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VAERS ID: 696841 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-05-26
Entered: 2017-05-30
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MY0095075131705MYS010459

Write-up: This spontaneous report as received from a healthcare professional refers to 44 girls of unknown ages. On unknown dates, the patients were vaccinated with doses of GARDASIL (dose, route and lot # not reported). Other suspect therapies included CERVARIX (dose, route and lot # not reported). On unknown dates, the patients died from these vaccines. It was unknown if autopsies were performed. Upon internal review death was considered to be medically significant. Additional information has been requested.; Sender''s Comments: US-009507513-1705USA014043: US-009507513-1705USA014044: US-009507513-1705USA014045: US-009507513-1705USA014046: US-009507513-1705USA014047:


VAERS ID: 697788 (history)  
Form: Version 1.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-11-26
Onset:2014-11-26
   Days after vaccination:0
Submitted: 2017-05-22
   Days after onset:907
Entered: 2017-05-30
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 142602 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Dyspnoea, Retching
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-27
   Days after onset: 1
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: VENITRIN; KANRENOL; NICETILE; STILNOX; CARDIOASPIRIN; lorazepam; losartan
Current Illness: Senile dementia, since 8 years; Activities of daily living impaired; 22-May-2017 10:05, Coronary artery sclerosis; Angiosclerosis; Kidney stone; Hypertensive; Cerebral damage
Preexisting Conditions: Flu vaccination
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014IT157147

Write-up: Case number PHHY2014IT157147 is an initial spontaneous report from a health care professional (physician) via health authority (reference number: 281950) received on 28 Nov 2014, with the follow-up information received from Quality Assurance Department (reference number: 340222) on 02 Dec 2014, and with a follow up report received from health authority on 12 Dec 2014. This report refers to a 94-year-old male patient. Medical history included senile dementia since 8 years, with total inability to perform common daily activities; myocardial coronarosclerosis with atherosclerotic and supra-aortic trunks angiosclerosis basis; hypertension since about 20 years and presence of small kidney stone at urinary tract without complication, cerebral decay. Historical drug included flu vaccines. His concomitant medications included losartan 100 mg; NICETILE 500mg oral for 15 days cyclically. Never took specific drugs to treat cerebral impairment as antipsychotic. Since 15 years on treatment with VENITRIN 5mg for coronary sclerosis; CARDIOASPIRIN for anti-aggregation/fluidzing; KANRENOL 100mg/die as antihypertensive; STILNOX 10 mg as needed to sleep and lorazepam 10 drops upon needed when agitated. Intake of losartan and CARDIOASPIRIN interrupted in September due to low blood pressure and frequent epistaxis. In the last 20 years, annually the patient received seasonal flu vaccination (manufacturer and batch number unknown) without any adverse reaction. He was vaccinated with first booster dose of FLUAD (batch number: 142602) intramuscularly on 26 Nov 2014 at 09:30 am. The patient daughter referred that in the afternoon the patient developed retch and breathing difficult so in the evening he was taken to emergency room. On the same date at night, the patient was hospitalized due to breathing difficulty. It was reported that lab exams (unspecified) were preformed in emergency room during the hospitalization. On 27 Nov 2014, the patient died. The cause of death was reported as breathing difficult. The causality of the event reported as suspected with the administration of FLUAD. Based on the performed review on FLUAD batch number: 142602, there is no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used that could compromise the quality of the product or that may be potentially related to the reported events, QA department confirmed that, the involved batches are compliant with internal procedures and with cGMP requirements. Follow-up information received from the Quality Assurance Department (reference number: 340222) on 02 Dec 2014: Updated FLUAD batch review report. Follow up report received from health authority on 12 Dec 2014. Updated medical history and concomitant drug information. Following an internal review of the data received on 28 Nov 2014. The manufacturer receipt date 28 Nov 2014 of the previously reported information was corrected from 01 Dec 2014 to 28 Nov 2014. Follow up received on 15 May 2017 from Health Authority (RNF: IT-MINISAL02-281950): Added reporter physician, patient details (initials), added medical history (hypertension, cerebral decay and historical drug vaccines (for flu)), updated indication of suspect drug, updated event verbatim (breathing difficult) with cause of death. Case Comment: Medical assessment: Though reported time-to-event (same day), indicates positive temporal relationship and causal association cannot be excluded. Patient''s advanced age, current medical conditions and concomitant medications are confounders to causality assessment. Lack of information on notes from in-hospital clinical examination, and details of lab examinations makes the comprehensive causality not assessable. Case will be reassessed after more details are available.


VAERS ID: 697730 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2014-03-17
Onset:2014-03-17
   Days after vaccination:0
Submitted: 2017-06-01
   Days after onset:1172
Entered: 2017-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB938A / 1 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H50850 / 1 RL / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Autopsy, Bacterial test negative, Cyanosis, Death, Electrocardiogram abnormal, Endotracheal intubation, Enterocolitis haemorrhagic, Helicobacter test negative, Hypotonia, Intestinal haemorrhage, Intussusception, Mechanical ventilation, Pallor, Pulse absent, Respiratory arrest, Respiratory syncytial virus test positive, Resuscitation, Rotavirus test positive, Salmonella test negative, Sudden death, Sudden infant death syndrome, Unresponsive to stimuli, Viral infection
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ischaemic colitis (narrow), Cardiomyopathy (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Noninfectious diarrhoea (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Vaccine not specified (no brand name)~~0.00~Patient|~Vaccine not specified (no brand name)~~0.00~Patient|~Vaccine not specified
Other Medications: COLECALCIFEROL; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Premature delivery (at 30th week); Respiratory failure (at birth)
Allergies:
Diagnostic Lab Data: Test Date: 20140319; Test Name: Culture; Result Unstructured Data: Test Result: negative; Comments: Macroscopit examination: Male infant, weighing 3914 g, Andean race, normal body shape, normal development. Vertex coccyx length: 37 cm. Vertex heel length: 57 cm. Foot length: 9 cm. Cranial circumference: 36 cm. Chest circumference: 37 cm. Abdominal circumference: 42 cm.; Test Date: 20140319; Test Name: Stool culture; Result Unstructured Data: Test Result: negative; Comments: Macroscopit examination: Male infant, weighing 3914 g, Andean race, normal body shape, normal development. Vertex coccyx length: 37 cm. Vertex heel length: 57 cm. Foot length: 9 cm. Cranial circumference: 36 cm. Chest circumference: 37 cm. Abdominal circumference: 42 cm.; Test Date: 20140319; Test Name: Stool culture; Result Unstructured Data: Test Result: negative; Comments: Macroscopit examination: Male infant, weighing 3914 g, Andean race, normal body shape, normal development. Vertex coccyx length: 37 cm. Vertex heel length: 57 cm. Foot length: 9 cm. Cranial circumference: 36 cm. Chest circumference: 37 cm. Abdominal circumference: 42 cm.; Test Date: 20140319; Test Name: Stool culture; Result Unstructured Data: Test Result: positive; Comments: Macroscopit examination: Male infant, weighing 3914 g, Andean race, normal body shape, normal development. Vertex coccyx length: 37 cm. Vertex heel length: 57 cm. Foot length: 9 cm. Cranial circumference: 36 cm. Chest circumference: 37 cm. Abdominal circumference: 42 cm.; Test Date: 20140319; Test Name: Stool culture; Result Unstructured Data: Test Result: negative; Comments: Macroscopit examination: Male infant, weighing 3914 g, Andean race, normal body shape, normal development. Vertex coccyx length: 37 cm. Vertex heel length: 57 cm. Foot length: 9 cm. Cranial circumference: 36 cm. Chest circumference: 37 cm. Abdominal circumference: 42 cm.; Test Date: 20140319; Test Name: Stool culture; Result Unstructured Data: Test Result: Negative; Comments: Macroscopit examination: Male infant, weighing 3914 g, Andean race, normal body shape, normal development. Vertex coccyx length: 37 cm. Vertex heel length: 57 cm. Foot length: 9 cm. Cranial circumference: 36 cm. Chest circumference: 37 cm. Abdominal circumference: 42 cm.; Test Date: 20140319; Test Name: Stool culture; Result Unstructured Data: Test Result: negative; Comments: Macroscopit examination: Male infant, weighing 3914 g, Andean race, normal body shape, normal development. Vertex coccyx length: 37 cm. Vertex heel length: 57 cm. Foot length: 9 cm. Cranial circumference: 36 cm. Chest circumference: 37 cm. Abdominal circumference: 42 cm.; Test Date: 20140317; Test Name: ECG; Result Unstructured Data: Test Result: isoelectric; Comments: Macroscopit examination: Male infant, weighing 3914 g, Andean race, normal body shape, normal development. Vertex coccyx length: 37 cm. Vertex heel length: 57 cm. Foot length: 9 cm. Cranial circumference: 36 cm. Chest circumference: 37 cm. Abdominal circumference: 42 cm.; Test Name: Investigation; Result Unstructured Data: Test Result: Male infant, weighing 3914 g, Andean race, normal; Comments: Macroscopit examination: Male infant, weighing 3914 g, Andean race, normal body shape, normal development. Vertex coccyx length: 37 cm. Vertex heel length: 57 cm. Foot length: 9 cm. Cranial circumference: 36 cm. Chest circumference: 37 cm. Abdominal circumference: 42 cm.; Test Name: Microbiology test; Result Unstructured Data: Test Result: positivity for Rotavirus; Comments: Macroscopit examination: Male infant, weighing 3914 g, Andean race, normal body shape, normal development. Vertex coccyx length: 37 cm. Vertex heel length: 57 cm. Foot length: 9 cm. Cranial circumference: 36 cm. Chest circumference: 37 cm. Abdominal circumference: 42 cm.; Test Name: Weight; Test Result: 3914 g; Comments: Macroscopit examination: Male infant, weighing 3914 g, Andean race, normal body shape, normal development. Vertex coccyx length: 37 cm. Vertex heel length: 57 cm. Foot length: 9 cm. Cranial circumference: 36 cm. Chest circumference: 37 cm. Abdominal circumference: 42 cm.; Test Date: 20140109; Test Name: Weight; Test Result: 2136 g; Comments: Macroscopit examination: Male infant, weighing 3914 g, Andean race, normal body shape, normal development. Vertex coccyx length: 37 cm. Vertex heel length: 57 cm. Foot length: 9 cm. Cranial circumference: 36 cm. Chest circumference: 37 cm. Abdominal circumference: 42 cm.
CDC Split Type: ITPFIZER INC2014081374

Write-up: This is a spontaneous report received from the Regulatory Authority. Regulatory Authority report number 242813. A hospital physician (contactable through Regulatory Authority only) referred that a 9-week-old Hispanic male patient received on 17Mar2014 at 09:30 first dose of PREVENAR 13 (Lot n. H50850 expiration date 31Jul2015) via an unspecified route of administration in the right thigh and first dose of INFANRIX HEXA (Lot n. A21CB938A expiration date 31May2015) via an unspecified route of administration in the left thigh, both for immunisation. Medical history included premature delivery (at 30th week), respiratory failure (at birth), 2136 g weight at birth. The patient was hospitalized at the Neonatal Intensive Care Unit from with the diagnosis: low birth weight preterm infants, large for gestational age, born with spontaneous delivery, respiratory distress syndrome, jaundice in the preterm. Obstetric history: maternal vaginal swab not performed, prophylactic corticosteroid for treatment of respiratory distress syndrome incomplete, breech position before labor. The patient was born at 30 weeks +4 days of gestational age by spontaneous delivery for unstoppable labor. At birth was made the first steps of resuscitation, about 1''30 ", for shortness of breath and mild sub-xiphoid retractions, a sustained lung inflation with neoPuff face mask (Fi02 30%) was performed, followed by cPAP (Fi02 21%), then transferred to neonatal Intensive Care. APGAR 7/8. Neonatal weight 2136 grams ($g 97 C), length 45.2 cm ($g 97 C), head circumference 29.6 cm (80 c). On entering the Neonatal Intensive Care Unit, the patient was placed in an incubator in nCPAP (Fi02 initial 27% quickly reduced to 21%) discontinued after 48 hours. Subsequently, the patient had good vital signs in ambient air. For the prophylaxis of preterm apnea caffeine was administered from birth until 28Jan2014 (33w +2 days). In the second day of life echocardiography was performed: normal; non-patency of the ductus arteriosus. At birth umbilical venous access was placed (replaced after 3 days by peripheral venous access) infusion and parenteral nutrition therapies and early minimal enteral nutrition was started. Parenteral nutrition was suspended in 8 days. Enteral Feeding : except for the first day in which it was administered pasteurized human milk, from the second day the patient always assumed breast milk. Blood sugar levels were always normal. The maximum postnatal weight loss was 14.5% in the fifth day, after which the weight gain has been adjusted. At birth was initiated broad-spectrum antibiotic prophylaxis with ampicillin - sulbactam and netilmicin, respectively suspended after 5 and 3 days. For the jaundice was required phototherapy in preterm 4th - 6th day of life. From the first week of life was initiated supplementation of preterm multivitamin and probiotics. For the prevention of anemia of preterm , at 23 days (from 31Jan2014) was administered as prophylaxis with martial bisglycinate iron chelate. For the prevention of Respiratory Syncytial Virus was administered first dose of palivizumab (PALIVIZUMAB) on 28Jan2014 (35 mg)). During hospitalization inflammatory markers were negative, cerebral ultrasound performed on 03Feb2014 was normal, reno-bladder ultrasound performed on 03Feb2014 was normal, eye exams on 04Feb2014 was normal. At discharge, at 34 weeks +2 days of gestational age (27 days old), the patient weighed 2548 grams (75-90 C), length 46.5 cm (75 C), cranial circumference 32.0 cm (50-75 C). Physical examination: general condition good. No family history of genetic diseases. The patient had a sister of 14 years in good health condition. Concomitant medications included colecalciferol (COLECALCIFEROL) from 16Jan2014 to 17Mar2014 oral at 2 drops, paracetamol (PARACETAMOL) on 17Mar2014 at 12 drops oral, BIMBOVIT-galenic food supplement- from 16Jan2014 to 17Mar2014 at 10 drops daily oral for vitamin supplementation of preterm and TECNOFER bisglycinate iron chelate -food supplement- from 31Jan2014 to 17Mar2014 at 8 drops daily oral as prophylaxis for the prevention of anemia of preterm. The patient experienced sudden death on 17Mar2014. At 14:30 patient''s mother was not hearing patient''s breath and therefore carried by its own means the patient to the emergency room. The patient came to the emergency room at 03:07 pm. Upon arrival absence of tone, diffuse cyanosis, absence of pulse and breathing were noted. Intubation performed orally. No defense reaction by the patient. Presence of liquid in the oropharyngeal cavity. Started cardiopulmonary resuscitation (chest compressions and ventilation with ambu and intravenous administration of adrenaline in peripheral venous line from the right arm where it was retrieved vein) in collaboration with the pediatrician and the nurse. Resuscitation was ended at 03:33 pm, during the whole period the ECG was always isoelectric been refractory to both maneuvers of compressions that in the administration of drugs. Currently, the patient weighed 3,900 kg. On the same day the patient performed vaccination, after returning home at around 11:00 am the patient began to cry. No fever: the mother, as recommended, administered paracetamol (12 drops) that immediately regurgitated. The patient ate a little bit at the breast (breast milk exclusively). At about 01:00 pm the child has calmed down a bit and slept in the mother''s bed as usual (in the center of the bed). The mother fell also asleep and then woke up and after 30 minutes and noticed that the child was not responsive to stimuli. The mother arrived in the emergency room with the child. Suspect SIDS. The patient died on 17Mar2014. The death report described that the patient experienced suspected hemorrhagic enteritis which caused acute poly-visceral anemia. Additional information received from product quality complaints group regarding Lot. H50850 was the following: Pfizer Investigational Report: The complaint records "Unexpected death after treatment with Prevenar batch H50850". This is the first complaint reported against this packed lot for an adverse event. There have been no additional complaints for lots packed with the same bulk lot. The batch records were reviewed and there were no relevant observations or errors associated with the packaging of the lot in question. The cold chain temperature control data for the bulk stock received and the data for the packed stock during its journey to the markets Distribution Centre were reviewed and found satisfactory before the batch was QP released thus confirming suitable storage conditions maintained. The Certificate of Analysis shows that all QC testing complied with specification and was QP released. Investigation at Havant shows that there were no issues reported during the Havant processes that would have affected the Strength, Identity, Safety, Purity or Quality of this packed lot number. Pfizer Investigational Report: Summary of the technical evaluation conducted for the bulk conjugate batches and associated activated saccharide batches in support of this reported Adverse Event. All investigations associated with these batches were reviewed from a manufacturing and technical perspective and all investigations were appropriately addressed and closed. Based on the review of the Batch Records, CoA and investigations associated with the batches, the release results are deemed satisfactory. No issues impacting the identity, strength, safety, purity or quality of the product were identified during the technical evaluation. An evaluation of the reserve sample and complaint sample was not applicable under this Adverse Event as the Adverse Event was reported for the bulk drug product lot. Pfizer Investigational Report: Summary of the technical evaluation conducted for the bulk conjugate batches and associated activated saccharide batches in support of this reported Adverse Event. All investigations associated with these batches were reviewed from a manufacturing and technical perspective and all investigations were appropriately addressed and closed. Based on the review of the Batch Records, CoA and investigations associated with the batches, the release results are deemed satisfactory. No issues impacting the identity, strength, safety, purity or quality of the product were identified during the technical evaluation. An evaluation of the reserve sample and complaint sample was not applicable. For this interim drug product lot. On the basis of this evaluation, there was no requirement to investigate this Adverse Event further or escalate to the Product Quality Complaint Trending Meeting. An evaluation of the complaint history confirmed that this is fourth compalint for this filled batch G09782 and the first complaint from packaged lot H50850. It is the first complaint for this product complaint classification/ subclass for filled batch G09782 that has been received bV for evaluation. No evidence was found to indicate the complaint occurred as a result of activities conducted at Pfizer. Pfizer will continue to monitor complaints for this Fill lot. No further action was required at this time. Autopsy was performed jointly with the Medical Examiner and post mortem diagnostics report was as follows: Clinical details: Neonatal SIDS; Newborn dead on arrival at Emergency Room on 17Mar2014 at 7:07 pm. No maternal systemic disease. Regular pregnancy. Stool microbiology results received afterwards showed positivity for Rotavirus. Macroscopic examination: Male infant, weighing 3914 g, Andean race, normal body shape, normal development. Vertex coccyx length: 37 cm. Vertex heel length: 57 cm. Foot length: 9 cm. Cranial circumference: 36 cm. Chest circumference: 37 cm. Abdominal circumference: 42 cm. Partly resolved rigor mortis. Purplish skin on head, neck, auricles, lips and nail bed. Bluish spot 1.5x1.5 cm in sacral area. Globose abdomen with flattened umbilical scar. Elsewhere, very pale skin. Eyes: eyeballs, present and normally shaped. Normally shaped ears, patent auditory meatus. Nose with patent choanae from which a citrine fluid leaks after manipulation. Normally shaped mouth. Patent anal orifice. Head: slightly dolichocephalic. Distended anterior fontanelle, 3 cm in size. Virtual posterior fontanelle. Intense congestion of galea capitis. When opening the cranial theca, leakage of a small amount of clear CSF. Patent longitudinal sinus. Protruding encephalon. Encephalon: (weight 582 g) symmetrical, of soft consistency; flattened convolutions at the vault and virtual sulci. Thin and shiny leptomeninges. Congested pial vessels. Regularly shaped vessels of the circle of Willis (removed in toto and fixed). At dissection: light colored cortex; white matter with diffuse petechiae. Extremely narrowed ventricular cavities. Aligned, normally present midlines. Brainstem and cerebellum within the normal range. Samples: E1) frontal, medial, left vault; E2 3) right base nuclei (medial E2, lateral E3); E4) Right temporal area; E5 6) Left thalamus (E5 upper, E6 lower); E7) Left temporal area and hippocampus; E8) postero parietal cranial vault, left; E9 10) anterior medial occipital, right (E9 upper, E10 lower); E11 12) hemicerebellum, left (E11 nuclei; E12 cortex); E13) mesencephalon; E14 15 16) pons (upper third, middle third, lower third); E17) bulb (upper tract); E18) bulb (lower tract) and bone marrow; ME) leptomeninges. Thymus: (weight 16 g) bilobed, greatly enlarged, soft, white pinkish with a few petechiae in the capsule. Thyroid: Normally shaped. Larynx: Normally shaped; clear mucosa. Thoracic/pericardial cavity: Containing a small amount of citrine pinkish fluid; smooth and shiny serous membranes, with some capsular petechiae. Expanded lungs. Intact diaphragmatic cupulae. Normal structure, location and rotation of viscera. Heart: (weight 21 g; transverse diameter: 4 cm; longitudinal diameter: 4 cm; antero posterior diameter: 1.5 cm). Rounded shape. Concordant atrio ventricular and ventriculo arterial connections. Anatomically patent oval foramen. Closed Botallus duct. Shiny parietal and valvular endocardium. Myocardium within normal range. Normally placed coronary arteries. Aorta and arterial vessels, cava and venous vessels: Normally shaped and placed. Severe vascular and circulating blood depletion. Lungs: (total weight 100 g) normally structured, aerated; negative test; soft texture, red pinkish color. At dissection: homogeneous, shiny and elastic parenchyma, reddish colored, discharge of aerated fluid on squeezing. Trachea and large bronchi: Normally shaped; clear mucosa; patent lumen. Abdominal cavity: During dissection, "explosive" expulsion of intestinal skein, with abnormally dilated, reddish loops and abundant citrine pinkish fluid. Esophagus: Intact mucosa; patent lumen. Stomach duodenum: Containing coagulated milk mixed with fluid mucus; clear, intact mucosa. Ileum: Abnormally dilated from the jejunum to the ileocecal valve, due partly to gas and partly to an abundant black reddish pultaceous material mixed with reddish slurry that is present over the entire length of the viscus. Very thin, reddish walls, with serous membrane partly opaque and partly veiled. Mucosa barely perceptible, overdistended, intensely reddish. Colon: Contracted. It looks like a thin whitish ribbon; regular mucosa; patent lumen; normally placed appendix. Liver: (weight 147 g): normally structured, intensely and diffusely light yellowish; of pasty texture. At dissection: blurred lobular design. Yellowish, oily appearance. Extrahepatic bile ducts: Normally present, patent lumen. Cholecystis contracted, containing very little dark brown bile. Pancreas: Normally structured. Spleen: (total weight 13 g): normally structured, smooth capsule, of parenchymatous texture. At dissection: retained red pulp. Adrenal glands: (total weight 5 g): normally shaped, of soft parenchymatous texture. At dissection: white yellowish adrenal cortex; reddish adrenal medulla, diffluent. Kidney: (total weight 38 g): normally structured, light colored, and of compact texture. At dissection: pale cortex and medulla, with evidence of congested arciform vessels. Pelvis and ureter: Intact mucosa; patent lumen. Bladder: Contracted, containing very little clear urine. Light colored, intact mucosa. Genital system: Appropriate for age and gender. Testicles in the scrotum. Lymphatic system: Modestly enlarged (evident) mesenteric lymph nodes, red pinkish. Musculoskeletal system: Suspected additional lumbar vertebra; 3 ossification nuclei at the sternum. Diffuse paleness of viscera and muscles associated with poor systemic blood supply. Fluid and organ samples were collected according to SIDS protocol for toxicology and microbiology tests. Micoscopic examination: Encephalon: Acute edema; glial nodule leukoencephalitis. Meninges: Lymphocytic meningitis. Heart: Edema. Lung: Lymphocytic interstitial pneumonia. Liver: Hepatitis and lymphocytic perihepatitis with microgranulomatous appearance; moderate fetal erythropoiesis. Kidney: Acute passive stasis. Ileum: Intense hyperplasia of lymphoreticular tissue. Accumulation of subserosal lymphocytes (invagination sign). Mesenteric lymph nodes: Diffuse hemorrhagic infarction. Stomach, colon, thymus, adrenal glands, thyroid, parathyroid: Normally present histoarchitecture. Diagnosis: Massive intestinal hemorrhage (likely due to obstruction following transient invagination). Acute plurivisceral anemia. Signs of viral infection (glial nodule leukoencephalitis, lymphocytic meningitis, lymphocytic interstitial pneumonia, lymphocytic perihepatitis and hepatitis having a microgranulomatous appearance) in a subject infected with intestinal rotavirus. Histology report: Diagnostic Opinion: chronic viral infection with CNS and liver involvement. intestinal hemorrhage likely due to acute obstruction from invagination. This picture is consistent with the positivity of laboratory tests for rotavirus (there is no evidence of causal links with recent vaccination). Other lab data performed on 19Mar2014 includes: stool culture for salmonella, negative. Stool culture for campylobacter, negative. Stool culture for shigella, negative. Research for rotavirus in stool positive. Research for fecal adenoviruses in stool, negative. Research for respiratory syncytial virus in nasopharyngeal swab, negative. Follow-up (20Mar2014, 24Mar2014 and 25Mar2014): New information received from Regulatory Authority includes: concomitant medications, medical history details, past drug history, vaccine history, birth weight updated, #of siblings, lab data, details of the event reported in the emergency room report. Follow-up (03Apr2014): Additional information was received from product quality complaints group regarding Lot. H50850. Follow-up (07Apr2014): New information received from Regulatory Authority includes: death report. Follow-up attempts completed. No further information expected. Follow-up (31May2017): New information received from the Regulatory Authority includes: post mortem diagnostics report and autopsy results.; Sender''s Comments: Linked Report(s) : 2014081374 Legacy paper report number; Reported Cause(s) of Death: Intestinal hemorrhage; Plurivisceral anemia; Viral infection; Autopsy-determined Cause(s) of Death: Intestinal hemorrhage; Plurivisceral anemia; Viral infection.


VAERS ID: 698202 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-05-22
Onset:2017-05-23
   Days after vaccination:1
Submitted: 2017-06-05
   Days after onset:13
Entered: 2017-06-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC844A / UNK LG / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S158844 / UNK LG / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB756BB / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Adverse drug reaction, Death, Intensive care, Resuscitation, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-05-23
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2017238791

Write-up: This is a spontaneous report from a contactable physician received via the Institut. Regulatory authority report number DE-PEI-PEI2017046510. A 9-week-old male patient of an unspecified ethnicity received the first doses of PREVENAR 13 (lot no.: S158844) intramuscular at 0.5ml, single at lateral thigh, ROTARIX (lot no.: AROLB756BB) oral at 1 DF, single INFANRIX HEXA (lot no.: A21CC844A) intramuscular at 1 DF, single at lateral thigh, all on 22May2017 at 12:00 a.m for prophylaxis. At the time of vaccination, the infant had no infections. Information on concomitant medication was not provided. None of the vaccines had been administered previously. The patient experienced exitus letalis on 23May2017. According to the infant''s mother, she had seen her son alive for the last time around midnight when everything looked ok. On 23May2017 at 08:00 o''clock, she found the infant lifeless in his cot. The infant was transported to the intensive care unit of a University childrens'' hospital. Cardiopulmonary resuscitation for 1.5 hours was without success. According to the attending pediatrician, an autopsy will be performed. He suspected sudden infant death syndrome (SIDS) or an adverse drug reaction. Authorities are investigating the infant''s death. The reporting physician stated that due to the circumstances of finding the child, SIDS was considered, but due to the temporal relationship with the vaccination, vaccination reaction cannot be excluded. This case is being treated according to the IfSG (Protection against Infection Act). No follow-up attempts needed, follow-up automatically provided by PEI.; Reported Cause(s) of Death: Due to the circumstances of finding the child, SIDS is considered, but due to the temporal relationship with the vaccination, vaccination reaction cannot be excluded.


VAERS ID: 698206 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-06-05
Entered: 2017-06-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. L023427 / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IL0095075131705ISR014738

Write-up: This spontaneous report was received from a consumer and a company representative and refers to an unknown number of infant patients (reported as babies) of unknown gender. There was no information about the patients'' concurrent conditions, concomitant therapies or medical history provided. Approximately from July 2016 to March 2017, the patients were vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown), lot # L023427 with an expiration date up to March 2017, orally (doses were not reported). The reporter stated that she knew about several deaths of babies in the last months (dates unspecified), which occurred a few weeks after they were vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown). The cause of death was not reported. The causality assessment was not provided by the primary reporter. Upon internal review, the event of death was considered to be medically significant. Additional information has been requested.


VAERS ID: 698215 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-04-11
Onset:0000-00-00
Submitted: 2017-06-05
Entered: 2017-06-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0000516868 / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Asthenia, Cough, Death, Pneumonia, Productive cough
SMQs:, Anaphylactic reaction (broad), Guillain-Barre syndrome (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: 2017-04-16
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20170411; Test Name: Body temperature; Result Unstructured Data: Lab result: 36.1 ?C
CDC Split Type: JP0095075131705JPN002907J

Write-up: Information has been received from the Agency (V17100152) on 30-MAY-2017. Initial information has been received from a physician via the Agency concerning a 79-year-old male patient who on 11-APR-2017 was vaccinated with PNEUMOVAX NP for prophylaxis (dose not reported, lot number: 9MS23R, lot number: 0000516868). There were no special notes on the pre-vaccination interview form (including underlying disease, allergy, vaccination and disease within the recent 1 month, currently taken medications, past adverse reaction and growth status) or family history. No other concomitant medication was reported. On 11-APR-2017, at 09:16, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) at the reporting hospital (as mentioned above). Body temperature before vaccination was 36.1 degree Celsius. The patient experienced physical deconditioning. On 14-APR-2017, at 10:00, the patient visited the reporting hospital for cough and sputum, where he was diagnosed with pneumonia (onset of pneumonia). The patient was admitted to hospital A. On 16-APR-2017, the patient died of pneumonia. Whether autopsy was performed was not reported. Reporter''s comment: Not provided. The reporting physician considered that pneumonia was serious due to death and hospitalization. The reporting physician felt that the causal relationship between pneumonia and pneumococcal vaccine, polyvalent (23-valent) was unknown. Additional information is not expected. Lot numbers 9MS23R /0000516868 has been verified to be a valid lot number for pneumococcal vaccine. Information has been received for a direct report from the Agency regarding a case provided by the physician. Reported Cause(s) of Death: Pneumonia.


