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VAERS ID: 622750 (history)  
Form: Version 1.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-11-16
Onset:2015-11-17
   Days after vaccination:1
Submitted: 2016-02-12
   Days after onset:87
Entered: 2016-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 155001A / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Agitation, Atrial fibrillation, Blood pressure increased, Death, Diarrhoea, Dyskinesia, Hyperpyrexia, Hypotension, Malaise, Psychomotor hyperactivity, Shock, Somnolence
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (narrow), Supraventricular tachyarrhythmias (narrow), 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), Pseudomembranous colitis (broad), Akathisia (broad), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypertension (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-20
   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: EUTIROX; LANOXIN; Clopidogrel; Cortisone acetate
Current Illness:
Preexisting Conditions: Lymphocytic hypophysitis; 1990, Thyroid adenoma treated with metabolic radiotherapy; 1993, Hypothyroidism treated with levothyroxine; Myocardial ischaemia; Atrial fibrillation; 1993, Hypothyroidism; 1990, Radiotherapy; Adenoma benign; 2008, Polyglandular autoimmune syndrome type II; 2008, Blood cortisol decreased; 2011, Atrial fibrillation; Fall; 2004, Rib fracture; 2013, Humerus fracture; 03/2014, Lumbar vertebral fracture; Diverticulitis; Diarrhoea
Allergies:
Diagnostic Lab Data: Blood pressure measurement, 100/50 mmHg, Low; Blood pressure measurement, 130/70 mmHg, High
CDC Split Type: PHHY2015IT154263

Write-up: Case number PHHY2015IT154263, is an initial spontaneous report received from a health care professional (reference number: 335985) on 23 Nov 2015. This case also contains QA reference number 1009285. This report refers to an 88 years old male patient. Historical conditions included chronic ischaemic heart disease, unspecified and chronic atrial fibrillation, autoimmune hypopituitarism and the patient whose anamnesis had been characterized by hypothyroidism due to toxic adenoma and thyroid adenoma treated with metabolic radiotherapy in 1990. In 1993 hypothyroidism has occurred (at that time the hypothyroidism has been classified as iatrogenic, due to sequels of radiotherapy), for this reason replacement therapy with levothyroxine had been started. In 1993 hypothyroidism was treated with levothyroxine. In 2008 diagnosis of type 2 autoimmune polyglandular syndrome had been formulated with involvement of the cortical region of the adrenal gland and of the thyroid gland, for this reason replacement therapy with cortisone acetate has also been introduced in order to compensate the deficiency of endogenous cortisol. In 2011 onset of atrial fibrillation about that had been decided not to undergo electrical cardioversion taking into account the patient''s age and the general health condition of the patient. Antiaggregant therapy with clopidogrel (manufacturer unknown) had been started in the meanwhile because the patient and his relatives did not accept oral anticoagulant therapy. In 2004, for the same pathology LANOXIN had also been added. It is important to notify that the patient underwent many traumatic falls causing bone fractures: in 1999 fracture of the distal extremity of the radius bone on the left side, in 2004 fracture of the X rib of the right hemi chest, in 2013 fracture of the surgical neck of the right humeral bone, in March 2014 fracture of the L lumbar spine. The patient, in addition, suffered from a marked diverticulitis of the colon with very frequent diarrheic episodes also very intense. Concomitant medications included clopidogrel (manufacturer unknown), LANOXIN and cortisone acetate (manufacturer unknown), EUTIROX. The patient was vaccinated with FLUAD (batch number: 155001A) intramuscularly on 16 Nov 2015. The physician would like to anticipate that from the data on his or her hands the patient underwent antiflu prophylaxis on a constant basis in these last years. The patient had arrived at his or her surgery accompanied by his wife on Monday morning 16 Nov 2015 asking for the repetition of the prescriptions of the drugs that he was taking in a chronic manner. The patient''s wife underwent anti flu vaccination, however, taking into account that the patient had declared that he would like to be vaccinated by his son in law who is a physician. The physician gave him the vaccine, a dose of FLUAD batch number: 155001A, urging him to have the vaccine injected as soon as possible, without interrupting the cold chain, and the physician discharged him. On 17 Nov 2015, the patient experienced hyperpyrexia, hypotension and psychomotor hyperactivity. On Wednesday, 18 Nov 2015 in the morning, the physician received a telephone call by the patient''s wife that reported to the physician that during the night the patient presented with very high hyperpyrexia and diarrhea. The treating physician suggested her to administer that patient with paracetamol that she had available at home, and loperamide, in case of persistence of the diarrhea, as she usually did, and to keep treating physician informed. In the first part of the afternoon treating physician received another telephone call by the patient''s wife that reported to treating physician the presence of very high hyperpyrexia, for this reason treating physician went to the patient''s home to visit him At the objective examination the patient was sleepy, however reactive, he could answer the questions, and, although with the usual difficulty in the movements he was cooperative as far as the procedures of the visit were concerned. No dyspnoea, no sweating, no agitation. The heart rhythm was chaotic due to atrial fibrillation, at the chest and at the abdomen no other relevant signs. The patient''s heart pressure of 130/70 mmHg, oxygen saturation within the normal limits, measured with the pulsimeter. Because treating physician could not detect any emergency symptoms, treating physician suggested continuing the treatment with paracetamol and to keep him informed On Thursday, 19 Nov 2015, around hour 05:15 p.m. approximately, the patient''s wife called to treating physician at his or her surgery and she reported in an agitated way that her husband suddenly had shown signs of severe malaise. After no more than ten minutes (treating physician surgery is located at a very short distance from the domicile of my patient) treating physician arrived and treating physician found that the patient was in a severe state of agitation. Even that time, no dyspnoea, no sweating was noted and oxygen saturation was within the normal limits, measured with the pulsimeter, blood pressure of 100/50, however, the treating physician was more focused on some movements almost rhythmic of the upper limbs and of the head, that almost could be configured as coreic movements that where accompanied by a verbal complaint. The patient answered only if he was called by his name with very high voice, however with syllables or complaints. Treating physician therefore, immediately called the first aid service. In the meanwhile also the patient''s son in law, who is a physician, arrived, who discharged current treating physician. On Friday, 20 Nov 2015 around 00 30 pm, the patient''s son in law called treating physician telling him that his father in law had died during that morning due to irreversible shock. It was unknown whether an autopsy was performed or not. The outcome and seriousness of the events diarrhea, sleepy, blood pressure increased, malaise, agitation and blood pressure decreased was not reported. The causality of the events hyperpyrexia, hypotension and psychomotor hyperactivity was reported as suspected. The reporter stated that the suspect drug may have contributed to death of the patient. Follow up information received from other health care professional on 24 Nov 2015 along with QA reference number on 26 Nov 2015. Added information included medical history: hypothyroidism from an unknown date in 1993, toxic adenoma, type 2 autoimmune polyglandular syndrome from an unknown date in 2008, deficiency of endogenous cortisol from an unknown date in 2008, atrial fibrillation from an unknown date in 2011, traumatic falls down, bone fractures/fracture of the distal extremity of the radius bone on the left side, from an unknown date in 1999, X rib of the right hemi chest from an unknown date in 2004, fracture of the surgical neck of the right humeral bone from an unknown date in 2013, fracture of the L lumbar spine from an unknown date in Mar 2014, diverticulitis and very frequent diarrheic episodes also very intense. Concomitant medication and adverse events: diarrhea, sleepy, heart rate abnormal, blood pressure increased, malaise, agitation and blood pressure decreased. Updated narrative accordingly. Follow up report received from a health care professional (reference number: 335985) on 07 Dec 2015: Updated past medical history (thyroid adenoma, hypothyroidism and its treatment).


VAERS ID: 622755 (history)  
Form: Version 1.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2015-11-18
Onset:2015-11-20
   Days after vaccination:2
Submitted: 2016-02-12
   Days after onset:84
Entered: 2016-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 154702 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Cardiac failure, Death, Hyperpyrexia, Nausea, Tremor, Vomiting
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-20
   Days after onset: 0
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: APIDRA; LANTUS; TAREG; LASIX; LOBIVON; PEPTAZOL; Cardioaspirin; Furosemide; Valsartan; Bisoprolol; Nifedipine; KCl; Aspirin; Pantoprazole; Allopurinol; Insulin
Current Illness: Diabetes mellitus; Hypertension; Chronic kidney disease; Cardiac valve prosthesis user; Cholelithiasis
Preexisting Conditions: Recent episodes of heart failure; Glaucoma; Coronary artery bypass, double bypass; Essential tremor; Ischaemic cardiomyopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2015IT153455

Write-up: Case number PHHY2015IT153455, is a spontaneous report initially received from a health care professional (reference number: 335741) on 21 Nov 2015. This report refers to an 82 year old female patient. Historical conditions included recent episodes of heart failure, glaucoma, essential tremor, ischemic-hypertensive cardiopathy, double aorto coronary bypass and aortic valve bioprosthesis. Current conditions included diabetes mellitus, hypertension and chronic renal failure and cholelithiasis. The patient was hospitalized on an unknown date due to her multiple diseases and she was under the treatment of furosemide (manufacturer unknown), valsartan (manufacturer unknown), bisoprolol (manufacturer unknown), nifedipine (manufacturer unknown), KCl (manufacturer unknown), aspirin, pantoprazole (manufacturer unknown), allopurinol (manufacturer unknown), insulin (manufacturer unknown). The patient was discharged from the hospital on 16 Oct 2015 and she was able to do activities of daily living. Concomitant medications included APIDRA, LANTUS, TAREG, LASIX, LOBIVON, PEPTAZOL and cardioaspirin. The patient was vaccinated with FLUAD (batch number: 154702, expiry date: Jun 2016) intramuscularly on 18 Nov 2015 after the physician evaluated the persistence of good general health conditions in particular cardiorespiratory conditions. On 19 Nov 2015, in the morning, the patient experienced mild hyperpyrexia, and nausea accompanied by some vomiting episodes. The physician went to patient''s home at around hour 00:30 pm and detected only nausea, increase in the tremor and probable reduction in the diuresis during the clinical examination. The patient was prescribed tachypirine tablets and PLASIL vials intramuscularly, as needed, physiological solution endovenously. In the afternoon, the patient''s daughter contact the physician again reporting that the nurse could not find a vein to administer the infusion and the conditions of patient appeared to be worsened. The physician suggested to call the first aid service to carry the patient to the emergency department. At 01:00 pm, the patient had no signs of heart failure. Later in the evening the patient was taken to the emergency room The patient died of heart failure on 20 Nov 2015 and autopsy was not performed. The outcome of the events mild hyperpyrexia, nausea, vomiting, increase in the tremor and probable reduction in the diuresis was not reported. Causality was suspected to FLUAD. Batch review report (reference number 1009329) received from quality assurance department on 31 Dec 2015: Based on the document review, it was stated that the concerned [FLUAD] batch number [154702] was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Non significant follow-up received from Quality Assurance Department (QA, reference number: 1009329) on 27 Nov 2015: updated QA reference number. Follow up report received from physician and health care professional (reference number: 335741) on 02 Dec 2015: Added new events (increase in the tremor and probable reduction in the diuresis), updated history, current condition, concomitant medication and expiry date of FLUAD, updated the event coding from mild fever to mild hyperpyrexia. Follow-up information from quality assurance department received on 31 Dec 2015: Added investigation summary.


VAERS ID: 622770 (history)  
Form: Version 1.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2015-11-07
Onset:2015-11-08
   Days after vaccination:1
Submitted: 2016-02-12
   Days after onset:96
Entered: 2016-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 155001 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Basophil percentage decreased, Blood creatinine increased, Blood uric acid increased, Cerebrovascular accident, Death, Eosinophil percentage increased, Glomerular filtration rate decreased, Haematocrit decreased, Lymphocyte percentage, Neutrophil percentage, Red cell distribution width increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haemorrhage laboratory terms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-08
   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: CLEXANE; EUTIROX; PEPTAZOL; LASIX; FOLINA; Heparin
Current Illness: Hypertension; International normalised ratio fluctuation, supervening difficulty to maintain INR within the range; Congestive cardiomyopathy, fibrillating heart dilated; Dementia Alzheimer''s type; Chronic kidney disease; Nephroangiosclerosis; Embolism arterial; Hypothyroidism; Cardiac fibrillation, fibrillating heart dilated
Preexisting Conditions: Shock haemorrhagic; Arrhythmia; Palpitations; 2012, Cerebrovascular accident; 2012 Cerebral ischaemia, cerebral ischemic events; 2012 Hemiparesis; 2012, Aphasia; COUMADIN/warfarin sodium; 2012, Endotracheal intubation; Leg amputation; Angiopathy; Intra-abdominal haematoma; Cognitive disorder
Allergies:
Diagnostic Lab Data: Basophil count, 0.4%, low; Blood creatinine, 1.26 mg/dl, high; Blood uric acid, 7.5 mg/dl, high; Eosinophil count, 5.8%, high; Glomerular filtration rate, 37 ml/min, low; Haematocrit, 36.8%, low; Lymphocyte count, 23.1%, low; Neutrophil count, 63.2%, high; Red cell distribution width, 52.9 fL, high, red cell distribution width-corpuscular volume (RDW CV); Red cell distribution width, 17.0%, high, red cell distribution width- standard deviation (RDW-SD).
CDC Split Type: PHHY2015IT147840

Write-up: Case number PHHY2015IT147840, is a spontaneous report initially received from a health care professional via Agency (reference number: 333607) on 09 Nov 2015 and 10 Nov 2015 (combined report). This report refers to a 91 years old female patient. The patient had vascular disease and suffered from cognitive impairment. The patient suffered from the outcomes of several previous stroke episodes as a result of frontal left ischemia (cerebral ischemic events)with aphasia and right hemiparesis in 2012. Nasogastric tube was placed in 2012. The patient''s medical history included thromboembolic or hemorrhagic shock, arrhythmias, palpitations. Current condition included hypertension. The patient had been suffering from fibrillating dilated cardiomyopathy for several years and of arterial thromboembolism with outcome of previous left leg amputation above the knee, mild chronic renal failure from angiosclerosis and Alzheimer''s disease. Her vaccination history included administration of FLUAD (batch number: not reported) in the previous years. The patient had been in therapy with anticoagulant therapy for years with COUMADIN that was changed with low molecular weight heparin due to supervening difficulty to maintain INR within the range. The dosage of heparin was reduced in Jul 2015 due to the hospitalization for abdominal hematoma. Concomitant medications included CLEXANE, EUTIROX, PEPTAZOL, LASIX, FOLINA and "Nutrison Standard" (dietary foods for special medical purposes). The condition of the patient at the time of vaccination was precarious. On the day of vaccination the patient was relatively clinically stable with normal vital signs (body temperature, blood pressure, heart rate and oximetry). The patient was vaccinated with FLUAD (batch number: 155001, expiry date: 31 Jul 2016) intramuscular on 07 Nov 2015 at 09:30 AM. The laboratory data included as red cell distribution width- corpuscular volume (RDW CV)- 17.0 percentage (11.5-14.5), red cell distribution width- standard deviation (RDW-SD)-52.9 fL (39.0-48.0), neutrophils 63.2 percentage, lymphocytes 23.1 percentage, eosinophils 5.8 percentage, basophils 0.4 percentage, serum/plasma creatinine 1.26 mg/dl (0.50 - 1.00), estimated glomerular filtration rate (eGFR) 37 mL/min/1.73m2 and Uric acid 7.5 mg/dl (2.4 - 5.7) and hematocrit was 36.5% (37.0-47.0). On 08 Nov 2015 at 10:30 AM the patient died due to cerebral stroke. It was reported that an autopsy was not performed. Seriousness, outcome and causality of the other events were not reported. The reporter stated that there was only temporal relation with vaccination as death occurred 24 hours after vaccination with FLUAD on random circumstance. The Centre assessed the relationship between the reaction and the vaccine as not related according to WHO''s algorithm. Batch review report reference number (1008846) received from quality assurance department on 08 Dec 2015: Based on the document review, it was stated that the concerned FLUAD batch number (155001) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow-up information from health care professional via Agency received on 12 Nov 2015: Medical history, vaccination history, concomitant medication and other clinically relevant information updated in the narrative. Non significant follow up received from quality assurance department (QA reference number: 1008846) received on 17 Nov 2015: Updated QA reference number only. Follow-up information from health care professional via Agency received on 30 Nov 2015: Added medical history (thromboembolic or hemorrhagic shock, arrhythmias, palpitations and hypertension) and laboratory data. Following internal review done on 14 Dec 2015 for the data received on 30 Nov 2015: Case follow up significant box was checked in the general tab as the correction (outcome and reported seriousness of the event Hematocrit decreased which was mentioned in the narrative) was done on 11 Dec 2015 inadvertently as non significant. Follow up information received from quality assurance department on 08 Dec 2015: Added expanded investigation summary. Follow-up information from health care professional via Agency received on 28 Jan 2016: Added Centre assessment.


VAERS ID: 622965 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2016-02-01
Onset:2016-02-02
   Days after vaccination:1
Submitted: 2016-02-17
   Days after onset:15
Entered: 2016-02-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER 201503172 / 1 RA / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR L0066 / 2 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Blister, Crying, Death, Lip discolouration
SMQs:, Severe cutaneous adverse reactions (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-02
   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: CNSA2016SA020121

Write-up: Based on additional information received on 03 February 2016, this case became medically confirmed. Initial unsolicited report received from a non-health care professional (distributed via company representative) on 03 February 2016. This case involves a three-month-old patient (gender was reported as unknown) who was vaccinated with a 0.5 ml second primary dose of Imovax Polio (batch number, route and site of administration was reported as unknown) on an unspecified date. It was not reported whether the patient''s first dose of IPV was ''Salk IPV'' or ''Sabin IPV''. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed blisters on the body. The parents had agreed to conduct an autopsy on the baby. Lab data and corrective treatments were not reported. On 02 February 2016, patient died. List of documents held by sender: none. Follow up information received from a non-healthcare professional via health authority on 03 February 2016. It was reported that, Imovax Polio expiry date was updated as 28-Feb-2017 and first dose of DTaP (expiry date: 07-Mar-2017). The patient received Imovax Polio on 01 February 2016. Patient had a medical history of BCG (lot# 2014012011-1) on 09-Nov-2015, left arm. 09 November 2015, patient received first dose of Hepatitis B vaccine (lot number 201311150) in right arm. On 11 December 2015, patient received second dose of Hepatitis B vaccine, (lot number 201311150) in right arm. On 11 December 2015, patient received Imovax Polio (Salk IPV), first dose, lot# L0066-4, left thigh (Manufacturer Sanofi Pasteur.) On 02 February 2016 next day of vaccination, patient had crying at about 3:00 AM. On the same day the patient''s lip was found purple at about 8:00AM, and at about 8:25, after diagnosis by the doctor, the patient had no vital signs and was dead. Sender''s Comments: Follow-up received on 03-Feb-2016 changes the case assessment as follows: This is a death case of a 3 months old child, who died at night within <24hours after concomitant vaccination with 2nd dose of IPV (VERO) and with 1st dose of DTaP from other manufacturer. Reportedly, the patient presented unspecified blisters on the body, which is unlisted with IPV (VERO). The cause of death is not reported. No adverse events occurred in the baby after previous vaccinations, including 1st dose of IPV (VERO). Time to onset is compatible with the role of vaccine, however more details regarding the baby (relevant medical history), the environmental factors (smoking in the family, position during sleep, etc), and autopsy result would be helpful to further assess this case. However, as two vaccines were administered simultaneously, the role of each component cannot be assessed.||Reported Cause(s) of Death: had blisters on the body; death


VAERS ID: 623026 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2016-02-09
Onset:2016-02-10
   Days after vaccination:1
Submitted: 2016-02-18
   Days after onset:8
Entered: 2016-02-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER 4K11B / UNK UN / SC
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 9KR06R / UNK UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR L1228 / UNK UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 14J01A / UNK UN / SC
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L007247 / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, 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: 2016-02-10
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPSA2016SA031000

Write-up: This case involves a three-month-old male patient who was vaccinated with a 0.5ml dose of ACTHIB (batch number: L1228, expiry date,site of administration was not reported) intramuscularly, a dose of PNEUMOCOCCAL VACCINE, a dose of HEPATITIS B VACCINE, a dose of ROTAVIRUS VACCINE, a dose of DIPHTHERIA, PERTUSSIS, TETANUS, POLIOMYELIT on 9 February 2016. The patient''s medical history and concomitant history was not reported. On 10 February 2016, one day following the vaccination, before dawn, the patient died suddenly. No laboratory data was reported.On 10 February 2016 the patient died. Diagnosis: Death (Death). Reporting physician''s seriousness assessment: Serious (Death). Reporting physician''s causality assessment: Not provided. It was reported that Autopsy did not reveal any gross findings. Documents held by sender: none.Sender''s Comments: This is a death case of a 3 months old child who died within <24 hours after concomitant vaccination with ActHIB (HIB [PRP/T] VACCINE) and with PCV, HBV vaccine, RV vaccine and DPT-IPV from other manufacturer. 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. In this case, autopsy was performed and did not reveal any significant findings. However, detailed autopsy report was not provided. As five vaccines were administered simultaneously, the role of each component cannot be assessed.Reported Cause(s) of Death: death nos Autopsy-determined Cause(s) of Death: death nos.


VAERS ID: 629558 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-02-18
Entered: 2016-02-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 14J01A / UNK UN / SC
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

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: 2016092600

Write-up: This is a spontaneous report from a contactable physician (forensic specialist). A 3-month-old male patient of unspecified ethnicity received simultaneously PREVENAR 13 (Lot number 14J01A, expiration date 31Aug2017) at 0.5 ml single, ACT-HIB at 1 dosage form single, hepatitis B vaccine (manufacturer unknown) at 1 dosage form single, rotavirus vaccine (manufacturer unknown) at 1 dosage form single and diphtheria vaccine/pertussis vaccine/polio vaccine/tetanus vaccine (manufacturer unknown) at 1 dosage form single all subcutaneously except oral rotavirus vaccine on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, in the morning of the next day of vaccination, the patient suddenly died. As of 12Feb2016, the cause of death was not reported and a legally-ordered autopsy was supposed to be conducted hereafter. No follow-up attempts are possible. No further information is expected.


VAERS ID: 629631 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2016-02-05
Onset:2016-02-05
   Days after vaccination:0
Submitted: 2016-02-18
   Days after onset:13
Entered: 2016-02-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
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: 2016-02-05
   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: Unknown, Cardiac disorder, severe
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2016090256

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 4-month-old female patient of unspecified ethnicity received PREVENAR 13 at 0.5 ml single and INFANRIX HEXA at 1 dosage form both via an unspecified route of administration, on 05Feb2016 at about 03:15 pm. Relevant medical history included severe cardiac disorder. Concomitant medications, if any, were not reported. The patient died during the night of 05Feb2016. Autopsy was performed but results were not provided.


