years has had a lot of respiratory problems, with suspected bronchiectasis and recurrent lower respiratory tract infections of varying severity. Because of this also gamma globulin treatment for hypogammaglobulinemia secondary to CLL. "The patient''s medical history covers several years and was very complicated from a haematological perspective," according to the reporter. Co-medications: acyclovir, BACTRIM FORTE, DENTAN, SYMBICORT TURBUHALER, KIOVIG and if necessary ALVEDON, omeprazole. Hemophagocytic lymphohistiocytosis.


VAERS ID: 682559 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2016-12-21
Onset:2016-12-21
   Days after vaccination:0
Submitted: 2016-12-26
   Days after onset:5
Entered: 2016-12-28
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Apnoea, Autopsy, Death, Pyrexia, Shock
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), 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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TH2016GSK191175

Write-up: This case was reported by a non-health professional and described the occurrence of fever in a 2-month-old male patient who received ROTARIX liquid formulation. On 21st December 2016, the patient received ROTARIX liquid formulation (oral). In December 2016, less than a week after receiving ROTARIX liquid formulation, the patient experienced shock (serious criteria death and GSK and medically significant) and apnea (serious criteria death and GSK medically significant). On 21st December 2016, the patient experienced fever (serious criteria death). On an unknown date, the outcome of the fever, shock and apnea were fatal. The patient died December 2016. The reported cause of death was shock, fever, and apnea. An autopsy was performed. It was unknown if the reporter considered the fever, shock and apnea to be related to ROTARIX liquid formulation. Additional details were provided as follows: This case was reported on local online newspaper on 23rd December 2016. The patient experienced fever when he returned home after vaccination. The patient''s father rubbed the patient''s body to relieve fever all time. In the evening of 22nd December 2016, the patient''s father''s friend came to visit his father at home and drank 12 bottles of beer and fell asleep. When the father woke up in the morning, the patient had died. As per police investigation, cause of death was unknown. It might be caused by high fever until shock or apnoea when the patient''s father was sleeping or the patient''s father lied on the patient. The patient was sent to autopsy. Further follow-up was expected.


VAERS ID: 675531 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-12-29
Entered: 2016-12-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWSA2016SA235709

Write-up: Initial unsolicited report received from the literature in Taiwan on 23 December 2016. The following is verbatim from the article: Abstract: Purpose: In March 1992, eight infants who had died within 36 hours of receiving whole-cell pertussis vaccine [DTwP] prompted the health authorities to suspend its use. The authors conducted an investigation of vaccination and sudden unexplained infant death (SUID) and repeated it more recently after switching to acellular pertussis vaccine [DTaP] in 2010. Methods: All SUIDs aged 31-364 days during 1990-1992 and 1996-2013 were selected from the death registration databases. The case-control investigation matched each case to two controls on clinic, sex, and birth date, whereas the follow-up self-controlled case series study compared risk of death during the 30-day post-vaccination risk periods with those in the control periods within the same case. Results: Sudden unexplained infant death was associated with never receiving DTwP (odds ratio 2.28, 95 percent confidence interval 1.25-4.15) in the case-control investigation. The odds ratios within 0-1, 2-7, 8-14, and 15-30 days of DTwP administration were 1.18, 0.26, 0.50, and 0.77. In the 1996-2013 self-controlled case series studies, this temporal shift between DTwP and SUID was consistently observed for female (incidence rate ratio 1.70, 0.75, 1.01, and 0.84) but not male or DTaP recipients. A pooled analysis showed significant risk within 2 days of receiving DTwP in female infants (incidence rate ratio 1.66, 95 percent confidence interval 1.05-2.60). Conclusions: Being unvaccinated and recent receipt of DTwP in female infants was significantly associated with SUID; the latter was consistent with a temporal shift pattern without overall increase in risk. The currently used pertussis vaccine, DTaP, did not increase risk of SUID. This case involves a two to three-months-old patients (gender not reported) who were vaccinated with first doses of DTwP, OPV, and HEPB (batch number, expiry date, dose, route and site of administration were not reported) on an unspecified date. The patient''s medical history and concomitant medications were not reported. On an unspecified date in the year 1992, the two infants were died (reported as ''suffered unexplained sudden death'') after 10 and 19 hours following vaccination respectively. Laboratory data were not reported. Autopsy information was not reported. The reporter assessed the causal relationship with DTWP, OPV and HEPB as possible (reported as ''temporal shift in the timing of death was consistently observed after receipt of DTwP and/or OPV in both the 1990-1992 and later 1996-2013 time periods). Documents held by sender: none. Sender''s Comments: This is a sudden death case of two infant who suddenly died without further details within less than 24 hours after simultaneous vaccination with DTWP, OPV and HEPATITIS B vaccines. No autopsy was done. Time to onset is compatible with the role of vaccines, however more details regarding the baby (relevant medical history) and the environmental factors (smoking in the family, position during sleep, etc.) would be helpful to further assess this case. However, detailed autopsy report was needed to further assess the case. As three vaccines were administered simultaneously, the role of each component cannot be assessed. Reported Cause(s) of Death: death/unexplained sudden death.


VAERS ID: 676039 (history)  
Form: Version 1.0  
Age: 1.25  
Sex: Female  
Location: Foreign  
Vaccinated:2016-12-15
Onset:0000-00-00
Submitted: 2016-12-30
Entered: 2017-01-02
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 140615 / 3 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Autopsy, Blood test abnormal, Brain oedema, Coma, Death, Hyperglycaemia, Somnolence, Subarachnoid haemorrhage, Thrombocytopenia
SMQs:, Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fall (A day before vaccination the baby fell, hit the head.)
Allergies:
Diagnostic Lab Data: Test Date: 201612; Test Name: Anaemia; Comments: Lab investigations, unspecified (Dec2016): hyperglycemia up to 30, thrombocytopenia, anemia (units and normal ranges not reported).; Test Date: 201612; Test Name: Blood test; Result Unstructured Data: Test Result: hyperglycaemia, thrombocytopenia, anaemia; Comments: Lab investigations, unspecified (Dec2016): hyperglycemia up to 30, thrombocytopenia, anemia (units and normal ranges not reported).; Test Date: 201612; Test Name: Hyperglycemia; Result Unstructured Data: Test Result: Up to 30; Comments: Lab investigations, unspecified (Dec2016): hyperglycemia up to 30, thrombocytopenia, anemia (units and normal ranges not reported).; Test Date: 201612; Test Name: Thrombocytopenia; Comments: Lab investigations, unspecified (Dec2016): hyperglycemia up to 30, thrombocytopenia, anemia (units and normal ranges not reported).
CDC Split Type: RUPFIZERINC2016602265

Write-up: This is a spontaneous report from a contactable physician received via a company representative. A 12-month-old patient of an unspecified ethnicity and gender received PREVENAR 13, via an unspecified route of administration on Dec2016 at single dose for immunisation. This was a re-vaccination, however non further information was provided on previous vaccinations. Medical history included that the baby fall the day before the vaccination and hit the head. The father was ill for acute respiratory tract infection. At the moment of the vaccination there were no complaints from parents. The patient''s concomitant medications were not reported. The patient experienced brain edema, coma, thrombocytopenia, subarachnoid hemorrhage, somnolence, hyperglycemia up to 30 and anemia all on Dec2016. All the events developed within one-two days after vaccination. In one day somnolence appeared, further coma developed and then brain edema with fatal outcome on the second day after vaccination. The patient died due to brain edema. An autopsy was performed that revealed brain edema. The outcome of all the other events was unknown. The patient underwent lab tests and procedures which included blood test (unspecified lab investigations) on Dec2016, showing hyperglycaemia, thrombocytopenia up to 30 and anaemia. The physician preliminary assessment was that all reported events were considered related to revaccination with PREVENAR 13, taking into account that all events developed within 1-2 days after vaccination. Sender''s Comments: Based on the information currently available, a causal relationship between the administration of PREVENAR 13 and the occurrence of the reported events is considered unlikely. The reported events are considered most likely as a coincidental. It was reported that the baby fall the day before the vaccination and hit the head. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: brain edema; Autopsy-determined Cause(s) of Death: brain edema.


VAERS ID: 677402 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-09
Entered: 2017-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Arthropathy, Cardiopulmonary failure, Chest pain, Condition aggravated, Death, General symptom, Hepatic infection, Immune system disorder, Kidney infection, Lupus nephritis, Malaise, Oxygen saturation decreased, Pain in extremity, Renal disorder, Systemic lupus erythematosus
SMQs:, Cardiac failure (narrow), Liver infections (narrow), Systemic lupus erythematosus (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Arthritis (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-12-31
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: Systemic lupus erythematosus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO0095075131701COL001379

Write-up: This spontaneous report as received from secretary of health, during a radio interview refers to a 16 year old female patient. The patient''s current condition included systemic lupus erythematosus. There was no information on patient''s concomitant medication. On 2013 the patient was vaccinated with GARDASIL (Lot#, dose and route unknown) dose 1 for prophylaxis. On an unspecified date, the patient was vaccinated with second dose of GARDASIL (Lot#, dose and route unknown) as prophylaxis. According to the news, the patient''s father reported that after application of the second dose of Gardasil, the patient developed the following adverse events. On an unknown date the patient experienced hepatic infection (hospitalization and medically significant), systemic lupus erythematosus (death, medically significant and hospitalization), physical problems (hospitalization), pain in extremity (hospitalization), low oxygen saturation (hospitalization), chest pain (hospitalization) and constant crisis (general symptom) (hospitalization). On 31-DEC-2016 the patient experienced cardiopulmonary failure (death and medically significant) and died during dialysis session. The patient''s death was related with her immunological system problems related with erythematous systemic lupus that started in 2011 with the following symptoms: joint alterations. This disease leaded the patient to develop kidney problems (unspecified date) and then to develop lupus nephritis (unspecified date) (death, medically significant and hospitalization) for which she needed dialysis. The reporter confirmed the patient died from her systemic illness and her death was not associated scientifically to Gardasil. The outcome of lupus nephritis, systemic lupus erythematosus and cardiopulmonary failure was reported as fatal. The outcome of hepatic infection, malaise, pain in extremity, oxygen saturation decreased, chest pain, general symptom and kidney infection was unknown. Causality assessment of hepatic infection, systemic lupus erythematosus, cardiopulmonary failure, lupus nephritis, malaise, pain in extremity, oxygen saturation decreased, chest pain, general symptom and kidney infection was reported to be not related to GARDASIL. No further information was provided. Additional information is not expected, since there are no contact details. This case is linked with 2017PVCL0002 and 2017PVCL0003 (same reporter link). Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between Gardasil and the reported events cannot be established. The lack of medical substantiation precludes a proper causality assessment of this report. Company Comment- No changes to Gardasil product safety information are warranted at this time. Merck and Co., Inc., also known as MSD, continues to monitor the safety profile of this vaccine. Sender''s Comments: CO-009507513-1701COL001408.


VAERS ID: 677653 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-10
Entered: 2017-01-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CO2017GSK001818

Write-up: This case was reported by a nurse via patient support programs and described the occurrence of death in a 2-month-old male patient who received ROTARIX lyophilized formulation. Co-suspect products included SYNFLORIX. Concomitant products included Polio-vaccine and PENTAVALENT vaccine. On an unknown date, the patient received the 1st dose of ROTARIX lyophilized formulation (oral) .5 ml and the 1st dose of SYNFLORIX .5 ml. On an unknown date, less than a year after receiving ROTARIX lyophilized formulation and SYNFLORIX, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to ROTARIX lyophilized formulation and SYNFLORIX. Additional details were reported as follows: The age at vaccination was not reported. The patient weight and height were unknown. There were not additional information about medical history of the patient and the batch and the expired date were unknown for the vaccines administered to the patient. Concomitant vaccine included Polio and penta (doses unknown) of a Laboratory. The patient received the doses included in the vaccine guidelines for the 2 months of old. The cause of death was unknown and the autopsy information was not provided.


VAERS ID: 678255 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2017-01-06
Onset:2017-01-10
   Days after vaccination:4
Submitted: 2017-01-17
   Days after onset:7
Entered: 2017-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER 4K17A / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 9KT03R / 1 UN / SC

Administered by: Other       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-01-10
   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:
Current Illness: Bronchopulmonary dysplasia (Weight: 980g); Prophylaxis; Retinopathy of prematurity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131701JPN006906

Write-up: Initial information has been received from a physician concerning 3-month-old male infant with chronic lung disease of extreme prematurity (980g) and retinopathy of prematurity who on 06-JAN-2017 was subcutaneously vaccinated with HEPTAVAX-II injection for the purpose of routine newborn vaccination (lot number and dose not reported). Concomitant medications included TETRABIK, ACTHIB and PREVENAR 13. On an unspecified date, the infant was born extremely premature in hospital A. On 19-DEC-2016, the infant was vaccinated with ACTHIB and PREVENAR 13 in hospital A. On 06-JAN-2017, the infant was vaccinated with HEPTAVAX-II and TETRABIK in hospital A. On 10-JAN-2017, the infant was taken to the reporting hospital by emergency, and cardio-respiratory arrest was confirmed. The infant died. The cause of death was cardio-respiratory arrest. Autopsy information was not reported. Reporter''s comment: The most recent vaccines were the HEPTAVAX-II and the TETRABIK, but within a month he also was vaccinated with ACTHIB and PREVENAR 13, therefore it is unknown which vaccine was the cause. The reporting physician considered cardio-respiratory arrest to be serious due to death. Upon internal review, cardio-respiratory arrest was determined to be medically significant. The reporting physician did not assess the relationship of cardio-respiratory arrest to HEPTAVAX-II. Additional information has been requested. Reported Cause(s) of Death: Cardio-respiratory arrest.


VAERS ID: 678608 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-18
Entered: 2017-01-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
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: Hepatitis B immunoglobulin
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GR2016GSK196229

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a infant subject who received Hepatitis B vaccine. Co-suspect products included hepatitis B immunoglobulin. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Hepatitis B vaccine. Additional information was provided. This case was reported in a literature article and described death no otherwise specified (NOS) in an infant of unspecified gender who was vaccinated with unspecified hepatitis B virus (HBV) vaccine (manufacturer unknown). The patient was born in 2015 at a regional hospital. In this retrospective study of clinical obstetrics file births recorded in the year 2015; mothers were either positive or negative for HBsAg. Out of 330 born infants, 168 were girls and 162 boys, 213 were born with normal birth and 117 with caesarean. 15 mothers had hepatitis B. 80% mothers were at low socioeconomic level and 60% had unattended pregnancy with vaginal delivery. No information on patient''s medical or family history or concurrent condition was provided. On an unspecified date, the patient received 1st dose of unspecified HBV vaccine (administration route and site unspecified; dose unknown; batch number not provided) as a newborn. The patient received hyperimmune gamma globulin concomitantly. On an unspecified date, an unknown period after vaccination with unspecified HBV vaccine, the patient died. The cause of death was not reported. It was unknown if an autopsy was performed. This case has been considered serious due to death. The authors did not comment on the relationship between death NOS and unspecified HBV vaccine. The authors concluded that "The female pups outweigh narrowly arrenon.H of perinatal mortality has been reduced greatly. Normal childbirth is still the first choice of obstetricians and cesarean alternative only in cases of pregnancies with complications. Hepatitis B remains a problem and must be given strict recommendations for continued vaccination and control antibodies in the first year".