VAERS ID: 698758 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-06-08
Entered: 2017-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -

Administered by: Other       Purchased by: Unknown
Symptoms: Autoimmune thyroiditis, Cardiac failure, Death
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Hypothyroidism (broad), Hyperthyroidism (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: 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: CN0095075131706HKG003588

Write-up: This spontaneous report was received from a female consumer who received GARDASIL and had adverse events (see case # 1705HKG014232). The consumer reported that among several fatal cases, there was an female who died of heart failure because of Hashimoto''s thyroiditis. No further information was provided. Upon internal review, heart failure and Hashimoto''s thyroiditis were considered medically significant. This is one of several reports from the same source. Additional information is not expected as the consumer did not provide consent to be contacted. Sender''s Comments: HK-00950713-1705HKG014232: HK-00950713-1706HKG003583: US-00950713-1706USA003592: HK-00950713-1706HKG003596: HK-00950713-1706HKG003603: HK-00950713-1706HKG003605: US-00950713-1706USA003607. Reported Cause(s) of Death: heart failure.


VAERS ID: 698922 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2017-05-01
Submitted: 2017-06-08
   Days after onset:38
Entered: 2017-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CB403A / UNK UN / IM
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 15F301 / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R29022 / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB366AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Bed sharing, Body temperature increased, Cardio-respiratory arrest, Cyanosis, Malaise, Nasal congestion, Resuscitation, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-05-19
   Days after onset: 18
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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2017087519

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of sudden death unexplained in a 8-week old male patient who received ROTARIX (batch number AROLB366AA, expiry date unknown). Co-suspect products included BEXSERO (batch number 15F301, expiry date unknown), INFANRIX-POLIO-HIB (batch number A20CB403A, expiry date August 2018) and PREVENAR 13 (batch number R29022, expiry date unknown). Concomitant products included paracetamol. On 18th May 2017, the patient received ROTARIX (intramuscular) 1 dosage form(s), BEXSERO (intramuscular) 1 dosage form(s), INFANRIX-POLIO-HIB (intramuscular) 1 dosage form(s) and PREVENAR 13 (intramuscular) 1 dosage form(s). On 19th May 2017, less than a day after receiving ROTARIX, BEXSERO and INFANRIX-POLIO-HIB, the patient experienced sudden death unexplained (serious criteria death, GSK medically significant and other), cardiopulmonary arrest (serious criteria GSK medically significant and other), body temperature increased (serious criteria other), unwell (serious criteria death), cyanosis (serious criteria other) and nasal congestion (serious criteria other). On 19th May 2017, the outcome of the sudden death unexplained was fatal. On an unknown date, the outcome of the cardiopulmonary arrest, body temperature increased, unwell, cyanosis, and nasal congestion were not recovered/not resolved. The patient died on 19th May 2017. The reported cause of death was sudden death unexplained. An autopsy was performed. The autopsy determined cause of death was unknown cause of death. It was unknown if the reporter considered the sudden death unexplained, cardiopulmonary arrest, body temperature increased, unwell, cyanosis and nasal congestion to be related to ROTARIX, BEXSERO and INFANRIX-POLIO-HIB. Initial information was received by a physician via regulatory authority on 07th June 2017: Baby developed temperature, unsettled and presented to accident and emergency in cardiopulmonary arrest. Post mortem examination cause of death unascertained. Had immunisations less than 24 hours prior to death. Unable to determine whether immunisations contributed. Baby developed temperature in early hours of morning, given CALPOL and described as snuffly. Mum fell asleep with baby on chest and woke to find baby blue. Cardiopulmonary resuscitation commenced and transferred to hospital but unable to resuscitate. Medically Significant Details: Unable to determine whether immunisations contributed to sudden unexpected death. Sudden unexplained death in infancy.


VAERS ID: 698778 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-06-08
Entered: 2017-06-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
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: CN0095075131706USA003607

Write-up: This spontaneous report was received from a female who received GARDASIL and had adverse events (see case # 1705HKG014232). The consumer stated news reported cases of disability a few years after the vaccination, fatal case. There are more and more adverse reaction cases after vaccination, many symptoms appear years after vaccination". No further information was provided. Upon internal review, disability and death were considered medically significant. This is one of several reports from the same source. Additional information is not expected as the consumer did not provide consent to be contacted. Sender''s Comments: HK-009507513-1705HKG014232: HK-009507513-1706HKG003588: US-009507513-1706USA003592: HK-009507513-1706HKG003596: HK-009507513-1706HKG003603: HK-009507513-1706HKG003605: HK-009507513-1706HKG003583:


VAERS ID: 698878 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-05-01
Onset:2017-05-01
   Days after vaccination:0
Submitted: 2017-06-09
   Days after onset:39
Entered: 2017-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC940B / 2 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH S15270 / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Death, Irregular breathing, Resuscitation
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), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALVEDON
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2017246528

Write-up: This is a spontaneous report from a contactable physician received from the Medical Products Agency (MPA). Regulatory authority report number SE-MPA-2017-003901. A 5-month-old male patient received the 2nd dose of PREVENAR 13, intramuscular, in the middle of May2017, at single dose, for vaccination; the 2nd dose of INFANRIX HEXA, intramuscular, in the middle of May2017, at 0.5 ml single, for vaccination. Relevant medical history was not reported. The patient was health, born at week 41. Previously the patient received 1st doses of Prevenar 13 and Infanrix Hexa for immunisation. The patient was warm in the evening and received paracetamol (ALVEDON). The next morning a strange sound was heard from the patient who was found lifeless with irregular breathing. After a few minutes cardiac arrest was established by health care professionals. Heart lung resuscitation (HLR) was ongoing for approximately 60 minutes until the patient had sinus rhythm for short periods. The patient died at the hospital after five hours. It was unknown if an autopsy was performed. The MPA assessed the causal relationship of the events cardiac arrest and respiratory failure with the suspect products Prevenar 13 and Infanrix Hexa as possible. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac arrest; Respiratory failure


VAERS ID: 699199 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Female  
Location: Foreign  
Vaccinated:2017-05-01
Onset:2017-05-01
   Days after vaccination:0
Submitted: 2017-06-12
   Days after onset:42
Entered: 2017-06-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood culture positive, Death, Meningococcal sepsis, Neisseria test positive, Polymerase chain reaction positive
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-05-22
   Days after onset: 21
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: 2017, Blood culture, positive meningitis; 06/05/2017, Polymerase chain reaction, Meningitis serotype W-135
CDC Split Type: ES2017GSK081004

Write-up: This case was reported by a consumer via interactive digital media and described the occurrence of meningococcal sepsis in a 4-month-old female patient who received Meningococcal C Vaccine. In May 2017, the patient received the 1st dose of Meningococcal C Vaccine. In May 2017, less than a month after receiving Meningococcal C vaccine, the patient experienced meningococcal sepsis (serious criteria death and GSK medically significant). On 22nd May 2017, the outcome of the meningococcal sepsis was fatal. The patient died on 22nd May 2017. The reported cause of death was meningococcal sepsis. The reporter considered the meningococcal sepsis to be unrelated to Meningococcal C Vaccine. Additional details were reported as follows: The case was received from a journalist via social listening program. The information was published online in a local newspaper. The patient died due to fulminant meningococcal sepsis. A culture had been performed, but the results were not available at the time of reporting. According to reporter it seemed to be a common cause but this time with fatal outcome. Follow up information was received from consumer via interactive digital media on 6th June 2017 and 7th June 2017: The patient was a gypsy child. In May 2017, less than a month after receiving a dose of BEXSERO and 1st dose of NEISVAC-C, the patient experienced meningococcal sepsis. The suspect vaccine Meningococcal C was changed to BEXSERO and NEISVAC C. The patient''s blood serum was analysed as the patient''s family did not allow to extract samples of spinal fluid. The polymerase chain reaction (PCR) of blood serum resulted positive for meningitis. On 5th June 2017, the sample was sent to an external laboratory which confirmed meningitis serotype was W-135. The patient''s family did not authorise autopsy. The reporter considered the meningococcal sepsis to be unrelated to NEISVAC-C and BEXSERO.


VAERS ID: 699408 (history)  
Form: Version 1.0  
Age: 1.17  
Sex: Female  
Location: Foreign  
Vaccinated:2008-07-22
Onset:2017-05-22
   Days after vaccination:3226
Submitted: 2017-06-13
   Days after onset:22
Entered: 2017-06-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Brain oedema, Cardio-respiratory arrest, Computerised tomogram head abnormal, Death, Drooling, Dysphagia, Dysphonia, Ear pain, Endotracheal intubation, Epiglottitis, Epiglottitis haemophilus, Haemophilus infection, Haemophilus test positive, Hypoxia, Intensive care, Oropharyngeal pain, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-05-25
   Days after onset: 3
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: AU0095075131706AUS004215

Write-up: Information was obtained on a request by the Company from the Agency via a Public Case Details (# 411015) concerning 10 year old female patient. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On 17-JUL-2007, the patient was vaccinated with the first dose of COMVAX (route of administration, anatomical location, lot# and expiration date were not reported). On 11-OCT-2007, the patient was vaccinated with the second dose of COMVAX (route of administration, anatomical location, lot# and expiration date were not reported). On 22-JUL-2008, the patient was vaccinated with the third dose of COMVAX (route of administration, anatomical location, lot# and expiration date were not reported) and was fully vaccinated. Previously well and healthy child with a 24 hour history of earache and sore throat. The patient did not attend the general practitioner (GP) as illness presented as a simple earache and sore throat. On 22-MAY-2017, the patient experienced sore throat and earache. On 23-MAY-2017, the patient experienced epiglottitis, dysphonia, drooling, dysphagia. Cardiorespiratory arrest in community, admitted to pediatric intensive care - intubated. The computed tomography (CT) scan was performed showing cerebral oedema consistent with global hypoxic injury. Haemophilus influenza isolated on blood culture collected. On 25-MAY-2017, the patient passed away. The cause of death was HIB epiglottitis, Haemophilus infection and vaccine failure. On 26-MAY-2017, the serotype b was identified. The events were considered to be possibly related to COMVAX. Additional information is not expected. Reported Cause(s) of Death: vaccine failure; Haemophilus infection.


VAERS ID: 699562 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-05-18
Onset:2017-05-19
   Days after vaccination:1
Submitted: 2017-06-14
   Days after onset:26
Entered: 2017-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER A20CB403A / UNK - / IM
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 15F301 / UNK - / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R29022 / UNK - / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB366AA / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Body temperature, Cardio-respiratory arrest, Cyanosis, Death, Restlessness, Resuscitation, Rhinorrhoea, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Akathisia (broad), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-05-19
   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: PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZERINC2017251454

Write-up: This is a spontaneous report received from a physician via the contactable Regulatory Agency (RA). The regulatory authority number is GB-MHRA-ADR 24020305. An 8 week old male patient of unknown ethnicity received, on 18May2017, PREVENAR 13 (Lot. R29022) intramuscularly, at 0.5 ml, single dose, for immunization. On the same date, on 18May2017, the patient received also ROTARIX (Lot. AROLB 366AA) intramuscularly, at 1 DF, single dose; BEXSERO (Lot. 15F301) intramuscularly, at 1 DF, single dose; and INFANRIX IPV HIB (Lot. A20CB403A, Expiration date: Aug2018) intramuscularly, at 1 DF, single dose; all for immunization. Relevant medical history was unknown. Concomitant medication included paracetamol. On 19May2017, the patient developed temperature in early hours of morning, given CALPOL and described as snuffly. Mum felt asleep with baby on chest and woke to find baby blue. Cardiopulmonary resuscitation commenced and transferred to hospital but unable to resuscitate. He was unsettled and presented to A&E in cardiopulmonary arrest and on 19May2017 the patient died. An autopsy was carried out and the cause of death was considered to be sudden death unexplained/death unexplained. Unable to determine whether immunizations contributed. The events persisted at the time of death. Post mortem Medically Significant Details: unable to determine whether immunizations contributed to sudden unexpected death. Sudden unexplained death in infancy. The RA considered the events to be serious for an unspecified reason. No follow-up attempts possible. No further information expected. Reported Cause(s) of Death: Sudden death unexplained; Autopsy-determined Cause(s) of Death: Death unexplained.


VAERS ID: 699611 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-06-15
Entered: 2017-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Unknown
Symptoms: Death, Multiple use of single-use product
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075131706USA005300

Write-up: Information was received from an unspecified reporter via a company representative, referring to 15 unspecified patients of unknown age and gender. The patients'' medical history, concurrent conditions and concomitant therapies were not provided. On unknown date, the patients were vaccinated with M-M-R II (albumin status HSA (human serum albumin), lot#, expiration date, concentration, dose, route and frequency were unknown) for prophylaxis. On unknown dates, the patients died, because the nurses used the same syringe needle on all 15 patients during the administration of M-M-R II, while the exact cause of death was not reported. This was reported in a journal. It was unknown if autopsy was performed. The causality between M-M-R II and the event was not provided. Upon internal review, death (exact reason unknown) was determined to be medically significant. Additional information is not expected since there is no contact information provided. Reported Cause(s) of Death: used the same syringe needle on all 15 patient (exact reason unknown).


VAERS ID: 699761 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-06-15
Entered: 2017-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Aspartate aminotransferase increased, Blood glucose increased, Death, Diarrhoea, Seizure, Tachycardia, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Premature baby
Allergies:
Diagnostic Lab Data: On an unknown date, the patient''s aspartate aminotransferase and blood glucose found to be elevated.
CDC Split Type: TR2017GSK091315

Write-up: This case was reported by a physician via sales rep and described the occurrence of convulsion in a 15-month-old patient who received ROTARIX. The patient''s past medical history included premature baby. On an unknown date, the patient received the 1st dose of ROTARIX (oral). On an unknown date, unknown after receiving ROTARIX, the patient experienced convulsion (serious criteria death, hospitalization and GSK medically significant), tachycardia (serious criteria hospitalization), diarrhea and vomiting. On an unknown date, the outcome of the convulsion was fatal and the outcome of the tachycardia, diarrhea and vomiting were unknown. The reported cause of death was convulsion. It was unknown if the reporter considered the convulsion, tachycardia, diarrhea and vomiting to be related to ROTARIX. Additional details were provided as follows: The patient experienced vomiting and diarrhea after vaccination with ROTARIX and the patient was hospitalized after 2 days. While in hospital the patient experienced tachycardia and next day, the patient experienced convulsion and died. This case has been linked with case TR2017GSK091316 reported by same reporter.


VAERS ID: 699913 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-11-15
Submitted: 2017-06-09
   Days after onset:936
Entered: 2017-06-16
   Days after submission:7
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 myocardial infarction, Death
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201700822

Write-up: This initial spontaneous case received on 01-Jun-2017, was reported by other non-health professional via health authority (ITMINISAL02-282261) and concerns a male patient of an unspecified age. On an unspecified date, the patient received INN Flu Vaccine Seasonal (batch number, expiry date, dose, anatomical location and route of administration: not reported). On 15-Nov-2014, the patient experienced acute myocardial infraction. On an unknown date, the patient died. It was unknown whether the autopsy performed at the time of this report. The reporter assessed the causality between the event (myocardial infarction) and the suspect vaccine as related. Health Authority assessed the case as serious (death).


VAERS ID: 699914 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-11-25
Submitted: 2017-06-09
   Days after onset:926
Entered: 2017-06-16
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Cardio-respiratory arrest, Death, Erythema, Metabolic acidosis, Multiple organ dysfunction syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (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), Guillain-Barre syndrome (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (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:
CDC Split Type: 201700824

Write-up: This initial spontaneous case received on 01-Jun-2017, was reported by other non-health professional via health authority (IT-MINISAL02-282197) and concerns a Female patient of unspecified age. On an unspecified date, the patient received INN flu vaccine seasonal, (dose, route of administration, anatomical location, trade name, manufacturer, batch number and expiration date: not reported). On 25-Nov-2014, the patient had asthenia, cardio-respiratory arrest, erythema diffuse, metabolic acidosis and multi organ failure. As a result the patient was died on an unspecified date and it was unknown if an autopsy was performed. The Health Authority stated that, the drug might have contributed for the events and assessed the causality between events and INN flu vaccine seasonal as related. This report was serious (death and medically significant).


VAERS ID: 699915 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-11-28
Submitted: 2017-06-09
   Days after onset:923
Entered: 2017-06-16
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: 201700821

Write-up: This initial spontaneous case was received on 01-Jun-2017, from the other non-health care professional via Health Authority (RPN: IT-MINISAL02-282428) and concerns a male patient of an unspecified age. On an unspecified date, the patient received the INN flu vaccine seasonal (dose, route of administration, anatomical location, trade name, manufacturer, batch number and expiration date: not reported). On 28-Nov-2014, the patient had distress respiratory and he was died on an unspecified date. It was unknown if an autopsy was performed. The Health Authority stated that, the drug might have contributed for the event and assessed the causality between event and INN flu vaccine seasonal as related. This report was serious (death).


VAERS ID: 699916 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-11-22
Submitted: 2017-06-09
   Days after onset:929
Entered: 2017-06-16
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-22
   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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201700820

Write-up: This initial spontaneous case received from other non-health professional via health authority (RNF: IT-MINISAL02-282102) on 01-Jun-2017, was and concerns a male patient of an unspecified age. On an unspecified date, the patient received Influenza vaccine, (batch number, expiry date, dose, anatomical location and route of administration: not reported) for an unknown indication. On 22-Nov-2014, the patient was suddenly died (as reported: sudden death). The cause of death was not reported. It was unknown whether the autopsy performed at the time of this report. The reporter assessed the causality between the event (death) and the suspect vaccine as related. Health Authority considered this case was serious (death).


VAERS ID: 700083 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2017-04-19
Onset:2017-04-19
   Days after vaccination:0
Submitted: 2017-06-16
   Days after onset:58
Entered: 2017-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS YHBVC530AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Vaccination complication
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-04-19
   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: No other medications
Current Illness: Hepatitis B core antibody negative
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN2017GSK090146

Write-up: This case was reported by a other health professional via regulatory authority and described the occurrence of unknown cause of death in a 18-year-old male patient who received ENGERIX B ADULT (batch number YHBVC530AA, expiry date unknown). Concurrent medical conditions included hepatitis B core antibody negative. On 19th April 2017, the patient received ENGERIX B ADULT (intramuscular) 20 ug. On 19th April 2017, several hours after receiving ENGERIX B ADULT, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On 19th April 2017, the outcome of the unknown cause of death was fatal. The patient died on 19th April 2017. The reported cause of death was unknown cause of death. An autopsy was performed. The reporter considered the unknown cause of death to be related to ENGERIX B ADULT. Additional details were provided as follows: The body temperature of the patient was 36.8 degree C before vaccination and the patient had no vaccine contraindication and signed the vaccine notification form before vaccination. The patient ever consulted vaccination in Feb2017 and consulted ENGERIX B ADULT cost, contraindication and noticed on the morning of 18th April 2017 but didn''t receive vaccine that time. The patient received ENGERIX B ADULT for no hepatitis B antibody from outpatient on 19th April 2017 at 10:05 am. The physician notified notices after vaccination to the patient. The patient played and used telephone when at rest after vaccination. It was reported that the patient was not abnormal when leaving the outpatient at 11:50 am on day of vaccination. The patient died that night and it was suspected as vaccine adverse event. The autopsy was done but the result was not available. Additional information was not reported. The impact on the original disease was not obvious. The reporter and reporter unit causality assessment both were yes and country (city or province) causality assessment was possible.


VAERS ID: 700056 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-11-24
Submitted: 2017-06-11
   Days after onset:929
Entered: 2017-06-19
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Multiple organ dysfunction syndrome
SMQs:, 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201700825

Write-up: This is initial spontaneous case from other non-health professional via Health Authority (RNF: IT-MINISAL02-283251) on 05-Jun-2017 and concerns a male patient of unknown age. On an unspecified date, the patient was administered with Influenza vaccine "trade name, manufacturer, batch no. not reported" (dose, expiry date, anatomical location, route of administration and indication were not reported). On 24-Nov-2014, the patient had multi-organ failure. It was unknown whether autopsy was done. The outcome of the event was fatal. The reporter assessed the causality between the events and vaccine as related. Health Authority assessed the event as serious (death, life-threatening and medically significant).


VAERS ID: 700057 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-11-12
Submitted: 2017-06-11
   Days after onset:941
Entered: 2017-06-19
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Petechiae
SMQs:, Haemorrhage terms (excl laboratory terms) (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: 201700831

Write-up: This is initial spontaneous case reported by other non-health professional via Health Authority (RNF reference number: IT-MINISAL02-294397) on 05-Jun-2017 and concerns a male patient of an unspecified age. On an unspecified date, the patient received the viral haemagglutinin "trade name, manufacturer, batch no. not reported" (INN flu vaccine, dose, route of administration, anatomical location, expiration date were not reported). On 12-Nov-2014, the patient had petechiae. On an unspecified date, the patient died. It was unknown whether an autopsy done. The reporter assessed the causality between the event and INN flu vaccine as related. Health Authority considered the event as serious (death).


VAERS ID: 700058 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-06-11
Entered: 2017-06-19
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Cyanosis, Death, Decreased appetite, Dyspnoea, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201700835

Write-up: This initial spontaneous case, received on 05-Jun-2017, was reported by other non-health professional via health authority (RNF: IT-MINISAL02-283025) and concerns a male patient of an unspecified age. On an unspecified date, the patient received INN Flu Vaccine (dose, route of administration, anatomical location, trade name, manufacturer, batch number and expiration date: not reported). On an unspecified date, the patient had asthenia, cyanosis, dyspnea, tachypnea and inappetence. As a result, the patient was died on an unspecified date and it was unknown if an autopsy was performed or not. The Health Authority stated that the drug might have contributed for the events and assessed the causality between events and INN flu vaccine as related. This report was serious (death).


VAERS ID: 700097 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-11-30
Submitted: 2017-06-11
   Days after onset:923
Entered: 2017-06-19
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Diarrhoea, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201700834

Write-up: This initial spontaneous case received on 05-Jun-2017, was reported by other non-health professional via health authority (RNF: IT-MINISAL02-282899) and concerns a female patient of an unspecified age. On an unspecified date, the patient received INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, trade name manufacturer, batch number and expiration date: not reported). On 30-Nov-2014, the patient experienced diarrhoea and fever. As a result, the patient was died on an unspecified date and it was unknown if an autopsy was performed or not. The Health Authority stated that, the outcome was not due to the INN Flu Vaccine Seasonal and assessed the causality between events and INN Flu Vaccine Seasonal as related. This report was serious (death).


VAERS ID: 700304 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-06-20
Entered: 2017-06-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

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? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Blood pressure high; Contracture; Diabetes mellitus; Right sided paralysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: SAPFIZERINC2017262909

Write-up: This is a spontaneous report from two contactable physicians, received via a sales representative. The two physicians reported the same event for two patients. This is the first of two reports. A 76-year-old patient of an unspecified race/ethnicity and gender received within the home care vaccination project PREVNAR 13 on an unspecified date, at single dose, for immunisation. Medical history included atrial fibrillation, diabetes mellitus, high blood pressure, contractures and right sided paralysis. The patient''s concomitant medications were not reported. Home care patient died on an unspecified date after vaccination. The relatives claimed that the death was due to receiving the vaccine. It was not reported if an autopsy was performed. Sender''s Comments: The limited information in this report precludes a full assessment of the case. However, per company guidance, "death cause unknown" is processed as "related" until sufficient information becomes available to confirm an unrelated cause of death. Considering the information currently available (the advanced old age and pre-existing metabolic disease, cerebrovascular disorders and arrhythmia), the patient''s death is more likely due to the underlying medical conditions unrelated to the vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): SA-PFIZER INC-2017264032 same reporters/product/event, different patient. Reported Cause(s) of Death: death.


VAERS ID: 700305 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-06-20
Entered: 2017-06-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 RA / 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: Medical History/Concurrent Conditions: Atrial fibrillation; Contracture; Right sided paralysis
Allergies:
Diagnostic Lab Data:
CDC Split Type: SAPFIZERINC2017264032

Write-up: This is a spontaneous report from two contactable physicians, received via a sales representative. The two physicians reported the same event for two patients. This is the second of two reports. A 87-year-old patient of an unspecified race/ethnicity and gender received within the home care vaccination project PREVNAR 13 on an unspecified date, at single dose, for immunisation. Medical history included atrial fibrillation, contractures and right sided paralysis. The patient''s concomitant medications were not reported. Home care patient died on an unspecified date after vaccination. The relatives claimed that the death was due to receiving the vaccine. It was not reported if an autopsy was performed. Sender''s Comments: The limited information in this report precludes a full assessment of the case. However, per company guidance, "death cause unknown" is processed as "related" until sufficient information becomes available to confirm an unrelated cause of death. Considering the information currently available (the advanced old age and pre-existing cerebrovascular disorders and arrhythmia), the patient''s death is more likely due to the underlying medical conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s): SA-PFIZER INC-2017262909 same reporters/product/event, different patient. Reported Cause(s) of Death: death.


VAERS ID: 700389 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2017-06-10
Onset:2017-06-13
   Days after vaccination:3
Submitted: 2017-06-21
   Days after onset:8
Entered: 2017-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. M048394 / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-06-13
   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: ENALAPRIL; SPIRONOLACTONE; amlodipine; BAYASPIRIN; pitavastatin calcium; MARZULENE-S
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Chronic gastritis; Hypercholesterolaemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131706JPN001298J

Write-up: Information has been received from a physician concerning a female patient in her 60s with history of angina pectoris, hypertension, hypercholesterolaemia, chronic gastritis who on 10-JUN-2017 was subcutaneously vaccinated with PNEUMOVAX NP injection for prophylaxis (Batch number: M048394, Lot number:0000635865). Concomitant therapies included enalapril maleate, spironolactone, amlodipine, BAYASPIRIN, pitavastatin calcium and MARZULENE-S. On 10-JUN-2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (described above). On 13-JUN-2017, the patient died. Death reason and information of autopsy were not reported. Reporter''s comment: The relationship to pneumococcal vaccine, polyvalent (23-valent) could not be ruled out. The reporting physician considered death to be related to pneumococcal vaccine, polyvalent (23-valent). Upon internal review, the death was determined to be medically significant. Additional information has been requested. We requested the G lot to be added to the database on 24-MAY-2017. Reported Cause(s) of Death: Death.


VAERS ID: 700820 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-06-23
Entered: 2017-06-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA0095075131706CAN010243

Write-up: This spontaneous report has been received from an unspecified source through an on-line article. The publication refers to a 99 female patients of unknown age which were part of the study performed by two professors in the reporting country of incident and published in a local newspaper. The patients'' pertinent medical history, concurrent conditions and concomitant medications were not provided. On unknown dates, the patients were vaccinated with GARDASIL (strength, dose, route of administration, Lot # and expiration date were not reported) for prophylaxis or with CERVARIX (strength, dose, route of administration, Lot # and expiration date were not reported) for prophylaxis. The physician came clean and warned that GARDASIL was not only ineffective and unnecessary, it was dangerous. It was mentioned the medically known fact that 98% of Human Papillomavirus (HPV) warts among sexually active women heal on their own within a year or two. According with The Vaccine Adverse Event Reporting System, on unknown dates it were reported 99 cases of females that resulted in death (causes not reported and unknown if an autopsy was performed). The Pap smears were still recommended for cervical cancer, even if HPV shots were administered and it was reported that people must kept in mind that only around 5% of vaccines adverse events were reported to the Centers for Disease Control (CDC)''s Vaccine Adverse Event Reporting Service (VAERS). The causality assessment between death and vaccination with GARDASIL or CERVARIX was considered as related.. Upon internal review, death was considered to be as a medically significant event. This is one of several reports received by the same reporter. Additional information has been requested.; Sender''s Comments: AU-009507513-1706AUS008802: AU-009507513-1706AUS008803: AU-009507513-1706AUS008804: AU-009507513-1706AUS009012: AU-009507513-1706AUS008209: AU-009507513-1706CAN010252: AU-009507513-1706CAN010258:


VAERS ID: 700821 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-06-23
Entered: 2017-06-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA0095075131706CAN010252

Write-up: This spontaneous report has been received from an unspecified source through an on-line article. The publication refers to 8 male patients of unknown age which were part of the study. The patients'' pertinent medical history, concurrent conditions and concomitant medications were not provided. On unknown dates, the patients were vaccinated with GARDASIL (strength, dose, route of administration, Lot # and expiration date were not reported) for prophylaxis or with CERVARIX (strength, dose, route of administration, Lot # and expiration date were not reported) for prophylaxis. The physician came clean and warned that GARDASIL was not only ineffective and unnecessary, it was dangerous. According with The Vaccine Adverse Event Reporting System, on unknown dates it were reported 8 cases of males that resulted in death (causes not reported and unknown if an autopsy was performed). The Pap smears were still recommended for cervical cancer, even if HPV shots were administered and it was reported that people must kept in mind that only around 5% of vaccines adverse events were reported to the Centers for Disease Control (CDC)''s Vaccine Adverse Event Reporting Service (VAERS). The causality assessment between death and vaccination with GARDASIL or CERVARIX was considered as related. Upon internal review, death was considered to be as a medically significant event. This is one of several reports received by the same reporter. Additional information has been requested.; Sender''s Comments: AU-009507513-1706AUS008802: AU-009507513-1706AUS008803: AU-009507513-1706AUS008804: AU-009507513-1706AUS009012: AU-009507513-1706AUS008209: AU-009507513-1706CAN010243: AU-009507513-1706CAN010258:


VAERS ID: 700822 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-06-23
Entered: 2017-06-26
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA0095075131706CAN010258

Write-up: This spontaneous report has been received from an unspecified source through an on-line article. The publication refers to 14 of patients of unknown age and gender which were part of "the study of effects of HPV vaccines on the public health" performed by two professors in the reporting country of incident and published in a local newspaper. The patients'' pertinent medical history, concurrent conditions and concomitant medications were not provided. On unknown dates, the patients were vaccinated with GARDASIL (strength, dose, route of administration, Lot # and expiration date were not reported) for prophylaxis or with CERVARIX (strength, dose, route of administration, Lot # and expiration date were not reported) for prophylaxis. The physician came clean and warned that GARDASIL was not only ineffective and unnecessary, it was dangerous. According with The Vaccine Adverse Event Reporting System, on unknown dates it were reported 14 cases that resulted in death (causes not reported and unknown if an autopsy was performed). The Pap smears were still recommended for cervical cancer, even if HPV shots were administered and it was reported that people must kept in mind that only around 5% of vaccines adverse events were reported to the Centers for Disease Control (CDC)''s Vaccine Adverse Event Reporting Service (VAERS). The causality assessment between death and vaccination with GARDASIL or CERVARIX was considered as related. Upon internal review, death was considered to be as a medically significant event. This is one of several reports received by the same reporter. Additional information has been requested. Sender''s Comments: AU-009507513-1706AUS008802: AU-009507513-1706AUS008803: AU-009507513-1706AUS008804: AU-009507513-1706AUS009012: AU-009507513-1706AUS008209: AU-009507513-1706CAN010243: AU-009507513-1706CAN010252.