VAERS ID: 623599 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-02-24
Entered: 2016-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute respiratory distress syndrome, Death, H1N1 influenza, Lower respiratory tract infection, Lymphopenia, Upper respiratory tract infection
SMQs:, Haematopoietic leukopenia (narrow), Interstitial lung disease (broad), Systemic lupus erythematosus (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), 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: 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: Non-Hodgkin''s Lymphoma refractory.
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLBEH2016058133

Write-up: Case Narrative: This medically confirmed literature report (initial receipt 19-Jan-2016) concerns an adult hematology-oncology patient (age, range 39-67 years; patient 5). The patient has a medical history of refractory T-cell non-Hodgkin lymphoma. Concomitant medications include a pre-allogeneic hematopoietic stem cell transplantation (pre-allo-HSCT) conditioning regimen. On an unknown date, the patient received a [?] well-matched'' influenza virus vaccine (brand and batch unknown). On an unknown date following influenza vaccination during the corresponding season, the hospitalized patient showed prolonged A(H1N1)pdm09 virus excretion sometime between November 2009 and April 2013. The patient experienced A(H1N1)pdm09 virus infection with no seroprotective HI Ab titers during onset of mild upper respiratory tract infection (URTI). Patient also developed severe lower respiratory tract infection (LRTI) and fatal viral ARDS. Oseltamivir ($g48 hr) and zanimivir ([?]48 hr) antiviral treatment was provided. Viral clearance did not occur. The patient''s serum HI titers were $g40 for the duration of A(H1N1)pdm09 infection. The patient displayed prolonged viral excretion during periods CD4+ and CD8+ T-cell lymphopenia. Virus excretion duration was not influenced by antiviral treatment, seroprotective HI titers or antibody-dependent cell-mediated cytotoxicity (ADCC) markers. The patient developed severe viral LRTI during profound CD4+ and CD8+ T-cell lymphopenia and intercurrent combined absence of ADCC markers. The onset of severe viral LRTI and ARDS during profound CD4+ and CD8+ T-cell lymphopenia coincided with innate cell-mediated immune reconstitution. The patient manifested granulocyte, monocyte and NK cell reconstitution after recent allo-HSCT. Viral clearance did not occur during profound CD4+ T-cell and CD8+ T-cell lymphopenia. Severe viral LRTI manifested during profound CD4+ and CD8+ T-cell lymphopenia and intercurrent absence of ADCC markers. The outcome was reported as death.***Case correction 16-Feb-2016: Core and assessments for AEs 1 to 6 and overall company assessment changed to unlisted for a fatal outcome. Reporter''s Comments: Reporter''s comments: The pathogenesis of severe influenza LRTI and ARDS remains unclear and is likely multifactorial. Patient 5 with (transient) profound T-cell lymphopenia and absence of ADCC markers developed severe virus-associated LRTI and ARDS during innate cell reconstitution. Our findings suggest that profound CD4+ and CD8+ T-cell lymphopenia and (transient) absence of ADCC markers may have provided a window of opportunity for the virus to reach lower alveolar compartments and trigger severe immunopathology by the excessive influx of neutrophils and macrophages. Vaccine improvements are needed to raise immunogenicity in this vulnerable patient group. Prolonged influenza virus excretion is associated with T-cell lymphopenia in hematology-oncology patients. CD8+ T-cells and ADCC markers afford clinical protection and combined CD4+ and CD8+ T-cell responses mediate viral clearance. Sender''s Comments: Company comments: Seriousness: Serious. Fatal. Listedness: Listed. Assessment based on the CCDS for CLS H1N1 Influenza Vaccine. Events reported are in the context of a potential lack of effect to the vaccine. Immunological response may be diminished if the patient is undergoing corticosteroid and immunosuppresant treatment. In this case, the patient is undergoing immunopuppressive treatment for stem cells transplant. This case is therefore assessed as listed. Causality: Unassessable. For the given population in the study, immunogenicity may not be as immediate or as robust as in healthier population. Although the author had specified the laboratory parameters and the clinical presentation during the time interval in scope of the article, there is no information on when the vaccine was received prior to onset of symptoms. A seroprotective response to influenza vaccines is anticipated 2 weeks after the vaccine is received, and laboratory parameters may not exhibit antibodies if investigated earlier. Company evaluation and comment: updated 22-Feb-2016. Seriousness: Serious. Fatal. Listedness: Unlisted. Assessment based on the CCDS for CLS H1N1 Influenza Vaccine, ARDS is unlisted. H1N1 Influenza infection and all other events are also unlisted due to fatal outcome. Causality: Unassessable. Events reported are in the context of a potential lack of effect to the vaccine. Immunological response may be diminished if the patient is undergoing corticosteroid and immunosuppressant treatment. In this case, the patient is undergoing immunosuppressive treatment for stem cells transplant. For the given population in the study, immunogenicity may not be as immediate or as robust as in healthier population. Although the author had specified the laboratory parameters and the clinical presentation during the time interval in scope of the article, there is no information on when the vaccine was received prior to onset of symptoms. A seroprotective response to influenza vaccines is anticipated 2 weeks after the vaccine is received, and laboratory parameters may not exhibit antibodies if investigated earlier.


VAERS ID: 629736 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-02-22
Entered: 2016-02-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Drug ineffective, Drug resistance, 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2016098073

Write-up: This is a spontaneous report from a contactable physician via the Regulatory Authority via an on-line database search. Regulatory authority report number E2B_00102222. This information was initially reported to Regulatory Authority between 09Jun2014 and 17Jul2014 from an unknown Agency (manufacturer control number 1402CAN004674). A 7-year-old patient of unspecified ethnicity received PREVNAR 13 at 0.5 ml single and PNEUMOVAX 23 at 1 dosage form single both via an unspecified route of administration, on unknown date. The patient also started to receive cefprozil (manufacturer unknown), on an unspecified date at an unspecified dose. Relevant medical history and concomitant medications were not reported. The patient experienced drug Ineffective, drug resistance and meningitis pneumococcal and died on an unspecified date. It was not reported if an autopsy was performed. The action taken for cefprozil was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 629737 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2016-02-16
Onset:2016-02-17
   Days after vaccination:1
Submitted: 2016-02-23
   Days after onset:6
Entered: 2016-02-25
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-17
   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: Sugar
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN2016GSK024242

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of unknown cause of death in a 6-month-old patient who received ENGERIX B pediatric. Co-suspect products included Sugar. On 16th February 2016, the patient received ENGERIX B pediatric and Sugar (oral) at an unknown dose and frequency. On 17th February 2016, 1 days after receiving ENGERIX B pediatric, 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 17th February 2016. 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 ENGERIX B pediatric. Additional details were provided as follows: After vaccination with ENGERIX B, in the meantime patient used sugared pills. On 17th February 2016, the patient was found dead at home. No other information was available.


VAERS ID: 629739 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-02-24
Entered: 2016-02-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arteriogram coronary abnormal, Cardiac disorder, Cardiomegaly, Cardiovascular insufficiency, Chest X-ray abnormal, Death, Echocardiogram abnormal, Feeding disorder, Heart injury, Impatience, Pneumonia, Screaming, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (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: Myocarditis, but neither any viruses or bacteria''s were found
Allergies:
Diagnostic Lab Data: On an unknown date the patient underwent laboratory examination; arteriogram coronary; lung X-ray; echocardiogram and coronarography; Arteriogram coronary, congenital abnorm ex; Chest X-ray, abnormal, heart enlargement; Echocardiogram, abnormal, heart damage
CDC Split Type: PL2016GSK022829

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of heart disorder in a 6-week-old female patient who received ENGERIX B pediatric. The patient''s past medical history included myocarditis (but neither any viruses or bacteria''s were found). On an unknown date, the patient received ENERGIX B pediatric at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced heart disorder (serious criteria death), circulatory insufficiency (serious criteria death and GSK medically significant), vomiting (serious criteria hospitalization), pneumonia (serious criteria GSK medically significant), screaming, impatience and feeding disorder. On an unknown date, the outcome of the heart disorder and circulatory insufficiency were fatal and the outcome of the vomiting, pneumonia, screaming, impatience and feeding disorder were unknown. The reported cause of death was circulatory insufficiency and heart disorder. It was unknown if the reporter considered the heart disorder, circulatory insufficiency, vomiting, pneumonia, screaming, impatience and feeding disorder to be related to ENGERIX B pediatric. Additional information was provided as follows: At 6 weeks of age, the patient received hepatitis B vaccine (brand unknown, but according to reporter''s relation in July 2013 this batch of that vaccine was withdrawn from market due to uneven texture). After a few days, the patient stopped suck from breast but was hungry and shouted impatiently. Shortly after that the patient started vomiting. One week after vaccination, the patient was transported to the hospital. The suspicion of pneumonia was established. On an unknown date, X-ray picture showed enlargement of heart, whereas echocardiography showed heart damage. The coronarography excluded congenital heart disease. It was concluded the patient need heart transplantation. On an unknown date, at the age of 4 months, the patient died of circulatory insufficiency due to heart damage was determined as cause of death.


VAERS ID: 629664 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-02-29
Entered: 2016-03-01
   Days after submission:1
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, Neoplasm malignant
SMQs:, 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: PL2016GSK027291

Write-up: This case was reported by a consumer via other and described the occurrence of cancer in a adult female 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 cancer (serious criteria death and GSK medically significant). On an unknown date, the outcome of the cancer was fatal. The reported cause of death was cancer. It was unknown if the reporter considered the cancer to be related to Hepatitis B vaccine. Additional details were provided as follows: The case was reported by the patient''s husband via a GSK employee. According to the reporter, the patient was vaccinated with hepatitis B vaccine and because of this she became ill on cancer and died. The reporter stated that the physician did not execute adequate qualifying examination before vaccination.


VAERS ID: 629676 (history)  
Form: Version 1.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-04-20
Onset:2015-04-26
   Days after vaccination:6
Submitted: 2016-03-01
   Days after onset:310
Entered: 2016-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0000308550 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Dysphagia, General physical health deterioration, Pneumonia aspiration, Pneumonia pneumococcal, Pyrexia, Streptococcus test positive
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-08-26
   Days after onset: 122
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: REMINYL
Current Illness: Dementia Alzheimer''s type
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Urinary pneumococcal antigen (26-APR-2015): positive; 04/25/2015, Body temperature, 37 degrees C; 04/26/2015, Body temperature, pyrexia, not provided
CDC Split Type: WAES1603JPN000063

Write-up: Initial information has been received from a physician via the Agency (reference no. V15101197), concerning a 74 year old male patient, who on 20-APR-2015 at around 16:00 was vaccinated parenterally with the first dose of PNEUMOVAX NP injection (lot# 0000308550, batch# 9MR01R; dose and expiry date were not reported). As for the special notes on the pre-vaccination interview form (including underlying disease, allergy, vaccination and diseases within the recent 1 month, medications currently taken, adverse reaction history and growth status), the patient had dementia of Alzheimer''s type and was taking REMINYL 4 mg tablet, 2 tablets in 2 divided doses daily. Family history was not reported. Concomitant therapies included also unspecified other antibiotic preparations. The patient''s body temperature before vaccination (on 20-APR-2015) was 37.0 degrees Celsius. On 26-APR-2015, the patient presented with pyrexia from 14:00 and visited the emergency outpatient department of the reporting hospital at 17:33. Urinary pneumococcal antigen was positive and the patient was diagnosed with pneumococcal pneumonia. The patient was urgently hospitalized on the same day. On an unspecified date in 2015, after admission, the patient''s condition improved with unspecified antibiotics (pneumococcal pneumonia was resolving). On an unspecified date, approximately in 2015, the patient repeatedly developed aspiration pneumonia due to decreased swallowing function (severe dysphagia also developed on an unknown date, approximately in 2015). On an unspecified date in 2015, the patient was placed under nutritional management with central venous catheter and peripheral parenteral nutrition due to severe dysphagia. On an unspecified date, approximately in 2015, gradual deterioration of general condition was noted. On 26-AUG-2015, the patient died. The cause of death was "gradual deterioration of general condition". Information on whether an autopsy was performed or not was not obtained. At the time of this report, the outcome of aspiration pneumonia and severe dysphagia was unknown. Reporter''s comment: It was considered that the vaccine was ineffective (not coded as an event by the Agency) and the patient developed pneumococcal pneumonia as a consequence of the natural course. The reporting physician felt that the events of pneumococcal pneumonia, aspiration pneumonia, severe dysphagia and gradual deterioration of general condition were not related to the vaccination with PNEUMOVAX NP with no other causative factors (including other diseases). Information has been received for a direct report from the Agency regarding a case provided by the physician. Additional information is not expected as no further information is available.


VAERS ID: 629679 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-01
Entered: 2016-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 1 UN / SC

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1602JPN012392

Write-up: Initial information has been received from a consumer concerning an elderly male patient of unknown age. Concurrent conditions or pertinent medical history were not reported. On an unknown date, when the patient was 85 or 90 year old, he was vaccinated for the first time with PNEUMOVAX NP (lot#, dose and frequency were unspecified) subcutaneously. Concomitant medications were not reported. On an unknown date, the patient died because of pneumonia without the second vaccination when he was about 100 year old. It was unknown whether an autopsy was performed. The reporter considered that pneumonia was serious due to death. The reporter did not assess the relatedness between PNEUMOVAX NP and pneumonia. Additional information is not expected since the reporter did not wish to be contacted.


VAERS ID: 629880 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-02
Entered: 2016-03-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Antibody test positive, Autopsy, Blood test normal, Bulbar palsy, CSF culture negative, Central nervous system inflammation, Coma scale abnormal, Coronary artery occlusion, Death, Depressed level of consciousness, Endocardial fibrosis, Endotracheal intubation, Gait disturbance, General physical health deterioration, Hypoaesthesia, Inguinal hernia repair, Intensive care, Lyssavirus test positive, Muscular weakness, Nerve conduction studies, Neurological examination abnormal, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Orchidopexy, Paralysis, Polymerase chain reaction, Rabies, Respiratory failure, Restlessness, Sensory loss, Somnolence, Tuberculin test negative, Vasodilatation, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (narrow), 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), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Akathisia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vasculitis (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), Hypokalaemia (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: Inguinal hernia
Preexisting Conditions: Myocardial infarction; Animal bite
Allergies:
Diagnostic Lab Data: Antibody test, Positive for rabies; Blood test, Normal; CSF culture, No bacteria; Coma scale, 15/15 to 10/15; Lumbar puncture, Normal with clear CSF; Nerve conduction studies, Motor conduction abnormality; Neurological examination, Sensory loss up to L2 segment; Nuclear magnetic resonance imaging, Inflammation of spinal cord, brain stem and thalam; Polymerase chain reaction, Negative for tuberculosis; Tuberculin test, Negative for tuberculosis; White blood cell count, Elevated unknown
CDC Split Type: LK2016GSK029855

Write-up: This case was reported in a literature article and described the occurrence of flaccid paralysis in a 45-year-old male patient who received Rabies Vaccine. The patient''s past medical history included myocardial infarction and dog bite. Concurrent medical conditions included inguinal hernia. On an unknown date, the patient received the 3rd dose of Rabies Vaccine. On an unknown date, an unknown time after receiving Rabies Vaccine, the patient experienced flaccid paralysis (serious criteria death, hospitalization and GSK medically significant), rabies (serious criteria death and GSK medically significant), consciousness decreased (serious criteria GSK medically significant), respiratory insufficiency (serious criteria GSK medically significant), lower extremities weakness of, numbness in leg, restlessness and drowsiness. The patient was treated with cefuroxime and acyclovir. On an unknown date, the outcome of the flaccid paralysis and rabies were fatal and the outcome of the consciousness decreased, respiratory insufficiency, numbness in leg, restlessness and drowsiness were not recovered/not resolved and the outcome of the lower extremities weakness of was unknown. The reported cause of death was respiratory paralysis and rabies. An autopsy was performed. The autopsy determined cause of death was vasodilatation and rabies. The reporter considered the flaccid paralysis to be related to Rabies Vaccine. It was unknown if the reporter considered the rabies, consciousness decreased, respiratory insufficiency, lower extremities weakness of, numbness in leg, restlessness and drowsiness to be related to Rabies Vaccine. Additional information was provided: This case was reported in a literature article and described the occurrence of rabies in a 45-year-old male who was vaccinated with unspecified rabies vaccines (manufacturer unknown) for post-exposure prophylaxis. The patient had history of unprovoked dog bite by a stray dog 20 days back. The patient''s concurrent condition included right-sided inguinal hernia. The patient had a medical history of myocardial infarction. No information on the patient''s family history was provided. No information on patient''s concomitant medication was provided. On unspecified dates, the patient received 3 doses of unspecified rabies vaccine (administration route and site unspecified; batch number not provided). On an unspecified date, an unknown period after vaccination with unspecified rabies vaccine, 1 patient presented to a local hospital for an elective right-sided inguinal hernia, mesh repair and orchidopexy. He underwent an uneventful intra-operative period. On post-operative day 1, he complained of weakness and numbness of the right leg and he was struggling to walk without aid. Neurological examination revealed a sensory loss up to L2 segment. There were no obvious constitutional symptoms or signs and no evidence of meningism. On the same day, he was transferred to the neuro-surgical unit at the other hospital for further investigation and management. On admission to the neuro-surgical unit he had downward plantar reflexes and motor power was less on the right lower limb in comparison to the left. Sensory level kept progressing up to T10 within the next 24 hours and an urgent magnetic resonance imaging (MRI) was done, which revealed inflammation of the spinal cord, brain stem and thalamus. Spinal haematoma was excluded. He became restless while in the ward and subsequently was found to be drowsy. With deteriorating levels in his Glasgow Coma scale (from GCS 15/15 to GCS 10/15) he was admitted to the neuro-intensive care unit for further management. Over the next 2 days, he developed an ascending flaccid paralysis and was intubated electively due to deteriorating level of consciousness and respiratory insufficiency. Diagnostic lumbar puncture was done which aspirated clear cerebrospinal fluid (CSF) and examination was normal. CSF culture did not grow any bacteria. Nerve conduction studies revealed motor conduction abnormality probably due to the involvement of the anterior horn cells or root by the same disease process of myelitis. Haematological and biochemical investigations were normal except for an elevated white cell count. Polymerase chain reaction and Mantoux test for tuberculosis was negative. A tracheostomy was performed early to facilitate weaning and removal of secretions. Within the next five days, he continued to deteriorate despite ventilatory and inotropic support. Antibiotics were commenced empirically. He was treated with intravenous cefuroxime 750mg 8 hourly along with intravenous acyclovir 500mg 8 hourly during his ICU stay. Seven days later, a vaccination record was produced by his relative whereby he was scheduled to receive his fourth and final dose of the anti-rabies vaccine while in intensive care unit (ICU). This information had not been conveyed to the anaesthetist at the local hospital prior to surgery neither by the patient or his family members. Antibody assay for rabies was positive. Despite maximum support in ICU he succumbed after 15 days following bulbar and probably respiratory muscle paralysis secondary to what was believed to be paralytic rabies. Post-mortem findings revealed a congested dura with dilated blood vessels and lymphocyte aggregation in peripheral regions of the spinal cord and perivascular cuffing which was in favour of a viral infection. Except for endocardial fibrosis and coronary artery occlusion (confirming an old myocardial infarction) the rest of the organs were unremarkable. Virology studies on the brain confirmed the diagnosis as Rabies. The authors did not comment on relationship between rabies and unspecified rabies vaccine. However they stated that the main concern in the patient was the probability of reduction in the efficacy of the vaccine due to immunosuppressive effect of anaesthesia and surgery. The authors stated that "A lesson that we could learn from this case report is that details of any pre or post exposure prophylaxis with regard to immunization already given must be recorded during the pre-operative assessment and it is also mandatory to document and explain the possible consequences to the patient prior to anaesthesia, although it has been reported rarely, that rabies vaccine per se can cause a neurological illness simulating "Guillain Barre" syndrome after post-exposure prophylaxis."


VAERS ID: 625336 (history)  
Form: Version 1.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2015-10-25
Onset:2016-02-21
   Days after vaccination:119
Submitted: 2016-03-04
   Days after onset:12
Entered: 2016-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UI425AC / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Cough, Diarrhoea, General physical health deterioration, Influenza, Influenza A virus test positive, Pneumonia, Polymerase chain reaction, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: 7 YEARS OF EVOLUTION (2009, EXACT DATE WAS NOT PROVIDED)
Preexisting Conditions: Medical History/Concurrent Conditions: WITH 7 YEARS OF EVOLUTION (2009, EXACT DATE WAS NOT PROVIDED)
Allergies:
Diagnostic Lab Data: 2009, blood pressure, Normal; 20160221, Influenza A virus test, Positive; 20160221, body temperature, 38.5 Celsius temperature
CDC Split Type: MXSA2016SA037122

Write-up: Initial unsolicited report received from a physician on 22-Feb-2016. This case involves an 83-years-old female patient who was vaccinated with a 0.5 ml dose of Fluzone Quadrivalent (batch number: UI425AC, expiry date: 03-Jun-2016) via intramuscular route in the left deltoid on 25-Oct-2015. The patient had medical history of angina heart disease with 7 years of evolution (2009, exact date was not provided) in treatment with several unknown drugs. It was reported that, on an unspecified date it was fitted with a permanent pacemaker as corrective treatment for the heart disease and history of arterial hypertension with 7 years of evolution (2009, exact date was not provided) in treatment with several unknown drugs. It was reported that during the treatment patient''s blood pressure levels were unknown. Concomitant medications were not reported. On 21-Feb-2016, 119 days after the vaccination, the patient experienced Pneumonia for type A influenza, cough, fever (38.5 degree Celsius), diarrhea, stomachache and overall decrease. On 21-Feb-2016, the patient was hospitalized. Laboratory investigations included blood pressure (results were unknown), rapid test for confirmation of influenza was positive to type A influenza and confirmatory PCR results were pending. Patient was prescribed 1 oral capsule 75 mg of Tamiflu every 12 hours and Avelox (route of administration, concentration and dose not provided). On 22-Feb-2016 the patient''s physician increased the dose of Tamiflu from 75 mg to 150 mg every 12 hours and added to the pretreatment ciprofloxacin and Fotamicin as a measure to reduce the exacerbation of pneumonia symptoms. At the time of this report the patient had not recovered from any adverse event. The duration of the hospitalization was 2 days approximately. Upon internal review, the case was considered as serious due to important medical events Pneumonia for type A influenza and Influenza. List of documents held by sender: none. Sender''s Comments: The events Pneumonia for type A influenza and diarrhea are unlisted, while other event is listed for INFLUENZA QUADRIVAL A-B VACCINE. Time to onset is not compatible. In this particular case, information about relevant medical history, allergies or concomitant medications, if any, are not provided. The suspected product is used as prophylaxis for type A influenza. Hence, considering this factor causality for Pneumonia for type A influenza with the suspect product can be excluded.


VAERS ID: 629874 (history)  
Form: Version 1.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2015-01-01
Submitted: 2016-03-04
   Days after onset:428
Entered: 2016-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Death, Dementia, Fall, Feeling abnormal, Headache, Pneumonia aspiration
SMQs:, Dementia (narrow), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1603JPN002073

Write-up: Initial information has been received from a consumer''s family concerning a 91 year old male patient who on an unspecified date was periodical vaccinated subcutaneously with PNEUMOVAX NP (Date of vaccination, dose and Lot Number not reported). Concomitant medication was not reported. In December 2014, the patient developed dementia. There was a facility in the same place of the hospital he usually went to, but no vacant beds at that time. Therefore, the patient was admitted to the hospital. On an unspecified date, the patient fell and complained of "headache" and "feeling poorly". In January 2015, the patient died due to developing pneumonia aspiration no longer than one month after he was hospitalized. The cause of death was pneumonia aspiration. Information on the autopsy was not reported. At the time of this report, the outcome of "dementia" "fall" "headache" "feeling poorly" were unknown. The reporter''s comment: not reported. The reporter considered that the pneumonia aspiration was serious due to death and the dementia was serious due to hospitalization. The reporter did not assess the seriousness of the "fall" "headache" and "feeling poorly". The reporter did not assess the relationship of "pneumonia aspiration" "dementia" "fall" "headache" and "feeling poorly" to PNEUMOVAX NP. Follow-up attempt was not made because the reporter did not wish to be contacted.


VAERS ID: 630816 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:2016-03-02
Onset:2016-03-03
   Days after vaccination:1
Submitted: 2016-03-07
   Days after onset:4
Entered: 2016-03-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L000428 / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-03
   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: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1603FIN002729

Write-up: Information has been received from Sanofi Pasteur MSD (reference # FI-1577272925-2016001967) on 04-MAR-2016. Case received from a nurse via the Health Authorities (HA report not yet received) on 03-MAR-2016. A 2-month-old infant patient of unknown sex received ROTATEQ (batch/lot number L000428, expiry date not reported) via oral route on 02-MAR-2016. The patient died on 03-MAR-2016. The patient''s outcome was reported as Fatal.


