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Found 596268 cases in entire database

Case Details (Sorted by Age)

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VAERS ID:243511 (history)  Vaccinated:2005-07-01
Age:31.0  Onset:2005-07-04, Days after vaccination: 3
Gender:Female  Submitted:2005-08-29, Days after onset: 56
Location:Foreign  Entered:2005-08-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions: UNK
Diagnostic Lab Data: CT scan 2005 Normal, Cerebrospinal fluid(CSF)examinations, performed post vaccination: normal.
CDC Split Type: D0047364A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSUNK  UN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Injection site erythema, Myalgia, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of paresthesia in a 31 year old female subject who was vaccinated with hepatitis A-B vaccine for prophylaxis. On 7/1/05, the subject received the first dose of hepatitis A-B vaccine (1ml, unknown, left deltoid). Approximately three days post vaccination, on 7/4/05, the subject experienced injection site redness. At an unspecified time post vaccination, on an unknown date in July 2005, the subject experienced paresthesia and arthralgia in the area of the lumbar vertebrae, and myalgia. On 7/25/05 the subject was hospitalized for these events. No medical cause for these events was found. Cerebrospinal fluid examinations and computed tomogram scan were normal. The subject was treated with corticosteroid. The events improved. On 8/2/05, the subject was released from hospital after nine days. On 8/23/05, the subject still experienced myalgia in the upper and lower legs on stress.

VAERS ID:244522 (history)  Vaccinated:2003-02-19
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2005-09-23
Location:Foreign  Entered:2005-09-23
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 51 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Dipyrone, Ibuprofen
Current Illness: UNK
Preexisting Conditions: Drug intolerance, Headache, penicillin allergy
Diagnostic Lab Data: Blood typing O Rh positive, Coombs test negative, HIV test negative, Hemoglobin 6g/dl, lactate dehydrogenase 900 U/l, Lactate dehydrogenase 09/24/2005 1100u/l, thrombocyte count 09/2003 70000, Thrombocyte count 08/18/2003 8000, Thrombocyte count 20000, Drug screen on Sept 18 2003 negative for methadone, benzodiamine, cocaine, amphetamine, tetrahydrocanabiol, opiate, barbiturate, and tri cyclic anti depressive. laboratory examination in Sept 2003 negative for hepatitis A,B,C. laboratory examination on Oct 22 2003 hipa test and Elisa test for anti PF4/heparin antibodies did not indicate heparin induced thrombocytopenia. Extern laboratory investigation including all examinations of protease activity, thrombotic thrombocytopenic purpura caused
CDC Split Type: D0047511A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS202B6 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Anxiety, Aphasia, Ascites, Blood lactate dehydrogenase increased, Cerebral artery embolism, Cerebral ischaemia, Coma, Coordination abnormal, Delirium, Embolism, Encephalitis, Epistaxis, Fatigue, Hyperventilation, Laboratory test abnormal, Petechiae, Platelet disorder, Pleural effusion, Sensory disturbance, Speech disorder, Thrombocytopenia, Thrombocytopenic purpura, Visual disturbance
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Haematopoietic thrombocytopenia (narrow), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), 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), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of thrombotic thrombocytopenic purpura in a 30 year old female subject who was vaccinated with combined Hepatitis A, Hepatitis B vaccine (Twinrix adult) for prophylaxis. Concurrent medical conditions included penicillin allergy and intolerance to metoclopramide hydrochloride (Paspertin). Concurrent medications included ibuprofen and a single dose of dipyrone (Nov algin)due to headache. Previous unspecified vaccinations were well tolerated. On Feb 19 2003 the subject received 1st dose of Twinrix adult (intramuscular, left deltoid). Approximately for half a year, an unknown time after 1st vaccination with Twinrix adult, the patient felt tired and exhausted. Gynecologic and endocrinologic examinations were without pathologic findings. On March 26 2003 the subject received 2nd dose of Twinrix adult (intramuscular, left deltoid). On Sept 4 2003 the subject received 3rd dose of Twinrix adult (intramuscular). vaccination was without complications according to the hospital report. On Sept 16 2003, 12 days after 3rd vaccination, the subject experienced thrombocytopenia with a number thrombocytes of 8000 (unit unknown), and marked petechiae at thighs and lower legs. On Sept 19 2003 the subject also experienced progressive cerebral ischemia. The subject was hospitalized on Sept 18 2003. Physical examination showed petechiae at thighs and lower legs on both sides. Neurological examination (roughly orientating) showed left sided media symptomatic with aphasia (speech disturbance). The subject experienced fear disturbance with hyperventilation. Encephalitis was suspected. According to neurological examination on Sept 19 2003 media symptomatic began with sensory disturbance at the right arm. Sensory disturbance spread. Than the subject developed coordinative disturbance at the arm (sensible ataxia) and receptive and expressive speech disturbance. Embolism in the region of Arteria cerebri media and coma vigil was diagnosed. On Sept 19 2003 neurological symptoms were resolved. According to psychiatric examination on Oct 08 2003 the subject had experienced delirium. There was no schizo affective psychosis. Personality structure was histrionic. On account of clinical picture and laboratory parameters thrombotic thrombocytopenic purpura was diagnosed. The patient was treated with Schlodecortin, 4 times fresh frozen plasma and 6 times plasma exchange (plasmapheresis). Initially therapy was successful. The number of thrombocytes increased from 8000 to 70000. Lactate dehydrogenase increased to 900 U/L. On Sept 24 2003 there was a relapse of thrombotic thrombocytopenic purpura. The subject developed filmy vision and mild nose bleeding. Lactate dehydrogenase was persistently increased to 1100 U/L. The subject experienced thrombocytopenia of 20000. Sonography of abdomen on Sept 23 2003 showed ascites as well as distinct pleural effusions right and left. On Oct 22 2003 pleural effusions and free intra abdominal fluid was not detectable any more. Electroencephalography, computed tomography of skull and abdomen, radiography of thorax, sonography of neck vessel and thyroid gland, and ophalmologic examination showed normal findings. The subject was treated with plasma exchange (plasma pheresis) and vincristine (Vincristin) on Oct 22 2003. Clinical picture and laboratory parameters improved continually. Neurologic examination on Oct 27 2003 did not show sensomotor deficits. Fear of the future was in regression. On Nov 07 2003 the subject was discharged from hospital. According to the hospital report it was assumed that thrombotic thrombocytopenic purpura was due to auto antibody formation against ADAMT/13-protease. Hereditary genesis was excluded. Vaccination with Twinrix adult was not discussed as cause of the events. The regulatory authority reported that the events were life threatening. At the time of reporting the events were resolved with sequelae.

VAERS ID:245426 (history)  Vaccinated:2005-09-08
Age:31.0  Onset:2005-09-25, Days after vaccination: 17
Gender:Male  Submitted:2005-10-14, Days after onset: 19
Location:Foreign  Entered:2005-10-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: On 02Oct05, blood tests were performed which retrieved normal hematologic parameters including INR but increased values for aspartate aminotransferase (504 IU/L); normal range: below 33), alanine aminotransferase (2947 IU/L; normal range; below 44), gamma GT (285 IU/L; normal range; below 50), alkaline phosphatase (222 IU/L); normal range: below 122), total bilirubin (11.6 mg/dl) and direct bilirubin (9.2mg/dl). Epstein Barr serology was positive for IgG; cytomegalovirus serology was positive for IgG and slightly positive for IgM; herpes simplex virus serology was negative; hep B and c serology were negative and hep A serology was positive for IgM and IgG. On 05Oct05, repeated blood tests showed the following: white blood cell count: 6400/m
CDC Split Type: B0396559A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS    
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS    
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER    
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Gamma-glutamyltransferase increased, Headache, Hepatitis A, Jaundice, Laboratory test abnormal, Myalgia, Pruritus, Viral infection, White blood cell disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Liver infections (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Haematopoietic leukopenia (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of possible hep A in a 31 yr old male subject who was vaccinated with hep A vaccine (Havrix), hep B vaccine (Engerix B), poliomyelitis vaccine and unspecified for prophylaxis. Previous and/or concurrent vaccination included yellow fever vaccine given on 8Sept05. On 8Sept05 the subject received unspecified dose of Havrix (unk, no lot number provided), unspecified dose of Engerix B (unk, no lot number provided), unspecified dose of poliomyelitis vaccine (unk, no lot number provided). On 25Sep05, 17 days after vaccination with Engerix B, Havrix and Poliomyelitis vaccine, the subject experienced severe headache, itching and myalgia. The took dafalgan codeine (4 tablets) and ibuprofen (Brufen 2 tablets on first day, 3 tablets on second day and 3 tablets on third day). These events lasted for 4-5 days. On 01Oct05, he developed jaundice. On 02Oct05, blood tests were performed which retrieved normal hematologic parameters including INR but increased values for aspartate aminotransferase (504 IU/L); normal range: below 33), alanine aminotransferase (2947 IU/L; normal range; below 44), gamma GT (285 IU/L; normal range; below 50), alkaline phosphatase (222 IU/L); normal range: below 122), total bilirubin (11.6 mg/dl) and direct bilirubin (9.2mg/dl). Epstein Barr serology was positive for IgG; cytomegalovirus serology was positive for IgG and slightly positive for IgM; herpes simplex virus serology was negative; hep B and c serology were negative and hep A serology was positive for IgM and IgG. On 05Oct05, repeated blood tests showed the following: white blood cell count: 6400/mm3 with 57% Neutrophils and 26% Lymphocytes. Aspartate aminotransferases and Alanine aminotransferase had decreased but were still high with 120 IU/l and 1200 IU/l respectively. Lactate dehydrogenase was normal and Gamma GT were measured at 324 IU/L. Total bilirubin was 13.8 mg/dl and indirect bilirubin 10.9mg/dl. A diagnosis of probably hep a was made. This case was assessed as medically serious (OMIC) by manf. According to the physician, at the time of reporting the events were improved.

VAERS ID:246437 (history)  Vaccinated:2005-09-12
Age:31.0  Onset:2005-09-12, Days after vaccination: 0
Gender:Female  Submitted:2005-10-31, Days after onset: 49
Location:Foreign  Entered:2005-10-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0397922A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Blood bilirubin increased, Fatigue, Headache, Nausea, Paraesthesia
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (narrow), Peripheral neuropathy (broad), Biliary system related investigations, signs and symptoms (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by foreign authorities via a physician and described the occurrence of Meulengracht''s syndrome intermittent elevated bilirubin (intermittent icterus) in a 31 year old female subject who was vaccinated with hepatitis B vaccine for prophylaxis. On 9/12/05 the subject received a dose of Engerix B. On 9/12/05, 1 minute after vaccination with Engerix B, the subject developed Meulengracht''s syndrome intermittent elevated bilirubin (intermittent icterus), arm tingling, prickliness, headache, fatigue and nausea. This case was assessed as medically serious (OMIC). On 9/16/05, the events were resolved.

VAERS ID:248240 (history)  Vaccinated:0000-00-00
Age:31.0  Onset:0000-00-00
Gender:Male  Submitted:2005-11-28
Location:Foreign  Entered:2005-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: D0048096A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  IMRA
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Gamma-glutamyltransferase increased, Headache, Hepatic enzyme abnormal, Pneumonia, Pyrexia, Splenomegaly
SMQs:, Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)
Write-up: This case was reported by a physician and described the occurrence of pneumonia in a approximately 31 year old male subject who was vaccinated with hepatitis A vaccine (Havrix) for prophylaxis. On an unspecified date the subject received unspecified dose of Havrix 1440 route unknown. At an unspecified time after vaccination, the subject experienced severe headache and high fever. the subject was hospitalised (neurology) due to suspected meningitis. Meningitis could not be confirmed. The subject was transferred to the internal unit. Pneumonia and splenomegaly were diagnosed. Investigations showed increased liver enzymes (aspartate aminotransferase, alanine aminotransferase and gamma glutamyl transferase). Hepatitis A virus IgM antibody was positive. At the time of reporting the outcome of the events was unspecified.

VAERS ID:248691 (history)  Vaccinated:0000-00-00
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2005-12-02
Location:Foreign  Entered:2005-12-05, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Pregnant; No medical history reported.
Diagnostic Lab Data:
CDC Split Type: E200504952
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTIPV: DT + IPV (FOREIGN)PASTEUR MERIEUX INST.    
RAB: RABIES (RABIE-VAX)SANOFI PASTEUR    
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion induced, Foetal cystic hygroma, Urinary tract infection
SMQs:, Congenital, familial and genetic disorders (narrow), Foetal disorders (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Case reported through local Health Authorities (reference number : PS0500854) CRAT reference 20030332. Initial report on 23-Nov-05: It was reported that a 31 year old woman who was pregnant (estimated date of beginning of pregnancy 01-Feb-03) was administered a dose of Typhoid vaccine (Typhim Vi batch number not reported), 3 dose of rabies vaccine (Vaccine rabique batch number not reported) between 3.5 and 6,5 weeks of pregnancy and a dose of Td-acP-IPV-Hb-HepB vaccine (Revaxis batch number not reported) on an unspecified date. As an hygroma (reported also as urinary tract malformation) was diagnosed, it was decided to proceed to a therapeutic abortion on an unspecified date. To be noted that the file mentioned that the fetus outcome was evaluated as "death without any link with the vaccine." It has to be noted that the file is very poorly documented. No additional data are awaited. The case is closed. In this case reported as hygroma with urinary tract malformation leading to therapeutic pregnancy termination, the only vaccine for which dates of exposure were specified was rabies vaccine. As of the current knowledge no cases of malformations have been attribute to this vaccine, and the reference center on teratogen agents has assessed the events as non related to the vaccines. No clear exposure was reported for the 2 other vaccines. Upon medical review on 6 Dec 2005. The vaccine administered was not a Td-acP-IVP-HB-HepB vaccine (REVAXIS) as stated in initial version but a Td IPV vaccine (REVAXIS).

VAERS ID:253814 (history)  Vaccinated:2006-02-20
Age:31.0  Onset:2006-02-20, Days after vaccination: 0
Gender:Female  Submitted:2006-04-07, Days after onset: 45
Location:Foreign  Entered:2006-04-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: B0417158A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS   LA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Arthralgia, Chills, Decreased appetite, Epistaxis, Fatigue, Headache, Injection site erythema, Muscle twitching, Myalgia, Nasal oedema, Nausea, Night sweats, Paraesthesia, Pruritus, Sleep disorder, Tremor, Urticaria, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a consumer and described the occurrence of nausea in a 31 year old female subject who was vaccinated with hepatitis B vaccine (Engerix B) for prophylaxis. Follow up was received from physician. The subject was not aware of any allergy and she was not taking any other medication. On 1/17/2006 after the first vaccination the patient has reported night sweats and nausea which lasted 3 days. On 2/20/2006 the subject received 2nd dose of Engerix B (left arm). On 2/21/2006, one day after the second vaccination with Engerix B, the subject experienced nausea dry wrenching and vomiting. Furthermore the subject noted that she shaked and shivered like when ill. On 2/23/2006 she went to the hospital where she was admitted for four hours, then discharged and treated with metoclopramide hydrochloride (Maxolon). The subject experienced also injection site pruritus and redness which lasted two weeks, body itching, headache, stomach pain, decreased appetite, muscle pain especially in hands and feet which was increasing every day, sore throat, profuse sweating, blood in nose, sleep disturbance, weakness and fatigue in limbs, tingling in fingers or toes, twitching all over the body and joint pain, swelling of the inner side of the nose. At the time of reporting the events were ongoing. On 3/29/2006 this case was updated to serious due to hospitalisation although the subject has not been hospitalised overnight. On 4 April 2006 the seriousness was confirmed and is mentioned that the subject was feeling better. Further information is been requested.

