National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

Found 129 cases where Vaccine is MEN or MENB or MENHIB or MNC or MNQ or MNQHIB and Patient Died and Submission Date on/before '2015-09-30'

Case Details

This is page 11 out of 13

Result pages: prev   2 3 4 5 6 7 8 9 10 11 12 13   next


VAERS ID: 512796 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:2013-08-19
Onset:2013-08-19
   Days after vaccination:0
Submitted: 2013-11-11
   Days after onset:84
Entered: 2013-11-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / UNK UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cardiac arrest, Culture negative, Death, Hypoxia, Irritability, Laboratory test, Metabolic function test, Nuclear magnetic resonance imaging, Polymerase chain reaction, Syncope, Toxicologic test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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 (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (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: Vitiligo; Constipation
Allergies:
Diagnostic Lab Data: Culture (date unknown): Negative
CDC Split Type: 2013315917

Write-up: This is a spontaneous report from a physician via the contactable regulatory authority received under the reference number GB-MHRA-ADR 22297675. A 5 month old female patient of an unspecified ethnicity started to receive PREVENAR 13 intramuscularly on 19Aug2013 at single dose, Men C vaccine (trade name unspecified) intramuscularly on 19Aug2013 at single dose and PEDIACEL intramuscularly on 19Aug2013 at single dose. Medical history included vitiligo and constipation. No congenital abnormalities were found. Healthy term baby with no past medical history of note. No relevant family history. Concomitant medication included macrogol, potassium chloride, sodium bicarbonate, MOVICOL. The patient had immunisations at 2:30pm. The patient was irritable at 7:30pm. at 8:30pm the patient was apnoeic leading to cardiac arrest that recovered at 9:10pm. The patient died due to severe hypoxic injury. No clear cause for collapse was ever found. There was no evidence of sepsis. Negative cultures and polymerase chain reaction reported. In the reporters opinion the events were considered serious due to being medically significant and fatal. Medically significant details: Collapse later that evening and cardiac arrest - cause of cardiac arrest is still unknown despite magnetic resonance imaging/toxicology/septic screen/metabolic screen. The patient did not receive a post mortem examination. Unclear whether the vaccinations played any part whatsoever in the collapse. In the opinion of the regulatory authority the events were considered serious for an unspecified reason. No follow-up attempts possible. No further information expected.


VAERS ID: 521292 (history)  
Form: Version 1.0  
Age: 1.2  
Sex: Female  
Location: Foreign  
Vaccinated:2013-09-16
Onset:2013-09-23
   Days after vaccination:7
Submitted: 2014-01-29
   Days after onset:128
Entered: 2014-01-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENHIB: MENINGOCOCCAL CONJUGATE + HIB (UNKNOWN) / UNKNOWN MANUFACTURER A76CA230A / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS A69DD408A / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. H0069789 / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH F47829 / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-09-23
   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
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014022489

Write-up: This is a spontaneous report from a contactable consumer, the patient''s parent. This is a report received from a foreign Regulatory Agency. Regulatory authority report number ADR22389233. A 14-month-old female patient of an unspecified ethnicity received PREVENAR (Lot Number: F47829; Expiration Date: Apr2014), MMRVAXPRO (Lot Number: H0069789), MENTORIX (Lot Number: A76CA230A or A76CA176B; Expiration Date May 2015), PRIORIX (Lot Number A69DD408A: Expiration Date: Feb2015); all via the "parenteral" route of administration on 16Sep2013 at single doses. The patient''s medical history and concomitant medications were not reported. On 23Sep2013, the patient died. It was unknown if an autopsy was performed and the cause of death was reported as "death unexplained". The reporter stated that they were unsure which injections their child was given as their general practitioner (GP) provided all the above batch numbers. The reporter was given six completely different batch numbers for three injections and was unsure that their child was given the incorrect vaccine. The reporter further stated that the GP was reluctant to inform the local regulatory authority. No follow up attempts possible. No further information expected.


VAERS ID: 526852 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Female  
Location: Foreign  
Vaccinated:2013-10-30
Onset:2014-03-04
   Days after vaccination:125
Submitted: 2014-03-26
   Days after onset:21
Entered: 2014-03-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial test negative, Culture throat, Death, Influenza virus test negative, Intensive care, Meningitis meningococcal, Streptococcus test negative, Upper respiratory tract infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-04
   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: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: The blood and cerebrospinal fluid samples were collected from the patient. However the reporter physician could not provide the results of test. Based on the information received from the laboratory supervisor; the blood culture remained negative for Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae. The laboratory supervisor verbally confirmed the test result but he refused to provide the results in written.
CDC Split Type: 2014SA034156

Write-up: Initial case was received from a health care professional via Sales representative on 17 March 2014. A 13-months-old female patient whose medical history and concomitant medication was not reported had received MENACTRA (dose, route and anatomical site of administration not reported) on 30 October 2013. On 25 February 2014, the patient was admitted to the hospital. The patient started treatment with suspected upper respiratory tract infection after the throat culture (the result of throat culture was not reported). On 26 February 2014, she was admitted to the private hospital and was transferred to Hospital with suspected meningococcal meningitis for the reason that the patient had an eruption. The patient was closely monitored by the reporting physician in the pediatric intensive care unit. The blood was closely monitored by the reporting physician in the pediatric intensive care unit. The blood and cerebrospinal fluid samples were collected from the patient. However the reporter physician could not provide the results of test. The patient died on 04 March 2014. Comment: This case could not be considered as the lack of efficacy. Because, MENACTRA is indicated in children aged from 12 months to 15 years as two doses (three months apart) according to our local labeling information. However, MENACTRA was administered to the patient as a single dose. The list of documents held by sender: None.