VAERS ID: 631286 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-08
Entered: 2016-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Ill-defined disorder; Pneumonia; Myelodysplastic syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1603JPN003339

Write-up: Initial information has been received from a consumer concerning a patient of unknown age and gender, with pneumonia, myelodysplastic syndrome and many other disorders, who had received vaccination together with the reporter. On an unspecified date, the reported patient was vaccinated with PNEUMOVAX NP injection drug, (Lot. number, anatomical location, vaccination date and dose were not reported). There was no concomitant medication reported. In 2015, the patient died. The cause of death was pneumonia. Information of the autopsy was not provided. The reporter did not assess the relationship of death due to pneumonia to pneumococcal vaccine. This case is linked to case 1603JPN003424. Additional information is not expected, since the reporter did not wish to be contacted.


VAERS ID: 631295 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-08
Entered: 2016-03-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-29
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: ES2016GSK032059

Write-up: This case was reported by a nurse via call center representative and described the occurrence of bacterial meningitis in a 18-month-old female patient who received BEXSERO. On an unknown date, the patient received BEXSERO (intramuscular) In February 2016, an unknown time after receiving BEXSERO, the patient experienced bacterial meningitis (serious criteria death and GSK medically significant) and fever. On 29th February 2016, the outcome of the bacterial meningitis was fatal. On an unknown date, the outcome of the fever was unknown. The patient died on 29th February 2016. The reported cause of death was meningitis. The reporter considered the bacterial meningitis and fever to be possibly related to BEXSERO. Additional information was provided as follows: This case was reported by the patient''s mother. The patient was vaccinated with one dose of BEXSERO in 2016. In February 2016, the patient started with fever and then was taken to the hospital where she was diagnosed with meningitis. On 29th February 2016, the patient died due to bacterial meningitis. No further information could be obtained.


VAERS ID: 631304 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-09
Entered: 2016-03-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bordetella test positive, Death, Foetal exposure during pregnancy, Pertussis
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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:
Allergies:
Diagnostic Lab Data: Laboratory test, Bordetella pertussis positive
CDC Split Type: ES2016GSK032025

Write-up: This retrospective pregnancy case was reported by a non-health professional via other and described the occurrence of pertussis in a unk infant exposed to dTpa in utero. The mother received the product. On an unknown date, the mother received dTpa vaccine. The mother''s last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The infant was exposed to dTpa vaccine at week 26 of gestation and during the second trimester of pregnancy. The infant was diagnosed with pertussis (serious criteria death, hospitalization and GSK medically significant) and maternal vaccine exposure. On an unknown date, the outcome of the pertussis was fatal and the outcome of the maternal vaccine exposure was unknown. The reported cause of death was pertussis. The reporter considered the pertussis and maternal vaccine exposure to be related to dTpa vaccine. Additional information was provided as follows: The patient''s mother received a dose of dTpa when she was 26 week pregnant. The patient was breastfed. The patient was admitted in a health centre due to whooping cough. Laboratory test was confirmed to be positive for Bordetella Pertussis. Two days after hospitalisation, the patient died due to whooping cough. No further information was available.


VAERS ID: 631357 (history)  
Form: Version 1.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-03-01
Submitted: 2016-03-10
   Days after onset:1105
Entered: 2016-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cervix carcinoma, Death, Smear cervix abnormal
SMQs:, Uterine and fallopian tube malignant tumours (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Smear cervix, Cervical cancer; Smear cervix, Did not pick it up
CDC Split Type: WAES1603AUS003337

Write-up: This spontaneous report was received from a consumer referring to a 33 year old female patient. Concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, when the patient was younger, the patient was vaccinated with a dose of cervical cancer vaccine (manufacturer unknown) (dose, route lot and expiration date not reported). The reporter stated that she had her regular pap smears her whole life (reported as most recently in December (year unspecified), which did not pick it up. Approximately in 2013, the patient was admitted to the hospital and over a week later, diagnosed with cervical cancer (March 2013) from which later died (date unspecified). Additional information is not expected.


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

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

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

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


VAERS ID: 631472 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-11-25
Onset:2016-02-12
   Days after vaccination:1540
Submitted: 2016-03-09
   Days after onset:26
Entered: 2016-03-14
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 4 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Cardio-respiratory arrest, Death, Drain placement, Influenza, Multiple organ dysfunction syndrome, Pathogen resistance, Pleural effusion, Pneumonia pneumococcal, Streptococcus test positive
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), 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), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-14
   Days after onset: 2
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: Unknown
Allergies:
Diagnostic Lab Data: Blood culture, Pneumococcus, serotype 14; Culture, Pneumococcus, serotype 14
CDC Split Type: 2016138600

Write-up: This is a spontaneous report from several contactable physicians. A 5-year-old female patient of an unspecified ethnicity received 4 doses of the PREVENAR 13: 1st dose on 28Jun2010, 2nd dose on 06Aug2010, 3rd dose on 23Noc2010 and 4th dose on 25Nov2011, each one at 0.5 ml single. The patient medical history and concomitant medications were not reported. The patient was previously healthy. On 12Feb2016, the patient was brought to the emergency department and was hospitalized due to pneumococcal pneumonia with pleural effusion, serotype 14. The patient was transferred on the same day to a peadiatric central hospital, due to clinical instability. The diagnosis was influenza A and Pneumococcal pneumonia. Blood culture and culture of the pleural fluid performed on an unknown date identified Pneumococcus, serotype 14. Pneumococcus was resistant to amoxicillin and clindamycin antibiotic treatment. Therapeutic measures taken as a result of pneumococcal pneumonia with pleural effusion included drain placement. At the central hospital ventilation was not possible and the patient deceased on 14Feb2016 at the hospital due to pneumococcal pneumonia with pleural effusion and influenza A. Additional causes of death (not events due to vaccine) were cardiorespiratory arrest and multiorgan failure. An autopsy was not performed.


VAERS ID: 631673 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-26
Onset:0000-00-00
Submitted: 2016-03-16
Entered: 2016-03-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Pain in extremity, Rhabdomyosarcoma
SMQs:, Tendinopathies and ligament disorders (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-01-26
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: Immunisation, cause of death: Not medically reported
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1603SWE007306

Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number SE-1577272925-2016002366) on 15-MAR-2016. Case received from a consumer/other non health professional via company MSD on 10-MAR-2016. The primary reporter was a relative to the patient. A female patient of unknown age received GARDASIL (batch number unknown) on 26-NOV-204. The patient experienced rhabdomyosarcoma on an unknown date. The family was worried that the vaccination have caused the patient''s rhabdomyosarcoma. The patient died on 26-JAN-2016. According to the family, the symptoms from the came quickly after the vaccination on 26-NOV-2014 and health care was sought in January 2015. Another family member who was the reporter, informs that the patient had pain in arm the entire fall after the summer. The reporter was married to the patient''s uncle. The reporter met the girl alone for two days initially before health care was sought. The reporter met the girl alone two days before treatment was applied initially and perceived that she had pain symptoms (recognition) in the long arm (early fall) and she recently got cold symptoms. Had at the health care contact in January 2015 fluid in the lung and was admitted urgently to hospital for treatment and investigation. It has not been clear to the reporter that the family believe that the vaccine has caused this until after a conversation with the family. The reporter''s understanding was that the close family feel bad because they turned a blind eye to her complaint and not sought treatment. Both the original tumor and the relapse came in December 2015. to find causes beyond themselves. The mother of the patient has been skeptical towards vaccines in general and approved the vaccination reluctantly. Unfortunately, the girl dose not live anymore so it not possible to (not further specified). The patient was young and otherwise healthy. The patient''s outcome was reported a Fatal.


VAERS ID: 631905 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Male  
Location: Foreign  
Vaccinated:2016-02-25
Onset:2016-02-27
   Days after vaccination:2
Submitted: 2016-03-15
   Days after onset:16
Entered: 2016-03-17
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENHIB: MENINGOCOCCAL CONJUGATE + HIB (MENITORIX) / GLAXOSMITHKLINE BIOLOGICALS A76CA287A / UNK UN / IM
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS A69CD904A / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L70547 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: CSF lymphocyte count increased, Computerised tomogram normal, Death, General physical health deterioration, Intensive care, Malaise, Nervous system disorder, Partial seizures, Resuscitation, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Malignant lymphomas (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-27
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Computerised tomogram, normal; Lumbar puncture, a few lymphocytes
CDC Split Type: 2016152399

Write-up: This is a spontaneous report received from a physician via the contactable Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-ADR 23376470. A 13-month-old male patient of an unspecified ethnicity received PREVENAR 13 (batch number L70547) single dose, MENITORIX (batch number A76CA287A) at 1DF single dose and MMR II (batch number A69CD904A) at 1DF single dose all of them given intramuscularly on 25Feb2016. The patient medical history included no allergies. The patient''s concomitant medications were not provided. It was reported that the patient had no prescribed medications however he may have used paracetamol, ibuprofen etc. On 27Feb2016, the patient died. The child became unwell two days later of immunisations being given therefore 999 emergency services were called and the patient was taken to the hospital. He had a rapid deterioration on admission. He also presented focal neurology and seizures. The patient underwent lab tests and procedures which included lumbar puncture showing few lymphocytes and computerised tomography (CT) scan resulting normal. The patient died in spite of full resuscitation and intensive care unit (ITU). The cause of death was reported as unexplained. It was unknown whether an autopsy was performed. The patient was not recovered from focal seizures, being unwell and neurologic disorder at the time of death.


VAERS ID: 632085 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-18
Entered: 2016-03-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 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: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1603POL008318

Write-up: Information has been received from a physician via a representative referring to an 11 year old female patient with asthma. Beyond the asthma diagnosis the patient was healthy. On an unknown date in 2015 the patient was vaccinated with the second dose of SILGARD (dose, route, lot# and expiration date were unknown). Concomitant medication was not reported. On an unknown date in 2015, about one week after the vaccination, the patient died at her home. An autopsy was done but it did not reveal the death cause. Additional information has been requested.


VAERS ID: 628234 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-21
Entered: 2016-03-21
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: FR2016GSK038708

Write-up: This case was reported by a consumer via market research programs and described the occurrence of unknown cause of death in a adult female patient who received Flu seasonal TIV Dresden. On an unknown date, the patient received Flu seasonal TIV Dresden at an unknown dose. On an unknown date, an unknown time after receiving Flu seasonal TIV Dresden, 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 Flu seasonal TIV Dresden. Additional details were provided as follows: The reporter reported that she did not want to be vaccinated because of the adverse events, especially for the vaccine against influenza. She reported that she believed the vaccine against influenza had killed her mother. No other information would be provided.


VAERS ID: 632132 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2016-03-02
Onset:2016-03-03
   Days after vaccination:1
Submitted: 2016-03-17
   Days after onset:13
Entered: 2016-03-21
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC636A / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L84250 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-03
   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: Paracetamol
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 02-MAR-2016, Physical examination, normal
CDC Split Type: 2016156904

Write-up: This is a spontaneous report received from the Agency, regulatory authority report number PB20160272. A 02-month-old male patient received one dose of the following suspect vaccines by unspecified route, on 02Mar2016, at 05.00 pm: PREVENAR 13 (lot number L84250) at 0.5 ml, single and INFANRIX HEXA (lot number A21CC636A) at 1 DF single. No relevant medical history was provided. Concomitant medication included paracetamol (unspecified trade name) 1 dose of 6 kg in a single routine administration on 02Mar2016 (no fever reported). On 02Mar2016, the patient took his baby bottle at 08.00 pm. On 03Mar2016, at 03.40 am, the patient took another baby bottle but only 120 ml over 150 ml. The mother took the patient with her in the bed, and the patient fell asleep against her. On 03Mar2016, the patient was subject to sudden infant death. At 08.00 am when the mother woke up, she found the patient dead. The medical report was reportedly pending. Based on the Method of Causality Assessment, the causal relationships between the suspect vaccines and the adverse event sudden infant death were assessed by the Agency as "doubtful". No follow-up attempts are possible. No further information is expected.


VAERS ID: 632140 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-21
Entered: 2016-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood electrolytes normal, Blood glucose normal, Communication disorder, Death, Depressed level of consciousness, Encephalitis viral, Hyperreflexia, Hypertonia, Liver function test normal, Malaise, Neurological decompensation, Nuclear magnetic resonance imaging brain abnormal, Pyrexia, Renal function test normal, Somnolence, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Hypokalaemia (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: No other medications
Current Illness: Animal bite, one month before onset of symptoms
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On physical examination, he showed increased muscular tone in all four limbs, with hyperreflexia. Extensor plantar responses were seen bilaterally. Magnetic Resonance Imaging brain revealed ill-defined T2/fluid-attenuated inversion recovery (FLAIR) hyperintense lesions involving the dorsal aspect of the medulla, pontine tegmentum, periaqueductal gray matter, collicular plate, as well as the central white matter of the midbrain. Foci of hyperintense signal were also seen in bilateral thalami, hypothalmi, and hippocampi. T2/FLAIR hyperintensities were also seen in cervical cord. The involved regions showed low signal intensity on T1-weighted (T1W) imaging. Diffusion-weighted (DW) imaging revealed a mild increase in the apparent diffusion coefficients (ADCs) in the involved regions. No evidence of blooming was seen in these areas. There was a subtle mass effect with effacement of the aqueduct and third ventricle. The basal ganglia and cortical gray matter and white matter showed normal signal intensity.
CDC Split Type: IN2016GSK038678

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a 5-year-old male patient who received Rabies NVS vaccine. Co-suspect products included Rabies NVS vaccine and Rabies NVS vaccine. Concurrent medical conditions included dog bite (one month before onset of symptoms). On an unknown date, the patient received the 1st dose of Rabies Vaccine, the 2nd dose of Rabies Vaccine and the 3rd dose of Rabies Vaccine. On an unknown date, less than a month after receiving Rabies Vaccine, Rabies Vaccine and Rabies Vaccine, the patient experienced vaccination failure (serious criteria death and GSK medically significant) and encephalitis viral (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure and encephalitis viral were fatal. The reported cause of death was viral encephalitis. It was unknown if the reporter considered the vaccination failure and encephalitis viral to be related to Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Additional information was provided: This case was reported in a literature article and described the occurrence of possible vaccination failure in a 5-year-old male who was vaccinated with unspecified anti-rabies vaccine (manufacturer unknown). The patient was bitten on the hands and face by a dog. No information on the patient''s medical or family history or concurrent condition was provided. No information on the patient''s concomitant medication was provided. On unspecified dates, the patient received 3 doses of unspecified anti-rabies vaccine (administration route and site unspecified; batch number not provided). On an unspecified date, an unknown period after vaccination with unspecified anti-rabies vaccine and one month after the bite, the patient presented with prodromal symptoms in the form of fever and malaise followed by altered sensorium, drowsiness and irrelevant talking. On physical examination, he showed increased muscular tone in all four limbs, with hyperreflexia. Extensor plantar responses were seen bilaterally. No signs of meningitis were seen. On day 6 after the onset of symptoms, to rule out other causes of neurological deficits, Magnetic Resonance Imaging (MRI) brain was performed on a 1.5-Tesla scanner, which revealed ill-defined T2/fluid-attenuated inversion recovery (FLAIR) hyperintense lesions involving the dorsal aspect of the medulla, pontine tegmentum, periaqueductal gray matter, collicular plate, as well as the central white matter of the midbrain. Foci of hyperintense signal were also seen in bilateral thalami, hypothalami, and hippocampi. T2/FLAIR hyperintensities were also seen in cervical cord. The involved regions showed low signal intensity on T1-weighted (T1W) imaging. Diffusion-weighted (DW) imaging revealed a mild increase in the apparent diffusion coefficients (ADCs) in the involved regions. No evidence of blooming was seen in these areas. There was a subtle mass effect with effacement of the aqueduct and third ventricle. The basal ganglia and cortical gray matter and white matter showed normal signal intensity. The findings were consistent with those of rabies encephalitis. Blood glucose, serum electrolytes, renal function tests, and liver function tests were found to be within normal limits. The neurological status of the patient continued to deteriorate. After 3 days, the patient expired. Considering the characteristic clinical presentation and rapid progression of the illness to death, laboratory confirmation of the disease was not obtained. No information on autopsy was provided. This was considered a possible vaccination failure. This case was considered serious due to death. Treatment was unknown. The outcome of the event was death. The authors did not comment on the relationship between the possible vaccination failure and unspecified anti-rabies vaccine. The authors stated that "Though rabies encephalitis has classical clinical features, MRI is the imaging of choice for its early diagnosis and it helps to differentiate rabies encephalitis from other encephalitis. Early diagnosis of rabies does not have any impact on patient prognosis, but it does enable prompt institution of public health measures." The article is not available for regulatory submission due to copyright restrictions.


VAERS ID: 628609 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Male  
Location: Foreign  
Vaccinated:2015-07-30
Onset:0000-00-00
Submitted: 2016-03-22
Entered: 2016-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC193A / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J58438 / UNK UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K012867 / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death neonatal, Escherichia infection, Sepsis, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Respiratory failure (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-08-17
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: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1603NZL009382

Write-up: Information was obtained on a request by the Company from the Agency concerning an 8 weeks old male patient (also reported as 6 weeks old). The patient''s concurrent conditions included other medical conditions (details were not reported). It was unknown whether the patient had any pre-existing renal or hepatic diseases, known allergies, familial factors, other chemicals or nutritional supplements and if he underwent any recent surgery, transfusion or had an X-ray with contrast media performed. On 30-JUL-2015, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) orally, 2 ml, lot # K012867 (expiration date was not reported). Other suspect therapies included DTaP-IPV-HepB-Hib (intramuscularly, 0.5 ml, lot # A21CC193A, site of administration and expiration date were not reported) and pneumococcal 13v conj vaccine (intramuscularly, 0.5 ml, lot # J58438, site of administration and expiration date were not reported), both of which were administered on 30-JUL-2015. the patient was well after the vaccinations. It was reported that the drug was not reduced and that no rechallenge was performed, however dechallenge was provided as no improvement. On 11-AUG-2015, the patient was admitted to hospital with Escherichia coli (E-coli) bacterial septicaemia of unknown source. He was discharged on 14-AUG-2015, attending daily for intravenous antibiotics (unspecified). On 17-AUG-2015, the patient died at home (reported as sudden death). The case was referred to the Coroner but at the time of reporting no further details were available. The Agency considered the event of sudden death to be severe and serious. The relatedness between the event and rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) was unknown (reported as unclassified). 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: 628727 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2016-03-16
Onset:0000-00-00
Submitted: 2016-03-23
Entered: 2016-03-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR L0067 / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-17
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: CNSA2016SA055301

Write-up: Initial unsolicited report received from the Health Authority via company representative on 17 March 2016. This case involves a two month female patient who was vaccinated with a first primary intramuscular 0.5 ml dose of Imovax Polio (batch number, expiration date, site of administration was not reported) on 16 March 2016. The patient medical history and concomitant medications were not reported. On 17 March 2016, one day following vaccination, patient died at 5:00 A.M. Lab data and corrective treatment was not reported. List of documents held by sender: none. Sender''s Comments: This case of sudden unexplained death is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Most frequent causes of sudden death in infants include infections, sudden infant death syndrome, inherent errors in metabolism, undiagnosed congenital anomalies. More information including and not limited to detailed autopsy report with review of the circumstances of death, clinical history, patient''s medical history, previous immunization history and its tolerance are needed to further assess this case. Reported Cause(s) of Death: death NOS.


VAERS ID: 629019 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-23
Entered: 2016-03-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: 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: 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: Myocardial ischaemia; Cardiac failure congestive
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZ2016GSK040703

Write-up: This case was reported in a literature article and described the occurrence of sudden cardiac death in a subject who received Flu seasonal TIV Dresden. Concurrent medical conditions included myocardial ischemia and congestive heart failure. On an unknown date, an unknown time after receiving Flu seasonal TIV Dresden, the subject developed sudden cardiac death. Serious criteria included death and GSK medically significant. The outcome of sudden cardiac death was fatal. The reported cause of death was cardiac arrest. It was unknown if the investigator considered the sudden cardiac death to be related to Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of sudden cardiac death in a patient of unspecified gender and age who had received an unspecified influenza vaccination (manufacturer unknown). The patient''s concomitant condition included myocardial ischemia and congestive cardiac failure. No further information on the patient''s concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date, the patient received an unspecified influenza vaccination. Dosage unknown; administration route and site unspecified; batch number was not provided. On an unspecified date between, an unknown time after the vaccination, the patient died of a sudden cardiac event. The death was reported to the national Centre for Adverse Reactions Monitoring. This was a fatal case. Cause of death was an unspecified cardiac event and it is unknown if a post-mortem was performed. Treatment was unknown. The authors commented that there was a temporal relationship between the vaccine and the event. The authors did not include any conclusion.


VAERS ID: 633079 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2016-02-01
Onset:2016-02-01
   Days after vaccination:0
Submitted: 2016-03-21
   Days after onset:48
Entered: 2016-03-23
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cyanosis, Death, Pallor
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (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: 2016162322

Write-up: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 5-month-ld male patient of an unspecified ethnicity received second dose of PREVENAR 13, at single dose on an unspecified date in Feb2016. The patient medical history and concomitant medications were not reported. In Feb2016, after vaccination, the patient was pale. On Mar2016, a month after vaccination, the patient experienced cyanosis. The patient''s condition worsened and he was rushed to a district hospital and later transferred to regional medical center for thorough diagnosis and treatment. The patient died on Mar2016 due to the events. It was not reported if an autopsy was performed.


VAERS ID: 633198 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-24
Entered: 2016-03-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Foetal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: NZ2016GSK040684

Write-up: This retrospective pregnancy case was reported in a literature article and described the occurrence of unknown cause of death in a neonate. The mother received dTpa vaccine (reduced antigen). The neonate was exposed to dTpa vaccine during the third trimester of pregnancy. The pregnancy resulted in a live neonate with no apparent congenital anomaly. The neonate was diagnosed with unknown cause of death. Serious criteria included death and GSK medically significant. Additional event(s) included maternal vaccine exposure. The outcome of unknown cause of death was fatal. The outcome(s) of the additional event(s) included maternal vaccine exposure (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 dTpa vaccine. Additional information was provided: This retrospective pregnancy case was reported in a literature article and it described the occurrence of a death in an infant whose mother had received BOOSTRIX during pregnancy (GlaxoSmithKline). The patient''s mother had received the vaccine as part of a campaign. However, the infant''s follow-up was performed as a part of a prospective observational study that only recruited women who were compliant with their antenatal care and who had had at least one ultrasound scan early in pregnancy. Women whose foetuses were found to have congenital anomalies, severe structural or chromosomal abnormalities during prenatal screening were excluded. No further information on the maternal obstetric history, expected date of delivery, date of last menstruation, patient''s concurrent medical conditions, medical and family history or concomitant medication was provided. On an unspecified date, between 28 and 38 weeks of gestation, the patient''s mother received a dose of BOOSTRIX. Dosage: Unknown; administration route unspecified; batch number not provided. On an unspecified date between September 2012 and May 2014, an unknown period after the vaccination, the patient was delivered and subsequently died. (Gestation, details of the delivery and Apgar scores unspecified). This was a fatal case, but the cause of death was not specified and it is unknown if a post-mortem was performed. Treatment was unknown. The authors did not comment on any possible causal relationship between the vaccine and the event. The authors concluded that "Administering tetanus-diphtheria-acellular pertussis vaccine during pregnancy has previously been demonstrated to provide protection for infants from pertussis during epidemics. We have shown no difference in infant outcomes in those who have been exposed to the vaccine in pregnancy when compared with the overall population. This provides further evidence to back up recommendations for vaccinating pregnant women with tetanus-diphtheria-acellular pertussis vaccine to prevent pertussis in their infants. However, the data on vaccine safety remain limited, and the need for ongoing surveillance and reporting of adverse events relating". This case is 1 of the 15 valid cases reported in the same literature article.