VAERS ID:255207 (history)  Vaccinated:2006-04-06
Age:31.0  Onset:2006-04-10, Days after vaccination: 4
Gender:Female  Submitted:2006-05-05, Days after onset: 25
Location:Foreign  Entered:2006-05-09, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Endometriosis
Diagnostic Lab Data:
CDC Split Type: Waes0604AUS00203
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED090609401 IMUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0535R IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Headache, Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth, Musculoskeletal stiffness, Myalgia, Nausea, Skin burning sensation
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician, via another company, concerning a group of patients. On 4/6/2006 approximately 20 patients (confirmed as 16 patients in follow up information) at a small company were vaccinated with Pneumococcal 23v polysaccharide vaccine and influenza virus split virion 3v vaccine inactivated Fluvax at the same time in same arm via intramuscular injection. Subsequently nearly all patients experienced an adverse reaction ranging from localised injection site swelling and redness to fever and joint pain. The physician felt that the reactions were more severe than he generally sees and the fact that so many patients experienced as adverse reaction may indicate an issue with the batch of Pneumococcal 23v polysaccharide vaccine (lot 652720/0535R, Batch No G3836, Expiry date 12/6/2007) and or the batch of influenza virus split virion 3v vaccine inactivated Fluvax Batch no 090609401. Follow up information has been received from the physician concerning a 31 year old female with history of endometriosis who on 4/6/2006 was vaccinated with Pneumococcal 23v polysaccharide vaccine and included influenza virus split virion 3v vaccine inactivated Fluvax as stated above. On 4/10/2006 the patient experienced red hot painful swollen burning left arm, nausea, headache, muscle pain, joint pain and stiffness. At the time of reporting on 4/27/2006 the patient was recovering from red, hot, painful, swollen, burning left, nausea, headache, muscle pain, joint pain and stiffness. The physician considered that the patients red, hot, painful, swollen, burning left, nausea, headache, muscle pain, joint pain and stiffness were related to the batch of Pneumococcal 23v polysaccharide vaccine (lot 652720/0535R, Batch No G3836, Expiry date 12/6/2007) and or the batch of influenza virus split virion 3v vaccine inactivated Fluvax Batch no 090609401. The patients red, hot, painful, swollen, burning left, nausea, headache, muscle pain, joint pain and stiffness were considered to be other important medical events by the reporting physician. Additional information is not expected.

VAERS ID:258703 (history)  Vaccinated:2006-05-10
Age:31.0  Onset:2006-05-10, Days after vaccination: 0
Gender:Male  Submitted:2006-06-22, Days after onset: 43
Location:Foreign  Entered:2006-06-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Revaxis
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Alanine aminotransferase: 214U/l; Bilirubin total: 3g/l; Body temperature: 39 deg C; Abdominal palpation, performed on 5/22/06: soft and without pain. Abdominal sonography, performed on 5/22/06, under good echogenic conditions; Liver: slightly enlarged to 19cm, normal form, normal plasticity, internal structure normal, no detectable intrahepatic mass. Portal vein: free of echo, antegrade perfusion (17 cm/sec). Hepatic veins, right and left: three-phase blood flow. Gall bladder: well filled, thin walls and no concrements. Bile ducts: no dilatation (neither intrahepatic, nor extrahepatic). Pancreas: in all three sections normal. Spleen: enlarged to 4.9 cm in hilum of the spleen area. Kidneys, both sides: normal size (12 cm), normal form, no n
CDC Split Type: D0049754A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS    
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Blood bilirubin increased, Chills, Decreased appetite, Diarrhoea, Dizziness, Fatigue, Headache, Jaundice, Pyrexia, Tremor, Weight decreased
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of icterus in a 30 year old male subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine for prophylaxis. At the time of vaccination the subject was completely healthy. Co-suspect vaccination included the first dose of tick-borne encephalitis vaccine given on 5/10/06 at 07:30. Concurrent vaccination included diphtheria tetanus and poliomyelitis vaccine given on 5/10/06 at 07:30. Previous vaccination included unspecified diphtheria, tetanus + pertussis vaccine, last received in 1996. The subject has never before been vaccinated with tick-borne encephalitis, hepatitis A or hepatitis B vaccines. On 5/10/06 at 07:30, the subject received the first dose of Twinrix adult (1 ml, unknown, unknown thigh). At the same date and time, the subject received FSME immunization and Revaxis. Approximately four and a half hours post vaccination, on 5/10/06, the subject experienced post vaccination reaction with dizziness, tremor, shaking, chills, melalgia, and gonalgia right. Less than one day post vaccination, in the evening of 5/10/06, the subject experienced first episode of fever (39 degree C). Furthermore, the subject was bedridden and experienced headache and severe fatigue (washed out and tired). The subject was treated with paracetamol and aspirin. On 5/11/06 the events improved slightly, but the subject was still bedridden. On 5/12/06 the events improved distinctly, but the subject still experienced further episodes of fever, melalgia, headache and severe fatigue. Less than one week post vaccination, on an unknown date in May 2006, the subject also experienced reduced appetite and, subsequently, mild weight loss. The subject did not experience nausea, heartburn, belching, or gastrointestinal pain. Defecation was every 1-2 day with semiliquic consistency of faeces without admixtures. Approximately two days post vaccination with Twinrix adult, on 5/12/06, the subject also experienced first signs of icterus as symptom of cholestatic liver disease. This case was assessed as medically serious (OMIC). Approximately five days post vaccination with Twinrix adult, on 5/15/06, icterus has improved, but in laboratory examinations, the subject showed increased alanine aminotransferase (214 U/l) and increased total bilirubin (3 g/l). Otherwise, the subject was already in good general state of health on 5/15/06. On 5/18/06 the subject showed only mild fatigue, but no focal complaints. The subject never experienced any kind of injection site reaction (neither redness, nor swelling, nor pain). At the time of reporting, the overall outcome of improved icterus, cholestatic liver disease, increased alanine aminotransferase, increased total bilirubin and mild fatigue was unspecified. The reporting physician suspected that all events were symptoms of acute post vaccination reaction, which was most likely related to vaccination with FSME immunization, because acute reactions with fever with typical for post vaccination reactions caused by FSME immunizations. On the other side, cholestatic liver disease was on typical adverse event associated with vaccination with FSME immunization. Therefore, the reporting physician considered also the possibility that the events were associated to vaccination with Twinrix adult. No further information will be available.

VAERS ID:259004 (history)  Vaccinated:2005-12-20
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2006-06-29
Location:Foreign  Entered:2006-06-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Ectopic pregnancy
Diagnostic Lab Data:
CDC Split Type: WAES0601USA01597
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0350R2  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Unintended pregnancy
SMQs:, Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a health professional concerning a 31 yr old female with a history of an ectopic pregnancy (11Nov05: approx 4 wks gestation-as a result pt was given methotrexate while in hospital) who on 20Dec05 was vaccinated with a 10mcg third dose of hep B virus vaccine rHBsAg (yeast) (thimerosal free) (lot 651816/0350R). Suspect therapy included methotrexate since approx Dec 2005, and was advised not to become pregnant for 3 months. Subsequently the pt discovered that she was pregnant. Her LMP date was not reported. The pt did not experience any adverse effects following vaccination. This case will be followed up. Follow up information indicated that on an unk date in Dec 2005, the pt had a spontaneous abortion. It was reported that the pt was not pregnant at the time follow up (28Apr06). Upon internal review, spontaneous abortion was considered to be an other important medical event (OMIC). Other business partner numbers included: E200505472. This report was received by manf on 28Jun06.

VAERS ID:261566 (history)  Vaccinated:2005-06-10
Age:31.0  Onset:2005-07-15, Days after vaccination: 35
Gender:Female  Submitted:2006-08-11, Days after onset: 392
Location:Foreign  Entered:2006-08-15, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Pregnancy
Diagnostic Lab Data:
CDC Split Type: WAES0509USA00879
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion, Unintended pregnancy
SMQs:, Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a health professional concerning a 31 year old female with a history of tow previous pregnancies who on 6/10/05 was vaccinated with the first dose varicella virus vaccine live. It was reported that on 7/15/05, the pt began her third pregnancy. No adverse effects were reported. It was unknown if medical attention was sought. Follow up information indicated that the pt had a therapeutic termination of pregnancy because the fetus was diagnosed with Trisomy 21. It was specified that the therapeutic abortion was done at 13 weeks of amenorrhea. For the reported, this event was not related to the vaccine. No other details were provided. The case is closed. The event was considered to be an other important medical event (OMIC). Other business partner numbers included E200503397.

VAERS ID:262194 (history)  Vaccinated:2006-03-29
Age:31.0  Onset:2006-04-06, Days after vaccination: 8
Gender:Male  Submitted:2006-08-24, Days after onset: 140
Location:Foreign  Entered:2006-08-28, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: History of neurodermatitis.
Current Illness:
Preexisting Conditions: History of neurodermatitis.
Diagnostic Lab Data: Albumin 56 g/l.
CDC Split Type: E200604150
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Laboratory test abnormal, Neuritis, Neurodermatitis, Pain, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Hypersensitivity (broad)
Write-up: It was reported that a 30 year old man with a history of neurodermatitis was vaccianted IM with a dose of Typhoid VI polysaccharide vaccine Typhim VI, lot number not reported, and concomitantly with a dose of meningococcal vaccine, Menecvac, lot no not reported, on 3/29/06. On 4/5/06 he was additionally vaccinated IM with a dose of tick born virus encephalitis vaccine, Encepur lot number not reported. On 4/6/06 he experienced dysesthesia and hyperpathia ascending from the right fore leg to knee, thigh, buttock, hip and back. He was admitted to hospital on 4/10/06. ECG and EEG were normal. Lab findings not specified. including CSF were all normal except albumin (56g/l). Exhaustive physical neurological examination were carried out and were normal except described dysaesthesia and hyperpathia. The pt had some neurodermatitis efflorescences in the area of right thigh and groins (not supposed to be related to vaccination). Diagnosis of neuritis after vaccination was established. he was treated with Lyrica (pregabalin) and zinc cream (neurodermatitis efflorescences). The pt was discharged from hospital on 4/16/06. He recovered completely within 3 weeks. File closed.

VAERS ID:263608 (history)  Vaccinated:2006-08-17
Age:31.0  Onset:2006-08-17, Days after vaccination: 0
Gender:Male  Submitted:2006-09-26, Days after onset: 40
Location:Foreign  Entered:2006-09-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Body temp, 8/17/06: $g38 degrees C.
CDC Split Type: B0439551A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALSAC12B013BF IM 
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Injection site pain, Injection site swelling, Malaise, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of syncope in a 31 year old male subject who was vaccinated with tetanus and diphtheria toxoids absorbed for prophylaxis. On 8/17/06, the subject received unspecified doe of Ditanrix (IM, unknown injection site). On 8/17/06, 12 hours after vaccination with Ditanrix, the subject experienced syncope which resolved spontaneously after a few minutes. He developed general malaise, asthenia, and fever ($g38 degrees C). He also had pain and swelling at the injection site. This case was assessed as medically serious (OMIC). The subject was treated with nimesulide, hydration therapy (oral rehydration salts) and paracetamol. At the time of reporting the events were improved. The regulatory authority reported that the events were possibly related to vaccination with Ditanrix.

VAERS ID:263815 (history)  Vaccinated:1998-04-21
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2006-09-29
Location:Foreign  Entered:2006-10-02, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Muscle biopsy performed on 10/21/05 showed florid histological lesions of macrophagic myofasciitis associated with numerous lymphocytes.
CDC Split Type: E200604918
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (GENHEVAC B)SANOFI PASTEUR  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Back pain, Dysphagia, Fatigue, Fibrosis tendinous, Hearing impaired, Lymphocytosis, Muscle disorder, Myalgia, Myofascitis, Sensory disturbance, Sleep disorder, Visual disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hearing impairment (narrow), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: It was reported that a female pt born on 4/4/1968 received the third dose of hepatitis B vaccine (GenHevac B, batch number not reported) via IM route on 4/21/1998. She had received a dose of Yellow fever (manufacturer unk) on 8/28/97, a dose of typhoid vaccine (Typhim VI) on 9/27/97, a dose of hepatitis A (Havrix) on 9/17/97, the eighth dose of Hepatitis B vaccine Engerix B) in Nov 1997. Between late 1999 and early 2000 the pt developed diffuse myalgia, asthenia, muscle fatigability in the upper and lower limbs, pain in the vertebral column, sensorial, auditory and visual disorder, deglutition and sleep disorders. Macrophagic myofasciitis was diagnosed on 10/21/05 (see lab data). The pt received a dose of typhoid vaccine (Typhim VI) on 1/8/03 and a dose of meningococcal A,C,Y and W135 vaccine (Menomune) on 1/14/03.

VAERS ID:264287 (history)  Vaccinated:2004-09-10
Age:31.0  Onset:2004-09-10, Days after vaccination: 0
Gender:Male  Submitted:2006-10-05, Days after onset: 755
Location:Foreign  Entered:2006-10-11, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES0610USA00560
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Hypersensitivity, No reaction on previous exposure to drug, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health professional concerning a 31 year old male who on 9/10/04 was vaccinated with a second dose of hepatitis B (batch HBV5070). On 9/10/04 the pt developed an allergic reaction characterized by edema like and breathing disorder during the evening post vaccination. The pt was treated with corticosteroids and was not hospitalized. It was noted that he did not received adrenaline. His level of anti Hbs antibodies was neg after receiving a second dose. The first dose was well tolerated and given in June of 2004, Engerix B (Batch ENG5431A6). Subsequently, the pt recovered from the allergic reaction on an unspecified date. Another assay of anti Hbs antibodies performed 15 days ago showed neg results and no allergological test was performed. The health professional considered allergic reaction, breathing disorder and oedema like reaction to be other important medical events (OMIC). Other business partner numbers included E200604982. Additional information is not expected.

VAERS ID:265974 (history)  Vaccinated:2004-04-15
Age:31.0  Onset:2004-04-22, Days after vaccination: 7
Gender:Male  Submitted:2006-11-03, Days after onset: 925
Location:Foreign  Entered:2006-11-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 30 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: Guillain-Barr‚ caused by Flu shot
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUSHIELD)PFIZER/WYETH    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Guillain-Barre syndrome, Muscular weakness, Neck pain, Paralysis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Arthritis (broad)
Write-up: Pain in the neck, muscle weakness, arms paralysis.

VAERS ID:266863 (history)  Vaccinated:2005-07-14
Age:31.0  Onset:0000-00-00
Gender:Male  Submitted:2006-11-15
Location:Foreign  Entered:2006-11-15
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Thyroxine sodium
Current Illness: Gilberts syndrome.
Preexisting Conditions: Partial thyroidectomy, thyroid goiter, total thyroidectomy, no history of allergies, alcohol use 5 units week, tobacco use none.
Diagnostic Lab Data: Erythrocyte sed rate 9/7/06 8mm, FBC normal, thyroid function test normal, 9/7/06 urea and electrolytes normal, liver function tests normal except BN 25.
CDC Split Type: B0437324A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVA011AA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Amnesia, Blood bilirubin increased, Headache, Lethargy, Malaise, Pain
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Dementia (broad), Biliary system related investigations, signs and symptoms (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of short term memory loss in an adult male subject who was vaccainted with Hep B vaccine (Engerix B) for prophylaxis. Previous and or concurrent vaccination included Hep b vaccine IM given on 11/25/04 and 1/06/05. On 7/14/05 the subject received 3rd dose of Engerix B 20mcg, IM. 14 days after vaccination with Engerix B, the subject experienced short term memory loss, lethargy, general body pain, headache and feeling unwell. At the time of reporting the events were unresolved. This case is a pharmaceutical product complaint. Verbatim text received the pt received his third dose of Engerix B on 7/14/05, it was recorded that pt was fit and well. On 7/28/05 the pt phoned to say that he was feeling unwell. The pt experienced short term memory loss, extreme lethargy, multiple aches around the body (worse in the mornings) and vague headaches. The pt had the first dose of Engerix B (ENG45344C6, exp 5/05) on 11/25/04 and the second dose ENG45392A6, exp 6/05) on 1/6/05 and was well after both vaccinations. The doctor reported adverse events in three male pts who received this batch. For two of the pts it was their third dose and for the other pt it was the first dose. This case is linked to B0437323A and B0437325A. Follow up information received 11/6/06. The subject was noted to be 31 year old male. The subjects medical history included thyroid goiter and subsequent subtotal thyroidectomy at the age of 17, and total thyroidectomy at the age of 20. Concurrent medical conditions included Gilberts syndrome. The pt had no history of allergies or tobacco use. The pts alcohol use was 5 units per week. The pt had previously received 1st and 2nd dose of Engerix B without experiencing any adverse effects. Concurrent medications included thyroxine sodium (Thyroxine). On 7/14/05 the subject received 3rd dose of Engerix B 20 mcg, IM. 14 days after vaccination with Engerix B, the subject experienced short term memory loss, lethargy, general body pain, headache and feelin

VAERS ID:268235 (history)  Vaccinated:2005-11-02
Age:31.0  Onset:0000-00-00
Gender:Male  Submitted:2006-12-04
Location:Foreign  Entered:2006-12-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: A0629295A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER3FV26221  UN
Administered by: Other     Purchased by: Other
Symptoms: Febrile convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of fever between 39.0 to 40.0 C (102.2 to 104.8 deg F) in a 31 year old male subject who was vaccinated with Fluviral for prophylaxis. On 11/2/05 the subject received unspecified doe of Fluviral unk. At an unspecified time on or prior to 1/4/06, after vaccination with Fluviral, the subject experienced fever between between 39.0 to 40.0 C (102.2 to 104.8 deg F) and febrile seizure. This case was assessed as medically serious by manufacturer (OMIC). at the time of reporting the events were resolving.