VAERS ID: 679134 (history)  
Form: Version 1.0  
Age: 1.92  
Sex: Female  
Location: Foreign  
Vaccinated:2015-10-17
Onset:2015-10-18
   Days after vaccination:1
Submitted: 2017-01-23
   Days after onset:463
Entered: 2017-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC516A / 3 LG / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M27713 / 3 LG / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Body temperature increased, Death, Diarrhoea, Dyspnoea, Injection site discolouration, Respiratory arrest, Resuscitation
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-03
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Vaccine not specified (no brand name)~~0.00~Patient|~Vaccine not specified (no brand name)~~0.00~Patient|~Pneumo (Prevnar13)~~0
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20151103; Test Name: Body temperature; Result Unstructured Data: Test Result: sudden increase of temperature
CDC Split Type: FRPFIZERINC2017023878

Write-up: This is a spontaneous report from a contactable lawyer via Pfizer legal division. A 23-month-old female patient received on 17Oct2015 the 3rd dose of PREVENAR 13 at 0.5 ml single in thigh and INFANRIX HEXA at 1 dose form both in thigh for vaccination. Previous vaccinations were administered on 10Jan2014 1st dose, and on 31Mar2014 2nd dose. The patient''s medical history and concomitant medications, if any, were not reported. On 18Oct2015, the patient experienced skin reaction on both vaccinated thighs with blue balls that had persisted for 10 days. On 31Oct2015, she experienced an episode of diarrhoea. During the night between 02Nov2015 and 03Nov2015, the patient experienced breathing difficulties, she was no longer able to breathe on lying position. On 03Nov2015 around 04:30 pm, the patient experienced sudden increase of temperature. She was not able to breathe. On 03Nov2015 at 08:00 pm, she did not breathe anymore. Resuscitation attempts by the emergency unit were unsuccessful. The patient died on 03Nov2015 at 09:17 pm. An autopsy was performed but the results were unknown. The parents blamed the vaccines. No follow-up attempts possible. No further information expected. Reported Cause(s) of Death: Breathing arrested.


VAERS ID: 679294 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Female  
Location: Foreign  
Vaccinated:2016-11-22
Onset:2016-12-27
   Days after vaccination:35
Submitted: 2017-01-24
   Days after onset:28
Entered: 2017-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH N71138 / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apathy, Blood chloride normal, Blood glucose increased, Blood pH decreased, Blood potassium increased, Blood sodium normal, Chest X-ray normal, Computerised tomogram, Cough, Echocardiogram abnormal, Endotracheal intubation, Exploratory operation, Gastroenteritis, Gastrointestinal tube insertion, Granulocyte percentage, Haematochezia, Haematocrit normal, Haemoglobin normal, Hypophagia, Infusion site swelling, Intensive care, Intussusception, Leukocytosis, Lymphocyte count increased, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume decreased, Mean platelet volume normal, Neutrophil count normal, Pallor, Peripheral coldness, Platelet count normal, Pulse absent, Pupillary reflex impaired, Red blood cell count normal, Respiration abnormal, Shock, Sudden cardiac death, Tachycardia, Ultrasound scan abnormal, Urine analysis, Urine output decreased, Vomiting, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Acute renal failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2016-12-29
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20161228; Test Name: Cl; Result Unstructured Data: Test Result: normal; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: Blood electrolytes; Result Unstructured Data: Test Result: hemolysis (K of 6.6). NA and Cl were normal; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: Glucose; Result Unstructured Data: Test Result: 109; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: K; Result Unstructured Data: Test Result: 6.6; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: Blood sodium; Result Unstructured Data: Test Result: normal; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: Blood test; Result Unstructured Data: Test Result: DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: Body temperature; Result Unstructured Data: Test Result: 37.8, Test Result Unit: Centigrade; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: Chest X-ray; Result Unstructured Data: Test Result: tubus in place; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: Echocardiography; Result Unstructured Data: Test Result: signs of heart contraction; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: Granulocyte count; Result Unstructured Data: Test Result: 7.7, Test Result Unit: x10 3/mm3; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: Granulocyte percentage; Test Result: 55.2 %; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: Haematocrit; Test Result: 35.4 %; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: Hemoglobin; Result Unstructured Data: Test Result: 11.6, Test Result Unit: g/dl; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: Pulse rate; Result Unstructured Data: Test Result: 182; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: Lymphocyte count; Result Unstructured Data: Test Result: 4.8, Test Result Unit: x10 3/mm3; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: Lymphocyte percentage; Test Result: 34.7 %; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: MCH; Test Result: 24.6 pg; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: MCHC; Result Unstructured Data: Test Result: 32.7, Test Result Unit: g/dl; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: MCV; Result Unstructured Data: Test Result: 75.1; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: Oxygen saturation; Result Unstructured Data: Test Result: 98; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: Physical examination; Result Unstructured Data: Test Result: patient looked pale/grey, was not in distress, ago; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: Platelet count; Result Unstructured Data: Test Result: 429, Test Result Unit: x10 3/mm3; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: RBC count; Result Unstructured Data: Test Result: 4.72, Test Result Unit: x10 3/mm3; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: Sonogram; Result Unstructured Data: Test Result: intussusception at RUQ; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0.352 (0.108-0.282) PDW (28Dec2016): 15.6 (9-17) P-LCC (28Dec2016): 95 (30-90) P-LCR (28Dec2016): 22.1 % (11-45) blood test (28Dec2016): DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis.; Test Date: 20161228; Test Name: Urine analysis; Comments: Mean cell volume (28Dec2016): 75.1 fL (80-100) MPV (28Dec2016): 8.2 fl O2sat (28Dec2016): 98 (borderline). Physical findings (28Dec2016): patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. mid (28Dec2016): 1.4 (10.1%) TRBC (28Dec2016): 0 TWBC (28Dec2016): 0 RDWR (28Dec2016): 13.7 row-cv (28Dec2016): unknown result (11-16) row-sd (28Dec2016): 38.8 fL (35-56) PCT (28Dec2016): 0
CDC Split Type: ILPFIZER INC2017023854

Write-up: This is a spontaneous report from a contactable healthcare professional received through the regulatory authority. Regulatory Authority report number not available. A 6 months old female patient of an unspecified race received on 22Nov2016 the second doses of PREVENAR 13 (lot N71138) as single dose, ROTATEQ and INFANRIX, all for immunisation. Medical history and concomitant medications were not provided. The patient had a twin sister, healthy, vaccinated, with normal development. The patient experienced intussusception on 28Dec2016, shock on 28Dec2016, sudden cardiac death successfully resuscitated on 28Dec2016, vomiting on 27Dec2016, in the emergency room (of the hospital) she was tachycardic, pale and with apathy on 28Dec2016. All these events required hospitalization since 28Dec2016 at 23:09 and were considered life-threatening. The patient died on 29Dec2016 at 00:40. Reasons of death: intussusception and shock. Clinical course of the events included the following information: 35 days after receiving the 2nd doses of vaccinations the baby experienced vomiting for 15 times, less on 28Dec2016, no blood no bile, no diarrhea, no blood in stool, without restlessness or attacking cry, no fever, no head or abdominal trauma, no sick contacts, cough, poor oral intake with minimal voiding. She was seen by the physician on 27Dec2016 and on 28Dec2016 and brought to the emergency Medical Center due to vomiting and was sent to the emergency room (in hospital) for further observation. She was treated as having gastroenteritis. In the Emergency Room (of the hospital) she was tachycardic, pale and with apathy. In the diaper currant jelly stool. Resuscitation was needed. The patient underwent tracheal intubation and NGT was inserted in the ER. Chest compression was required several times as the pulse disappeared. She was treated with adrenaline with pulse coming back, with bicarbonate, kalium gluconate, dopamine drip was initiated in the ER. After stabilization, intussusception was discovered. Sonography that was performed next to the patient bed, showed intussusception at RUQ. After few minutes an impression of free air. According to the consultation with "on call" pediatric intensive care physician, "on call" pediatric surgeon and head of pediatric surgery unit, it was decided to take the patient to the exploration in surgery room, as she became stable. During the organization of the surgery inside the surgery room the pulse was lost 2 times, with recovery after chest compression and epinephrine, but at the end the pulse was lost without recovery with signs of heart contraction in the echocardiography. In the operation room (before the beginning of the procedure to fix intussusception) another resuscitation was required, this one was not successful and the baby died. After prolonged resuscitation with presence of pediatric surgeon, pediatrician, senior anesthesiologists and PICU team, the death of the patient was announced at 00:40 on 29Dec2016. Relevant lab data performed on 28Dec2016 included: pulse 182; temperature 37.8 ?C, O2 saturation 98 (borderline). Physical findings: patient looked pale/grey, was not in distress, agonal breathing, alert, looked very sick, apathetic, without significant dry symptoms, capillary fill 5-6 seconds, cold periphery, peripheral pulse unfelt, very weak femoral pulse, pupils wide and reacted slowly, nose clear, tympanic membranes normal, pharynx: normal appearing, oist mucous membranes, neck: normal range of motion and no rigidity, lungs: no increased work of breathing, no stridor, no wheezes, no fecal sounds clear b/l, heart: tachycardia, no murmur, abdomen: soft, lightly swell, without signs for peritoneal irritation, no tender, no hernia, skin: no trunk rash. Urine analysis: pending. Glucose: 109. Electrolytes: hemolysis (K of 6.6). NA and Cl were normal. CBC: WBC: 13.9 x10 3/mm3, granulocytes: 7.7 x10 3/mm3 (55.2%), lymphocytes: 4.8 (34.7%), mld: 1.4 (10.1%), HGB: 11.6 g/dl, MCV: 75.1 fL (80-100), PLT: 429 x10 3/mm3, HCT: 35.4 %, RBC: 4.72 x10 3/mm3, MVP: 8.2 fl, MCHC: 32.7 g/dl, TRBC: 0; TWBC: 0, RDWR: 13.7, row-cv: unknown result, row-sd: 38.8 fL, PCT: 0.352, PDW: 15.6, P-LCC: 95 (30-90), P-LCR: 22.1 % (11-45). At chest x-ray: tubus in place. Blood test: DEX -131, in lab potassium - 9, PH 6.74, sugar 2.6, WBC - 30K with lymphocytosis. IV fluid bolus was given and the patient had no further emesis. IV normal saline (in ml) 140. The patient received intravenous infusion outside of vein, significant swelling of the elbow and forearm, impression of a cold hand and was referred to ER for further treatment and evaluation. Still without given urine, drinking, continued to vomit. The outcome of intussusception and shock was fatal. Vomiting did not resolve. The other events outcome was unknown. The parents were suggested to perform autopsy or alternatively entire body CT. The parents refused the autopsy but accepted the CT. Reported Cause(s) of Death: shock; Intussusception.


VAERS ID: 679435 (history)  
Form: Version 1.0  
Age: 1.5  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-25
Entered: 2017-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Blindness, Combined immunodeficiency, Coordination abnormal, Death, Diarrhoea, Encephalitis, Encephalitis mumps, Inflammation, Lethargy, Nervous system disorder, Nuclear magnetic resonance imaging brain abnormal, Pyrexia, Rash, Seizure, Transmission of an infectious agent via product
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (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:
Current Illness: Immune system disorder (before he was vaccinated)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131701GBR009746

Write-up: This spontaneous report was received from a physician via social media via a company representative regarding a male patient of unknown age. It was reported that the patient may have had an impaired immune system. On an unknown date (at the age of 18 months), the patient was vaccinated with MEASLES, MUMPS, AND RUBELLA (dose and route unknown) (lot number and expiration date unknown) for prophylaxis. No concomitant medication were reported. On an unknown date, 4 months later, the patient was diagnosed with severe combined immunodeficiency disease (SCID). On an unknown date, over the following months, he was treated with drugs to treat symptoms of fever, rash, diarrhoea, lethargy and seizures. Although treated to treat the symptoms, the boy''s condition worsened. On an unknown date, when the boy was four, he was uncoordinated and was losing his sight. Further tests discovered damage to the central nervous system and chronic inflammation. On an unknown date, magnetic resonance imaging (MRI) scans detected encephalitis, or brain inflammation caused by infection. But despite being given antibiotics, antivirals and antifungal drugs, he died at the age of five due to mumps virus in his brain (encephalitis mumps) by which time he was blind. The post mortem examination found a virus strain in the boy''s brain that came from the MEASLES, MUMPS, AND RUBELLA vaccine. The physician stated that the boy may have had an impaired immune system before he was vaccinated, which made him more susceptible to a severe reaction. The outcome of encephalitis mumps was reported as fatal. The cause of death was reported as encephalitis mumps. The outcome of combined immunodeficiency, inflammation, nerve injury, coordination abnormal, lethargy, rash, seizure, transmission of an infectious agent via product and blindness was unknown. The causality for the events of combined immunodeficiency, inflammation, nerve injury, coordination abnormal, lethargy, rash, seizure, transmission of an infectious agent via product and blindness was unknown. The reporter considered encephalitis mumps to be related to MEASLES, MUMPS, AND RUBELLA. Upon internal review, the events of encephalitis mumps, severe combined immunodeficiency disease, seizure, transmission of an infectious agent via product and blindness were considered as medically significant. Additional information has been requested. Sender''s Comments: GB-009507513-1701GBR009643:; Reported Cause(s) of Death: mumps virus in his brain.