VAERS ID: 629370 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2015-12-24
Onset:2015-12-26
   Days after vaccination:2
Submitted: 2016-03-28
   Days after onset:92
Entered: 2016-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 201612692 / 1 RA / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR K0143 / 2 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Circulatory collapse, Death, Ear haemorrhage, Epistaxis, Mouth haemorrhage, Pneumonia, Respiratory failure
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), 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), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-12-26
   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: CNSA2016SA056470

Write-up: Initial unsolicited report received from a health authority (CDC) via company representative on 17 March 2016. This case involves a three-month-old male patient who was vaccinated with a 0.5 ml second primary dose of IMOVAX POLIO (batch number, expiry date were not reported) intramuscularly in thigh and also received a first primary dose of DTP (batch number, expiry date was not reported) intramuscularly in arm, both vaccine was administered on 24 December 2015. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced bilateral pneumonia, respiratory and circulatory failure. On 25 December 2015, patient was given breastfeeding. (at about 11:00 pm). On 26 December 2015, two days post vaccination, the patient fell asleep at about 0:00 am and nothing abnormal occurred to the patient. The autopsy results states that he had experienced respiratory and circulatory failure caused by bilateral pneumonia. Laboratory investigation and corrective treatment were not reported. On 26 December 2015 (at about 5:00 AM), patient found dead (fatal). There was dark red blood outflowed from the patient''s ear and mouth and there was bloody foam around the patient''s nose. List of documents held by sender: none. Sender''s Comments: This case report involves a 3 months old male infant who died two days after receiving IPV (VERO) and DIPHTHERIA AND TETANUS TOXOIDS AND PERTUSSIS of another manufacturer. Few clinical details were reported. Autopsy evidenced respiratory and circulatory failure caused by a bilateral pneumonia, however complete autopsy results were not provided. Given the short latency between the vaccinations and death, the underlying pneumonia likely started before the vaccinations. The role of the vaccines can therefore be reasonably excluded. For further assessment, more information including but not limited to detailed autopsy report with review of the circumstances of death, clinical history, patient''s medical history, and additional testing to identify the responsible pathogen would be needed. Reported Cause(s) of Death: bilateral pneumonia; Respiratory and circulatory failure; Autopsy-determined Cause(s) of Death: bilateral pneumonia; Respiratory and circulatory failure.


VAERS ID: 633347 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-03-23
Entered: 2016-03-28
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 4 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cerebral venous thrombosis, Death, Meningitis pneumococcal
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-04
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: AUG-2011, Premature birth; Mastoiditis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2016163938

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sale representative. A 4-year-old female patient, born prematurely, had received 4 doses of PREVENAR 13 but the dates, lot numbers, route and sites of injections were unknown. It was only confirmed that the patient vaccination schedules were up to date. The patient had received also an unspecified hexavalent vaccine and unspecified measles, mumps and rubella vaccine. The patient had a medical history of bilateral mastoiditis, otherwise her health status was good. Concomitant medications, if any, were not reported. On 04Feb2016, the patient experienced pneumococcal meningitis complicated with cerebral thrombophlebitis. The patient was hospitalized for the events. Therapeutic measures taken in response to the events were unknown. The patient died in Feb2016. The reporter was not able to indicate the exam that led to diagnosis and the pneumococcal serotype.


VAERS ID: 629844 (history)  
Form: Version 1.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-09-17
Onset:0000-00-00
Submitted: 2016-03-29
Entered: 2016-03-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED 30349421A / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cerebral haemorrhage, Death
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-11-09
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: GBBEH2016060368

Write-up: This consumer spontaneous report (initial receipt 16-Mar-2016) concerns a 40 year-old male patient. On the 17-Sep-2015, the patient received Enzira (Influenza virus vaccine polyvalent, batch number 30349421A). On an unspecified date, the patient developed a bleed in his brain. He died on the 09-Nov-2015. The outcome was fatal. Reporter''s Comments: The patient''s family thought that the reason for his death was the administration of the vaccine. Sender''s Comments: Company comments: Seriousness: Serious. Fatal outcome. Listedness: Unlisted. Assessment according to the CSL Inactivated Influenza Virus Vaccine CCDS and Afluria Product Information, bleed in the brain is unlisted. Causality: Unassessable. Time to onset of intracranial bleeding was not specified but fatal outcome was approximately 7 weeks following vaccination. There was insufficient information for causality assessment such as past medical history, concomitant treatment, risk factors of intracranial bleeding, sequence of events which led to fatal outcome, results of investigation and coroners (autopsy) findings. Causality is therefore unassessable. Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 629958 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2016-03-22
Onset:2016-03-25
   Days after vaccination:3
Submitted: 2016-03-31
   Days after onset:6
Entered: 2016-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 RA / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR L0067 / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-25
   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: Medicinal Product Name as Reported by the Primary Source: DTP
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNSA2016SA061443

Write-up: Initial unsolicited report received Health Authority (CDC) via company representative on 25 March 2016. This case involves a patient (age and gender was not reported) who was vaccinated with 0.5 ml one dose of IPV (VERO) (Imovax polio) (batch number, expiry date, dose in series, route and site of administration were unknown) on 22 March 2016. The patient''s medical history was not reported. The patient was concomitantly vaccinated with one dose of DIPHTHERIA AND TETANUS TOXOIDS AND PERTUSSIS (DTP) on 22 March 2016. On 25 March 2016, 03 days following the vaccination, the patient died (unspecified reason). No details of autopsy were reported. The patient''s laboratory data and corrective treatment was not reported. The outcome was fatal. List of documents held by sender: none. Sender''s Comments: This is a poorly documented death case. Patient died three days after vaccination with IPV (VERO) and no further information is provided in this case. Further data regarding examination of the death scene in details, environmental factors (room temperature, sleeping position), mother''s smoking habit and medical history (medication, illness or complications during pregnancy, maternal age) are needed to fully assess the case. The results of autopsy will also be necessary to confirm the absence of underlying disease. Based on the available information, no conclusion can be drawn. Reported Cause(s) of Death: death NOS.


VAERS ID: 633564 (history)  
Form: Version 1.0  
Age: 1.3  
Sex: Male  
Location: Foreign  
Vaccinated:2016-03-22
Onset:2016-03-22
   Days after vaccination:0
Submitted: 2016-03-25
   Days after onset:3
Entered: 2016-03-31
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pyrexia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-22
   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: 2016173537

Write-up: This is a spontaneous report from a contactable other healthcare professional via the Health Department. Regulatory authority number not available. A 15-month-old male patient of an unspecified ethnicity received a single dose of PREVENAR 13 and a single dose of NEISVAC-C, both via an unspecified route of administration on 22Mar2016. the patient medical history and concomitant medications were not reported. On 22Mar2016 patient had fever, with outcome of unknown and on the same date sudden death occurred. the patient died on 22Mar2016 and it was not reported if an autopsy was performed.


VAERS ID: 630172 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2016-03-16
Onset:0000-00-00
Submitted: 2016-04-04
Entered: 2016-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR K0143 / 1 RA / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-24
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: CNSA2016SA060483

Write-up: Initial unsolicited report received from the Health Authority (CDC) via company representative on 24-Mar-2016. This case involves a two-month-old patient (gender not reported) who was vaccinated with 0.5ml dose of IPV (VERO) (IMOVAX POLIO) (batch number: unknown, route and site of administration was not reported) on 16-Mar-2016. Medical history and concomitant medications were not reported. On 24-Mar-2016, the patient died. Laboratory investigations and corrective treatment were not reported. List of documents held by sender: none. Sender''s Comments: This case concerns sudden death of a 2-month-old infant 8 days after receiving IPV (VERO). However, this case is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Most frequent causes of sudden death in infants include infections, sudden infant death syndrome, inherent errors in metabolism, undiagnosed congenital anomalies. More information including and not limited to detailed autopsy report with review of the circumstances of death, clinical history, patient''s medical history, previous immunization history and its tolerance are needed to further assess this case. Reported Cause(s) of Death: death NOS.


VAERS ID: 630307 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2016-03-21
Onset:0000-00-00
Submitted: 2016-04-05
Entered: 2016-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR L0067 / 1 LL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-23
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: CNSA2016SA060263

Write-up: Initial unsolicited report received from a Health Authority (CDC) via company representative on 24 March 2016. This case involves a 02-month-old patient (gender not reported) who was vaccinated with 0.5 ml dose of IPV (VERO) (Imovax polio) (batch number, expiry date, dose, dose in series, route and site of administration were unknown) on 21 March 2016. The patient''s medical history and concomitant medications were not reported. On 23 March 2016, 2 days following the vaccination, the patient died. Cause of death was unspecified. Autopsy details were not reported. The patient''s laboratory data and corrective treatment was not reported. The outcome was reported as fatal. List of documents held by sender: none. Follow up information received from Health Authority (CDC) via company representative on 24 March 2016. This case involves a female patient who was vaccinated with primary first dose of Imovax Polio vaccine (lot number: L0067-1, expiry date: 28 February 2017) in left thigh. On 23 March 2016, the baby had breastfeeding at about 11:00 pm. On 24 March 2016, the baby was found dead at about 3:00 am. Sender''s Comments: Follow-up information received on 24 March 2016 changes the previous medical assessment of this case as follows: This case concerns the death of a 2-month-old infant 3 days after receiving IPV (VERO). On 23-Mar-2016 (the day before death), the patient was breastfed at 11:00PM and the patient was found dead at about 3:00am on 24-Mar-2016. Airway obstruction could be a possible cause of death. However, this case is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Most frequent causes of sudden death in infants include infections, sudden infant death syndrome, inherent errors in metabolism, undiagnosed congenital anomalies. More information including and not limited to detailed autopsy report with review of the circumstances of death, clinical history, patient''s medical history, previous immunization history and its tolerance are needed to further assess this case.; Reported Cause(s) of Death: death NOS.


VAERS ID: 634129 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-01
Entered: 2016-04-06
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2016180870

Write-up: This is a spontaneous report obtained from a contactable physician (internist) through a Pfizer sales representative. An elderly patient of an unspecified gender and ethnicity received PREVENAR 13 intramuscularly, at 0.5 ml, single dose, on an unspecified date, at the end of Jan2016. Relevant medical history and concomitant medications were unknown. On an unspecified date, shortly after receiving the vaccination, the patient died due to pneumonia. It was not reported if an autopsy was performed. Infecting organisms was not identified. The reporter assessed the event as unrelated to PREVENAR 13.


VAERS ID: 634139 (history)  
Form: Version 1.0  
Age: 1.6  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-04
Entered: 2016-04-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M10951 / 4 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Mastoiditis, Meningitis pneumococcal, 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:
Preexisting Conditions: PREVENAR 13, Immunization, first dose, at the age of 4 months; PREVENAR 13, Immunization, second dose, at the age of 5 months; PREVENAR 13, Immunization, third dose, at the age of 10 months
Allergies:
Diagnostic Lab Data: Blood culture, serotype 38
CDC Split Type: 2016187812

Write-up: This is a spontaneous report from a contactable physician. A 19-month-old male received as immunization PREVENAR 13 at 0.5 ml single: the first dose at the age of 4 months (lot# J21101), second dose at the age of 5 months (lot# J21161), third dose at the age of 10 months (lot# J95176) and the fourth dose at the age of 18 months (lot# M10951). The patient was not a preterm baby, did not have an immune defect and did not have any chronic underlying disease. Concomitant medications were not provided. In 2015, the clinical diagnosis of meningitis and bacteremia with focus mastoiditis have been made. Serotype was 38. The pathogen material was a blood culture. The events were fatal. No follow-up attempts possible. No further information expected.


VAERS ID: 634141 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2016-02-02
Onset:2016-02-02
   Days after vaccination:0
Submitted: 2016-04-04
   Days after onset:61
Entered: 2016-04-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC618B / 2 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M70337 / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cardiac imaging procedure abnormal, Cardio-respiratory arrest, Catheterisation cardiac normal, Computerised tomogram abnormal, Death, Echocardiogram abnormal, Neurological examination normal, Resuscitation
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), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-02-02
   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: Unknown, Pulmonary artery atresia with right ventricle hypotrophy; Unknown, Congenital tricuspid valve atresia; Unknown to ongoing, Heart disease; Unknown, Myocardial ischaemia; Unknown, Coronary disease; Unknown, steal syndrome; Unknown, Thrombosis; 01-OCT-2015 to unknown. Arteriovenous shunt placement with 3 mm-Goretex prosthesis between aorto-brachiocephalic trunk and right pulmonary artery'' Unknown, Noradrenaline'' Unknown, COROTROPE; Unknown, Femoral artery thrombosis; Unknown, Enterocolitis; Unknown. Staphylococcus epidermidis septicemia with unspecified treatment; 08-DEC-2015 PREVENAR 13, Drug indication, immunization, first dose; 08-DEC-2015, INFANRIX HEXA, Drug indication, Immunisation. first dose
Allergies:
Diagnostic Lab Data: Catheterisation cardiac, Revealing no anastomosis stenosis; Computerised tomogram, Patent prosthesis with large anastomoses; Echocardiogram, Goretex prosthesis patency; Imaging procedure, Tricuspid atresia and pulmonary atresia with; Neurological examination, Normal
CDC Split Type: 2016183108

Write-up: This is a spontaneous report obtained from a contactable Health Care Professional through the National Health Products Safety Agency (ANSM); regulatory authority report number: FR-AFSSAPS-LY20160467. A 4-month-old male patient received the second doses of the following suspect vaccines by intramuscular route, on 02Feb2016; PREVENAR 13 (Lot. M70337) and INFANRIX HEXA (Lot. A21CC618B). The patient was born at 39 weeks and 2 days post-last menstrual period with weight 2,440 kg, height 48 cm, cranial circumference 33 cm and Apgar score 9-10-10. There was no risk of maternal fetal infection. The patient had had an antenatal diagnosis, at 32 weeks post last menstrual period, of tricuspid valve atresia, pulmonary artery atresia with right ventricle hypotrophy. Congenital cardiopathy was considered severe and of poor prognosis with a risk of sudden death due to agitation/crying related to left ventricle ischemia, coronary abnormalities, coronary steal syndrome, or thrombosis on Goretex but likely related to bronchiolitis, hypoxia, Neonatal adaptation was good. Imaging confirmed tricuspid atresia and pulmonary atresia with normally inserted vessels. Ductal dependant cardiopathy required emergent systemic to pulmonary shunt. On 01Oct2015, the neonate underwent systemic to pulmonary shunt with 3 mm-Goretex prosthesis between aorto-brachiocephalic trunk and right pulmonary artery. Initially, postoperative course was satisfactory. Then desaturation gradually worsened within 15 days, prompting transfer to the intensive care unit for fluid replacement, transfusion and administration of noradrenaline (unspecified trade name) and COROTROPE. Transthoracic echocardiography revealed Goretex prosthesis patency, with restriction pattern in both anastomoses. Computed tomography showed patent prosthesis with large anastomoses. Then, heart catheterization was performed, revealing no anastomosis stenosis, a well-patent prosthesis and 2 satisfactory pulmonary arteries. On 20Oct2015, given poor saturation with 3 mm-Goretex, a switch to a 3.5 mm-Goretex was decided. Postoperative course was marked by a clear improvement of symptomatology with extubation on day 2. Neurological examination was normal but check with magnetic resonance imaging had to be performed. The patient developed right femoral artery thrombosis, enterocolitis and Staphylococcus epidermidis septicemia. Past product history included, on 08Dec2015, vaccination with the first doses of PREVENAR 13 and INFANRIX HEXA. No concomitant treatment was reported. Current treatment of Staphylococcus epidermidis septicemia was not specified. The patient developed cardio-respiratory arrest on 02Feb2016, which led to the patient''s death on that day. On 02Feb2016, the patient had no illness. was smiling, had no fever and no behavior change, allowing vaccination with the second doses. A few seconds after the second injection, the patient developed sudden cardiorespiratory arrest refractory to prolonged resuscitation (about 2h) performed by the emergency medical service. The patient was considered as dead upon arrival to the emergency room. An autopsy was performed, results were not available. Based on the Official Method of Causality Assessment, the causal relationships between the suspect vaccines and the adverse event cardiorespiratory arrest were assessed by the Agency as "likely". No follow up attempts possible. No further information expected.


VAERS ID: 634148 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2011-09-01
Submitted: 2016-04-07
   Days after onset:1680
Entered: 2016-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENHIB: MENINGOCOCCAL CONJUGATE + HIB (MENITORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Meningitis, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Noninfectious meningitis (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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHFR2011GB06185

Write-up: Case number PHFR2011GB06185 is an initial spontaneous report from an unspecified health care professional via the Health Authority (MHRA ADR 21313749) received on 28 Oct 2011 with a follow up received from the quality assurance department (reference number: 131727) on 05 Dec 2011. This report refers to a 2-year-old male patient. The patient''s medical history was not provided. Concomitant vaccinations included 3 doses of PEDIACEL and MMR and PREVENAR given on unspecified dates. The patient was vaccinated with MENJUGATE (batch, unknown) NEISVAC-C and MENITORIX administered on unknown dates. In Sep 2011, 380 days after MENITORIX vaccination, 618 days after NEISVAC-C vaccination and 674 days after his MENJUGATE vaccination, the patient experienced Meningitis serogroup C and vaccinations failure. It was reported that on 07 Sep 2011 the patient had returned from traveling and on 12 Sep 2011 he had a sample taken. The patient died in Sep 2011 and the cause of death was Meningitis serogroup C. It was unknown whether an autopsy was performed. Since the batch number was not reported, a batch specific review could not be performed. Based on the Annual Product Review (APR) of MENJUGATE vaccine, it was concluded that MENJUGATE manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the compliant production, testing and supply processes for MENJUGATE vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event. Follow up information received from the quality assurance department on 05 Dec 2011: updated batch review report. This case has been identified as a duplicate of case B0755690A and will be deleted. All information will be transferred to case B0755690A which stands as a case of record for this patient.


VAERS ID: 634380 (history)  
Form: Version 1.0  
Age: 1.3  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-08
Entered: 2016-04-08
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: Pneumonia, Sudden death, Viral infection
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1604PHL004559

Write-up: Information has been received from an unspecified reporter via an online article, referring to a 15 month old female patient. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unknown date the patient was vaccinated with a dose of MMR (manufacturer unknown) (lot#, dose, dose# and route unknown). She was healthy and showed no signs of illness yet died suddenly in her sleep one afternoon after two weeks of vaccination. The post mortem revealed a viral infection and traces of pneumonia. Causality as not assessed by the reporter. This is one of several reports received from the same source. Additional information has been requested.


VAERS ID: 634393 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-08
Entered: 2016-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK UN / SC
HEP: HEP B (FOREIGN) / MERCK & CO. INC. - / UNK UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 14J01A / UNK UN / SC
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1604JPN003460

Write-up: This spontaneous report was received from a physician (forensic specialist), referring to a 3 month old male patient of unspecified ethnicity. The patient''s pertinent medical history and concurrent conditions were not reported. The patient received simultaneously PREVENAR 13 (Lot number 14J01A, expiration date of 31-AUG-2017) at 0.5 ml, ACTHIB at 1 dosage form, HEPTAVAX-II at 1 dosage form, ROTATEQ at 1 dosage form and DTaP-IPV (manufacturer unknown) at 1 dosage form; all subcutaneously except oral ROTATEQ on an unspecified date. Concomitant medications were not reported. On an unspecified date, in the morning of the next day of vaccination, the patient suddenly died. As of 12-FEB-2016, the cause of death was not reported and a legally-ordered autopsy was supposed to be conducted hereafter. The reporting physician considered that sudden death was serious due to death. The reporting physician did not assess the causality of sudden death to HEPTAVAX-II and ROTATEQ. The reporting physician considered PREVENAR 13, ACTHIB and DTaP-IPV (manufacturer unknown) as suspect drugs. No follow-up attempts are possible. No further information is expected.


VAERS ID: 634419 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-08
Entered: 2016-04-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 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: Living in residential institution
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1604CAN001280

Write-up: Information has been received from Pfizer (MFR# 2016181316) on 04-APR-2016. Information has been received from a physician referring to an unknown number of patients of unspecified age and gender, who lived in nursing home. The patient''s concurrent conditions, concomitant medication and medical history were not provided. The physician read an article somewhere about a fairly recent study in nursing home patients that showed increased death rate when given a second dose of PNEUMOVAX 23 (lot#, dose, route and vaccination dates were unspecified) 8-10 years later. It was unknown if autopsies were performed or not. Additional information has been requested.


VAERS ID: 630830 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2016-04-04
Onset:0000-00-00
Submitted: 2016-04-11
Entered: 2016-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR L01921 / 1 LL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-04-05
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: CNSA2016SA068209

Write-up: Initial unsolicited report received from a POV physician via company representative on 05 April 2016. This case involves a two month-old female patient who was vaccinated with a 0.5 ml primary first dose of IPV (VERO) (Imovax Polio) (batch number: L0192-1, expiry date, was not reported) intramuscularly in the left thigh on 04 April 2016. The patient''s medical history and concomitant medications were not reported. On 05 April 2016, one day following the vaccination, the patient was found abnormal in the morning and was declared death after she was taken to the hospital. The patient''s laboratory data and corrective treatment was not reported. The autopsy had been carried out while the result had not been provided yet. The outcome of the event was reported as fatal. List of documents held by sender: none. Sender''s Comments: This case concerning sudden death of a 2-month-old female patient 2 days after receiving IPV (VERO) is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Most frequent causes of sudden death in infants include infections, sudden infant death syndrome, inherent errors in metabolism, undiagnosed congenital anomalies. More information including and not limited to detailed autopsy report with review of the circumstances of death, clinical history, patient''s medical history, previous immunization history and its tolerance are needed to further assess this case.; Reported Cause(s) of Death: death NOS; Autopsy-determined Cause(s) of Death: death NOS.


VAERS ID: 634417 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-11
Entered: 2016-04-11
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: Death, Malaise, Moaning, Mydriasis, Nasopharyngitis, Rash macular
SMQs:, Anticholinergic syndrome (broad), Hypersensitivity (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: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1604GBR006144

Write-up: Information has been received from Sanofi Pasteur (MSD) (SPM) (manufacturer control # 2016003486) as part of business agreement on 08-APR-2016. Case received from a consumer/other non health professional on 04-APR-2016. A 13-month-old male child patient received MMR (manufacturer unknown, batch number unknown) on an unknown date. The patient experienced Horrible moaning on an unknown date. One pupil was stuck in dilation on an unknown date, Minor cold on an unknown date, Sick on 06-NOV-2015 and Purple blotches on skin on an unknown date. The patient''s outcome was reported as Fatal. The patient died on unspecified date. This case was identified in a lay press article: The child died in his mother''s arms in an ambulance just minutes after being taken seriously ill at his parents'' home. Medics have ruled out meningitis and blood poisoning as possible causes of the tot''s death. But more tests are needed over the next few months to try to provide answers for mum and dad. The cause of death has not yet been identified. The not knowing is so hard. Back in November [the child] was coping with a minor cold when he had his tea and a bath and was put to bed. [The mother] stayed with [him] who had just recently had the MMR vaccine and he woke up a number of times before being sick at 1.30am on November 6. [His mother], said: "We knew something was seriously wrong. He wasn''t crying anymore. He was just making this horrible moaning noise and one of his pupils was stuck in dilation. "We called the first responders who got to us very, very quickly. "They were treating him when these purple blotches started appearing on his skin in front of our eyes. "That was when the paramedics came and took him into the ambulance. "I got into the ambulance with him, with his dad driving in the car behind. "We only got 10 minutes out of [our street] before he died, I was holding him. The Hospital did everything they could to try to save him. [The parents] and the paramedics at the scene were told to take an emergency pill because the medics were convinced that [the child] was suffering from meningitis. But that has now been ruled out as more tests are being carried out to try to find out how [the child] died."