VAERS ID:270157 (history)  Vaccinated:2006-12-01
Age:31.0  Onset:2006-12-01, Days after vaccination: 0
Gender:Male  Submitted:2007-01-08, Days after onset: 38
Location:Foreign  Entered:2007-01-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Salbutamol sulphate; Fluticasone + salmetrol
Current Illness:
Preexisting Conditions: Asthma
Diagnostic Lab Data:
CDC Split Type: B0453055A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTIPV: DT + IPV (FOREIGN)PASTEUR MERIEUX INST.  IM 
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Feeling hot, Hyperhidrosis, Hypoxia, Somnolence
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad)
Write-up: This case reported by a regulatory authority and described the occurrences of somnolence in a 31-year-old male subject who was vaccinated with meningicoccal polysaccharide groups A,C,W and Y (ACWY Vax), hepatitis A and polysaccharide typhoid vaccine for prophylaxis (Hepatyrix). Concurrent medical conditions included asthma. Concurrent medications included Salbutamol and Seretide. Co-suspect vaccine included Revaxis. On 1 December 2006 the subject received unspecified dose of ACWY vax (1 ml, intramuscular), unspecified dose of Hepatyrix (1 ml, intramuscular). On 1 December 2006, less than one day after vaccination with ACWY vax and Hepatyrix, the subject became very hot, perspiring, drowsy and did not improve with lying down. The regulatory authority reported that the events were clinically significant (or requiring intervention) (OMIC). The subject was treated with adrenaline and oxygen and was taken to A&E. Reported as possible anaphylaxis. On 1 December 2006, the events were resolved.

VAERS ID:272965 (history)  Vaccinated:2006-11-07
Age:31.0  Onset:2006-11-21, Days after vaccination: 14
Gender:Male  Submitted:2007-02-23, Days after onset: 94
Location:Foreign  Entered:2007-02-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: Electromyogram 18Jan2007 normal.
CDC Split Type: B0458467A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal rigidity, Electromyogram normal, Paraparesis
SMQs:, Acute pancreatitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: This case was reported by a physician and described the occurrence of paraparesis lower extremity in a 31 year old male subject who was vaccinated with Twinrix for prophylaxis. On 7 November 2006, the subject received 1st dose of Twinrix (intramuscular, unknown deltoid), lot number not provided. On 21 November 2006, 14 days after vaccination with Twinrix, the subject experienced paraparesis of lower extremities and unspecified abdominal spasms. The patient visited a neurologist who performed an electromyogram which was normal. The physician considered the vents were clinically significant (or requiring intervention). At the time of reporting the paraparesis was resolved and the spasms in abdominal area was unresolved.

VAERS ID:277484 (history)  Vaccinated:2007-03-22
Age:31.0  Onset:2007-03-22, Days after vaccination: 0
Gender:Male  Submitted:2007-04-26, Days after onset: 35
Location:Foreign  Entered:2007-04-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: MYCOSIS
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0466280A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB082ES IMLA
Administered by: Other     Purchased by: Other
Symptoms: Guillain-Barre syndrome, Headache, Muscular weakness, Nausea, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Vestibular disorders (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of Guillian Barre syndrome in a 31-year-old male subject who was vaccinated with Twinrix, OPV, diphtheria vaccine, and tick-borne encephalitis vaccine (FSME vaccination) for prophylaxis. Relevant medical history included a mycosis on the chest 2 weeks prior to the onset of the events. Previous and/or concurrent vaccination included Twinrix, (intramuscular) given on 7 February 2007. This dose had been unventful. On 22 March 2007 the subject received 2nd dose of Twinrix adult, (intramuscular, unknown). In March 2007 the subject received unspecified dose of Polio vaccine, unspecified dose of FSME and diphtheria vaccination (unknown). On 22 March 2007, 5 minutes after vaccination with Twinrix adult, 1 week after with FSME, diphtheria and Polio vaccine, the subject experienced nausea, vertigo and headache. After administration of an unspecified treatment a transitory improvement was noted, but as no general improvement occurred, the patient was hospitalised with a suspected diagnosis of Guillian Barre syndrome. During the night in the hospital, he experienced weakness in the legs. On 27 March 2007, the diagnosis of Guillian Barre syndrome was confirmed. He was treated with immunoglobulins leading to an improvement. At the time of reporting the events were improved.

VAERS ID:277810 (history)  Vaccinated:2006-07-05
Age:31.0  Onset:2006-07-05, Days after vaccination: 0
Gender:Female  Submitted:2007-05-02, Days after onset: 301
Location:Foreign  Entered:2007-05-03, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 14Jun06)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound 09Nov06 normal, diagnostic procedure "o/s scan showed echogenic bowel and 2 vc", ultrasound "showed echogenic bowel, single umbilical artery and nuchal thickening", serum varicella zoster virus antibody 21Jun06 negative, Apgar sc
CDC Split Type: WAES0608CAN00020
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Antibody test, Apgar score abnormal, Caesarean section, Drug exposure during pregnancy, Gastrointestinal disorder, Neonatal hypoxia, Premature separation of placenta, Single umbilical artery, Ultrasound scan abnormal, Ultrasound scan normal, Umbilical cord abnormality
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Congenital, familial and genetic disorders (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Neonatal disorders (narrow), Respiratory failure (broad)
Write-up: Information has been received from a physician for the Pregnancy registry for Varivax, concerning a 31 year old female with a history of 0 pregnancies and 0 live births who on 05-JUL-2006 was vaccinated with Varivax (no immunity to chicken pox). On 27-JUL-2006, the patient came back to her physician''s office and was determined to be 6 weeks pregnant (LMP 14-JUN-2006). The physician initially reported that there was no adverse effects. On 09-NOV-2006 patient had a normal ultrasound. It was also reported that the patient had an "o/s scan" (date not provided) which showed echogenic bowel + 2 vc. The patient also had an ultrasound (no dates provided) which showed echogenic bowel, single umbilical artery and muchal thickening. Patient was referred to genetic counseling. The physician stated that "the report of the ultrasound was normal except for single umbilical artery"; patient declined triple-maker screening (TMS). On 17-MAR-2007 the patient experienced placenta abruptio and underwent an emergency cesarean section. On 17-MAR-2007 patient delivered a male baby weighing 3035 grams, 39 weeks 4 days from LMP with umbilical cord 2 vessels, single umbilical artery, Apgar score test 5, 6 and 7. Obstetrician informed by telephone that newborn male may have suffered from hypoxia (current status unknown). The physician stated that the infant had no adverse event. Upon internal review, placenta abruptio was considered to be an other important medical event. No further information is available.

VAERS ID:281196 (history)  Vaccinated:2007-02-26
Age:31.0  Onset:2007-03-08, Days after vaccination: 10
Gender:Male  Submitted:2007-06-11, Days after onset: 94
Location:Foreign  Entered:2007-06-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Central nervous system function Mar2007 Normal, Erythrocyte sedimentation rate Mar2007 23mm/H, X-ray Mar2007 Normal
CDC Split Type: B0473831A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB123BC IMLA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEUR  IMUN
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEUR  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Central nervous system function test normal, Myelitis, Paraesthesia, Red blood cell sedimentation rate increased, X-ray normal
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of mild myelitis in a 31-year-old male subject who was vaccinated with Havrix, Diftavax and Stamaril for prophylaxis. On 26 February 2007, the subject received unspecified dose of Havrix (intramuscular, unknown injection site), unspecified dose of Diftavax (intramuscular, unknown injection site), unspecified dose of Stamaril (subcutaneous, unknown injection site). On 8 March 2007, 10 days after vaccination with Diftavax, Havrix and Stamaril, the subject experienced paresthesia of both legs. The subject was hospitalised and the regulatory authority considered the event was clinically significant (or requiring intervention). The laboratory tests performed were normal. Only erythrocyte sedimentation rate was increased (23 mm / H). X-ray and central nervous function test were normal. The diagnosis of mild myelitis was made. On 23 March 2007, the subject was discharged from hospital. At the time of reporting the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with Havrix, Diftavax and Stamaril.

VAERS ID:282300 (history)  Vaccinated:0000-00-00
Age:31.0  Onset:1996-09-01
Gender:Female  Submitted:2007-06-19, Days after onset: 3943
Location:Foreign  Entered:2007-06-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: POLLEN ALLERGY, RHINITIS
Diagnostic Lab Data: Anticardiolipin antibodies Positive, Antinuclear factor Positive, Cytomegalovirus serology Positive, Herpes simplex serology Positive, Rheumatoid factor Positive, Skin biopsy See lab text, Skin biopsy was suggestive of a toxidermia. Anti-RoSSA antibodies: positive at 1/80, Factor V Leyden: absence of mutation
CDC Split Type: B0475444A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  SCUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  SCUN
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEUR  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Antinuclear antibody positive, Asthma, Atrophy of tongue papillae, Biopsy skin abnormal, Bronchitis, Cardiolipin antibody positive, Cytomegalovirus serology, Herpes simplex, Herpes simplex serology positive, Mucosal erosion, Rash maculo-papular, Rheumatoid factor positive, Scab, Sicca syndrome, Skin lesion, Stevens-Johnson syndrome, Symblepharon
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Systemic lupus erythematosus (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Periorbital and eyelid disorders (narrow), Skin tumours of unspecified malignancy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was report by the Regulatory Authority and described the occurrence of Stevens Johnson syndrome in a 31-year-old female subject who was vaccinated with Havrix, GlaxoSmithKline, Typhim Vi, Sanofi Pasteur MSD and Stamaril, Sanofi Pasteur MSD for prophylaxis. The subject''s medical history included several rhinitis during her childhood. Concurrent medical condition included allergy to pollen. In 1996, the subject received an unspecified dose of Havrix (batch number not available, subcutaneous), an unspecified dose of Typhim Vi (batch number not available, subcutaneous) and an unspecified dose of Stamaril (batch number not available, subcutaneous). In September 1996, approximately 15 days after these vaccinations, the subject developed generalized maculopapular rash and scabbed skin lesions with mucosal erosion. The subject was hospitalised. Herpes simplex and cytomegalovirus serologies were positive. Skin biopsy was suggestive of a toxidermia. Anticardiolipin antibodies, rheumatoid factor and antinuclear factor were positive. Anti Rossa antibodies were positive at 1/80. Factor V Leyden showed an absence of mutation. Diagnosis of Stevens Johnson syndrome was made. At the time of reporting, the events were resolved with the following sequelae (loss of tongue papillae, sicca syndrome, symblepharon, asthma and several bronchitis). According to, the events were dubiously related to the vaccination with Havrix and co-suspects vaccines (Typhim Vi, Stamaril). No more information will be available. This case has been closed.

VAERS ID:282609 (history)  Vaccinated:2007-05-04
Age:31.0  Onset:2007-05-04, Days after vaccination: 0
Gender:Male  Submitted:2007-06-21, Days after onset: 48
Location:Foreign  Entered:2007-06-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0476080A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
TD: TETANUS DIPHTHERIA (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of fainting in a 31-year-old male subject who was vaccinated with Hepatyrix for prophylaxis. On 04 May 2007, the subject received unspecified dose of Hepatyrix and Revaxis (1 injection, intramuscular). On 04 May 2007, less than one day after vaccination with Hepatyrix and Revaxis, the subject fainted. The regulatory authority reported that the event was clinically significant (or requiring intervention). On 04 May 2007, the event had resolved.

VAERS ID:282842 (history)  Vaccinated:2007-05-04
Age:31.0  Onset:2007-05-04, Days after vaccination: 0
Gender:Male  Submitted:2007-06-25, Days after onset: 52
Location:Foreign  Entered:2007-06-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0476341A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  IM 
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority (MHRA) and described the occurrence of fainting in a 31-year-old male subject who was vaccinated with Hepatyrix, GlaxoSmithKline. On 4 May 2007 the subject received unspecified dose of Hepatyrix (intramuscular). On 4 May 2007, less than one day after vaccination with Hepatyrix, the subject fainting. This case was assessed as medically serious by GSK. On 4 May 2007, the event was resolved.

VAERS ID:285722 (history)  Vaccinated:2006-05-17
Age:31.0  Onset:2006-05-17, Days after vaccination: 0
Gender:Female  Submitted:2007-07-24, Days after onset: 433
Location:Foreign  Entered:2007-07-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Thyroxine sodium; Acyclovir
Current Illness: Unknown
Preexisting Conditions: The subject''s medical history and concurrent conditions were not reported.
Diagnostic Lab Data: UNK
CDC Split Type: A0607178A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Immediate post-injection reaction, Injection site erythema, Injection site streaking, Paraesthesia, Skin warm
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of redness of the hand in a 31-year-old female subject who was vaccinated with Twinrix for prophylaxis. Concurrent medications included Synthroid and acyclovir for unspecified indications. On 17 May 2006, the subject received 1st dose of Twinrix in an unspecified arm. The pharmacist reported that , "Immediately after the injection," on 17 May 2006, the subject''s, "hand turned red and the arm was warm. During the same day, one brown line appeared on the arm following the veins." The subject also experienced injection site redness. the red hand and warm arm resolved on 17 May 2006 and the brown line on the arm and the injection site redness resolved on 19 May 2006. The pharmacist considered the events to probably be related to vaccination with Twinrix. Follow-up received on 17 July 2007 via a regulatory authority indicated that the subject experienced paresthesia one minute after vaccination with Twinrix. The paresthesia resolved 24 hours after the onset of symptoms. This case was assessed as medically serious by GSK.

VAERS ID:291597 (history)  Vaccinated:1999-11-04
Age:31.0  Onset:1999-12-01, Days after vaccination: 27
Gender:Female  Submitted:2007-09-28, Days after onset: 2857
Location:Foreign  Entered:2007-09-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Scintigraphy Sep2005 see text, Scintigraphy Jun2007 see text In September 2005, bone scintigraphy confirmed enthesopathy of Achilles tendon insertions and sacroilitis. In June 2007, bone scintigraphy evidenced a marked worsening of sub- and
CDC Split Type: B0488315A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  UNRA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Enthesopathy, Juvenile arthritis, Musculoskeletal pain, Paraesthesia, Pericarditis, Sacroiliitis, Scintigraphy, Spondyloarthropathy
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Guillain-Barre syndrome (broad), Chronic kidney disease (broad), Arthritis (narrow), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by the regulatory authority and described the occurrence of pericarditis in a 31-year-old female subject who was vaccinated with Engerix B, GlaxoSmithKline for prophylaxis. The subject belongs to the association under reference 2182. On 4 November 1999, the subject received a first dose of Engerix B (unknown batch reference). In December 1999, the subject experienced paresthesia of lower limbs. From October 2001, she experienced episodes of pericarditis. From April 2002, she developed articular troubles. At an unspecified date, a diagnosis of Still''s disease or seronegative auto-immune pathology was evoked due to the association of rheumatism and pericarditis. Then enthesopathy, especially of right Achilles tendon insertion appeared. In September 2005, bone scintigraphy confirmed enthesopathy of Achilles tendon insertions and sacroilitis. In October 2005, she still presented chronic inflammatory rheumatism. In June 2007, bone scintigraphy evidenced a marked worsening of sub- and retro-calcaneus enthesopathies. Signs of sacroilitis observed in September 2005 were no more present. It was concluded to seronegative chronic inflammatory rheumatism related to a spondyloarthropathy with enthesopathy. This case was assessed as medically serious by GSK. At the time of reporting, the events were unresolved. According to the intrinsic imputability, the events were dubiously related to Engerix B. This case has been closed; no more information will be available.