VAERS ID: 680041 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-24
Entered: 2017-01-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood immunoglobulin A decreased, Blood immunoglobulin E increased, Blood immunoglobulin G normal, Blood immunoglobulin M normal, CD4/CD8 ratio decreased, Cytogenetic analysis, Cytomegalovirus test positive, Death, Decreased appetite, Diarrhoea, Erythema, Flow cytometry, Gastrointestinal infection, Growth retardation, Haematochezia, Herpes simplex test positive, Infection, Lymphocytosis, Malnutrition, Natural killer cell count, Papule, Pneumonia, Polymerase chain reaction, Poor feeding infant, Pyrexia, T-lymphocyte count normal, Vomiting, Weight decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow), Opportunistic infections (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: BACILLUS CALMETTE-GUERIN vaccine
Current Illness: Combined immunodeficiency
Preexisting Conditions: BACILLUS VALMETTE-GUERIN Vaccine
Allergies:
Diagnostic Lab Data: Lab tests were performed on an unspecified date; Cytomegalovirus test, positive; Herpes simplex test, positive; Lymphocyte count, 7380 cells /uL
CDC Split Type: CN2017GSK009361

Write-up: This case was reported in a literature article and described the occurrence of diarrhea in a 52-day-old male patient who received Hepatitis B vaccine. Co-suspect products included BACILLUS CALMETTE-GUERIN Vaccine. Concurrent medical conditions included severe combined immunodeficiency syndrome. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose and BACILLUS CALMETTE-GUERIN Vaccine at an unknown dose and frequency. On an unknown date, less than a year after receiving Hepatitis B vaccine, the patient experienced diarrhea (serious criteria death and hospitalization), malnutrition (serious criteria death), pneumonia (serious criteria death, hospitalization and GDK medically significant), gastrointestinal infection (serious criteria death), fever (serious criteria hospitalization), lymphocytosis (serious criteria hospitalization), growth retardation (serious criteria GSK medically significant), hematochezia (serious criteria GSK medically significant), poor feeding infant, vomiting, papule, anorexia and weight loss. The patient was treated with cefuroxime sodium, latamoxef and fusidate sodium. On an unknown date, the outcome of the diarrhea, malnutrition, pneumonia and gastrointestinal infection were fatal and the outcome of the fever, lymphocytosis, growth retardation, hematochezia, poor feeding infant, vomiting, papule, anorexia and weight loss were unknown. The reported cause of death was diarrhea, recurrent infection, malnutrition, pneumonia and gastrointestinal infection. It was unknown if the reporter considered the diarrhea, malnutrition, pneumonia, gastrointestinal infection, fever, lymphocytosis, growth retardation, hematochezia, poor feeding infant, vomiting, papule, anorexia and weight loss to be related to Hepatitis B vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence fever, poor feeding, emesis, diarrhoea, haematochezia and military red papules on the skin in a 52-day-old male infant who was vaccinated with unspecified hepatitis B vaccine abd BACILLUS CALMETTE-GUERIN (BCG) (manufacture unknown for both). The patient was II-2 child. The patient''s old brother (II-1) had died at the age of 8 months with respiratory distress syndrome. The patient''s concurrent condition included atypical X- severe combined immunodeficiency (X-SCID). The patient was mixed-fed during infancy. No information on concomitant medication was provided. On an unspecified date, the patient received unspecified hepatitis B vaccine and unspecified BCG (administration route and site unspecified; dosage unknown; batch number not provided for both) as routine immunisations. The patient had no obvious signs of infections until 52 days after birth. On an unspecified date, an unknown period after vaccinations and 52 days after birth, the patient suffered from fever, poor feeding, emesis, diarrhoea, and haematochezia as well as military red papules on skin, which lasted for 6 days. At day 58, he was admitted for persistent fever and prolonged diarrhoea, followed by pneumonia that poorly responded to antibiotics including cefuroxime sodium, latamoxef, cefperazonesulbactam, and sodium fusidate. At the age of 15 month, the patient developed recurrent fever, pneumonia and persistent intestinal infections. The patient presented with anorexia, weight loss, and growth retardation for about 396 days before his death. On an unspecified date, the patient died. The patient died of malnutrition as a result of repeated infections and diarrhoea, which is a accumulated secondary consequence from immune-insufficiency. It was not reported if an autopsy was performed. The consent of re-sampling was rejected from patient''s parents before his death. The patient showed a lymphocytosis (7380 cells/uL) at the first time admitted in hospital. The patient was serologically positive for cytomegalovirus and herpes simplex virus (HSV-2). Baseline immunologic analysis of the patient''s peripheral blood revealed: Immunoglobulin serum IgA of the patient was below detectable range (less than 0.0667 g/L), serum IgE (IU/mL): less than 0.2 while serum IgM (0.48 g/L), serum IgG (3.15 g/L) and aCD3/aCD28 were within normal range. NK cells-CD3-CD16+CD56+:23.8% (1756 cells/uL), B cells-CD19+: 19.9% (1469 cells/uL) T cells-CD3+: 28.2% (20181 cells/uL). Signal joint T cell receptor excision circles (sjTREC) levels were measured by real-time polymerase chain reaction (PCR), the result showed that the patient had a relative lower sjTREC production compared to healthy control (51 copies/uL vs. 135 copies/uL). The patient''s mother had a normal sjTREC production. The genomic deoxy ribonucleic acid (DNA) from the peripheral blood mononuclear cell (PBMC)s of the patient and his mother was extracted. X-linked short tandem repeat (X-STR) typing of the patient revealed: Locus D3S1358-Allele 17, TH01- Allele 7, 9, D21S11-Allele 30, D18S51- Allele 12, 15, Penta E- Allele16, 18, D5S818- Allele 11, 12, D7S820- Allele 11, D16S539- Allele 9,11, CSF1PO- Allele 11, Penta D- Allele 12, 13, AMEL- Allele X,Y, vWA- Allele14, 18, D8S1179- Allele 13, 15, TPOX- Allele 8, FGA- Allele 24,26 and X-STR typing of the his mother patient revealed Locus D3S1358-Allele 17, TH01- Allele 7, 9, D21S11- Allele 30,32.2, D18S51- Allele 12, 13, Penta E- Allele, 18, D5S818- Allele 11, D13S317- Allele 11, D7S820- Allele 11, D16S539- Allele 9, CSF1PO-Allele 10, 11, Penta D- Allele 12, AMEL- Allele X, vWA0 Allele14, D8S1179- Allele 13, 14, TPOX- Allele 8, 9, FGA- Allele 24. The short tandem repeat (STR) fingerprint excluded the possibility of maternal lymphocyte engraftment. DNA sequence analysis revealed a c.52delG (p.L18CfsX) in exon 1 of IL2RG gene. The G deletion was also presented in his mother''s IL2RG gene. The patient also showed markedly elevated CD3-CD19- lymphocytes (51.1%). The patient had a relative lower CD4/CD8 ration (0.91, reference 1.1-2.0). In addition, majority of T cells in the patient''s PBMCs were of memory phenotype with CD45RO expression. The patient exhibited an atypical immune-phenotype characterized as TlowB+NK+. Determination of the subfamilies of TCR VB of the patient and his mother by flow cytometry revealed that the TCR repertoires in both were diverse and normally distributed. Subsequently, the patient was diagnosed with atypical X- SCID. This case has been considered serious due to death/hospitalisation. The authors did not comment on the relationship between the event of fever; poor feeding; emesis; diarrhoea; haematochezia; military red papules on the skin and unspecified hepatitis B vaccine. The authors concluded that "Complete loss of function of IL2RG results in early-onset of SCID, particularly in boys due to its chromosome linkage. The inflicted children typically have serious infections with T-NK-B+ immuno-phenotype. To our knowledge, the patient described in our study is the first report with a deletion at nucleotide 52 in exon 1 of IL2RG. This adds to the ever-growing cases which could improve the diagnosis of atypical SCID patient. However, gene analysis itself is insufficient for the diagnosis. It must be accompanied with cell function analysis to bridge the genetic defect with immuno-phenotype change and variant clinical presentations".


VAERS ID: 679593 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-25
Entered: 2017-01-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Death, Encephalitis
SMQs:, Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131701GBR009643

Write-up: Information has been received from a physician through social media via a company representative concerning a 13 month old female patient. The patient''s concurrent medical conditions, medical history and allergies were not provided. On an unknown date, the patient was vaccinated with MMR (manufacturer unknown) (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. In 2015, the patient died from encephalitis after being given the MMR. It was unknown if an autopsy was unknown. The reporter considered the encephalitis virus came from the live MMR vaccine and caused the death. Upon internal review, encephalitis was considered to be medically significant. This is one of several reports received from the same reporter. Additional information has been requested. Sender''s Comments: GB-009507513-1701GBR009746: Reported Cause(s) of Death: encephalitis.


VAERS ID: 679764 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-27
Entered: 2017-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
CHOL: CHOLERA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
DTOX: DIPHTHERIA TOXOIDS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
SMALL: SMALLPOX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Multiple sclerosis
SMQs:, Optic nerve disorders (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (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: FRSA2017SA010348

Write-up: Initial unsolicited report received from a consumer on 16-JAN-2017. This case is linked to: 2017SA010382 (2017-FRA-000525) and 2017SA010397 (2017-FRA-000526) (same reporter). This case involves a male patient (unknown age) who was vaccinated with a dose of DIPHTHERIA TOXOID (TRADENAME UNK), SMALLPOX VACCINE (TRADENAME UNK) and CHOLERA VACCINE (TRADENAME UNK) (batch number, expiry date, dose, dose in series, route and site of administration were not reported), on an unspecified date. The patient medical history was not reported and patient also had a family history of serious immune reactions following vaccinations. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had multiple sclerosis. On an unspecified date the patient died at the age of 36 years (cause of death not reported). Lab data and corrective treatment were not reported. The outcome of the event was reported as fatal. It was unknown whether the autopsy was performed, as the autopsy details were not reported. The case was reported serious by the reporter. List of documents held by sender: none. Sender''s Comments: Patient was vaccinated SMALL POX VACCINE, DIPHTHERIA TOXOID, CHOLERA VACCINE and patient had multiple sclerosis and patient died with unknown cause of death. This is poorly document case, as additional information regarding time to onset, medical history, vaccination date, concomitant medical, laboratory investigation if any, etiology work up, patient has family history of serious immune reaction following vaccination details and autopsy details are needed to further assess the case. Based on available information the role of vaccine cannot be assessed. ACAM2000 is currently distributed only in one country. Reported Cause(s) of Death: multiple sclerosis.


VAERS ID: 679766 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-27
Entered: 2017-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest X-ray abnormal, Death, Diarrhoea, Drain placement, Echocardiogram normal, Foetal exposure during pregnancy, Gastrostomy, Infection, Intensive care, Oesophageal anastomosis, Oesophagostomy, Respiratory distress, Salivary hypersecretion, Secretion discharge, Tracheo-oesophageal fistula
SMQs:, Anaphylactic reaction (broad), Congenital, familial and genetic disorders (narrow), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-08-19
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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: INSA2017SA007980

Write-up: Upon second medical examination of the case during internal review, a significant correction was performed on 14-JAN-2017 to update the vaccine details. The unsolicited literature case was identified on 14-Jan-2017 via full article. This case involves an 11-month-old-female infant patient who had Tracheo-Esophageal fistula, respiratory distress, saliva secretion excessive, serous discharge and drug exposure in utero with Olanzapine. Relevant medical history and concomitant medications were unknown for both mother and infant. There was no history of maternal alcohol intake, smoking, or exposure to other potential teratogenic drugs or exogenous hormones throughout the pregnancy. Concurrent condition for mother was bipolar disorder. Patient with bipolar disorder with mixed episodes who had been treated with olanzapine in the psychiatric outpatient department for the last 7 years who delivered a full-term female baby with TEF in September 2013. One week after her marriage in February 2008, the patient developed psychotic symptoms such as excessive talking, episodes of crying and laughing, and for getting things frequently. Following initial unsuccessful local treatment, she was taken to the psychiatry department of a tertiary care hospital. After initial management of acute symptoms there, she continued her treatment from our institute, where she was prescribed Oleanz (10 mg tablet orally once daily). In December 2008, she had a miscarriage at 4 months'' gestation, following which she stopped taking the medication of her own choice. A careful history/enquiry from the parents failed to reveal any data available regarding congenital malformation of the aborted fetus. In 2009, she conceived again (it is noteworthy that the patient was not taking olanzapine during this pregnancy) and delivered a full-term healthy female child in January 2010. This child is presently healthy. Eight months after delivery of this baby the patient had a recurrence of psychotic symptoms for which she was prescribed the same treatment. In December 2012, she conceived a third time but due to persistent psychiatric symptoms, olanzapine was continued throughout the pregnancy by the treating psychiatrist, who considered there to be a favorable benefit: risk ratio for the patient at that time. She received regular antenatal care and was compliant with all prescriptions and instructions, including prophylactic folic acid and two doses of tetanus toxoid. All baseline hematological (hemoglobin 13.8 g/dL, total leukocyte count 6000/lL, platelets 2.3 lac/lL, etc.) and biochemical investigations (random blood sugar 98 mg/dL, blood urea 27 mg/dL, etc.) were within the normal limits. Tests for trisomy 21 and 18 (nuchal translucency scan and dual marker tests) and rubella were negative. No fetal abnormality was detected in abdomen ultrasonography in any trimester. In September 2013, she delivered a full-term female baby by vaginal delivery. Immediately after delivery, the baby experienced respiratory distress and excessive salivation, for which she was admitted to the neonatal intensive care unit. On examination, a red rubber catheter could not be negotiated beyond 10 cm in the esophagus. The chest X-ray was suggestive of TEF; however, 2-dimensional echocardiography revealed normal cardiac structure and function. Other concomitant anomalies including vertebral, anal, renal, limb (components of VACTERL [Vertebral defects, Anal atresia, Cardiac defects, Tracheo-Esophageal fistula, Renal anomalies, and Limb abnormalities]), eye, ear, and nasal defects were ruled out. The TEF was repaired using esophageal-esophageal anastomosis with a drainage tube in the fifth intercostal space. On the second post-operative day, there was excess serous discharge from the drainage tube. For this reason, cervical esophagotomy was performed and a gastrostomy was inserted for feeding purposes. The baby was discharged in a stable condition with advice for full breast milk feeding through gastrostomy, some required medications (multivitamin syrup, calcium, anti-emetic and antibiotics) for an appropriate duration, and regular vaccination. However, although the baby was well until this point, she was re-hospitalized at 11 months of age because of diarrhea and unfortunately died on 19 August 2014, probably because of widespread infection (no definitive record of the last hospitalization is available and a postmortem was not performed). Seriousness criteria were congenital anomaly and hospitalization. Corrective treatment was unknown. Addendum 14-JAN-2017: Upon second medical examination of case at time of internal review the vaccine details were added in this case. Sender''s Comments: Sanofi Company Comment dated 17-Jan-2017: The case describes about neonate who was exposed to olanzapine and tetanus toxoid in utero by trans placental exposure and developed trachea-esophageal fistula. Based on strong temporal association known drug safety profile causal association between drug suspect and event cannot be excluded.