VAERS ID: 634733 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-03-18
Onset:2014-11-06
   Days after vaccination:963
Submitted: 2016-04-14
   Days after onset:524
Entered: 2016-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS AHPVA143AA / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Altered state of consciousness, Arrhythmia, Death, Dyspnoea, Electrocardiogram abnormal, Epilepsy, Respiratory arrest, Screaming, Seizure, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-06
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: (12 August 2011): Body temperature before the vaccination: 36.8 degrees C; (06 November 2014): Electrocardiogram revealed ventricular fibrillation.
CDC Split Type: JP2016JPN048164

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of arrhythmia in a adolescent female patient who received CERVARIX (batch number AHPVA143AA, expiry date unknown). On 12th August 2011, the patient received the 1st dose of CERVARIX (intramuscular). On 20th September 2011, the 2nd dose was an unknown dose. On 28th March 2012, the 3rd dose was an unknown dose. On 8th March 2014, 2 years and 209 days after receiving CERVARIX, the patient experienced transient alteration of awareness (serious criteria GSK medically significant). On 6th November 2014, the patient experienced arrhythmia (serious criteria death), respiratory arrest (serious criteria GSK medically significant), convulsion (serious criteria GSK medically significant), dyspnoea and screaming. On an unknown date, the patient experienced ventricular fibrillation (serious criteria GSK medically significant) and epilepsy (serious criteria GSK medically significant). On an unknown date, the outcome of the arrhythmia was fatal and the outcome of the ventricular fibrillation, respiratory arrest, transient alteration of awareness, convulsion, epilepsy, dyspnoea and screaming were unknown. The patient died on 6th November 2014. The reported cause of death was arrhythmia. It was unknown if the reporter considered the arrhythmia to be related to CERVARIX. It was not reported if the reporter considered the ventricular fibrillation, respiratory arrest, transient alteration of awareness, convulsion, epilepsy, dyspnoea and screaming to be related to CERVARIX. The subject experienced 4 episodes of loss-of-consciousness attacks on 08 March 2013, 14 April 2014, 15 April 2014, and 07 June 2014. On an unknown date, the subject underwent close examinations at Medical Center A for suspected arrhythmia and epilepsy. However, no obvious abnormality was noted. The subject was followed up without definitive diagnosis. On 06 November 2014, at 20:05, when the subject was watching TV, the subject suddenly shouted and went into a hazy state. Then, the subject temporarily recovered. Ten minutes later, the subject suffered from dyspnoea again, followed by convulsion, and experienced respiratory arrest. An emergency unit was contacted, and cardiac compression was started. However, the subject did not recover. Ventricular fibrillation was noted in the first electrocardiogram performed in an ambulance. At 21:03, no palpable heartbeat was detected upon the arrival to the reporting hospital. Cardiac compression, endotracheal intubation, securing an intravenous line, and cardiopulmonary resuscitation technique were continued. However, the subject did not respond, and died. Results of relevant tests and procedures associated with the diagnosis: (12 August 2011): Body temperature before the vaccination: 36.8 degrees C. (06 November 2014): Electrocardiogram revealed ventricular fibrillation.


VAERS ID: 631638 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-15
Entered: 2016-04-15
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: Bacterial infection, Death, Mumps, Sepsis
SMQs:, Oropharyngeal infections (narrow), 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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1604GBR009112

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # 2016003639) on 13-APR-2016. Case received from a consumer/other non health professional on 08-Apr-2016. Case was identified from an article in lay press. A 3-year-old male child patient received MMR (manufacturer unknown, batch number unknown) on an unknown date. The patient experienced Sepsis on an unknown date. The patient''s outcome was reported as Fatal. The patient died in February 2016. The Reporter stated that the patient was born in 2011 and died last Feb after suffering from sepsis caused by a bacterial infection. His family claim doctors presumed he had mums, but he had been vaccinated and no mumps test was performed on him.


VAERS ID: 631936 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-15
Entered: 2016-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Death
SMQs:, Guillain-Barre 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: WAES1604JPN010448

Write-up: This spontaneous report was received from a consumer referring to a patient of unknown age and gender. The patient''s medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX NP injection, (daily dose unknown) parenteral (dose, lot number, expiration date and frequency were not provided). Concomitant medications were not reported. On an unknown date, the patient fell into a bad condition (asthenia) and died after vaccination with PNEUMOVAX NP. No information regarding the autopsy was provided. The cause of death was reported as asthenia (reported as fell into a bad condition). The reporter did not assess the relationship of "fell into a bad condition and died" to PNEUMOVAX NP. Additional information is not expected because the reporter did not wish to be contacted.


VAERS ID: 632453 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2015-09-15
Onset:2015-10-04
   Days after vaccination:19
Submitted: 2016-04-20
   Days after onset:199
Entered: 2016-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A21CC227A / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J52867 / UNK UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. K021115 / 2 MO / PO

Administered by: Other       Purchased by: Other
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: 2015-10-04
   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: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1604NZL012712

Write-up: Information has been received from regulatory authority (agency# 118270) concerning a 6 month old male patient. The patient had no known allergy, other chemicals, nutritional supplements or other medical conditions. On 15-SEP-2015 the patient was vaccinated with the second dose of ROTATEQ (lot # K021115 with unknown expiration date, 2 ml, oral). Other suspect vaccines included hib conj vaccine (unspecified carrier), diphtheria toxoid, pertussis acellular vaccine (unspecified), poliovirus vaccine inactivated (unspecified), tetanus toxoid (DTaP-Hexa) (lot# A21CC227A, 0.5 ml, intramuscular) and pneumococcal 13v conj vaccine (lot# J52867, 0.5 ml, intramuscular) on 15-SEP-2015. The child died suddenly (severe) 2.5 weeks later on 04-OCT-2015. The cause of death was unclassifiable. The relationship was reported as unclassified. 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: 632467 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2015-10-20
Onset:2015-11-08
   Days after vaccination:19
Submitted: 2016-04-20
   Days after onset:163
Entered: 2016-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21FC442A / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH L57988 / UNK UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L001320 / UNK MO / PO

Administered by: Other       Purchased by: Other
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: 2015-11-08
   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: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1604NZL012790

Write-up: Information was obtained on a request by the Company from the agency (HA# 119094) on 18-APR-2016 concerning an 8 week old female patient. Information about the patient''s pre-existing renal disease, pre-existing hepatic disease, recent surgery, transfusion, X-ray with contrast media, known allergy, familial, other chemicals, nutritional supplements and other medical conditions was unknown. On 20-OCT-2015 the patient was vaccinated with a dose of ROTATEQ (lot # L001320, 2 ml, oral). Other suspect therapies included pneumococcal 13v conj vaccine (crm197) (0.5 ml, intramuscular, lot# L57988) and diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), hib conj vaccine (tet toxoid), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (0.5 ml, lot# A21FC442A, intramuscular), both received on 20-OCT-2015. On 08-NOV-2015, the patient got sudden death. The cause of death was unknown. It was unknown if autopsy was performed. The dechallenge result was reported as no improvement. The reporter considered the event to be unlikely related to ROTATEQ, pneumococcal 13v conj vaccine (crm197) and diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), hib conj vaccine (tet toxoid), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid. The original reporter was unknown. Additional information is not expected since no further information could be obtained from the Agency.


VAERS ID: 632398 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2016-04-13
Onset:2016-04-18
   Days after vaccination:5
Submitted: 2016-04-21
   Days after onset:3
Entered: 2016-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K010050 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Loss of consciousness, Musculoskeletal stiffness, Pyrexia, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-04-18
   Days after onset: 0
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1604GBR012905

Write-up: This spontaneous report was received from a Coroner''s office notification letter via company representative regarding a 13 year old female patient. Information on her concurrent conditions and medical history were not reported. On 13-APR-2016 the patient was vaccinated with GARDASIL lot # K010050, expiry date February 2017 (dose number, dose, route and anatomical location were not specified). Concomitant medication were not reported. On 13-APR-2016 night, the patient complained of a stiff neck and had mild temperature. On an unknown date in April 2016 (a couple of days later), the patient began vomiting. On 17-APR-2016, she went to hospital and was sent to home. On 18-APR-2016 the patient collapsed at home and the death was confirmed at hospital. The cause of death was not specified. Outcome of loss of consciousness, adverse event, vomiting, pyrexia and musculoskeletal stiffness was unknown at the time of reporting. On 18-APR-2016 the patient died. The cause of death was not specified. Relatedness of the events with GARDASIL was not reported. This case was linked to case# 1603GBR007278 (same reporter link). Additional information has been requested.


VAERS ID: 635043 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Unknown  
Location: Foreign  
Vaccinated:2016-04-21
Onset:2016-04-22
   Days after vaccination:1
Submitted: 2016-05-02
   Days after onset:10
Entered: 2016-05-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC463A / 3 AR / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Encephalitis, Multiple organ dysfunction syndrome, Pyrexia
SMQs:, 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), Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-04-22
   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: CECLOR
Current Illness: Heart disease congenital
Preexisting Conditions: Hepatitis B vaccine, Prophylaxis, 1st dose domestic non-GSK product; ENGERIX B pediatric, Prophylaxis, 2nd dose, 10ug, 0.5ml, vaccination site, batch and anatomical location of injection site unknown
Allergies:
Diagnostic Lab Data: 04/22/2016, Body temperature, 37.6 degree C, elevated
CDC Split Type: CN2016GSK058318

Write-up: This case was reported by a physician via sales rep and described the occurrence of multi-organ failure in a 6-month-old patient who received ENGERIX B pediatric (batch number AHBVC463A, expiry date unknown). Co-suspect products included MENINGITIS A and CECLOR unknown for infection. Previously administered products included hepatitis B vaccine (1st dose domestic non-GSK product) and ENGERIX B pediatric (2nd dose, 10ug, 0.5ml, vaccination site, batch and anatomical location of injection site unknown). Concurrent medical conditions included heart disease congenital. On 21st April 2016, the patient received the 3rd dose of ENGERIX B pediatric, .5 ml and MENINGITIS A. On 22nd April 2016, the patient started CECLOR at an unknown dose and frequency. On 22nd April 2016, 1 days after receiving ENGERIX B pediatric and MENINGITIS A and less than a day after starting CECLOR, the patient experienced multi-organ failure (serious criteria death and GSK medically significant), meningoencephalitis (serious criteria death and GSK medically significant) and fever (serious criteria death). On 22nd April 2016, the outcome of the multi-organ failure, meningoencephalitis and fever were fatal. The patient died on 22nd April 2016. The reported cause of death was heart disease congenital, meningoencephalitis, multi-organ failure and fever. An autopsy was not performed. The reporter considered the multi-organ failure, meningoencephalitis and fever to be unrelated to ENGERIX B pediatric. It was unknown if the reporter considered the multi-organ failure and meningoencephalitis to be related to CECLOR. Additional details were provided as follows: The patient had followed 0, 1, 6 months schedule of ENGERIX B paediatric. On an unknown date, the patient received 1st dose as domestic vaccine (non-GSK product), the patient received 2nd dose as ENGERIX B pediatric (10ug, 0.5ml, vaccination site, batch and anatomical location of injection site unknown) and on 21st April 2016, the patient received the 3rd dose of ENGERIX B paediatric (10ug, 0.5ml, batch 463AA). On 21st April 2016, the patient developed fever (body temperature was 37.6 degree C) and on same day, the patient received epidemic cerebrospinal meningitis group A vaccine (batch and anatomical location of injection site unknown). On 22nd April 2016 in the afternoon, the patient was taken to the vaccination site to visit the physician. The patient was prescribed CECLOR (dosage form, package, usage unknown) for treatment. In the evening, the parents took the patient to other hospital to visit the physician. But the patient died when parents were registering at hospital. Hospital diagnoses were congenital heart disease, intracranial infection and multiple organ failure. The physician considered the events were not related to vaccines. The parents refused autopsy, so local CDC (Centre for Disease Control) could not get the final conclusion.


VAERS ID: 633973 (history)  
Form: Version 1.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-09-17
Onset:2015-10-22
   Days after vaccination:35
Submitted: 2016-05-03
   Days after onset:194
Entered: 2016-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / CSL LIMITED 30349421A / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, Autopsy, Biopsy brain abnormal, Death
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Noninfectious encephalitis (narrow), Demyelination (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2015-11-11
   Days after onset: 20
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: GBBEH2016061724

Write-up: This medically confirmed health authority report (initial receipt 20-Apr-2016) concerns a 40 year-old male patient. On 17-Sep-2015, the patient received Enzira vaccine (batch number 30349421A) via the subcutaneous route for flu vaccination. On 22-Oct-2015, the patient experienced acute disseminated encephalomyelitis. The diagnosis of acute disseminated encephalomyelitis was confirmed on the brain biopsy and subsequent post mortem. The patient was initially treated with antivirals/antibiotics, then immunosuppression when the diagnosis of acute disseminated encephalomyelitis was more secure. Prior to the admission, the patient was well. The patient died on 11-Nov-2015. The outcome was fatal. Reporter comments: The health authority assessed the case as serious (life threatening, fatal and medically significant). It was difficult to prove acute disseminated encephalomyelitis directly secondary to vaccine. The vaccination predisposed to acute disseminated encephalomyelitis. May have contributed to acute disseminated encephalomyelitis which eventually resulted in the patient''s death. Sender''s Comments: Seriousness: Serious. Fatal outcome. Listedness: Unlisted. Assessment according to the CCDS for CSL Inactivated Influenza Virus Vaccine and the AFLURIA Product Information, acute disseminated encephalomyelitis is unlisted (encephalomyelitis is listed as per the CCDS and unlisted as per the AFLURIA PI). Causality: Possible. Time to onset is approximately 5 weeks following vaccination. The case meets level 1 diagnostic certainty for ADEM as the diagnosis was made on brain biopsy. Encephalomyelitis is considered a class effect of Influenza vaccines in general and proposed pathomechanism is immune-mediated damage myelin due to viral or vaccine-associated products. The illness is generally monophasic with complete recovery; hence an outcome of fatal as in this case is unusual and other factor such as concomitant medical condition and clinical course that caused fatal outcome were not specified. Causality is considered possibly related to CSL IVV due to the plausible temporal association, absence of other risk factors (not specified)such as other vaccination and viral infection. Reported Cause(s) of Death: Acute disseminated encephalomyelitis; Autopsy-determined Cause(s) of Death: Acute disseminated encephalomyelitis.


VAERS ID: 634215 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-05-02
Entered: 2016-05-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Unknown
Preexisting Conditions: Influenza vaccine, Prophylaxis, one dose received on an unknown date
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR2016GSK061067

Write-up: This case was reported by a consumer via local affiliate and described the occurrence of pneumonia in a adult female patient who received Seasonal Influenza vaccine. Previously administered products included Influenza vaccine (one dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Seasonal Influenza vaccine. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced pneumonia (serious criteria death and GSK medically significant). On an unknown date, the outcome of the pneumonia was fatal. The reported cause of death was pneumonia. It was unknown if the reporter considered the pneumonia to be related to Seasonal Influenza vaccine. Additional details were received as follows: The age at vaccination was not reported. The reporter stated that, the patient received 2 dosage of Influenza vaccine (vaccine''s manufactory was not informed) and presented with pneumonia. A year from the date of reporting, the patient had died. The reporter related the patient''s death to Influenza vaccine. No further information was provided.


VAERS ID: 635296 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Male  
Location: Foreign  
Vaccinated:2016-04-14
Onset:2016-04-17
   Days after vaccination:3
Submitted: 2016-05-03
   Days after onset:16
Entered: 2016-05-05
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M87610 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-04-17
   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: Unknown, Nephrotic syndrome; Unknown, Salmonellosis; Immunocompromised, under steroids treatment
Allergies:
Diagnostic Lab Data: Culture stool, positive for salmonella
CDC Split Type: 2016237696

Write-up: This is a spontaneous report received from the Health Authority, Regulatory authority number ES-AGEMED-119525335. A physician, who is contactable through Health Authority only, reported that a 5 year-old male patient of an unspecified ethnicity, received PREVENAR 13 (Lot number M87610), intramuscular on 14Apr2016 at 0.5 ml, single. Medical history included nephrotic syndrome, salmonellosis and immunocompromised as he was receiving steroids treatment. On 16apr2016 he was admitted at hospital with cyanosis due to salmonella infection. the patient underwent lab tests and procedures which included stool cultures positive for salmonella on an unspecified date. the patient''s concomitant medications were not repotted. the patient experienced cardio-respiratory arrest on 17Apr-2016 and died. It was not reported if an autopsy was performed. the relatedness of the suspect drug to the event, assessed by the Health authorities with the modified Karl-Lasagna method was: unlikely. Follow-up attempts not possible. No further information expected.


VAERS ID: 635331 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-05-02
Entered: 2016-05-05
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M50386 / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacteraemia, Blood culture positive, CSF culture positive, Haemolytic uraemic syndrome, Meningitis, Neisseria test positive, Pneumococcal infection
SMQs:, Haemolytic disorders (narrow), Noninfectious meningitis (narrow), Renovascular disorders (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: 2015, Blood culture, meningitis, bacteraemia without focus, suspected pn; 2015, culture, meningitis, bacteraemia without focus, suspected pn; 2015, Serology test, 12F; Liquor culture (2015): Meningitis, bacteraemia without focus, suspected pneumococcus associated Hemolytic-uremic Syndrome
CDC Split Type: 2016237559

Write-up: This is a spontaneous report from a contactable physician. A 5-month-old male patent of an unspecified ethnicity received PREVENAR 13 the first single dose on unknown date at the age of 2 months (lot/batch number L65421) and the second single dose on unknown date at the age of 5 months (lot/batch number M50386). Relevant medical history and concomitant medications were not reported. the patient experienced meningitis, suspected pneumococcus associated hemolytic-uremic syndrome serotype: 12F and bacteraemia without focus in 2015 with fatal outcome. It was not reported if an autopsy was performed. the patient underwent blood culture and liquor culture which showed meningitis, bacteraemia without focus, suspected pneumococcus associated Hemolytic-uremic Syndrome, serotype: 12F. No follow-up attempts possible. No further information expected.


VAERS ID: 635443 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-05-09
Entered: 2016-05-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Foetal exposure during pregnancy, Pertussis
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ES2016GSK056130

Write-up: This retrospective pregnancy case was reported by a non-health professional via other and described the occurrence of pertussis in a female infant exposed to DTPA in utero. The mother received the product. On an unknown date, the mother received DTPA vaccine. The mother''s last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The infant was diagnosed with pertussis (serious criteria death, hospitalization and GSK medically significant) and maternal vaccine exposure. On an unknown date, the outcome of the pertussis was fatal and the outcome of the maternal vaccine exposure was unknown. The infant died in April 2016. The reported cause of death was pertussis. It was unknown if the reporter considered the pertussis and maternal vaccine exposure to be related to DTPA. vaccine. Additional details were provide as follows: This information was received from newspaper by a safety technician. The age of the patient was around 2 month. The patient''s mother was vaccinated during the pregnancy against whooping cough. The immunization of the mother was not always guaranteed the child immunization. The patient was admitted in the hospital and she was very serious. The patient was died due to whooping cough at the time of reporting. It was claimed that vaccinated patient were not 100 percentage immunized. Further information regarding the case was not available in the article.


VAERS ID: 635450 (history)  
Form: Version 1.0  
Age: 0.21  
Sex: Unknown  
Location: Foreign  
Vaccinated:2016-04-25
Onset:2016-04-27
   Days after vaccination:2
Submitted: 2016-05-09
   Days after onset:12
Entered: 2016-05-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A20CB284A / 1 UN / UN
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 140401 / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB286AA / 1 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-04-27
   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: Premature condition, at 32 weeks of gestation and was perfectly health otherwise
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2016GSK063057

Write-up: This case was reported by a other health professional via local affiliate and described the occurrence of unknown cause of death in a 11-week-old patient who received ROTARIX (batch number AROLB286AA, expiry date 30th September 2017). Co-suspect products included INFANRIX-IPV +HIB (batch number A20CB284A, expiry date 30th September 2017) and BEXSERO (batch number 140401, expiry date 31st October 2016). the patient''s past medical history included premature birth (at 32 weeks of gestation and was perfectly healthy otherwise). On 25th April 2016, the patient received the 1st dose of ROTARIX (oral), the 1st dose of INFANRIX-IPV + HIB and the 1st dose of BEXSERO. On 25th April 2016, several hours after receiving ROTARIX, INFANRIX-IPV + HIB and BEXSERO, the patient experienced fever. On 27th April 2016, 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 and the outcome of the fever was not reported. the patient died on 27th April 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 and fever to be related to ROTARIX, INFANRIX-IPV + HIB and BEXSERO. Additional details were received as follows: the same night of the vaccination, the patient developed fever (possibly post immunization fever). On the 27th April 2016, the patient was died of unknown cause. the exact cause od death was unknown and no further information was available. the practice manager was awaiting post mortem results for further information and to determine the cause of death.


VAERS ID: 635553 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Foreign  
Vaccinated:2016-04-22
Onset:2016-04-25
   Days after vaccination:3
Submitted: 2016-05-11
   Days after onset:16
Entered: 2016-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC622A / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M60561 / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB149AA / 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: 2016-04-25
   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: SAB SIMPLEX
Current Illness: 04/22/2016, Gastrooesophageal reflux disease, mild experienced on 22nd April 2016
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2016GSK064023

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of sudden infant death in a 2-month-old male patient who received ROTARIX (batch number AROLB149AA, expiry date unknown). Co-suspect products included INFANRIX HEXA (batch number A21CC622A, expiry date unknown) and PREVENAR 13 (batch number M60561, expiry date unknown). Concurrent medical conditions included gastroesophageal reflux (mild experienced on 22nd April 2016). Concomitant products included SAB SIMPLEX. On 22nd April 2016, the patient received the 1st dose of ROTARIX (oral), the 1st dose of INFANRIX HEXA and the 1st dose of PREVENAR 13. On 25th April 2016, 3 days after receiving ROTARIX and INFANRIX HEXA, the patient experienced sudden infant death (serious criteria death and GSK medically significant). On 25th April 2016, the outcome of the sudden infant death was fatal. The patient died on 25th April 2016. The reported cause of death was sudden infant death syndrome. An autopsy was performed. The reporter considered the sudden infant death to be unlikely related to ROTARIX and INFANRIX HEXA. Additional details were provided as follows: During the days after vaccination, no adverse events were observed. An autopsy was performed but its report was not provided. Autopsy determined cause of death as sudden infant death syndrome (SIDS) and no signs of other causes were reported. Follow up information had been requested by regulatory authority. The reporter considered the sudden infant death to be unlikely related to PREVENAR 13 as well.


VAERS ID: 635609 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-05-10
Entered: 2016-05-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M02005 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Body temperature, 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: Unknown
Allergies:
Diagnostic Lab Data: Body temperature
CDC Split Type: 2016245591

Write-up: This is a spontaneous report from a contactable other healthcare professional. An 11 week-old female patient of an unspecified ethnicity received PREVENAR 13 (Lot/batch number M02005, expiry date 31Dec2017) on an unspecified date, at a single dose. No medical history or concomitant medications were reported. The other healthcare professional called to report the death of this patient that occurred two days after the vaccination with PREVENAR 13. An autopsy performed but at the time of the report the post-mortem result was not yet available. The patient had a temperature on the evening after the vaccination with outcome unknown.


VAERS ID: 635622 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:2016-05-10
Onset:2016-05-10
   Days after vaccination:0
Submitted: 2016-05-13
   Days after onset:3
Entered: 2016-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L020468 / 3 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-05-10
   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: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1605AND005735

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # unknown) on 11-MAY-2016. Information has been received from a pharmacist of the Regional Health Authority (ARS) (agency # unknown) concerning a 5 month old female patient. There was no known medical history. On 10-MAY-2016 the patient was vaccinated with the third dose of ROTATEQ (lot # L020468, expiation date February 2017, oral, dose unspecified) and PREVENAR (lot#, expiration date, dose and route unspecified). On the same day, 3-4 hours following vaccines, the patient suddenly died. the cause of death was unspecified. the autopsy was performed on 11-MAY-2016 and the result was pending. the reporter requested to pharmacists not to distribute the concerned batch until more information. As a current knowledge there was no data in favor of an association between rotavirus vaccine and sudden infant death. Upon internal review, sudden death was determined to be medically significant. Additional information is not expected as no further information can be obtained from the agency.


