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Found 9 cases where Vaccine is HEPATYP and Serious

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Table

   
AgeVaccine CountCountPercent
< 3 Years5111.11%
total111.11%
12-17 Years1111.11%
total111.11%
17-44 Years1222.22%
3111.11%
5111.11%
total444.44%
65-75 Years1111.11%
total111.11%
Unknown1111.11%
3111.11%
total222.22%
TOTAL9100%

Case Details

VAERS ID: 443757 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2011-06-14
Onset:2011-07-07
   Days after vaccination:23
Submitted: 2011-11-28
   Days after onset:144
Entered: 2011-11-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPATYP: HEP A + TYP (HEPATYRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bladder perforation
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? No
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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0762693A

Write-up: This case was reported by a consumer (subject''s wife) and described the occurrence of bladder perforation in a male subject of unspecified age who was vaccinated with HEPATYRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 14 June 2011 the subject received unspecified dose of HEPATYRIX. On 7 July 2011, 23 days after vaccination with HEPATYRIX, the subject experienced bladder perforation. The subject was hospitalised. At the time of reporting the outcome of the event was unspecified.


VAERS ID: 448687 (history)  
Form: Version 1.0  
Age: 0.68  
Sex: Female  
Location: Foreign  
Vaccinated:2011-09-27
Onset:2011-10-13
   Days after vaccination:16
Submitted: 2012-02-01
   Days after onset:111
Entered: 2012-02-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPATYP: HEP A + TYP (HEPATYRIX) / GLAXOSMITHKLINE BIOLOGICALS G5790 / UNK UN / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER A83CA152B / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS A69SC476 / UNK UN / UN
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS 48011K / UNK UN / SYR
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER G5386 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Deafness unilateral, Sudden hearing loss, Tinnitus
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012AU005336

Write-up: Case number PHHY2012AU005336, is an initial spontaneous report received from Health authority via CSL on 19 Jan 2012: This case refers to 12-month-old infant female patient. She was vaccinated with RABIPUR (batch number: 482011K), PRIORIX (other manufacturer, batch number A69SC476), STAMARIL (other manufacture, batch number: G5386-7) and VIVAIRRIX (other manufacture, batch number: G5790) on 27 Sep 2011. She was also vaccinated with RABIPUR (batch number: 48011K) and MENCEVAX (other manufacture, batch number: A83CA152B) on 5 Oct 2011. One week post vaccination, on 13 Oct 2011, she developed sudden hearing loss in left ear and ringing in the ear. She was hospitalized on an unspecified date. The outcome reported as patient recovered on 13 Oct 2011. The causality of the events reported as possible.


VAERS ID: 450103 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-12-14
Onset:2011-12-14
   Days after vaccination:0
Submitted: 2012-02-22
   Days after onset:70
Entered: 2012-02-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPATYP: HEP A + TYP (HEPATYRIX) / GLAXOSMITHKLINE BIOLOGICALS ATYAB033AD / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Bacterial test negative, Blood culture negative, Body temperature increased, Chills, Cytomegalovirus test negative, Decreased appetite, Ear pain, Ear, nose and throat examination normal, Epstein-Barr virus antibody positive, Fatigue, Feeling cold, Full blood count normal, Headache, Lethargy, Liver function test normal, Malaise, Musculoskeletal stiffness, Myalgia, Nausea, Pain, Photophobia, Renal function test normal, Tremor, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Headache; Sunburn
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood culture, 22Dec2011, negative; Body temperature, 19Dec2011, 37.9deg C; Body temperature, 22Dec2011, 38.5deg C; CMV IgM antibody negative, 22Dec2011, negative; Complete blood count, normal; Complete blood count, 22Dec2011, normal; Cytomegalovirus test, 22Dec2011, negative; ENT examination, 19Dec2011, normal; ENT examination, 22Dec2011, normal; Epstein-Barr virus IgG antibod, 22Dec2011, past infection; Heart rate, 22Dec2011, 82bpm; Leptospira test positive, 22Dec2011, negative; Liver function test, 19Dec2011, normal; Liver function test, 22Dec2011, normal; Oxygen saturation, 19Dec2011, 99%; Oxygen saturation, 22Dec2011, 99%; Renal function test, 22Dec2011, normal
CDC Split Type: B0772943A