VAERS ID: 680658 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-27
Entered: 2017-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2016GSK000066

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Hepatitis B vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination as not reported. The question and the reply for this case were: For which reasons didn''t you have your child vaccinated against hepatitis B? 2 of my close relations died following the injection of this vaccine. This case is linked to case FR2010GSK000067, reported by same reporter.


VAERS ID: 680659 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-27
Entered: 2017-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2010GSK000049

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a child patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Hepatitis B vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The autopsy details were not reported. The question and the reply for this case were: For which reasons didn''t you have your child vaccinated against hepatitis B? Too much problem, I experienced a case of baby died because of this vaccine.


VAERS ID: 680660 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-27
Entered: 2017-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Amyotrophic lateral sclerosis, Death
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2010GSK000054

Write-up: This case was reported by a consumer via market research programs and described the occurrence of amyotrophic lateral sclerosis in a patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced amyotrophic lateral sclerosis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the amyotrophic lateral sclerosis was fatal. The reported cause of death was amyotrophic lateral sclerosis. It was unknown if the reporter considered the amyotrophic lateral sclerosis to be related to Hepatitis B vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The autopsy details were not provided. The question and the reply for this case were: For which reasons didn''t you have your child vaccinated against hepatitis B? We experienced two people vaccinated one died of a ALS and the other a girl of 14 years is suffering from lupus. This case is linked to FR2010GSK000056, reported by same reporter.


VAERS ID: 680282 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-27
Entered: 2017-01-30
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Multiple sclerosis
SMQs:, Optic nerve disorders (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2010GSK000076

Write-up: This case was reported by a consumer via market research programs and described the occurrence of multiple sclerosis in a 31-year-old male patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced multiple sclerosis (serious criteria death and GSK medically significant). On an unknown date, the outcome of the multiple sclerosis was fatal. The reported cause of death was multiple sclerosis. It was unknown if the reporter considered the multiple sclerosis to be related to Hepatitis B vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The autopsy details were not reported. The question and the reply for this case were: Do you think the vaccine against hepatitis B is useless or of little use, could you tell us why? It is less talked of now probably because of the risk of multiple sclerosis. One of my neighbours died of this disease which occurred after vaccination. He was 31 years old. The autopsy details were not reported.


VAERS ID: 680662 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-01-27
Entered: 2017-01-30
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2010GSK000067

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to Hepatitis B vaccine. Additional information was provided: This case is one of the multiple cases reported following the market research. The age at vaccination was not reported. The question and the reply for this case were: For which reasons didn''t you have your child vaccinated against hepatitis B: 2 of my close relations died following the injection of this vaccine. This case is linked to case FR2010GSK000066, reported by same reporter.


VAERS ID: 680575 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-10-25
Onset:2016-11-13
   Days after vaccination:19
Submitted: 2017-02-01
   Days after onset:80
Entered: 2017-02-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUENZ TETRA) / MEDIMMUNE VACCINES, INC. HF2241 / UNK NS / IN

Administered by: Other       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-11-13
   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: CO-TRIMOXAZOLE; FUROSEMIDE; AMILORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Palliative care
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBAstraZeneca2016SF38129

Write-up: A spontaneous report has been received from Pharmacist via RA concerning a 4 year old, female patient. Her medical history included palliative care. Concomitant medications included sulfamethoxazole, trimethoprim, furosemide and amiloride. On an unknown date, she received nasal FLUENZ TETRA (Intranasal), Lot number: HF2241. On 13-Nov-2016, the patient died. It was unsure whether there was any link to death however because the child who had multiple comorbidities died within a few weeks of this being administered. The cause of death was unexplained. It was unknown whether autopsy was performed or not. The reporter assessed the report to be serious due to death and important medical event. Sender''s Comments: The report concerns a 4-year-old female patient with fatal outcome with FLUENZ TETRA. The cause of death is not further specified. There is limited information on patients relevant medical history, concurrent diseases and autopsy report which makes the causal assessment difficult. Reported Cause(s) of Death: PATIENT DIED.


VAERS ID: 681155 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-09-14
Onset:0000-00-00
Submitted: 2017-02-03
Entered: 2017-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (FOREIGN) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Adenocarcinoma, Asthma, Blood test, Bronchoscopy abnormal, C-reactive protein increased, Chest X-ray, Chest X-ray abnormal, Chest pain, Computerised tomogram liver abnormal, Computerised tomogram thorax abnormal, Death, Dizziness, Dyspnoea, Electrocardiogram, Fatigue, Haemoptysis, Headache, Hepatic lesion, Hypoxia, Lung cancer metastatic, Lymph node pain, Malaise, Metastases to bone, Metastases to liver, Myalgia, Pain, Pneumonia, Pulmonary embolism, Syncope, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), 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? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ASPIRIN; bendroflumethiazide; cholecalciferol; ursodiol
Current Illness: Biliary cirrhosis primary; Flu vaccination
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131701GBR014528

Write-up: Information has been received from a consumer via the Agency (HA# GB-MHRA-EYC 00149108) on 31-JAN-2017, referring to a 68 year old female patient with biliary cirrhosis primary. On 14-SEP-2016 and 12-OCT-2016, the patient was vaccinated with HBVAXPRO, each time, 10 microgram, parenteral respectively. Other suspect therapy included influenza virus vaccine (unspecified) (manufacturer unknown). Concomitant therapies included aspirin, bendroflumethiazide, cholecalciferol and ursodeoxycholic acid. On an unknown date, the patient experienced lymph node aches, headaches for 5 weeks, dizziness and fainting, asthma-like symptoms, muscle pain, pain, fatigue, vague illness, most of these were still ongoing. The patient had never felt so ill in all her life, she was supposed to have another dose in three months but she would never have another one of these, she did not know if this had happened because they gave her the flu jab at the same time. Seek advice details: the patient had been going to the doctors for the last three weeks, they had only just decided to do chest x-rays and so forth, they did do an electrocardiogram and blood tests, the patient was now finding it difficult to breathe. Then it was informed that this patient with a diagnosis of metastatic carcinoma of the lung was admitted to hospital 2 months ago but sadly passed away last month in hospital. From the death notification: the patient was admitted with increasing shortness of breathe despite being on antibiotic therapy for pneumonia. A computerized tomography pulmonary angiography (CTPA) was performed which showed acute on chronic pulmonary embolisms bilaterally for which she was started on treatment dose dalteparin before being switched to rivaroxaban. The computerized tomography (CT) also showed a lesion in the right lobe of her liver and lytic lesions in her ribs. A bronchoscopy was performed and this found a primary adenocarcinoma of which metastasis to the liver and bone. During the admission she became increasingly hypoxic with some specks of haemoptysis. She also had a raised white blood count and C-reactive protein and was started on intravenous antibiotics. A chest x-ray also showed some new consolidation. Despite antibiotic therapy the patient required more oxygen to maintain her oxygen saturations and the patient was due to start of Optiflow therapy. The patient did not recover from lymph node aches, headaches for 5 weeks, dizziness and fainting, asthma-like symptoms, muscle pain, pain, fatigue, vague illness. The outcome of the event breathing difficult was unknown. The patient had an episode where she developed central chest pain with no electrocardiogram (ECG) changes and passed away soon after this. Causality assessment for all events were not reported. All events were considered to be medically significant by Agency.


VAERS ID: 681262 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-01-01
Submitted: 2017-02-03
   Days after onset:399
Entered: 2017-02-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Drug ineffective, Meningitis pneumococcal
SMQs:, Lack of efficacy/effect (narrow), Opportunistic infections (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Holoprosencephaly
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZERINC2017043822

Write-up: This is a spontaneous report from a contactable pediatrician participating in the meeting of Agency for Medical Research and Development. This report was received via a Pfizer employee (not a sales representative). A 5-year-old male patient of an unspecified ethnicity received a dose of PREVENAR, subcutaneous on an unspecified date at a single dose for immunisation. Medical history included holoprosencephaly. The patient''s concomitant medications were not reported. On an unknown date in Jan2016, the patient experienced meningitis pneumococcal due to an unknown serotype. The clinical outcome of the events, meningitis pneumococcal due to an unknown serotype and drug ineffective, was fatal as the patient died on an unknown date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Sender''s Comments: Based on the information currently available, a lack of efficacy with PREVENAR in this patient cannot be excluded. Further information like confirmative serotype results is needed for a full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: Meningitis pneumococcal due to an unknown serotype; Meningitis pneumococcal due to an unknown serotype.


VAERS ID: 681496 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-01-17
Onset:2017-01-17
   Days after vaccination:0
Submitted: 2017-02-06
   Days after onset:20
Entered: 2017-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK LG / IM
MENHIB: MENINGOCOCCAL CONJUGATE + HIB (MENITORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LG / IM
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LG / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK LG / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pyrexia, Resuscitation, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-01-18
   Days after onset: 1
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: Echocardiogram (Patent Foramen Ovale on previous echo, clinically insignificant and not requiring any treatment.); Viral meningitis (aged 4 weeks old, made full recovery)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2017044569

Write-up: This is a spontaneous report from physician via the contactable regulatory authority. Regulatory authority number GB-MHRA-ADR 23826560. A 13-month-old male patient of an unspecified race/ethnicity received PREVENAR 13, intramuscular in the thigh, on 17Jan2017, at 0.5 ml single, for routine vaccination; MENITORIX, intramuscular in the thigh, on 17Jan2017, at 1DF single, for routine vaccination; BEXSERO, intramuscular in the thigh, on 17Jan2017, at 1DF single, for routine vaccination; MMR, intramuscular in the thigh, on 17Jan2017, at 1DF single, for routine vaccination. The patient''s medical history included viral meningitis (aged 4 weeks old, made full recovery), echocardiogram (Patent Foramen Ovale on previous echo, clinically insignificant and not requiring any treatment). Concomitant medications were not reported. The vaccinations were given in general practitioner surgery, 2 into each thigh. No local reaction or symptoms suggestive of anaphylaxis. The patient had a mild fever in the evening so parents gave paracetamol and ibuprofen. He did not appear severely ill (both parents were doctors) and was put to bed as usual. Parents heard him stir briefly at 2:30 am but he resettled himself. Found unresponsive with no signs of life just after 07:00 am the following morning. Full resuscitation was attempted but it was unsuccessful. As part of unexplained child death investigations, the physician contacted a communicable diseases consultant, who felt this was unlikely to be caused by the vaccination but as death had occurred within 24 hours, to notify to yourselves at the Regulatory Agency. The reporter considered the event serious as the patient died. The cause of death was not reported. It was unknown if an autopsy was performed. The regulatory authority considered the events serious for an unspecified reason. The outcome of fever was not recovered. No follow-up attempts possible. No further information expected. Reported Cause(s) of Death: Death unexplained.


VAERS ID: 681716 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2016-10-12
Onset:0000-00-00
Submitted: 2017-02-07
Entered: 2017-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthma, Blood test, Bronchoscopy abnormal, Chest X-ray, Chest pain, Computerised tomogram abnormal, Death, Dizziness, Dyspnoea, Electrocardiogram, Fatigue, Haemoptysis, Headache, Hepatic lesion, Hypoxia, Lung adenocarcinoma, Lung consolidation, Lymph node pain, Malaise, Metastases to bone, Metastases to liver, Myalgia, Pain, Pneumonia, Pulmonary embolism, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), 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: Aspirin; Bendroflumethiazide; Colecalciferol; Ursodeoxycholic acid
Current Illness: Biliary cirrhosis primary
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On an unknown date the patient had Blood test, chest X-ray and Electrocardiogram and result was unknown. On an unknown date the patient had the computerized tomography test and the result was found as "showed acute on chronic pulmonary embolisms, a lesion". On an unknown date the patient had the Bronchoscopy and the result was found a primary adenocarcinoma of which metastasis. Blood test, unknown; Chest X-ray, unknown; Computerized tomogram, showed acute on chronic pulmonary embolisms, a lesion; Electrocardiogram, unknown.
CDC Split Type: GB2017013628

Write-up: This case was reported by a consumer via regulatory authority and described the occurrence of lymph node pain in a 68-year-old female patient who received Seasonal Influenza vaccine. Co-suspect products included HBVAXPRO and HBVAXPRO. Concurrent medical conditions included primary biliary cirrhosis. Concomitant products included Aspirin, Bendroflumethiazide, colecalciferol and ursodeoxycholic acid. On an unknown date, the patient received Seasonal Influenza vaccine (unknown) 1 dosage form(s). On 14th September 2016, the patient received HBVAXPRO (parenteral) 10 ug. On 12th October 2016, the patient received HBVAXPRO (parenteral) 10 ug. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced lymph node pain (serious criteria other), headache (serious criteria other), dizziness (serious criteria other), fainting (serious criteria other), asthma-like condition (serious criteria other), muscle pain (serious criteria other), pain (serious criteria other), fatigue (serious criteria other), ill feeling (serious criteria other) and breathing difficult (serious criteria other). On an unknown date, the outcome of the lymph node pain, headache, dizziness, fainting, asthma-like condition, muscle pain, pain, fatigue and ill feeling were not recovered/not resolved and the outcome of the breathing difficult was unknown. It was unknown if the reporter considered the lymph node pain, headache, dizziness, fainting, asthma-like condition, muscle pain, pain, fatigue, ill feeling and breathing difficult to be related to Seasonal Influenza vaccine. Additional details: The age of vaccination was not provided. Initial information received from Consumer via Regulatory Authority on 31st January 2017: Lymph node aches, headaches for 5 weeks, dizziness and fainting, asthma-like symptoms, muscle pain, pain, fatigue, vague illness, most of these are still ongoing. I have never felt so ill in all my life, I am supposed to have another dose in three months but I will never have another one of these, I do not know if this has happened because they gave me the flu jab at the same time. Seek advice details: I have been going to the doctors for the last three weeks, they have only just decided to do chest x-rays, and so forth, they did do an electrocardiogram and blood tests, I am now finding it difficult to breath. Follow up received: I regret to inform you that this patient with a diagnosis of metastatic carcinoma of the lung was admitted to hospital 2 months ago but sadly passed away last month in hospital. From the death notification: the patient was admitted with increasing shortness of breath despite being on antibiotic therapy for pneumonia. A computerized tomography pulmonary angiography (CTPA) was performed which showed acute on chronic pulmonary embolisms bilaterally for which she was started on treatment dose dalteparin before being switched to rivaroxaban. The computerized tomography (CT) also showed a lesion in the right lobe of her liver and lytic lesions in her ribs. A bronchoscopy was performed and this found a primary adenocarcinoma of which metastasis to the liver and bone. During this admission she became increasingly hypoxic with some specks of haemoptysis. She also had a raised white blood count and C-reactive protein and was started on intravenous antibiotics. A chest x-ray also showed some new consolidation. Despite antibiotic therapy the patient required more oxygen to maintain her oxygen saturations and the patient was due to start of Optiflow therapy. The patient had an episode where she developed central chest pain with no electrocardiogram (ECG) changes and passed away soon after this.