VAERS ID: 549793 (history)  
Form: Version 1.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-10-21
Entered: 2014-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Basophil percentage, Blood glucose normal, CSF glucose increased, CSF white blood cell count increased, Convulsion, Death, Encephalitis, Flow cytometry, Haemoglobin decreased, Headache, Herpes zoster meningoencephalitis, Leukaemoid reaction, Lymphocyte percentage decreased, Mean cell haemoglobin increased, Mean cell volume normal, Monocyte percentage increased, Neutrophil percentage increased, Platelet count normal, Polymerase chain reaction, Rash vesicular, Red blood cells CSF positive, White blood cell count normal
SMQs:, Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BACTRIM Adult; Acyclovir
Current Illness:
Preexisting Conditions: Varicella, during childhood with no identified exposure to the virus prior to the event; Myeloid leukaemia; Allogenic bone marrow transplantation therapy, He was reported to have done well after the transplant and that he had only suffered a chronic limited skin graft-versus-host disease that had not required continued immunosuppresants; MELPHALAN, Surgical preconditioning; FLUDARABINE, Surgical preconditioning; ALEMTUZUMAB, Surgical preconditioning; TACROLIMUS
Allergies:
Diagnostic Lab Data: Basophil count, 1 percent; Blood glucose, 154; CSF glucose, 159 mg/dL; CSF white blood cell count, 576/mm3; Haemoglobin, 13.2 g/ml; Lymphocyte percentage, 7 percent; Mean cell haemoglobin, 91 pg; Mean cell volume, 94.7 fL; Monocyte count, 21 and 24 percent; Monocyte percentage, 7 percent; Neutrophil percentage, 85 percent; Platelet count, 166/mcL; Polymerase chain reaction, more than 1.0 x 10E8 copies/ml; Polymerase chain reaction, 327000 copies/ml; Red blood cells CSF positive, 252/,mm3; White blood cell count, 10.4/mcL
CDC Split Type: CH2014GSK005479