VAERS ID: 635739 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-05-11
Entered: 2016-05-13
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 UN / IM

Administered by: Unknown       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: 2016248969

Write-up: This is a spontaneous report from a non-contactable physician received via a Field Force Manager (FF). A 4-month-old patient of an unspecified ethnicity and gender received PREVENAR 13 solution for injection in pre-filled syringe, intramuscular, at the age of 2 months (on unspecified date) and at the age of 4 months (on unspecified date in 2016). Regimen reported was 2, 4 and 12-15 months. the patient medical history and concomitant medications were reported as unknown. In winter of 2016, two days after the second injection of pneumococcal 13-val conj vaccine, the patient died due to infectious encephalopathy. An autopsy was not performed (refusal of the patient''s parents). Physician related the patient''s death to infectious encephalopathy due to pneumococcal 13-val conj vaccine. No follow-up attempts are possible. No further information is expected.


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

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

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

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


VAERS ID: 635862 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-05-17
Entered: 2016-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (IMOVAX) / SANOFI PASTEUR - / 1 AR / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activated partial thromboplastin time normal, Acute prerenal failure, Autopsy, Blood calcium decreased, Blood creatinine increased, Blood glucose abnormal, Blood phosphorus decreased, Blood potassium decreased, Blood pressure decreased, Blood sodium normal, Blood urea increased, Cardiac arrest, Confusional state, Cyanosis, Decreased appetite, Depressed level of consciousness, Disorientation, Drug ineffective, Dysarthria, Dyspnoea, Encephalomyelitis, Endotracheal intubation, Fatigue, Haemoglobin normal, Headache, Intensive care, Metabolic acidosis, Myoclonus, Neutrophil percentage increased, Procalcitonin, Prothrombin time normal, Rabies, Respiratory alkalosis, Respiratory arrest, Salivary hypersecretion, Tachycardia, Tachypnoea, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (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 (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (narrow), 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: Antirabies serum
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, 37 Celsius temperature; Serum creatinine, 1.9 milliequivalent(s)/litre; WBC, 19.0^10E3/DL; Neutrophils, 86%; Hemoglobin, 13 gram(s)/decilitre; Serum sodium, 143 millimole(s)/litre; Serum potassium, 3.4 millimole(s)/litre; Serum glucose, 232 milligram(s)/decilitre; Serum calcium, 8.6 milligram(s)/decilitre; Procalcitonin, LESS THAN 0.5 nanogram(s)/millilitre
CDC Split Type: IRSA2016SA091558

Write-up: Initial unsolicited report received from the literature on 06 May 2016. The following is verbatim from the article: Abstract: It was reported that in some individuals who received post exposure rabies vaccine, clinical features of rabies developed at the shorter time compared to individuals who were exposed, but not received the vaccine, which called "early death" phenomenon. We reported an early death phenomenon in a 67 year old woman who was bitten by a jackal, although receiving three dose of rabies vaccine. Results show that the immune response to rabies has a dual role, sometimes has a favorable effect on survival but sometimes amplification the disease. This case involves a 67-years-old female patient who was vaccinated with three 1.0 ml injection of Imovax Rabies (batch number, expiration date, route of administration was not reported) in deltoid muscle on an unspecified date on 0 day, 3 day and 7 day in conjunction with Antirabies Serum (batch number, expiration date, route and site of administration was not reported) on an unspecified dates on 0 day. The patient had history of bite of her finger by jackal 10 days before admission. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had shortness of breath, headache, fatigue, anorexia. It was reported that patient''s symptoms began gradually the day before admission and then were aggravated. Patient was confused, disoriented, with slurred speech and had sialorrhea. It was reported that third hour after admission tachycardia, tachypnea, and sialorrhea were increased, blood pressure had dropped and cyanosis occurred in the distal parts of upper and lower extremities. The patient level of consciousness was decreased gradually, and myoclonus had started. In the fourth hours of admission, the patient developed respiratory and cardiac arrest and were transferred to Intensive Care Unit after intubation. Patient experienced acute encephalomyelitis. It was reported that it was ineffective administration of rabies vaccine. The unspecified date, patient was hospitalized. On an unspecified date, following vaccination patient was diagnosed with rabies. Lab data included temperature 37 degree Celsius, pulse rate 100 per min, blood pressure 210/110 mmHg, and respiration rate 26 per min. prerenal azotemia (blood urea nitrogen level of 54 mEq/L and serum creatinine of 1.9 mEq/L) with mixed respiratory alkalosis and metabolic acidosis. Blood tests: White blood cell count, 19.0^10E3/dL with 86 percent neutrophils; hemoglobin 13.0 g/dL; serum sodium 143 mmol/L; serum potassium 3.4 mmol/L; serum glucose 232 mg/dL; and serum calcium 8.6 mg/dL; serum phosphorus 2.7 mg/dL; prothrombin time and partial thromboplastin time were normal and procalcitonin were less than 0.5 ng/ml. Corrective treatments included ceftriaxone, acyclovir, sodium valproate, phenytoin, clonazepam. On an unspecified date, on third day of hospitalization, patient died despite treatment. At the time of death outcome of events were not reported. It was reported that to confirm the diagnosis, an autopsy was performed giving more attention to the brain. There were many punctuate hemorrhages and multiple infarcts involving the cortex, basal ganglia, and hippocampus. An acute encephalomyelitis characterized by a lymphohistiocytic infiltrate, perivascular lymphocytic infiltration, and neuronophagia was reported in the cortical gray matter, along with patchy changes in the white matter. Eosinophilic intracytoplasmic inclusion bodies indicative of Negri bodies were present within Purkinje cells, and larger neurons of the brainstem. Documents held by sender: none. Sender''s Comments: This death case extracted from the literature article refers to a 67 years old female who died 12 days after the jackal bite. Three doses of RABIES (HDC) VACCINE was administered on days 0, 3 and 7 along with antirabies serum. On day 9 patient developed shortness of breath, headache, fatigue and anorexia. Next day patient was admitted to the hospital, her symptoms were aggravated. She was confused, disoriented, with slurred speech and had sialorrhea. On the 3rd day of hospitalization, she died. Autopsy was performed, however detailed autopsy report was not provided. The case was considered as Post-Exposure Prophylaxis (PEP) failure. The recommended post exposure regimen of RABIES (HDC) VACCINE is 5 doses administered on Days 0, 3, 7, 14 and 28, with administration of rabies immunoglobulin (RIG) into the wound together with the 1st dose of vaccine. However, in this case the site of RIG injection is not reported, and as this patient was bitten in a finger, limited volume of RIG can be injected into the wound (risk of compartment syndrome) which may lead to PEP failure. Also, fingers are highly innervated areas, which is an additional aggravating criterion. Taking into consideration very short incubation period, the rabies virus had to enter nerves endings before the systemic response to the vaccine could appear, therefore the role of vaccine in causing PEP failure is unlikely in this case. Reported Cause(s) of Death: rabies; Autopsy-determined Cause(s) of Death: rabies.


VAERS ID: 636174 (history)  
Form: Version 1.0  
Age: 1.18  
Sex: Male  
Location: Foreign  
Vaccinated:2016-04-06
Onset:2016-05-07
   Days after vaccination:31
Submitted: 2016-05-18
   Days after onset:11
Entered: 2016-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS AFLBA127AA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Drug administered to patient of inappropriate age, Off label use
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-05-07
   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: BR2016GSK068650

Write-up: This case was reported by a nurse via sales rep and described the occurrence of unknown cause of death in a 14-month-old male patient who received FLUARIX TETRA (batch number AFLBA127AA, expiry date unknown). On 6th April 2016, the patient received FLUARIX TETRA. On 6th April 2016, an unknown time after receiving FLUARIX TETRA, the patient experienced off label use and inappropriate age at vaccine administration. On 7th May 2016, 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 and outcome of the off label use and inappropriate age at vaccine administration were unknown. The patient died on 7th May 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, off label use and inappropriate age at vaccine administration to be related to FLUARIX TETRA. Additional information was provided as follows: The patient received FLUARIX TETRA at the age of 14 months which led to inappropriate age at vaccination and off label use. The autopsy was performed but results were not provided. This case is 1 of the 5 case reported by same reporter.


VAERS ID: 636305 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-04-13
Onset:2016-04-15
   Days after vaccination:2
Submitted: 2016-05-19
   Days after onset:34
Entered: 2016-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Altered state of consciousness, Blood test normal, Computerised tomogram, Cyanosis, Death, Depressed level of consciousness, Dizziness, Erythema, Fall, Gastroenteritis viral, General physical health deterioration, Headache, Loss of consciousness, Malaise, Nuclear magnetic resonance imaging, Pain in extremity, Pallor, Pulse absent, Somnolence, Urine analysis, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-04-17
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: HPV vaccine, Prophylaxis, 1st dose
Allergies:
Diagnostic Lab Data: 04/2016, Blood test, normal; 04/2016, Computerised tomogram, results not provided; 04/2016, Heart rate, normal; 04/2016, Nuclear magnetic resonance imaging, inconclusive; 04/2016, Urine analysis, result not provided
CDC Split Type: GB2016GSK068196

Write-up: This case was reported by a non-health professional via local affiliate and described the occurrence of unknown cause of death in a 13-year-old female patient who received HPV vaccine. Previously administered products included HPV vaccine (1st dose). On 13th April 2016, the patient received the 2nd dose of HPV vaccine. On 15th April 2016, 2 days after receiving HPV vaccine, the patient experienced pain in arm and erythema. On 16th April 2016, the patient experienced headache, vomiting and stomach virus. On 17th April 2016, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), unconscious (serious criteria hospitalization and GSK medically significant), consciousness abnormal (serious criteria GSK medically significant), dizziness, pallor, cyanosis, fall, drowsiness, pulse absent, consciousness decreased (serious criteria GSK medically significant) and general physical health deterioration. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the unconscious, consciousness abnormal, headache, vomiting, dizziness, stomach virus, pain in arm, erythema, pallor, cyanosis, fall, drowsiness, pulse absent, consciousness decreased and general physical health deterioration were unknown. The patient died on 17th April 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, unconscious, consciousness abnormal, headache, vomiting, dizziness, stomach virus, pain in arm, erythema, pallor, cyanosis, fall, drowsiness, pulse absent, consciousness decreased and general physical health deterioration to be related to HPV vaccine. Additional details were provided as follows: This case was reported in the daily mail article. Before the vaccination the patient was perfectly normal and active. On 13th April (Wednesday-the exact year of the date was not reported but as per the date and the weekday it was considered as 2016), the patient received 2nd dose of HPV vaccine (trade name not reported). On Friday, the patient was complaining of a sore arm, no swelling just redness. Then on the Saturday, she complained of severe headache and by the evening she was throwing up. Then on the Sunday, she was very pale and was taken to the hospital. At the hospital, the patient was asked to take a urine test and on the way to the toilet, the patient fell to the floor and was very drowsy. The doctor had made a comment, saying that the patient came across as a lazy child and the patient was sent home. One of the nurses also made a comment, saying that the patient was fine. The patient was said to have a suspected stomach bug, by the doctors. When the patient returned to her home she was in a really bad state. The patient was provided with water so she would not dehydrate. An hour later, the patient turned blue and had no pulse and was not responding. The patient died in hospital 5 days later on April 17. The patient''s sister said that at the hospital it was just the machines that were keeping the patient alive. The patient had also suffered from dizziness, was unconscious, fell ill, her condition rapidly worsened and patient was in and out of consciousness. The patient''s family believed her death was linked directly to the cervical cancer jab. The family of the patient said that following the patient''s death she underwent a Computerised Tomography scan but it was unable to find a cause. The patient had a blood test and had her heart rate checked too and everything was found to be normal. The MRI scan (magnetic resonance imaging) at the hospital was too inconclusive. An autopsy had been carried out. However, the results were said to not be available for several months. According to the patient''s family the hospital did not take them seriously and if they would have done more tests they could have picked something up. No further information was provided.


VAERS ID: 637627 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-05-23
Entered: 2016-05-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Skin ulcer
SMQs:, 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: WAES1605MYS010724

Write-up: This spontaneous report was received from a physician via company representative and through an unspecified reporter of an online post. The post refers to thousands of girls/women, whose current conditions and medical history was not known. The reporter of the online post stated that the GARDASIL (dosage details and lot number were not reported) was not only causing massive open sore reactions, but it was causing death right after the vaccination shot. Hence the causality of the event was considered related. Upon internal review "death" was determined to be medically significant. The case is linked to 1605MYS009128 and 1605MYS009749 (same reporter link). Additional information has been requested.


VAERS ID: 642005 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-05-23
Entered: 2016-05-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 2 UN / UN

Administered by: Other       Purchased by: Other
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: 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: Premature baby
Allergies:
Diagnostic Lab Data:
CDC Split Type: AD2016GSK071681

Write-up: This case was reported by a consumer via call center representative and described the occurrence of cardiopulmonary arrest in a 5-month-old female patient who received BEXSERO. The patient''s past medical history included premature birth. In May 2016, the patient received the 2nd dose of BEXSERO. In May 2016, less than a day after receiving BEXSERO, the patient experienced cardiopulmonary arrest (serious criteria death and GSK medically significant). In May 2016, the outcome of the cardiopulmonary arrest was fatal. The patient died in May 2016. The reported cause of death was cardiopulmonary arrest. An autopsy was performed. It was unknown if the reporter considered the cardiopulmonary arrest to be related to BEXSERO. Additional information was provided as follows: This case was reported by a grandmother who was a far relative of the patient. The patient was born premature but was healthy. According to the reporter, the patient was vaccinated on 9th or 10th May 2016 with BEXSERO and after the administration, the patient was taken to the kindergarten. About midday, the parents received a call that they should go to the hospital because their daughter was very sick. When they arrived, the patient had died. The patient had a cardiorespiratory arrest at the kindergarten and when the ambulance arrived she was reanimated but while driving to the hospital, she died in the ambulance. An autopsy was done but the report was pending. According to the reporter, the cause of the death could be natural, a negligence of the kindergarten, the vaccine or not determined pathology. The patient was buried on 12th May 2016. It was reported that there was a 5 months old patient that died on the same day who received PREVENAR 13 and ROTATEQ and about 15 days before had received a hexavalent vaccine and BEXSERO. This case has not been created as a new case as the information was not confirmed completely at the time of reporting and further information on this was expected.


VAERS ID: 637187 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2015-12-01
Onset:2015-12-01
   Days after vaccination:0
Submitted: 2016-05-25
   Days after onset:175
Entered: 2016-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA874CB / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute kidney injury, Anaemia, Atrial flutter, Blood creatinine increased, C-reactive protein increased, Death, Dehydration, Escherichia infection, Fatigue, General physical health deterioration, International normalised ratio increased, Metastases to lung, Prothrombin time shortened, Renal cancer, Urinary tract infection, Vasculitic rash
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver-related coagulation and bleeding disturbances (narrow), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Supraventricular tachyarrhythmias (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), Vasculitis (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad), Dehydration (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-01-02
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LASIX; Ramipril
Current Illness: Unknown
Preexisting Conditions: Atrial fibrillation; Cardiac failure chronic; Pulmonary hypertension; Cardiac pacemaker insertion; Atrioventricular block complete; Haematuria; Benign prostatic hyperplasia
Allergies:
Diagnostic Lab Data: Unknown date: Creatinine: 138 mcmol/L; Unknown date: International Normalized Ratio: 3 and above 8; Unknown date: Prothrombin time: 5 and above 8; Unknown date: C-reactive protein: 15-20 and 307.
CDC Split Type: SE2016072260

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of vasculitis in a 89-year-old male patient who received FLUARIX (batch AFLUA874CB, expiry date unknown). The patient''s past medical history included atrial fibrillation, cardiac failure chronic, pulmonary hypertension, cardiac pacemaker insertion, third degree AV block, hematuria and benign prostatic hyperplasia. Concomitant products included LASIX and Ramipril. In December 2015, the patient received FLUARIX. In December 2015, less than a month after receiving FLUARIX, the patient experienced vasculitis (serious criteria death) and acute renal failure (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vasculitis and acute renal failure were fatal. The patient died on 2nd January 2016. The reported cause of death was vasculitis and renal failure. An autopsy was performed. The autopsy determined cause of death was renal cancer. The reporter considered the vasculitis and acute renal failure to be possibly related to FLUARIX. RA Verbatim: Report from a hospital physician concerning an 89-year-old male with atrial fibrillation, chronic heart failure, pulmonary hypertension, pacemaker due to AV-block III, clinical hematuria and benign prostatic hyperplasia. The patient had been vaccinated with FLUARIX (vaccine against flu) in December 2015 and had afterwards developed deteriorated general condition. On 15-17 December, the patient was admitted with anamnesis of decreased condition since ten days which was according to records was consistent with a switch to atrial flutter. Chest x-ray showed some signs of failure with progress of pleural fluid bilaterally. At the hospital, the patient had an elevated PT/INR value of 5.3 and rising creatinine to 138 micromoles/L (ref creatinine 60-105 micromoles/L) which was connected to that the patient was dehydrated. The patient is discharged home when he still is very tired and exhausted, according to the records. Upon a home visit later on, the PT/INR value is above 8 and the patient has a reduced general condition and is referred to the geriatric department on December 28. CRP as in the previous admission had been somewhat elevated to 15-20 was now rising to 307. UTI was suspected and CLAFORAN was initiated. Urine culture showed growth of E. coli. Blood culture was without remarks. The patient had gradually rising creatinine to 416 and poor diuresis 100-150 ml/day. It was previously, in May 2014, seen a "decimeter large" cystic change that was now considered as a left-sided kidney tumor. It was also assessed metastases to the left lung plus pneumonia. The patient died after a few days. Autopsy showed that the kidney cyst was a kidney cancer that grew over towards the adrenal gland, pancreas, hardly had anything to do with the death since it had been present for a long time, according to the reporter. According to the reporter, vasculitis with kidney failure is described after vaccination and has entered vasculitis and acute renal failure as suspected adverse events of FLUARIX. Concomitant medication with LASIX Retard and Ramipril. SPC: "Vasculitis is in very rare occasions associated with transient renal involvement".


VAERS ID: 642089 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2015-04-28
Onset:0000-00-00
Submitted: 2016-05-25
Entered: 2016-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER 30110D13 / 2 UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER K7089 / 2 UN / UN
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS 139VPN026C / 2 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS QROLA077AA / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Gastrointestinal obstruction, Intestinal obstruction
SMQs:, Gastrointestinal obstruction (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: BR2016GSK072189

Write-up: This case was reported by a other health professional via licensee and described the occurrence of intestinal obstruction in a 15-month-old male patient who received MENJUGATE (batch number 940011, expiry date unknown). Co-suspect products included BCG vaccine (batch number 3074, expiry date unknown), Pneumococcal vaccine (batch number 139VPN026C, expiry date unknown), ROTARIX (batch number QROLA077AA, expiry date unknown), Poliomyelitis vaccine inactivated (batch number K7089, expiry date unknown) and DTPA-HBV+HIB Vaccine (batch number 30110D13, expiry date unknown). Concomitant products included Pneumococcal vaccine, ROTARIX, Poliomyelitis vaccine inactivated, and DTPA-HBV+HIB vaccine. On 3rd March 2015, the patient received the 1st dose of MENJUGATE. On 31st October 2014, the patient received BCG vaccine. On 28th April 2015, the patient received the 2nd dose of Pneumococcal vaccine, the 2nd dose of ROTARIX (oral), the 2nd dose of Poliomyelitis vaccine inactivated and the 2nd dose of DTPA-HBV+HIB Vaccine. On an unknown date, an unknown time after receiving MENJUGATE, Pneumococcal vaccine, ROTARIX, Poliomyelitis vaccine inactivated, DTPA-HBV+HIB vaccine, Pneumococcal vaccine, ROTARIX, Poliomyelitis vaccine inactivated and DTPA-HBV+HIB vaccine, the patient experienced intestinal obstruction (serious criteria death, GSK medically significant and other: Serious as per reporter) and GI tract obstruction (serious criteria death, GSK medically significant and other: Serious as per reporter). On an unknown date, the outcome of the intestinal obstruction and GI tract obstruction were fatal. The reported cause of death was GI tract obstruction and intestinal obstruction. It was unknown if the reporter considered the intestinal obstruction and GI tract obstruction to be related to MENJUGATE, Pneumococcal vaccine, ROTARIX, and Poliomyelitis vaccine inactivated.


VAERS ID: 642266 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-05-31
Entered: 2016-05-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 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: WAES1605CAN013305

Write-up: This spontaneous report was received from a physician via company representative regarding a female patient of unknown age. The patient''s pertinent medical history and drug reactions or allergies were not reported. On an unknown date the patient was vaccinated with GARDASIL (dosage details and lot number were not reported). Concomitant medications were not reported. The physician expressed a concern since one patient informed her of a newspaper article that linked a death of a young woman due to GARDASIL vaccination on an unknown date. The cause of death was unknown. Physician would like information and reassurance on the safety of GARDASIL 4 and 9. Causality was not reported. Additional information has been requested.


VAERS ID: 642422 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-05-24
Onset:2016-05-25
   Days after vaccination:1
Submitted: 2016-05-27
   Days after onset:2
Entered: 2016-06-01
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-05-25
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2016276050

Write-up: This is a spontaneous report from a contactable nurse and from a contactable healthcare assistants via a sales representative. A female patient of an unspecified age and ethnicity received PREVENAR 13 at single dose, rotavirus vaccine (unknown manufacturer) and acellular pertussis, diphtheria vaccine, haemophilus influenza b, hepatitis b vaccine, polio vaccine, tetanus vaccine (unknown manufacturer) all via an unspecified route of administration on 24May2016. the patient was a premature baby. Concomitant medications were not reported. the patient died on 25May0216. the event was described as: death of a premature baby the day after vaccination. It was not reported if an autopsy was performed.


VAERS ID: 642423 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-05-31
Entered: 2016-06-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IT2016GSK075415

Write-up: This case was reported by a non-health professional via call center representative and described the occurrence of sudden death in a 2-month-old female patient who received DTPa-HBV-IPV-HIB). Co-suspect products included Pneumococcal vaccine and Rotavirus vaccine. On an unknown date, the patient received DTPa-HBV-IPV-HIB at an unknown dose, Pneumococcal vaccine at an unknown dose and Rotavirus vaccine at an unknown dose. On an unknown date, 1 day after receiving DTPa-HBV-IPV-HIB, Pneumococcal vaccine and Rotavirus vaccine, the patient experienced sudden death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the sudden death was fatal. The reported cause of death was sudden death was fatal. The reported cause of death was sudden death. An autopsy was performed. The reporter considered the sudden death to be possibly related to DTPa-HBV-IPV-HIB, Pneumococcal vaccine and Rotavirus vaccine. Additional details were received as follows: The age at vaccination was not reported. This case was reported in an article of a newspaper. The patient was a newborn baby, found dead in the cradle after 1st vaccination cycle with DTPa-HBV-IPV-HIB, Pneumococcal vaccine and Rotavirus vaccine of an unknown brand. The rescuers at the hospital tried to resuscitate the patient but the patient was already died. It was reported that, the event was not medically confirmed at the time of reporting and the autopsy was ongoing but the results were not available.


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

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

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

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


VAERS ID: 642549 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-03
Entered: 2016-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / 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: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1605GBR014267

Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # 2016005611) on 27-MAY-2016. Case received from a other health professional on 24-May-2016. A patient of unknown sex/age received ZOSTAVAX (batch number unknown) on an unknown date. the reporter claimed to have heard where an immunocompromised patient had been vaccinated with ZOSTAVAX and died on unspecified date. the reporter did emphasize this was what she had heard and was a rumor and could give no further details. the patient''s outcome was reported as fatal.