VAERS ID: 681778 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-10-12
Onset:0000-00-00
Submitted: 2017-02-07
Entered: 2017-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthma, Blood test, Bronchoscopy abnormal, C-reactive protein increased, Chest X-ray abnormal, Chest pain, Computerised tomogram thorax abnormal, Death, Dizziness, Dyspnoea, Electrocardiogram, Fatigue, Haemoptysis, Headache, Hepatic lesion, Hypoxia, Lung adenocarcinoma, Lung consolidation, Lymph node pain, Malaise, Metastases to bone, Metastases to liver, Myalgia, Osteolysis, Pain, Pneumonia, Pulmonary embolism, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Non-haematological malignant tumours (narrow), 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: Aspirin; Bendrofluemethiazide; Colecalciferol; Ursodeoxycholic acid
Current Illness: Biliary cirrhosis primary
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHFR2017GB000952

Write-up: Case number PHFR2017GB000952, is a spontaneous report received from a consumer via health authority (health authority number: GB-MHRA-ADR 23740950) on 31 Jan 2017. This report refers to a 68 years old female patient. Past medical history was not reported. Current condition included primary biliary cirrhosis. Concomitant medications included Aspirin, colecalciferol and ursodeoxycholic acid. The patient was vaccinated with seasonal influenza vaccine INN (manufacturer unknown and batch number: not reported) on an unspecified date. The patient was also vaccinated with HBVAXPRO(manufacturer unknown and batch number: not reported) at a dose of 10 mcg parenteraly on 14 Sep 2016. On 12 Oct 2016, the patient again received HBVAXPRO vaccine at a dose of 10 mcg parenteraly on 14 Sep 2016. On an unknown date, the patient developed lymph node aches, headaches for 05 weeks, dizziness and fainting, asthma like symptoms, muscle pain, pain, fatigue and vague illness. It was reported that most of these were still ongoing. The patient stated that she had never felt so ill in all her life. She was supposed to have another dose in three months but she would never had another one of these. She mentioned that she did not know if this had happened because they gave her the flu jab at the same time. The patient had been going to the physician for the last three weeks, they had only just decided to do chest x-rays and so forth, they did do an electrocardiogram and blood tests (unspecified results). The patient stated that she was not finding it difficult to breath. On an unspecified date the patient was diagnosed with metastatic carcinoma of the lung and was admitted to hospital for 02 months ago but sadly passed away last month in the hospital. It was reported that the patient was admitted with increasing shortness of breath despite being on antibiotic therapy for pneumonia. A computerized tomography pulmonary angiography (CTPA) was performed which showed acute on chronic pulmonary embolisms bilaterally for which she was started on treatment dose dalteparin before being switched to rivaroxaban. The computerized tomography (CT) also showed a lesion in the right lobe of her liver and lytic lesions in her ribs. A bronchoscopy was performed and this found a primary adenocarcinoma of which metastasis to the liver and bone. During the admission she became increasingly hypoxic with some specks of haemoptysis. She also had a raised while blood count and c-reactive protein and was started on intravenous antibiotics. A chest x-ray also showed some new consolidation. Despite antibiotic therapy the patient required more oxygen to maintain her oxygen saturations and the patient was due to start of optiflow therapy. The patient had an episode where she developed central chest pain with no electrocardiogram (ECG) changes and passed away soon after this. The outcome of the event dyspnoea was unknown. The outcome of the events lymph node pain, headache, dizziness, syncope, asthma, myalgia, pain, fatigue and malaise was reported as condition unchanged. The case was assessed as serious (medically significant). The causality of the events were not reported. The case was assessed as lost to follow up at initial.


VAERS ID: 681996 (history)  
Form: Version 1.0  
Age: 9.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-10-13
Onset:2014-11-12
   Days after vaccination:30
Submitted: 2017-02-09
   Days after onset:820
Entered: 2017-02-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K004215 / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Death, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-11
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug use for unknown indication
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AT0095075131702AUT001916

Write-up: Information has been received from a physician via Health authority (Agency# AT-BASGAGES-170314) on 03-FEB-2017 regarding a 9 year old male patient. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On 13-OCT-2014, the patient was vaccinated intramuscularly with GARDASIL unknown dosage for an unspecified indication. On 12-NOV-2014, the patient experienced respiratory distress. The patient died on 11-DEC-2014. The cause of death was reported as respiratory distress. Causality assessment was not provided by the reporter. Additional information is not expected as no further information can be obtained from the health authority. Reported Cause(s) of Death: respiratory distress.


VAERS ID: 682421 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2012-09-25
Onset:0000-00-00
Submitted: 2017-02-13
Entered: 2017-02-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB325B / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F84847 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2017057930

Write-up: This is a spontaneous report from a physician via the Health Authority (Paul-Ehrlich-Institut, PEI = contactable), Regulatory Authority report number DE-PEI-PEI2017011792. A 3-month-old male patient of unspecified race/ethnicity received PREVENAR 13 (Lot# F84847), intramuscular, on 25Sep2012, at single dose, for prophylactic vaccination and INFANRIX HEXA (Lot# A21CB325B), intramuscular, on 25Sep2012, at single dose, for prophylactic vaccination. The patient''s relevant history and concomitant medications were not reported. The patient died on an unknown date in 2012, cause of death was unknown. It was unknown if an autopsy was performed. Causal relationship between the adverse event and suspect products was assessed as not applicable by physician. No follow-up attempts needed, follow-up automatically provided by PEI.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 682422 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2017-01-10
Onset:0000-00-00
Submitted: 2017-02-13
Entered: 2017-02-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC873A / 1 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R37142 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2017058054

Write-up: This is a spontaneous report from a physician via the Health Authority (Paul-Ehrlich-Institut, PEI = contactable), Regulatory Authority report number DE-PEI-PEI2017011792. A 3-month-old male patient of unspecified race/ethnicity received PREVENAR 13 (Batch# F84847), intramuscular, on 25Sep2012, at single dose, for prophylactic vaccination and INFANRIX HEXA (Batch# A21CB325B), intramuscular, on 25Sep2012, at unspecified dose, for prophylactic vaccination. The patient''s relevant history and concomitant medications were not reported. The patient died on an unknown date in 2017, cause of death was unknown. It was unknown if an autopsy was performed. Causal relationship between the adverse event and suspect products was assessed as not applicable by physician. No follow-up attempts needed, follow-up automatically provided by PEI.; Reported Cause(s) of Death: Unknown cause of death.


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: 682451 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-13
Entered: 2017-02-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis pneumococcal, Streptococcus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute leukemia (found in the consolidation phase of treatment)
Allergies:
Diagnostic Lab Data: Test Date: 2012; Test Name: Serology test; Result Unstructured Data: Test Result: Serotype: 14
CDC Split Type: FRPFIZER INC2017047490

Write-up: This is a literature report from a Journal. This is the 4th of 8 reports. MATERIALS AND METHODS: From 2003 to 2013, 233 pediatrics wards working with 168 microbiology departments were asked to report all cases of bacterial meningitis. The methodology of the surveillance network was previously described. The following diagnostic criteria were used for Streptococcus pneumoniae meningitis in children aged 1 day to 15 years: clinical signs associated with positive cerebrospinal fluid (CSF) culture and/or positive CSF antigen testing, positive CSF polymerase chain reaction findings and/or positive culture of a normally sterile body site associated with CSF pleocytosis (more than 10 cells/uL). Vaccine status was documented in the immunization chart of each child and checked in the investigator''s medical dossier for each patient. S. pneumoniae infection was identified by standard methods in the microbiology laboratory of each hospital. Isolates were serotyped at the National Reference Center for Pneumococci by agglutination with latex particles sensitized with antisera from the Statens Serum Institute. To characterize pneumococcal VBT and VF meningitis, we used the following definitions: VBT defined as a PM in a child who had received more than equal to 1 PCV dose and for which the pneumococcal isolate was a PCV serotype, and VF defined as a subset of VBT occurring in a child who had completed the series of PCV or who had received the appropriate catch-up doses. Children whose PCV vaccinations were up-to-date for age but who had not completed a full age-appropriate series before their PM were considered VBT but not VF. Moreover, a 2-week interval was required between PCV administration and disease onset to be considered VBT or VF. Meningitis in children who received PCV7 doses and at least 1 PCV13 as a booster dose was also considered PCV13 VF because 1 dose of PCV13 in a child older than 12 months induced similar immunity for the 6 additional serotypes as 3 doses of PCV13 in infants. Data were entered with use of 4D v6.4 and analyzed by use of Stata SE 9.1 (Stata Corp.) and Statview II. RESULTS: From 2003 to 2013, 1233 cases of PM in children were diagnosed: 943 children (76.5%) from 2003 to 2010 in the PCV7 era and 290 (23.5%) from 2011 to 2013 in the PCV13 era. VBT accounted for 39 (3.2%) cases: 24 (2.0%) with at least 1 PCV7 dose and 15 (1.2%) with at least 1 PCV13 dose. All cases but one were in children younger than 5 years at diagnosis [mean age, 19.5 months (range, 2.6-150.1 months); 41% girls]. The underlying conditions were reported for 11 patients: congenital meningeal breach (n = 2), posttraumatic meningeal breach (n = 2), cochlear implant (n = 1), recurrent meningitis without immunodeficiency (n = 1) and immunodeficiency (n = 5). Among the 5 patients with immunodeficiency, we found acute leukemia in the consolidation phase of treatment (n = 1), X-linked agammaglobulinemia (n = 1) and hypogammaglobulinemia (IgG, n = 2; IgG2 subclass, n = 1). In the PCV7 era, 6 of 943 children (0.6%) were considered to have VF (Table 1). One child died of PM because of serotype 14, despite PCV7 vaccination and absence of immunodeficiency. In the PCV13 era, 2 of 290 children (0.7%) were considered to have VF (Table 1). Table 2 shows the 31 cases of VBT but not VF. In the PCV7 and PCV13 eras, 13 of 18 and 9 of 13 children, respectively, were adequately vaccinated for age. Serotype 19F was the most frequent cause of the VF, even after the introduction of PCV13. VF and VBT were more frequent after the beginning of vaccination with PCV7 and PCV13, and its frequency decreased thereafter. DISCUSSION: This study is the largest focusing on VBT and VF PM after PCV7 and PCV13 implementation. In our series, serotype 19F was most frequently responsible for PCV7 failure. It was reported the only 2 other cases of PM with PCV13 VF. Underlying conditions that likely altered host defenses against S. pneumoniae infection were rarely found in our cases of PCV VF. The largest number of our VF cases occurred within 2 years after the implementation of PCV, before a decrease in number (even if the period of observation is lower after PCV13). These trends could be explained by herd immunity in the pediatric population after the decrease in PCV VT carriage.12 Indeed, as for Haemophilus influenzae serotype b vaccination, herd immunity plays an important role in conjugate vaccine effectiveness. Our study has several limitations. First, although our bacterial meningitis network has been established for 12 years and the number of pediatric and bacteriologic departments participating and the response rates of these services have remained stable throughout the period considered, some cases of VF might have escaped our surveillance. Second, we did not systematically investigate the immunological status (including antibody values by enzyme-linked immunosorbent assay and OPA for each VT) of all children with VF. However, our study was a large nationwide survey of 1233 cases of PM in children, providing data not reported by any other surveillance system. In conclusion, PM because of VT despite PCV vaccinations are rare and mostly occur in children younger than 2 years without an underlying condition or more rarely in older children with an underlying condition. Three years after PCV13 implementation, serotype 19A PM is not completely eradicated. Assessing the immune response after vaccination in children with PCV failure would help better understand the underlying mechanisms. A 50.6-month-old patient of an unspecified ethnicity and gender received pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein); lot number(s) unknown, via an unspecified route of administration on an unspecified date as single dose for immunization. Medical history included an underlying condition of acute leukaemia (found in the consolidation phase of treatment) from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced vaccine failure and pneumococcal meningitis because of serotype 14 in 2012. The patient underwent lab tests and procedures which included serology test: serotype: 14 in 2012. Clinical details were as follows: The patients exact age was 50.6 months old at the time of diagnosis in 2012. The time from the last dose to diagnosis was not reported (NR). The age(s) of dose 1, dose 2 and booster dose were NR. The outcome of vaccine failure and pneumococcal meningitis because of serotype 14 was fatal. It was not reported if an autopsy was performed. Pfizer is a marketing authorization holder of pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein), in the reporter''s country. This may be a duplicate report if another marketing authorization holder pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein), has submitted the same report to the regulatory authorities. Sender''s Comments: Based on the information currently available, vaccine failure and pneumococcal meningitis because of serotype 14 with pneumococcal 7-valent conjugate vaccine in this patient cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety valuation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): FR-PFIZER INC-2017047396 Same article, different patient, drug, and event; Reported Cause(s) of Death: pneumococcal meningitis; vaccine failure.


VAERS ID: 682654 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2017-02-04
Onset:2017-02-05
   Days after vaccination:1
Submitted: 2017-02-15
   Days after onset:10
Entered: 2017-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR L14211 / 1 RA / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR M74631M / 1 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-05
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNSA2017SA020412

Write-up: Initial unsolicited report received from the health authority (CDC) via company representative on 07 Feb 2017. This case involves a two-month-old female patient who was vaccinated with 0.5 ml first primary dose of Imovax Polio (Batch number: M74631M, expiration date: Aug 2018) via intramuscular route in the left arm and 0.5 ml first primary dose of Act-HIB (Batch number: L1421-1, expiration date: Aug 2017) via intramuscular route in the right arm at about 11:00 A.M. on 04-Feb-2017. Patient''s medical history and concomitant medications were not reported. On 05-Feb-2017 at about 01:40 A.M., 14 hour 40 min following vaccination, the patient was found dead. The detailed death time was not provided. Laboratory investigations and corrective treatment were not reported. It was unknown if autopsy was performed or not. List of the document held by sender: none. Sender''s Comments: In this case it was reported that the two month old female patient received HIB (PRP/T) VACCINE and IPV (VERO) and next day baby was found dead. This is very poorly documented case. However more information on the sleeping position, environmental factors, or if there any congenital anomaly and detail autopsy report would be helpful to further assess this case. Reported Cause(s) of Death: baby was found dead/Death.