VAERS ID: 701065 (history)  
Form: Version 1.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2005-04-15
Onset:0000-00-00
Submitted: 2017-06-27
Entered: 2017-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Hepatitis A, Inappropriate schedule of drug administration, Vaccination failure
SMQs:, Liver infections (narrow), Lack of efficacy/effect (narrow), Medication errors (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, 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: DE2017GSK097037

Write-up: This case was reported by a physician via call center representative and described the occurrence of hepatitis in a 68-year-old female patient who received TWINRIX ADULT. Co-suspect products included TWINRIX ADULT and TWINRIX ADULT. On 29th June 2004, the patient received the 1st dose of TWINRIX ADULT. On 15th April 2005, the patient received the 3rd dose of TWINRIX ADULT. In April 2005, not applicable after receiving TWINRIX ADULT and TWINRIX ADULT, not applicable after receiving TWINRIX ADULT and TWINRIX ADULT and unknown after receiving TWINRIX ADULT, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced hepatitis A (serious criteria death and hospitalization) and vaccination failure (serious criteria GSK medically significant). On an unknown date, the outcome of the hepatitis A was fatal and the outcome of the vaccination failure and drug dose administration interval too long were unknown. The reported cause of death was hepatitis A. It was unknown if the reporter considered the hepatitis A and vaccination failure to be related to TWINRIX ADULT, TWINRIX ADULT and TWINRIX ADULT. Additional details were provided as follows: The 3rd dose of TWINRIX ADULT was given late, which led to lengthening of vaccination schedule. It was not reported, whether the dose was given late accidentally or intentionally. It was reported that after a journey, 24 hours hospitalization, the patient died on an unspecified date. Hepatitis A infection was found in the patient. The case was considered as suspected vaccination failure as the exact time to onset and laboratory confirmation was not provided at the time of reporting.


VAERS ID: 701271 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-01
Onset:2014-11-11
   Days after vaccination:10
Submitted: 2017-06-28
   Days after onset:959
Entered: 2017-06-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 143301 / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Confusional state, Diarrhoea, Encephalitis, Pyrexia, Retching
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014IT158294

Write-up: Case number PHHY2014IT158294, is an initial spontaneous report from a health care professional via Health Authority (HA, reference number: 282093) received on 02 Dec 2014, with the follow-up information received from Quality Assurance Department (reference number: 341917) on 16 Dec 2014. This report refers to an 87-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUAD (batch number: 143301, expiration date: 31 Jul 2015) on an unknown date in Nov-2014. On 11 Nov 2014, after 48 hours of vaccination, the patient experienced meningoencephalitis with associated symptoms confusional state, fever, diarrhea, retching, abdominal pain. At the time of this report, the outcome of the event was fatal. The cause of death was meningoencephalitis. It was unknown whether autopsy was done. The reporter assessed the events to be serious (life threatening and death) and causality to be suspected to the administration of FLUAD. The reporter stated that, on 01-Dec-2014, the agency announced the first tests results that, there was no presence of andotoxins and the content and characteristics of the vaccine virus antigen were compliant with quality standards, on 03-Dec-2014, committee concluded that there was no evidence of a causal relationship between the reported fatal event and the administration of FLUAD and on 23 Dec-2014, agency released the final test results (abnormal toxicity test, or ATT, and sterility test) and confirmed that, the vaccine was safe. Based on the performed review on FLUAD batch number: 143301, there is no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used the could compromise the quality of the product or that may be potentially related to the reported events. QA department confirmed that, the involved batches are complaint with internal procedures and with cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 341917) on 10 Dec 2014: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 341917) on 16 Dec 2014: Updated FLUAD batch review report. Follow up received on 14-Jun-2017: This is a serious follow-up literature case. Reporter information was added, event meningoencephalitis was updated and previously reported events confusional state, retching abdominal pain, diarrhea and fever were subsumed. The outcome from unknown to fatal was updated. It was reported that, the agency announced the first tests results that, there was no presence of endotoxins and the content and characteristics of the vaccine virus antigen were complaint with quality standards, agency concluded that there was no evidence of a causal relationship between the reported fatal events and the administration of FLUAD and reassured other countries about the safety of the flu vaccine and agency released the final test results (abnormal toxicity test, or ATT, and sterility test) and confirmed the vaccine was safe.


VAERS ID: 701272 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2014-11-14
Onset:2014-11-16
   Days after vaccination:2
Submitted: 2017-06-28
   Days after onset:954
Entered: 2017-06-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUA3: INFLUENZA (SEASONAL) (FLUAD) / NOVARTIS VACCINES AND DIAGNOSTICS 143301 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal X-ray, Acute kidney injury, Agitation, Asthenia, Atrial fibrillation, Bacterial test negative, Blood gases, CSF culture negative, CSF glucose decreased, CSF protein increased, CSF red blood cell count positive, CSF test abnormal, CSF white blood cell count increased, Coma scale abnormal, Confusional state, Electrocardiogram, Fibrin D dimer increased, Lumbar puncture, Malaise, Multiple organ dysfunction syndrome, N-terminal prohormone brain natriuretic peptide increased, Pain, Platelet count decreased, Procalcitonin increased, Transient ischaemic attack
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-11-16
   Days after onset: 0
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: LACIREX; CARDIOASPIRIN
Current Illness: Benign essential hypertension; Acute renal failure, unspecified; Unspecified transient cerebral ischemia (Transient ischaemic attack); 28-Jun-2017 10:47; Atrial fibrillation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Abdominal X-ray, unknown; 22-NOV-2014, Bacterial test, Negative; CSF was negative for development of bacterial flora in presence of antibiotic therapy, no colonies; Blood gases, Unknown; CSF glucose depressed, 1; CSF protein elevated, 690; CSF red blood cell count positive elevated, 1200 ml; CSF white blood cell count elevated per mcl (mainly neutrophils) 600/microl; Coma scale significant, 5; 16-NOV-2014, Coma scale significant, 12; Electrocardiogram, Unknown; Fibrin D dimer elevated, 14245; Lumbar puncture Significant CSF collected appeared cloudy with yellow colour, slightly haematic, Abnormal; Microscopy, Unknown; N-terminal prohormone brain natriuretic peptide, 33990 pg/ml; Platelet count depressed, 14000 (units and normal values were not reported); Procalcitonin, 159
CDC Split Type: PHHY2014IT155910

Write-up: Case Description: Case number PHHY2014IT155910 is an initial spontaneous report received from a health care professional via health authority (HA reference number: 281215) on 27 Nov 2014, with a combined follow up received from Health Authority on 28 Nov 2014 and 01 Dec 2014 respectively, with a follow-up information received from Quality Assurance Department (reference number: 339779) on 02 Dec 2014. This report refers to a 79 years old female patient. Her current conditions included benign essential hypertension, acute renal failure, unspecified, unspecified transient cerebral ischemia and atrial fibrillation and concomitant medications were LACIRIX 4 mg film coated tablet and CARDIOASPIRIN 100 mg gastro-resistant tablet. She was vaccinated with FLUAD (batch number: 143301, and expiry date: Jul 2015) via intramuscular route as a dose of 0.5 ml on 14 Nov 2014. On 16 Nov 2014, two days after vaccination, she experienced meningoencephalitis. She went to emergency room with paramedical intervention because she presented with diffuse pain, asthenia and general malaise. She was less cooperative during the visit with apparent confusion, GSC 12 and atrial fibrillation with high ventricular response. She was admitted in the emergency medicine department and the events rapidly worsened and she entered in coma status (GSC 5) with associated multi-organ failure. Nephrology and reanimation advice were performed. Spinal tap was done and CSF collected appeared cloudy with yellow colour and slightly haematic with protein in liquor): 690 mg/dl, glucose in liquor: 1 mg/dl, leukocytes in liquor: 600/mcl (mainly neutrophils) and erythrocytes: 1200 x ml. Her procalcitonin was 159 ng/ml, ProBNP was 33990 pg/ml and D-dimer was 14245 ng/ml. CBC was done and her platelet count was 14000 (units and normal values were not reported). She also underwent ECG, microscopic examination of blood sample, systemic arterial blood gas and abdominal X-ray (results were not reported). She was hospitalized on 17 Nov 2014 due to agitation status with suspected stroke (ICTUS). Complications were acute renal failure, transient cerebral ischaemia and atrial fibrillation. She was treated with steroids and unspecified antibiotics. She was discharged on 19 Nov 2014 with principal diagnosis of comatose state from likely bacterial meningitis. She died on 18 Nov 2014, within 48 hours of vaccination. The cause of death was reported as meningoencephalitis. On 22 Nov 2014, the result of bacterial culture of CSF was negative for development of bacterial flora in presence of antibiotic therapy. The health authority reported the event as serious and causality of the event as not related to vaccination due to strong evidences resulting from liquor analysis. The HA stated that autopsy was not performed. The health care professional considered the events as serious (Death) and did not provided the causality between the events and suspect vaccine. Based on the performed review on FLUAD batch number: 143301, there is no evidence of any objections which occurred during the entire manufacturing process, including manufacturing of active ingredients, adjuvant and components used that could compromise the quality of the product or that may be potentially related to the reported events. QA department confirmed that, the involved batches are compliant with Internal procedures and with CGMP requirements. On 1 December of unknown year, the Agency announced the first test results; there was no presence of endotoxins and the content and characteristics of the vaccine virus antigen were compliant with quality standards.9 On 3 December of unknown year Committee concluded that there was no evidence of a causal relationship between the reported fatal events and the administration of FLUAD and reassured other countries about the safety of the flu vaccine. Combined follow up received from Health Authority on 28 Nov 2014 and 01 Dec 2014 respectively: updated date of vaccination (14 Nov 2014) and HA comment (autopsy was not performed). Follow-up information received from the Quality Assurance Department (reference number: 339779) on 02 Dec 2014: Updated FLUAD batch review report. Follow-up information was received from the physician via Health Authority (Agency: IT-MINISAL02-281215) on 01-Jun-2017: Physician was added as a reporter. Patient initials and date of birth were updated, suspect vaccine''s route of administration was updated, event verbatim was updated and reporter causality was updated. Follow up received on 14-Jun-2017: This is a serious follow-up literature case received. Event updated from meningitis NEC to meningoencephalitis, cause of death updated and accordingly changes were made and hence, narrative was amended.


VAERS ID: 701320 (history)  
Form: Version 2.0  
Age: 2.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-06-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 5 - / UN

Administered by: Other       Purchased by: ?
Symptoms: Bacterial test, Drug ineffective, Empyema, Pneumonia pneumococcal, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (narrow), 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:
Current Illness: Enzyme abnormality; Granulocytes abnormal; Nephrotic syndrome; Pneumocystis jirovecii pneumonia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Culture; Result Unstructured Data: Test Result: done on pleural empyema material
CDC Split Type: DEPFIZERINC2017276680

Write-up: This is a spontaneous report from a contactable physician. A 4 year-old male patient of unspecified race/ethnicity received PREVENAR 13 at 0.5 ml single via an unspecified route of administration at age 3 months, 5 months, 7 months, 13 months and 24 months for prophylactic vaccination on unspecified dates. Medical history (chronic underlying diseases) included nephrotic syndrome, pneumocystis jirovecii pneumonia, mannose-binding lectin deficiency and suspected granulocyte dysfunction. The patient was not a premature baby and did not have immune deficiency. The patient''s concomitant medications were not reported. The patient experienced respiratory insufficiency, pneumococcal pneumonia, pleural empyema and dyspnea on an unspecified date in 2016. The patient underwent lab tests and procedures which included culture done on pleural empyema material; no serotyping was performed. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected. Sender''s Comments: Based on the information currently available, a lack of efficacy with the suspect vaccine in this patient cannot be completely excluded. Further information like confirmative pathological/serotype results are needed for full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety valuation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: respiratory insufficiency; pneumococcal pneumonia; pleural empyema; dyspnoea; drug ineffective.


VAERS ID: 701354 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-01-10
Submitted: 2017-06-29
   Days after onset:1630
Entered: 2017-06-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201700017

Write-up: This serious initial spontaneous case, received on 04-APR-2017 was reported by a physician via regulatory (RNF: IT-MINISAL02-189667) concerns a male patient on unspecified age. On an unspecified date, the patient was administered with Influenza vaccine: dose, route of administration and batch number: not reported) for an unknown indication. On 10-Jan-2013, the patient experienced Guillain-Barre syndrome as a result the patient was died on an unspecified date. It was unknown whether autopsy was done. Action taken with Influenza vaccine was not reported. The reporter assessed the causality between Influenza vaccine and Guillain-Barre syndrome as related. Health Authority considered the case as serious (Death). Case correction received on 21-Apr-2017: labelling of the event was done for all the remaining RSI.


VAERS ID: 702417 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2001-12-10
Onset:2009-05-24
   Days after vaccination:2722
Submitted: 2017-07-03
   Days after onset:2962
Entered: 2017-07-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Brain operation, Death, Infantile spasms, Meningitis pneumococcal, Pyrexia, Quadriparesis, Respiratory failure, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), 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), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2009-05-24
   Days after onset: 0
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 213 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IT2017GSK099952

Write-up: This case was reported by a consumer via regulatory authority and described the occurrence of death in a 3-month-old female patient who received INFANRIX. On 10th December 2001, the patient received INFANRIX. On 11th December 2001, 1 days after receiving INFANRIX, the patient experienced fever (serious criteria hospitalization) and vomiting (serious criteria hospitalization). In December 2001, the patient experienced pneumococcal meningitis (serious criteria hospitalization and GSK medically significant). On 24th may 2009, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the patient experienced West''s syndrome (serious criteria disability and GSK medically significant), quadriparesis (serious criteria disability and GSK medically significant) and respiratory failure (serious criteria GSK medically significant), quadriparesis (serious criteria disability and GSK medically significant) and respiratory failure (serious criteria GSK medically significant and clinically significant/intervention required). On an unknown date, the outcome of the death was fatal and the outcome of the fever, vomiting, pneumococcal meningitis, West''s syndrome, quadriparesis and respiratory failure were unknown. The patient died on 24th May 2009. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death, fever, vomiting, pneumococcal meningitis, West''s syndrome, quadriparesis and respiratory failure to be related to INFANRIX. Additional details were provided as follows: The reporter was patient''s mother. The patient experienced fever and vomiting and she was hospitalized. On 13th December 2001, the patient further experienced pneumococcal meningitis. The patient remained in hospital for 7 months and underwent brain surgery. In 2002, less than a year after receiving INFANRIX, the patient was discharged with diagnosis of West syndrome, tetraparesis and respiratory failure which occurred on unspecified time. On 24th May 2009, 7 years 5 months 14 days after receiving the INFANRIX, the patient died due to unspecified cause. Death was reported as outcome of events; as the death occurred after 7 years, it was not clear which event was the cause of death. The patient''s mother stated that, a medical commission considered that there was just a temporal causality between INFANRIX and adverse events. However, it was not clear what events were evaluated by this commission. Further information and clarifications have been requested to the reporter.


VAERS ID: 703236 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-07-06
Entered: 2017-07-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS M81571 / UNK AR / UN

Administered by: Other       Purchased by: Other
Symptoms: Drug administered at inappropriate site, Nervous system disorder, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Medication errors (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: GB2017103759

Write-up: This case was reported by a consumer via regulatory authority and described the occurrence of neurological disorder in a 64-year-old male patient who received Seasonal Influenza vaccine (batch number M8157-1 ?, expiry date unknown). In 2015, the patient received Seasonal Influenza vaccine (unknown). In 2015, less than a year after receiving Seasonal Influenza vaccine, the patient experienced neurological disorder (serious criteria death) and tingling of extremity. On an unknown date, the patient experienced pain in arm and vaccine administered at inappropriate site. On an unknown date, the outcome of the neurological disorder was fatal and the outcome of tingling of extremity, pain in arm and vaccine administered at inappropriate site were unknown. The reported cause of death was neurological disorder. It was unknown if the reporter considered the neurological disorder, tingling of extremity and pain in arm to be related to Seasonal Influenza vaccine. Additional details, The reported batch number doesn''t match with GSK batch number. The age at vaccination was not provided. Initial information was received on 05 July 2017. Initial unsolicited report received from a consumer (patient''s daughter) on 29-Jun-2017 and additional information received on 29-Jun-2017. This case involves a 64-year-old male patient who was vaccinated with an Influenza Vaccine (batch number: M8157-1, expiry date and route of administration was unknown), in the arm on an unspecified date in 2015. The patient''s medical history and concomitant medications were not reported. On an unspecified date in 2015, following the vaccination, the patient started feeling a lot of tingling and pain in his arm and eventually he developed some neurological problems which led to his death. This was a case of potential medication error due to vaccine administered at inappropriate site. The patient''s medical history and concomitant medications were not reported. On an unspecified date in 2015, following the vaccination, the patient started feeling a lot of tingling and pain in his arm and eventually he developed some neurological problems which led to his death. This was a case of potential medication error due to vaccine administered at inappropriate site. The patient''s laboratory data and corrective treatment were not reported. On an unknown date, the patient was died. It was unknown whether the autopsy performed or not. It was also reported that her mother then killed herself because it was too much for her to bear and she would also like to know how this vaccine is administered because the pharmacy that gave her father the vaccine did not inject it into the deltoid region. It was more in the middle section of the arm opposite to the elbow, where the crease is. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder''s compliance with the requirements set out in Directive and Module of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none. Sponsor comment: A 64 years old male who received influenza vaccine (from unknown manufacturer) and experienced feeling a lot of tingling and pain in his arm and eventually he developed some neurological problems which led to his death, however diagnosis was not confirmed. Exact time to onset is unknown. Details on patient''s medical history, concurrent condition, concomitant medication, time to onset, name of vaccine administered, confirm diagnosis, cause of death and autopsy report would be helpful to assess the cause. Based on the available information no conclusion can be drawn.


VAERS ID: 702728 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2009-08-27
Onset:2017-06-01
   Days after vaccination:2835
Submitted: 0000-00-00
Entered: 2017-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Death, Gram stain positive, Pneumococcal sepsis, Serology test, Streptococcus test positive
SMQs:, Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-06-26
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Splenectomy (Spleen removal due to trauma)
Allergies:
Diagnostic Lab Data: Test Date: 201706; Test Name: Culture; Result Unstructured Data: Test Result: Pneumococcus Gram positive; Test Date: 201706; Test Name: Serology test; Result Unstructured Data: Test Result: Pending results
CDC Split Type: PTPFIZERINC2017283043

Write-up: This is a spontaneous report from a contactable nurse, the patient''s sister in law, received via a sales representative. An approximately 40 year-old male patient of an unspecified race and ethnicity received a dose of PREVENAR on 27Aug2009 at 0.5 ml single for immunisation. Medical history included splenectomy in 2009 (spleen removal due to trauma). The patient''s concomitant medications were not reported. The patient was a gymnastics and karate teacher. The patient experienced pneumococcal sepsis in Jun2017 and was hospitalized as a result of the event. The patient underwent tests and procedures on Jun2017, which included culture: pneumococcus gram positive and serotype identification: pending results. The patient was deceased on 26Jun2017. The reported cause of death was pneumococcal sepsis. An autopsy was performed but results were not yet available and have not been provided. Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 7-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative serotype results is needed for full medical assessment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: Pneumococcal sepsis.


VAERS ID: 702812 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2007-05-01
Submitted: 0000-00-00
Entered: 2017-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 - / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, General physical health deterioration, Neurodegenerative disorder, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
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: FR0095075131706FRA011705

Write-up: This spontaneous report was identified in a book concerning an approximately 14 years old female patient. Information about concurrent condition, concomitant medication and medical history of the patient was not provided. On an unknown date in 2006 at the age of 13, the patient received three injections of GARDASIL (strength, lot# and route not provided) for prophylaxis. It was reported that on an unknown date in May 2007, a few times after her last GARDASIL vaccination, her general health status was deteriorated and she became paralysed due to a neurodegenerative disease. The outcome of both events was unknown. The patient died on 2009. The cause of death was not provided and it was unknown whether autopsy was done. Causality assessment was not provided. Upon internal review, the events of neurodegenerative disease and death were determined to be medically significant. Additional information has been requested. Reported Cause(s) of Death: unknown.


VAERS ID: 702814 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131706FRA011712

Write-up: This spontaneous report was received from an unspecified reporter in form of a book publication and refers to a 16-year-old female patient. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of unspecified human papillomavirus (HPV) vaccine (manufacturer unknown) (dose, route and site of administration were unknown). On an unknown date, reported as immediately after vaccination, the patient had a heart attack. On an unknown date, the patient died. The cause of death was heart attack of unknown aetiology. It was not reported whether an autopsy was performed. Causal relationship between heart attack and HPV vaccine (manufacturer unknown) was not reported. Upon internal review, the event of heart attack of unknown aetiology was determined to be medically significant. Additional information has been requested. Reported Cause(s) of Death: heart attack of unknown aetiology.


VAERS ID: 702818 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Death, Microbiology test normal, Toxicologic test normal
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131706FRA011733

Write-up: This spontaneous report was identified in a book. In a study published in 2012, referring to a 14 year old female patient (also reported as 19 years old). Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6,11,16,18) RECOMB.VACC)(strength, dose, frequency, route and lot# were not reported) for prophylaxis. Then the patient died shortly after vaccination. The autopsies revealed no anatomic, microbiologic, toxicologic abnormalities that may have caused the death. Fragments of HPV-16L1 antigen have been discovered in the nervous system of the patients. The causality between death and QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6,11,16,18) RECOMB.VACC) was not reported. Upon internal review, the event death was considered as medically significant.


VAERS ID: 702823 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Malaise
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131706FRA011800

Write-up: This spontaneous report was reported in a book by a writer. The case was reported as testimony from outside of the country. The case refers to a female patient of unknown age. The patient''s medical history and concomitant medications were not reported. The patient was reported to be perfectly healthy before vaccination. On an unknown date, the patient was vaccinated with unspecified human papillomavirus vaccines (manufacturer unknown) dosing details not provided, for prophylaxis. On an unknown dates, the patient became more and more sicker as injections were made. Subsequently, the patient died during her sleep after the third injection (date unknown). The reporter did not provide the causality. The event of malaise was considered to be serious due to patent''s death. Additional information has been requested. Reported Cause(s) of Death: sick.


VAERS ID: 702824 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131706FRA011807

Write-up: Information was received from an unspecified reporter, referring to two female patients of unknown age. The patients'' concurrent condition, concomitant medication and medical history were not provided. On unknown dates, the patients were vaccinated with human papillomavirus (HPV) vaccines (manufacturer unknown) (lot#, expiration date, concentration, dose, frequency and route were unknown) for prophylaxis. On unknown dates, the patients died. It was unknown if autopsy was performed and what caused the death. Upon internal review, death was considered to be medically significant.


VAERS ID: 702826 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Respiratory paralysis
SMQs:, Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Respiratory failure (narrow), Hypokalaemia (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: FR0095075131707FRA000237

Write-up: This spontaneous report has been reported as a testimony and published in a book, received from the author and refers to a female patient of unknown age. The patient was healthy, had never any disease and had never smoked. There was no information about the patient''s concurrent conditions and concomitant therapies. On an unknown date, the patient was vaccinated with GARDASIL (dose, route of administration, lot # and expiration date were not reported). On an unknown date, less than one month after the last vaccine dose, the patient''s friend discovered her lifeless body on the morning - the patient died from a respiratory paralysis. The relatedness between the event and GARDASIL was not reported. Upon internal review, the event of respiratory paralysis was considered to be medically significant. Additional information is not expected as follow - up with the reporter is not possible.


VAERS ID: 703376 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131706FRA011772

Write-up: This spontaneous report was received from an unknown reporter, via a book, referring to a female patient of unknown age. The patient''s concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on 26-OCT-2010, a mother of a young girl wrote about the danger of the two HPV vaccines (unspecified). She reported the case of 8 female patient who died (unknown cause of death), on an unknown date, after vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported), on an unknown date (related cases: 1707FRA000374, 1707FRA000375, 1707FRA000376, 1707FRA000377, 1707FRA000378, 1707FRA000379 and1707FRA000380.) The causality between death with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) was not reported. Upon internal review, death was determined to be a medically significant event. Imputability: C1 S1 I1. This is one of several reports received from the same source. Additional information is not expected because there is no contact information.; Sender''s Comments: FR-009507513-1707FRA000374: FR-009507513-1707FRA000375: FR-009507513-1707FRA000376: FR-009507513-1707FRA000377: FR-009507513-1707FRA000378: FR-009507513-1707FRA000379: FR-009507513-1707FRA000380.


VAERS ID: 703377 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131707FRA000374

Write-up: This spontaneous report was received from an unknown reporter, via a book, referring to a female patient of unknown age. The patient''s concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on 26-OCT-2010, a mother of a young girl wrote about the danger of the two HPV vaccines (unspecified). She reported the case of 8 female patient who died (unknown cause of death), on an unknown date, after vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported), on an unknown date (related cases: 1706FRA011772, 1707FRA000375, 1707FRA000376, 1707FRA000377, 1707FRA000378, 1707FRA000379 and1707FRA000380.) The causality between death with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) was not reported. Upon internal review, death was determined to be a medically significant event. C1 S1 I1. This is one of several reports received from the same source. Additional information is not expected because there is no contact information.; Sender''s Comments: FR-009507513-1706FRA011772: FR-009507513-1707FRA000375: FR-009507513-1707FRA000376: FR-009507513-1707FRA000377: FR-009507513-1707FRA000378: FR-009507513-1707FRA000379: FR-009507513-1707FRA000380:


VAERS ID: 703378 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131707FRA000375

Write-up: This spontaneous report was received from an unknown reporter, via a book, referring to a female patient of unknown age. The patient''s concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on 26-OCT-2010, a mother of a young girl wrote about the danger of the two HPV vaccines (unspecified). She reported the case of 8 female patient who died (unknown cause of death), on an unknown date, after vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported), on an unknown date (related cases: 1706FRA011772, 1707FRA000374, 1707FRA000376, 1707FRA000377, 1707FRA000378, 1707FRA000379 and1707FRA000380.) The causality between death with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) was not reported. Upon internal review, death was determined to be a medically significant event. C1 S1 I1. This is one of several reports received from the same source. Additional information is not expected because there is no contact information.; Sender''s Comments: FR-009507513-1706FRA011772: FR-009507513-1707FRA000374: FR-009507513-1707FRA000376: FR-009507513-1707FRA000377: FR-009507513-1707FRA000378: FR-009507513-1707FRA000379: FR-009507513-1707FRA000380:


VAERS ID: 703379 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131707FRA000376

Write-up: This spontaneous report was received from an unknown reporter, via a book, referring to a female patient of unknown age. The patient''s concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on 26-OCT-2010, a mother of a young girl wrote about the danger of the two HPV vaccines (unspecified). She reported the case of 8 female patient who died (unknown cause of death), on an unknown date, after vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported), on an unknown date (related cases: 1706FRA011772, 1707FRA000374, 1707FRA000375, 1707FRA000377, 1707FRA000378, 1707FRA000379 and1707FRA000380.) The causality between death with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) was not reported. Upon internal review, death was determined to be a medically significant event. C1 S1 I1. This is one of several reports received from the same source. Additional information is not expected because there is no contact information.; Sender''s Comments: FR-009507513-1706FRA011772: FR-009507513-1707FRA000374: FR-009507513-1707FRA000375: FR-009507513-1707FRA000377: FR-009507513-1707FRA000378: FR-009507513-1707FRA000379: FR-009507513-1707FRA000380:


VAERS ID: 703381 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131707FRA000378

Write-up: This spontaneous report was received from an unknown reporter, via a book, referring to a female patient of unknown age. The patient''s concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on 26-OCT-2010, a mother of a young girl wrote about the danger of the two HPV vaccines (unspecified). She reported the case of 8 female patient who died (unknown cause of death), on an unknown date, after vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported), on an unknown date (related cases: 1706FRA011772, 1707FRA000374, 1707FRA000375, 1707FRA000376, 1707FRA000377, 1707FRA000379 and 1707FRA000380.) The causality between death with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) was not reported. Upon internal review, death was determined to be a medically significant event. C1 S1 I1. This is one of several reports received from the same source. Additional information is not expected because there is no contact information.; Sender''s Comments: FR-009507513-1706FRA011772: FR-009507513-1707FRA000374: FR-009507513-1707FRA000375: FR-009507513-1707FRA000376: FR-009507513-1707FRA000377: FR-009507513-1707FRA000379: FR-009507513-1707FRA000380:


VAERS ID: 703382 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131707FRA000379

Write-up: This spontaneous report was received from an unknown reporter, via a book, referring to a female patient of unknown age. The patient''s concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on 26-OCT-2010, a mother of a young girl wrote about the danger of the two HPV vaccines (unspecified). She reported the case of 8 female patient who died (unknown cause of death), on an unknown date, after vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported), on an unknown date (related cases: 1706FRA011772, 1707FRA000374, 1707FRA000375, 1707FRA000376, 1707FRA000377, 1707FRA000378 and 1707FRA000380.) The causality between death with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) was not reported. Upon internal review, death was determined to be a medically significant event. Imputability: C1 S1 I1. This is one of several reports received from the same source. Additional information is not expected because there is no contact information. Sender''s Comments: FR-009507513-1706FRA011772: FR-009507513-1707FRA000374: FR-009507513-1707FRA000375: FR-009507513-1707FRA000376: FR-009507513-1707FRA000377: FR-009507513-1707FRA000378: FR-009507513-1707FRA000380.