Write-up: This case was reported by a physician and described the occurrence of myalgia in a 16-year-old female subject who was vaccinated with HEPATYRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of HEPATYRIX (unknown route, unknown lot number). At an unspecified time after vaccination with HEPATYRIX, the subject experienced severe headaches, nausea and vomiting. On two occasions, the subject went to emergency room and received unspecified treatment. At the time of reporting the events were unresolved. Follow up information received on 15 February 2012: The case was upgraded to serious. The subject had no concomitant medication, no concurrent condition and no allergy. The subject did not use alcohol or tobacco. Concurrent medical conditions included headache and sunburn on 13 December 2011. The subject sought advice before traveling. On 14 December 2011 the subject received unspecified dose of HEPATYRIX (intramuscular, left deltoid). Lot number provided. On 14 December 2011, less than one day after vaccination with HEPATYRIX, the subject experienced myalgia. fatigue, severe headache, nausea, unwell and mild photophobia. On 15 December 2011, the subject experienced soreness and stiffness. Intermittent nausea and headache were worse. The physician considered the events were disabling. At examination on 15 December 2011, the subject was very tired. No rash was observed. Body temperature was 37.9 deg C and SpO2 was 99%. No abnormality was detected at ENT examination, abdomen was soft and no hepatosplenomegaly was noted. On 18 December 2011, the subject developed vomiting and tremor; she was still unwell. On 21 December 2011, the subject suffered from ear pain which resolved spontaneously. On 22 December 2011, at examination, the subject presented with chills, loss of appetite and cold feeling. Nausea, vomiting, headache and myalgia were still present. Body temperature was 38.6 deg C, pulse was regular (82bpm), SpO2 was 99%. ENT examination was normal, no adenopathy was observed, no rash, no meningism. No abnormality detected at physical examination. The diagnosis was not confirmed. On 29 December 2011, the mother reported that her daughter was better but still lethargic. Laboratory test, including complete blood count, renal function test and hepatic function test of 19 December and 22 December 2011 were normal. Blood culture of 22 December 2011 was negative (no growth after 5 days incubation). Serology was negative for Leptospira and Cytomegalovirus, and consistent with a past Epstein-Barr Virus infection. The subject was treated with intravenous fluid(s), prochlorperazine, PANADOL, ONDANSETRON, droperidol, omeprazole and BRUFEN. On 4 January 2012, the events were resolved. The mother reported that her daughter has left for a trip and that she was fully recovered. The physician considered the events were possibly related to vaccination with HEPATYRIX.


VAERS ID: 451180 (history)  
Form: Version 1.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-09-26
Onset:0000-00-00
Submitted: 2012-03-06
Entered: 2012-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPATYP: HEP A + TYP (HEPATYRIX) / GLAXOSMITHKLINE BIOLOGICALS ATYAB030AB / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Typhoid fever
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Oral contraceptive; Salbutamol sulphate
Current Illness: Unknown
Preexisting Conditions: Patient''s medical history was described as fit and well.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0785037A

Write-up: This case was reported by a physician and described the occurrence of typhoid in a 30-year-old female subject who was vaccinated with HEPATYRIX (GlaxoSmithKline). The subject''s medical history was described as ''fit and well''. Previous vaccinations included TYPHIM (non-gsk) given in 2005. Concurrent medications included oral contraceptive pill and Salbutamol. on 26 September 2011 the subject received an unspecified dose of HEPATYRIX (1 injection, batch number ATYAB030AB, expiry date June 2013). At an unspecified time after vaccination with HEPATYRIX, the subject went on a holiday to an unknown country and experienced typhoid while she was there. It was reported that the subject was diagnosed and admitted to hospital overnight. At the time of reporting the event was resolved.