VAERS ID: 642953 (history)  
Form: Version 1.0  
Age: 6.0  
Sex: Female  
Location: Foreign  
Vaccinated:2016-05-31
Onset:2016-05-31
   Days after vaccination:0
Submitted: 2016-06-07
   Days after onset:7
Entered: 2016-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Death, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-05-31
   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: BY2016GSK078313

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a 6-year-old female patient who received PRIORIX. Co-suspect products included DTP (A or W not known) (DTP vaccine). On 31st May 2016, the patient received PRIORIX (subcutaneous) and DTP vaccine (intramuscular) .5 ml. On 31st May 2016, less than a day after receiving PRIORIX and DTP vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and loss of consciousness (serious criteria GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the loss of consciousness was unknown. The patient died on 31st May 2016. The reported cause of death was unknown cause of death. The reporter considered the unknown cause of death to be possibly related to PRIORIX and DTP vaccine. It was unknown if the reporter considered the loss of consciousness to be related to PRIORIX and DTP vaccine. Additional details were provided as follows: On 31st May 2016 at 4 pm, the child received 2 vaccines. The first was DTP vaccine (manufacturer unknown) and then in 3 minutes, PRIORIX was administered. During the PRIORIX injection, the patient lost consciousness and emergency help was done, but the patient died. The cause of death was not reported. No more information was available.


VAERS ID: 638393 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2016-04-19
Onset:2016-05-19
   Days after vaccination:30
Submitted: 2016-06-07
   Days after onset:19
Entered: 2016-06-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, H1N1 influenza, Nasopharyngitis, Pathology test, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-06-01
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 2016, Pathology test, results were provided
CDC Split Type: BR2016GSK080258

Write-up: This case was reported by a physician via sales rep and described the occurrence of H1N1 influenza in a adult male patient who received FLUARIX TETRA. On 19th April 2016, the patient received FLUARIX TETRA. In May 2016, 30 days after receiving FLUARIX TETRA, the patient experienced weight loss. On 19th May 2016, the patient experienced H1N1 influenza (serious criteria death) and cold (serious criteria hospitalization). On an unknown date, the outcome of the H1N1 influenza was fatal and the outcome of the cold and weight loss were not reported. The patient died on 1st June 2016. The reported cause of death was H1N1 influenza. It was unknown if the reporter considered the H1N1 influenza, cold and weight loss to be related to FLUARIX TETRA. Additional details were provided as follows: On 19th May 2016, the patient developed cold and was hospitalized for 3 days. On 22nd May 2016, the patient had hospital discharge. The patient was well but did not specify very much. Approximately 1 month after the vaccination, the patient suffered from weight loss of 20 kilograms. On 1st June 2016, the patient died but the reporter did not know the exact cause of the death. The patient underwent pathology test but further details were not specified. No further information was provided.


VAERS ID: 643115 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2016-06-06
Onset:2016-06-07
   Days after vaccination:1
Submitted: 2016-06-13
   Days after onset:6
Entered: 2016-06-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (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, Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-06-08
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZA2016GSK082633

Write-up: This case was reported by a physician via licensee and described the occurrence of unknown cause of death in a 4-month-old male patient who received ROTARIX. Co-suspect products included HEXAXIM and PREVENAR. On 6th June 2016, the patient received ROTARIX (oral). On an unknown date, the patient received HEXAXIM at an unknown dose and PREVENAR at an unknown dose. On 7th June 2016, 1 days after receiving ROTARIX, the patient experienced loose stools. In June 2016, 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 and the outcome of the loose stools was unknown. The patient died on 8th June 2016. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death and loose stools to be related to ROTARIX. Additional details were provided as follows: Age at vaccination was not reported. On 6th June 2016 Monday, the patient received ROTARIX, PREVENAR and HEXAXIM. On Tuesday, the patient had loose stools. On 8th June 2016, 41 hours after vaccination, the patient passed away. Unfortunately, the reporter did not have any batch details at the time of the report. The reporter has given permission to be contacted.


VAERS ID: 639044 (history)  
Form: Version 1.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-11-01
Onset:0000-00-00
Submitted: 2016-06-14
Entered: 2016-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Biopsy bronchus abnormal, Bronchoscopy, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Cough, Death, Dyspnoea, Eosinophil percentage increased, Exposure during pregnancy, General physical health deterioration, HIV test negative, Haemoglobinuria, Hepatitis viral test negative, Lung adenocarcinoma, Lung infection, Mycobacterium test negative, Neutrophil percentage increased, Pneumonia klebsiella, Pneumothorax, Productive cough, Rales, Sepsis, Weight decreased, Wheezing, White blood cell count increased
SMQs:, Haemolytic disorders (narrow), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypersensitivity (broad), Proteinuria (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (narrow), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: neutrophil count; Test Result: 83 %; Test Name: eosinophil count; Test Result: 5.4 %; Test Name: leucocyte count; Result Unstructured Data: 21580 cell(s)/cubic millimeter
CDC Split Type: BRSA2016SA108607

Write-up: Initial unsolicited pregnancy report received from the literature on 01 June 2016. Introduction: Lung adenocarcinoma usually occurs in male smoker patients after the 5th decade of life. Typical images are unilateral peripheral lesions invading pleura or causing bronchial obstruction. Scarcely adenocarcinoma simulates CAP, particularly in patients below 30 years, non-smokers and, occurring during pregnancy, is associated to high risk of death. Discussion: When an adenocarcinoma appears as consolidation is often misdiagnosed as CAP mainly if affecting a young nonsmoker patient. Although uncommon during pregnancy, lung cancer has a worse prognosis and a longer delay to be diagnosed because of a reluctance of both physician and patient to expose the fetus to radiation and take medication. In this case symptoms started during pregnancy, but adenocarcinoma was investigated with bronchoscopy after several months of therapeutic failure. Conclusion: The lesson brought by this case is the need of bronchoscopy for differential diagnosis of pulmonary consolidations in cases of therapeutic failures, even in nonsmoking young patients, mostly if a pregnant woman. This case involves 23-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (Anti-Influenza Vaccine) (batch number, route and site of administration: not reported) on an unspecified date in November 2013 while she was pregnant. Pregnancy information included LMP: not reported, estimated delivery date: December 2013, pregnancy trimester: third (late pregnancy). It was reported that the patient was non-smoker. Patient''s medical history and concomitant medications were not reported. On an unspecified date in November 2013, following the vaccination, the patient had cough, mucoid sputum and dyspnea. The patient denied chest pain, hemoptysis and fever. The patient decided to wait for the child birth in December to be treated. On unspecified date, post vaccination, the patient had weight loss of 14 Kg in 6 months. On an unspecified date in June 2014, post vaccination, patient was in poor general condition, had crackling rales and diffuse bilateral wheezing. On an unspecified date, post vaccination, patient had extensive bilateral consolidation, pneumothorax on the right side, adenocarcinoma with invasive focus in bronchial wall and sepsis secondary to KPC lung infection. In June 2014, the patient was admitted in tertiary hospital. Laboratory investigations included chest x-rays, Computerized tomography (CT) which confirmed bilateral consolidation, especially in the lower lobes and basal portions of the upper lobes, negative HIV Rapid Test and AFB (Acid Fast Bacillus) in sputum, negative serology for viral hepatitis and HIV, anatomopathology of lung sample obtained by transbronchial biopsy: adenocarcinoma with invasive focus in bronchial wall. Leukocytosis (21,580/mm3) with 17576 (83%) neutrophils, 1365 (5.4%) eosinophil, hemoglobinuria (+++). In January 2014, patient started corrective treatment antibiotic (with no improvement). Patient changed antibiotics. In June 2014 she started using Azithromicin and Cefuroxime. The patient was treated with Carbotaxol (negative EGFR gene excluded additional oral chemotherapy) for six months. Pregnancy outcome was reported as live birth. The patient died in December 2014 due to sepsis secondary to KPC lung infection. Autopsy was not reported. Documents held by sender: none.; Sender''s Comments: The reported symptoms and investigations are consistent with the diagnosis of adenocarcinoma of lung. The cause of death was reported as sepsis secondary to KPC lung infection. Date of Influenza vaccination and the exact time to onset is unknown. Although the patient was a non-smoker, no information about other risk factors including exposure to asbestos or other carcinogens like radon gas, metal dust, family history, etc. was reported. Complete information on detailed autopsy results, vaccination details, medical history, etc. will be needed for further assessment. However, based on the nature of the event, a role of the vaccine seems unlikely.; Reported Cause(s) of Death: sepsis secondary to KPC lung infection; sepsis secondary to KPC lung infection.


VAERS ID: 643154 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-14
Entered: 2016-06-14
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: WAES1606KOR006428

Write-up: This spontaneous report was received from an unspecified reporter via an internet article and refers to an unspecified number of female patients. There was no information about the patients'' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with unspecified HPV vaccine (manufacturer unknown) (exact dose, dose number, lot #, expiration date, route of administration and anatomical location were not reported). On unknown dates, the patients died. It was unknown if an autopsy was done. Causality assessment was not provided. Upon internal review, the event of death was considered to be medically significant. This is one of several reports received from the same reporter. Additional information is not expected due to lack of the reporter''s contact details.


VAERS ID: 643172 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2016-05-12
Onset:2016-05-12
   Days after vaccination:0
Submitted: 2016-06-14
   Days after onset:33
Entered: 2016-06-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 14L07A / 3 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac failure, Cardio-respiratory arrest, Chest X-ray abnormal, Death, Electrocardiogram abnormal, Enema administration, Malaise, Myocarditis, PO2 decreased, Pallor, Poor sucking reflex, Rhinorrhoea, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-05-14
   Days after onset: 2
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:
Current Illness:
Preexisting Conditions: 27-APR-2016, PREVENAR 13, Immunisation, 2nd dose
Allergies:
Diagnostic Lab Data: 12-MAY-2016, Body temperature, 36.5 Centigrade; 14-MAY-2016, Chest X-ray, diagnosed of cardiac failure; 14-MAY-2016, Electrocardiogram, diagnosed of cardiac failure; 14-MAY-2016, PO2, rapid decrease
CDC Split Type: 2016289853

Write-up: This is a spontaneous report received from the Agency. Regulatory authority report number V16100175. A 5-month-old male patient received the third dose of PREVENAR 13 (Lot # 14L07A, Expiration date 31Oct2016), subcutaneously on 12May2016 at 0.5 ml, single. Medical history and concomitant medications were not reported. On 27Apr2016, the patient had received the second dose of four-combination vaccine. Clinical course was reported as follows: On 12May2016, the third dose of PREVENAR 13 was given by a pediatrician. On the vaccination day, the patient had a mild running nose and body temperature was 36.5 Centigrade. In the morning on 13May2016, he had a weak suck and vomited for three times. Gradually, he seemed unwell and looked pale following which he visited a pediatrician where treatment with NAUZELIN and enema (resulted in watery stools) were given. Thereafter, he was referred to the reporting hospital around 18:00 and treated with maintenance medium with SOLITAX 200 mL and slept. He was hospitalized for treatment due to no feeding and placed under observation with drip infusion. The patient was suspected as developing fulminant myocarditis on 13May2016. On 14May2016 at 8:30, a rapid decrease of SpO2 was observed and a diagnosis of cardiac failure was made based on the results of electrocardiogram and chest X-ray. On the way to transfer to another hospital, he went into cardiopulmonary arrest and was confirmed dead at the hospital. The patient died on 14May2016. An autopsy was not performed. The reporter classified the event as serious (fatal) and commented as follows: fulminant myocarditis was most likely suspected by clinical course and laboratory findings; however, it was not confirmed because autopsy imaging and pathological anatomy were not conducted.


VAERS ID: 639450 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2016-06-06
Onset:2016-06-07
   Days after vaccination:1
Submitted: 2016-06-16
   Days after onset:9
Entered: 2016-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER 4K13C / 1 LL / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR L1506 / 1 RA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 15803A / 1 LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Death, Imaging procedure, Resuscitation
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: 2016-06-07
   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: JPSA2016SA110076

Write-up: Initial unsolicited case received from the pediatrician via health authority(under reference number-V16100186) and follow-up information received from another pediatrician via our partner companies, on 08-Jun-2016. This case involves a five-month-old male patient who was vaccinated with a 0.5 ml first dose of ACTHIB (batch number-L1506) in the right arm, a 0.5 ml first dose of PREVENAR (manufacturer: other and batch number-15803A) in the left arm and a 0.5 ml first dose of TETRABIK (manufacturer: other and batch number-4K13C) in the right thigh, all via subcutaneous route on 06-Jun-2016. Patient''s birth weight was reported as 2676 grams. Patient''s medical history and concomitant medications were not reported. On 07-Jun-2016, the patient slept in the morning and at around 11:00 AM (one day following the vaccination), the patient''s mother noticed that he was not breathing, patient was found in a state of cardiorespiratory arrest. Patient was transferred to another reporting hospital by an ambulance and patient was confirmed dead after corrective treatment. Lab data was not reported. The patient received corrective treatment with resuscitation measures including the administration of BOSMIN. The outcome was reported as fatal and date of death was 07-Jun-2016. It was reported that "No apparent cause of death was identified on autopsy imaging (Ai)". It was reported that the autopsy would be performed. Diagnosis: Cardiorespiratory arrest. Reporting pediatricians'' seriousness assessment: Serious (Death). Reporting pediatricians'' causality assessment: Related. Reporting pediatricians'' comment: No other possible factors for the event were identified. It was reported that "Although the causal relationship was unknown, the patient received the vaccination on the day before he died and the event could have been influenced by the vaccination somehow". List of documents held by sender: none. Sender''s Comments: In this case, the 5-month-old patient received HIB (PRP/T) Vaccine, Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus, Pertussis And Poliomyelitis (Inactivated) Vaccine (Adsorbed). The day after morning, the patient was sleeping then his mother noticed that he was not breathing, and found in a state of cardiorespiratory arrest and died despite resuscitation measures. No apparent cause of death was identified on autopsy imaging (Ai). An autopsy would be performed. Further information on the risks factors including any underlying disease or undiagnosed cardiorespiratory congenital anomaly; patient''s sleeping position; circumstances and patient''s medical condition at the time of death and detailed autopsy report would be needed for a complete assessment. The patient received three vaccines simultaneously making it difficult to assess the role of one vaccine in particular. The autopsy report will be needed to further assess this case. Reported Cause(s) of Death: Cardiorespiratory arrest.


VAERS ID: 643170 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2012-08-20
Onset:0000-00-00
Submitted: 2016-06-16
Entered: 2016-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H005342 / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Drowning, Epilepsy, Fatigue, Headache, Pain, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (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: WAES1606SWE006738

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control number 2016006125) on 14-JUN-2016. Case received from a consumer/other non health professional via Health Authority on 09-JUN-2016 under reference number SE-MPA-2016-003363. A female adolescent patient of unknown age received GARDASIL, (batch number unknown) on an unknown date. The patient experienced tired, headache, dizziness, epilepsy, pain in body and sudden death with unknown cause on an unknown date. The patient''s outcome reported as fatal for event sudden death with unknown cause. The patient died on unspecified date. The patient''s outcome was reported as unknown for the events tired, headache, dizziness, epilepsy and pain in body. Translation of HA narrative: "A consumer report regarding a girl who on unknown date was vaccination with GARDASIL. After the first dose, the girl was tired and had a headache. The reporter indicates that it then got worse that the girl fainted in the school, and she "got a referral to a doctor and they claimed that it is epilepsy." The reporter indicates that the girl received medication but it is not specified what is given and the girl "feels even worse". After the third dose the girl experience a large attack in school but they did not find anything wrong according to the reporter. The girl had headache and took ALVEDON every day, sometimes 2-3 times, she had vertigo and had pain in the body according to the reporter. Dates for when side effects started are not specified in the report. In 2014 at age 16 the girl died and the reporter states that forensic medicine does not know the cause but that she was found drowned. The reporter indicates that everything started after the vaccination with GARDASIL. HA assesses "death of unknown cause" in the report as "unclassified" as relevant information will be sought from consumer and health care." The HA assessed the causal relationship: -between tiredness and GARDASIL as possible; -between headache and GARDASIL as possible; -between dizziness and GARDASIL as possible; -between epilepsy and GARDASIL as not assessed; -between general body pain and GARDASIL as possible; -between sudden death, cause unknown and GARDASIL as not assessed.


VAERS ID: 643199 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-16
Entered: 2016-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 14J01A / UNK UN / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2016JPN084031

Write-up: This case was reported by a physician via other manufacturer and described the occurrence of sudden death in a 3-month-old male subject who received ROTARIX. Co-suspect products included PREVENAR 13 (batch number 14J01A, expiry date unknown), ACTHIB and diphtheria toxoid + Pertussis toxoid + poliomyelitis vaccine + tetanus toxoid (DPT Polio vaccine). On an unknown date, the subject received ROTARIX (oral) 1. ml. PREVENAR 13 (subcutaneous) .5 ml. ACTHIB (subcutaneous) 1 dosage form(s) and DPT POLIO VACCINE (subcutaneous ) 1 dosage form(s). On an unknown date, 1 day after receiving ROTARIX, the subject experienced sudden health (serious criteria death and GSK medically significant). On an unknown date, the outcome of the sudden death was fatal. the reported cause of death was sudden death. It was unknown if the reporter considered the sudden death to be related to ROTARIX. Medical history and concomitant medications were not reported. On an unspecified date, in the morning of the next day of vaccination, the subject suddenly died. As of 12Feb2016, the cause of death was not reported and a legally-ordered autopsy was supposed to be conducted hereafter.


VAERS ID: 643191 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-17
Entered: 2016-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Anaemia, Autopsy, Cardiac arrest, Cardiac failure, Death, Haemoglobin decreased, Histiocytosis haematophagic, Irritability, Selective eating disorder
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Haemoglobin, 4.5 g/dL, depressed
CDC Split Type: PHHY2008GB35701

Write-up: A young infant arrested 1 day after immunization with DTP (manufacturer and batch no. unknown), haemophilus-b vaccine (manufacturer and batch no. unknown), meningococcal C vaccine (manufacturer and batch no. unknown) and oral polio vaccine (manufacturer and batch no. unknown). The infant had developed difficulty in feeding and had been irritable 6 hours previously. Postmortem results showed haemophagocytosis in the spleen and bone marrow (responsible for the low haemoglobin of 4.5 g/dl). The anemia had induced cardiac failure. No further information are available. For the other vaccinations see cases MA2008-1882 to MA2008-1884. Expected assessment according to agency: the described symptoms, except for difficulties in feeding and irritable, are unexpected after vaccination with DPT-IMPSTOFF. On a case live, the case is considered unexpected. No change in benefit-risk-ratio. No measures necessary. We received on 16 SEP 2008 from the author the information that the information is confidential. No change in assessment. We received on 30 SEP 2008 from the Medicines and Healthcare products Regulatory Agency, the following information: the patient had suffered from haematophagic histiocytosis. Expected assessment according to agency: the described symptoms, except for difficulties in feeding and irritable, are unexpected after vaccination with DPT-IMPFSTOFF Behring. On a case level, the case is considered unexpected. No change in benefit-risk-ration. No measures necessary. MHRA no. ADR 20313410 On 167 June 2016, this case has been identified as a duplicate. Cases B0537568A, PHHY2008GB35703, PHHY2008GB35704 and PHHY2008GB35705 have been deleted. All information has been kept in this case: This case was reported in a literature article and described the occurrence of cardiac failure in a infant patient who received DTP (A or W not known). Co-suspect products included HIB unk, Men C NVD and Oral polio vaccine. On an unknown date, the patient received DTP (A or W not known) at an unknown dose, Haemophilus influenza vaccine at an unknown dose, Meningococcal C vaccine at an unknown dose and oral polio vaccine at an unknown dose. On an unknown date, 1 day after receiving DTP (A or W not known), Haemophilus influenza vaccine, Meningococcal C vaccine and oral polio vaccine, the patient experienced cardiac failure (serious criteria death, hospitalization and GSK medically significant), haemophagocytosis (serious criteria death, hospitalization and GSK medically significant), anemia (serious criteria death and hospitalization), feeding disorder of infancy or early childhood (serious criteria death) and irritable (serious criteria death). Rechallenge with DTP (A or W not known) was negative. On an unknown date, the outcome of the cardiac failure, haemophagocytosis, anemia, feeding disorder of infancy or early childhood and irritable were fatal. The reported cause of death was cardiac failure and hemophagocytosis. An autopsy was performed. The autopsy determined cause of death was histiocytosis haematophagic. It was unknown if the reporter considered the cardiac failure, haemophagocytosis, anemia, feeding disorder of infancy or early childhood and irritable to be related to DTP (A or W not known), Haemophilus influenza vaccine, Meningococcal C vaccine and oral polio vaccine.


VAERS ID: 643228 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-17
Entered: 2016-06-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pneumococcal sepsis
SMQs:, Infective pneumonia (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PREVENAR 13, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2016300999

Write-up: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 2-year-old patient of unspecified ethnicity and gender received PREVENAR 13, via an unspecified route of administration, on an unspecified date, at single dose. The patient''s medical history and concomitant medications were not reported. The patient previously received PREVENAR 13. The patient experienced pneumococcal sepsis in 2014 with fatal outcome in 2014. Pneumococcal sepsis was caused by a serotype not covered by PREVENAR 13. It was not reported if an autopsy was performed.