VAERS ID: 703383 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131707FRA000380

Write-up: This spontaneous report was received from an unknown reporter, via a book, referring to a female patient of unknown age. The patient''s concurrent conditions, medical history and concomitant therapies were not reported. It was reported that, on 26-OCT-2010, a mother of a young girl wrote about the danger of the two HPV vaccines (unspecified). She reported the case of 8 female patient who died (unknown cause of death), on an unknown date, after vaccination with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported), on an unknown date (related cases: 1706FRA011772, 1707FRA000374, 1707FRA000375, 1707FRA000376, 1707FRA000377, 1707FRA000378 and 1707FRA000379). The causality between death with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) was not reported. Upon internal review, death was determined to be a medically significant event. Imputability: C1 S1 I1. This is one of several reports received from the same source. Additional information is not expected because there is no contact information. Sender''s Comments: FR-009507513-1706FRA011772: FR-009507513-1707FRA000374: FR-009507513-1707FRA000375: FR-009507513-1707FRA000376: FR-009507513-1707FRA000377: FR-009507513-1707FRA000378: FR-009507513-1707FRA000379.


VAERS ID: 703741 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-06-29
Onset:2017-06-30
   Days after vaccination:1
Submitted: 2017-07-11
   Days after onset:11
Entered: 2017-07-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER A036A / 1 UN / SC
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 9KT16R / 2 UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR M1308 / 2 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 16F01A / 2 UN / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB604AA / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Cough, Infantile apnoea, Nasopharyngitis, Respiratory arrest, Rhinorrhoea, Sudden infant death syndrome
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-07-02
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2017JPN106052

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of death infant sudden in a 3-month-old male subject who received ROTARIX (batch number AROLB604AA, expiry date unknown). Co-suspect products included ACTHIB (batch number M1308, expiry date unknown), PREVENAR (batch number 16F01A, expiry date unknown), QUATTROVAC (batch number A036A, expiry date unknown) and HEPTAVAX 2 (batch number 9KT16R, expiry date unknown). Concomitant products included ROTARIX. On 29th June 2017, the subject received the 2nd dose of ROTARIX (oral). On 26th May 2017, the subject received the 1st dose of ACTHIB (subcutaneous). On 29th June 2017, the 2nd dose was an unknown dose. On 26th May 2017, the subject received the 1st dose of PREVENAR (subcutaneous). On 29th June 2017, the 2nd dose was an unknown dose. On 29th June 2017, the subject received the 1st dose of QUATTROVAC (subcutaneous). On 26th May 2017, the subject received the 1st dose of HEPTAVAX 2 (subcutaneous). On 29th June 2017, the 2nd dose was an unknown dose. On 30th June 2017, 1 days after receiving ROTARIX formulation, the subject experienced cough, nasal discharge and common cold. On 2nd July 2017, the subject experienced death infant sudden (serious criteria death and GSK medically significant), respiratory arrest (serious criteria GSK medically significant) and infantile apnoeic attack (serious criteria GSK medically significant). On an unknown date, the outcome of the death sudden was fatal and the outcome of the respiratory arrest, infantile apnoeic attack, cough, nasal discharge and common cold were unknown. The subject died on 2nd July 2017. The reported cause of death was death infant sudden. An autopsy was performed. It was unknown if the reporter considered the death infant sudden, respiratory arrest, infantile apnoeic attack, cough, nasal discharge and common cold to be related to ROTARIX. Clinical course: On 26 May 2017, the subject received the first doses of ROTARIX, ACTHIB, PREVENAR and HEPTAVAX-II. No particular abnormality was noted. On 29 June 2017, at 3:50 p.m., he received the second doses of ROTARIX, ACTHIB, PREVENAR and HEPTAVAX-II, and first dose of QUATTROVAC. No concern was noted in screening questionnaires. The body temperature before the vaccinations was 36.6 degrees Celsius. He had no particular family history. On 30 June 2017, coughing, nasal discharge and cold symptoms developed. On 02 July 2017, at 2:50 a.m., the mother noticed that he was in respiratory arrest. He was transported to the department of emergency at a hospital by ambulance. At 4:11, his death was confirmed. On 04 July 2017, an autopsy was performed. There were findings around intrapulmonary bronchus, but the details were unknown. Sudden death which was involved in virus was suspected. Reporter''s comment: As detailed autopsy findings were unknown, the following was the reporting physician''s view: Involvement of vaccinations could not completely be denied; however, possibilities of apneic attack in upper respiratory tract especially caused by respiratory syncytial virus (RSV) were also considered.


VAERS ID: 703535 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR0095075131707BRA001067

Write-up: Information has been received from a consumer referring to a patient of unknown gender and age. The patient''s medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route, lot # and expiration date not reported) for prophylaxis. On an unknown date, the patient died. The cause of death was unknown. It was unknown if autopsy was performed. The causality assessment was not provided. Upon internal review, the event of patient died was considered to be medically significant. This is one of several reports receiving from the same reporter.; Sender''s Comments: BR-009507513-1707BRA001136:


VAERS ID: 703850 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-04-18
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R59051 / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Pneumonia pneumococcal, Streptococcus test positive
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-06-21
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: HIV infection
Preexisting Conditions:
Allergies: 07/21/2017: HIV infection (under antiretroviral treatment, with more recent CD4 T-lymphocyte count of 219/mm3.)
Diagnostic Lab Data: Test Date: 2017; Test Name: Blood culture; Result Unstructured Data: Test Result: Streptococcus pneumoniae
CDC Split Type: PTPFIZER INC2017299645

Write-up: This is a spontaneous report from a contactable physician received from INFARMED - Regulatory authority report number PT-INFARMED-J201706-243. A 79-year-old male patient of unspecified race/ethnicity received PREVENAR 13 (lot# R59051), via an unspecified route of administration, on 18Apr2017, at 0.5 ml single, for immunisation. Medical history included ongoing HIV infection. Concomitant medications were not reported. On an unspecified date in 2017 the patient experienced pneumonia pneumococcal. Pneumonia was confirmed as a result of blood culture with growth of Streptococcus pneumoniae sensitive to penicillin and levofloxacin. The patient died on 21Jun2017 due to the event. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: pneumonia pneumococcal.


VAERS ID: 703851 (history)  
Form: Version 2.0  
Age: 0.92  
Sex: Male  
Location: Foreign  
Vaccinated:2016-05-12
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-07-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 LL / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 RA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 120615 / 1 RL / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: RUPFIZER INC2017297416

Write-up: This is a spontaneous report from a contactable consumer from legal organization (investigation department) received from local PQC group and from Pfizer legal division. A male child of unspecified age and race/ethnicity received PREVENAR 13 (batch 120615) on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not reported. In June (unspecified year) the child died. Cause of death was not specified. It was unknown if an autopsy was performed. A criminal proceeding initiated on 20Mar2017 concerning the death of a child was mentioned but no further information was provided.; Reported Cause(s) of Death: Death.


VAERS ID: 704033 (history)  
Form: Version 2.0  
Age: 0.42  
Sex: Female  
Location: Foreign  
Vaccinated:2017-06-30
Onset:2017-07-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2017-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER 4K18C / 3 LA / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 16D01A / 3 RA / SC

Administered by: Other       Purchased by: ?
Symptoms: Death, Nasopharyngitis
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-07-10
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Ventricular septal defect (under follow-up observation)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZERINC2017303278

Write-up: This is a spontaneous report from a contactable physician. A 5-month-old patient of unknown race/ethnicity and gender received PREVENAR 13 at 0.5 ml single and diphtheria vaccine, pertussis vaccine, polio vaccine, tetanus vaccine (unknown Manufacturer) at 1 DF single, both subcutaneously, on 30Jun2017, for immunisation. Medical history included ongoing ventricular septal defect which was under follow-up observation. The patient''s concomitant medications were not reported. Around 05Jul2017, 5 days after vaccinations, the patient experienced cold symptoms. The patient seemed fine and showed only cold symptoms without fever and cold medication was prescribed for a diagnosis of cold. Therapeutic measures were taken as a result of cold symptoms. On 10Jul2017 the patient died. It was not reported if an autopsy was performed. Sender''s Comments: Based on the information currently available, fatal cold is not related to the vaccination with PREVENAR 13 but represents an intercurrent medical condition. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: Cold symptoms with a diagnosis of cold.


VAERS ID: 704110 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2017-07-07
Onset:2017-07-08
   Days after vaccination:1
Submitted: 2017-07-18
   Days after onset:10
Entered: 2017-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR - / UNK UN / UN
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 162801 / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB638AF / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-07-08
   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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2017GSK109830

Write-up: This case was reported by a nurse via local affiliate and described the occurrence of unknown cause of death in a 9-week-old female patient who received BEXSERO (batch number 162801, expiry date February 2018). Co-suspect products included ROTARIX (batch number AROLB638AF, expiry date November 2018), PREVENAR and PEDIACEL. On 7th July 2017, the patient received BEXSERO, ROTARIX (oral), PREVENAR and PEDIACEL. On 8th July 2017, 1 days after receiving BEXSERO and ROTARIX, 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 8th July 2017. 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 BEXSERO and ROTARIX. Additional details were provided as follows: The patient died on 8th July 2017 and was found by the mother in the morning. It was unknown if the reporter considered the unknown cause of death to be related to PEDIACEL and PREVENAR. This case was linked with GB2017GSK109832, as reported by the same reporter. No further information was provided. Follow up to be sent.


VAERS ID: 704312 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IL0095075131707ISR006967

Write-up: This spontaneous report as received from a consumer refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (vaccination date, dose, lot#, route not provided) for prophylaxis. On an unknown date the patient died hours after receiving GARDASIL. It was unknown if autopsy was done. The causality was unknown. Upon internal review, death was considered as medically significant.


VAERS ID: 704825 (history)  
Form: Version 1.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-07-10
Entered: 2017-07-20
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER M81571 / UNK AR / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Nervous system disorder, Pain in extremity, Paraesthesia, Suicide of relative
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament 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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201700988

Write-up: This initial serious spontaneous case, was received from a consumer (patient''s daughter) via health authority on 05-Jul-2017, concerning a 64-year-old male patient. The patient''s medical history and concomitant medications were not reported. On an unspecified date in 2015, the patient was vaccinated with influenza virus vaccine polyvalent, batch number: M81571 (as reported M8157-1), anatomical location: arm, route of administration, expiry date: not reported). On an unspecified date in 2015, following the vaccination, the patient started feeling a lot of tingling and pain in his arm and eventually he developed some neurological problems which led to his death. The patient''s laboratory data and corrective treatment were not reported. It was also reported that her mother then killed herself because it was too much for her to bear and she would also like to know how this vaccine is administered because the pharmacy that gave her father the vaccine did not inject it into the deltoid region. It was more in the middle section of the arm opposite to the elbow, where the crease is. Outcome of the events tingling of extremity and pain in arm was not reported. Outcome of the event neurological disorder was fatal. Cause of death was reported as neurological disorder. It was unknown whether the autopsy performed or not. The health authority assessed this case as serious due to death. The heath authority provided the causal relationship between the event and suspect product as unassessable. Case Comment: This case concerns as 64-year-old male patient, who developed some neurological problem after receiving a dose of Seasonal Influenza Vaccine, which resulted in fatal outcome. Exact time to onset of the event, patient''s medical history, concurrent conditions, concomitant medications, final diagnosis and cause of death was not reported. Based on the available information the causal role of suspect vaccine cannot be assessed.


VAERS ID: 704754 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2016-08-08
Onset:2016-08-08
   Days after vaccination:0
Submitted: 2017-07-21
   Days after onset:347
Entered: 2017-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Cerebrohepatorenal syndrome, Condition aggravated, Death, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Congenital, familial, neonatal and genetic disorders of the liver (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2016-08-08
   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: Cerebrohepatorenal syndrome, Child diagnosed from birth as having a peroxiosomal disorder. The type was undiagnosed but since.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2017112017

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of death unexplained on a 2-month-old male patient who received BEXSERO. Co-suspect products included INFANRIX-IPV+Hib, ROTARIX and PREVENAR 13. Concurrent medical conditions included Zellweger syndrome (child diagnosed from birth as having a peroxiosomal disorder. The type was undiagnosed but since). Additional patient notes included death has been diagnosed as Zellweger''s. On 8th August 2016, the patient received BEXSERO (intramuscular), INFANRIX-IPV+Hib (intramuscular) 1 dosage form(s), ROTARIX (oral) and PREVENAR 13 (intramuscular). On 8th August 2016, several hours after receiving BEXSERO, INFANRIX-IPV+Hib and ROTARIX, the patient experienced death unexplained (serious criteria death, GSK medically significant and other). On an unknown date, several hours after receiving BEXSERO, the patient experienced cardiac arrest (serious criteria GSK medically significant and other) and unresponsive to stimuli (serious criteria GSK medically significant and other). On 8th August 2016, the outcome of the death unexplained was fatal. On an unknown date, the outcome of the cardia arrest and unresponsive to stimuli were unknown. The patient died on 8th August 2016. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death unexplained, cardiac arrest and unresponsive to stimuli to be related to BEXSERO, INFANRIX-IPV+Hib and ROTARIX. Initial information received from physician via regulatory authority on 19th July 2017. Child diagnosed from birth as having a peroxiosomal disorder. The type was undiagnosed but since death has been diagnosed as Zellweger''s. Was in hospital a long time before discharge home with long oxygen. Had a resuscitation plan in place as this condition is life limiting. Decision to have routine immunisations in hospital given background history. Had them OK and observed for an hour but became unresponsive a few hours later at home. Possibly related to immunisations or due to background condition. Came back to hospital in cardiac arrest and died. Family asking about whether the immunisations should be given in this group of patients. Is this a known adverse drug reaction in this group of patients, has this been seen before? Medically Significant Details: child died a few hours after having routine immunisations which were done in hospital due to background. Possibly related to immiunisations possibly related to background condition.


VAERS ID: 704938 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BR0095075131707BRA009274

Write-up: Information has been received from a consumer, referring to multiple patients of unknown ages and genders. The patients'' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (strength, dose, anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis. On unspecified dates, the patients died due to an unspecified reason. It was unknown if autopsies were performed. The reporting consumer stated that "she has talked to a physician who does not recommends PNEUMOVAX 23 vaccine use, because "there are death cases" (on unspecified dates)". Upon internal review, the event of death was considered to be medically significant. The causality between the vaccination with PNEUMOVAX 23 and the event was not reported. This is one of several reports received from the same source.


VAERS ID: 705468 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-07-20
Onset:2017-07-21
   Days after vaccination:1
Submitted: 2017-07-25
   Days after onset:4
Entered: 2017-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Cardio-respiratory arrest, Cyanosis, Death, Mood altered, Resuscitation
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), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-07-21
   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: DIGOSIN
Current Illness: Pulmonary artery stenosis; Supravalvular aortic stenosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP2017JPN113250

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of cardio-respiratory arrest in a 2-month-old male subject who received ROTARIX. Co-suspect products included pneumococcal vaccine. Concurrent medical conditions included supravalvular aortic stenosis and pulmonary artery stenosis. Concomitant products included DIGOSIN. On 20th July 2017, the subject received ROTARIX (oral) and pneumococcal vaccine (subcutaneous). On 21st July 2017, 1 days after receiving ROTARIX, the subject experienced cardio-respiratory arrest (serious criteria death and GSK medically significant), bad mood and cyanosis of lip. On 21st July 2017, the outcome of the cardio-respiratory arrest was fatal. On an unknown date, the outcome of the bad mood and cyanosis of lip were unknown. The subject died on 21st July 2017. The reported cause of death was cardio-respiratory arrest. It was unknown if the reporter considered the cardio-respiratory arrest, bad mood and cyanosis of lip to be related to ROTARIX. Clinical course: On 20 July 2017, at around 15:30, ROTARIX and pneumococcal vaccine were administered at clinic. On 21 July 2017, at 02:05 am, the subject was in a bad mood. The mother was going to breastfeed him and noticed cyanosis of lip. Therefore, she called an ambulance. Upon the arrival of the ambulance, he was in cardio-respiratory arrest, and resuscitation was started. After he arrived at the reporting hospital, resuscitation was continued, but he had no response. His death was confirmed. Reporter''s comment: Other causative factor: Supravalvular aortic stenosis.


VAERS ID: 705344 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2017-06-20
Onset:2017-06-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2017-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R94838 / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-06-22
   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: VITAMIN D
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Extrapyramidal syndrome (with muscular hypotonia, global especially with visual developmental delay); Hypotonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZERINC2017315160

Write-up: This is a spontaneous report obtained from a contactable physician through the regulatory authority; regulatory authority report number: CH-SM-2017-05803. A 3 month-old male patient of an unspecified race and ethnicity received intramuscular PREVENAR 13 (Lot. R94838) on an unknown date, in Jun2017 (exact date was not known, probably on 20 or 21Jun2017), at 0.5 ml, single dose, for immunization. The patient was born full term, birth weight 3550 grams, via cesarean section due to loops of the umbilical cord. Good primary neonatal adaption, APGAR 8/9/9. Body weight in Jun2017 was 6.5 kg. During course an unknown disability was diagnosed with supposed extrapyramidal syndrome with muscular hypotonia, global especially with visual developmental delay. Concomitant medication included VITAMIN D. On 22Jun2017, the patient died due to SIDS (sudden infant death syndrome). This case was reported as serious (results in death). It was unknown if autopsy was performed. A causal relationship between pneumococcal 13-val conj vac (dipht crm197 protein) and SIDS (Sudden infant death syndrome) was assessed as possible. Causality: "Due to timely causal relationship and missing details regarding risk factors (e.g. sleeping position, family bed, hyperthermia) only a limited assessment can be made. In addition the unknown disability could be a risk factor". Causality was assessed as possibly related between event and suspect drug according to WHO. Comments: From the medical viewpoint due to study dates which show no increased risk for SIDS after vaccinations it was assumed that this was an accidental meet of SIDS with vaccination. The causality with vaccine pneumococcal 13-val conj vac (dipht crm197 protein) cannot be excluded for sure due to timely causal relationship. We assess the causality of pneumococcal 13-val conj vac (dipht crm197 protein) as possible due to criteria. No follow-up attempts possible. No further information expected. Reported Cause(s) of Death: Sudden infant death syndrome.


VAERS ID: 705619 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-07-06
Onset:2017-07-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER N1D891V / 1 LG / UN
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-07-07
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylactic vaccination
Preexisting Conditions: Comments: Relevant comorbidities including immunity status was reported as unknown.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131707GBR010906

Write-up: Initial unsolicited report received from health care professional on 14-Jul-2017. This case is related to case SW50157l (same reporter). This case involves nine-month-old female patient who was vaccinated with primary dose of PEDIACEL (Batch number: N1D891V, expiration date, dose and route was not reported) in thigh on an unspecified date. The patient''s medical history and concomitant medications were not reported. Relevant comorbidities including immunity status was reported as unknown. On 07 Jul 2017, within 24 hours of receiving PEDIACEL the patient died (cause of death was not reported). The information about autopsy was not reported. The reporter felt the causality between the reaction and the drug. Follow-up report received from health care professional on 18-Jul-2017. It was reported that two-month-old (also reported as 9-week-old) was vaccinated with PEDIACEL as well as primary dose of ROTAVIX and MENINGITIS B and PREVENAR (batch number, expiry date, dose, route and site of administration was not reported for last three vaccines) on 06-Jul-2017. On 06-Jul-2017, on the same day after vaccination, the patient experienced low grade fever at home and was put to bed. It was also reported that patient was fit and well during the vaccination and left the clinic shortly after vaccination. List of documents held by sender: none. Sender''s Comments: Follow-up information received on 18-Jul-2017, changes the previous medical assessment. In this case a 9 weeks old female experienced low grade fever on the same day of vaccination and died within 24 hours of receiving PEDIACEL. The patient was concomitantly vaccinated with ROTAVIX, Meningitis B and PREVENAR vaccines (other manufacturer). No information is provided on conditions at the time of death, sleeping position, patient''s medical history especially any congenital anomaly or prematurity, previous vaccination history, autopsy and results of investigations, etc. This case is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Moreover, as multiple vaccines were administered concomitantly, the role of each component cannot be assessed separately. GB-SA-SW50157L. Reported Cause(s) of Death: Death.


VAERS ID: 707815 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SAPFIZERINC2017340261

Write-up: This is a spontaneous report received from a contactable physician. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date, at single dose for immunization. The patient''s medical history was and concomitant medications were not reported. On an unspecified date, 2 weeks after pneumococcal 13-val conj vac (dipht crm197 protein) vaccination, the patient died. The cause of death was not reported and it was unknown if an autopsy was performed. Sender''s Comments: Based on the limited information available a causal relationship between the reported event of death (unknown cause) and PREVNAR 13 cannot be completely excluded. The case will be reevaluated should additional information including the cause of death, patient information, age, concomitant diseases, concomitant medication etc become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: died.


VAERS ID: 708220 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-08-14
Entered: 2017-08-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 5 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Biopsy skin, Blood test, CSF test, Death, Lyssavirus test positive, Paralysis, Polymerase chain reaction, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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, scratched by cat on nose
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unspecified dates between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan PCR targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection or rabies nucleoprotein antigen). The patient''s laboratory results for RVNA titres by RFFIT were: CSF-negative: serum-7.5 IU/mL. The patient''s CSF and nuchal skin was positive for viral RNA by real-time PCR and saliva negative. Subsequently, the patient was diagnosed with paralytic rabies. Patient period of survival from onset of illness until death was 10 days. On an unspecified date, the patient died. Post-mortem result for brain tissue was positive viral RNA by real-time PCR.
CDC Split Type: IN2017GSK125908

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a 15-year-old female subject who received Rabies Vaccine. Concurrent medical conditions included animal bite (scratched by cat on nose). On an unknown date, less than a year after receiving Rabies Vaccine, Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included rabies with serious criteria of death and GSK medically significant and paralysis with serious criteria of death and GSK medically significant. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included rabies (fatal) and paralysis (fatal). The reported cause of death was rabies and paralysis. An autopsy was performed. The investigator considered that there was a reasonable possibility that the vaccination failure, rabies and paralysis may have been caused by Rabies Vaccine, Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Relevant Tests: Lab tests performed on unspecified dates between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan PCR targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection or rabies nucleoprotein antigen). The patient''s laboratory results for RVNA titres by RFFIT were: CSF-negative: serum-7.5 IU/mL. The patient''s CSF and nuchal skin was positive for viral RNA by real-time PCR and saliva negative. Subsequently, the patient was diagnosed with paralytic rabies. Patient period of survival from onset of illness until death was 10 days. On an unspecified date, the patient died. Post-mortem result for brain tissue was positive viral RNA by real-time PCR. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Biopsy skin result was see text unknown. On an unknown date, Blood test result was see test unknown. On an unknown date, CSF test result was see test unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described suspected vaccination failure in a 15-year-old female patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure. The patient was a part of the retrospective analysis of all clinically suspected human rabies cases, whose samples were received between January 2012 and December 2014 (3 years), is presented in this study with the aim to describe clinical, demographic, prophylactic and-most importantly-the laboratory diagnostic aspects of this fatal yet preventable disease. No information on the patient''s medical or family history or concomitant medication or concurrent condition was provided. The patient has been scratched by cat on nose. On unspecified dates, the patient received 5 doses of unspecified rabies vaccine (administration route and site unspecified; batch number not provided). The patient had not received rabies immunoglobulin. Age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient was suspected for human rabies. The incubation period was 2 months. Between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan PCR targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, salvia and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result for RVNA titres by RFFIT were: CSF-negative; serum-7.5 IU/mL. The patient''s CSF and nuchal skin was positive for viral RNA by real-time PCR and saliva negative. Subsequently, the patient was diagnosed with paralytic rabies. Patient period of survival from onset of illness until death was 10 days. On an unspecified date, the patient died. Post-mortem result for brain tissue was positive viral RNA by real-time PCR. This case has been considered as suspected vaccination failure being the time to onset was unknown. This case has been considered serious due to death/suspected vaccination failure. The authors did not comment on the relationship between paralytic rabies and unspecified rabies vaccine. The author concluded, "rabies continues to cause a significant number of human deaths. A national programme for rabies control initiated recently should help achieve priority for control of this neglected disease. Efforts to initiate/upgrade additional rabies diagnostic facilities, and enhance human and animal rabies surveillance are essential to indicate the true disease burden and institute appropriate public health measures. Adequate doses of rabies vaccines and RIG must be made available in public health care centres, especially in rural areas across the county. Health authorities should focus on increasing awareness about appropriate post-exposure prophylaxis for this preventable disease, which otherwise has a fatal outcome." This is 1 of the 15 valid cases reported in the same literature article.


VAERS ID: 708223 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-08-14
Entered: 2017-08-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 5 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Biopsy brain abnormal, Biopsy skin, Biopsy skin normal, Blood test, CSF test normal, Death, Encephalitis, Lyssavirus test positive, Paralysis, Polymerase chain reaction positive, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: 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, bitten by dog
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unspecified dates between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan PCR targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result for RVNA titres by RFFIT were: CSF-15 IU/ml and serum not received. The patient''s laboratory results for viral RNA by real-time PCR were: CSF-negative, saliva-negative; nuchal skin-negative. Subsequently, the patient was diagnosed with paralytic rabies. The laboratory result for viral RNA by real-time PCR of brain tissue was positive.
CDC Split Type: IN2017GSK125918

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a 12-year-old male subject who received Rabies Vaccine. Concurrent medical conditions included animal bite (bitten by dog). On an unknown date, less than a month after receiving Rabies Vaccine, Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included rabies with serious criteria of death and GSK medically significant, paralysis with serious criteria of death and GSK medically significant encephalitis with serious criteria of death and GSK medically significant. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included rabies (fatal), paralysis (fatal) and encephalitis (fatal). The reported cause of death was rabies and paralysis. An autopsy was performed. The investigator considered that there was a reasonable possibility that the vaccination failure, rabies, paralysis and encephalitis may have been caused by Rabies Vaccine, Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Relevant Tests: Lab tests performed on unspecified dates between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan PCR targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result for RVNA titres by RFFIT were: CSF-15 IU/ml and serum not received. The patient''s laboratory results for viral RNA by real-time PCR were: CSF-negative, saliva-negative; nuchal skin-negative. Subsequently, the patient was diagnosed with paralytic rabies. The laboratory result for viral RNA by real-time PCR of brain tissue was positive. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Biopsy skin result was see text unknown. On an unknown date, Blood test result was see test unknown. On an unknown date, CSF test result was see test unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described suspected vaccination failure in 12-year-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown). The patient was a part of the retrospective analysis of all clinically suspected human rabies cases, whose samples were received between January 2012 and December 2014 (3 years), is presented in this study with the aim to describe clinical, demographic, prophylactic and - most importantly - the laboratory diagnostic aspects of this fatal yet preventable disease. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. The patient had been bitten by dog. On unspecified dates, the patient received 5 doses of unspecified rabies vaccine (administration route and site unspecified; batch number not provided). The patient had not received rabies immunoglobulin. Age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient was suspected for human rabies. The incubation period was 30 days. Between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result for RVNA titres by RFFIT were: CSF-15 IU/ml and serum not received. The patient''s laboratory results for viral RNA by real-time PCR were: CSF-negative, saliva-negative; nuchal skin-negative. Subsequently, the patient was diagnosed with paralytic rabies. Patient period of survival from onset of illness until death was 21 days. On an unspecified date, the patient died. The laboratory result for viral RNA by real-time PCR of brain tissue was positive. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death/suspected vaccination failure. The authors did not comment on the relationship between paralytic rabies and unspecified rabies vaccine. The author concluded, "rabies continues to cause a significant number of human deaths in this country. A national programme for rabies control initiated recently should help achieve priority for control of this neglected disease. Efforts to initiate/upgrade additional rabies diagnostic facilities, and enhance human and animal rabies surveillance are essential to indicate the true disease burden and institute appropriate public health measures. Adequate doses of rabies vaccines and RIG must be made available in public health care centres, especially in rural areas across the country. Health authorities should focus on increasing awareness about appropriate post-exposure prophylaxis for this preventable disease, which otherwise has a fatal outcome". This is 1 of the 15 valid cases reported in the same literature article.