VAERS ID:295503 (history)  Vaccinated:2007-04-18
Age:31.0  Onset:2007-04-18, Days after vaccination: 0
Gender:Female  Submitted:2007-11-05, Days after onset: 201
Location:Foreign  Entered:2007-11-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Methadone hydrochloride
Current Illness: Unknown
Preexisting Conditions: ALCOHOLISM, HEPATITIS C, OPIOID DEPENDENCE, POLYTOXICOMANIA, THIN For another event of same patient see case D0054924B (non serious).
Diagnostic Lab Data: Alanine aminotransferase 2007 3x higher; Alanine aminotransferase 2007 83U/l; Albumin 2007 2.6g/dl; Alkaline phosphatase 2007 213U/l; Alkaline phosphatase 2007 1.5x higher; Anti-HBc antibody 2007 negative; Aspartate aminotransferase 2007 3x
CDC Split Type: D0054924A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  SCLA
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Anti-HBc antibody negative, Aspartate aminotransferase increased, Asthenia, Blood albumin decreased, Blood alkaline phosphatase increased, Blood bilirubin increased, Blood cholinesterase decreased, Blood lactate dehydrogenase increased, Blood sodium decreased, Body temperature increased, C-reactive protein increased, Electrocardiogram normal, Flank pain, Gamma-glutamyltransferase increased, Haemoglobin increased, Hepatitis A antibody, Hepatitis A antibody negative, Hepatitis B antibody negative, Hepatitis C antibody positive, Hepatitis acute, Incorrect route of drug administration, Jaundice, Nausea, Ocular icterus, Protein albumin ratio, Prothrombin time, Red blood cells urine negative, Vomiting, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatitis, non-infectious (narrow), Liver infections (narrow), Acute pancreatitis (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Conjunctival disorders (narrow), Chronic kidney disease (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)
Write-up: This case was reported by a regulatory authority (Regulatory Authority (vaccines, biologicals) # DE-PEI-PEI2007009785) and described the occurrence of hepatitis with unknown aetiology in a 31-year-old female subject who was vaccinated with (Twinrix adult, GlaxoSmithKline) for prophylaxis. The subject''s medical history included hepatitis C. The subject''s medical history included alcoholism and polytoxicomania (intravenous abuse of heroin). Concurrent medical conditions included Methadone hydrochloride (Methadone). Previous vaccination included (Twinrix adult, GlaxoSmithKline, subcutaneous, unknown site of injection) given on 21 March 2007. Subcutaneous instead of intramuscular application was wrong route of administration. On 18 April 2007 the subject received 2nd dose of Twinrix adult (1 ml, subcutaneous, unknown application site). Subcutaneous instead of intramuscular application was wrong route of administration. Basic immunisation was incomplete. On 26 April 2007, 8 days after 2nd vaccination with Twinrix adult, the subject experienced acute hepatitis of unclear aetiology. As differential diagnosis toxic aetiology or activation due to known Hepatitis C or state after vaccination with Twinrix adult was considered. At the time of reporting PCR was negative for HCV-RNA. The subject was hospitalised for 17 days from 30 April to 05 May 2007. At hospital icterus at skin, scleral icterus, weakness, nausea, vomiting, flank pain and subfebrile body temperature were diagnosed. Bilirubin increased from 8.4 to 24. Values of hepatic enzymes were several fold increased than normal. There were no cyanosis and no peripheral edema palpable. At the time of reporting acute hepatitis and increased values of liver enzymes resolved spontaneously. No re-activation of acute hepatitis occurred. At the time of reporting the outcome of the other events was unspecified. The reporting physician reported that the events were possibly related to vaccination with Twinrix adult. According to hospital report vaccination with Twinrix adult was

VAERS ID:298018 (history)  Vaccinated:2003-11-14
Age:31.0  Onset:2003-11-28, Days after vaccination: 14
Gender:Female  Submitted:2007-11-28, Days after onset: 1461
Location:Foreign  Entered:2007-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Joint complaints, Psoriasis, Recurrent infection, Stress
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0496500A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Balance disorder, Body temperature decreased, Chronic fatigue syndrome, Disturbance in attention, Dizziness, Encephalopathy, Fatigue, Headache, Hypothyroidism, Influenza, Malaise, Muscular weakness, Myalgia, Palpitations, Pyrexia, Sleep disorder, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypothyroidism (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Chronic kidney disease (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a drug insurance pool source and described the occurrence of hypothyroidism in a 31-year-old female subject who was vaccinated with Twinrix GlaxoSmithKline for prophylaxis. Concurrent medical conditions included from 2 year-old psoriasis, later joint complaints. The subject presented recurrent infection and stress. Previous and/or concurrent vaccination included Twinrix (GlaxoSmithKline) given on 8 January 2003 and 26 March 2003. On 14 November 2003 the subject received 3rd dose of Twinrix (unknown). In November 2003, approximately 14 days after vaccination with Twinrix, the presented symptoms of chronic fatigue syndrome/myalgic encephalopathy. The subject had muscular pain, headache, sleeping problems including increased need for sleep as the subject felt tired. The subject''s immunological symptoms showed general illness feeling and flu-symptoms. The subject neurological symptoms showed dizziness, unsteadiness and muscular weakness. Cognitive failure showed exhaustion, some concentration problems and difficulty with exercises. the subject''s autonomic and neuroendocrine symptoms showed palpitation, drop in base temperature and changed temperature regulation with fever feeling. From 2004 the subject had hypothyroidism. in October 2006 the reporter statement concluded that the subject presented a chronic ewaustio syndrome and myalgic encephalopathy. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.

VAERS ID:301805 (history)  Vaccinated:2006-11-07
Age:31.0  Onset:2006-11-09, Days after vaccination: 2
Gender:Female  Submitted:2008-01-07, Days after onset: 424
Location:Foreign  Entered:2008-01-07
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: CT scan 29Nov2006 normal
CDC Split Type: B0501107A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Amyotrophy, Back pain, Cervical root pain, Computerised tomogram normal, Myalgia, Neuralgic amyotrophy
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a foreign regulatory authority and described the occurrence of Parsonage-turner syndrome in a 31-year-old female subject who was vaccinated with Engerix B for prophylaxis. On 07 November 2006 the subject received a booster dose of Engerix B (intramuscular). On 09 November 2007, two days after vaccination with Engerix B, the subject experienced back pain and paravertebral and brachial myalgia (cervicobrachialgia). On 26 November 2006, CT scan showed no anomaly. On 04 January 2007, as the patient presented with a slight amyotrophy of posterior fasciculus of right deltoid, Parsonage-turner syndrome was diagnosed. There was no muscle biopsy considered as required. The events resolved within an unspecified delay. The agency reported that the events were disabling and considered the events as dubiously related to vaccination with Engerix B, according to the foreign method of imputability. This case has been closed; no more information will be available.

VAERS ID:304972 (history)  Vaccinated:2004-07-22
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:Foreign  Entered:2008-02-14
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Hepatitis B surface antibody 05Mar2007 8IU/l
CDC Split Type: D0055937A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSENG5402B6 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Hepatitis B antibody, Musculoskeletal pain, No therapeutic response, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Lack of efficacy/effect (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of rheumatism joint pain in an approximately 32-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis. The subject was described as a normal healthy person. There was no concurrent medical condition or concurrent medication or any other risk factors. On 22 July 2004, 25 August 2004 and 19 January 2005 the subject received 3 doses of Engerix B (intramuscularly into an unspecified muscle). Approximately 2-3 months later, in spring 2005, the subject experienced rheumatism joint pain in hands, shoulders and knees. The pain remained some days at one location and then moved to another location. The subject was treated by a rheumatologist, but did not receive medication. The physician considered rheumatism joint pain as disabling. Initially it was reported that approximately half a year after vaccination with Engerix B, the subject was not responding to vaccination (hepatitis B surface antibodies were 8 U/l). On follow-up, received on 12 February 2008, it was reported that on 05 March 2007, 2 years after the 3rd vaccination with Engerix, the subject was not responding to vaccination. At the time of reporting rheumatism joint pain was improved, but with sequelae. The physician considered rheumatism joint pain was possibly related to vaccination with Engerix B.

VAERS ID:305486 (history)  Vaccinated:2008-02-04
Age:31.0  Onset:2008-02-06, Days after vaccination: 2
Gender:Male  Submitted:2008-02-22, Days after onset: 16
Location:Foreign  Entered:2008-02-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test unknown; Body temperature 06Feb2008 36.6deg C
CDC Split Type: B0508107A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test, Body temperature increased, Dysarthria, Gingivitis, Influenza like illness, Malaise, Tongue discolouration, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Gingival disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of blurred vision in a 31-year-old male subject who was vaccinated with Engerix B for prophylaxis. Previous and/or concurrent vaccination included hepatitis B vaccine recombinant given on July 2006 and April 2007. On 4 February 2008 the subject received 3rd dose of Engerix B. On 6 February 2008, 2 days after vaccination with Engerix B, the subject attended the occupational health nurse as he was feeling unwell, flu like symptoms and his body temperature was 36.6 deg C. He was send home but in the evening he experienced blurred vision and slurred speech therefore he was admitted to the causality where he was treated with ibuprofen (Bupren). The subject was discharged but then he developed white spots on his tongue and his gums became inflamed. The subject went to the general practitioner surgery where he was treated with metronidazole (Flagyl). On 12 February 2008 the subject felt still unwell and he was readmitted to hospital on 13 February 2008. Relevant test included blood test (results were pending). At the time of reporting the outcome of the events was unspecified.

VAERS ID:308641 (history)  Vaccinated:1995-08-02
Age:31.0  Onset:1998-05-27, Days after vaccination: 1029
Gender:Male  Submitted:2008-03-31, Days after onset: 3596
Location:Foreign  Entered:2008-03-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Biopsy muscle normal; Lumbar puncture 06Jun1998 normal; Nuclear magnetic resonance imaging 06Jun1998 normal
CDC Split Type: B0514312A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Biopsy muscle normal, Lumbar puncture normal, Myalgia, Neuropathy peripheral, Nuclear magnetic resonance imaging normal, Pyramidal tract syndrome, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of neuropathy in a 34-year-old male subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline), GENHEVAC B. Previous and/or concurrent vaccination included hepatitis B vaccine recombinant; GlaxoSmithKline; intramuscular; unknown given on 16 January 1995 and 18 February 1995. On 2 August 1995, the subject received a 3rd dose of ENGERIX B adult (20mcg, intramuscular, unknown). On 6 August 1996, the subject received a 4th dose of GENHEVAC B (intramuscular, unknown). On 27 May 1998, 33 months after vaccination with ENGERIX B adult, and 21 months after vaccination with GENHEVAC B, the subject reported leg myalgia, neuropathy and pyramidal syndrome. On 04 June 1998, MRI and lumbar puncture were normal and sleep disorder. The subject was hospitalised at an unspecified date. A muscular biopsy showed no macrophagic myofasciitis. On 21 August 2003, a sleeping test showed anomalies (NOS). The subject was treated with anti-epileptic medication and symptomatology improved. On 07 February 2008, no diagnosis had been made. Myalgia and neuropathies improved 6 months after initiation of REQUIP. At the time of reporting, myalgia, neuropathy and pyramidal were unresolved and outcome of sleep disorder was unknown. The agency considered the events as unlikely related to GENHEVAC B and ENGERIX B. This case has been closed; no more information will be available.

VAERS ID:315514 (history)  Vaccinated:2007-04-05
Age:31.0  Onset:2007-05-11, Days after vaccination: 36
Gender:Female  Submitted:2008-06-06, Days after onset: 392
Location:Foreign  Entered:2008-06-09, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Abortion spontaneous
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707USA00948
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a health professional concerning a 31 year old female who on an unspecified date in 2007 was vaccinated intramuscularly with a dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (batch #, lot#, route and site of administration not reported). The patient became pregnant 3 weeks after vaccination. No adverse effect was reported. Follow-up information received on 22-Aug-2007. It was reported that the woman was 31 years old at the time of the vaccination on 05-Apr-2007, LMP was 11-May-2007, 5 weeks post vaccination. No adverse effect reported. Relevant history included that the woman had 1 child, after an uncomplicated pregnancy, and 1 spontaneous abortion. Follow-up information received on 30-MAY-2008: The patient had an early spontaneous abortion before week 12. The patient had one spontaneous abortion previously. Case is closed. Other business partner numbers included: E2007-04267.

VAERS ID:316349 (history)  Vaccinated:1995-09-23
Age:31.0  Onset:1996-01-01, Days after vaccination: 100
Gender:Male  Submitted:2008-06-16, Days after onset: 4549
Location:Foreign  Entered:2008-06-16
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: In 2001, the subject was a soccer player and used to go cycling (mountain bike).
Diagnostic Lab Data: Neurological examination, Feb2008, see lab text; February 2008, Neurological examination showed: left upper limb paralysis and motor deficiency, decreased muscular strength of left arm at three fifth, left Babinski sign, reflex pyramidal sy
CDC Split Type: B0524731A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Extensor plantar response, Extrapyramidal disorder, Gait disturbance, Hemiparesis, Micturition urgency, Monoplegia, Motor dysfunction, Multiple sclerosis, Muscular weakness, Neurological examination abnormal, Polyneuropathy
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by the Regulatory Authority (numbers RE20080224 and RE0810161) and described the occurrence of multiple sclerosis in a 36-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject belongs to an association under number 2240. In 2001, the subject was a soccer player and used to go cycling (mountain bike). On 23 September 1995, the subject received a dose of ENGERIX B (batch number unknown). According to the subject, he presented with the first symptoms in the middle of 1996, approximately one year after vaccination with ENGERIX B. In 2001, he presented with progressive multiple sclerosis. In 2002 or 2003, he experienced walking difficulty with a walk perimeter inferior to 500 meters. In 2004, he presented with left hemiparalysis. On 01 April 2004, multiple sclerosis diagnosis was made. Since 2005, he was treated with COPAXONE. In 2006, the subject experienced sensory-motor brachiocrural hemiparalysis with a walking perimeter at 50 meters and a support. From 2008, the patient was treated with SOLUMEDROL every two months. In February 2008, neurological examination evidenced left upper limb paralysis and motor deficiency with decreased muscular strength of left arm at three fifth, left Babinski sign and reflex pyramidal syndrome. The subject presented with severe asthenia and pressing micturition, stable under DITROPAN. The Regulatory Authority reported that the events were disabling. At the time of reporting, the events were unresolved. The regulatory authority considered the events as unlikely related to vaccination with ENGERIX B, according to the country''s method of imputability.

VAERS ID:316409 (history)  Vaccinated:2008-04-29
Age:31.0  Onset:2008-04-29, Days after vaccination: 0
Gender:Female  Submitted:2008-06-17, Days after onset: 49
Location:Foreign  Entered:2008-06-17
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN
Current Illness: Fibroadenoma removal
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0524319C
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALSAC12B019BA IMRA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Malaise, Myalgia, Presyncope, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority (foreign regulatory authority # L200805-285) and described the occurrence of lipothymia in a 31-year-old female subject who was vaccinated with DITANRIX adult (GlaxoSmithKline). Concurrent medical conditions included fibroadenoma removal in 2007. Concurrent medications included ibuprofen given on 18 April 2008. There was no previous history of adverse reaction to other drug. Previous vaccinations included DITANRIX (GlaxoSmithKline) given on 3 September 1998 and 17 October 1998. After these 2 first doses (at unspecified time after vaccination), the subject experienced general malaise and lipothymia. See cases B0524319A and B0524319B for tolerance to these vaccinations. On 29 April 2008, the subject received 3rd dose of DITANRIX adult (intramuscular, unknown injection). On 29 April 2008, less than one day after vaccination with DITANRIX adult, the subject experienced lipothymia, near fainting, general malaise, febrile reaction (39.0 Deg. C.), joint pain, vomiting and myalgia. No local lesion and no laboratory findings observed. The adverse events became more intense whenever there were administration of this vaccine. The regulatory authority reported that the events were disabling and clinically significant (or requiring intervention) since the events motivated labour incapacity for 3-4 days. The subject was treated with metoclopramide and paracetamol. At the time of reporting the events were resolved.