VAERS ID: 456287 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2011-04-26
Onset:2011-06-02
   Days after vaccination:37
Submitted: 2012-05-25
   Days after onset:358
Entered: 2012-05-29
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB921CA / UNK UN / IM
HEPATYP: HEP A + TYP (HEPATYRIX) / GLAXOSMITHKLINE BIOLOGICALS ATYAB030AC / UNK UN / IM
RAB: RABIES (IMOVAX) / SANOFI PASTEUR E0762 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Myelitis transverse
SMQs:, Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: Not reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: E201203227

Write-up: This invalid case (no patient identifiers provided) was reported by the Health Authority on 16/May/2012, Ref: GB-MHRA-ADR 21641513. This case is medically confirmed. An unknown patient with unreported medical history received rabies vaccine BP, batch E0762-2, intramuscularly, 1ml, site not reported, and ENGERIX B (GSK), batch AHBVB921CA, and hepatitis A and typhoid vaccine (GSK), batch ATYAB030AC, both intramuscularly, all on 26/Apr/2012. On 2/June/2012, 6 weeks post vaccination, the patient experienced transverse myelitis. No further details were provided. The reporter and HA considered the case to be serious for disability and hospitalisation criteria.


VAERS ID: 475451 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2011-02-09
Onset:2011-03-21
   Days after vaccination:40
Submitted: 2012-11-26
   Days after onset:616
Entered: 2012-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPATYP: HEP A + TYP (HEPATYRIX) / GLAXOSMITHKLINE BIOLOGICALS ATYAB030AA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Chromaturia, Flank pain, Herpes virus infection, Herpes zoster, Malaise, Typhoid fever, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Salbutamol sulphate; Tiotropium; fluticasone+salmeterol; Risedronic acid; Prednisolone; Piroxicam; Paracetamol; Omeprazole; Montelukast sodium; Mometasone furoate; Losartan potassium; Hypromellose; Nitroglycerine; Colecalciferol; Diltiazem
Current Illness: Asthma; Cardiac Syndrome X; Chronic Kidney Disease; Gastric and Duodenal Ulcer; Hypertension; Malignant Neoplasm of Kidney
Preexisting Conditions: Malignant Kidney
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0845691A

Write-up: This case was reported by a healthcare professional (a nurse) and described the occurrence of typhoid fever in a 72-year-old female who was vaccinated with HEPATYRIX (GlaxoSmithKline). The subject''s medical history included malignant kidney ("renal malignancy"). Concurrent medical conditions included asthma, cardiac syndrome x, chronic kidney disease, gastric and duodenal ulcer, hypertension and malignant neoplasm of the kidneys. Concurrent medications included VENTOLIN, tiotropium, fluticasone propionate+salmeterol xinafoate, risedronic acid, prednisolone, piroxicam, paracetamol, omeprazole, montelukast sodium, mometasone furoate, losartan potassium, hypromellose, nitroglycerine (GTN), colecalciferol (FULTIUM-D3), diltiazem hydrochloride, bendrofluazide and aminophylline. On 9 February 2011 the subject received unspecified single dose of HEPATYRIX (1 injection; batch number: ATYAB030AA, expiry date: June 2013). On 21 March 2011, 40 days after vaccination with HEPATYRIX, the subject experienced feeling unwell, experienced flank and abdominal pain and had red urine. The subject was hospitalised. On 25 March 2011, 44 days after vaccination with HEPATYRIX, the subject was diagnosed with typhoid fever (vaccination failure) and experienced "herpes infection" which "was explained to the patient as having shingles". At the time of reporting the events were resolved.