VAERS ID: 708239 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-08-14
Entered: 2017-08-15
   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: Autopsy, Biopsy brain abnormal, Biopsy skin, Blood test, CSF test normal, Death, Lyssavirus test positive, Paralysis, Polymerase chain reaction positive, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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, bitten by dog
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unspecified dates between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result of 1st sample for RVNA titres by RFFIT were: CSF-negative and serum-15 IU/mL. The patient''s laboratory result of 2nd sample for RVNA titres by RFFIT were: CSF-15 IU/ml and serum-60 IU/mL. The laboratory results of 1st sample for the detection of viral RNA by real-time PCR: CSF and salvia negative; nuchal skin not received. The laboratory results of 2nd sample for the detection of viral RNA by real-time PCR: CSF, saliva and nuchal skin were negative. Subsequently, the patient was diagnosed with paralytic rabies. Post-mortem result for brain tissue was positive viral RNA by real-time PCR.
CDC Split Type: IN2017GSK125909

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a 21-year-old female subject who received Rabies Vaccine. Concurrent medical conditions included animal bite (bitten by dog). On an unknown date, less than a month after receiving Rabies Vaccine, Rabies Vaccine and Rabies Vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included rabies with serious criteria of death and GSK medically significant and paralysis with serious criteria of death and GSK medically significant. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included rabies (fatal) and paralysis (fatal). The reported cause of death was rabies and paralysis. An autopsy was performed. The investigator considered that there was a reasonable possibility that the vaccination failure, rabies and paralysis may have been caused by Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Relevant Tests: Lab tests performed on unspecified dates between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result of 1st sample for RVNA titres by RFFIT were: CSF-negative and serum-15 IU/mL. The patient''s laboratory result of 2nd sample for RVNA titres by RFFIT were: CSF-15 IU/ml and serum-60 IU/mL. The laboratory results of 1st sample for the detection of viral RNA by real-time PCR: CSF and salvia negative; nuchal skin not received. The laboratory results of 2nd sample for the detection of viral RNA by real-time PCR: CSF, saliva and nuchal skin were negative. Subsequently, the patient was diagnosed with paralytic rabies. Post-mortem result for brain tissue was positive viral RNA by real-time PCR. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Biopsy skin result was see text unknown. On an unknown date, Blood test result was see test unknown. On an unknown date, CSF test result was see test unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described the suspected vaccination failure in a 21-year-old female patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure. The patient was a part of the retrospective analysis of all clinically suspected human rabies cases, whose samples were received between January 2012 and December 2014 (3 years), is presented in this study with the aim to describe clinical, demographic, prophylactic and-most importantly-the laboratory diagnostic aspects of this fatal yet preventable disease. No information on the patient''s medical or family history or concomitant medication or concurrent condition was provided. The patient had been bitten by dog. On unspecified dates, the patient received 3 doses of unspecified rabies vaccine (administration route and site unspecified; batch number not provided). The patient had not received rabies immunoglobulin. Age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient was suspected for human rabies. The incubation period was 30 days. Between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, salvia and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result of 1st sample for RVNA titres by RFFIT were: CSF-negative and serum-15 IU/mL. The patient''s laboratory result of 2nd sample for RVNA titres were: CSF- 15 IU/ml and serum-60 IU/mL. The laboratory results of 1st sample for the detection of viral RNA by real-time PCR: CSF and saliva negative; nuchal skin not received. The laboratory results of 2nd sample for the detection of viral RNA by real-time PCR: CSF, saliva and nuchal skin were negative. Subsequently, the patient was diagnosed with paralytic rabies. Patient period of survival from onset of illness until death was 27 days. On an unspecified date, the patient died. Post-mortem result for brain tissue was positive viral RNA by real-time PCR. This case has been considered as suspected vaccination failure being the full schedule and time to onset was unknown. This case has been considered serious due to death/suspected vaccination failure. The authors did not comment on the relationship between paralytic rabies and unspecified rabies vaccine. The author concluded, "rabies continues to cause a significant number of human deaths. A national programme for rabies control initiated recently should help achieve priority for control of this neglected disease. Efforts to initiate/upgrade additional rabies diagnostic facilities, and enhance human and animal rabies surveillance are essential to indicate the true disease burden and institute appropriate public health measures. Adequate doses of rabies vaccines and RIG must be made available in public health care centres, especially in rural areas across the county. Health authorities should focus on increasing awareness about appropriate post-exposure prophylaxis for this preventable disease, which otherwise has a fatal outcome." This is 1 of the 15 valid cases reported in the same literature article.


VAERS ID: 708246 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-08-14
Entered: 2017-08-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Biopsy brain, Biopsy skin, Blood test, CSF test, Death, Encephalitis, Lyssavirus test positive, Polymerase chain reaction positive, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), 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: No other medications
Current Illness: Animal bite, bitten by dog
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unspecified dates between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result for CSF was negative and serum was not received for RVNA titres by RFFIT. The patient''s laboratory result for the detection of viral RNA by real-time PCR for CSF was negative; salvia was positive and nuchal skin was not received. Subsequently, the patient was diagnosed with encephalitic rabies. The brain tissue laboratory result for the detection of viral RNA by real-time PCR was not received.
CDC Split Type: IN2017GSK125916

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a 27-year-old male subject who received Rabies Vaccine. Concurrent medical conditions included animal bite (bitten by dog). On an unknown date, unknown after receiving Rabies Vaccine, the subject developed vaccination failure. Serious criteria included death GSK medically significant. Additional event(s) included rabies with serious criteria of death and GSK medically significant and encephalitis with serious criteria of death and GSK medically significant. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included rabies (fatal) and encephalitis (fatal). The reported cause of death was rabies and encephalitis. An autopsy was performed. The investigator considered that there was a reasonable possibility that the vaccination failure, rabies and encephalitis may have been caused by Rabies Vaccine. Relevant Tests: Lab tests performed on unspecified dates between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralizing antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result for CSF was negative and serum was not received for RVNA titres by RFFIT. The patient''s laboratory result for the detection of viral RNA by real-time PCR for CSF was negative; saliva was positive and nuchal skin was not received. Subsequently, the patient was diagnosed with encephalitic rabies. The brain tissue laboratory result for the detection of viral RNA by real-time PCR was not received. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Biopsy skin result was see text unknown. On an unknown date, Blood test result was see test unknown. On an unknown date, CSF test result was see test unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described suspected vaccination failure in 27-year-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis. The patient was a part of the retrospective analysis of all clinically suspected human rabies cases, whose samples were received between January 2012 and December 2014 (3 years), is presented in this study with the aim to describe clinical, demographic, prophylactic and-most importantly-the laboratory diagnostic aspects of this fatal yet preventable disease. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. The patient had been bitten by dog. On unspecified dates, the patient received 1 doses of unspecified rabies vaccine (administration route and site unspecified; batch number not provided). The patient had not received rabies immunoglobulin. Age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient was suspected for human rabies. The incubation period was 1.5 years. Between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralizing antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result for CSF was negative and serum was not received for RVNA titres by RFFIT. The patient''s laboratory result for the detection of viral RNA by real-time PCR for CSF was negative; salvia was positive and nuchal skin was not received. Subsequently, the patient was diagnosed with encephalitic rabies. Patient period of survival from onset of illness until death was 3 days. On an unspecified date, the patient died. The brain tissue laboratory result for the detection of viral RNA by real-time PCR was not received. This case has been considered as suspected vaccination failure being the full schedule and time to onset was unknown. This case has been considered serious due to death/suspected vaccination failure. The authors did not comment on the relationship between paralytic rabies and unspecified rabies vaccine. The author concluded, "rabies continues to cause a significant number of human deaths. A national programme for rabies control initiated recently should help achieve priority for control of this neglected disease. Efforts to initiate/upgrade additional rabies diagnostic facilities, and enhance human and animal rabies surveillance are essential to indicate the true disease burden and institute appropriate public health measures. Adequate doses of rabies vaccines and RIG must be made available in public health care centres, especially in rural areas across the country. Health authorities should focus on increasing awareness about appropriated post-exposure prophylaxis for this preventable disease, which otherwise has a fatal outcome." This is 1 of the 15 valid in the same literature article.


VAERS ID: 708247 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-08-14
Entered: 2017-08-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Antibody test, Autopsy, Biopsy skin, CSF test, Death, Encephalitis, Lyssavirus test positive, Polymerase chain reaction, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), 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: No other medications
Current Illness: Animal bite, bitten by dog on the face
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unspecified dates between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result of sample for CSF and serum for RVNA titres by RFFIT were not received. The patient''s samples for the detection of viral RNA by real-time PCR for CSF, nuchal skin were not received; saliva was positive. Subsequently, the patient diagnosed with encephalitic rabies. The brain tissue results for the detection of viral RNA by real-time PCR were not received.
CDC Split Type: IN2017GSK125912

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a 66-year-old male subject who received Rabies Vaccine. Concurrent medical conditions included animal bite (bitten by dog on the face). On an unknown date, less than a month after receiving Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included rabies with serious criteria of death and GSK medically significant and encephalitis with serious criteria of death and GSK medically significant. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included rabies (fatal) and encephalitis (fatal). The reported cause of death was rabies and encephalitis. An autopsy was performed. The investigator considered that there was a reasonable possibility that the vaccination failure, rabies and encephalitis may been caused by Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Relevant Tests: Lab tests performed on unspecified dates between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result of sample for CSF and serum for RVNA titres by RFFIT were not received. The patient''s samples for the detection of viral RNA by real-time PCR for CSF, nuchal skin were not received; saliva was positive. Subsequently, the patient diagnosed with encephalitic rabies. The brain tissue results for the detection of viral RNA by real-time PCR were not received. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Biopsy skin result was see text unknown. On an unknown date, Blood test result was see test unknown. On an unknown date, CSF test result was see test unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described suspected vaccination failure in a 66-year-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure. The patient was a part of the retrospective analysis of all clinically suspected human rabies cases, whose samples were received between January 2012 and December 2014 (3 years), is presented in this study with the aim to describe clinical, demographic, prophylactic and-most importantly-the laboratory diagnostic aspects of this fatal yet preventable disease. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. The patient had been bitten by dog one face. On unspecified dates, the patient received 4 doses of unspecified rabies vaccine (administration route and site unspecified; batch number not provided). The patient had not received rabies immunoglobulin. Age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient was suspected for human rabies. The probable incubation period was 15 days. Between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralizing antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory results of sample for CSF and serum for RVNA titres by RFFIT were not received. The patient''s samples for the detection of viral RNA by real-time PCR for CSF, nuchal skin were not received; saliva was positive. Subsequently, the patient was diagnosed with encephalitic rabies. Patient period of survival from onset of illness until death was 9 days. On an unspecified date, the patient died. The brain tissue results for the detection of viral RNA by real-time PCR were not received. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death/suspected vaccination failure. The authors did not comment on the relationship between paralytic rabies and unspecified rabies vaccine. The author concluded, "rabies continues to cause a significant number of human deaths. A national programme for rabies control initiated recently should help achieve priority for control of this neglected disease. Efforts to initiate/upgrade additional rabies diagnostic facilities, and enhance human and animal rabies surveillance are essential to indicate the true disease burden and institute appropriate public health measures. Adequate doses of rabies vaccines and RIG must be made available in public health care centres, especially in rural areas across the country. Health authorities should focus on increasing awareness about appropriate post-exposure prophylaxis for this preventable disease, which otherwise has a fatal outcome." This is 1 of the 15 valid cases reported in the same literature article.


VAERS ID: 708248 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-08-14
Entered: 2017-08-15
   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, Autopsy, Biopsy brain, Biopsy skin normal, Blood test, Death, Lyssavirus test positive, Paralysis, Polymerase chain reaction, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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, bitten by dog on the face
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unspecified date between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result of 1st sample for RVNA titres by RFFIT were: CSF-negative; serum-3.7 IU/mL. The patient''s laboratory result of 1st sample for the detection of viral RNA by real-time PCR: CSF-positive, saliva and nuchal were negative. The patient''s laboratory result of 2nd sample for RVNA titres by RFFIT: CSF, serum -nor received. The patient''s laboratory result of 2nd sample for detection of viral RNA by real-time PCR: CSF-not received, saliva and nuchal skin was negative. Subsequently, the patient was diagnosed with paralytic rabies. The laboratory results of brain tissue for the detection of viral RNA by real-time PCR was not received.
CDC Split Type: IN2017GSK125911

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a 33-year-old male subject who received Rabies Vaccine. Concurrent medical conditions included animal bite (bitten by dog on the face). On an unknown date, less than a month after receiving Rabies Vaccine, Rabies Vaccine and Rabies Vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included rabies with serious criteria of death and GSK medically significant and paralysis with serious criteria of death and GSK medically significant. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included rabies (fatal) and paralysis (fatal). The reported cause of death was rabies and paralysis. An autopsy was performed. The investigator considered that there was a reasonable possibility that the vaccination failure, rabies and paralysis may have been caused by Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Relevant Tests: Lab tests performed on unspecified date between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result of 1st sample for RVNA titres by RFFIT were: CSF-negative; serum-3.7 IU/mL. The patient''s laboratory result of 1st sample for the detection of viral RNA by real-time PCR: CSF-positive, saliva and nuchal were negative. The patient''s laboratory result of 2nd sample for RVNA titres by RFFIT: CSF, serum -nor received. The patient''s laboratory result of 2nd sample for detection of viral RNA by real-time PCR: CSF-not received, saliva and nuchal skin was negative. Subsequently, the patient was diagnosed with paralytic rabies. The laboratory results of brain tissue for the detection of viral RNA by real-time PCR was not received. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Biopsy skin result was see text unknown. On an unknown date, Blood test result was see test unknown. On an unknown date, CSF test result was see test unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described suspected vaccination failure in a 33-year-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure. The patient was a part of the retrospective analysis of all clinically suspected human rabies cases, whose samples were received between January 2012 and December 2014 (3 years), is presented in this study with the aim to describe clinical, demographic, prophylactic and-most importantly-the laboratory diagnostic aspects of this fatal yet preventable disease. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. The patient had been bitten by dog on face. On unspecified dates, the patient received 3 doses of unspecified rabies vaccine (administration route and site unspecified; batch number not provided). The patient had not received rabies immunoglobulin. Age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient was suspected for human rabies. The incubation period was 24 days. Between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result of 1st sample for RVNA titres by RFFIT were: CSF-negative; serum-3.7 IU/mL. The patient''s laboratory result of 1st sample for the detection of viral RNA by real-time PCR: CSF-positive, saliva and nuchal were negative. The patient''s laboratory result of 2nd sample for RVNA titres by RFFIT: CSF, serum -nor received. The patient''s laboratory result of 2nd sample for detection of viral RNA by real-time PCR: CSF-not received, saliva and nuchal skin was negative. Subsequently, the patient was diagnosed with paralytic rabies. Patient period of survival from onset of illness until death was 6 days. On an unspecified date, the patient died. The laboratory results of brain tissue for the detection of viral RNA by real-time PCR was not received. This case has been considered as suspected vaccination failure being the full schedule and time to onset was unknown. This case has been considered serious due to death/suspected vaccination failure. The authors did not comment on the relationship between paralytic rabies and unspecified rabies vaccine. The author concluded, "rabies continues to cause a significant number of human deaths. A national programme for rabies control initiated recently should help achieve priority for control of this neglected disease. Efforts to initiate/upgrade additional rabies diagnostic facilities, and enhance human and animal rabies surveillance are essential to indicate the true disease burden and institute appropriate public health measures. Adequate doses of rabies vaccines and RIG must be made available in public health care centres, especially in rural areas across the country. Health authorities should focus on increasing awareness about appropriate post-exposure prophylaxis for this preventable disease, which otherwise has a fatal outcome." This is 1 of the 15 valid cases reported in the same literature article.


VAERS ID: 708249 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-08-14
Entered: 2017-08-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 5 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Antibody test, Autopsy, Biopsy brain, Biopsy skin, Blood test, CSF test, Death, Paralysis, Polymerase chain reaction, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: Rabies Immunoglobulin
Current Illness: Animal bite, bitten by dog on right calf
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unspecified dates between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result of 1st sample RVNA titres by RFFIT were: CSF-15 IU/mL; serum-not received. The patient''s laboratory results of 2nd sample for CSF, saliva, nuchal skin for viral RNA by real-time PCR were negative. The patient''s laboratory result of 2nd sample for RVNA titres by RFFIT for CSF-7.5 IU/mL; serum was not received. The laboratory results of 2nd samples CSF, saliva, and nuchal skin for the detection of viral RNA by real-time PCR were not received. Subsequently, the patient was diagnosed with paralytic rabies. The laboratory results of brain tissue for the detection of viral RNA by real-time PCR was not received. This case has been considered as suspected vaccination failure being time to onset was unknown.
CDC Split Type: IN2017GSK125913

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a 9-year-old male subject who received Rabies Vaccine. Co-suspect products included Rabies Immunoglobulin. Concurrent medical conditions included animal bite (bitten by dog on right calf). On an unknown date, less than a month after receiving Rabies Vaccine, Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included rabies with serious criteria of death and GSK medically significant and paralysis with serious criteria of death and GSK medically significant. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included rabies (fatal) and paralysis (fatal). The reported cause of death was rabies and paralysis. An autopsy was performed. The investigator considered that there was a reasonable possibility that the vaccination failure, rabies and paralysis may have been caused by Rabies Vaccine, Rabies Vaccine, Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Relevant Tests: Lab tests performed on unspecified dates between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result of 1st sample for RVNA titres by RFFIT were: CSF-15 IU/mL; serum-not received. The patient''s laboratory results of 2nd sample for CSF, saliva, nuchal skin for viral RNA by real-time PCR were negative. The patient''s laboratory result of 2nd sample for RVNA titres by RFFIT for CSF-7.5 IU/mL; serum was not received. Subsequently, the patient was diagnosed with paralytic rabies. The laboratory results of brain tissue for the detection of viral RNA by real-time PCR was not received. This case has been considered as suspected vaccination failure being time to onset was unknown. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Biopsy skin result was see text unknown. On an unknown date, Blood test result was see test unknown. On an unknown date, CSF test result was see test unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described suspected vaccination failure in 9-year-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown). The patient was a part of the retrospective analysis of all clinically suspected human rabies cases, whose samples were received between January 2012 and December 2014 (3 years), is presented in this study with the aim to describe clinical, demographic, prophylactic and - most importantly - the laboratory diagnostic aspects of this fatal yet preventable disease. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. The patient had been bitten by dog on right calf. On unspecified dates, the patient received 5 doses of unspecified rabies vaccine (administration route and site unspecified; batch number not provided). The patient had received rabies immunoglobulin. Age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient was suspected for human rabies. The incubation period was 21 days. Between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result of 1st sample for RVNA titres by RFFIT were: CSF-15 IU/mL; serum-not received. The patient''s laboratory results of 2nd sample for CSF, saliva, nuchal skin for viral RNA by real-time PCR were negative. The patient''s laboratory result of 2nd sample for RVNA titres by RFFIT for CSF-7.5 IU/mL; serum was not received. The laboratory results of 2nd samples CSF, saliva, and nuchal skin for the detection of viral RNA by real-time PCR were not received. Subsequently, the patient was diagnosed with paralytic rabies. Patient period of survival from onset of illness until death was 3 months. On an unspecified date, the patient died. The laboratory results of brain tissue for the detection of viral RNA by real-time PCR was not received. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death/suspected vaccination failure. The authors did not comment on the relationship between paralytic rabies and unspecified rabies vaccine. The author concluded, "rabies continues to cause a significant number of human deaths in this country. A national programme for rabies control initiated recently should help achieve priority for control of this neglected disease. Efforts to initiate/upgrade additional rabies diagnostic facilities, and enhance human and animal rabies surveillance are essential to indicate the true disease burden and institute appropriate public health measures. Adequate doses of rabies vaccines and RIG must be made available in public health care centres, especially in rural areas across the country. Health authorities should focus on increasing awareness about appropriate post-exposure prophylaxis for this preventable disease, which otherwise has a fatal outcome". This is 1 of the 15 valid cases reported in the same literature article.


VAERS ID: 708251 (history)  
Form: Version 1.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-08-14
Entered: 2017-08-15
   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, Autopsy, Biopsy brain abnormal, Biopsy skin normal, Blood test, Death, Encephalitis, Lyssavirus test positive, Polymerase chain reaction positive, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), 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: No other medications
Current Illness: Animal bite, bitten by dog on face
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unspecified dates between January 2012 and December 2014, the patient was suspected for human rabies. The incubation period was 15 days. Between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result of sample for RVNA titres by RFFIT were: CSF negative and serum not received. The laboratory results of sample for the detection of viral RNA by real-time PCR: CSF positive; saliva not received and nuchal skin negative. The laboratory results of 2nd sample for the detection of viral RNA by real-time PCR: CSF, saliva and nuchal skin were negative. Subsequently, the patient was diagnosed with encephalitis rabies. Post-mortem result for brain tissue was positive for viral RNA by real-time PCR.
CDC Split Type: IN2017GSK125910

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a 46-year-old male subject who received Rabies Vaccine. Concurrent medical conditions included animal bite (bitten by dog on face). On an unknown date, less than a month after receiving Rabies Vaccine, Rabies Vaccine and Rabies Vaccine the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included rabies with serious criteria of death and GSK medically significant and encephalitis with serious criteria of death and GSK medically significant. The outcome of the vaccination failure was fatal. The outcome(s) of the additional event(s) included rabies (fatal) and encephalitis (fatal). The reported cause of death was rabies and encephalitis. An autopsy was performed. The investigator considered that there was a reasonable possibility that the vaccination failure, rabies and encephalitis may have been caused by Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Relevant Tests: Lab tests performed on unspecified dates between January 2012 and December 2014, the patient''s was suspected for human rabies. The incubation period was 15 days. Between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result of sample RVNA titres by RFFIT were: CSF negative and serum not received. The laboratory results of sample for the detection of viral RNA by real-time PCR: CSF positive; saliva not received and nuchal skin negative. The laboratory results of 2nd sample for the detection of viral RNA by real-time PCR: CSF, saliva and nuchal skin were negative. Subsequently, the patient was diagnosed with encephalitis rabies. Post-mortem result for brain tissue was positive for viral RNA by real-time PCR. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Biopsy skin result was see text unknown. On an unknown date, Blood test result was see test unknown. On an unknown date, CSF test result was see test unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described suspected vaccination failure in a 46-year-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis. The patient was a part of the retrospective analysis of all clinically suspected human rabies cases, whose samples were received between January 2012 and December 2014 (3 years), is presented in this study with the aim to describe clinical, demographic, prophylactic and-most importantly-the laboratory diagnostic aspects of this fatal yet preventable disease. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. The patient had been bitten by dog on face. On unspecified dates, the patient received 3 doses of unspecified rabies vaccine (administration route and site unspecified; batch number not provided). The patient had not received rabies immunoglobulin. Age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient was suspected for human rabies. The incubation period was 15 days. Between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result of sample for RVNA titres by RFFIT were: CSF negative and serum not received. The laboratory results of sample for the detection of viral RNA titres by real-time PCR: CSF positive; saliva not received and nuchal skin negative. The laboratory results of 2nd sample for the detection of viral RNA by real-time PCR: CSF, saliva and nuchal skin were negative. Subsequently, the patient was diagnosed with encephalitis rabies. Patient period of survival from onset of illness until death was 5 days. On an unspecified date, the patient died. Post-mortem result for brain tissue was positive for viral RNA by real-time PCR. This case has been considered as suspected vaccination failure being the full schedule and time to onset was unknown. This case has been considered serious due to death/suspected vaccination failure. The authors did not comment on the relationship between paralytic rabies and unspecified rabies vaccine. The author concluded, "rabies continues to cause a significant number of human deaths. A national programme for rabies control initiated recently should help achieve priority for control of this neglected disease. Efforts to initiate/upgrade additional rabies diagnostic facilities, and enhance human and animal rabies surveillance are essential to indicate the true disease burden and institute appropriate public health measures. Adequate doses of rabies vaccines and RIG must be made available in public health care centres, especially in rural areas across the country. Health authorities should focus on increasing awareness about appropriate post-exposure prophylaxis for this preventable disease, which otherwise has a fatal outcome." This is 1 of the 15 valid cases reported in the same literature article.


VAERS ID: 708254 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-08-14
Entered: 2017-08-15
   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, Autopsy, Biopsy brain, Biopsy skin, Blood test, CSF test, Death, Paralysis, Rabies, Vaccination failure, Viral test
SMQs:, Lack of efficacy/effect (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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, bitten by dog on left lower limb
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unspecified dates between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan PCR targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result for CSF was 7.5 IU/mL and serum was 15 IU/mL for RVNA titres by RFFIT. The patient''s laboratory result for the detection of viral RNA by real-time PCR for CSF-test not done; saliva and nuchal skin-not received. Subsequently, the patient was diagnosed with paralytic rabies. The brain tissue laboratory result for the detection of viral RNA by real-time PCR was not received.
CDC Split Type: IN2017GSK125917

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a 21-year-old male subject who received Rabies Vaccine. Concurrent medical conditions included animal bite (bitten by dog on left lower limb). On an unknown date, less than a month after receiving Rabies Vaccine, Rabies Vaccine and Rabies Vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included rabies with serious criteria of death and GSK medically significant and paralysis with serious criteria of death and GSK medically significant. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included rabies (fatal) and paralysis (fatal). The reported cause of death was rabies and paralysis. An autopsy was performed. The investigator considered that there was a reasonable possibility that the vaccination failure, rabies and paralysis may have been caused by Rabies Vaccine, Rabies Vaccine and Rabies Vaccine. Relevant Tests: Lab tests performed on unspecified dates between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan PCR targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result for CSF was 7.5 IU/mL and serum was 15 IU/mL for RVNA titres by RFFIT. The patient''s laboratory result for the detection of viral RNA by real-time PCR for CSF-test not done; saliva and nuchal skin-not received. Subsequently, the patient was diagnosed with paralytic rabies. The brain tissue laboratory result for the detection of viral RNA by real-time PCR was not received. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Biopsy skin result was see text unknown. On an unknown date, Blood test result was see text unknown. On an unknown date, CSF test result was see text unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described suspected vaccination failure in 21-year-old male patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis. The patient was a part of the retrospective analysis of all clinically suspected human rabies cases, whose samples were received between January 2012 and December 2014 (3 years), is presented in this study with the aim to describe clinical, demographic, prophylactic and most-importantly-the laboratory diagnostic aspects of this fatal yet preventable disease. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. The patient had been bitten by dog on left lower limb. On unspecified dates, the patient received 3 doses of unspecified rabies vaccine (administration route and site unspecified; batch number not provided). The patient had not received rabies immunoglobulin. Age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient was suspected for human rabies. The incubation period was 25 days. Between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result for CSF was 7.5 IU/mL and serum was 15 IU/mL for RVNA tires by RFFIT. The patient''s laboratory result for the detection of viral RNA by real-time PCR for CSF-test not done; saliva and nuchal skin-not received. Subsequently, the patient was diagnosed with paralytic rabies. Patient period of survival from onset of illness until death was 14 days. On an unspecified date, the patient died. The brain tissue laboratory result for the detection of viral RNA by real-time PCR was not received. This case has been considered as suspected vaccination failure being the full schedule and time to onset was unknown. This case has been considered serious due to death/suspected vaccination failure. The authors did not comment on the relationship between paralytic rabies and unspecified rabies vaccine. The author concluded, "rabies continues to cause a significant number of human deaths in specific country. A national programme for rabies control initiated recently should help achieve priority for control of this neglected disease. Efforts to initiate/upgrade additional rabies diagnostic facilities, and enhance human and animal rabies surveillance are essential to indicate the true disease burden and institute appropriate public health measures. Adequate doses of rabies vaccines and RIG must be made available in public health care centres, especially in rural areas across the country. Health authorities should focus on increasing awareness about appropriate post-exposure prophylaxis for this preventable disease, which otherwise has a fatal outcome." This is 1 of the 15 valid cases reported in the same literature article.