VAERS ID:317253 (history)  Vaccinated:1995-02-01
Age:31.0  Onset:2003-01-01, Days after vaccination: 2891
Gender:Female  Submitted:2008-06-24, Days after onset: 2000
Location:Foreign  Entered:2008-06-24
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Antinuclear antibody, Mar2003, Positive; Nuclear magnetic resonance ima, 13Mar2003, Abnormal; Nuclear magnetic resonance ima, Aug2007, Abnormal; Physical examination, Jan2003, Abnormal; Virus serology test, Mar2003, Negative; March 2003, no
CDC Split Type: B0526183A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 3IMLA
Administered by: Other     Purchased by: Other
Symptoms: Antinuclear antibody positive, Hyperaesthesia, Hypoaesthesia, Multiple sclerosis, Nuclear magnetic resonance imaging abnormal, Sensation of heaviness, Sensory disturbance, Virus serology test negative
SMQs:, Peripheral neuropathy (narrow), Systemic lupus erythematosus (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Optic nerve disorders (broad), Demyelination (narrow)
Write-up: This case was reported by the regulatory authority (MP20080362) and described the occurrence of multiple sclerosis in a 31-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject belongs to an association under reference 2198. On 20 December 1993, 21 January 1994 and 28 February 1994, the subject received three injections of ENGERIX B (intramuscular, unspecified batch reference). In February 1995, the subject received the 4th dose of ENGERIX B (intramuscular, unknown batch reference). In January 2003, around 8 years after vaccination with ENGERIX B, the subject experienced first signs of multiple sclerosis with sensory disorders such as left lower limb numbness. The subject was treated with SOLUPRED, 20 mg, without any success. Clinical exam evidenced left lower limb hypoesthesia. On 13 March 2003, MRI evidenced medullar hypersignal at C5 and punctiform cerebral hypersignal. Biological tests were normal and virus serology tests were negative. Anti-nuclear antibodies were positive at 1/80 (flecked), at the limit of a significant result. In June 2003, a multiple sclerosis was diagnosed. On unspecified date, she presented with right arm heavy and hyperesthesia in right fingers. In August 2007, MRI did not reveal new signs. At this time, the subject was treated with COPAXONE. The subject was hospitalised and the regulatory authority reported that the events were disabling. At the time of reporting, the events were unresolved. The authority reported that the events were dubiously related to ENGERIX B vaccine, according to the foreign intrinsic imputability.

VAERS ID:319833 (history)  Vaccinated:2008-05-29
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2008-07-18
Location:Foreign  Entered:2008-07-21, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Rubella immunity confirmed
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807USA03155
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0673F1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Amenorrhoea, Blighted ovum, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (broad)
Write-up: Information was received from a health care professional concerning a 31-year-old female patient who on 29-Mar-2008 was vaccinated intramuscularly into the deltoid muscle with a second dose of MMR II (Lot # 654606/0673F, batch number NE65550) while pregnant. On 30-Jun-2008, the patient presented to the reporter as menstruation had been absent. The patient was pregnant (about 7th week of gestation). A twin pregnancy was diagnosed with one amniotic cavity smaller than the other and empty (blighted ovum). The estimated delivery date was 11-Feb-2009. The other amniotic cavity was normal and timely. In 1979 the patient received MMR II (manufacturer unknown), toleration was not reported. In 1992 rubella immunity was documented. Blighted ovum was considered to be an other important medical event. Other business partner numbers included E2008-06214.

VAERS ID:322067 (history)  Vaccinated:1994-05-09
Age:31.0  Onset:2000-07-01, Days after vaccination: 2245
Gender:Female  Submitted:2008-08-12, Days after onset: 2964
Location:Foreign  Entered:2008-08-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: HYPERTENSION ARTERIAL
Preexisting Conditions: APPENDECTOMY, JOINT LIGAMENT RUPTURE
Diagnostic Lab Data: Electromyogram, Sep2000, normal
CDC Split Type: B0532294A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS1172A6 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Balance disorder, Dysaesthesia, Electromyogram normal, Multiple sclerosis, Paraesthesia, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Vestibular disorders (broad)
Write-up: This case was reported by a foreign regulatory authority and described the occurrence of multiple sclerosis in a 37-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject''s medical history included appendectomy in 1971 and joint ligament rupture in 1988. Concurrent medical condition included hypertension arterial since 2001. Previous vaccinations included three doses of ENGERIX B on 19 November 1992, 21 December 1992 and 18 January 1993, intramuscularly (batch number 955D6, 911C6 and 859D6 respectively). On 09 May 1994, the subject received the fourth dose of ENGERIX B (intramuscular, batch number 1172A6). In July 2000, six years after vaccination with ENGERIX B, the subject presented with paresthesia and sensibility disturbances of fingers of both hands. In September 2000, canalis carpi syndrome diagnosis was mentioned but was ruled out because of a normal electromyogram. Until 2003, upper limbs dysesthesia was noticed, with fluctuating periods. At the beginning of 2003, the subject presented with instability on walking. In July 2004, multiple sclerosis diagnosis was made. A treatment with interferon beta-1a (Rebif) was initiated. In 2005, the patient experienced a new multiple sclerosis flare-up with walking disorders which tapered off in three months after treatment with bolus of corticoids. In 2006, as flare-up persisted and symptoms got worse, the subject was treated with COPAXONE. The foreign regulatory authority reported that the events were disabling. At the time of reporting, the events were unresolved. The agency considered multiple sclerosis as unlikely related to vaccination with ENGERIX B, according to the foreign method of imputability.

VAERS ID:325168 (history)  Vaccinated:2008-01-01
Age:31.0  Onset:2008-01-01, Days after vaccination: 0
Gender:Female  Submitted:2008-09-09, Days after onset: 251
Location:Foreign  Entered:2008-09-16, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Arthralgia
Preexisting Conditions: Infection
Diagnostic Lab Data: ophthalmological exam, ??Jan08, no pathologies; magnetic resonance imaging, 27Feb08, normal; serum B. burgdorferi Western blot IgM Ab, 06?Mar08, negative; cerebrospinal fluid culture, 06Mar08, normal
CDC Split Type: WAES0809USA00101
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Borrelia burgdorferi serology, Borrelia burgdorferi serology negative, CSF culture negative, Diplopia, Dizziness, Hypoaesthesia, Immunology test, Inappropriate schedule of drug administration, Nuclear magnetic resonance imaging normal, Ophthalmological examination normal, Paralysis, Vertigo, Visual disturbance
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), 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 (narrow), Ocular motility disorders (broad), Medication errors (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a 31 year old female consumer who in January 2008, was vaccinated with a third dose of GARDASIL. One to two weeks post-vaccination, she developed dizziness, double vision, numbness and paralysis. On 06-MAR-2008 she was admitted to a neurological department of a hospital. An infection was excluded in hospital. Dizziness and double vision were ongoing at the time of reporting. The outcome of numbness and paralysis was not reported. The first dose of GARDASIL was administered in July 2007, and the second dose of GARDASIL was in October 2007 and were well tolerated. The family physician was contacted and confirmed the events of the patient. A doctor''s report was sent indicating that the patient was hospitalized from 06-MAR-2008 to 08-MAR-2008. At the end of January 2008 the patient developed continuous vestibular vertigo with abnormal vision (rotating colored circles). She was referred to the ophthalmologist and the examination showed no pathologies. Approximately 14 days prior to hospitalization the patient experienced blurred vision and a few days prior she complained of weakness of both hands with mild hypoaesthesia. A Cranial MRI from 27-FEB-2008 and cerebro spinal fluid on 06-MAR-2008 showed normal results and an infectious genesis of the symptoms was ruled out. There was no indication of a chronic inflammatory CNS disease. Borrelia IgM was negative. The abnormal vision resolved in an unspecified time. Vestibular vertigo and blurred vision were ongoing. The outcome of hypoaesthesia and weakness was not reported. The patient had had a history of borreliosis in 2006, and since then recurrent arthralgia. Other business partner numbers included E2008-08099. Additional information has been requested.

VAERS ID:329779 (history)  Vaccinated:1991-01-20
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2008-10-19
Location:Foreign  Entered:2008-10-23, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OIF-2 2003-2005
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Headache - pain in both legs, cramps
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Unknown
Symptoms: Headache, Muscle spasms
SMQs:, Dystonia (broad)
Write-up: Sever headache, legs (conjunctions) cramps

VAERS ID:336315 (history)  Vaccinated:2008-08-29
Age:31.0  Onset:2008-08-29, Days after vaccination: 0
Gender:Female  Submitted:2008-12-30, Days after onset: 123
Location:Foreign  Entered:2008-12-31, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0810USA02053
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0975R IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ10481 IMLA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURZ10481 IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chills, Dizziness, Dyspnoea, Hyperhidrosis, Loss of consciousness, Nausea, Retching, Vaccination complication
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a physician from a local health authority concerning a 31 year old female patient who on 29-AUG-2008 was vaccinated with a dose of REVAXIS (lot #Z1048-1) into the left deltoid muscle. Simultaneously, the patient was vaccinated with a dose of RECOMBIVAX HB (batch #ND36080/lot# 6553198/0975R, expiry date August 2008) IM into the right deltoid muscle. Four to eleven hours post vaccination (on 29-AUG-2008) the patient chills, sweating, nausea, retching, dyspnea and dizziness. Eleven hours post vaccination the patient lost consciousness for 20 minutes. The patient was not hospitalized. A contacted emergency physician diagnosed a "usual" vaccination reaction. The patient completely recovered after 2 days. It was reported that the patient experienced unconsciousness for twenty minutes in the night after vaccination. She called the emergency doctor who did not come. The patient was not admitted to a hospital for clarification of the etiology of the unconsciousness. No information was available because there was no doctor''s report. the other symptoms were also not verified by a physician. Upon internal review on 18-DEC-2008, this case was upgraded because of the serious adverse event "consciousness loss" as an other medical important event. Other business partner numbers included: E2008-08507. Additional information is not expected. Case is closed.

VAERS ID:337200 (history)  Vaccinated:2008-09-19
Age:31.0  Onset:2008-11-05, Days after vaccination: 47
Gender:Female  Submitted:2009-01-13, Days after onset: 69
Location:Foreign  Entered:2009-01-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: MYASTHENIA GRAVIS
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0060106A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB127CA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Myasthenia gravis
SMQs:
Write-up: This case was reported by a regulatory authority (#DE-PEI-PEI2008020987) and described the occurrence of exacerbation of myasthenia gravis in a 31-year-old female subject who was vaccinated with TWINRIX ADULT (GlaxoSmithKline). Previous vaccination included FSME IMMUNE (Baxter BioScience) given on 23 May 2007 (unknown route and application site). Concurrent medical conditions included myasthenia gravis since the beginning of June 2007. On 19 September 2008 and 17 October 2008 the subject received a dose of TWINRIX ADULT (unknown route and application site). On 5 November 2008, 19 days after 2nd vaccination and 47 days after 1st vaccination with TWINRIX ADULT, the subject experienced a myasthenia gravis episode. This diagnose was confirmed by NMR, cerebrospinal fluid puncture and neurological examination. Paralysis of other genesis was excluded. The subject was hospitalised for an unspecified period of time. According to the questionnaire provided by the regulatory authority symptoms were unresolved at the time of reporting on 24 December 2008 and the subject suffered from sequela. No further information will be available.

VAERS ID:337656 (history)  Vaccinated:1998-04-01
Age:31.0  Onset:2008-08-01, Days after vaccination: 3775
Gender:Female  Submitted:2009-01-19, Days after onset: 171
Location:Foreign  Entered:2009-01-20, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Herpes simplex; smoker; VON WILLEBRAND''S disease
Preexisting Conditions: Duodenal ulcer; herpes zoster
Diagnostic Lab Data: Skin biopsy, Aug2008, abnormal
CDC Split Type: B0553251A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Biopsy skin abnormal, Dermatofibrosarcoma, Injection site erythema, Injection site irritation, Injection site nodule
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Extravasation events (injections, infusions and implants) (broad), Skin malignant tumours (narrow), Skin tumours of unspecified malignancy (broad), Non-haematological malignant tumours (narrow)
Write-up: This case was reported by a regulatory authority (# NO-NOMAADVRE-FHI-2009-7027) and described the occurrence of dermatofibrosarcoma in a 41-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). The subject''s medical history included duodenal ulcer and herpes zoster. Concurrent medical conditions included herpes simplex, smoker since 21 years (15 cigarettes daily at the time of reporting) and Von Willebrand''s disease. In April 1998, the subject received unspecified dose of HAVRIX (parenteral, unknown injection site). At an unspecified time after vaccination, the subject experienced injection site redness and irritation for weeks. There was a red/brown spot of about 2 mm in diameter at the injection site. In 1998, some weeks after vaccination, the subject made a skin tattoo around the injection site. At that time, the skin was still irritated and red. In spring 2008, the red spot grew larger in course. In August 2008, a biopsy was performed and revealed a dermatofibrosarcoma protuberans and an injection site granuloma. The subject was hospitalised and the regulatory authority reported that the events were life threatening. In October 2008, a surgery was performed. At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with HAVRIX.

VAERS ID:341183 (history)  Vaccinated:1995-09-23
Age:31.0  Onset:0000-00-00
Gender:Male  Submitted:2009-03-05
Location:Foreign  Entered:2009-03-05
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Citalopram hydrobromide; PRAZEPAM; Fluoxetine hydrochloride
Current Illness: Alcohol use; Anxiodepressive syndrome; Chronic smoking; Depressive syndrome; Hyperleukocytosis; Transaminases increased
Preexisting Conditions: Family medical history included colic neoplasia and chronic alcoholism in subject''s father. Previous vaccination included diphtheria, tetanus, poliomyelitis vaccine in 1965, smallpox vaccine in 1966. Boosters of diphtheria, tetanus, poliomyelitis vaccine were done in 1981, 1982, 1995 and 1996 without any problem.
Diagnostic Lab Data: Alanine aminotransferase, Feb2005, 51; Albumin CSF, Apr2004, 324mg/l; Angiotensin converting enzyme, Apr2004, negative; Anti-DNA antibody, Apr2004, negative; Antinuclear antibody, Apr2004, negative; Blood electrolytes, 26Jun2006, normal; Bo
CDC Split Type: B0561339A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNLA
Administered by: Other     Purchased by: Other
Symptoms: Abasia, Activities of daily living impaired, Alanine aminotransferase increased, Albumin CSF abnormal, Angiotensin converting enzyme, Antinuclear antibody negative, Anxiety, Asthenia, Balance disorder, Blood albumin, Blood electrolytes normal, Borrelia burgdorferi serology negative, C-reactive protein normal, CSF protein, CSF protein normal, Cerebellar syndrome, Clumsiness, Cognitive disorder, Complement factor C3, Complement factor C4, Condition aggravated, Congenital joint malformation, Cranial nerve disorder, Cryoglobulins absent, DNA antibody negative, Demyelination, Diplopia, Disability, Dysarthria, Dyskinesia, Dysphagia, Dysphemia, Dysphonia, Erectile dysfunction, Extensor plantar response, Fall, Fatigue, Full blood count normal, Fundoscopy normal, Gait disturbance, Gait spastic, Gamma-glutamyltransferase increased, HIV test negative, Hemiparesis, Hepatitis A antibody positive, Hepatitis B antibody positive, Hepatitis B surface antigen positive, Hepatitis C test negative, Hyperreflexia, Hypertonia, Hypoaesthesia, Irritability, Lhermitte's sign, Limb immobilisation, Liver disorder, Liver function test abnormal, Lumbar puncture, Lymphocyte count decreased, Lymphocytosis, Memory impairment, Mental disorder, Micturition disorder, Micturition urgency, Motor dysfunction, Multiple sclerosis, Muscle spasticity, Nuclear magnetic resonance imaging brain abnormal, Nystagmus, Ophthalmoplegia, Optic neuritis, Pallor, Paraesthesia, Paresis, Positive Rombergism, Protein total normal, Pulmonary function test, Pyramidal tract syndrome, Rheumatoid factor negative, Scan brain, Sleep disorder, Speech disorder developmental, Syphilis test, Syphilis test negative, Transaminases increased, Urethral intrinsic sphincter deficiency, Urodynamics measurement, Urological examination abnormal, Vision blurred, Visual acuity reduced, Visual evoked potentials abnormal, Visual impairment, Wheelchair user, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver infections (narrow), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hostility/aggression (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Ocular infections (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by GSK Legal department and described the occurrence of multiple sclerosis in a 32-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject''s medical history included appendectomy in 1972 and sprained foot at 30-year-old. Concurrent medical conditions included chronic smoking (20 pack-year) and alcohol use. Family medical history included colic neoplasia and chronic alcoholism for the subject''s father. Previous vaccination included Dt-Polio in 1965, smallpox vaccine in 1966. Boosters of DT-Polio were done in 1981, 1982, 1995 and 1996 without any problem. On 05 April 1995, the subject received a first dose of ENGERIX B (dosage, injection site and batch unknown). On 03 May 1995, the subject received a second dose of ENGERIX B (dosage, injection site and batch unknown). On 23 September 1995, according to the subject''s wife the subject received a dose of Hep B (unknown batch, manufacturer and injection site). During spring 1996, according to the subject''s wife the subject experienced balance disorder, unable to walk straight, stammer and left side limping. According to the physician these events were related to working condition and sequels of ankle wound due to sport practice. In 2001, about 6 years after vaccination with ENGERIX B, the subject experienced optic neuritis retrobulbar, associated with balance disorder. In 2002 and 2003, the subject started to experience walking difficulty with walk perimeter decreased (less than 500m). EDSS was less than 4.5. In February 2004, the subject experienced diplopia. On 24 February 2004, ophthalmologic exam evidenced right nystagmus, adiadochokinesia and abnormal gait. Optic fundi and visual fields were normal. In February 2004, the subject experienced left side blurred vision with horizontal diplopia. On 02 March 2004, cerebral scan was normal. A physical examination was performed by a neurologist gait disorder, positive Romberg''s sign, axial cerebellar syndrome and right eye adduction paresis. There was no Lhermitte sign