VAERS ID: 682748 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-09
Entered: 2017-02-15
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic shock, Death
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN2017GSK018686

Write-up: This case was reported in a literature article and described the occurrence of allergic shock in a subject who received Hepatitis B vaccine. On an unknown date, 1 hr after receiving Hepatitis B vaccine, the subject developed allergic shock. Serious criteria included death and GSK medically significant. The outcome of allergic shock was fatal. The reported cause of death was allergic shock. The investigator considered that there was a reasonable possibility that the allergic shock may have been caused by Hepatitis B vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of allergic shock in a patient of unspecified age and gender who was vaccinated with unspecified hepatitis B virus (HBV) vaccine (manufacture unknown). The patient was reported in the data that were collected, and analysed by descriptively epidemiological method, on adverse events following immunization (AEFI) of HBV vaccine reported by AEFI Monitoring System from 2009 to 2014. No information on patient''s medical history or family history or concomitant medication or concurrent condition was provided. On an unspecified date during 2009-2014, the patient received unspecified HBV vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date during 2009-2014, 1 hour after vaccination, the patient developed an allergic shock (abnormal reaction). Subsequently, the patient died. It was unknown if an autopsy was performed. This case has been considered serious due to death. Treatment was unknown. The authors considered the event of allergic shock related with unspecified HBV vaccine. The authors stated "data suggested abnormal reactions of HepB mainly occurred shortly after vaccination, and rescue effort should focus on adverse reactions appearing within 1 d after vaccination, to avoid more severe consequence". The authors concluded that "The HepB vaccine showed high safety, of which the AEFI were mainly general reactions and allergic reactions".


VAERS ID: 682751 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-01-18
Onset:2017-01-18
   Days after vaccination:0
Submitted: 2017-02-15
   Days after onset:28
Entered: 2017-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood potassium increased, Blood test, Death, Hyperkalaemia, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-01-18
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrioventricular septal defect (congenital heart disease with complete atrioventricular septal defect); Bilateral hydronephrosis; Pelvic kidney; Trisomy 21
Allergies:
Diagnostic Lab Data: Test Name: Potassium; Result Unstructured Data: Test Result: 9.7, Test Result Unit: mmol/l; Comments: Potassium (on an unspecified date): hyperkalemia at 9.7 mmol/L; Test Name: Blood test; Result Unstructured Data: Test Result: severe renal failure; Comments: Potassium (on an unspecified date): hyperkalemia at 9.7 mmol/L
CDC Split Type: FRPFIZERINC2017060121

Write-up: This is an initial spontaneous report received from the Agency, regulatory authority report number BX20170155. A 2-month-old male patient received PREVENAR 13 0.5 ml, single and INFANRIX HEXA 1 DF, single, both intramuscular on 18Jan2017 for immunization (lot numbers not provided). Relevant medical history included Trisomy 21, congenital heart disease with complete atrioventricular septal defect, and congenital uropathy with left pelvic kidney and moderate bilateral hydronephrosis. No concomitant treatment was reported. The patient died on 18Jan2017. The patient died at home around 2 hours following vaccines injections on 18Jan2017. Blood sampling performed before vaccine injections revealed severe renal failure with hyperkalemia at 9.7 mmol/L. Causality Assessment between the suspect vaccines and death was not provided based on the Official Method but the death was reported as "not attributable to vaccines regarding potassium levels". No FU attempts possible. No further information expected. Reported Cause(s) of Death: hyperkalemia.


VAERS ID: 682752 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-15
Entered: 2017-02-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis pneumococcal
SMQs:, Opportunistic infections (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2017062897

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 2-year-old patient of an unspecified gender received PREVENAR 13 on an unknown date, at single dose, for immunisation. The patient''s medical history and concomitant medications, if any, were not reported. On an unknown date in 2017 (a few days before reporting) the patient rapidly died due to pneumococcal meningitis. At the time of reporting the pneumococcus serotype was not yet known. The reporter stated that the patient was "correctly vaccinated".; Sender''s Comments: Based on the information currently available, a lack of efficacy with PREVENAR 13 in this patient cannot be excluded. Further information like confirmative serotype results and vaccination schedule is needed for a full medical assessment.; Reported Cause(s) of Death: Pneumococcal meningitis, pneumococcus serotype not yet known; Pneumococcal meningitis, pneumococcus serotype not yet known.


VAERS ID: 683055 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-17
Entered: 2017-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death
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:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute renal insufficiency (Then again she was hospitalized with acute renal failure); Ichthyosis (After delivery she was hospitalized for about two weeks); Pneumonia (Hospitalization was required)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2017067014

Write-up: This is a spontaneous report obtained from a contactable consumer (patient''s mother). A 4 month-old female patient of an unspecified race and ethnicity received, PREVENAR 13 on an unknown date, single dose, for immunization. Relevant medical history included ichthyosis, pneumonia and acute renal insufficiency. Concomitant medications were unknown. It was reported that the infant died at the age of 4 months. Patient''s clinical course was the following: she was born with a disease ichthyosis and after delivery she was hospitalized for about two weeks. Next she stayed at home. Then experienced pneumonia and hospitalization was required. Then again she was hospitalized with acute renal insufficiency. Then she was at home, she wasn''t ill, and nothing happened. Physician was informed about all diseases of the patient. The doctor did not report any contraindication to the vaccination. She was vaccinated with PREVENAR 13. Two days later, in the morning, the patient was found dead. Proceeding against doctor was conducted. Autopsy was performed (no results available).; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 683194 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-20
Entered: 2017-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (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: DESA2017SA026822

Write-up: Initial unsolicited report received from a lawyer on 08-Feb-2017. This case is linked to 2017SA026819 (2017-DEU-000963), 2017SA026820 (2017-DEU-000964), 2017SA026824 (2017-DEU-000966) (Same reporter). This case involves a female patient (age reported as more than 2 years old) who was vaccinated with 0.1 ml two injections of IPV (VERO) (IPV (INACTIVATED POLIO VACCINE) NOS / IPV (VERO)) (batch number, expiry date and site of administration was not reported), via subcutaneous route on an unknown date. The patient''s medical history and concomitant medications were not reported. On an unknown date, 23 days after the vaccination, the patient developed ascending Landry paralysis. On an unspecified date, following vaccination patient had Guillan Barre syndrome. it was case of off label use. The patient''s laboratory data and corrective treatment were not reported. On an unknown date, patient died. It was unknown whether autopsy was performed. List of documents held by sender: none.; Sender''s Comments: Reportedly the patient experienced Guillain-Barre syndrome (GBS) with a fatal outcome following administration of two 0.1 mL doses IPV (VERO) (out of label use of the vaccine). GBS is not an expected event following the use of IPV (VERO). Time to onset is compatible, but available information is not detailed enough to confirm the diagnosis and classify this case report according to the Brighton Collaboration definition. Patient medical history, concomitant medication, results of investigations (cytoalbuminologic dissociation, EMG, nerve conduction studies, MRI) and etiological work-up (infections) are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.; Reported Cause(s) of Death: Guillan Barre syndrome/ascending Landry paralysis.


VAERS ID: 683898 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Male  
Location: Foreign  
Vaccinated:2017-02-13
Onset:2017-02-15
   Days after vaccination:2
Submitted: 2017-02-27
   Days after onset:12
Entered: 2017-02-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER M022069 / UNK UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Death, Influenza, Influenza A virus test positive, Investigation abnormal, Lung infiltration, Polymerase chain reaction positive, Pyrexia, Right ventricular enlargement, Viral upper respiratory tract infection
SMQs:, Cardiac failure (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pulmonary hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Routine childhood immunisation
Preexisting Conditions: Comments: blanco
Allergies:
Diagnostic Lab Data: Test Date: 20170215; Test Name: Body temperature; Result Unstructured Data: Lab result: 38.5 ?C
CDC Split Type: NL0095075131702NLD011344

Write-up: SPECIFIC HISTORY This moderately documented serious (Death) spontaneous report from a specialist doctor concerns a male aged 14 months, with pyrexia (measured body temperature 38.5 degrees Celsius) and death NOS following administration of NEISVAC C and MMRVAXPRO for routine childhood immunisation. The pyrexia occurred two days after vaccination, the patient recovered after one hour. The patient was found dead three days after vaccination. Concomitant medication was not reported. The reporter mentioned that the most likely cause of death is an Infuenza A virus infection. PAST MEDICAL HISTORY / COMEDICATION / FAMILY HISTORY The patient has no known medical history. The patient has no known past drug therapy. PHYSICAL FINDINGS AND INVESTIGATIONS Tests showed a diffuse lung infiltration and a widened right heart ventricle. Polymerase chain reaction from the lung tissue showed Influenza A positive. Myocarditis is still to be excluded. TREATMENT AND CLINICAL COURSE Two days after both vaccinations, during the afternoon the patient had a cold and developed pyraxia (measured body temperature 38.5 degrees Celsius). He didn''t cough nor had dyspnoea. The pyrexia was treated with paracetamol. The patient recovered within one hour. The reporter mentioned that the patient didn''t felt warm anymore, he ate normal and that he had a normal behaviour. The next morning he was found dead in his bed. Estimated time of death was between 2 and 4 a.m. CAUSALITY ASSESSMENT Causality for the pyrexia and vaccination NEISVAC C was considered possible because of the latency period. The causality for the pyrexia and MMRVAXPRO were considered as unlikely because of the short latency period. Causality for the death NOS and vaccinations NEISVAC C and MMRVAXPRO were considered as not assessable because of lack of data. CONCLUDING SUMMARY / KEY WORDS male, 14 months, pyrexia, death NOS, Influenza A virus infection, NEISVAC C?, MMRVAXPRO. Company Causality Assessment: Melding ZV20170223045549 is Reported Cause(s) of Death: Influenza.


VAERS ID: 683955 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2016-10-25
Onset:2017-02-15
   Days after vaccination:113
Submitted: 2017-02-27
   Days after onset:12
Entered: 2017-02-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal distension, Abdominal pain, Anaemia, Appendicectomy, Cardio-respiratory arrest, Crying, Death, Haematochezia, Intestinal mass, Intussusception, Lethargy, Loss of consciousness, Pneumonia, Pyrexia, Rales, Respiratory distress, Surgery, Ultrasound abdomen abnormal, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-20
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ML0095075131702MLI009873

Write-up: Information has been received from a physician referring to an 8 months old male patient, who was enrolled in an Active Pharmacovigilance program. Information about concomitant therapy, concurrent condition and medical history was not provided. On 16-AUG-2016, the patient started therapy with first dose of ROTATEQ (liquid, oral, strength, dose, lot # and expiration date were unknown, once, for prevention). Then, the patient was administered the second and the third ROTATEQ on 20-SEP-2016 and 25-OCT-2016, respectively. The disease began on 15-FEB-2017 with inconsolable crying, fever, vomiting and bloody stools. The parents consulted a health center where the infant received treatment. Later that night, the baby developed intermittent episodes of inconsolable crying and drawing up his legs to the abdomen. The episodes seemed to become more frequent and more severe over time, and were followed by vomiting that became bilious. On 16-FEB-2017, the parents consulted at a clinic due to the addition of abdominal distension. A prescription with ceftriaxone, methylprednisolone, paracetamol, RINGER LACTATE and metopimazine was prescribed. The parents consulted again on 17-FEB-2017 at the same clinic because the clinical signs persisted. The baby was referred to a hospital in the pediatric department where he was admitted. On examination his condition was bad, he was lethargic with lung crackling. The abdomen was distended without mass. A provisional diagnosis of pneumonia was made. A treatment with amoxicillin, clavulanic acid, and paracetamol was done. On 18-FEB-2017, the child presented abdominal distension and then an abdominal ultrasound was performed and showed a target sign suggesting intussusception. The baby was transferred to the Department of Pediatric Surgery where he had surgery the same day towards the evening. At the opening, the exploration found an ileo-caeco-colic intussusception without necrosis with the mass palpated to the rectum. A manual reduction and an appendectomy were performed. On 20-FEB-2017 the baby developed anemia with respiratory distress, abdominal distension and loss of consciousness. He was transferred to the Department of Pediatrics where he presented cardio-respiratory arrest and then died at 13:05 on 20-FEB-2017. The outcome of pneumonia was unknown. The reporter considered intussusception to be not related to ROTATEQ. The causality between ROTATEQ and other events was unknown. Upon internal review, the events intussusception, respiratory distress, loss of consciousness and pneumonia were determined to be medically significant. Additional information is not expected as there was no follow up available. Company Causality Assessment: Based on the clinically relevant information currently available for this individual case, the reported events are considered unlikely related to ROTATEQ. The evidence is not sufficient to suggest a relationship between the vaccination and the reported serious adverse events. Causality assessment is impacted by the time of onset with the events occurring over three months after the last dose (third dose) of the vaccine. In addition, information regarding the patient''s concurrent conditions, medical history and concomitant medications was not provided. Company Comment- No changes to the product safety information are warranted at this time. Merck and Co., Inc., known as MSD outside of the countries, continues to monitor the safety profile of the product. Reported Cause(s) of Death: anemia; intussusception; loss of consciousness; respiratory distress.