VAERS ID: 493427 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-03-21
Onset:2013-04-05
   Days after vaccination:15
Submitted: 2013-06-04
   Days after onset:60
Entered: 2013-06-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
CHOL: CHOLERA (NO BRAND NAME) / UNKNOWN MANUFACTURER KV0316A1 / UNK UN / UN
DTIPV: DT + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER H7185 / UNK UN / UN
HEPATYP: HEP A + TYP (HEPATYRIX) / GLAXOSMITHKLINE BIOLOGICALS J5360 / UNK UN / UN
RAB: RABIES (IMOVAX) / SANOFI PASTEUR H1037 / UNK UN / UN
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER H5380 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial test negative, Borrelia test negative, CSF culture negative, CSF glucose, CSF mononuclear cell count increased, CSF protein, CSF white blood cell count increased, Encephalitis brain stem, Enterovirus test negative, Fungal test negative, Gene mutation identification test negative, HIV test negative, Influenza virus test negative, Intensive care, Meningitis, Mycobacterium tuberculosis complex test negative, Polymerase chain reaction, Streptococcus test negative, Viral test negative
SMQs:, Noninfectious encephalitis (narrow), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
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: No relevant medical history, no risk factors and no concurrent conditions. No previous reaction to a vaccine or a drug.
Allergies:
Diagnostic Lab Data: 08-Apr-13: CSF sample showed white cells $g1000, polys 70%, protein 1.56, glucose 3.1, culture negative. 12-Apr-13: CSF sample showed white cells 480, 70% mononuclears, protein 1.02, glucose 2.1 culture negative, PCR negative for meningococcus, pneumococcus, haemophilus influenzae, TB, HSV, enterovirus and listeria. 165 rRNA gene is negative, cryptococcal antigen negative and serologies for HIV and borellia negative
CDC Split Type: E201302859

Write-up: This case was received from a health care professional on 15-Apr-13. This case is medically confirmed. A 19 year old female patient with an unreported medical history and concomitant medication received a dose of STAMARIL (batch number not reported) route and site not reported on 21-Mar-13. On an unreported date, ten days post vaccination, the patient experienced meningitis which is now developing into rhomboencephalitis. This meningitis was culture negative. At the time of the reporting the reporter suspects that this may be YEL-AND and the CSF is to be tested for the presence of yellow fever virus. Results are pending at the time of reporting. The patient has not recovered. Follow up received from the HCP on 24-May-13. The patient received the STAMARIL vaccine (batch number H5380-4) for planned travel. The patient also received RABIES BP (batch number H1037-1), REVAXIS (batch number H7185-1), VIATIM (batch number J5360-2) and a cholera vaccine (batch number KV0316A1) on unreported dates. The patient has no relevant medical history, no risk factors, no concurrent conditions and was not receiving any concomitant medications. The reporter confirmed the diagnosis of rhombo-encephalitis and onset date for the patient''s symptoms as 05-Apr-13, i.e 15 days p-v. The patient was admitted to the intensive care unit and received corrective treatment with steroids, unspecified antibiotics, acyclovir and TB treatment emperically. CSF sample on 08-Apr-13 showed white cells $g1000, polys 70%, protein 1.56, glucose 3.1, culture negative. CSF sample on 16-Apr-13 showed white cells 480, 70% mononuclears, protein 1.02, glucose 2.1 culture negative, PCR negative for meningococcus, pneumococcus, haemophilus influenzae, TB, HSV, enterovirus and listeria. At the time of reporting, the patient has recovered and remains on empiric TB treatment and the yellow fever virus results are pending. Additional information received from the initial reporter on 31-May-13. The patient''s initials was provided. The patient has no experience of a previous reaction to a vaccine or a drug. On on 05-Apr-13 the patient was diagnosed with rhomboencephalitis with no infectious agent identified. The event was considered severe and life threatening and possibly related to the vaccines. The date of the diagnostic tests was corrected from 16-Apr-13 to 12-Apr-13. Additional tests results were reported for the 12-Apr-12, and these include Varicella virus negative, 165 rRNA gene negative, cryptococcal antigen negative and serologies for HIV and borellia negative. The reporter stated that the patient received corrective treatment with high doses of steroids. The patient recovered well and the yellow virus culture results are pending. The reporter did not report any further information regarding the events of meningitis and YEL-AND.


VAERS ID: 514418 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-22
Entered: 2013-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPATYP: HEP A + TYP (HEPATYRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Malaise, Typhoid fever
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0944927A

Write-up: This case was reported by a physician and described the occurrence of typhoid in a 21-year-old male subject who was vaccinated with HEPATYRIX (GlaxoSmithKline). Concurrent vaccinations included unspecified recommended travel vaccine given on an unspecified date. On an unspecified date prior to travel the subject received unspecified dose of HEPATYRIX (1 injection, unknown). The subject was traveling around on a long holiday. The physician reported that after an unspecified period of time, the subject took ill in the last week of his holiday and had contracted typhoid. He ws reported to have been admitted to hospital for four weeks once he arrived home. At the time of reporting the outcome of the events were was unspecified.