Write-up: This case was reported in a literature article and described the occurrence of varicella-zoster virus meningoencephalitis in a 55-year-old male patient who received DTPa. Co-suspect products included Meningococcal vaccine unknown, 10PN-PD-Dit. Haemophilus influenzae type b vaccine. Hepatitis A vaccine, Hepatitis B vaccine and Polio Trivalent Inactivated. The patient''s past medical history included chickenpox (during childhood with no identified exposure to the virus prior to the event), leukemia myelogenous and allogenic bone marrow transplantation therapy (He was reported to have done well after then transplant and that he had only suffered a chronic limited skin graft-versus-host disease that had not required continued immunosuppressants). Previously administered products included melphalan, fludarabine, alemtuzumab and tacrolimus. Concomitant products included BACTRIM Adult and acyclovir. On an unknown date, the patient received DTPa vaccine at an unknown dose, Meningococcal vaccine at an unknown dose, Pneumococcal vaccine at an unknown dose, Haemophilus influenzae type b vaccine at an unknown dose, Hepatitis A vaccine at an unknown dose, Hepatitis B vaccine at an unknown dose and Inactivated polio vaccine at an unknown dose. On an unknown date, 244 days after receiving DTPa vaccine, Meningococcal vaccine, Pneumococcal vaccine, Haemophilus influenzae type b vaccine, Hepatitis A vaccine, Hepatitis B vaccine and Inactivated polio vaccine, the patient experienced varicella-zoster virus meningoencephalitis (serious criteria death and GSK medically significant), cerebrospinal leukemoid reaction (serious criteria death), seizures (serious criteria GSK medically significant), headache and vesicular skin rash. The patient was treated with antivirals for systemic use and medication unknown (Unspecified Treatment). On an unknown date, the outcome of the varicella-zoster virus meningoencephalitis and cerebrospinal leukemoid reaction were fatal and the outcome of the seizures, headache and vesicular skin rash were unknown. The reported cause of death was acute meningoencephalitis and leukemoid reaction. An autopsy was performed. It was not reported if the reporter considered the varicella-zoster virus meningoencephalitis, cerebrospinal leukemoid reaction, seizures, headache and vesicular skin rash to be related to DTPa vaccine, Meningococcal vaccine, Pneumococcal vaccine, Haemophilus influenzae type b vaccine, Hepatitis A vaccine, Hepatitis B vaccine and Inactivated polio vaccine. Additional details provided: This case was reported in a literature article and it described the occurrence of a varicella-zoster virus meningoencephalitis in a male subject who was at least 55 years old at the time of the event and had been vaccinated with unspecified DTP, meningococcal, pneumococcal, Haemophilus influenzae b, hepatitis A and B and inactivated poliovirus vaccines (manufacturers unknown). The subject had a medical history of chicken pox during childhood with no identified exposure to the virus prior to the event. He had not been vaccinated for measles or herpes zoster virus. He also had a previous history of acute myelogenous leukaemia with diploid cytogenetics that been treated with allogenic haematopoietic transplantation using a fully matched brother when he was 54 years old. He was reported to have done well after the transplant and that he had only suffered a chronic limited skin graft-versus-host disease that had not required continued immunosuppressants. The conditioning for the transplant had consisted of melphalan, fludarabine and alemtuzumab. In addition to that, tacrolimus had been used for graft-versus host disease prophylaxis. Concurrent medications at the time of the event included BACTRIM and acyclovir. No further information on his medical history, concurrent medical conditions or concomitant medication was provided. On an unspecified date, 1 year after the allogeneic haematopoietic transplantation, the subject received unspecified DTP, meningococcal, pneumococcal, Haemophilus influenzae b, hepatitis A and B and inactivated poliovirus vaccines for (dosages, administration routes and sites unknown; batch numbers not provided). On an unknown date, 1 year and 8 months after the transplantation, the subject presented with headache, seizures and vesicular skin rash. This is a serious case as the outcome was fatal. Diffuse meningeal enhancement without focal lesions was revealed on magnetic resonance imaging. Cerebrospinal fluid analysis showed xanthochromic fluid with a red blood cell level of 252/cmm, white blood cell level of 576/cmm and glucose level of 159 mg/dL. Two cerebrospinal fluid cytology specimens contained monocytic cells that resembled blasts morphologically with delicate chromatin, moderate gray-blue cytoplasm with vacuoles and azurophilic granules, as well as the occasional mitosis. The corresponding flow cytometry showed 21% and 24% mature monocytes without immunophenotypic aberrancy. No myeloblasts or cells of the prior leukemic immunophenotype (CD341, CD1171, CD331, CD131, CD14-) were identified by flow cytometry. There was no nucleated red contamination. No cytogenetics studies were performed on the cerebrospinal fluid. Blood tests showed a blood glucose level of 154, a white blood count level of 10 400/mL (normal range 4.5-11), a haemoglobin of 13.2 g/mL (normal range 12-16), mean corpuscular volume of 94.7 fl (normal range of 82-100), mean corpuscular haemoglobin of 91 pg (normal range 27-34), platelets level of 166 000/mL (normal range 150-400) with a differential of 85% neutrophils, 7% lymphocytes, 7% monocytes and 1% basophils. Blood flow cytometry showed no blasts and 7% mature monocytes with no aberrancy. The morphologically immature cells seen in the cerebrospinal fluid were not present in his blood, which according to the authors, suggested that these cells originated in the cerebrospinal fluid. Cerebrospinal fluid and blood polymerase chain reaction for varicella-zoster virus revealed $g1.0 x 108 and 327 000 copies (Vira core) respectively. Treatment consisted of antiviral treatment and supportive care. The outcome of the event was fatal. Autopsy results indicated subacute/chronic meningoencephalitis with no acute leukaemia involving the central nervous system. The authors did not comment on any causal relationship between the vaccines received by the subject and the events. The authors concluded that "When considering acute myelogenous leukaemia relapse in the cerebrospinal fluid of an allogenic haematopoietic transplantation subject, flow cytometric and microbiology studies should be considered to rule out a reactive process. Disseminated varicella-zoster virus is the most frequent late infection of allogenic haematopoietic transplantation".


VAERS ID: 575910 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-18
Onset:2014-11-26
   Days after vaccination:8
Submitted: 2015-03-12
   Days after onset:105
Entered: 2015-03-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, Agitation, Altered state of consciousness, Asthenia, Blood test, Brain death, Brain oedema, CSF test normal, Central nervous system lesion, Coma scale abnormal, Computerised tomogram head abnormal, Crying, Death, Depressed level of consciousness, Diarrhoea haemorrhagic, Diet refusal, Dystonia, Endotracheal intubation, Fatigue, Gastroenteritis, Headache, Hypertension, Intensive care, Intermittent claudication, Intracranial pressure increased, Irritability, Leukaemia, Lumbar puncture normal, Mechanical ventilation, Mucous stools, Muscle contracture, Pain in extremity, Paraesthesia, Paresis, Personality change, Posture abnormal, Pupillary light reflex tests abnormal, Pyramidal tract syndrome, Pyrexia, Seizure, Somnolence, Tachycardia, Unresponsive to stimuli, Vomiting
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Hostility/aggression (broad), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (narrow), Hypertension (narrow), Demyelination (narrow), Retinal disorders (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Haematological malignant tumours (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-12-06
   Days after onset: 10
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: Thrombocytopenia; Leukaemia; Dysmorphism; Facial asymmetry; Speech disorder developmental; Developmental delay
Preexisting Conditions: Benzodiazepines; Mechanical ventilation; Finger deformity; Endotracheal intubation
Allergies:
Diagnostic Lab Data: Blood test, Results not provided; 11/26/2014, Body temperature, greater than or equal to 38 degrees C, High; 11/27/2014, Body temperature, greater than or equal to 38 degrees C, High; CSF test, Normal, The liquor was without suggestive changes of infection; Coma scale, 8, Significant; Computerised tomogram head, Cerebral death, Significant, CT scan was performed to confirm patient status (cerebral death); 11/27/2014, Computerised tomogram head, Normal; 12/03/2014, Computerised tomogram head, Abnormal, Significant, Changes suggestive of ADEM (encephalomyelitis of immunological cause); 12/05/2014, Computerised tomogram head, Abnormal, Significant, CT showed worsening of initial lesions with diffuse cerebral edema on 05 Dec 2014 and signs of wedge; 12/03/2014, Lumbar puncture, Normal, cytochemical examination was without significant variations; bacteriology and virology examinations and search of oligoclonal bands were undergoing. The liquor was without suggestive changes of infection and the results were normal
CDC Split Type: PHHY2014PT165618