VAERS ID: 708259 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-08-14
Entered: 2017-08-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Antibody test, Biopsy brain, Blood test, CSF test, Death, Lyssavirus test positive, Paralysis, Polymerase chain reaction, Polymerase chain reaction positive, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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, bitten by dog
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests performed on unspecified dates between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result of 1st sample for CSF and serum for RVNA titres by RFFIT were negative. The patient''s laboratory result of 2nd sample for RVNA titres by RFFIT by CSF was negative and serum-30 IU/ml. The 1st sample for the detection of viral RNA by real-time PCR for CSF and saliva were negative; nuchal skin was positive. The 2nd sample for the detection of viral RNA by real-time PCR for CSF was negative and for saliva and nuchal skin were not received. Subsequently, the patient was diagnosed with paralytic rabies. The brain tissue laboratory result for the detection of viral RNA by real-time PCR was not received.
CDC Split Type: IN2017GSK125915

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a 12-year-old female subject who received Rabies Vaccine. Concurrent medical conditions included animal bite (bitten by dog). On an unknown date, unknown time after receiving Rabies Vaccine, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included rabies with serious criteria of death and GSK medically significant and paralysis with serious criteria of death and GSK medically significant. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included rabies (fatal) and paralysis (fatal). The reported cause of death was rabies and paralysis. An autopsy was performed. The investigator considered that there was a reasonable possibility that the vaccination failure, rabies and paralysis may have been caused by Rabies Vaccine. Relevant Tests: Lab tests performed on unspecified date between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result of 1st sample for CSF and serum for RVNA titres by RFFIT were negative. The patient''s laboratory result of 2nd sample for RVNA titres by RFFIT for CSF was negative and serum-30 IU/ml. The 1st sample for the detection of viral RNA by real-time PCR for CSF and saliva were negative; nuchal skin was positive. The 2nd sample for the detection of viral RNA by real-time PCR for CSF was negative and for saliva and nuchal skin were not received. Subsequently, the patient was diagnosed with paralytic rabies. The brain tissue laboratory result for the detection of viral RNA by real-time PCR was not received. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Biopsy skin result was see text unknown. On an unknown date, Blood test result was see test unknown. On an unknown date, CSF test result was see test unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described suspected vaccination failure in a 12-year-old female patient who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post-exposure prophylaxis. The patient was a part of the retrospective analysis of all clinically suspected human rabies cases, whose samples were received between January 2012 and December 2014 (3 years), is presented in this study with the aim to describe clinical, demographic, prophylactic and-most importantly-the laboratory diagnostic aspects of this fatal yet preventable disease. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. The patient had been bitten by dog. On unspecified dates, the patient received 1 doses of unspecified rabies vaccine (administration route and site unspecified; batch number not provided). The patient had not received rabies immunoglobulin. Age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient was suspected for human rabies. The probable incubation period was 5 years. Between January 2012 and December 2014, the patient''s clinical samples were collected to test for rabies virus neutralising antibody (RVNA) titres by rapid fluorescent focus inhibition test (RFFIT). (In this study, the clinical samples included cerebrospinal fluid (CSF), serum, saliva and nuchal skin biopsy collected antemortem, and brain tissue obtained post-mortem. None of the samples were obtained from infected patients specifically for this study. Nucleic acid extraction followed by real-time TaqMan polymerase chain reaction (PCR) targeting the nucleoprotein (N) gene was performed on brain tissues, CSF, saliva and nuchal skin biopsy samples, for detection of rabies viral RNA. Brain tissues were also subjected to the Fluorescent Antibody Test (FAT) for the detection of rabies nucleoprotein antigen). The patient''s laboratory result of 1st sample for CSF and serum for RVNA titres by RFFIT were negative. The patient''s laboratory result of 2nd sample for RVNA titres by RFFIT for CSF was negative and serum-30 IU/ml. The 1st sample for the detection of viral RNA by real-time PCR for CSF and saliva were negative; nuchal skin was positive. The 2nd sample for the detection of viral RNA by real-time PCR for CSF was negative and for saliva and nuchal skin were not received. Subsequently, the patient was diagnosed with paralytic rabies. Patient period of survival from onset of illness until death was 8 days. On an unspecified date, the patient died. The brain tissue laboratory result for the detection of viral RNA by real-time PCR was not received. This case has been considered as suspected vaccination failure being the full schedule and time to onset was unknown. This case has been considered serious due to death/suspected vaccination failure. The authors did not comment on the relationship between paralytic rabies and unspecified rabies vaccine. The author concluded, "rabies continues to cause a significant number of human deaths. A national programme for rabies control initiated recently should help achieve priority for control of this neglected disease. Efforts to initiate/upgrade additional rabies diagnostic facilities, and enhance human and animal rabies surveillance are essential to indicate the true disease burden and institute appropriate public health measures. Adequate doses of rabies vaccines and RIG must be made available in public health care centres, especially in rural areas across the country. Health authorities should focus on increasing awareness about appropriate post-exposure prophylaxis for this preventable disease, which otherwise has a fatal outcome." This is 1 of the 15 valid cases reported in the same literature article.


VAERS ID: 709105 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-08-21
Entered: 2017-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Pneumococcal infection, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Haemophilus Influenzae, Prophylaxis, received unknown number of Haemophilus vaccine doses
Allergies:
Diagnostic Lab Data:
CDC Split Type: SE2017GSK041779

Write-up: This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a child male patient who received SYNFLORIX. Previously administered products included SYNFLORIX (in the past the patient received unknown number of SYNFLORIX doses). On an unknown date, the patient received SYNFLORIX at an unknown dose. On an unknown date, unknown after receiving SYNFLORIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and pneumococcal infection (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the pneumococcal infection was fatal. The reported cause of death was pneumococcal infection. The reporter considered the vaccination failure and pneumococcal infection to be related to SYNFLORIX. Additional details were provided as follows: The age at vaccination was not reported. In the past the patient received unknown number of SYNFLORIX doses. In 2013, the patient experienced pneumococcal infection and died. This case was considered as a suspected vaccination failure since the details regarding the completion of the primary immunization for pneumococcal infection, details regarding time to onset and laboratory confirmation for pneumococcal infection was not provided. Follow up would be performed. Follow up information was received from a nurse via sales rep on 16th August 2017: The age at vaccination was not reported. Previously administered products included unknown number of unspecified haemophilus vaccine. On an unknown date, the patient received Haemophilus influenzae vaccine, the patient haemophilus infection (serious criteria death and GSK medically significant). The nurse had reviewed the patient''s records and it was stated that the patient did not suffer from pneumococcal infection but instead haemophilus infection and died. The reporter considered the haemophilus infection to be unrelated to SYNFLORIX and Haemophilus influenza vaccine. The reporter considered the vaccination failure to be unrelated to Haemophilus influenza vaccine. This case was considered as a suspected vaccination failure since the details regarding the completion of the primary immunization for haemophilus infection, and details regarding the completion of the primary immunization for haemophilus infection, and details regarding time to onset and laboratory confirmation for haemophilus infection was not provided. The nurse did not want to give any further information about this case.


VAERS ID: 709363 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2017-05-17
Onset:2017-06-01
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2017-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. M030909 / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Anaemia, Autopsy, CSF test normal, Cardiac arrest, Culture negative, Death, Echocardiogram normal, Immune system disorder, Ocular hyperaemia, Pyrexia, Rash erythematous, Rotavirus infection, Rotavirus test positive, Ultrasound scan normal, Vasculitis, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Glaucoma (broad), Cardiomyopathy (broad), Vasculitis (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-06-17
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PREVENAR 13; meningococcal C conj vaccine (dip toxoid); INFANRIX HEXA
Current Illness: Prophylactic vaccination
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ES0095075131708ESP005882

Write-up: My son was born completely healthy and after the vaccines of 2 months of age + ROTATEQ had fever and then was positive to rotavirus and then one week after having fever died due to vasculitis, a failure of the immune system induced by the vaccines. FOLLOW UP INFORMATION RECEIVED ON 09/08/2017 LITERALLY TRANSCRIBED ''''We are waiting for the autopsy report, although they have advanced us the causes of death via phone. He was vaccinated with the vaccines of two months of age on 14 May and on 17 May with rotate vaccine (lot number M030909) and on 1 Jun we took him to emergency because he had fever, red spots in the body, round the mouth and red eyes, he was followed up at emergency room in order to see if he worsen and on 4 June was admitted due to positive to rotavirus, he was hospitalized for 5 days, after stools came to normal colour he was discharged and stayed at home for two days and on the third day was hospitalized again with fever, at emergency room they only found him anaemia and a slight increase in leukocytes, but apparently non serious, various cultures were ruled and even cerebrospinal fluid was taken and without having definite results after 6 days of being hospitalized, with different antibiotics?the child had an arrest and died. The vasculitis was discovered in the autopsy. My son was a healthy child that was visited by two different pediatricians, before the vaccines hips ultrasound was ruled and heart contrast ultrasound and nothing was strange. Few days after the vaccines complications started. I''m sure it all came due to vaccines, my child had contact just with his father and his mother, no contact with small children, at home we maximized the precautions of healthiness and cleanliness? after having mentally reviewed thousand times there were no physical way that my child could took rotavirus in natural way, rotavirus was suffered days after rotate vaccine and at a time this caused him a vasculitis. ''''THE INITIAL DATE THAT FIGURED IN THE REPORT WAS NOT CORRECTED, OF ADMINISTRATION OF THE OTHER VACCINES BECAUSE COINCIDES WITH THE ONE THAT WAS REGISTERED IN THE PATIENT''S MEDICAL HISTORY. CALENDAR VACCINE DATA ARE TAKEN FROM THE MEDICAL HISTORY OF THE PATIENT (DATE, LABORATORIES AND BATCHES). Reporter''s comment: Who did suffer the adverse reaction? A family member. Did your physician or pharmacist report the adverse reaction? No. Contact consent: Yes, I give my consent.; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: Diffuse vasculitis.


VAERS ID: 709454 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2010-10-25
Onset:2010-10-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LA / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 RA / UN

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Autopsy, Cyanosis, Death, Microscopy, Vaccination complication
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2010-10-25
   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: CNSA2017SA151511

Write-up: Initial unsolicited report received from the literature on 16-Aug-2017. This case was linked with 2017SA151529, 2017SA151538, 2017SA151548. (Same article). The following is the verbatim from the article: Immunization plays an important role in the prevention of infectious diseases and it is currently one of the best measures to prevent diseases. With the implementation of the Expanded Program on Immunization, the types of vaccines have increased and the immunization rate of type 2 vaccines has also increased. The constant public attention paid to suspected abnormal reactions to immunization and the increasing number of negative reports related to vaccines, caused people to be more worried about the safety of vaccines. The improper handling of this matter can easily lead to medical disputes. Past literatures reported that most cases of deaths reported following vaccination are pure coincidences, while there were also some reports that believed vaccines can induce or aggravate potential diseases. This paper determined the cause of death of four infants who died following vaccination through an autopsy of their bodies, determining the relation between the vaccines and cause of death, and providing a reference for reducing the occurrence of coincidental events and the promotion of safe vaccination services. At the same time, it can help to reduce the negative impact of vaccine events and reduce public concerns about vaccination. Materials and Methods: Data Source: The diagnostic data of four cases of deaths following vaccination between January-2010 to December-2016 from an expert group on abnormal reactions to vaccination were collected. The data were taken from the AEFI Surveillance System. Each case has complete birth information, vaccination information, death information, laboratory test results, as well as the autopsy reports. They were all cases of death following vaccination, and the possibility of death by violence and exogenous intoxication was ruled out. Analysis Method: The vaccination units reported the deaths due to suspected abnormal reactions to vaccination to the county-level disease control and prevention institution where the vaccine recipients were located. Either by the fastest methods, such as phone call, within two hours in accordance with the requirements of the "National Suspected Abnormal Reactions to Vaccination Surveillance Program". The county-level disease control and prevention institution immediately submit direct online reports of the cases through the National Immunization Information Management System after verification. Investigation of deaths due to suspected abnormal reactions to vaccination after receiving the report, the municipal center for disease control and prevention immediately organized experts on the diagnosis and investigation of abnormal reactions to vaccination to conduct an investigation and collect vaccination, clinical treatment, death and other related data. The preliminary results of the investigation were reported within seven days. The parents were persuaded to carry out an autopsy during the investigation and the results of the autopsies were recorded. Diagnosis of deaths due to suspected abnormal reactions to vaccination the investigation was carried out by the municipal or provincial expert group on the investigation and diagnosis of abnormal reactions to vaccination. Clinical manifestations, autopsy results and the results of vaccine quality test were combined for a comprehensive analysis and a conclusion was made on the investigation and diagnosis based on the laws, administrative regulations, departmental regulations and technical specifications. Epidemiological analysis a descriptive approach was used to analyze the autopsy results and the investigation and diagnostic data of the death cases. This case involves 12-months-old female patient who was vaccinated with first dose of INFLUENZA VACCINE on the deltoid region of her left upper arm, and second dose of MENINGOCOCCAL POLYSACCHARIDE on the deltoid region of her right upper arm (Batch number, expiry date, dose, and route of administration were not reported for both the vaccines) on 25 Oct 2010 at 11:20:00 A.M. The patient medical history and concomitant medications were not reported. On 25 Oct 2010, 50 minutes after the vaccinations, the patient died due to anaphylactic shock, and the patient also had a cyanosis of the lips and fingernail beds (as per autopsy report). The patient relevant lab tests and corrective treatment were not reported. The patient autopsy revealed that the patient had normal development. A microscopic examination of the laryngeal mucosa revealed vasodilation, congestion, localized tissue edema, inflammatory cell infiltration and the presence of eosinophils. There was diffuse alveolar septal widening, inflammatory cell infiltration and eosinophils in the lungs. Toluidine blue staining indicated an increase in mast cells in the submucosal layer of multiple sites and degranulation of mast cells. Identification of the cause of death: Death caused by anaphylactic shock. The diagnostic conclusion of the municipal expert group on the diagnosis of abnormal reactions was an abnormal reaction to vaccination. Upon internal review the company decided to consider the event as serious due to important medical event cyanosis of the lips and fingernail beds. List of documents held by sender: none. Sender''s Comments: Patient died due to anaphylactic shock 50 minutes after receiving a group A meningococcal polysaccharide and split-virus influenza vaccines. Time to onset is compatible with the role of vaccines. The autopsy revealed that the child had normal development and that here was cyanosis of the lips and fingernail beds. A microscopic examination of the laryngeal mucosa revealed vasodilation, congestion, localized tissue edema, inflammatory cell infiltration and the presence of eosinophils. There was diffuse alveolar septal widening, inflammatory cell infiltration and eosinophils in the lungs. Toluidine blue staining indicated an increase in mast cells in the submucosal layer of multiple sites and degranulation of mast cells. As a result the cause of death was identified as anaphylactic shock however autopsy report was not provided. Additional information including but not limited to the patient anamnesis including allergic history (food allergy and patient''s immunization history are needed to further assess this case. Moreover, as two vaccines were administered concomitantly, the role of each component cannot be assessed separately. Reported Cause(s) of Death: Anaphylactic shock; Autopsy-determined Cause(s) of Death: Anaphylactic shock.


VAERS ID: 709458 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Death, Encephalopathy, Multiple organ dysfunction syndrome, Myocarditis
SMQs:, 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 (broad), Noninfectious encephalopathy/delirium (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), 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: 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: KRSA2017SA152952

Write-up: Initial unsolicited report received from the literature on 17 Aug 2017. The following is the verbatim from the article: Purpose: In recent years, research on reported adverse events following immunization (AEFI) and claims filed for compensation has been lacking. We reviewed reported AEFIs and compensation claims in specific country from 2011 to 2016. Materials and Methods: We listed all of the AEFI registered in the System and reviewed the list of claims filed and serious AEFIs reported from 2011 to 2016. Results: An average of 278 AEFI cases was reported annually from 2011 to 2016. Of these, 31 deaths were reported. However, there was no association found between these deaths and vaccinations when evaluating vaccine lot, reviewing autopsies, and considering underlying diseases. AEFI reporting rate was as high as 20.8 cases for bacillus Calmette-Gu?rin (BCG) vaccine, 7.3 cases for 23-valent pneumococcal polysaccharide vaccine (PPV23), and 5.4 cases for human papillomavirus vaccine per 100,000 vaccination doses in 2016. Of the 469 total cases that claimed vaccine injury compensation from 2011 to 2016, the BCG vaccine was most commonly involved, with 235 cases (50%), followed by influenza vaccine and PPV23, with 90 and 55 cases, respectively. Of these cases, 96% of BCG-related AEFI were compensated, while only 31% and 49% of AEFI following influenza and PPV23 vaccination, respectively, were compensated. Common characteristics of uncompensated cases included the elderly subjects, receiving influenza vaccine, having underlying disease, or a very short time interval between vaccination and symptoms. Conclusion: We have maintained vaccine safety management system through both rapid response to serious AEFI and vaccine injury compensation in order to sustain public trust in the National Immunization Program. This case involves four-months-old patient (gender not reported) who was vaccinated with a dose of DTAP AND IPV (Batch number, expiry date, dose, dose in series, route, and site of administration were unknown) on an unknown date. The patient medical history and concomitant medications were not reported. On an unknown date, one day following the vaccination, the patient developed acute myocarditis and encephalopathy with multi- organ failure due to which the patient died on an unknown date. The patient relevant lab tests were not reported. The patient corrective treatment was unknown. It was not known whether autopsy was performed or not. List of documents held by sender: none. Sender''s Comments: The case is about 4-month-old baby who developed acute myocarditis and encephalopathy with multi-organ failure one day after DTaP-IPV. Time to onset is compatible with the role of vaccine. Further information on the risks factors including any underlying disease or undiagnosed cardio-respiratory congenital anomaly; circumstances and patient''s medical condition at the time of death and detailed autopsy report would be needed for a complete assessment. Based on the limited information the role of the vaccine cannot be assessed. Reported Cause(s) of Death: encephalopathy; Multi-organ failure; myocarditis.


VAERS ID: 709524 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-09-23
Entered: 2017-08-24
   Days after submission:701
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthenia, Autopsy, Death, Decreased appetite, Pyrexia, Vaccination complication
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Influenza
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015315240

Write-up: This is a spontaneous report from an internet source, from a contactable consumer (patient''s mother) received via a Pfizer sales representative. A 4-month-old (4 months and a half) male patient of an unspecified received PREVENAR 13, via an unspecified route of administration, on an unspecified date, at single dose. Relevant medical history included influenza. Concomitant medications were not reported. The patient experienced fever, asthenia and anorexia on an unspecified date. The patient died on an unspecified date two days after vaccination due to the events. The autopsy revealed that the child had made a vaccination reaction with fever, asthenia and anorexia. Vaccination was performed by the paediatrician without respecting mother''s warning which said him that the patient had a cold and asked him if it was better to delay the vaccination.


VAERS ID: 709551 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-08-23
Entered: 2017-08-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Rabies, Vaccination failure
SMQs:, Lack of efficacy/effect (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: Animal bite, bitten by a dog during an outbreak of rabies
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MZ2017GSK130714

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a subject who received Rabies Vaccine. Concurrent medical conditions included animal bite (bitten by a dog during an outbreak of rabies). On an unknown date, unknown after receiving Rabies Vaccine and Rabies Vaccine, the subject developed vaccination failure. Serious criteria included death, hospitalization GSK medically significant. Additional event(s) included rabies virus infection with serious criteria of death, hospitalization and GSK medically significant. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included rabies virus infection (fatal). The reported cause of death was rabies virus infection. The investigator considered that there was a reasonable possibility that the vaccination failure and rabies virus infection may have been caused by Rabies Vaccine and Rabies Vaccine. Additional information was provided. This case was reported in a literature article and described suspected vaccination failure in a patient age between 2 and 29 years of unspecified gender who was vaccinated with unspecified rabies vaccine (manufacturer unknown) for post exposure prophylaxis. The patient was part of the study that aimed to determine the clinical and epidemiological features of human rabies cases detected during the outbreak, risk factors for developing rabies, and the epidemiological features of animal bites in cities. The patient was a resident. The patient was bitten by a dog. (In this study, date of animal bite ranged between 15 February 2014 and 5 June 2014 and in 2 cases information was not provided). Subsequently, the patient was referred to prophylaxis centre. [In this study, post-exposure vaccination and rabies immunoglobulin are offered at specialized prevention facilities, named Prophylaxis Centres, which were scattered throughout the country. Out of 14 cases of human rabies, 8 were male and 6 were females]. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On unspecified dates, the patient received 2 doses of unspecified rabies vaccine (administration site and route unspecified; batch number not provided) as post-exposure vaccination. The age of vaccination was not provided. On an unspecified date between 14 April and 14 August 2014, an unknown period after the vaccination, the patient was admitted to Hospital for the rabies infection. Subsequently the patient died. It was unknown if an autopsy was performed. In this study, the time interval between the admission and death was 0 and 5 days. This case has been considered as suspected vaccination failure being time to onset was unknown. This case has been considered serious due to death/hospitalisation/suspected vaccination failure. The authors did not comment on the relationship between human rabies infection and unspecified rabies vaccine. The authors concluded "our study shows that weak control measures, including low coverage rates of dog immunization, poor control of stray and unowned dogs, inadequate management of bites, and poor availability of an adherence to post-exposure prophylaxis, are major factors driving rabies outbreaks in cities. Non of the cases of human rabies that occurred during the outbreak were notified through the routine surveillance system, showing that rabies is seriously under-reported. Overall, we recommend aggressive interventions that include regular canine mass vaccination campaigns, improvement of the provision of vaccines to humans and animals, accompanied by regular campaigns to remove stray dogs and massive education in communities and primary schools."


VAERS ID: 709724 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Contraindication to vaccination, Death
SMQs:, Medication errors (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: Immunocompromised
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU0095075131708AUS011015

Write-up: Information has been received from Seqirus (reference# FRM-9561), as a part of a business agreement, on 24-AUG-2017. This spontaneous report was received from a nurse via Seqirus and refers to a patient of unknown age and gender. The patient was immunocompromised. No information regarding the patient''s medical history and concomitant medication was reported. On an unknown date, the patient was vaccinated with ZOSTAVAX injection (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, the patient died. The cause of death was not reported. It was unknown, whether the autopsy had been performed. The relatedness between the event and ZOSTAVAX was not provided. Upon internal review, the event of death was considered to be medically significant. Additional information has been requested.


VAERS ID: 710190 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-08-25
Entered: 2017-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Diphtheria, Oropharyngeal pain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: LA2017GSK131314

Write-up: This case was reported in a literature article and described the occurrence of diphtheria in a child patient who received DTP vaccine. On an unknown date, the patient received the 1st dose of DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, the patient experienced diphtheria (serious criteria death and GSK medically significant) and sore throat. On an unknown date, the outcome of the diphtheria was fatal and the outcome of the sore throat was unknown. The reported cause of death was diphtheria. The reporter considered the diphtheria and sore throat to be related to DTP vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of diphtheria infection in an child aged between 0.1 and 16 year of unspecified gender who was vaccinated with unspecified DTP vaccine (manufacturer unknown). The patient was part of the retrospective case-control study to determine risk factors for diphtheria during the outbreak in a particular Province where the majority of reported cases occurred during 1April 2012 and 31 May 2013. The study reviewed individual diphtheria case reports and the national database to identify those meeting the national case definition. Out of 62 diphtheria cases, 31 were male and 31 were female. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received 1 dose of unspecified DTP vaccine (administration site and route unspecified; batch number not provided). Vaccination history was confirmed by examining the interviewee''s vaccination card, if available. If the vaccination care was not available, the history was noted based on recall. The age of vaccination was not provided. (In this study, the Regulatory Authority estimates of national immunization coverage with DTP3 for children aged one year in this area were reviewed during 1980-2012). On an unspecified date between 1April 2012 and 31 May 2013 during diphtheria outbreak, an unknown period after the vaccination, the patient had sore throat. Subsequently, the patient was reported for diphtheria infection. [In this study, the national clinical case definition for diphtheria was an illness with laryngitis or pharyngitis or tonsillitis, and an adherent pseudo membrane of the tonsils, pharynx or nose. The case-patient was identified as a person meeting the surveillance case definition with illness onset during 1April 2012 and 31 May 2013. It was reported, in this area, laboratory confirmation was not required for classification as a confirmed case. Among the 62 clinical cases, reports indicated that all patients had sore throat, 61 (98%) had fever, 56 (90%) had difficulty swallowing, 32 (52%) had difficulty breathing, and 12 (19%) died]. On an unspecified date, the patient died due to diphtheria. It was unknown if an autopsy was performed. In this study, specimens were collected from 2 patients. This case has been considered serious due to death. Treatment was unknown. [Of the 12 deceased case-patients, 8 were admitted for treatment with the median time between date of onset and admission of 3 days (range 2 and 23 days). 1 had undergone treatment in city, 3 had undergone treatment in province, 2 had undergone treatment in district 1 had undergone treatment in rural health facility 3 had undergone treatment in village. It was observed that national treatment guidelines and diphtheria anti toxin (DAT) were not available. In addition, it was not standard practice for Td vaccine to be given as a booster dose to convalescing diphtheria patients]. The authors did not comment on the relationship between the event of diphtheria infection and unspecified DTP vaccine. The authors concluded "Suboptimal DTP3 coverage likely caused the outbreak. To prevent continued outbreaks, access to routine immunization services should be strengthened, outreach visits need to be increased, and missed opportunities need to be minimized. In the short term, to rapidly increase population immunity, three rounds of DTP immunization campaign should be completed; targeting children aged 0-14 years in affected provinces".


VAERS ID: 710198 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-08-28
Entered: 2017-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Unknown       Purchased by: Other
Symptoms: Death, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
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: CN2017GSK131808

Write-up: This case was reported by a consumer via call center representative and described the occurrence of unknown cause of death in an unspecified number of patients who received CERVARIX. On an unknown date, the patient received CERVARIX at an unknown dose. On an unknown date, unknown after receiving CERVARIX, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and paralysis (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the paralysis was unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death and paralysis to be related to CERVARIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter found there were cases about after using CERVARIX developed fatal or paralysis during searching in the internet. This case has been linked with CN2017GSK132258, as reported by the same reporter.


VAERS ID: 710143 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2011-01-26
Onset:2011-01-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2017-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Autopsy, Cyanosis, Death, Pallor, Respiratory arrest, Vaccination complication
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2011-01-27
   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: MEDILAC-VITA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNSA2017SA151529

Write-up: Initial unsolicited report received from the literature on 16-Aug-2017. Case was linked with: 2017SA151511 (same article). Verbatim of the article: Immunization plays an important role in the prevention of infectious diseases and it is currently one of the best measures to prevent diseases. With the implementation of the Expanded Program on Immunization, the types of vaccines have increased and the immunization rate of type 2 vaccines has also increased. The constant public attention paid to suspected abnormal reactions to immunization and the increasing number of negative reports related to vaccines, caused people to be more worried about the safety of vaccines. The improper handling of this matter can easily lead to medical disputes. Past literatures reported that most cases of deaths reported following vaccination are pure coincidences, while there were also some reports that believed vaccines can induce or aggravate potential diseases. This paper determined the cause of death of four infants who died following vaccination through an autopsy of their bodies, determining the relation between the vaccines and cause of death, and providing a reference for reducing the occurrence of coincidental events and the promotion of safe vaccination services. At the same time, it can help to reduce the negative impact of vaccine events and reduce public concerns about vaccination. Materials and Methods: Data Source: The diagnostic data of four cases of deaths following vaccination between January-2010 to December-2016 from an expert group on abnormal reactions to vaccination were collected. The data were taken from the Immunization Program Information Management AEFI Surveillance System. Each case has complete birth information, vaccination information, death information, laboratory test results, as well as the autopsy reports. They were all cases of death following vaccination, and the possibility of death by violence and exogenous intoxication was ruled out. Analysis Method: The vaccination units reported the deaths due to suspected abnormal reactions to vaccination to the county-level disease control and prevention institution where the vaccine recipients were located. Either by the fastest methods, such as phone call, within two hours in accordance with the requirements of the "National Suspected Abnormal Reactions to Vaccination Surveillance Program". The county-level disease control and prevention institution immediately submit direct online reports of the cases through the National Immunization Information Management System after verification. Investigation of deaths due to suspected abnormal reactions to vaccination after receiving the report, the municipal center for disease control and prevention immediately organized experts on the diagnosis and investigation of abnormal reactions to vaccination to conduct an investigation and collect vaccination, clinical treatment, death and other related data. The preliminary results of the investigation were reported within seven days. The parents were persuaded to carry out an autopsy during the investigation and the results of the autopsies were recorded. Diagnosis of deaths due to suspected abnormal reactions to vaccination the investigation was carried out by the municipal or provincial expert group on the investigation and diagnosis of abnormal reactions to vaccination. Clinical manifestations, autopsy results and the results of vaccine quality test were combined for a comprehensive analysis and a conclusion was made on the investigation and diagnosis based on the laws, administrative regulations, departmental regulations and technical specifications. Epidemiological analysis a descriptive approach was used to analyze the autopsy results and the investigation and diagnostic data of the death cases. This case involves a three-month-old male patient, who was vaccinated with 0.5 ml first dose injection of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (Batch number, expiry date, route and site of administration were not reported) and second dose of POLIOMYELITIS VACCINE (ORAL) (ORAL POLIOMYELITIS VACCINE) via oral route (Batch number, expiry date, dose not reported) on 26-Jan-2011 around 12 PM. Patient medical history was not reported. Concomitant medication included tablets of gastrointestinal agent and BACILLUSSUBTILIS/CALCIUMLACTATE/CYANOCOBALAMIN/NICOTINAMIDE/PYRIDOXINE HYDROCHLORIDE/RIBOFLAVIN/STREPTOCOCCUS FAECALIS/THIAMINE HYDROCHLORIDE/ZINC OXIDE (MEDILAC-VITA) (Batch number, expiry date, dose, route and site of administration were not reported) on 26-Jan-2011 around 12 PM. On 26-Jan-2011, same day after the vaccination, patient was observed for 30 minutes after the injection and subsequently discharged after no adverse reactions were observed and at night patient slept after playing a while and drinking milk and patient was completely normal around 12 AM that night. On 27-Jan-2011 06:00 AM, 18 hours following the vaccination, patient stopped breathing and died due to anaphylactic shock, cyanosis of the fingernail beds, and the toenail beds were pale (as per autopsy report). Patient''s other laboratory test and corrective treatment was not reported. Patient''s other autopsy report stated that patient had the body was 62 cm long, and had normal development. Normal facial features, and there was no discharge from the lips, nose and external auditory canal. Toluidine blue staining indicated an increase in mast cells in the submucosal layer of multiple sites and occasional degranulation of mast cells. The diagnostic conclusion of the municipal expert group on the diagnosis of abnormal reactions was an abnormal reaction to vaccination. The case was also considered as serious due of important medical events: cyanosis and pale nail beds. Documents held by sender: none.; Sender''s Comments: This case was reported for an infant male patient who died approximately 12 hours after vaccination with a DTaP and oral polio vaccine. It was reported that immediately following the vaccination, the child was fine throughout a 30-minutes of observation period after the vaccination. The patient was later visited at home by a local physician who prescribed live combined bacillus subtilis and enterococcus faecium granules (the child was said to have had poor digestion) with multivitamins, which the patient took before bedtime and and slept. It was reported that the child was completely normal around 12 a.m. that night but was found to have stopped breathing around 6 a.m. An autopsy revealed that the body was 62 cm long, and had normal development. The child had normal facial features, and there was no discharge from the lips, nose and external auditory canal. There was cyanosis of the fingernail beds, and the toenail beds were pale. Toluidine blue staining indicated an increase in mast cells in the submucosal layer of multiple sites and occasional degranulation of mast cells and that the cause of death was identified as anaphylactic shock; however the detailed autopsy report was not provided. For detailed or further review of this case a detailed medical history will be valuable: any previous allergic (drug or food) reaction, previous allergy to a vaccine or other allergies, notable symptoms of anaphylaxis and or other reactions between the time of vaccination and likely time of death, as the time lag of over 12hrs with no symptoms or signs is somehow not typical of anaphylaxis. Anaphylaxis symptoms usually occur within minutes of exposure to an allergen, though sometimes, however, it can occur a half-hour or longer after exposure. In addition, since, two vaccines (diphtheria, tetanus, and acellular pertussis vaccine and oral poliomyelitis vaccine) were administered concomitantly, the role of each component cannot be assessed separately.; Reported Cause(s) of Death: anaphylactic shock; cyanosis of the fingernail beds; toenail beds were pale; Autopsy-determined Cause(s) of Death: anaphylactic shock; cyanosis of the fingernail beds; toenail beds were pale.