VAERS ID: 643232 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-18
Entered: 2016-06-20
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 UN / ID

Administered by: Other       Purchased by: Other
Symptoms: Altered state of consciousness, Biopsy skin normal, CSF test normal, Cardiac arrest, Coma, Deafness, Death, Dizziness, Encephalitis, Headache, Lyssavirus test positive, Musculoskeletal stiffness, Nuclear magnetic resonance imaging brain abnormal, Polymerase chain reaction, Pyrexia, Rabies, Rhinorrhoea, Saliva analysis normal, Somnolence, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), 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), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Animal bite, Bitten by a mongoose on the toes of her right leg (category III exposure)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab test performed on unknown date. The rabies virus neutralizing antibody (RVNA) titre by rapid fluorescent focus inhibition test (RFFIT) in CSF was 2048 (normal value and range not provided). CSF RVNA titre by RFFIT repeated after 2 weeks was greater than 16,384 (endpoint not determined). The patient was diagnosed with rabies encephalitis based on the history of animal exposure, compatible clinical and imaging findings and by evidence of rabies specific neutralizing antibodies in CSF; Biopsy skin, negative for rabies viral antigen; Nuclear magnetic resonance imaging brain, consistent with encephalitis; Polymerase chain reaction, CSF and saliva negative for rabies RNA
CDC Split Type: IN2016GSK086771

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a 45-year-old female patient who received Rabies Vaccine. Co-suspect products included Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Concurrent medical conditions included animal bite (Bitten by a mongoose on the toes of her right leg (category III exposure)). On an unknown date, the patient received the 1st dose of Rabies Vaccine (intradermal), the 2nd dose of Rabies Vaccine (intradermal), the 3rd dose of Rabies Vaccine (intradermal) and the 4th dose of Rabies Vaccine (intradermal). On an unknown date, less than a month after receiving Rabies Vaccine, Rabies Vaccine and Rabies Vaccine and several days after receiving Rabies Vaccine, the patient experienced vaccination failure (serious criteria death, hospitalization and GSK medically significant), rabies (serious criteria death, hospitalization and GSK medically significant), encephalitis (serious criteria death, hospitalization and GSK medically significant), hearing loss (serious criteria hospitalization and GSK medically significant), altered state of consciousness (serious criteria hospitalization and GSK medically significant), coma (serious criteria death, hospitalization and GSK medically significant), cardiac arrest (serious criteria death, hospitalization and GSK medically significant), nasal discharge (serious criteria hospitalization), fever (serious criteria hospitalization), headache (serious criteria hospitalization), dizziness (serious criteria hospitalization), drowsiness (serious criteria hospitalization) and stiff neck (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure, rabies, encephalitis, coma and cardiac arrest were fatal and the outcome of the hearing loss, altered state of consciousness, nasal discharge, fever, headache, dizziness, drowsiness and stiff neck were unknown. The reported cause of death was rabies, encephalitis and cardiac arrest. The reporter considered the vaccination failure and rabies to be related to Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. It was unknown if the reporter considered the encephalitis, hearing loss, altered state of consciousness, coma, cardiac arrest, nasal discharge, fever, headache, dizziness, drowsiness and stiff neck to be related to Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Additional information was provided: This case was reported in a literature article and described the occurrence of vaccination failure in a 45-year-old female who was vaccinated with unspecified cell culture rabies vaccine (manufacturer unknown). No information on patient''s medical history or family history or concurrent condition or concomitant medication was provided. The patient had been bitten by mongoose on the toes of her right leg (category III exposure). On unspecified dates, on day 0 (the day of the bite), 3, 7, and 28, the patient received 4 doses of a unspecified cell culture rabies vaccine by intradermal route (2 sites, 0.1 ml each) (administration site unspecified; batch number not provided). Rabies immunoglobulin (RIG) was not administered that was crucial in category III exposure. On an unspecified date, 1 month after being bitten by the mongoose, the patient presented with fever of 1-week duration associated with a headache, dizziness, hearing loss and 1-day history of altered sensorium. Subsequently the patient was hospitalised. On examination, the patient was drowsy, arousable to pain with a Glasgow coma scale of 9 (E2V3M4). The patient had aerophobia and neck stiffness and the cerebellar signs were positive. The patient also had hearing loss and nasal regurgitation. After 3 weeks of admission, the patient underwent magnetic resonance imaging brain which showed features consistent with encephalitis. Corneal impression smears and nuchal skin biopsy were negative for rabies viral antigen by a fluorescent antibody test. Cerebrospinal fluid (CSF) and saliva were negative for rabies viral RNA by real-time polymerase chain reaction. However, the rabies virus neutralising antibody (RVNA) titre by rapid fluorescent focus inhibition test (RFFIT) in CSF was 2048 (normal value and range not provided). CSF RVNA titre by RFFIT repeated after 2 weeks was greater than 16,384 (endpoint not determined). The patient was diagnosed with rabies encephalitis based on the history of animal exposure, compatible clinical and imaging findings and by evidence of rabies specific neutralizing antibodies in CSF. The presence and the significant increase of RVNA titres in CSF had been considered diagnostic of rabies regardless of immunization status. The patient eventually became comatose and in spite of intensive care, developed cardiac arrest and expired 1-month after hospital admission. It was unknown if the autopsy was performed. This case was considered as vaccination failure. This case was considered serious due to death. Treatment was unknown. The authors did not comment on the causality relationship for rabies encephalitis with unspecified cell culture rabies vaccine. The authors stated that "despite prompt and adequate vaccination, the patient was not administered RIG, crucial in category III exposures. This lapse may have resulted in her acquiring the disease. All exposures to wild animals are classified as WHO category III exposures and necessitate administration of both active (vaccination) and passive (RIG) immunization, in addition to immediate washing and flushing of all bite wounds and scratches".


VAERS ID: 643253 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-21
Entered: 2016-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Autopsy, Death, Dizziness, Headache, Loss of consciousness, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1606GBR008621

Write-up: This spontaneous report was received from a PR vendor via internet news article refers to a 13 year old female patient. The patient''s medical history and concurrent conditions were not reported. On April 13th (year unspecified), the patient was vaccinated with quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. Vaccine (manufacturer unknown) (dosing regimen and frequency unknown) (lot number and expiry date unknown) intramuscularly. On April 13th (year unspecified), after receiving vaccination, the girl experienced severe abdominal pain, headache and dizziness. On April 16th (year unspecified), the girl vomited while complaining of pain and on approximately April 17th (reported as next day), she saw a doctor but the doctor diagnosed her symptom as a simple abdominal pain. On an unknown date (5 days after receiving vaccination) an hour after getting back home from the hospital, the patient lost her consciousness and died in 4 hours after transferring to the hospital. The cause of death was not reported. It was also reported that the older sister of the girl stated that the patient was healthy before receiving the vaccination. It was reported that an autopsy was requested but the result were received yet. The action taken with the therapy with quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. Vaccine (manufacturer unknown) was unknown. The outcome of the events loss of consciousness, abdominal pain, vomiting, headache and dizziness was not reported. The relatedness of the events to the therapy with quadrivalent human papillomavirus (types 6, 11, 16, 18) recomb. Vaccine (manufacturer unknown) was unknown. Upon internal review the event loss of consciousness and death was considered as medically significant. This is one of the many cases from the same source. Additional information is not expected as no follow-up was required or available.


VAERS ID: 640568 (history)  
Form: Version 1.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-23
Entered: 2016-06-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Biopsy bone marrow abnormal, Biopsy skin abnormal, Blood bilirubin increased, Blood lactate dehydrogenase increased, Chemotherapy, Chest X-ray abnormal, Computerised tomogram abdomen abnormal, Computerised tomogram thorax abnormal, Death, Epstein-Barr virus test negative, General physical health deterioration, Haemoglobin decreased, Hepatic function abnormal, Histiocytosis haematophagic, Hyperbilirubinaemia, Hyperferritinaemia, Injection site nodule, Injection site ulcer, Lymphadenopathy, Neoplasm skin, Pancytopenia, Platelet count decreased, Pleural effusion, Polymerase chain reaction positive, Pyrexia, Red blood cell count decreased, Skin plaque, Splenomegaly, T-cell lymphoma, T-lymphocyte count decreased, White blood cell count decreased
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (broad), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Skin tumours of unspecified malignancy (narrow), Malignant lymphomas (narrow), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Haematological malignant tumours (narrow), Non-haematological tumours of unspecified malignancy (narrow), Infective pneumonia (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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On unknown date, histopathologic examination of the lesion showed a granulomatous and mixed cellular infiltration. The biopsy showed an ulcerated epidermis and infiltration of atypical lymphoid cells along the full thickness of the dermis which extended into the subcutaneous fat with an angiocentric pattern. The biopsy from the red plaque on the trunk showed infiltration of small to large lymphoid cells with irregular nuclei around dermal appendages and blood vessels. PCR showed monoclonal rearrangement, indicating the presence of a monoclonal T-cell population. T-lymphocyte subtype, CD4 18% (N: 40-55%), CD8 27% (N: 18-30%), and CD4/CD8: 0.67 (N: 0.9-3.6). Abdomen CT scan showed mild bilateral pleural effusion, left axillary adenopathy, and splenomegaly. Bone marrow biopsy demonstrated dyshaematopoiesis of myeloid cells and erythroid cells.
CDC Split Type: CN2016GSK089431

Write-up: This case was reported in a literature article and described the occurrence of T-cell lymphoma in a 27-year-old male patient who received FLUARIX. On an unknown date, the patient received FLUARIX. On an unknown date, several days after receiving FLUARIX, the patient experienced injection site nodule and injection site ulcer. On an unknown date, several months after receiving FLUARIX, the patient experienced T-cell lymphoma (serious criteria death and GSK medically significant), hemophagocytic syndrome (serious criteria death and GSK medically significant), fever (serious criteria death), skin plaque (serious criteria death), pancytopenia (serious criteria death and GSK medically significant), hepatic function disorder (serious criteria death), splenomegaly (serious criteria death), hyperferritinemia (serious criteria death), hyperbilirubinemia (serious criteria death and GSK medically significant) and skin tumor (serious criteria death). The patient was treated with topical antibiotic (NOS), dexamethasone, HEPATOPROTECT, ifosfamide, pirarubicin, vindesine, methylprednisolone and arsenic trioxide. On an unknown date, the outcome of the T-cell lymphoma, hemophagocytic syndrome, injection site nodule, injection site ulcer, fever, skin plaque, pancytopenia, hepatic function disorder, splenomegaly, hyperferritinemia, hyperbilirubinemia and skin tumor were fatal. The reported cause of death was hemophagocytic syndrome and T-cell lymphoma. The reporter considered the T-cell lymphoma to be related to FLUARIX. It was unknown if the reporter considered the hemophagocytic syndrome, injection site nodule, injection site ulcer, fever, skin plaque, pancytopenia, hepatic function disorder, splenomegaly, hyperferritinemia, hyperbilirubinemia and skin tumor to be related to FLUARIX. Additional information was provided: This case was reported in a literature article and described the occurrence of peripheral T-cell lymphoma, not otherwise specified (NOS) in 27-year-old male who was vaccinated with FLUARIX (GlaxoSmithKline). No information on patient''s medical history or family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received an injection of FLUARIX on the left upper arm (administration route unspecified; dosages unknown batch number not provided). On an unspecified date, an unknown period after vaccination with FLUARIX, the patient developed a nodule and ulcer at the inoculation site of vaccine on the left upper arm. Within a few days after the injection, the nodule grew to 2 cm in diameter. The patient was presented at a peripheral hospital and was treated with topical antibiotics, but the lesion continued to increase in size and gradually became more indurated and ulcerated. There was no regional lymphadenopathy. Five months after the initial presentation, debridement of the lesion was done. Histopathologic examination of the specimen showed a granulomatous and mixed cellular infiltration. Subsequently, the patient was diagnosed with granulomatous reaction following vaccination. However, over a period of 2 months, the lesion continued to enlarge while the patient became febrile along with the appearance of numerous red plaques on his trunk and limbs. The patient was then referred to another hospital for evaluation of the enlarging ulcer, plaques and fever. Skin biopsies for histopathology, immunohistochemistry and molecular analyses were obtained from the ulcerated tumour on the left arm and a plaque on the trunk. The biopsy from the left arm showed an ulcerated epidermis and infiltration of atypical lymphoid cells along the full thickness of the dermis which extended into the subcutaneous fat with an angiocentric pattern. Re-evaluation of the initial biopsy also revealed infiltration of atypical lymphocytes. The biopsy from the red plaque on the trunk showed infiltration of small to large lymphoid cells with irregular nuclei around dermal appendages and blood vessels. Immunohistochemistry on the specimen from the left arm lesion showed the majority of the lymphoid cells to be positive for CD3, CD7, and CD2; but negative for CD4, CD8, CD10, CD19, CD30, CD79, Bcl-2, and Bcl-6. The pan B-cell marker CD20 was negative and betaF1 staining was negative on paraffin sections. Natural killer (NK) lineage marker CD56 and the cytotoxic effectors granzyme B and perforin were strongly expressed. The Ki-67 proliferation index was relatively high. Infiltrating cells of the trunk biopsy were positive for CD3, CD2, and CD56, and negative for CD4, CD8, CD10, CD19, CD30, and CD34, and expressed granzyme B and perforin weakly. Immunohistochemistry and molecular analysis of the skin biopsies excluded extranodal NK/T-cell lymphoma, primary cutaneous CD4-positive small/medium T-cell lymphoma (CD4+SMTL), primary cutaneous CD8-positive aggressive epidermotropic T-cell lymphoma (CD8+AECTCL), and primary cutaneous gamma/delta T-cell lymphoma (CGD-TCL). In situ hybridization with fluorescein conjugated ribonucleic acid (RNA) probe for the small Epstein-Barr virus (EBV)-encoded ribonucleic acid (RNA)1 and 2 (EBER1/2) showed no evidence of EBV infection. Using a primer for the V and J regions of T-cell receptor (TCR) gamma chain, polymerase chain reaction (PCR) showed monoclonal rearrangement, indicating the presence of a monoclonal T-cell population. T-cell lymphoma cell line Jurkat and B-cell lymphoma cell line Raji used as positive controls. Laboratory evaluation revealed pancytopenia [red blood cell count of 3.36 x 10E12/L (normal range (N): 4-5.5 x 10E12/L), white blood cell count of 1.98 x 10E9/L (N: 4-10 x 10E9/L), haemoglobin 90 g/L (N: 120-160 g/L), platelet count 76 x 10E9/L (N: 100-300 x 10E9/L), T-lymphocyte subtype, CD4 18% (N: 40-55%), CD8 27% (N: 18-30%), and CD4/CD8: 0.67 (N: 0.9-3.6).], hyperbilirubinemia [total bilirubin 24.8 mcmol/L (N: 2-18 mcmol/L)], transaminitis (aspartate aminotransferase (AST) 223 U/L (N: less than 64 U/L), alanine aminotransferase (ALT) 283 U/L (N: less than 64 U/L) and raised lactic dehydrogenase 723 U/L (N: 80-285 U/L) levels. A chest X-ray showed mildly increased pulmonary markings and a chest and abdomen computed tomographic (CT) scan showed mild bilateral pleural effusion, left axillary adenopathy, and splenomegaly. Examination of the oral cavity and pharynx was unremarkable. A bone marrow biopsy demonstrated dyshaematopoiesis of myeloid cells and erythroid cells. Subsequently, after discussion with hematology and pathology colleagues, the patient was diagnosed with peripheral T-cell lymphoma, not otherwise specified (NOS). The patient received 15 mg dexamethasone daily for high fever and liver-protective drugs for elevation of liver enzymes. The fever persisted and the tumour on his left arm enlarged to 8 x 10 cm in diameter with obvious necrosis. The patient was then transferred to the department of haematology. Combination chemotherapy with ifosfamide, pirarubicin, vindesine, and methylprednisolone were administered due to his severe systemic symptoms. Two days later, the laboratory data revealed progressively abnormal liver function tests (AST at 667 U/L and ALT at 1,060 U/L). The combination chemotherapy was changed to arsenic trioxide and dexamethasone. Although plaques on the trunk showed some improvement, the patient''s general condition continued to deteriorate as he developed progressive liver dysfunction and severe hyperbilirubinemia (total bilirubin at 196.2 and direct bilirubin at 179.3 units and normal values not provided for both). A bone marrow biopsy showed infiltration with abnormal cells. On the 46th day of hospitalisation, the patient died. It was unknown if an autopsy was performed. This case was considered serious due to death. The authors commented that "The association of the lymphoma with the vaccination and the underlying mechanisms for the occurrence of T-cell lymphoma were unclear". The authors concluded that "Influenza virus vaccine (FLUARIX) administered to our patient has been standardized for the influenza season and is formulated to contain hemagglutinin, Triton X-100, and Tween 80. The vaccine does not contain preservatives and aluminum adjuvant. Most experts consider that chronic antigenic stimulation, local infection, inflammatory responses, and even the patient''s immune status might play an important role in the process of malignant transformation. Our patient''s clinical course was characterized by high fever, pancytopenia, splenomegaly, hyperferritinemia, and hemophagocytosis in the bone marrow; features suggesting that lymphoma-associated hemophagocytic syndrome (LAHS) should be considered as the cause of death. In general, cutaneous T-cell lymphomas expressing CD56, granzyme B, and perforin often exhibit a rapidly progressive course and poor response to chemotherapy". This article is not available for regulatory submission due to copyright restriction.


VAERS ID: 640691 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2014-12-24
Onset:0000-00-00
Submitted: 2016-06-23
Entered: 2016-06-27
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC093C / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH J81984 / 1 LL / 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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2016308865

Write-up: This is a spontaneous report received from a contactable physician via Product Quality Complaints Group. A patient of unspecified age ethnicity and gender received a single dose of PREVENAR 13 (Lot # J81984, Expiration Date May2017), via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient received PREVENAR 13 and died on an unspecified date. It was not reported if an autopsy was performed.


VAERS ID: 643777 (history)  
Form: Version 1.0  
Age: 1.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-06-13
Submitted: 2016-06-22
   Days after onset:9
Entered: 2016-06-27
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Sepsis, Streptococcus test positive
SMQs:, Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-06-13
   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:
Current Illness:
Preexisting Conditions: Heart disorder; Hypoplastic left heart syndrome; PREVENAR 13; Drug indication: Immunisation, first dose; PREVENAR 13; Drug Indication: immunization, second dose
Allergies:
Diagnostic Lab Data: JUN-2016, Serology test, serotype 35B
CDC Split Type: 2016303561

Write-up: This is a spontaneous report from a contactable physician (pediatrician) through a Pfizer sales representative. A 14-month-old patient of an unspecified gender and ethnicity received the third dose of PREVENAR 13 subcutaneously on an unspecified date at 0.5 ml single. Medical history included ongoing heart disorder and ongoing hypoplastic left heart syndrome, the patient''s concomitant medications were not reported. The patient had previously received the first and the second dose of pneumococcal 13-val conj vac on unspecified date. On around 13Jun2016, the patient experienced sepsis due to which died on 13Jun2016. The reporting pediatrician classified the event as serious (fatal) and assessed it as unrelated to 13-val conj vac. The reporting pediatrician commented that days had passed after the vaccination when the event developed. Therefore, pneumococcal 13-val conj vac was not a direct cause of death. Heart disorder as the underlying disease was greatly related to the death. In this case, serotype 35B which was not covered by pneumococcal 13-val conj vac was detected.


VAERS ID: 643792 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-23
Entered: 2016-06-27
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 4 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Meningitis pneumococcal, Pneumonia, Sepsis, Streptococcus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Serology test, pneumococcus serotype 3
CDC Split Type: 2016307114

Write-up: This is a literature report. A 3-year-old patient of an unspecified gender received four single doses of PREVENAR 13, all via an unspecified route of administration on an unspecified date. The patient experienced purulent meningitis caused by pneumococcus serotype 3 resulting in death (vaccination failure) on an unspecified date. It was not reported if an autopsy was performed. The seventh block of presentation on Vaccination possibilities against invasive neuroinfections included 3 presentations. The first concerned the vaccination strategy for meningococcal diseases and recommended guidelines, the second presentation was about current incidence of invasive pneumococcal diseases and the last one presented two case reports on severe course of invasive pneumococcal infections in immunized children monitored by the Authority. The first report presented a case of a three year old child duly vaccinated with PREVENAR 13 according to the vaccination schedule, who suffered from purulent meningitis caused by pneumococcus serotype 3 resulting in death. The second report presented a case of a young child duly vaccinated with SYNFLORIX, who developed bilateral pneumonia associated with sepsis due to pneumococcus serotype 19A. This serotype is not included in the above mentioned vaccine. No follow-up attempts needed. No further information expected.


VAERS ID: 641010 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2016-05-16
Onset:2016-06-01
   Days after vaccination:16
Submitted: 2016-06-29
   Days after onset:28
Entered: 2016-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, CSF glucose, CSF lactate, CSF test abnormal, Culture negative, Death, Endotracheal intubation, Formication, Full blood count normal, Glucose urine present, Guillain-Barre syndrome, Hyporeflexia, Immunoglobulin therapy, Myalgia, Protein urine present, Pyrexia, Red blood cells urine positive, Renal function test normal, Retching
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Angioedema (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-06-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METFORMIN; GLIBENCLAMIDE; LOSARTAN POTASSIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension; Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20160612; Test Name: body temperature; Result Unstructured Data: 40 Celsius temperature; Test Date: 20160607; Test Name: complete blood count; Result Unstructured Data: NORMAL; Test Date: 20160608; Test Name: renal function test; Result Unstructured Data: NORMAL
CDC Split Type: BRSA2016SA114813

Write-up: Initial unsolicited report received from a health care professional (nurse) via Institute on 14-JUN-2016. This case involves a 46-year-old male patient who was vaccinated with a single dose of INFLUENZA VACCINE (batch number, expiry date, dose, dose in series, site of administration were not reported), intramuscularly on 16-May-2016. It was unknown if the patient presented any reaction with this vaccine before. The patient had a medical history of hypertension, diabetes and obesity. Concomitant medications included metformin 850 MG 2 tablets/day, glibenclamide 5 MG one tablets/day and losartan potassium 50 MG for all route of administration was oral. On 07-Jun-2016, 22 days following the vaccination, the patient experienced formication, myalgia, loss of muscular strength in the left upper member, gagging and underactive in some reflex (It was reported that these symptoms started on the next month of vaccination). On 08-Jun-2016, 23 days after vaccination, the patient also experienced worsening of the clinical condition. On 12-Jun-2016, 27 days after vaccination, the patient experienced episodes of high fever with maximum of 40 degree Celsius (the pick of 40). On an unspecified date in Jun-2016, the patient developed Guillain-Barre syndrome (hypothesis of a diagnosis of Guillain-Barre syndrome). It was reported that on 12-Jun-2016, the patient was intubated. On 07-Jun-2016, patient was admitted on the emergency room and hospitalized. The duration of hospitalization was reported as 07-Jun-2016 to13-Jun-2016. Lab data included 07-Jun-2016, CSF collection (Results: glucose and lactate levels altered), Complete CBC Result: Normal and on 08-Jun-2016, besides unspecific exams of monitoring, a renal function test was performed with normal results. On 13-Jun-2016, some unspecific cell cultures with normal results and turbid urine with high levels of proteins, glucose and erythrocytes. The patient received corrective treatment with Immunoglobulin human intravenous for "worsening of the clinical condition". The patient died (passed away) on 13-Jun-2016. Cause of death: Possible related to Guillain-Barre syndrome post-immunization (No conclusion). It was unknown if the autopsy was performed or not. List of documents held by sender: none. Sender''s Comments: In this case, the reported symptoms and the investigation results (especially CSF) are consistent with the diagnosis of Guillain-Barre syndrome. Guillain-Barre Syndrome is listed with both INFLUENZA SPLIT TRITON THIOMERSAL LOWER CONTENT VACCINE and INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE but not severe to that extent which resulted in death. Complementary investigation results including etiological infectious work-up as GBS is often preceded by an infection, the most frequent being Campylobacter jejuni, patient''s medical history and autopsy results confirming the cause of death, etc. are needed to further assess this case. Based on the available information, no conclusion on a role of the vaccine can be drawn. Reported Cause(s) of Death: Guillain-Barre syndrome.


VAERS ID: 643939 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-06-29
Entered: 2016-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Encephalopathy, Gastroenteritis rotavirus, Hepatitis fulminant, Pyrexia, Rotavirus test positive, Vaccination failure, Vomiting
SMQs:, Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-03-06
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: 02/21/2016, Rotavirus test, rota positive
CDC Split Type: LB2016GSK091121

Write-up: This case was reported by a physician via sales rep and described the occurrence of hepatitis fulminant in a 22-month-old male patient who received ROTARIX. Co-suspect products included ROTARIX. On an unknown date, the patient received the 1st dose of ROTARIX (oral) and the 2nd dose of ROTARIX (oral). On 21st February 2016, an unknown time after receiving ROTARIX and ROTARIX, the patient experienced vaccination failure (serious criteria GSK medically significant), diarrhea rotavirus (serious criteria hospitalization and GSK medically significant), vomiting (serious criteria hospitalization) and fever (serious criteria hospitalization). On an unknown date, the patient experienced hepatitis fulminant (serious criteria death and GSK medically significant) and encephalopathy (serious criteria death and GSK medically significant). The patient was treated with SUPRAX. On an unknown date, the outcome of the hepatitis fulminant and encephalopathy were fatal and the outcome of the vaccination failure was unknown and the outcome of the diarrhea rotavirus, vomiting and fever were not recovered/not resolved. The patient died on 6th March 2016. The reported cause of death was hepatitis fulminant and encephalopathy. An autopsy was not performed. The reporter considered the vaccination failure, diarrhea rotavirus, vomiting and fever to be related to ROTARIX and ROTARIX. The reporter considered the hepatitis fulminant and encephalopathy to be unrelated to ROTARIX. Additional details were provided as follows: The reporting physician who followed up with the patient. He knew about the case from parents when they visited him for another consultation (the other brother was sick). On an unknown date, the patient was vaccinated with 2 doses of ROTARIX. The age at vaccination was not reported. On an unspecified time after vaccination, the patient experienced severe diarrhea, vomiting and fever. The patient was hospitalized and rotavirus test was found to be positive. This case was considered as a suspected vaccination failure case since the time to onset of the events was unknown. The patient took SUPRAX for 5 days but the problem wasn''t resolved. The parents changed the hospital at last day of hospitalization the patient died. On 6th March 2016, the patient died due to fulminant hepatitis and encephalopathy. After several tests, the physician concluded that the family had genetic problem related to metabolism and his brother, genetic result showed same disorder, because of that, dehydration highly impact their health (they needed to prevent dehydration).


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