Write-up: Case number PHHY2014PT165618 is an initial spontaneous report from a physician via health authority (HA reference number: PT-INFARMED-N201412-297) received on 17 Dec 2014 with a combined follow up information received physician and quality assurance department (QA reference number: 343913) on 19 Dec 2014 with a follow up report received from the physician on 23 Dec 2014 and a follow up information received from physician via health authority (HA reference number: PT-INFARMED-N201412-599) on 13 Feb 2015. This report refers to a 5 years old female patient. Her vaccination history included a dose of hepatitis A vaccine (manufacturer and batch number: not reported) one year before and first dose of BEXSERO (batch number: not reported) on 24 Aug 2014 and there was no adverse reactions after first dose. It was reported that the patient had no relevant clinical history until the date of the adverse event. She had no history of recent traveling. There was no history of other contacts infected with similar symptoms. In the postpartum, she had neonatal pathology thrombocytopenia following which she was admitted in oncology institute and was discharged with diagnosis of latent transient leukemia. The patient was followed for more than a year. Her current conditions included minor dysmorphia, deficiency in the fingers, facial asymmetry and retardation in development and speech and these were being investigated at genetic institute (no other information available). Her concomitant medications were not reported. Antecedents of adverse reactions to other medicines were unknown. She was vaccinated with second dose of BEXSERO (batch number: unknown) intramuscularly in 18 Nov 2014. On 26 Nov 2014, she had gastroenteritis of unknown etiology (diarrhea for duration of three days) characterized by blood and mucus and vomiting. She had a cerebral computed tomography (CT) scan done on 27 Nov 2014 which was normal. On 27 Nov 2014, she had fever with a body temperature greater than or equal to 38 degree C and strong headaches. She received a fluid therapy. On 30 Nov 2014, fever, bloody diarrhoea and headache stopped. The fever resolved when gastroenteritis was resolved. It was reported that she was very prostrate and sleepy. She was discharged since the symptoms improved. During the weekend, she experienced lack of strength, prostration and irritation and the events got worsened. She only wanted to sleep and there was a changed in level of conscience. This state worsened on 30 Nov 2014. On 02 Dec 2014, three weeks after second dose of vaccination; she went to the emergency department of the residential rea at 3 am in the morning with marked agitation and irritability. She was already apyretic and had gastrointestinal complaints. She had prostration, partial food refusal, paraesthesia and pain in the right lower limb with claudication. She was discharged after observation and analytical study performed referred her as normal. At home she was slightly better, but during the night appeared irritable and was shouting and crying. She had dystonic posture with cephalic deviation towards right, paresis of left upper limb and 4 episodes of vomiting. On 03 Dec 2014 morning, she was reactive slightly with conjugated deviation of the sight to the right and was greatly irritable while handling. She was transported to the hospital emergency room. On 03 Dec 2014, she was almost not able to respond. A CT scan performed showed changes suggestive of acute disseminated encephalomyelitis which was further described as new hypodense cortical-subcortical focus in the left internal (medial) parietal region, badly delimited with mass effect which could be of ischemic or infectious nature. On objective examination, she presented variations of the conscious state (agitation periods and irritability which were calmed down with mother''s contact) with conjugated deviation of the eyes to the right. Her pupils were isochoric and photoreactive. She had left upper limb paresis with pyramidal signal of the 4 members (left$gright), arterial hypertension and tachycardia. The physician reported that event was hyperacute. There was no fever. No nuchal rigidity was observed by the physician. She had depressed or altered level of consciousness, personality change, inconsistent or absent response to external stimuli, visual field defect, presence of primitive reflexes and motor weakness. She was greatly neurologically affected and whole body contracted. Her Glasgow coma scale was almost in score 8. During hospitalization, diagnostic tests were performed with samples of cerebrospinal fluid (CSF). Lumbar puncture was performed and cytochemical examination was without significant variations; bacteriology and virology examinations and search of oligoclonal bands were undergoing. The liquor was without suggestive changes of infection and the results were normal. No magnetic resonance imaging (MRI) was performed. She was detected with immunological complications. She had convulsive seizure which ceded with intravenous diazepam. Methylprednisolone was started intravenously at a dose of 30 mg/kg and she was transferred to the intensive care unit with the diagnosis of probable acute disseminated encephalomyelitis (ADEM). After this diagnosis, she was transferred to another hospital for neurological observation. She was then admitted in the intensive pediatric unit care during the night (on 04 Dec 2014 at 2:30 am). On admission, she presented the same neurological state (ECG 9) with arterial hypertension and tachycardia. The neurological state worsened and the outcome was not favorable. She was treated with benzodiazepines for the event. During the night, the events became worse and she required ventilation. She was intubated and measures of intracranial hypertension control were implemented without success. Repeated cranioencephalic CT showed worsening of initial lesions with diffuse cerebral edema on 05 Dec 2014 and signs of wedge. All sedoanalgesic medications introduced were suspended. Cerebral death was declared by the physician. The patient was only declared dead nearly 28 hours after, on 06 Dec 2014 at 11 am. After cerebral death, a CT scan was performed to confirm the patient''s status (cerebral death). The child was hospitalized during 4 days until being declared the brain death. The physician stated that blood tests were performed and the results of the blood tests were not reported and there might be stored specimens for additional testing. The physician did not have any additional information from genetic institute and no reports were available. According to the physician, stool tests were not performed and no information about gastroenteritis etiology was available. The final diagnosis was acute disseminated encephalomyelitis (ADEM). An autopsy was not performed as the parents refused it. The health authority assessed the event serious. The health authority reported the causality of the event as suspected to be related to the use of BEXSERO. The physician who analyzed the patient stated that vaccination or viral infection were two possible causes that led to the occurrence of the event. As per physician who evaluated the patient in the intensive pediatric care, she had a problematic immunity system and the cause of acute disseminated encephalomyelitis could be associated to gastroenteritis or vaccination as both conditions influence immunity system. The physician was not able to establish an association and had doubts about it. Based on the performed review on BEXSERO batches 131401A, 130301, 143301 and 144901, there was no evidence of any objections which occurred during the manufacturing process of finished product, including adjuvant and components used, that could compromise the quality of the product or that might be potentially related to the reported events. The quality assurance department confirmed that the involved batches were compliant with internal procedures and with current good manufacturing practices (cGMP) requirements. Combined follow up information received physician and quality assurance department (QA reference number: 343913) on 19 Dec 2014: Updated vaccination history, medical history, suspect vaccine date, events (encephalitis recoded as ADEM and added all other events) and physician comment and batch investigation summary updated. Follow up report was received from the physician on 23 Dec 2014: Updated lab investigations and reporter''s comments. Follow up information received from physician via health on 13 Feb 2015: Updated events (altered state of consciousness, cerebral oedema, convulsion, dystonia, eating disorder, hypertension, pain in extremity, pupillary light reflex tests abnormal, tachycardia, crying, paraesthesia, diarrhea, diarrhea hemorrhagic, pyramidal tract syndrome and hyporesponsive to stimuli), laboratory tests, procedure, clinical course of the event and treatment.