VAERS ID: 684058 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-02-27
Entered: 2017-02-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Hepatitis B surface antibody negative, Hepatitis B surface antigen negative
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: Hepatitis B immunoglobulin
Current Illness: Unknown
Preexisting Conditions: Premature baby
Allergies:
Diagnostic Lab Data: Lab tests were performed on an unspecified date. Hepatitis B surface antibody, 15 IU/L; Hepatitis B surface antigen, negative
CDC Split Type: SG2017GSK027529

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a 6-month-old subject who received Hepatitis B vaccine. Co-suspect products included Hepatitis B Immunoglobulin. The subject''s past medical history included premature birth. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the subject developed unknown cause of death. Serious criteria included death and GSK medically significant. The outcome of unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Hepatitis B vaccine. Relevant Tests: Lab tests were performed on an unspecified date. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Hepatitis B surface antibody result was 15 IU/L. On an unknown date, Hepatitis B surface antigen result was negative unknown. Additional information was provided. This case was reported in a literature article and described death NOS in a 6-month-old infant of unspecified gender who was vaccinated with ENGERIX (GlaxoSmithKline). The patient was a part of the prospective cohort study that evaluated the serologic vaccine responses in preterm infants (defined as those born at less than 37 weeks of gestation) born to HBsAg positive mothers using the current Advisory Committee on Immunization Practices (ACIP) 2005 guidelines. The study recruited HBsAg positive mothers and their newborns from Hospital, a tertiary academic hospital, over 6 years from June 2009 and December 2015 and retrospectively recruited via convenience sampling in 2 years (June 2013 to April 2015) in 2 tertiary pediatric centers. The patient was a preterm infant. The patient was born to HBsAg positive mother. (In this study there were 24 preterm infants. Out of 24 mothers with preterm infants, 10 were also positive for HBeAg. 17 mothers with preterm infants had HBV DNA titers tested and 9 mothers had levels that were significantly elevated (more than 20,000 IU/mL). No information on patient''s concomitant medication or concurrent condition was provided. On an unspecified date, the patient received ENGERIX (10 mcg) (administration route and site unspecified; dosages unknown; batch number not provided). The patient was also administered 110 IU/ML hepatitis B immunoglobulin (HBiG) at birth. [In this study, premature infants below a birth weight of 2kg received a 4-dose vaccine schedule (at birth, on reaching 2kg, 1 month after the second dose, and 6 months after receiving the second dose), and those equal to or above 2kg received a 3-dose vaccine schedule (at birth, 1 month of age and 6 months of age) as recommended by ACIP 2005 guidelines]. On an unspecified date, at 4 months of age, an unknown period after vaccination, the patient was found negative for HBsAg and had 15 IU/L seroprotective HBsAb level. At the age of 6 months, the patient died. The cause of death was unknown. It was not reported if the autopsy was performed. This case has been considered serious due to death. Treatment was unknown. The authors did not comment on the relationship between low seroconversion and death NOS and ENGERIX. The authors concluded that "The current ACIP recommended vaccination schedule results in adequate antibody responses in preterm infants of HBsAg positive mothers". This is 1 of the 2 valid cases from the same literature article.


VAERS ID: 684123 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-02-17
Onset:0000-00-00
Submitted: 2017-02-28
Entered: 2017-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 9KT02R / 1 UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR M1124 / 1 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 16C01A / 1 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
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: Weight gain poor
Preexisting Conditions: Medical History/Concurrent Conditions: Neurosis (Mother)
Allergies:
Diagnostic Lab Data: Test Date: 20170217; Test Name: Body temperature; Result Unstructured Data: Test Result: 37.3, Test Result Unit: Centigrade
CDC Split Type: JPPFIZERINC2017081377

Write-up: This is an initial spontaneous report received from Agency under the regulatory authority report number of v16101098. A 2-month-old male patient of an unspecified ethnicity received the 1st dose of PREVENAR 13 (Lot number: 16C01A, Expiration date: 28Feb2019) at 0.5ml single, ACT-HIB (Lot number: M1124) at 1 DF, single, and HEPTAVAX (Lot number: 9KT02R) at 1 DF, single, all given subcutaneously on 17Feb2017 11:45 for immunization. Body temperature before vaccination was 37.3 Centigrade. Medical history included ongoing weight gain poor. Family history on his mother of neurosis was reported. Birth weight was 2528 g. Concomitant medications were not reported. In the morning on 18Feb2017, the patient death was reported by police (details unspecified). The patient died on 17Feb2017 or 18Feb2017. It was not reported if an autopsy was performed but forensic autopsy was to be conducted. The reporter classified the event as serious (fatal) and evaluated the event as not assessable and commented as follows: Although it was not officially reported, possibility of sudden infant death syndrome (SIDS) was suggested. No follow-up attempts possible. No further information expected. Reported Cause(s) of Death: possibility of sudden infant death syndrome.


VAERS ID: 684359 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2017-02-17
Onset:0000-00-00
Submitted: 2017-03-02
Entered: 2017-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 9KT02R / 1 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR M1124 / 1 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 16C01A / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
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:
Preexisting Conditions: Medical History/Concurrent Conditions: Weight gain poor
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPSA2017SA031872

Write-up: Initial unsolicited report received from a pediatrician via the Health Authority under Reference number: V16101098 on 23-Feb-2017. This case involves a two-month-old male patient who was simultaneously vaccinated with 0.5 ml first primary dose of ActHIB via subcutaneous route (Batch number: M1124, expiration date and site of administration were not reported) and with first primary doses of Prevenar13 (manufacturer: Other) (Batch number: 16C01A) and Heptavax-II (manufacturer: Other) (Batch number: 9KT02R) (expiration date, dose, route and site of administration were not reported for both the vaccines) at 11:45 A.M. on 17-Feb-2017. Patient''s body temperature before the vaccination was 37.3 degree Celsius and remarkable history was reported as weight gain poor. Patient''s mother had medical history of neurosis. On an unknown date (reported as 17-Feb-2017 or 18-Feb-2017), following the vaccination, the patient died from an unspecified cause. In the morning on 18-Feb-2017, the police informed the reporter that the patient had died. The circumstances of the vaccination were explained to the police. It was reported that the reporter was not informed of details including the symptoms at the time of discovery, possibly in concern of the police investigation. Laboratory investigations and corrective treatment were not reported. It was informed that a forensic autopsy would be performed. Diagnosis: Death. Reporting pediatrician''s seriousness assessment: Serious (Death). Reporting pediatrician''s causality assessment: Unknown. Reporting pediatrician''s comment: A possibility of sudden infant death syndrome (SIDS) was indicated, although it was not a formal report. List of the document held by sender: none. Sender''s Comments: This is a death case of a 2 months old child who died after vaccination with ActHIB, PREVENAR13 and HEPTAVAX-II vaccines. No autopsy report was provided. Time to onset is compatible with the role of vaccine, however more details regarding the baby (relevant medical history) and the environmental factors (smoking in the family, position during sleep, etc.) would be helpful to further assess this case. However, detailed autopsy reports are needed to further assess the case. As three vaccines were administered simultaneously, the role of each component cannot be assessed. Reported Cause(s) of Death: died from an unspecified cause.


VAERS ID: 684400 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2016-12-12
Onset:0000-00-00
Submitted: 2017-03-02
Entered: 2017-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. M036639 / UNK UN / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Death, Encephalitis, Herpes zoster, Meningoencephalitis herpetic, Pneumonia aspiration, Polymerase chain reaction positive, Rash, Rash macular, Upper respiratory tract infection, Varicella, Varicella virus test positive
SMQs:, Anaphylactic reaction (broad), Noninfectious encephalitis (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-01-16
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: Chronic lymphocytic leukaemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU0095075131702AUS008565

Write-up: Information was obtained on a request by the Company from a physician via agency (OPR # 402220) concerning a 71 year old male patient. The patient''s pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 12-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX 1 dose unspecified 1 time, intramuscularly, lot # M036639, for prophylaxis. Report Description: Varicella with cutaneous rash complicated by meningoencephalitis; likely aspiration pneumonia resulting in death. Patient background included known chronic lymphocytic leukaemia as a contraindication to live vaccine. Cerebrospinal Fluid (CSF) Polymerase Chain Reaction (PCR) positive for Varicella-zoster virus (VZV); specimen and extract referred to laboratory- limited sequencing consistent with vaccine strain; awaiting full sequencing. Follow up information 01: The Emergency Department noted record the vaccine being given one month before the presentation on 06-JAN-2017 which equated with early December 2016 - with a prodrome of Upper Respiratory Tract Infection (URTI) symptoms for about a week before the rash onset, the approximate incubation period would be 3 weeks which was consistent with varicella. The presentation for meningoencephalitis was on 06-JAN-2017. Follow up information 02: It was a widespread chicken pox rash starting over the entire face then front and back of trunk with minor spotting on the limbs. Follow up information 03: the vaccine batch number was M036639 given on 12-DEC-2016. The patient''s wife noticed "red blotches" on the patient''s face 02-JAN-2017 before the rash was formally diagnosed on the patient''s presentation 03-JAN-17 therefore rash onset could be 02-JAN-2017 instead of 03-JAN-2017 (depending on whether the rash onset needs to be medically verified). The patient''s specimens and extract were forwarded to Laboratory for sequencing. Because there was no available commercial assay to differentiate vaccine from wild-type virus, they performed in-house assays and cannot issue a formal report (ie not validated for this application). Laboratory have performed two assays. The first was a real-time PCR that detected a polymorphism by probe present in the vaccine strain that was not present in wild-type strains. The second assay was a conventional PCR of the same genetic region that demonstrated four single nucleotide polymorphisms on sequencing of the PCR product that they informed us characteristically distinguish vaccine from wild-type strains. Laboratory intend to perform a third assay of a different genetic region to substantiate the above results. However, this data was as good as it got for the purposes of determining whether the causative virus was the vaccine strain. The Agency considered Meningoencephalitis herpetic, Varicella and Herpes zoster to be possible related to ZOSTAVAX. Additional information is not expected as no further information can be obtained from the regulatory authority. Reported Cause(s) of Death: Varicella with cutaneous rash complicated by meningoencephalitis; likely aspiration pneumonia resulting in death.


VAERS ID: 684519 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-02-17
Onset:0000-00-00
Submitted: 2017-03-03
Entered: 2017-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 9KT02R / 1 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR M1124 / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 16C01A / 1 UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Death, Sudden infant death syndrome
SMQs:, Neonatal disorders (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: Prophylaxis; Weight gain poor
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20170217; Test Name: Body temperature; Result Unstructured Data: Lab result: 37.3 ?C
CDC Split Type: JP0095075131702JPN001870J

Write-up: Initial information has been received from a physician via the Agency concerning a 2-month-old male patient who on 17-FEB-2017 was vaccinated with the first dose of HEPTAVAX-II for prophylaxis (lot number: 9KT02R, dose not reported). Special notes on the pre-vaccination interview form (including underlying disease, allergy, vaccination and disease within the recent 1 month, currently taken medications, past adverse reaction and growth status) included poor weight gain. Family history included neurosis (for the mother). Weight at birth was 2528 g. Other suspect therapies included ACTHIB (first dose, lot number: M1124, vaccination date: 17-FEB-2017, dose: unknown, indication: unknown) and PREVENAR 13 (first dose, lot number: 16C01A, vaccination date: 17-FEB-2017, dose: unknown, indication: unknown). No other concomitant therapy was reported. On 17-FEB-2017, at 11:45, the patient was vaccinated with hepatitis b vaccine (recombinant), haemophilus b conjugate vaccine (tetanus toxoid conjugate), and pneumococcal polysaccharide conjugate vaccine (adsorbed) (as stated above). Body temperature before vaccination was 37.3 degrees C. On the same day (or 18-FEB-2017), the patient died. On 18-FEB-2017, the patient''s death was informed by the police in the morning. The police also stated that forensic autopsy would be performed. Reporter''s comment: The circumstance on the vaccination was explained to the police. Details including symptoms when the patient was found dead were unknown because the case was under the police investigation. Possible sudden infant death syndrome (SIDS) was suggested. The reporting physician felt that the causal relationship of death to hepatitis b vaccine (recombinant) was unknown, and considered haemophilus b conjugate vaccine (tetanus toxoid conjugate) and pneumococcal polysaccharide conjugate vaccine (adsorbed) as suspect drugs. Information has been received for a direct report from the Agency regarding a case provided by the physician. Additional information has been requested. Reported Cause(s) of Death: Death.


VAERS ID: 684659 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-03
Entered: 2017-03-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Unknown
Symptoms: Death
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: Common cold
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131702JPN002119J

Write-up: A consumer obtained the information from a television information program long before and reported that a patient (gender and age unknown) with a common cold who on an unspecified date was subcutaneously vaccinated with PNEUMOVAX NP injection for prophylaxis (Lot number and dose not reported). There was no concomitant medication reported. On an unspecified date, the patient''s personal physician inoculated pneumococcal vaccine, polyvalent (23-valent) without noticing that the patient was suffering a common cold. (described above). On an unspecified date, the patient died. The cause of death and autopsy information were not obtained. Reporter''s comment: Not provided. Upon internal review, the death was determined to be serious as an other important medical event. The reporter did not assess the causal relationship of death to pneumococcal vaccine, polyvalent (23-valent). Follow-up attempt was not made because the reporter did not wish to be contacted.; Reported Cause(s) of Death: Death.


VAERS ID: 684963 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-02
Entered: 2017-03-07
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FJ2017GSK028146

Write-up: This case was reported by a non-health professional via other and described the occurrence of unknown cause of death in a 14-year-old female patient who received HPV vaccine. On an unknown date, the patient received HPV vaccine at an unknown dose. On an unknown date, less than a day after receiving HPV vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to HPV vaccine. Additional details were provided as follows: This case was reported in the lay press via a GSK employee. The patient was the youngest of children. She was staying with her parents while her two elder siblings were residing with their relatives attending tertiary institutions. The patient had brought her letter to the parents to sign consenting for her to be vaccinated. When her parents asked her she said that the vaccination would take place in the next week. The patient''s mother said that her daughter had woken early on Thursday morning and had a healthy breakfast before saying goodbye to her parents. The mother said if they knew that the patient would be vaccinated on that day, then they would have picked her and dropped her home considering its remote location and the adverse weather conditions on Thursday. The family of five could not accept the loss of their daughter and sister who allegedly passed away on the same day she was administered Human Papilloma Virus (HPV) vaccination at her school. The mother was still trying to come to terms with the death of the patient whose body was discovered in their home on Thursday. The patient''s distraught father said his daughter was the chatterbox of the family and said that she would be greatly missed. In a statement, the Agency offered its sincere and heartfelt condolences to the family for their loss, adding they would await the police investigation report before commenting on the detail of the case. The statement said that the HPV (human papilloma virus) vaccine protects against cervical cancer, which could be a major killer of women. However, studies show that there were no serious safety concerns associated with HPV vaccine. According to the CDC, one of the world''s leading medical authorities, HPV vaccine was very safe, and it was effective at protecting against some HPV types that could be very bad.