VAERS ID: 527772 (history)  
Form: Version 1.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2012-06-20
Onset:2012-12-17
   Days after vaccination:180
Submitted: 2014-04-07
   Days after onset:475
Entered: 2014-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPATYP: HEP A + TYP (HEPATYRIX) / GLAXOSMITHKLINE BIOLOGICALS G0326 / UNK UN / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. NP18230 / UNK UN / IM
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER G5399 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Aphasia, Basilar artery thrombosis, Computerised tomogram head abnormal, Coordination abnormal, Dizziness, Dysphagia, Ear pain, Eye pain, Eyelid ptosis, Hypoaesthesia, Neck pain, Pain, Quadriplegia, Visual impairment, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 12/16/2012, Blood pressure, 142/86 mmHg; Computerised tomogram, basilar arthery thrombosis; 12/16/2012, Heart rate, 82 bpm
CDC Split Type: WAES1404PRT003667

Write-up: Information has been received from Sanofi Pasteur MSD [MFR # E2014-02911] on 03-APR-2014. Case received from the Health Authorities on 28-MAR-2013 under the reference number C201403-108 via the local site Sanofi Pasteur MSD. The primary reporter was a physician. A 41-year-old male patient had received a dose of MMRII (batch number reported as NP18230), a dose of STAMARIL (batch number G5399-3) 0,5 ml and a dose of VIATIM (batch number G0326-7) 0,5 ml. All vaccines were administered via intramuscular route on 20-Juh-2012, in the context of traveller vaccination medical visit. On 14-Dec-2012, the patient developed unspecified symptoms i.e. vomiting, dizziness and numbness of the face. He took paracetamol and decided to lie down to rest. When he got up vomited in a jet for the first time. The next day he felt better, while retaining some dizziness and began to feel pain in the right ear and eye, with vision difficulties on that side. The symptoms worsened on the next day with onset of neck pain and severe pain on the right side. He went to hospital on 16-Dec-2012. Heart rate was at 82 bpm and blood pressure at 142/86 mmHg. He was treated with magnesium metamizol and thiocolchicoside intravenously, with a slight improvement. He was sent home with a prescription of paracetamol and thiocolchicoside. On the following day, i.e. 17-Dec-2012, the situation much worsened and the patient was sent to hospital in coma. CT scan was performed and revealed basilar artery thrombosis. Gastro-enteric diet therapy was instituted with enoxaparin 40 mg/day subcutaneously, lactulose 10g/day per os, hidraclorotiazide/amiloride 50 mg+5mg per day orally, pantoprazole 20 mg per day os, sertraline 50 mg/day orally and acetylsalicyclic acid 150 mg/day orally. The patient was hospitalized in the neurology medical services between 21-Dec-2012 and 20-Mar-2013, and was transferred to a medicine and rehabilitation center. At the time of reporting he was admitted in a continuing care center with poor prognosis and indication of unrecoverable. He presented with an incomplete tetraplegia with predominance on the right, hard grade 3/4 in limbs, bilateral eyelid ptosis and sharp right. He was conscious and cooperating. He presented with expressive aphasia and marked dysphagia. The Health Authorities mentioned that he "kept possible physiotherapy". The patient could move his four limbs, although uncoordinated. He responded to stimuli and understood what he was asked to do. He was completely dependent. There was a reference to a prescription on 20-Jun-2012 of mefloquine 20 mg tablets weekly per os, indicated in prophylaxis of malaria, but there was no certainty that the patient took the tablet. To be noted that the patient had no history of arterial hypertension, diabetes mellitus or dyslipidemia. He did not take any medication, had never been smoking, drank a glass of wine or beer during the meals, inconsistently. He did not present any of the known risk factors for cardiovascular events. He used to eat well, sometimes too much. He used to have a demanding profession in physical terms as he was a mason. His father died being hit by a car and his mother died over 70 years old and was hypertensive. The grandfather died aged more than 8 form a stroke and there was a reference to an episode type AIT not confirmed in the younger brother. He was not taking any concomitant medication. The outcome was persisting without recovery.


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