VAERS ID: 576034 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2015-02-26
Onset:2015-03-03
   Days after vaccination:5
Submitted: 2015-03-17
   Days after onset:13
Entered: 2015-03-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 131301 / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Blood bicarbonate decreased, Blood pH decreased, Bradycardia, C-reactive protein increased, Carbon dioxide increased, Death, Dehydration, Electrocardiogram abnormal, Endotracheal intubation, Hyperpyrexia, Hypothermia, Laboratory test abnormal, Leukopenia, Livedo reticularis, Mechanical ventilation, Neutropenia, Neutrophil count decreased, Pallor, Peripheral venous disease, Platelet count decreased, Pyrexia, Septic shock, Sinus tachycardia, Tachyarrhythmia, Thrombocytopenia, Waterhouse-Friderichsen syndrome, X-ray abnormal
SMQs:, Agranulocytosis (broad), Angioedema (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Toxic-septic shock conditions (narrow), Acute central respiratory depression (broad), Accidents and injuries (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (narrow), Hypokalaemia (broad), Sepsis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-03-03
   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: No other medications
Current Illness: Unknown
Preexisting Conditions: 03/03/2015, Endotracheal intubation; 03/03/2015, Mechanical ventilation
Allergies:
Diagnostic Lab Data: 03/03/2015, Blood bicarbonate, 11.8, Significant; 03/03/2015, Blood pH, 6.89, Low; 03/03/2015, C-reactive protein, 5.88 mg, High; 03/03/2015, Carbon dioxide, 62, Significant; 03/03/2015, Electrocardiogram, Abnormal, Significant, evidence of sinus tachycardia with tendency to bradycardia crisis; 03/03/2015, Electrocardiogram, Abnormal, Significant, idioventricular rhythm with enlarged QRS at heart rate of 65 to 70/minutes; 03/03/2015, Heart rate, 190/min, High; 03/03/2015, Heart rate, 195/min, High; Laboratory test, Abnormal, Significant, infection has been characterized as a MenB serogroup; 03/03/2015, Neutrophil count, 700/mmc, Low; 03/03/2015, Platelet count, 59.0/mmc, Low; 03/03/2015, X-ray, Abnormal, Significant, reduction in the lung diaphany at the III medium superior of the right lung without representation of the intestinal meteorism with distension of one intestinal ansa projectively in the mesogastrium
CDC Split Type: PHHY2015IT026937