VAERS ID:344763 (history)  Vaccinated:2007-06-18
Age:31.0  Onset:2007-06-18, Days after vaccination: 0
Gender:Female  Submitted:2009-04-23, Days after onset: 675
Location:Foreign  Entered:2009-04-24, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 23May07)
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, scan at 11 weeks gestation and the baby had died at 5 weeks gestation
CDC Split Type: WAES0708USA02360
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTIPV: DT + IPV (FOREIGN)PASTEUR MERIEUX INST.  UNUN
HEPA: HEP A (VAQTA)MERCK & CO. INC.  UNUN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURERA53238 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Intra-uterine death, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Information has been received from a health care professional concerning a 31 year old pregnant female who on approximately 18-JUN-2007 was vaccinated with VAQTA (Manufacturer unknown). Concomitant therapy included STAMARIL (Batch #A5323-8), REVAXIS and typhoid vaccine (manufacturer unknown). Following the vaccinations the patient was found to be pregnant at approximately three weeks gestation at the time of STAMARIL vaccination. The last menstrual period was 23-MAY-2007. There was no other history reported. There was no adverse effect reported. Follow-up information received from a health care professional on 17-APR-2009. This case has been upgraded from non serious to serious. The patient weighed 89kg. The patient had no maternal risk factors and no recreational drug use. There were no previous pregnancies. The patient did not receive any fertility treatment. The patient underwent a scan at 11 weeks gestation and was informed that the baby had died at five weeks gestation. The patient then experienced a miscarriage in July 2007. The reporter considered the events to be serious. Other business partner numbers include E200704347 and 55997.

VAERS ID:345039 (history)  Vaccinated:2007-06-18
Age:31.0  Onset:2007-07-01, Days after vaccination: 13
Gender:Female  Submitted:2009-04-27, Days after onset: 666
Location:Foreign  Entered:2009-04-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Pregnant, LMP date: 23/MAY/07 Sex: Female. The patient weighs 89 kg. The patient had no maternal risk factors and no recreational drug use. No previous pregnancies. The patient did not received any fertility treatment.
Diagnostic Lab Data:
CDC Split Type: E200704347
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR  UNUN
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEUR  UNUN
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURA5323 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: This is a pregnancy follow up case with no adverse effect reported. This case was initially reported by a health care professional on 02-Jul-07 (no: 55997). This case concerns a 31 year old female patient. On 18-Jun-07, the patient received STAMARIL, batch number A5323-8. The patient also received REVAXIS, batch number not reported and a Hepatitis A vaccine and typhoid vaccine around the same time (exact date not reported). Following the vaccinations, the patient was found to be pregnant at approximately three weeks gestation at the time of the STAMARIL. The date of the last menstrual period was 23-May-07. Follow-up information received from a health care professional on 17-Apr-09. This case has been upgraded from non serious to serious. The patient weighs 89 kg. The patient had no maternal risk factors and no recreational drug use. There were no previous pregnancies. The patient did not received any fertility treatment. The patient underwent a scan at 11 weeks gestation and was informed that the baby had died at five weeks gestation. The patient then experienced a miscarriage in Jul-07. The reporter considered the events to be serious.

VAERS ID:349802 (history)  Vaccinated:0000-00-00
Age:31.0  Onset:0000-00-00
Gender:Male  Submitted:2009-06-22
Location:Foreign  Entered:2009-06-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Flu-like symptoms
Preexisting Conditions:
Diagnostic Lab Data: angiography, Fluorescein angiography: numerous placoid lesions occupying the entire posterior pole
CDC Split Type: WAES0906USA02467
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Angiogram abnormal, Eye disorder, Influenza like illness, Retinal deposits, Retinal pigment epitheliopathy, Visual acuity reduced, Vitritis
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (narrow), Ocular infections (narrow)
Write-up: Information has been received from the author of a literature article, title stated above, concerning a 31 year old male patient, who had no particular preceding pathology, consulted (a clinician) because of a sudden bilateral drop in visual acuity in a flu-like setting. Questioning revealed vaccination against hepatitis B three days previously. Ophthalmological examination found a visual acuity of counting fingers in the left eye and 2/10 in the right eye. In the fundus oculi, there was low-density hyalitis, with multiple white-yellowish confluent retinal foci, predominantly in the right eye, without associated vascularity. Fluorescein angiography showed numerous placoid lesions occupying the entire posterior pole. These lesions were hypofluourescent at the early phase and hyperfluorescent at the late phase. The patient was placed on corticotherapy at full dose for 20 days, then rapidly tapering. Six months later, the visual acuity rose again to 6/10 in the right eye and 9/10 in the left eye. Only some atrophic, cicatricial lesions persisted. Upon internal review, placoid pigment epitheliopathy was considered to be an other important medical event. No further information available. A copy of the published article is attached as further documentation of the patient''s experience.

VAERS ID:351577 (history)  Vaccinated:2009-06-27
Age:31.0  Onset:2009-06-30, Days after vaccination: 3
Gender:Male  Submitted:2009-07-15, Days after onset: 15
Location:Foreign  Entered:2009-07-16, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: spinal tap, 04?Jul09, 130 elements/mm3, especially lymphocytes; cerebrospinal fluid analysis, 04?Jul09, negative results for herpes; cerebrospinal fluid analysis, 04?Jul09, negative results for listeria; cerebrospinal fluid analysis, 04?Jul
CDC Split Type: WAES0907USA01397
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  UNUN
RAB: RABIES (IMOVAX)SANOFI PASTEUR 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: CSF lymphocyte count increased, Fatigue, Headache, Lumbar puncture abnormal, Meningitis viral, Polymerase chain reaction, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Malignant lymphomas (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case received from a health care professional in country on 08-JUL-2009: A 31 year old male patient received the first dose of IMOVAX and a dose of RECOMBIVAX HB (manufacturer unknown, lot not reported) on 27-JUN-2009 and three days later, on 30-JUN-2009, he was febrile and had cephalgia. One week post vaccination, the patient went to the physician''s office to received the second dose before going round the world but the second dose was not administered because presence of fever, fatigue and cephalgia. Lumbar punction was performed and showed130 elements/mm3, especially lymphocytes (normal <10 elements/mm3). Viral and bacterial work up was performed in cerebrospinal fluid and found negative results for herpes, listeria, HIV, bacteriae and PCR enterovirus. The patient was diagnosed with lymphocytic meningitis. No aetiology was found at the time of reporting. Lymphocytic meningitis was considered by the reporter as other important medical event. Other business partner numbers include E2009-05806.

VAERS ID:352226 (history)  Vaccinated:2009-06-12
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2009-07-22
Location:Foreign  Entered:2009-07-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0907USA02892
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.NH45170 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Computerised tomogram, Headache, Meningitis, Nuclear magnetic resonance imaging, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health professional on 13-JUL-2009: It was reported by a gynecologist that a 31 year old female who had been marginally vaccinated in the past, was vaccinated with MMR II ( lot#NH45170) injection route not reported, into the upper arm on 12-JUN-2009. Subsequently, on an unspecified date p. v. the patient experienced fever to 40 degree C. she was hospitalized for 4 weeks because of "initiating" meningitis. No lumbar puncture was carried out. MRI and CT were carried out. Results were unknown by the reporter. At the time of report, the patient still complained of headache. Relevant test/lab data: MRI and CT: results unknown. Other business partner numbers included E2009-05860. Additional information has been requested.

VAERS ID:354025 (history)  Vaccinated:2009-04-14
Age:31.0  Onset:2009-04-15, Days after vaccination: 1
Gender:Female  Submitted:2009-08-12, Days after onset: 119
Location:Foreign  Entered:2009-08-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: carotid artery ultrasound, ??09, normal; magnetic resonance imaging, ??09, normal; activated coagulation time, ??09, normal
CDC Split Type: WAES0908USA01516
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Coagulation time normal, Hypoaesthesia, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Ultrasound Doppler, Ultrasound scan normal
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Information has been received from the Foreign Health Authority, reference number ES-AGEMED-825347132, concerning a 31 year old female who on 14-APR-2009 was vaccinated with a dose of GARDASIL. 24 hours after vaccination, on 15-APR-2009 the patient presented with a left hemihypoesthesia which she recovered from on the 16-APR-2009. In the Health Authority''s report, hypoesthesia has been coded. On 2009 (exact date not reported) a cranial MRI was performed along with a carotid sonogram and a coagulation test to rule out a possible systemic illness, results were all normal. Case reported serious by the Foreign Health Authorities with other medically important condition as criteria. Other business partner number included E200907841. Case is closed.

VAERS ID:358514 (history)  Vaccinated:2009-08-20
Age:31.0  Onset:2009-08-21, Days after vaccination: 1
Gender:Male  Submitted:2009-09-28, Days after onset: 38
Location:Foreign  Entered:2009-09-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Alanine aminotransferase, 31Aug2009, 138U/l; Bilirubin, 31Aug2009, 2.64mg/dl; Body temperature, 21Aug2009, up to 39degC; Erythrocyte sedimentation rate, 31Aug2009, 17/43; Gamma GT, 31Aug2009, 138U/l; Hepatitis C antibody, 2009, negative; Li
CDC Split Type: D0062994A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB106AC3IMUN
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Blood bilirubin increased, Body temperature increased, Gamma-glutamyltransferase increased, Hepatitis C antibody negative, Jaundice, Liver function test normal, No reaction on previous exposure to drug, Paraesthesia, Performance status decreased, Pyrexia, Red blood cell sedimentation rate increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority (DE-PEI-PEI2009020507) and described the occurrence of jaundice in a 31-year-old male subject who was vaccinated with TWINRIX ADULT (GlaxoSmithKline). Previous 3 vaccinations with TWINRIX ADULT in 1999 were well tolerated. On 20 August 2009 the subject received 4th dose of TWINRIX ADULT (intramuscularly, unknown deltoid). Approximately on 21 August 2009, 1.5 to 2 days to after vaccination with TWINRIX ADULT, the subject experienced jaundice, fever (up to 39 degC), mild paresthesia skin and deterioration of performance status. The reporting physician considered this could be due to a possible "viral infection which coincided by chance or be a consequence of the vaccination". This case was assessed as medically serious by GSK. Liver values were normal on 21 August 2009. On 31 August 2009 Bilirubin was 2.64 mg/dl, Alanine aminotransferase was 138 U/l, Gamma GT was 138 U/l and Erythrocyte sedimentation rate was 17/43. Hepatitis C infection was excluded. At the time of reporting, on 10 September 2009, the events were improved. No further information will be available.

VAERS ID:360609 (history)  Vaccinated:2009-09-09
Age:31.0  Onset:2009-09-29, Days after vaccination: 20
Gender:Male  Submitted:2009-10-09, Days after onset: 10
Location:Foreign  Entered:2009-10-13, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No allergy
Diagnostic Lab Data: not reported
CDC Split Type: 200904188
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEUR  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Decreased appetite, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case received from a healthcare professional in a foreign country on 01 October 2009 under the local reference number JVA0901339. A 31-year-old male patient, with no medical history of allergy, had received his dose of YF-VAX (batch number unknown, route and site of administration not reported) on 09 September 2009, at the quarantine station. On 29 September 2009, i.e. 20 days post-vaccination, the patient experienced generalized urticaria. He visited an other hospital and received "internal remedy" and drip infusion. However, his symptoms worsened. The patient developed pyrexia and anorexia on an unspecified date. On 30 September 2009, the patient visited the hospital again. He received drip infusion of steroid. However, his symptoms "went from bad to worse". On 01 October 2009, the patient was seen in the reporter''s hospital. He was hospitalized. The patient received corrective therapies with MONOAMMONIUM GLYCYRRHIZINATE and DEXCHLORPHENIRAMINE. The patient''s symptoms were "diminishing a little". He was still under observation at the time of the report.

VAERS ID:365245 (history)  Vaccinated:2009-09-07
Age:31.0  Onset:2009-09-19, Days after vaccination: 12
Gender:Female  Submitted:2009-11-04, Days after onset: 46
Location:Foreign  Entered:2009-11-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0600473A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSABABB159BB IMUN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURERATYPB074BD IMUN
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURERD51232 SCUN
Administered by: Other     Purchased by: Other
Symptoms: Brain oedema, Intracranial pressure increased
SMQs:, Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a regulatory authority (043208) and described the occurrence of brain edema in a 31-year-old female subject who was vaccinated with TYPHERIX (GlaxoSmithKline), TWINRIX ADULT and STAMARIL. On 7 September 2009 the subject received unspecified dose of TYPHERIX (intramuscular), unspecified dose of TWINRIX ADULT (intramuscular), unspecified dose of STAMARIL (subcutaneous). On 19 September 2009, 12 days after vaccination with STAMARIL, TWINRIX ADULT and TYPHERIX, the subject experienced brain edema and intracranial pressure. The subject was hospitalised. At the time of reporting the outcome of the events was unspecified.

VAERS ID:367768 (history)  Vaccinated:2009-11-10
Age:31.0  Onset:2009-11-10, Days after vaccination: 0
Gender:Female  Submitted:2009-11-16, Days after onset: 6
Location:Foreign  Entered:2009-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0063848A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Paraesthesia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a consumer and described the occurrence of unconscious in a 31-year-old female subject who was vaccinated with HAVRIX 1440 (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 10 November 2009 the subject received a dose of HAVRIX 1440 (unknown route and application site). Approximately 2 minutes after vaccination with HAVRIX 1440, the subject experienced loss consciousness and faint. The subject had to lie down suddenly. After vaccination tickling sensation spread over arm, then the subject was fainting. This case was assessed as medically serious by GSK. At the time of reporting on 11 November 2009 the events were resolved, the subject was completely recovered. According to the subject a physician stated that the events were unrelated to vaccination with HAVRIX 1440. Follow-up information has been requested.