VAERS ID: 685066 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-07
Entered: 2017-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ES2017GSK031130

Write-up: This case was reported in a literature article and described the occurrence of unknown cause of death in a elderly subject who received Flu seasonal TIV Dresden. On an unknown date, less than a year after receiving Flu seasonal TIV Dresden, the subject developed unknown cause of death. Serious criteria included death, hospitalization and GSK medically significant. The outcome of unknown cause of death was fatal. The reported caused of death was unknown cause of death. It was unknown if the investigator considered the unknown cause of death to be related to Flu seasonal TIV Dresden. Additional information was provided. This case was reported in a literature article and described death NOS in an adult aged 65 or more of unspecified gender who was vaccinated with unspecified influenza vaccine (manufacturer unknown). The patient was a part of the prospective study that aimed to analyse the clinical characteristics and outcomes of pneumococcal pneumonia, empyema, and primary bacteraemia that have occurred in adult patients aged more that or equal to 65 years and to describe serotype distribution since PCV-13 authorization compared with the previous period (2006-2010), including a sub-analysis of very elderly patients (80 years). The study was conducted in two hospitals from 01 June 2010 to 30 June 2015. (In this study, out of the total 30 patient died, 10 were female). No information on patient''s medical history or family history or concurrent condition or concomitant condition was provided. On an unspecified date during the year prior to admission, the patient received unspecified seasonal influenza vaccine (administration route unknown; dosage unknown; batch number not provided). On an unspecified date between 1 June 2010 and 30 June 2015, (In this study, out of 262 episodes (involving 243 patients; range: 1-4 episodes per patient), 249 episodes were pneumonias, 11 were primary bacteremia''s, and 2 were empyema''s). Subsequently, on an unspecified date, the patient died. The cause of death was unknown. It was not reported if the autopsy was performed. (In this study, out of total 30 patients died during hospitalisation, 14 were attributed to PCV-13 serotype infected, 22 had bacteraemia, 8 had CNS vascular disease, 6 had dementia and 20 had septic shock. 10 patients had invasive ventilation whereas 15 had ICU admission). This case has been considered serious due to death/hospitalisation. Treatment was unknown. The authors did not comment on the relationship between death NOS and unspecified seasonal influenza vaccine. However, the authors stated "Mortality was related with the presence of complications at admission". The authors concluded that "despite the fact that the elderly patient seen at the hospital with pneumococcal pneumonia, empyema or primary bacteraemia had a high burden of comorbidities, the rate of pneumococcal vaccination in our setting was very low. Except for septic shock, the main outcome variables (including mortality) were similar to the ones observed in the period preceding PCV-13 authorization. Serotypes included in PCV-13 were responsible for most pneumococcal infections although a decreasing tendency was observed during the study period, probably due to the effect of paediatric vaccination. The implementation of the new (2015) ACIP recommendations in our setting could improve this scenario". The article is not available for submission due to copyright restriction.


VAERS ID: 685277 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-03
Entered: 2017-03-07
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ2017GSK030271

Write-up: This case was reported in a literature article and described the occurrence of myocardial infarction in a subject who received Flu seasonal TIV Dresden. On an unknown date, an unknown time after receiving Flu seasonal TIV Dresden, the subject developed myocardial infarction. Serious criteria included death and GSK medically significant. The outcome of myocardial infarction was fatal. The reported cause of death was myocardial infarction. The investigator considered the myocardial infarction to be unlikely related to Flu seasonal TIV Dresden. Additional information was provided. This case was reported in a literature article and described the occurrence of myocardial infarction in a patient of unspecified age and gender who was vaccinated with unspecified 2016 seasonal influenza vaccine (manufacturer unknown). No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received unspecified 2016 seasonal influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On an unspecified date in 2016, an unknown period after vaccination, the patient developed myocardial infarction. On an unspecified date, the patient died of myocardial infarction. It was unknown if an autopsy was performed. [The majority of reports were submitted by nurses (80%), followed by GPs (14%) and pharmacists (5%)]. This case has been considered serious due to death/per Centre. [A serious adverse event is determined by Centre according to internationally agreed criteria (i.e., results in death or is life threatening, causes or prolongs hospitalisation, results in persistent or significant disability/incapacity or is a congenital abnormality]. The treatment for the event of myocardial infarction was not reported. The authors stated "the death was considered unlikely to be due to the vaccination".


VAERS ID: 685120 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2017-02-07
Onset:2017-02-07
   Days after vaccination:0
Submitted: 2017-03-08
   Days after onset:29
Entered: 2017-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER M71574V / 3 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R37142 / 2 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M031795 / 3 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Histology
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-02-07
   Days after onset: 0
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: 19.1;10029436~DTaP+IPV+HepB+Hib (no brand name)~~0.00~Patient|19.1;10029436~DTaP+IPV+HepB+Hib (no brand name)~~0.00~Patient|19.1
Other Medications:
Current Illness: Seborrheic dermatitis (eczema)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20170210; Test Name: Autopsy; Result Unstructured Data: Test Result: not provided, expanding heart; Test Name: Histology; Result Unstructured Data: Test Result: pending results
CDC Split Type: DEPFIZER INC2017098075

Write-up: This is a spontaneous report received from the Health Authority. Regulatory Authority report number DE-PEI-PEI2017019453. A 3-month-old male patient of an unspecified ethnicity received PREVENAR 13. (Lot # R37142) intramuscular at 0.5ml, single in right upper leg, ROTATEQ, (Lot # M031795) oral 1 DF, HEXYON, (Lot # M71574V) intramuscular at 1 DF in left upper leg, all on 07Feb2017 for immunisation. Medical history included ongoing seborrhoeic dermatitis eczema. The patient''s concomitant medications were not reported. Previous vaccinations with Hexyon, Prevenar 13 and RotaTeq administrated on 15Dec2016 had been well tolerated as well as vaccinations with Hexyon and RotaTeq administered on 10Jan2017. On 07Feb2017, the patient was admitted to hospital where he died in the evening at 21:08. An autopsy was performed on 10Feb2017. According to the attending hospital (only verbal information), a previously unknown tumor of the heart was detected. Results of histological examinations were pending. The causes of death were reported as unknown. Autopsy was performed on 10Feb2017. The autopsy report was not provided. Additional information from act: Event was reported as "exitus letalis." The child was completely vaccinated. Causal relationship between event and suspect drugs was not assessable. This case is being treated according to the act. No follow-up attempts needed, follow-up automatically provided by regulatory authority.; Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 685467 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-10
Entered: 2017-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis pneumococcal
SMQs:, Opportunistic infections (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZERINC2017101218

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A child patient, 4-5 years old, of an unspecified race/ethnicity and gender received PREVENAR 13, via an unspecified route of administration at 0.5 ml, single on an unspecified date for immunisation. The patient''s medical history and concomitant medications, if any, were not reported. On an unspecified date, the patient experienced pneumococcal meningitis leading to patient''s death. Therapeutic measures taken in response to the event were unknown. It was not reported if an autopsy was performed. Sender''s Comments: Based on the information currently available, a lack of efficacy with PREVENAR 13 in this patient cannot be excluded. Further information like confirmative serotype results and vaccination schedule is needed for a full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: pneumococcal meningitis.


VAERS ID: 685515 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-09-01
Submitted: 2017-03-12
   Days after onset:923
Entered: 2017-03-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Unknown
Symptoms: Death, Neoplasm malignant, Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131703JPN000406J

Write-up: Initial information has been received from a patient''s family concerning an 82-year-old male patient. The patient''s concurrent conditions, medical histories and concomitant therapies were not reported. Around 2006, the patient was subcutaneously vaccinated with PNEUMOVAX NP for prophylaxis (Lot number and dose not reported). The patient was not vaccinated again after that. In September 2014, the patient developed carcinoma and was hospitalised. Until the patient developed cancer, the patient was well. On an unknown date, during hospitalisation, pneumonia developed. On an unknown date, the patient recovered from pneumonia. On an unknown date, the patient developed pneumonia again. In approximately October 2016, the patient died. The cause of death was pneumonia. Information regarding autopsy was not reported. At the time of the report, the outcome of carcinoma was unknown. Reporter''s comment: not provided. The reporter did not assess the relationship of pneumonia (1st time, 2nd time) and carcinoma to PNEUMOVAX NP. The reporter considered pneumonia (2nd time) to be serious due to death and carcinoma to be serious due to hospitalisation. The reporter didn''t assess the seriousness of pneumonia (1st time). Upon internal review, pneumonia (1st time, 2nd time) and carcinoma were determined to be medically significant. Follow-up attempt was not made because the reporter did not wish to be contacted. Reported Cause(s) of Death: Pneumonia.


VAERS ID: 685623 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-03-13
Entered: 2017-03-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

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: 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: JP0095075131703JPN000233J

Write-up: Initial information has been received from a non-healthcare professional concerning a 70 male patient who in 2012 was vaccinated with PNEUMOVAX NP injection subcutaneously for prophylaxis (Lot number and dose not reported.) There was no concomitant medication reported. In 2012, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (mentioned above). In 2012, the patient developed pneumonia. In 2012, the patient died of pneumonia. The cause of death was pneumonia. Information on whether or not autopsy was performed was not obtained. Reporter''s comment: not provided. The reporter considered that the pneumonia was serious due to death. Upon internal review, pneumonia was determined to be medically significant. The reporter did not assess the relationship of pneumonia to pneumococcal vaccine, polyvalent (23-valent). Follow-up attempt was not made because the reporter did not wish to be contacted. Reported Cause(s) of Death: Pneumonia.


VAERS ID: 685828 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-07-01
Onset:0000-00-00
Submitted: 2017-03-14
Entered: 2017-03-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Death, Decreased appetite, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131703JPN000873J

Write-up: Information has been received from a patient''s distant relative concerning a 95-year-old female patient who in July 2016 was vaccinated for the first time with PNEUMOVAX NP injection for prophylaxis. (Lot number and dose not reported.) There were no concomitant medications reported. In July 2016, the patient was vaccinated with PNEUMOVAX NP for the first time (described above). The patient experienced difficulty breathing and was transported to hospital and hospitalized. The patient gradually experienced decreased appetite. In January 2017, the patient died. Information regarding cause of death and autopsy were not reported. At the time of the report, the outcomes of dyspnoea and inappetence were unknown. Reporter''s comment: The patient''s family said that the death had no causal relationship with vaccination. It was likely due to the patient''s old age. The reporter considered dyspnoea to be serious due to hospitalization. The reporter did not assess the seriousness of inappetence. Upon internal review, death was determined to be medically significant. The reporter did not assess the relationship of dyspnoea and inappetence to PNEUMOVAX NP. The reporter felt that death was not related to PNEUMOVAX NP. Follow-up attempt was not made because the reporter did not wish to be contacted. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between PNEUMOVAX vaccine and the reported event cannot be established. The lack of medical substantiation precludes a proper causality assessment of this report. Company Comment- No changes to the vaccine safety information are warranted at this time. Merck and Co., Inc., known as MSD outside of two countries, continues to monitor the safety profile of PNEUMOVAX vaccine. Reported Cause(s) of Death: Death.


VAERS ID: 685939 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2013-03-01
Onset:0000-00-00
Submitted: 2017-03-15
Entered: 2017-03-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Unknown
Symptoms: Cough, Death, Pneumonia, Syncope, Viral upper respiratory tract infection
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Unspecified disorder of intestine (when the paient was young, cecum)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131703JPN000390J

Write-up: Initial information has been received from a patient''s family member concerning an 80-year-old male patient. The patient had no medical history and was healthy except cecum when he was young. In March 2013, the patient was subcutaneously vaccinated with pneumococcal vaccine, polyvalent (23-valent) injection (manufacturer unknown) for prophylaxis (lot number and dose not reported). There was no concomitant medication reported. In March 2013, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent). There were no side effects in particular. In 2015, the patient went to hospital due common cold-like symptoms and cough, and was told that the condition of his lungs was bad (onset of pneumonia). After that, the patient visited the hospital once a month and took medicine for treatment for about one year. In 2016, the patient collapsed suddenly. He was in a hazy state, but could respond to others when called. The patient was hospitalized immediately. In approximately May 2016 (5 to 6 days after hospitalization), the patient died. The cause of death was pneumonia. Autopsy information was not reported. At the time of the report, the outcome of hazy state was unknown. Reporter''s comment: not provided. The reporter did not assess the relationship of pneumonia and hazy state to pneumococcal vaccine, polyvalent (23-valent). The reporter considered pneumonia to be serious due to death. The reporter considered hazy state to be serious due to hospitalization. Upon internal review, pneumonia and hazy state were determined to be medically significant. Follow-up attempt was not made because the reporter did not wish to be contacted. Reported Cause(s) of Death: Pneumonia.


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: 685997 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:1970-08-25
Onset:0000-00-00
Submitted: 2017-03-16
Entered: 2017-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: CSF test normal, Death, Electroencephalogram abnormal, Gait disturbance, Meningitis, Seizure, Skull X-ray, Skull X-ray normal
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 1974-10-05
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: 19.1;10010904~DTP (no brand name)~1~0.00~Patient
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DESA2017SA040717

Write-up: Initial unsolicited report received from the literature (forwarded by a lawyer) on 01-Mar-2017. This case is linked with: 2017SA040606, 2017SA040624, 2017SA040892, 2017SA040642, 2017SA040652, 2017SA040699, 2017SA040743, 2017SA040758, 2017SA040771, 2017SA040781, 2017SA040802, 2017SA040817, 2017SA040831, 2017SA040838, 2017SA040815, 2017SA040811, 2017SA040577, 2017SA040608, 2017SA040615, 2017SA040621, 2017SA040625, 2017SA040635, 2017SA040639, 2017SA040655, 2017SA040662, 2017SA040669, 2017SA040700, 2017SA040706, 2017SA040710, 2017SA040729, 2017SA040585. (same literature). This case involves a five-year-old female patient, who received second dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (DPT) (Batch number, expiry date, dose, dose in series, route were not reported), on 25-Aug-1970. Patient''s medical history was not reported. It was reported that there was a normal physical development. Patient''s concomitant medications were not reported. On an unknown date, approximately four hours after the vaccination, patient had convulsions occurred for up to 30 minutes. On an unknown date, after the vaccination patient had pronounced seizure susceptibility. On an unknown date, after the vaccination, patient was hospitalized and minor gait disturbance was detected and later with 18 months purulent meningitis of unclear etiology occurred and later patient experienced convulsions without fever. Patient received first vaccination of DPT on 14-Jul-1970 and four hours of vaccination, patient had convulsions occurred for up to 30 minutes. Patient''s laboratory data includes, pneumencephalogram was without pathological findings, as well cerebral spinal fluid (CSF) and In an EEG of 19-May-1971 "marked seizure susceptibility" was detected. Patient''s corrective treatment was not reported. Outcome of the events'' convulsions, pronounced seizure susceptibility and minor gait disturbance were not reported. Patient died on 05-Oct-1974 (1502 days after vaccination). It was not reported whether autopsy was done or not. Upon internal review the event convulsion was considered as serious because of important medical event. Documents held by sender: none. Sender''s Comments: This literature case includes a patient was vaccinated in 1970 with DPT vaccine and had experience experienced convulsions, pronounced seizure susceptibility and minor gait disturbance and 18 months later patient had purulent meningitis of unspecified aetiology and died after few years. Time to onset is not compatible, but additional information regarding patient medical history, autopsy report, etiological work up, concomitant medication, autopsy report and more investigation results to rule out the alternative cause are needed for complete assessment of the case. Based on available information no conclusion can be drawn. Reported Cause(s) of Death: patient died on 05 Oct 1974.


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