Write-up: Case number PHHY2015IT026937, is a combined initial spontaneous report from a physician via Novartis employee and a healthcare professional via health authority (HA, reference number: 297337) received on 05 Mar 2015, with a follow up report received from the quality assurance department (QA, reference number: 355706) on 06 Mar 2015, with a combined follow up report received from a biologist via Novartis employee and a lay press newspaper article (journalist) on 05 Mar 2015 and from a lay press newspaper article on 06 Mar 2015, with a combined follow up report received from a lay press article and the QA department (reference number: 355706) on 09 Mar 2015 and 10 Mar 2015 respectively, with a follow up report received from the HA on 13 Mar 2015. This report refers to an 11 weeks old male neonate. Medical history and concomitant medications were not reported. He was vaccinated with first dose of BEXSERO (batch number: 131301, expiry date: 31 Mar 2015) on 26 Feb 2015. Further to the vaccination, the patient showed unspecified increased polymerase chain reaction (PCR) value, neutropenia, thrombocytopenia (septic shock). On 03 Mar 2015, the pediatrician visited the patient''s home and suggested hospitalization due to severity of conditions including fever. On 03 Mar 2015 at hour 12:48, he was admitted to a pediatric ward due to hyperpyrexia for 6 hours. At the pediatric ward it was noted that the patient was in poor clinical conditions, sufferance behavior, pale and septic color, dehydrated, tachycardic pulse (heart rate (FC) was 190/minutes). At the same department venous access was found. He was given Ceftriaxone (300 mg) and Methylprednisolone (10 mg) endovenously. The ceftriaxone showed no response. The condition worsened. The patient was transferred another emergency department from the pediatric ward of the local town with the assistance of the pediatrist and of an anesthesiologist at 13:50 hours. During hospital admission, there was a marked increase in C-reactive protein level with a value of 5.88 mg. He was in critical conditions. The patient had paleness of the skin, marble-like appearance, hypostasis phenomena, peripheral pulses filiform, hypothermia, tachyarrhythmic cardiac sounds, sensorium obnubilation with tendency to the soporous status. Hematobiochemical blood drawn has been performed and hemogasanalysis through venous access at the femoral vein showed very severe mixed acidosis. His blood pH was 6.89, pCO2 was 62, EB was 20.8 and bicarbonate was 11.8. Due to this observation, a tracheal intubation was performed and mechanical ventilation was started. An electrocardiogram showed evidence of sinus tachycardia at heart rate of 195/minutes with tendency to bradycardia crisis. For this reason, endotracheal Adrenaline was given along with Hydrocortisone at anti-shock dosage (250 mg) and sodium bicarbonate (20 cc) was given endovenously at 14:10 hour. At hour 14:20, in order to be able to find a venous access more congruous and taking into account the extreme criticality of the situation, an intra-osseous puncture under emergency was performed. A physiological solution (unspecified) was infused at anti-shock velocity (40 ml/hour). His arterial pressure was not detectable (Dinamap method), unique vital parameter was detectable in the ECG. He was given bicarbonate infusion at a dose of 10 cc at 14:25 hours. On the same day at 14:40 hours, 20 mg of Ceftriaxone was administered endovenously. At 14:46 hour, a chest-abdominal X-ray was requested which showed reduction in the lung diaphany at the III medium superior of the right lung without representation of the intestinal meteorism with distension of one intestinal ansa projectively in the mesogastrium. At 14:50 hour, a peripheral blood smear test was performed which showed evidences of leucopenia with severe neutropenia (700/mmc) and thrombocytopenia (59.000/mmc). On the basis of this result (highly evocative for a septic picture) a Gentamycin was administered endovenously at a dose of 12.5 mg at 15.00 hours. His condition was extremely critical with succeeding bradycardia at 15:10 hours. He was given prolonged external cardiac massage and further bicarbonate and adrenaline infusions were performed. An ECG recording shows idioventricular rhythm with enlarged QRS at heart rate (FC) of 65 to 70/minutes. At 15:30 hour, there was absence of response to any stimulation, fixed mydriasis and extreme bradycardia resistant to the resuscitation maneuvers. At 15:50 hours, there was no cardiac electrical activity. Death was certified due to septic shock. Autoptic evaluation was requested. On 04 Mar 2015, a blood sample of the pediatric patient was sent to an institute where the search for bacterial DNA with CRP real time method gave positive outcome for Neisseria meningitidis B serum group. Biologist highlighted that a single lower dosage of vaccination, was not considered sufficient to confer protection. In a lay press it was reported that a syndrome of Waterhouse-Friderichsen (a form of complication to meningitis) killed the infant. Initially BEXSERO was considered as a possible cause of death, but the results of the analysis did not confirm this hypothesis. It was possible that, when he was vaccinated and seemed to be healthy, the infant was already incubating the disease. The physicians confirmed that there would be no correlation between the events and the vaccine administered one week prior. A tissue sample was collected from the body of the baby which would be subjected to histological examination. Based on analysis performed on the first blood samples, it was reported that the baby had been hit by an event "fulminant infectious." On 05 Mar 2015, autoptic examination was performed but definitive results were not available. The causality of the event septic shock was reported as suspected by health authority and for the event syndrome of Waterhouse-Friderichsen was reported as non-suspected by the physicians. Based on the performed review on BEXSERO batch 131301, there is no evidence of any objections which occurred during the manufacturing process of finished product, including adjuvant and components used, that could compromise the quality of the product or that may be potentially related to the reported events. QA confirmed that the involved batch is compliant with internal procedures and with cGMP requirements. Non-significant follow up report received from the quality assurance department (QA, reference number: 355706) on 06 Mar 2015: Updated QA reference number. Combined follow up report from a biologist via Novartis employee and from a lay press newspaper article (journalist) received on 05 Mar 2015 and from a lay press newspaper article received on 06 Mar 2015: Added event (syndrome of Waterhouse-Friderichsen), analysis information and causality of the event. Follow up report received from the QA department (reference number: 355706) on 10 Mar 2015: Updated BEXSERO vaccine batch review report. A combined follow up report received from a lay press article and the QA department on 09 Mar 2015 and 10 Mar 2015 respectively: Updated reporter''s statement and batch review report. Follow up report received from the HA on 13 Mar 2015: Updated details on hospitalization, condition during transfer to a second hospital, event details, laboratory tests, procedures and treatments received, cause of death and other clinically relevant information in the narrative.