VAERS ID: 710745 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-08-30
Entered: 2017-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (TIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, H1N1 influenza, Influenza A virus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab tests were performed on an unspecified date. The patient''s respiratory specimen was obtained as part of routine influenza surveillance activities. The specimen was analysed for the presence of influenza virus, by real-time polymerase chain reaction (RT-PCR), at the local laboratory or the National Influenza Centres (NICs). The patient was found positive for A (H1N1) pmd09 virus.
CDC Split Type: SE2017GSK134022

Write-up: This case was reported in a literature article and described the occurrence of vaccination failure in a subject who received Flu seasonal TIV Dresden. On an unknown date, unknown after receiving Flu seasonal TIV Dresden, the subject developed vaccination failure. Serious criteria included death and GSK medically significant. Additional event(s) included H1N1 influenza with serious criteria of death. The outcome of vaccination failure was fatal. The outcome(s) of the additional event(s) included H1N1 influenza (fatal). The reported cause of death was H1N1 influenza. The investigator considered that there was a reasonable possibility that the vaccination failure and H1N1 influenza may have been caused by Flu seasonal TIV Dresden. Relevant Tests: Lab tests were performed on an unspecified date. The patient''s respiratory specimen was obtained as part of routine influenza surveillance activities. The specimen was analysed for the presence of influenza virus, by real-time polymerase chain reaction (RT-PCR), at the local laboratory or the National Influenza Centres (NICs). The patient was found positive for A (H1N1) pmd09 virus. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza A virus test result was positive unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature article and described suspected vaccination failure in a patient aged more than 1-year of unspecified gender who was vaccinated with unspecified influenza vaccine (manufacturer unknown). The patient was a part of study to test the feasibility of collecting influenza virus strain-based antigenic and genetic data; and to assess the collected data and explore the benefits of non-aggregate strain-based reporting. In this study, among vaccinated cases, 400 were males and 396 were females; of the influenza cases reported in this study, 492 of 521 were not immunocompromised and 29 had an underlying disease. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received unspecified influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, vaccination status was known for 798 of the 1,633 cases from all 11 countries. 130 had been vaccinated with the influenza vaccine for the 2013/14 influenza season]. Age of vaccination was not provided. On an unspecified date between week 40/2013 and week 39/2014, an unknown period after vaccination, the patient''s respiratory specimen was obtained as part of routine influenza surveillance activities. The specimen was analysed for the presence of influenza virus, by real-time polymerase chain reaction (RT-PCR), at the local laboratory or the National Influenza Centres (NICs). The patient was found positive for A (H1N1) pmd09 virus. Subsequently, the patient died. It was unknown if the autopsy was performed. This case has been considered as suspected vaccination failure being the time to onset was unknown. This case has been considered serious due to death/suspected vaccination failure. Treatment was unknown (In this study, exposure to antiviral drugs was reported as known for 725 of 1,633 influenza cases, and of these 576 had not been treated with antiviral drug). The authors did not comment on the relationship between influenza infection and unspecified influenza vaccine. The authors stated, "In this pilot study, 34/41 of fatal cases were related to A (H1N1) pdm09 infection, compared with 58% in eight countries reporting outcomes through hospital surveillance in 2013/14. In the hospital surveillance data, many of the influenza viruses are reported without subtype and therefore no exact comparison is possible. Overall, only 41 (3%) of the 1,633 viruses characterised were from fatal cases which does not show a bias of the data towards fatal case specimens being characterised. An earlier analysis of the 2013/14 season showed that fatal outcomes occurred mostly in adults more than 40 years of age; this pilot study showed the highest number of deaths in those equal to or more than 65 years of age. Based on our limited data on severe infection, hospitalised cases affected by A (H3N2) virus infection were mostly school aged children and the elderly, in line with the results of the meta-analysis for seasonal influenza".


VAERS ID: 710506 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2017-08-09
Onset:2017-08-10
   Days after vaccination:1
Submitted: 2017-08-30
   Days after onset:20
Entered: 2017-08-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Ascites, Bradycardia, Cardio-respiratory arrest, Choking, Cyanosis central, Death, Dyspnoea, Fontanelle depressed, Gastrointestinal hypomotility, Generalised tonic-clonic seizure, Hypertrophic cardiomyopathy, Pericardial effusion, Respiratory disorder, Tachypnoea
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-08-11
   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: 08/10/2017, Oxygen saturation, 80 percent
CDC Split Type: BR2017GSK132936

Write-up: This case was reported by a other health professional and described the occurrence of hypertrophic cardiomyopathy in a 8-week-old female patient who received ROTARIX liquid formulation. Co-suspect products included Pneumococcal 10 Valent vaccine. Concomitant products included Pentavalent vaccine and Poliomyelitis vaccine inactivated. On 9th August 2017, the patient received ROTARIX liquid formulation (oral) and Pneumococcal 10 Valent vaccine. On10th August 2017, 1 days after receiving ROTARIX liquid formulation, the patient experienced hypertrophic cardiomyopathy (serious criteria death and GSK medically significant), pericardial effusion (serious criteria death and GSK medically significant), ascites (serious criteria death and GSK medically significant), cyanosis central (serious criteria GSK medically significant), generalized tonic-clonic seizure (serious criteria GSK medically significant), bradycardia (serious criteria GSK medically significant), cardiopulmonary arrest (serious criteria GSK medically significant), choking (serious criteria GSK medically significant), dyspnea, tachypnea, respiratory disorder, bowel peristalsis decreased and fontanelle depressed. The patient was treated with fenoterol and methylprednisolone. On an unknown date, the outcome of the hypertrophic cardiomyopathy, pericardial effusion and ascites were fatal and the outcome of the cyanosis central, generalized tonic-clonic seizure, bradycardia, cardiopulmonary arrest, choking, dyspnea, tachypnea, respiratory disorder, bowel peristalsis decreased and fontanelle depressed were unknown. The patient died on 11th August 2017. The reported cause of the death was hypertrophic cardiomyopathy, pericardial effusion and ascites. An autopsy was performed. It was unknown if the reporter considered the hypertrophic cardiomyopathy, pericardial effusion, ascites, cyanosis central, generalized tonic-clonic seizure, bradycardia, cardiopulmonary arrest, choking, dyspnea, tachypnea, respiratory disorder, bowel peristalsis decreased and fontanelle depressed to be related to ROTARIX liquid formulation. Additional details were provided as follows: The patient went to health care unit due to choked at home. The patient arrived in good general condition, stayed under observation at the health care unit for 2 hours and was discharged in good condition. On same day, at 23:20 PM, the patient was brought to hospital with tachypnea, dyspnea (RR 72 IRPM) with severe respiratory signs, central cyanosis, afebrile. Sat O2: 80%. Regular heart rate with normal heart sounds. Flat abdomen, weak peristalsis, depressible, without mass or painful compression, anterior fontanelle depressed. The patient was treated with macronebulization with Fenoterol, IV methylprednisolone 3 mg. At 23:40 PM, the patient presented generalized clonic tonic seizures, bradycardia and cardiorespiratory arrest. CPR and relevant medications were performed without success. The patient died at 00:40 hs, on 11th August 2017. Necropsia report were pending. Cause of death were described as hypertrophic cardiomyopathy, pericardial (non-inflammatory) effusion and C-Ascites. It was unknown if the reporter considered the hypertrophic cardiomyopathy, pericardial effusion, ascites, cyanosis central, generalized tonic-clonic seizure, bradycardia, cardiopulmonary arrest, choking, dyspnea, tachypnea, respiratory disorder, bowel peristalsis decreased and fontanelle depressed to be related to Pneumococcal 10 Valent vaccine as well.


VAERS ID: 710764 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-08-09
Onset:2017-08-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2017-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER N3A29 / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER 159VPN027I / UNK UN / UN
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER AROLB594AA / UNK MO / PO

Administered by: Other       Purchased by: ?
Symptoms: Ascites, Autopsy, Bradycardia, Cardio-respiratory arrest, Choking, Cyanosis central, Death, Dyspnoea, Fontanelle depressed, Generalised tonic-clonic seizure, Hypertrophic cardiomyopathy, Pericardial effusion, Respiratory symptom, Resuscitation, Tachypnoea
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Congenital, familial and genetic disorders (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (narrow), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-08-10
   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: PENTAVALENT VACCINE; PNEUMOCOCCAL 10 VALENT; ORAL ROTAVIRUS VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRSA2017SA159426

Write-up: Initial unsolicited report received from healthcare professional via partner company on 23 Aug 2017 and transmitted to Sanofi on 25 Aug 2017. This case involves a two months old female patient who was vaccinated with a dose of IPV (VERO) (INACTIVATED POLIOMYELITIS VACCINE) (Batch number: N3A29, expiry date, dose, site of administration were not reported and route of administration was unknown) on 09 Aug 2017. The patient''s medical history was unknown. Patient received DIPHTHERIA, TETANUS, PERTUSSIS, HAEMOPHILUS INFLUENZAE, AND HEPATITIS B VACCINES (PENTAVALENT VACCINE) (batch number: 279X6013E), PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL 10 VALENT) (batch number: 159VPN027I) and dose of ROTAVIRUS VACCINE (ORAL ROTAVIRUS VACCINE) (batch number: AROLB594AA) as concomitant medication on 09-Aug-17. On 10-Aug-2017 one day following vaccination patient went to health care unit because infant choked at home. The infant arrived in good general condition, stayed under observation at the health care unit for 2 hours and was discharged in good condition. 10-Aug-2017 at 23:20 PM, one day following vaccination the child was brought to hospital with tachypnea, dyspnea (RR 72 irpm) with severe respiratory signs, central cyanosis, afebrile. On 10-Aug-2017 at 23:40 PM, one day following vaccination, the child presented generalized clonic tonic seizures, bradycardia and cardiorespiratory arrest. CPR and relevant medications were performed without success, and patient was died at 12:40 AM (11 Aug 2017). Patient investigations includes: Oxygen saturation (O2 sats): 80%, Regular heart rate with normal heart sounds. Flat abdomen, weak peristalsis, depressible, without mass or painful compression, anterior fontanelle depressed. Patient was treated with macro nebulization with Fenoterol, METHYLPREDNISOLONE (IV METHYLPREDINISOLONE) 3mg. On 10 Aug 2017 patient recovered from choking and outcome of other events was not reported. Autopsy report was pending. On 11 Aug 2017 at 00:40 hrs., 2 days following vaccination, the patient died due to hypertrophic cardiomyopathy, pericardial (non-inflammatory) effusion and c-ascites (Reported as causes of death). Upon internal review the case was also considered as serious because of important medical event: choking. List of documents held by sender: none.; Sender''s Comments: This case was reported for an infant male patient who died approximately 2 days after vaccination. It was reported that the infant choked at home on the next day of vaccinations and was discharged after 2 hours of observation in good condition. At 23:20 hours on the same day, the patient was brought to the hospital with complaints of tachypnea, dyspnea with severe respiratory signs, central cyanosis, afebrile and saturated oxygen level of 80%. Physical examination showed regular heart rate with normal heart sounds, flat abdomen, weak peristalsis, depressible, without mass or painful compression and anterior fontanelle depressed. As a result patient was treated with macronebulization with Fenoterol and IV methylpredinisolone however at 23:40 hours patient presented with generalized clonic tonic seizures , bradycardia and cardiorespiratory arrest. A cardiopulmonary resuscitation was performed without success and the patient died at 00:40 hours. The cause of death was reported as hypertrophic cardiomyopathy, pericardial (non-inflammatory) effusion and C-Ascites. As hypertrophic cardiomyopathy is a congenital condition it could have manifested the reported events resulting in death. Further information on medical history including birth history, immune status at the time of vaccination, previous vaccination and tolerance, autopsy and results of investigations, etc. are needed to further assess the case. In addition, since, multiple vaccines (Poliomielites inactivated, Pentavalent vaccine, oral Rotavirus vaccine and Pneumococcal 10 valent) were administered concomitantly, the role of each component cannot be assessed separately.; Reported Cause(s) of Death: C-Ascites; cardiorespiratory arrest; Hypertrophic cardiomyopathy; Pericardial (non-inflammatory) effusion; Autopsy-determined Cause(s) of Death: C-Ascites; cardiorespiratory arrest; Hypertrophic cardiomyopathy; Pericardial (non-inflammatory) effusion.


VAERS ID: 710807 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-04-03
Onset:2017-04-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2017-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20915001B / 1 RA / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER UFA15008 / 2 LL / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR L1179 / 1 LL / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER ASPNA800AB / 1 RL / UN

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Autopsy, Bronchospasm, Chest X-ray normal, Cough, Death, Dyspnoea, Echocardiogram normal, Endotracheal intubation, General physical health deterioration, Generalised oedema, Infection, Intensive care, Mechanical ventilation, Pneumonia, Pulmonary congestion, Rales, Respiratory syncytial virus test negative, Respiratory tract infection, Status asthmaticus, Ultrasound abdomen normal, Ultrasound chest, Vaccination complication
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (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), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-05-11
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 21 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLSA2017SA157392

Write-up: Initial unsolicited case received from physician via health authority (Under reference number: PL-URPL-N1015/2017) on 24-Aug-2017. This case involves a one month old female patient who was vaccinated with 0.5 ml first injection of ACT-HIB (batch number: L1179-3, expiry date: 30 Apr 2017 and route of administration was not reported) in left thigh, 0.5 ml second injection of EUVAX B (batch number: UFA15008, expiry date: Apr 2018 and route of administration was not reported) in left thigh, 0.5 ml first injection of DTP (batch number: 20915001B, expiry date: Mar 2018 and route of administration was not reported; manufacturer: BIOMED S.A.) in right arm and 0.5 ml first injection of SYNFLORIX (batch number: ASPNA800AB, expiry date: Mar 2018 and route of administration was not reported; manufacturer: GlaxoSmithKline Biologicals S.A.) in right thigh on 03-Apr-2017 at 12:00 PM. The patient''s medical history and concomitant medication were not reported. The child was born by spontaneous labour, at due term, Apgar score 10 points and birth weight 4100 grams. Course of pregnancy and labour without complications. The mother of the child had been receiving EUTHYROX during pregnancy. According to the family medical history, a brother of the child''s grandmother died in early childhood because of pneumonia. On 06 Apr 2017 at 10:00 AM, 2 days and 22 hours following the vaccination patient had symptoms of generalized infection, cough, dyspnea, bronchospasm, acute respiration failure, status asthmaticus and pneumonia. Bronchospasm was progressing. The child''s condition was not improving despite treatment and the child was admitted to the Paediatric Department due to cough and intensified dyspnea on 21-Apr-2017. Patient was admitted to the Intensive Paediatric Care Department on 26-Apr-2016 at 04:42 p.m. due to acute respiratory failure and was connected to respirator. At the moment of admission to the Intensive Paediatric Care Department patient had serious general condition, intensified dyspnea, sibilant rales above lungs on auscultation. On 28-Apr-2017 at 12:56 p.m. after consultation with the treating team at the Intensive Paediatric Care Department and after conversation with parents; physician took a decision about suspicion of adverse post-vaccinal reaction (the form does not envisage suspicion of such reaction). Death was determined on 11-May-2017 at 03:00 a.m. Postmortem examination was ordered. Pneumonia of unknown etiology was the cause of death of the child determined by a pathomorpholotist (results of microscopic examinations did not reveal anything); this information was obtained as a result of conversation with a physician reporting suspicion of adverse post-vaccinal reaction. Autopsy report: Clinical diagnosis - acute respiratory failure, status asthmaticus. Initial anatomicopathologic diagnosis - pneumonia. Microscopically - specimens for microscopic examination were sampled. Macroscopically - a female gender corpse - infant. Generalized oedemas. Excessive alimentation. Regular structure. Skull: symmetrically, regularly arched, pachymeninx smooth on the internal side, slightly mat. Brain of regular gyri, no focal changes on the cross-section. Chest: symmetrically, regularly arched. Mediastinum with regularly localized organs. Trachea and bronchi of regular course and lumen, with pale pink, smooth mucosa. Mediastinal lymph nodes not enlarged. Thin and smooth pleura. Lungs: congested, regular size and shape, of non-homogenous grey-pink and red colour on the surface and on the cross-section. Heart - regularly localized in the pericardial sac, free from adhesions and fluids. Pericardium on the internal side and epicardium smooth and glossy. Heart muscle of greyish colour on cross-sections, of fibrillary structure. Valves - regularly formed. Regular topographic relationships in the area of big efferent vessels of the heart. Coronary vessels of regular ostia points. Abdominal cavity: symmetrically, regularly arched, of regular positioning of organs. Peritoneum: smooth and glossy. Liver of smooth surface, of regular size, shape and consistency. Parenchyma of micropapular structure on cross-sections. Gallbladder and bile ducts not changed. Pancreas: regular, of lobulated structure. Spleen: regular size, parenchyma of livid-red colour of papulo-trabecular structure on cross-sections. Kidneys: regular size, greyish cortex is separated from livid-like medullar part. Calyxes and pelvises of regular shape and volume, of whitish mucosa. Ureters of regular course and diameter, urinary bladder of regular structure. Oesophagus of regular course, grey mucosa. Stomach of regular size and volume, of greyish mucosa, regularly plicated. Duodenum, small intestine and large intestine of regular lumen, dense meconium in the initial segment of the large intestine. Genitals developed and formed adequately for the age and gender. Osteoarticular system of regular contours. Patient had symptoms of bronchospasm with low laboratory parameters of inflammatory state in the clinical examination. No signs of inflammation in chest x-ray. SpO2 (peripheral capillary oxygen saturation) 78-80%, without oxygen and respiratory effort. In the control x-ray mediocrely intensified inflammatory changes. Two-time test for the presence of RSV virus negative. Clinical exponents of status asthma with low inflammatory parameters were observed. Radiological and ultrasound images of lungs did not reflect serious condition of the child. Persisting serious bronchospasm, low exponents of inflammatory state, inadequate radiological image of lungs in relation to the child''s condition were observed. Microbiological examinations did not reveal an etiological factor of infection. No deviations were determined in heart ECHO, ultrasound examination of abdominal cavity and transparietal ultrasound examination. Basic health care physician recommended CECLOR and NEBBUD. TARTRIAKSON, inhalations were introduced. Antibiotic treatment was introduced (first Ampicillin, then BIOTRAKSON and SUMMAMED and bronchodilating medications and passive oxygen therapy. Due to intensified symptoms of respiratory failure the child was intubated and connected to respirator. Biological material for culture was sampled and empiric antibiotic treatment of wide spectrum of action was introduced. Despite intensive treatment: antibiotic treatment of wide spectrum of action, bronchodilating medications, mechanical ventilation with PCV and HFOV, systematic deterioration of the child''s general condition was observed. Patient was not recovered from status asthmaticus, cough, dyspnea, bronchospasm, acute respiration failure. The patient was hospitalized from 21-Apr-2017 to 11-May-2017. The child was hospitalized for 21 days. Reporter comment: I would like to underline strongly that the report of suspicion of adverse post-vaccinal reaction resulted from the fact that the parents of the child associated occurrence of acute infection of respiratory tract with performed vaccinations. The clinical picture of the disease was very atypical and it was difficult to combine it with something that might have been caused it. In the opinion of the team treating the child, a fact of vaccination was one of possibilities. Unfortunately the report form does not envisage a possibility of reporting suspicion of post-vaccinal reaction. EXPERT''S ASSESSMENT - PART I: Cough is an adverse reaction mentioned in the Summary of Product''s Characteristics (SmPC) of DTP as expected. It is an unexpected reaction for the remaining vaccines. In case of other vaccines against virus hepatitis B with marketing authorization cough has been mentioned in SmPC as expected. 34 cases of cough after ACT-HIB, 4 after EUVAX B and 76 cases of cough after SYNFLORIX have been reported in database till 28-Jul-2017. Dyspnea, as expected reaction associated with administration of a vaccine was mentioned in Summaries of Products'' Characteristics of DTP and EUVAX B. It is an unexpected reaction for ACT-HIB and SYNFLORIX. 34 cases of dyspnoea after administration of ACT-HIB and 84 cases after administration SYNFLORIX have been reported in database till 28-Jul-2017. Respiratory disturbances and bronchitis are expected for the vaccine DTP. Bronchospasm, acute respiratory failure and pneumonia are unexpected reactions for all four administered vaccines. 2 cases of bronchospasm after ACT-HIB, EUVAX B and SYNFLORIX have been reported in database till 28-Jul-2017. No case of bronchospasm after DTP has been reported. 1 case of acute respiratory failure after EUVAX B and 1 case after DTP and 3 cases of respiratory failure after SYNFLORIX and ACT-HIB have also been reported. Moreover, 32 cases of pneumonia after ACT-HIB, 11 cases after DTP, 6 cases after EUVAX B and 70 cases of pneumonia after SYNFLORIX have been also reported in the database. During searching of database as pneumococcal polysaccharide conjugate vaccine (adsorbed) 1.633 cases of pneumonia after administration of this kind of vaccine have been noted. S. pneumoniae is responsible for non-invasive infections, associated with mucosae, i.e. sinusitis, otitis media and pneumonia. Symptoms in the form of cough, dyspnea, and bronchospasm and, in consequence, acute respiratory failure are in the scope of the definition of status asthmaticus, the occurrence if which is associated with bronchial tree patency disorders, manifesting as dyspnea and cough. Taking into account immunological basis of bronchial asthma, elastic collagen fibers may be destroyed. These fibers are replaced with fibers that have no ability to deform, which contributes to decreasing of reversibility of bronchospasm throughout duration of the disease. Dry (unproductive) cough occurs usually in acute period of upper respiratory tract diseases but it is also a symptom of acute bronchitis, bronchiolitis and pneumonia. Allergic diseases of respiratory system, especially bronchial asthma, manifest as periodic or long-lasting cough that occurs sometimes as equivalent of dyspnea. Expert''s assessment - part II: Status asthmaticus in children is the most serious clinical form of bronchial asthma, when exacerbation of bronchi obturation does not regress despite proper conventional treatment; it is a serious attack of dyspnea persisting for longer than 6 hours. Status asthmaticus is always life-threatening for a patient. Mortality in status asthmaticus is evaluated at approx. 2%. Bronchial asthma or status asthmaticus have not been mentioned as expected reactions in the above mentioned Summaries of Products Characteristics, however, due to the fact that allergic reactions, anaphylactic reactions, or hypersensitivity reactions, are expected adverse reaction of immunological system for all four products, relationship between performed vaccinations and occurrence of status asthmaticus has not been excluded. No case of status asthmaticus has been reported till 28-Jul-2017, while searching database according to tradenames, whereas 1 case of status asthmaticus has been reported while analyzing database as pneumococcal polysaccharide conjugate vaccine (adsorbed). Reported status asthmaticus referred to a 13-valent pneumococcal vaccine. Taking the above into consideration, causal relationship between performed vaccinations and occurrence of described adverse reactions has not been excluded. Due to simultaneous administration of four vaccines it is impossible to indicate exclusively one that contributed to occurrence of symptoms. Time relation indicates causal relationship. The person reporting the adverse post-vaccinal reaction qualified it as serious. Due to the character of adverse reactions, resulting in the patient''s death and qualification of the report by the physician, the Agency considered the adverse post-vaccinal reaction as serious. List of documents held by sender: none. Sender''s Comments: The patient experienced Pneumonia, cough, dyspnoea, bronchospasm, respiratory failure and status asthmaticus post vaccination with ACTHIB, EUVAX B. Pneumonia was confirmed as the cause of death in autopsy. The patient was also vaccinated with DTP and SYNFLORIX vaccines (other MFR) on the same day. No information regarding patients medical history has been reported. Unspecified Microbiological examinations did not reveal an etiological factor of infection. Due to vaccination with multiple products it would be difficult to assess the causality with respect to one vaccine. Additional information regarding patient''s medical condition at the time of vaccination would be required to rule out alternate infectious etiology. Based on reported information and multiple suspects the role of one particular vaccine could not be assessed. Reported Cause(s) of Death: pneumonia of unknown origin; Autopsy-determined Cause(s) of Death: pneumonia of unknown origin.


VAERS ID: 711016 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2015-07-13
Onset:2017-08-28
   Days after vaccination:777
Submitted: 0000-00-00
Entered: 2017-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. K025137 / UNK UN / SC

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-08-28
   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: CA0095075131708CAN013755

Write-up: This spontaneous report was received from a nurse referring to a 53 year old female patient. Information about concurrent condition, concomitant medication and medical history was not provided. On 13-JUL-2015, the patient was vaccinated with ZOSTAVAX II lot # K025137 (dose, route and frequency unknown) to prevent shingles. On 28-AUG-2017, the patient died of a heart attack. The reporter stated she had no reason to believe the event was related to ZOSTAVAX II. It was unknown if autopsy was done. Upon internal review, died of a heart attack was determined to be medically significant. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the ZOSTAVAX II vaccine and the reported event cannot be established. Information regarding concurrent conditions, concomitant medications, medical history, clinical course and diagnostic work up was not provided. In addition is unknown if autopsy was performed. Company Comment- No changes to the ZOSTAVAX II vaccine safety information are warranted at this time. Merck and Co., Inc. continues to monitor the safety profile of the vaccine.; Reported Cause(s) of Death: heart attack.


VAERS ID: 711352 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-04-19
Onset:2017-04-19
   Days after vaccination:0
Submitted: 2017-09-05
   Days after onset:139
Entered: 2017-09-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS YHBVC530AA / 1 RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Hepatitis B antibody negative, Takayasu's arteritis
SMQs:, Vasculitis (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-04-19
   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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 04/19/2017, Hepatitis B antibody, negative; 04/19/2017, Physical examination, not reported
CDC Split Type: CN2017GSK135501

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of Takayasu''s arteritis in a 19-year-old male patient who received ENGERIX B adult (batch number YHBVC530AA, expiry date May 2018). On 19th April 2017, the patient received the 1st dose of ENGERIX B adult 20 ug. On 19th April 2017, several hours after receiving ENGERIX B adult, the patient experienced Takayasu''s arteritis (serious criteria death and GSK medically significant). On 19th April 2017, the outcome of the Takayasu''s arteritis was fatal. The patient died on 19th April 2017. The reported cause of death was Takayasu''s arteritis. An autopsy was performed. It was unknown if the reporter considered the Takayasu''s arteritis to be related to ENGERIX B adult. Additional details were provided as follows: The patient had no historic adverse drug reaction or adverse event. The patient had a physical examination and was detected that the hepatitis B antibody was negative. The age at vaccination was unknown. On 19 April 2017, at 10:08 AM, the patient received ENGERIX B adult on the deltoid of the right upper arm. On the same day, the patient died in the evening. The autopsy was performed and the result showed the causes of death were Takayasu arteritis, arteriolitis and visceral abnormality. Additional information was unknown.