VAERS ID:370174 (history)  Vaccinated:2009-11-14
Age:31.0  Onset:2009-11-14, Days after vaccination: 0
Gender:Female  Submitted:2009-11-25, Days after onset: 11
Location:Foreign  Entered:2009-11-25
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluticasone and solmeterol
Current Illness: Unknown
Preexisting Conditions: I take 4 puffs twice a day to manage my asthma
Diagnostic Lab Data: UNK
CDC Split Type: B0605357A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN))UNKNOWN MANUFACTURER  UNLA
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Drug exposure during pregnancy, Limb discomfort, Nasopharyngitis
SMQs:, Dementia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: This prospective pregnancy case was reported by a regulatory authority (GB-MHRA-FLU 00028305) and described the occurrence of common cold in a 31-year-old female subject who was vaccinated with PANDEMIC vaccine H1N1 (unspecified) and influenza vaccine. Concurrent medications included SERETIDE. On 14 November 2009 the subject received unspecified dose of PANDEMIC vaccine H1N1 unspecified (left arm). On a unspecified date the subject also received unspecified dose of influenza vaccine (unknown, left arm). On 14 November 2009, less than one day after vaccination with PANDEMIC vaccine H1N1 unspecified, at an unspecified time after vaccination with influenza vaccine, the subject experienced common cold and arm discomfort. As the subject was 24 weeks pregnant she also experienced and vaccine exposure during pregnancy. The regulatory authority reported that the events were disabling. At the time of reporting outcome of common cold outcome was unknown and arm discomfort was improved. Reaction severity: Bad enough to affect every day activities. Reaction Description: I am 24 weeks pregnant. My last period was on 29 May 2009. I had both the H1N1 vaccine and season flu vaccine in my left arm.

VAERS ID:370554 (history)  Vaccinated:2009-10-09
Age:31.0  Onset:2009-10-09, Days after vaccination: 0
Gender:Female  Submitted:2009-11-25, Days after onset: 47
Location:Foreign  Entered:2009-11-30, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Pregnant: yes; result: spontaneous abortion; due date: 12-Mar-2010
Diagnostic Lab Data: Platelet count, normal, 13-Oct-2009; platelet count, low, 10-Oct-2009
CDC Split Type: 2009021503
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL))CSL LIMITED  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Body temperature increased, Drug exposure during pregnancy, Platelet count decreased, Vaginal haemorrhage
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Report received from a regulator on 20-NOV-2009. A 31 year-old female patient (initials: unknown, pregnant: 18 weeks) received PANVAX H1N1 (batch number; yet to be identified) on 09-OCT-2009. The medical history is unknown. Concomitant medication included an unspecified anti-depressant. On 10-OCT-2009, 24 hours after PANVAX vaccine was administered, the patient was admitted into hospital for observation due to a slight temperature of 38.6C (unsure of who recorded this information). Investigations revealed low platelet count. The patient was discharged on 11-OCT-2009. The patient had her platelet count rechecked on 13-OCT-2009 and results were within normal range. On 16-OCT-2009, the patient had per vaginal bleeding which lead to a miscarriage on 18-OCT-2009. The medical officer involved stated that the miscarriage was unlikely due to the vaccine but due to the low platelets on 10-OCT-2009. The patient outcome is unknown. The regulator considered events possible to the suspect drug. This case was reported as serious because of hospitalisation and medical significance. The company considered events unassessable to the suspect drug due to insufficient data relating to the patient''s medical history and concomitant medications. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:370792 (history)  Vaccinated:2008-08-07
Age:31.0  Onset:2008-09-07, Days after vaccination: 31
Gender:Male  Submitted:2009-11-30, Days after onset: 449
Location:Foreign  Entered:2009-12-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Measles; Rubella
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0911USA03163
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Impaired work ability, Mononeuropathy multiplex, Neuralgia, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad)
Write-up: Information has been received from a Health Authority concerning a 31 year old male with a medical history of measles and rubella in childhood who was vaccinated on 07-AUG-2008 with one dose of MMR II vaccine intramuscularly, manufacturer, batch number and site not reported. On 07-SEP-2009, one month post vaccination, the patient experienced severe neuropathic pain predominantly in the lower limb, multifocal sensory abnormalities (not specified) and at the time of reporting was unable to work for a year. The patient has not recovered. Both the reporter and the MHRA considered this to be serious reaction due to disability/incapacity and other medically significant reason. The MHRA have coded the events of mononeuritis multiplex, neuropathic pain and work problem. No more information is expected, this case is closed.

VAERS ID:371422 (history)  Vaccinated:2009-09-20
Age:31.0  Onset:2009-10-10, Days after vaccination: 20
Gender:Male  Submitted:2009-12-03, Days after onset: 54
Location:Foreign  Entered:2009-12-03
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Anti-HBs antibody, 10Oct2009, negative; Hepatitis B surface antigen, 10Oct2009, negative
CDC Split Type: B0607544A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2UNAR
Administered by: Other     Purchased by: Other
Symptoms: Anti-HBs antibody negative, Hepatitis B surface antigen negative, No therapeutic response
SMQs:, Lack of efficacy/effect (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 32-year-old male subject who was vaccinated with ENGERIX B ADULT (GlaxoSmithKline). On 20 November 2008, 30 December 2008 and 20 September 2009 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B ADULT (unknown route, unknown deltoid). Lot numbers not provided. On 10 October 2009, 20 days after vaccination with 3rd dose of ENGERIX B ADULT, the anti-HBs antibodies and HBs Antigens were titred and were negative. The healthcare professional considered the event was life threatening. This case has been reported to a regulatory agency. This is one of 14 cases reported by the same reporter. These cases concerned 14 subjects working in a factory where they had received Hepatitis B vaccination.

VAERS ID:371428 (history)  Vaccinated:2009-09-20
Age:31.0  Onset:2009-10-10, Days after vaccination: 20
Gender:Male  Submitted:2009-12-03, Days after onset: 54
Location:Foreign  Entered:2009-12-03
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Tobacco user
Preexisting Conditions:
Diagnostic Lab Data: Anti-HBs antibody, 10Oct2009, negative; Hepatitis B surface antigen, 10Oct2009, negative
CDC Split Type: B0607562A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2UNAR
Administered by: Other     Purchased by: Other
Symptoms: Anti-HBs antibody negative, Hepatitis B surface antigen negative, No therapeutic response
SMQs:, Lack of efficacy/effect (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 31-year-old male subject who was vaccinated with ENGERIX B ADULT (GlaxoSmithKline). Concurrent medical conditions included tobacco use. On 21 November 2008, 31 December 2008 and 20 September 2009 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B ADULT (unknown route, unknown deltoid). Lot numbers not provided. On 10 October 2009, 20 days after vaccination with 3rd dose of ENGERIX B ADULT, the anti-HBs antibodies and HBs Antigens were titred and were negative. The healthcare professional considered the event was life threatening. This case has been reported to a regulatory agency. This is one of 14 cases reported by the same reporter. These cases concerned 14 subjects working in a factory where they had received Hepatitis B vaccination.

VAERS ID:371430 (history)  Vaccinated:2008-11-20
Age:31.0  Onset:2009-10-10, Days after vaccination: 324
Gender:Male  Submitted:2009-12-03, Days after onset: 54
Location:Foreign  Entered:2009-12-03
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Tobacco use
Preexisting Conditions:
Diagnostic Lab Data: Anti-HBs antibody, 10Oct2009, negative; Hepatitis B surface antigen, 10Oct2009, negative
CDC Split Type: B0607573A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anti-HBs antibody negative, Hepatitis B surface antigen negative, No therapeutic response
SMQs:, Lack of efficacy/effect (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 32-year-old male subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). Concurrent medical conditions included tobacco use. On 20 November 2008, 30 December 2008 and 21 September 2009 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B adult (unknown route, unknown deltoid, unknown lot number). On 10 October 2009, 19 days after vaccination with 3rd dose of ENGERIX B adult, the anti-HBs antibodies and HBs Antigens were titred and were negative. The healthcare professional considered the event was life threatening. This case has been reported to a regulatory agency. This is one of 14 cases received by the same reporter. These cases concerned 14 subjects working in a factory where they had received Hepatitis B vaccination.

VAERS ID:372253 (history)  Vaccinated:2009-11-26
Age:31.0  Onset:2009-11-26, Days after vaccination: 0
Gender:Female  Submitted:2009-12-08, Days after onset: 12
Location:Foreign  Entered:2009-12-08
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluoxetine hydrochloride; Ranitidine hydrochloride; Omeprazole; Hyoscine; FORCEVAL; Dicyclomine hydrochloride; Ferrous sulfate; Folic acid; Zopiclone; Mebeverine hydrochloride
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0609507A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IJUN
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN))UNKNOWN MANUFACTURER  IJUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Injection site erythema, Injection site warmth, Local swelling, Mass, Pain in extremity
SMQs:, Angioedema (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a consumer via a foreign regulatory authority (#GB-MHRA-FLU 00030871) and described the occurrence of local superficial swelling in a 31-year-old female subject who was vaccinated with PANDEMIC H1N1 vaccine (unspecified, manufacturer unspecified). Concurrent medications included PROZAC, ranitidine hydrochloride, omeprazole, hyoscine, FORCEVAL, dicyclomine hydrochloride, cyanocobalamin, ferrous sulfate, folic acid, zopiclone and mebeverine hydrochloride. On 26 November 2009, the subject received a single dose of PANDEMIC H1N1 vaccine unspecified (1 injection) and a single dose of Influenza virus vaccine (1 injection). On 26 November 2009, less than one day after vaccination with Influenza virus vaccine and PANDEMIC H1N1 vaccine unspecified, the subject experienced local superficial swelling, localized mass, lump, arm pain and redness and warming of injection site. The regulatory authority reported that the events were disabling. At the time of reporting the outcome of the events were unspecified. Reaction Severity: Bad enough to affect every day activities. Reaction Description: not pregnant.

VAERS ID:374678 (history)  Vaccinated:2009-12-10
Age:31.0  Onset:2009-12-11, Days after vaccination: 1
Gender:Male  Submitted:2009-12-21, Days after onset: 10
Location:Foreign  Entered:2009-12-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2009021750
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL))CSL LIMITED 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Periorbital oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Report received from a physician, via the regulatory on 11-Dec-2009. A 31 year-old male patient (date of birth unknown) received PANVAX H1N1 influenza vaccine, batch number unknown, for the first time on an unknown date. Patient''s medical history and concomitant medications unknown. On 11-DEC-2009, after vaccination, the patient developed periorbital oedema. Treatment details and outcome are unknown. The reporter considered events probably related to the suspect drug, and serious because of medical significance. The company considered events unassessable in relation to the suspect drug because time to event, medical history and concomitant medications are all unknown. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:376482 (history)  Vaccinated:2009-11-01
Age:31.0  Onset:2009-11-01, Days after vaccination: 0
Gender:Female  Submitted:2010-01-11, Days after onset: 71
Location:Foreign  Entered:2010-01-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Bronchial Asthma
Preexisting Conditions: Acute hearing loss
Diagnostic Lab Data: Computerized tomogram head, 16 Nov 2009, normal. Neurologic examination of 16 November 2009: Sensibility disorder with tickling in fingers and feet, mild paresis at right side, arm holding test weaker at the right side, leg holding test normal, gait normal, Troemer and Babinsky signs negative, Magnetic resonance tomogram on 17 November 2009: Head: Meningeal enhancement of contrast medium and discrete haemorrhagia of tentorium after cerebrospinal fluid puncture at the left more than at the right. Cervical spine and spinal canal: Normal findings, no sign for lesion in cervical myelon. Extra- and transcranial colour duplex Sonography on 16 November 2009: normal. Somatic evoked potential on 18 November 2009: no sign for lesion in somatosensitiv
CDC Split Type: D0064755A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK))GLAXOSMITHKLINE BIOLOGICALS  UNAR
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Babinski reflex test, Cardiovascular autonomic function test normal, Computerised tomogram head, Deafness, Diarrhoea, Electroneurography, Haemorrhage intracranial, Immediate post-injection reaction, Lumbar puncture, Meningeal disorder, Neurological examination abnormal, No reaction on previous exposure to drug, Nuclear magnetic resonance imaging abnormal, Paresis, Somatosensory evoked potentials, Ultrasound scan normal, Visual evoked potentials normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Pseudomembranous colitis (broad), 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 (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a foreign regulatory authority (# DE-PEI-PEI2009025298) and described the occurrence of possible neuritis in a 32-year-old female subject who was vaccinated with PANDEMRIX H1N1 (GlaxoSmithKline). Previous vaccinations with not further specified vaccines have been well tolerated as far as known. On an unknown date in November 2009 the subject received a dose of PANDEMRIX H1N1 (unknown route and application site). Approximately one week post vaccination with PANDEMRIX H1N1, on 15 November 2009, the subject experienced possible neuritis or, by differential diagnosis, beginning GUILLIAN-BARRE syndrome. The subject was hospitalised in the neurological department of a hospital for an unknown period of time. At the time of reporting, on 17 November 2009, the event was unresolved. Follow-up information was received on 04 January 2010 via the regulatory authority. The subject''s medical history included acute hearing loss at the left in 2008. Concurrent medical conditions included bronchial asthma. Co-suspect vaccine included unspecified influenza virus vaccine (Influenza vaccine, manufacturer unknown), given on week before PANDEMRIX. Immediately after vaccination with PANDEMRIX, the subject developed diarrhea, which resolved after one day. On 15 November 2009, one week after vaccination with PANDEMRIX H1N1, 2 weeks after vaccination with Influenza vaccine, the subject experienced tickling paresis in the hands, later in the feet. The subject was hospitalised on 16 November 2009 to a stroke unit. The subject had sensitive hemi-symptoms at the left, without inclusion of the face. Because of quickly worsening symptoms, the suspect of GILLIAN-BARRE syndrome was raised at first and the subject was treated with SANDOGLOBULIN. This was stopped after the first dose, because examination showed no sign for GBS. MRI of the head with contrast medium on 17 November 2009 showed meningeal enhancement of contrast medium and discrete haemorrhagia of tentorium after cerebrospinal fluid puncture, at the left more than at the right. Neurography, visual evoked potentials, somatic evoked potentials and motor evoked potentials were without pathologic findings. In further course the symptoms resolved completely and the subject could be mobilised. Just before discharge the subject had acute hearing loss at the right side. Immediate treatment with pentastarch and cortisone infusions was started and the symptoms resolved. On 25 November 2009, after 10 days the subject was discharged. No further information will be available.

VAERS ID:377119 (history)  Vaccinated:2009-12-22
Age:31.0  Onset:2009-12-22, Days after vaccination: 0
Gender:Female  Submitted:2010-01-15, Days after onset: 24
Location:Foreign  Entered:2010-01-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug allergy-penicillin
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0622596A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB683AA UNLA
Administered by: Other     Purchased by: Other
Symptoms: Hyperhidrosis, Hypoaesthesia, Influenza like illness, Pain, Paraesthesia, Tachycardia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of tachycardia in a 31-year-old female subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). Concurrent medical conditions included drug allergy to penicillin and to LENTOGESIC. On 22 December 2009, the subject received unspecified dose of ENGERIX B adult (unknown route, left deltoid). On 22 December 2009, during vaccination with ENGERIX B adult, the subject experienced a severe burning pain, tingling and numbness in the left arm. The injection was stopped and the subject had only received about 0.1 ml of the vaccine. Tachycardia and sweating began and the subject was transferred to the trauma unit. No treatment was given to her. On 23 December 2009, the subject experienced influenza like symptoms for the next 48 hours. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were completely resolved. The healthcare professional considered the events were probably related to vaccination with ENGERIX B adult.