VAERS ID: 577666 (history)  
Form: Version 1.0  
Age: 1.17  
Sex: Female  
Location: Foreign  
Vaccinated:2015-03-12
Onset:2015-03-31
   Days after vaccination:19
Submitted: 2015-04-24
   Days after onset:24
Entered: 2015-05-11
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Blood electrolytes normal, Body temperature decreased, Breath holding, C-reactive protein increased, Cardiomegaly, Death, Diagnostic procedure, Heart sounds abnormal, Hepatic function abnormal, Hepatomegaly, Infection, Lymphadenopathy mediastinal, Resuscitation
SMQs:, Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-03-31
   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: Albuterol
Current Illness: Immunisation
Preexisting Conditions: Hypertrophic cardiomyopathy; Cardiomegaly; 02/2015, Bronchial hyperreactivity
Allergies:
Diagnostic Lab Data: Blood electrolytes (31-MAR-2015): Normal. 03/31/2015, Body temperature, no temperature; 03/31/2015, C-reactive protein, 4.6; 03/31/2015, Hepatic function abnormal, disorder in liver function; 03/31/2015, Investigation, enlarged liver; 03/31/2015, Investigation, enlarged hypertrophic heart; 03/31/2015, Investigation, gallop rhythm; 03/31/2015, Investigation, mediastinal lymphadenopathy
CDC Split Type: WAES1504NLD020599

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (Case Report N. NL-1577272925-E2015-03678) on 21-APR-2015. Fatal case received from the Health Authorities on 16-Apr-2015 under the reference number NL-LRB-195796. Initial source was a physician from a community health service. Medically confirmed. Case reported as serious by the Agency (category reported by the Agency: results in death). A 14-month-old female patient (weight 9 kg, height 75 cm) had received the first dose of MMRVAXPRO, lot number unknown, subcutaneous route, site of vaccination left upper arm and the first dose of NEISVAC-C, Baxter, lot number unknown, intramuscular route, site of vaccination left thigh on 12-Mar-2015. Concomitant medication was salbutamol since a few weeks. The patient developed an infection (not further specified) on 31-Mar-2015 with a latency of 19 days after vaccination. The clinical course was not clear. About 12 or 14 days after vaccination there was a period of about 5 days of fever, followed by a period of 2 days without fever. At the day the patient died, on 31-Mar-2015, there was an emergency call for medical assistance because of sudden breath holding spells. There was a resuscitation by the general practitioner and after that the patient was transferred to the hospital. The medical history indicated that the patient had bronchial hyperreactivity since Feb-2015 for which she was in follow-up by a pediatrician. The patient had no known past drug therapy. Physical findings and investigations on 31-Mar-2015: gallop rhythm. Autopsy: Enlarged hypertrophic heart. Enlarged liver. Mediastinal lymphadenopathy. Blood and lab results: cultures were deployed, results were not yet known except for CRP 4.6, electrolytes normal, disorder in liver function. No temperature. Preliminary conclusion: fatal infection in a patient with a preexistent serious heart disease. Cause of death unknown for the moment, but possible hypertrophic obstructive cardiomyopathy. Treatment and clinical course: despite resuscitation the patient died 10 minutes after she arrived in the hospital. Causality assessment reported by the Agency: causality for the event infection (not other specified) and both vaccinations was considered not assessable because of the inconsistent information of the latency of the period of fever and the not clear clinical course. It was most likely that the patient had preexistent cardiac problems (enlargement of the heart and hypertrophic cardiomyopathy) and died by an infection. Patient outcome: fatal. Date of death 31-Mar-2015. More information to follow. The following was coded by the Agency: infection. Upon internal review the company judged relevant to code the following adverse events fever and breath holding spells which were mentioned in the narrative but not coded. Noteworthy: the Agency reported that it was unknown if an autopsy was performed, but the narrative reported results of the autopsy: enlarged hypertrophic heart. Enlarged liver. Mediastinal lymphadenopathy.


VAERS ID: 584986 (history)  
Form: Version 1.0  
Age: 0.42  
Sex: Female  
Location: Foreign  
Vaccinated:2013-08-19
Onset:2013-08-19
   Days after vaccination:0
Submitted: 2015-07-07
   Days after onset:687
Entered: 2015-07-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER J01101 / UNK UN / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER VN920622 / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G19208 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cardiac arrest, Culture negative, Death, Hypoxia, Irritability, Nuclear magnetic resonance imaging, Polymerase chain reaction, Resuscitation, Syncope, Toxicologic test normal
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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 (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-08-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOVICOL; Unknown
Current Illness:
Preexisting Conditions: Constipation; Vitiligo
Allergies:
Diagnostic Lab Data: 19-AUG-2013, Culture, negative; 19-AUG-2013, Nuclear magnetic resonance imaging, not reported; 19-AUG-2013, Polymerase chain reaction, negative; 19-AUG-2013, Toxicologic test, negative; Weight, 8 kg; Metabolic screen: 19-Aug-2013: not reported; Septic screen: 19-Aug-2013: not reported
CDC Split Type: 2013BAX043887