VAERS ID: 711624 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-08-22
Onset:2017-08-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2017-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR M1282 / 2 LA / SC

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Bedridden, Blood albumin decreased, Blood alkaline phosphatase increased, Blood bilirubin decreased, Blood chloride normal, Blood creatine phosphokinase decreased, Blood creatine phosphokinase increased, Blood creatinine decreased, Blood lactate dehydrogenase increased, Blood potassium increased, Blood sodium decreased, Blood urea increased, Blood uric acid normal, Cardiac massage, Cardio-respiratory arrest, Clonic convulsion, Coma, Condition aggravated, Death, Electroencephalogram abnormal, Eosinophil percentage increased, Epilepsy, Haematocrit normal, Haemoglobin normal, Heart rate decreased, Hypoxic-ischaemic encephalopathy, Lymphocyte count increased, Lymphocyte percentage increased, Mean cell haemoglobin concentration decreased, Mean cell volume increased, Monocyte percentage, Neutrophil count increased, Neutrophil percentage decreased, Oxygen saturation immeasurable, Platelet count decreased, Protein total decreased, Pulse absent, Pyrexia, Red blood cell count decreased, Resuscitation, Seizure, Shock, Tachycardia, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Agranulocytosis (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Myocardial infarction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-08-23
   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: PHENOBAL; HORIZON; DANTRIUM; GABALON; LIFOROS; POTASSIUM GLUCONATE
Current Illness: Constipation; Epilepsy; Hypoxic encephalopathy (DUE TO TRAUMA AND WAS RECEIVING TREATMENT); Spastic quadriplegia
Preexisting Conditions: Medical History/Concurrent Conditions: Tracheostomy
Allergies:
Diagnostic Lab Data: Test Date: 20170502; Test Name: creatine phosphokinase; Result Unstructured Data: 41 unit(s)/litre; Test Date: 20170502; Test Name: Alkaline phosphatase; Result Unstructured Data: 549 unit(s)/litre; Test Date: 20170502; Test Name: LDH; Result Unstructured Data: 254 unit(s)/litre; Test Date: 20170502; Test Name: Creatinine; Test Result: 0.12 mg/dl; Test Date: 20170502; Test Name: Bilirubin Total; Test Result: 0.2 mg/dl; Test Date: 20170502; Test Name: Albumin; Result Unstructured Data: 4.0 gram(s)/decilitre; Test Date: 20170502; Test Name: Protein Total; Result Unstructured Data: 6.2 gram(s)/decilitre; Test Date: 20170509; Test Name: Albumin; Result Unstructured Data: 3.7 gram(s)/decilitre; Test Date: 20170509; Test Name: Hemoglobin; Result Unstructured Data: 12.0 gram(s)/decilitre; Test Date: 20170509; Test Name: lymphocytes; Test Result: 53.9 %; Test Date: 20170509; Test Name: Eosinophils; Test Result: 12.8 %; Test Date: 20170509; Test Name: Eosinophils; Test Result: 12 %; Test Date: 20170509; Test Name: LDH; Result Unstructured Data: 226 unit(s)/litre; Test Date: 20170509; Test Name: Creatinine; Test Result: 0.11 mg/dl; Test Date: 20170509; Test Name: Hematocrit; Test Result: 35.8 %; Test Date: 20170509; Test Name: Red blood cell count; Result Unstructured Data: 4.01 X10E6/MCL; Test Date: 20170509; Test Name: Uric acid; Test Result: 3.3 mg/dl; Test Date: 20170509; Test Name: Chloride; Result Unstructured Data: 110 millimole(s)/litre; Test Date: 20170509; Test Name: lymphocytes; Test Result: 52 %; Test Date: 20170509; Test Name: Neutrophils; Test Result: 28.5 %; Test Date: 20170509; Test Name: Protein Total; Result Unstructured Data: 5.9 gram(s)/decilitre; Test Date: 20170509; Test Name: Alkaline Phosphatase; Result Unstructured Data: 552 unit(s)/litre; Test Date: 20170509; Test Name: Bilirubin total; Result Unstructured Data: LESS THAN 0.2 milligram(s)/decilitre; Test Date: 20170517; Test Name: Albumin; Result Unstructured Data: 4.0 gram(s)/decilitre; Test Date: 20170517; Test Name: Protein Total; Result Unstructured Data: 6.0 gram(s)/decilitre; Test Date: 20170517; Test Name: Creatinine; Test Result: 0.13 mg/dl; Test Date: 20170517; Test Name: LDH; Result Unstructured Data: 238 unit(s)/litre; Test Date: 20170517; Test Name: Sodium; Result Unstructured Data: 137 millimole(s)/litre; Test Date: 20170517; Test Name: Red blood cell count; Result Unstructured Data: 3.96 X10E6/MCL; Test Date: 20170517; Test Name: Hemoglobin; Result Unstructured Data: 12.0 gram(s)/decilitre; Test Date: 20170517; Test Name: Eosinophils; Test Result: 13.6 %; Test Date: 20170517; Test Name: Eosinophils; Test Result: 9 %; Test Date: 20170517; Test Name: WBC; Result Unstructured Data: 11.4 X10E3/MCL; Test Date: 20170517; Test Name: Alkaline phosphatase; Result Unstructured Data: 778 unit(s)/litre; Test Date: 20170517; Test Name: Hematocrit; Test Result: 35.6 %; Test Date: 20170517; Test Name: lymphocytes; Test Result: 58 %; Test Date: 20170517; Test Name: Neutrophils; Test Result: 30.4 %; Test Date: 20170517; Test Name: lymphocytes; Test Result: 51.3 %; Test Date: 20170517; Test Name: Bilirubin total; Test Result: 0.2 mg/dl; Test Date: 20170711; Test Name: Bilirubin Total; Test Result: 0.2 mg/dl; Test Date: 20170711; Test Name: Protein Total; Result Unstructured Data: 5.6 gram(s)/decilitre; Test Date: 20170711; Test Name: Creatinine; Test Result: 0.13 mg/dl; Test Date: 20170711; Test Name: Alkaline phosphatase; Result Unstructured Data: 761 unit(s)/litre; Test Date: 20170711; Test Name: LDH; Result Unstructured Data: 338 unit(s)/litre; Test Date: 20170711; Test Name: creatine phosphokinase; Result Unstructured Data: 45 unit(s)/litre; Test Date: 20170711; Test Name: Red Blood Cell Count; Result Unstructured Data: 4.26 X10E6/MCL; Test Date: 20170711; Test Name: Hematocrit; Test Result: 36.3 %; Test Date: 20170711; Test Name: Sodium; Result Unstructured Data: 134 millimole(s)/litre; Test Date: 20170711; Test Name: Eosinophils; Test Result: 8.8 %; Test Date: 20170711; Test Name: Eosinophils; Test Result: 12 %; Test Date: 20170711; Test Name: Hemoglobin; Result Unstructured Data: 12.6 gram(s)/decilitre; Test Date: 20170711; Test Name: Neutrophils; Test Result: 31.6 %; Test Date: 20170711; Test Name: lymphocytes; Test Result: 52 %; Test Date: 20170711; Test Name: lymphocytes; Test Result: 53.5 %; Test Date: 20170711; Test Name: WBC; Result Unstructured Data: 10.0 X10E3/MCL; Test Date: 20170711; Test Name: Aspartate aminotransferase; Result Unstructured Data: 51 unit(s)/litre; Comments: AST (GOT); Test Date: 20170711; Test Name: Alanine aminotransferase; Result Unstructured Data: 73 unit(s)/litre; Comments: AST (GPT); Test Date: 20170822; Test Name: Sodium; Result Unstructured Data: 137 millimole(s)/litre; Test Date: 20170822; Test Name: Sodium; Result Unstructured Data: 137 millimole(s)/litre; Test Date: 20170822; Test Name: lymphocytes; Test Result: 44.7 %; Test Date: 20170822; Test Name: Creatine phosphokinase; Result Unstructured Data: 36 unit(s)/litre; Test Date: 20170822; Test Name: Aspartate Aminotransferase; Result Unstructured Data: 37 unit(s)/litre; Comments: AST (GOT); Test Date: 20170822; Test Name: Alanine Aminotransferase; Result Unstructured Data: 49 unit(s)/litre; Comments: AST (GPT); Test Date: 20170822; Test Name: Neutrophils; Test Result: 30.9 %; Test Date: 20170822; Test Name: Protein Total; Result Unstructured Data: 6.5 gram(s)/decilitre; Test Date: 20170822; Test Name: Red Blood Cell Count; Result Unstructured Data: 4.13 X10E6/MCL; Test Date: 20170822192000; Test Name: body temperature; Result Unstructured Data: 37.6 Celsius temperature; Test Date: 20170822; Test Name: Albumin; Result Unstructured Data: 4.0 gram(s)/decilitre; Test Date: 20170822; Test Name: Hemoglobin; Result Unstructured Data: 12.2 gram(s)/decilitre; Test Date: 20170822; Test Name: Eosinophils; Test Result: 9.8 %; Test Date: 20170822; Test Name: LDH; Result Unstructured Data: 255 unit(s)/litre; Test Date: 20170822; Test Name: Alkaline phosphatase; Result Unstructured Data: 641 unit(s)/litre; Test Date: 20170822; Test Name: Hematocrit; Test Result: 37.5 %; Test Date: 20170822; Test Name: Bilirubin Total; Test Result: 0.2 mg/dl; Test Date: 20170822; Test Name: Creatinine; Test Result: 0.12 mg/dl; Test Date: 20170823; Test Name: Protein total; Result Unstructured Data: 6.0 gram(s)/decilitre; Test Date: 20170823; Test Name: Aspartate aminotransferase; Result Unstructured Data: 472 unit(s)/litre; Comments: AST (GOT); Test Date: 20170823; Test Name: MONOCYTES; Test Result: 8 %; Test Date: 20170823; Test Name: Platelet count; Result Unstructured Data: 4.7 X10E4/MCL; Test Date: 20170823; Test Name: Alanine aminotransferase; Result Unstructured Data: 161 unit(s)/litre; Comments: AST (GPT); Test Date: 20170823; Test Name: Mean corpuscular volume; Result Unstructured Data: 98.7 femtolitre(s); Test Date: 20170823; Test Name: MCHC; Result Unstructured Data: 30.3 gram(s)/decilitre; Test Date: 20170823; Test Name: Albumin; Result Unstructured Data: 3.5 gram(s)/decilitre; Test Date: 20170823; Test Name: WBC; Result Unstructured Data: 19.9 X10E3/MCL; Test Date: 20170823; Test Name: Neutrophils; Result Unstructured Data: 8040 PER MCL; Test Date: 20170823; Test Name: Eosinophils; Test Result: 1 %; Test Date: 20170823; Test Name: Creatinine; Test Result: 0.53 mg/dl; Test Date: 20170823; Test Name: Hemoglobin; Result Unstructured Data: 13.4 gram(s)/decilitre; Test Date: 20170823; Test Name: Potassium; Result Unstructured Data: 6.3 millimole(s)/litre; Test Date: 20170823; Test Name: Bilirubin total; Result Unstructured Data: LESS THAN 0.2 milligram(s)/decilitre; Test Date: 20170823; Test Name: LDH; Result Unstructured Data: 2446 unit(s)/litre; Test Date: 20170823; Test Name: Alkaline phosphatase; Result Unstructured Data: 1056 unit(s)/litre; Test Date: 20170823; Test Name: Creatine phosphokinase; Result Unstructured Data: 413 unit(s)/litre; Test Date: 20170823; Test Name: lymphocytes; Test Result: 59 %; Test Date: 20170823; Test Name: lymphocytes; Test Result: 50.7 %; Test Date: 20170823; Test Name: Neutrophils; Test Result: 40.4 %; Test Date: 20170823; Test Name: WBC; Result Unstructured Data: 19.9 X10E3/MCL
CDC Split Type: JPSA2017SA159984

Write-up: Initial unsolicited report received from a pharmacist via our partner company on 24-Aug-2017 and transmitted to Sanofi on 24-Aug-2017 and additional information received form a pharmacist via the authority, Pharmaceuticals and Medical Devices Agency (under the reference number: V17100407) on 25-Aug-2017. This case involves a 17-month-old male patient who was vaccinated with 0.5ml second primary dose of ACTHIB via subcutaneous route (lot number: M1282, expiry date and site of administration not reported) on 22-Aug-2017 at 10:00 AM. Patient''s concurrent condition was reported as Hypoxic encephalopathy. The body temperature before the vaccination was 36.9 degree C. Concomitant medications included PHENOBARBITAL (PHENOBAL), DIAZEPAM (HORIZON), DANTROLENE SODIUM (DANTRIUM) capsule via oral route, BACLOFEN (GABALON) tablet via oral route, LACTULOSE (LIFOROS) syrup via oral route and POTASSIUM GLUCONATE. On 22-Aug-2017, at 19:00, 9 hours after the vaccination, patient''s heart rate was around 190/min (190/min or above and below 200/min).The body temperature was 37.6 degree C. At 19:20, 09 hours and 20 minutes after the vaccination, patient developed convulsion. Electroencephalography had shown signs of epileptic convulsion, the patient had never presented with physical convulsion including febrile convulsion before. At 19:25, 09 hours and 25 minutes after the vaccination, a convulsion of the right upper limb, tongue, and right toes was noted. At 19:30, 09 hours and 30 minutes after the vaccination, clonic convulsion transitioned to generalized convulsion. At 19:45, the patient received Diazepam Suppositories at 14 mg. At 20:00 and at 21:20, the patient received Diazepam Injection at 3 mg. On 23-Aug-2017, at 01:00 AM, 15 hours after the vaccination, patient''s heart rate was 30/min, and the patient got into a coma state. At 01:14, 15 hours and 14 minutes after the vaccination patient''s pulse was not palpable, and the heartbeat waveform could not be confirmed on the monitor. At 01:15, 15 hours and 15 minutes after the vaccination patient''s external cardiac massage was started. At 01:19, 15 hours and 19 minutes after the vaccination, the patient received Bosmin at 1 mL. At 01:21, 15 hours and 21 minutes after the vaccination patient''s (also reported as 01:23), patient''s heartbeat temporarily returned, but his condition was bad. At 13:35, 27 hours and 35 minutes after the vaccination, patient''s heart rate was 51/min, and SpO2 was not measurable. At 13:48, 27 hours and 48 minutes after the vaccination the patient died of the convulsion. Other laboratory investigations and corrective treatment were not reported. It was unknown if autopsy was done or not. Diagnosis: Convulsion Reporting pharmacist''s seriousness assessment: Serious (Death) Reporting pharmacist''s causality assessment: Related Reporting pharmacist''s comment: The patient had been admitted to the reporting hospital 1 year before for hypoxic encephalopathy due to trauma and was receiving treatment, which was considered to be another possible causative factor for the event. He was on a ventilator, and the general condition was not quite favorable. Follow-up information received from a pediatrician via partner company, on 30-AUG-2017 and transmitted to Sanofi on 30-AUG-2017. Patient received ACTHIB in left upper arm. The patient had an underlying disease: Hypoxic encephalopathy onset on 06-Apr-2016 any medication: none. Concurrent condition: Spastic quadriplegia onset on 06-Apr-2016, Constipation onset in Nov-2016, Epilepsy onset on 11-Apr-2016. On 21-Apr-2016, surgical history: Tracheostomy. Historical condition, allergic history, alcohol consumption, smoking history, past history of adverse drug reaction, Combination therapy was reported as none. Concomitant medication details was updated as: PHENOBARBITAL (PHENOBAL) 12.5 mg powder twice a day from 11-APR-2016 to 23-AUG-20 17 orally (gastric tube) for Epilepsy, DIAZEPAM (HORIZON) 0.33 mg thrice a day from 25-APR-2016 to 23-AUG-2017 orally (gastric tube) for Spastic quadriplegia, DANTROLENE SODIUM (DANTRIUM) 5 mg capsule thrice a day from 21-JUL-2016 to 23-AUG-2017 orally (gastric tube) for Spastic quadriplegia, BACLOFEN (GABALON) 1.66 mg tablet thrice a day from 07-SEP-2016 to 23-AUG-2017 orally (gastric tube) for Spastic quadriplegia, LACTULOSE (LIFOROS) syrup via oral route therapy dates: unknown and POTASSIUM GLUCONATE therapy dates: unknown. On 22-Aug-2017 at 13:48, following the vaccination, the patient died of shock, pyrexia and tachycardia. It was reported that the cause of death was reported as hypoxic encephalopathy. No autopsy findings were available. No test (such as DLST or blood concentration measurement) was performed to confirm the adverse event. ActHIB was not readministered. On 06-Apr-2016, the patient was admitted to the reporting hospital. Lab data included: On 02-MAY-2017, Total Protein: 6.2 g/dL (L), Albumin: 4.0 g/dL (L), Total Bilirubin: less than 0.2 mg/dL (L), Creatinine: 0.12 mg/dL (L), Alkaline Phosphatase Level: 549 U/L (H), LDH: 254 U/L (H), creatine phosphokinase: 41 U/L (L). On 09-MAY-2017, RBC: 4.01 x10E6/mcl (L), Hb: 12.0 g/dL (L), Ht: 35.8 percentage (L), Segmnt 29.0 percentage (L), Eosinophills: 12.0 (12.8) percentage (H), lymphocytes: 52.0 (53.9) percentage (H), Neutophills: 28.5 percentage (L), Total lymphocytes: 4258 per mcl (H), Total Protein: 5.9 g/dL (L), Albumin: 3.7 g/dL (L), Total Bilirubin: less than 0.2 mg/dL (L), Creatinine: 0.11 mg/dL (L), Uric acid: 3.3 mg/dL (L), Alkaline Phosphatase Level: 552 U/L (H), LDH: 226 U/L (H), Chloride: 110 mmol/L (H), IP: 5.1 mg/dL (H). On 17-MAY-2017, WBC: 11.4 x10E3/mcl (H), RBC: 3.96 x10E6/mcl (L), Hb: 12.0 g/dL (L), Ht: 35.6 percentage (L), Segmnt 27.0 percentage (L), Eosinophills: 9.0 (13.6) percentage (H), lymphocytes: 58.0 (51.3) percentage (H), Neutophills: 30.4 percentage (L), Total lymphocytes: 5848 per mcl (H), Total Protein: 6.0 g/dL (L), Albumin: 4.0 g/dL (L), Total Bilirubin: 0.2 mg/dL (L), Creatinine: 0.13 mg/dL (L), Alkaline Phosphatase Level: 778 U/L (H), LDH: 238 U/L (H), Sodium: 137 mmol/L (L), IP: 5.3 mg/dL (H). On 11-JUL-2017, WBC 10.0 x10E3/mcl (H), RBC: 4.26 x10E6/mcl (L), Hb: 12.6 g/dL (L), Ht: 36.3 percentage (L), Segmnt 31.0 percentage (L), Eosinophills: 12.0 (8.8) percentage (H), lymphocytes: 52.0 (53.5) percentage (H), Neutophills: 31.6 percentage (L), Total lymphocytes: 5350 per mcl (H), Total Protein: 5.6 g/dL (L), Total Bilirubin: 0.2 mg/dL (L), Creatinine: 0.13 mg/dL (L), AST (GOT): 51 U/L (H), ALT (GPT): 73 U/L (H), Alkaline Phosphatase Level: 761 U/L (H), LDH: 338 U/L (H), creatine phosphokinase: 45 U/L (L), Sodium: 134 mmol/L (L), IP: 5.3 mg/dL (H). On 22-AUG-2017 RBC: 4.13 x10E6/mcl (L), Hb: 12.2 g/dL (L), Ht: 37.5 percentage (L), Neutophills: 30.9 percentage (L), Eosinophills: 19.8 percentage (H), lymphocytes: 44.7 percentage (H), Total Protein: 6.5 g/dL (L), Albumin: 4.0 g/dL (L), Total Bilirubin: 0.2 mg/dL (L), Creatinine: 0.12 mg/dL (L), AST (GOT): 37 U/L (H), ALT (GPT): 49 U/L (H), Alkaline Phosphatase Level: 641 U/L (H), gama-GTP: 69 U/L (H), LDH: 255 U/L (H), creatine phosphokinase: 36 U/L (L), Sodium: 137 mmol/L (L), IP: 5.3 mg/dL (H). On 23-AUG-2017; WBC 19.9 x10E3/mcl (H), Hb: 13.4 g/dL (L), MCV: 98.7 fL, MCHC: 30.3 g/dL (L), PLT: 4.7 x10E4/mcl (L), MET-M: 1.0 percentage (H), Segmnt 22.0 percentage (L), Eosinophills: 1.0 percentage (L), lymphocytes: 59.0 (50.7) percentage (H), monoocytes: 8.0 percentage (H), Neutophills: 40.4 percentage (L) and 8040 per mcl (H), Total lymphocytes: 10089 per mcl (H), Total Protein: 6.0 g/dL (L), Albumin: 3.5 g/dL (L), Total Bilirubin: less than 0.2 mg/dL (L), Urea nitrogen: 26.1 mg/dL (H), Creatinine: 0.53 mg/dL (L), AST (GOT): 472 U/L (H), ALT (GPT): 161 U/L (H), Alkaline Phosphatase Level: 1056 U/L (H), LDH: 2446 U/L (H), creatine phosphokinase: 413 U/L (H), Potassium: 6.3 mmol/L (H). On 23 Aug 2017 the patient was died. Diagnosis: Convulsion Reporting pediatrician''s seriousness assessment: Serious (Death) Reporting pediatrician''s causality assessment: Related Diagnosis: Shock Reporting pediatrician''s seriousness assessment: Serious (Death) Reporting pediatrician''s causality assessment: Related Diagnosis: Pyrexia Reporting pediatrician''s seriousness assessment: Serious (Death) Reporting pediatrician''s causality assessment: Related Diagnosis: Tachycardia Reporting pediatrician''s seriousness assessment: Serious (Death) Reporting pediatrician''s causality assessment: Related Reporting pediatrician''s comment: In this case, the pyrexia, tachycardia, and convulsion developed 9 hours after the vaccination with ActHIB, and lead to the cardiorespiratory arrest 15 hours after the vaccination. The causal relationship between ActHIB and the pyrexia, tachycardia, and convulsion could not be ruled out. However, the patient was a high-risk child who had been bedridden and under continuous ventilator management due to hypoxic encephalopathy following cardio-respiratory arrest, and the underlying disease itself could be a risk for his death. Therefore, it was inconceivable that ActHIB was the only factor related to his death. Documents held by sender: none.; Sender''s Comments: Follow-up information received on 30-AUG-2017, changes the previous medical assessment of the case as follows: This 17-month-old child with medical history of post-traumatic hypoxic encephalopathy, tracheostomy, and under treatment on a ventilator and with Phenobal (Phenobarbital) and Hoziron (Diazepan), Dantrium (Dantrolene) for Epilepsy and Spastic Quadriplegia for more than a year (since April 2016) received the second dose of ActHIB vaccination. Nine hours after, fever and tachycardia occurred followed by convulsions (from clonic convulsion transitioned to generalised convulsion). EEG with signs of epileptic convulsion. Followed by cardiorespiratory arrest. The conditions worsened and the patient died despite the resuscitative measures. The cause of death was reported as hypoxic encephalopathy. No autopsy findings were available. No laboratory results were provided. Based on available information the role of vaccine can be excluded.; Reported Cause(s) of Death: convulsion; Pyrexia; Shock; Tachycardia.


VAERS ID: 711924 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IL0095075131709ISR000844

Write-up: This spontaneous report was received from a patient''s mother via company representative and refers to a female patient of 3.5 months old. The patient''s medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) (dose, strength, route, lot number and expiry date were not reported) for prophylaxis. Other suspect therapies included unspecified vaccines received on unspecified dates (reported as vaccinated with all the vaccines including rotavirus vaccine, live, oral, pentavalent (manufacturer unknown)). On an unspecified date, the patient died at the age of 3.5 months. Information about the cause of death and autopsy was unknown. The company representative was not certain and she estimated that the event occurred a year or two years ago. The reporter didn''t assess the causal relationship of death to rotavirus vaccine, live, oral, pentavalent (Manufacturer unknown) and other vaccines. Upon internal review, the event death was considered to be medically significant.


VAERS ID: 711927 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KR0095075131708KOR013788

Write-up: This literature report was received from a physician regarding 17 patients (elderly and adult). The objective was to assess adverse events following immunization (AEFI) and claims filed for compensation had been lacking. Reported AEFIs and compensation claims from 2011 to 2016 were reviewed. On an unknown date, the patients were vaccinated with pneumPRODIAX-23 for prophylaxis. Other suspect drugs included influenza virus vaccine. Total of 31 deaths have been filed between 2011 and 2016. Among them influenza vaccine and PRODIAX-23 were accounted for majority of deaths in adult and elderly (17 out of 18 cases). 10 out of 15 elderly subjects were reported to have an underlying disease. In all elderly death cases, causes of death other than vaccination, compounded by underlying disease and old age, were strongly suspected. Finally, rapid assessments for reported death cases had low association with immunization. The review included the reported AEFIs and related claims filed from 2011 to 2016, introduced the results of rapid responses to serious AEFIs during the same period, and compared the characteristics between compensated and dismissed cases. None of the 31 reported death cases during past six years showed causal association with a vaccine received under rapid response and evaluation. The authors considered the report of 17 deaths as related to PRODIAX-23 and influenza vaccine. Upon internal review, the event death was considered to be medically significant. Additional information has been requested.


VAERS ID: 712130 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2017-08-17
Onset:2017-08-18
   Days after vaccination:1
Submitted: 2017-09-11
   Days after onset:24
Entered: 2017-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC911A / 2 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB840AD / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-08-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Premature baby, 30 weeks and 2 days gestation, birth weight 1190 g; Neonatal respiratory distress syndrome, grade II, requiring intubation and administration of surfactant; Hyperbilirubinaemia, requiring phototherapy; Foot deformity, Pes calcaneus both sides
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2017GSK138234

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of unknown cause of death in a 3-month-old female patient who received ROTARIX liquid formulation (batch number AROLB840AD, expiry date unknown). Co-suspect products included INFANRIX HEXA (batch number A21CC911A, expiry date unknown). The patient''s past medical history included premature baby (30 weeks and 2 days of gestation, birth weight 1190 g), infant respiratory distress syndrome (grade II, requiring intubation and administration of surfactant), hyperbilirubinemia (requiring phototherapy) and foot deformity (Pes calcaneus both sides). On 17th August 2017, the patient received the 2nd dose of ROTARIX liquid formulation (oral) and the 2nd dose of INFANRIX HEXA (intramuscular). On 18th August 2017, 1 days after receiving ROTARIX liquid formulation and INFANRIX HEXA, 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 18th August 2017. The reported cause of death was unknown cause of death. An autopsy was performed. It was unknown if the reporter considered the unknown cause of death to be related to ROTARIX liquid formulation and INFANRIX HEXA. Additional information was provided as follows: The patient''s mother was a smoker during pregnancy. The further course of pregnancy was without problems. There were no further malformation and no concomitant medication. The patient was administered INFANRIX HEXA in the left upper leg. An autopsy was performed and the results were pending. There was no death case known in the siblings of the patient. Follow up has been requested by the regulatory authority.


VAERS ID: 712181 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2017-09-11
Entered: 2017-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Deafness unilateral, Death, Fall, Herpes zoster
SMQs:, Accidents and injuries (narrow), Hearing impairment (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: Unknown
Preexisting Conditions: INFLUVAC, Prophylaxis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZA2017GSK138982

Write-up: This case was reported by a nurse via licensee and described the occurrence of fall in a 87-year-old male patient who received ENGERIX B. Previously administered products included INFLUVAC. On an unknown date, the patient received ENGERIX B at an unknown dose. On an unknown date, unknown after receiving ENGERIX B, the patient experienced fall (serious criteria death), deafness unilateral (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the fall was fatal and the outcome of the deafness unilateral and shingles were unknown. The reported cause of death was fall. It was unknown if the reporter considered the fall, deafness unilateral and shingles to be related to ENGERIX B. Additional details were provided as follows: The patient''s wife came into the clinic and told the nurse that she and her husband had the ZOSTAVAX (MSD) vaccines either late last year or early this year. the age at vaccination was not reported. The nurse had no any record of the ZOSTAVAX (MSD) vaccine being given at their clinic though. The patient also had INFLUVAC and ENGERIX B over the past year. The patient developed shingles that came out on his head and also went deaf in his one ear. The patient''s wife could not remember when the patient had these symptoms. The patient had a fall, went to the hospital and was sent home without having had any tests or scans and he then passed away around 2 weeks ago. The nurse did not have any further details.


VAERS ID: 712314 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131709GBR005632

Write-up: This spontaneous report was received from an other patient''s mother, a court, an unspecified reporter, a company representative and 2 other unspecified reporters, referring to a female patient of unknown age (reported as young). The patient''s medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (lot#, expiration date, dose and route of administration were unknown). On an unknown date in 2017 (reported as earlier this year), the patient died. The cause of death was provided as administration of HPV vaccine. The court considered the patient''s death to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown). Upon internal review, the event of patient''s death was determined to be medically significant. This is one of several reports received from the same reporter. Sender''s Comments: GB-009507513-1709GBR005272: GB-009507513-1709GBR002674: Reported Cause(s) of Death: HPV Vaccine administration.


VAERS ID: 712637 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-03-21
Onset:2016-03-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2017-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER L0068 / 1 LL / IM

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Death
SMQs:, Acute central respiratory depression (broad), Hostility/aggression (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNSA2017SA167564

Write-up: This unsolicited case belongs to the batch of ICSRs that has been forwarded to the company by the Health Authorities on 05-Sep-2017 in the format of line listing. A two-month-old female patient, whose medical history and concomitant therapies were not reported, had received a 0.5 ml first dose of IPV (SALK) (lot number L0068-1, manufacturer reported as Pasteur) in left thigh via intramuscular route (muscle) on 21-Mar-2016 at 9:30:00 AM. Fever was reported as no. Vaccination site swelling was reported as no. Vaccination site induration was reported as no. Preliminary diagnosis reported by the HA was other. On 24-Mar-2016 at 3:00:00 AM, 2 days and 17 hours, 30 minutes post-vaccination, other primary diagnosis reported by the HA was asphyxia. Final diagnosis reported by the HA was other. It was unknown whether autopsy performed or not and cause of death was not reported. It was reported that the patient was not hospitalized. At the time of the report, the outcome was reported as death (fatal). AEFI classification was reported as coincidence by the HA. Sender''s Comments: Poorly documented case received through a line listing of several thousand of cases from the health authority. Based on the data provided, the role of vaccine cannot be assessed. Reported Cause(s) of Death: asphyxia.


VAERS ID: 712831 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Respiratory disorder
SMQs:, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131709GBR005923

Write-up: Information has been received from a paralegal via a company representative referring to a 19 years old female patient. The patient''s concurrent condition, historical condition and concomitant therapy were unknown. On an unknown date, the patient was administered with unidentified Merck human papillomavirus (HPV) vaccine (name and lot number were not provided) for prophylaxis. On an unknown date, the patient experienced respiratory problem and the patient dead. On an unknown date, the autopsy was performed. The first autopsy test result was inconclusive. The second autopsy test result was respiratory problems. The reason of respiratory problems was either genetic disorder or HPV Vaccine. The relationship between the death and vaccine was unknown.; Autopsy-determined Cause(s) of Death: respiratory problems.


VAERS ID: 712875 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2017-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Deafness unilateral, Death, Fall, Herpes zoster
SMQs:, Accidents and injuries (narrow), Hearing impairment (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-08-23
Permanent Disability? Yes
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: ZA0095075131709ZAF002642

Write-up: Information has been received from a nurse via Amayeza referring to an approximately 87 years old male patient. The patient''s concurrent conditions and concomitant medications were not provided. The patient'' historical medications included INFLUVAC and ENGERIX-B over the past year. Either late last year (2016) or early this year (2017), the patient was vaccinated with ZOSTAVAX (dose, route, site of administration, lot # and expiration date unknown) for prophylaxis. (However, the reporting nurse did not have any record of the with ZOSTAVAX vaccine being given at their clinic.) On an unknown date, the patient developed shingles that came out on his head and the patient also went deaf in his one ear. On unknown date (approximately in 2017), the patient had a fall, went to the hospital and was sent home without having had any tests or scans and he then passed away 2 weeks ago (approximately on 23-AUG-2017). It was unknown if an autopsy was performed. The cause of the death was unknown. The outcome of shingles, deaf in one ear and fall was unknown. Causality assessment was not provided. Upon internal review, deaf in one ear was determined to be disability and medically significant, and passed away was determined to be medically significant.


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