Write-up: This case was considered invalid as it is a duplicate of 2013315917. This case has been migrated from another database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up report may indicate in the appropriate field that it is an initial report. This is a regulatory report of fatal hypoxia, cardiac arrest, apnoea, syncope and irritable in a 5 month old Female patient subsequent to NEISVAC-C (0.5 ml Suspension for injection in pre-filled syringe). This report was received by Regulatory Authorities (reference number: 22297675) via a Physician and forwarded to Baxter. Suspect Product Details: on 19Aug2013 at 1430 hours, the patient received NEISVAC-C, intramuscularly (lot number, dose and injection site were not reported). The patient also received vaccinations with PEDIACEL, intramuscularly and PREVENAR 13, intramuscularly on the same date and time. The lot numbers, doses and injection sites were not reported. The action taken was Not Applicable. Baxter and the Reporter considered PEDIACEL and PREVENAR 13 as co-suspect drugs. Event Details: On 19Aug2013, about four hours after having been vaccinated (1900 hours), the patient became irritable. At an unreported time, the patient experienced syncope (described as collapsed). The patient recovered from the syncope at an unreported time. At 2030 hours, the patient was apnoeic which led to cardiac arrest. The patient was successfully resuscitated by 2110 hours. However, the patient died on 19Aug2013 due to hypoxia (described as severe hypoxic injury). The cause of the cardiac arrest was unknown despite magnetic resonance imaging, toxicology tests, septic screen and a metabolic screen. An unspecified culture and polymerase chain reaction (PCR) were negative, no evidence of sepsis. An autopsy was not performed. Outcome: Hypoxia: Fatal, Cardiac Arrest: Recovered/resolved, Apnoea: Not reported, Syncope: Recovered/resolved, Irritable: Not reported. Medical History: Constipation, Vitiligo. Concomitant Therapy: MOVICOL. Causality Assessment: Unassessible for all suspect products. The reporter stated it was "unclear" whether the vaccinations played any part in the collapse. Follow-up Information (28Feb2014): Additional information was received from a physician. Suspect product information was added or revised. Suspect Product Details: The lot number for NEISVAC-C was VN920622. The lot number for the PEDIACEL used was J0110-1 and the lot number for the PREVENAR 13 that was used was G19208. Follow-up Information (14Apr2014): Batch review results for NEISVAC-C lost number VN920622 were received. The review did not reveal any quality issues. This batch (VN920622) of NEISVAC-C was manufactured and released in compliance with established procedures and specifications. This investigation did not identify any product quality issues with this batch that could be associated with the reported events. Follow-up Information (22May2014): Follow-up information received from the physician. Suspect product details were added (unit dose). Suspect Product Details: On 19Aug2013, at 14:30 the patient received NEISVAC-C one dose (lot number VN920622) administered intramuscularly (site of administration not reported). Follow-up (02Jul2015): This is a follow-up report to notify that the case 2013BAX043887 and 2013315917 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 2013315917.


VAERS ID: 607577 (history)  
Form: Version 1.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:2015-05-26
Onset:2015-06-12
   Days after vaccination:17
Submitted: 2015-08-14
   Days after onset:63
Entered: 2015-08-19
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 144801 / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2015-06-12
   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: PHHY2015DE097863

Write-up: Case number PHHY2015DE097863, is an initial spontaneous report from Health Authority (reference number: DE-PEI-PEI2015048324) received on 11 Aug 2015. This report refers to a 28-month-old male patient. Historical conditions were not reported. No concomitant medication was reported. Vaccination history included administration of first dose of BEXSERO (batch number: 144801) on 02 Mar 2015 and the patient tolerated the vaccine well. The patient was vaccinated with the second dose of BEXSERO (batch number: 144801) intramuscularly on 26 May 2015. On 12 Jun 2015, 17 days after receiving the second vaccination, the patient died from an unknown cause. Causality was not reported. It was not reported whether an autopsy was performed.


VAERS ID: 607836 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-08-21
Entered: 2015-08-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Malaise, 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: PHHY2015PR101253

Write-up: Case number PHHY2015PR101253 is an initial spontaneous report received from a consumer (patient''s mother who was a nurse) via sales representative on 14 Aug 2015. This report refers to a female patient whose age was not reported. Past medical history and concomitant medications were not reported. She was vaccinated with the first dose of MENVEO (batch number: not reported) in 2013. Some months later, she went to doctor''s office as she was not feeling well and was diagnosed with cancer. In 2014, the patient died from cancer. The causality of the event was not reported.


Result pages: prev   2 3 4 5 6 7 8 9 10 11 12 13   next

New Search

Link To This Search Result:

https://www.medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=11&VAX[]=MEN&VAX[]=MENB&VAX[]=MENHIB&VAX[]=MNC&VAX[]=MNQ&VAX[]=MNQHIB&DIED=Yes&SUB_YEAR_HIGH=2015&SUB_MONTH_HIGH=09


Copyright © 2019 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166