VAERS ID:380188 (history)  Vaccinated:2010-02-09
Age:31.0  Onset:2010-02-09, Days after vaccination: 0
Gender:Female  Submitted:2010-02-11, Days after onset: 2
Location:Foreign  Entered:2010-02-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1002KOR00021
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Immediate post-injection reaction, Loss of consciousness, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: Information has been received via a business partner company from a 31 year old female who on 09-FEB-2010 was vaccinated with GARDASIL (intentional use for unlabelled age). On 09-FEB-2010 the patient experienced passing out and one vomiting while unconscious. It happened while she was massaging the injection site with an alcohol swab at the hospital right after the vaccination. The patient received unspecified treatment, and recovered in an hour without any problems. Upon internal review in the business partner company, syncope was considered to be an other important medical event. The causality with GARDASIL was not reported. Additional information has been requested.

VAERS ID:380531 (history)  Vaccinated:2009-12-30
Age:31.0  Onset:2009-12-30, Days after vaccination: 0
Gender:Female  Submitted:2010-02-16, Days after onset: 48
Location:Foreign  Entered:2010-02-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Food Allergy
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0632771A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Cough, Dyspnoea
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of anaphylaxis in a 31-year-old female subject who was vaccinated with CERVARIX, GlaxoSmithKline. Concurrent medical conditions included food allergy. On 30 December 2009 the subject received 1st dose of CERVARIX (intramuscular, unknown injection site). Lot number not provided. On 30 December 2009, less than one day after vaccination with CERVARIX, the subject experienced anaphylaxis, cough and dyspnea. The physician considered the events were clinically significant (or requiring intervention). On 30 December 2009, the events were resolved. The physician considered the events were almost certainly related to vaccination with CERVARIX. No further information could be obtained, the case has been closed.

VAERS ID:382092 (history)  Vaccinated:2009-11-26
Age:31.0  Onset:2009-11-26, Days after vaccination: 0
Gender:Female  Submitted:2010-03-05, Days after onset: 99
Location:Foreign  Entered:2010-03-08, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID
Current Illness: Hypothyroidism
Preexisting Conditions: Spontaneous abortion
Diagnostic Lab Data: sonogram
CDC Split Type: 2010022175
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN))UNKNOWN MANUFACTURER090204201 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Report received from a regulatory on 24-FEB-2010. A 31 year old pregnant female patient (details unknown, pregnancy due date: 28-JUL-2010) received PANVAX H1N1 (batch number: 090204201) on 26-NOV-2009. The patient has an ongoing medical history of chronic hypothyroidism. Concomitant medication includes SYNTHROID. The patient is not a healthcare worker. The patient does have health problems or allergies. There are no previous adverse events. The patient does not have any acute illnesses. On 03-FEB-2010, 30 days after PANVAX vaccination, the patient had a miscarriage. The patient was G4P1A3. The patient informed the health department after reading an article in the press. The patient was sure the miscarriage was due to the vaccination. The health department''s impression was abortion at 8 weeks pregnant, temporal cause. The patient did require medical consultation but not hospitalisation. No treatment was received. The patient outcome is recovered. The reporter states the case was not related to administration error. This case was reported as serious because of medical significance. The company considered the event possible to the suspect drug, PANVAX. Batch review request was performed for 090204201 on 29-DEC-2009. On completion of this investigation, it has been determined that all deviations related to the manufacture of this lot were assessed as having no impact on product quality. All QC testing was satisfactory with no out of specification results reported. There are no outstanding issues related to this lot that would potentially affect product quality. In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:382597 (history)  Vaccinated:2010-02-21
Age:31.0  Onset:2010-02-21, Days after vaccination: 0
Gender:Female  Submitted:2010-03-13, Days after onset: 20
Location:Foreign  Entered:2010-03-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: 8 weeks pregnant, no complications
Diagnostic Lab Data: HCG levels tested at 361 on 02/17/2010 and rose to 1129 on 02/22/2010. After miscarriage, levels had dropped to 400 on 02/24/2010, confirming miscarriage between these dates.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL))CSL LIMITED 0UNLA
Administered by: Unknown     Purchased by: Public
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin decreased, Drug exposure during pregnancy, Haemorrhage, Muscle spasms, Ultrasound scan abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility disorders (narrow)
Write-up: Started cramping, followed by bleeding the following day. Attended ER night of February 22nd and had follow-up ultrasound on 23rd which confirmed complete miscarriage of fetus. Bleeding continued for 7 more days then stopped.

VAERS ID:383839 (history)  Vaccinated:2009-10-14
Age:31.0  Onset:2009-11-10, Days after vaccination: 27
Gender:Female  Submitted:2010-03-29, Days after onset: 138
Location:Foreign  Entered:2010-03-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1003USA03994
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1737U2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Monoplegia
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Information has been received from a health authority (case # 113680, local case # IT131/10) concerning a 31 year old (also reported as 41 year old) female patient who was vaccinated on 14-OCT-2009 with the third dose of RECOMBIVAX HB (lot # 657280/1737U, batch # NJ29390). On 10-NOV-2010 she presented with hypostenia followed by lower leg paralysis with L3 level. On 20-NOV-2009 she was admitted to the hospital and administered remedial treatment (NOS). The outcome was recovered with sequel. The case is closed. Other business partner numbers include E2010-01789. No further information is available.

VAERS ID:386546 (history)  Vaccinated:2010-03-01
Age:31.0  Onset:2010-04-01, Days after vaccination: 31
Gender:Female  Submitted:2010-05-03, Days after onset: 32
Location:Foreign  Entered:2010-05-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immune system deficit
Preexisting Conditions:
Diagnostic Lab Data: Unk
CDC Split Type: D0067488A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNGM
Administered by: Other     Purchased by: Other
Symptoms: Fatigue, Hepatic enzyme increased, Myalgia, Nausea, Oropharyngeal pain, Paraesthesia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a consumer and described the occurrence of increase in liver values in a 31-year-old female subject (herself) who was vaccinated with TWINRIX ADULT (GlaxoSmithKline). A physician or other health care professional has not verified this report. The consumer reported that her "immune system was not in the best condition at the time of vaccination". Approximately in the end of March 2010 the subject received 1st dose of TWINRIX adult (unknown route, unknown gluteal). In the first time after vaccination "all was fine". Approximately 1,5 weeks after vaccination with TWINRIX adult, the subject experienced nausea, vomiting, fatigue, muscle pain, throat pain, sometimes pins and needles in both hands and increase in liver values. This case was assessed as medically serious by GSK. At the time of reporting, on 29 April 2010, the events were unresolved. Further information was requested.

VAERS ID:386623 (history)  Vaccinated:2010-03-08
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2010-05-03
Location:Foreign  Entered:2010-05-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201002482
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI))SANOFI PASTEUR1002026 IJUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bradycardia, Hypoglycaemia, Hypotension, Myalgia, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (narrow)
Write-up: Case received from Institute via Sanofi pasteur on 23 April 2010 under the reference number BR2010-081. A 31-year-old female patient with no reported medical history had received her injection of PANDEMIC INFLUENZA VACCINE vaccine batch number 1002026 on 08 March 2010 (number in series, route and anatomical site of vaccination not reported). On an unspecified date, the patient experienced bradycardia, hypotension and hypoglycemia. It evolved to myalgia and paresthesia of both lower members. The patient was hospitalized and received corrective treatment with Glucose IV. She recovered after 48 hours. According to the reporter the status of this case was confirmed at the time of the report. List of documents held by sender: none.

VAERS ID:390369 (history)  Vaccinated:2010-02-02
Age:31.0  Onset:2010-02-03, Days after vaccination: 1
Gender:Female  Submitted:2010-06-10, Days after onset: 126
Location:Foreign  Entered:2010-06-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0659628A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK))GLAXOSMITHKLINE BIOLOGICALS  IMRA
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRA
Administered by: Other     Purchased by: Other
Symptoms: Movement disorder, Nervous system disorder, Sleep disorder, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was reported by a consumer (the patient) and described the occurrence of neurological problem in a 31-year-old female subject who was vaccinated with PANDEMRIX H1N1 (GlaxoSmithKline), SEASONAL INFLUENZA vaccine. The subject was in good physical condition before vaccination (military recruit who just had physical fitness test before). On 2 February 2010 the subject received unspecified dose of PANDEMRIX H1N1 (intramuscular, right arm), unspecified dose of SEASONAL INFLUENZA vaccine (intramuscular, right arm). On 3 February 2010, 1 day after vaccination with PANDEMRIX H1N1 and SEASONAL INFLUENZA vaccine, the subject experienced neurological problem at right arm without further specification. The subject was hospitalized and after discharge she also experienced weight loss, vomiting, sleep disturbance and inability to use arm. At the time of reporting, the events were unresolved, she was still not able to use the right arm. Patient refused to provide the name of the treating physician.

VAERS ID:390718 (history)  Vaccinated:2010-06-07
Age:31.0  Onset:2010-06-07, Days after vaccination: 0
Gender:Female  Submitted:2010-06-15, Days after onset: 8
Location:Foreign  Entered:2010-06-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0659826A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hypoaesthesia, Pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of pain in a 31-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 7 June 2010, the subject received unspecified dose of CERVARIX (0.5 ml, intramuscular, unknown injection site). On 7 June 2010, less than one day after vaccination with CERVARIX, the subject experienced pain and numbness. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:390953 (history)  Vaccinated:2009-11-27
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2010-06-17
Location:Foreign  Entered:2010-06-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2010024396
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL))CSL LIMITED090203202 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cardiac arrest, Congestive cardiomyopathy, Intensive care, Mechanical ventilation, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (narrow), Respiratory failure (broad)
Write-up: Report received from a foreign Regulator on 10-Jun-2010. A female patient received a single dose of PANVAX H1N1 influenza Vaccine (batch: 090203202) on 27-Nov-2009. On an unspecified date, the patient developed VF (ventricular fibrillation) arrest and dilated cardiomyopathy. Treatment for the event included ICU (treatment in an intensive care unit), unspecified inotropes, and ventilation. At the time of reporting, the patient had not yet recovered. The reporter considered the events to be serious due to inpatient hospitalisation. The reporter assessed the causality as possible in relation to the suspect drug PANVAX H1N1 influenza vaccine. The company considered the events unassessable due to lack of information regarding time to onset. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:395413 (history)  Vaccinated:2010-03-27
Age:31.0  Onset:2010-04-15, Days after vaccination: 19
Gender:Female  Submitted:2010-08-16, Days after onset: 123
Location:Foreign  Entered:2010-08-16
Life Threatening? No
Died? Yes
   Date died: 2010-04-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2010CO36664
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS))NOVARTIS VACCINES AND DIAGNOSTICS106836P1 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Death, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Initial report received from a physician on 03 Jun 2010: This pregnant patient was vaccinated with H1N1 (manufacturer unknown; batch number 106836P1) intramuscularly on 27 Mar 2010. The patient died on 15 Apr 2010 which was reported as early postpartum maternal mortality. The reporter did not suspect a causal relationship between drug and the event. Follow up report received from the quality assurance department on 11 Aug 2010: Initially reported batch number 106836P1 of given influenza vaccine was confirmed to be a Novartis pandemic vaccine S-OIV FLUVIRIN.

VAERS ID:395795 (history)  Vaccinated:2010-05-01
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2010-08-18
Location:Foreign  Entered:2010-08-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown personal or family medical history. Unknown history of adverse reaction to a vaccine or a drug. Unknown concomitant therapy.
Diagnostic Lab Data: not reported
CDC Split Type: 201004365
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN))UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Paralysis
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Report described in "media announcement" and reported via Vaccine Information Service (VIS) of Sanofi Pasteur on 13 August 2010. Local reference number BR2010-215. In news (unspecified), it was described that three patients in the southern region of State, have developed GUILLAIN-BARRE syndrome after receiving the influenza A/H1N1 vaccine during the campaign promoted by the the Ministry of Health. The Health departement of the city did a survey, trying to collect data, concerning the three patients : the batch number, manufacturing laboratory, anatomical site of application of the vaccine. The case is linked with the cases 2010-04363 and 2010-04364 (corresponding to the 2 other patients mentioned in this report). A 31-year-old female patient, with unknown medical history, had received a dose of Influenza A/H1N1 vaccine in May 2010 (unknown route, lot number and administration site). She developed the disease in May 2010 and the first signs of paralysis occurred four days after receiving the vaccine. She sought medical help, but for lack of resources from the private hospital where she checked, she was transferred into another hospital where the diagnosis of GUILLAIN-BARRE syndrome was made. Performed exams and results were not provided. The patient had four affected limbs (lower and superior limbs) by paralysis. While she was in hospital, she began to regain movement but she had not yet fully recovered. She received treatment with IV immunoglobulins (5 "bottles" per day) for 7 days and performed physiotherapy. At the time of reporting, the events were reported as "ongoing". Seriousness criteria reported : "hospitalization" and "persistent or significant disability or incapacity".

VAERS ID:397664 (history)  Vaccinated:2010-05-17
Age:31.0  Onset:2010-05-17, Days after vaccination: 0
Gender:Female  Submitted:2010-09-07, Days after onset: 113
Location:Foreign  Entered:2010-09-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: unknown personal and family medical history, unknown previous history of adverse event to a vaccine or a drug
Diagnostic Lab Data: unknown
CDC Split Type: 201004714
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI))SANOFI PASTEURUP217AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Headache, Mydriasis, Pyrexia, Visual impairment
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Report received from Institute through the VIS (Vaccination Information Service) of sanofi pasteur on 25 August 2010 under the local reference number BR2010-341. A 31-year-old female patient, with unknown personal and family medical history, unknown previous history of adverse event to a vaccine or a drug and unknown concomitant therapies, had received a dose of H1N1, batch number UP217AA, route and anatomical site of administration unknown, on 17 May 2010. On 17 May 2010, i.e the day of vaccination, the patient presented with severe headache, vision disturbances and fever. Two days later, she still had these symptoms and was found to have dilated pupils. Neurological and ophthalmological assessments were requested, however, until 04 August 2010, she still had not had a physical evaluation (it was not mentioned any update regarding the patient''s symptoms, on the report). The case was under investigation. Corrective treatment was unknown. The patient outcome was not reported. This case was assessed as "medically important condition".

VAERS ID:404116 (history)  Vaccinated:2010-05-20
Age:31.0  Onset:2010-05-20, Days after vaccination: 0
Gender:Female  Submitted:2010-10-18, Days after onset: 151
Location:Foreign  Entered:2010-10-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201005294
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN))UNKNOWN MANUFACTURERUH037AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Arthralgia, Myalgia, Rash pruritic
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This Case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur, from the Ministry of Health through foreign Institute (local case reference number BR2010-589). A 33-year-old female patient, whose medical history and concomitant therapies were not reported, had received a dose of H1N1 vaccine (Sanofi pasteur Inc. lot number UH037AA corresponding to lot number 1003077 which was allocated at packaging by Institute, route and anatomical site of administration not reported) on 20 May 2010, and the patient presented 12 hours later with myalgia, arthralgia and pruritic rash. Anaphylaxis was reported. The patient was not hospitalized. She had good evolution of the symptoms. According to the report, this case has been confirmed. The case was classified as "Moderate". Outcome was not reported. No further information was provided. No seriousness criterion was reported for this case; however it has been assessed as a significant medical condition due to the Anaphylaxis. Documents held by sender: None.

VAERS ID:404232 (history)  Vaccinated:2010-05-11
Age:31.0  Onset:2010-05-11, Days after vaccination: 0
Gender:Female  Submitted:2010-10-18, Days after onset: 160
Location:Foreign  Entered:2010-10-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Patient reports not being allergic to eggs.
Diagnostic Lab Data: Not reported
CDC Split Type: 201005164
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN))UNKNOWN MANUFACTURERUH040AB UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This Case report is part of a batch of several hundreds of reports associated with H1N1 vaccine, that was received on 25 August 2010 by sanofi pasteur, from the Ministry of Health through foreign Institute (local case reference number BR2010-472). A 31-year-old female patient who reported not being allergic to egg, had received a dose of H1N1 vaccine (batch number UH040AB route and anatomical site of administration not reported) on 11 May 2010 and presented with pruritus in the lower limbs and with rash. She was taken to the emergency room and was treated by the physician on duty. She was released after an hour. According to the report, this case has been confirmed. The case was classified as "Moderate". Outcome was not reported. No further information was provided. This case was assessed as serious due to the mention of Anaphylaxis. Documents held by sender: None.

VAERS ID:404578 (history)  Vaccinated:2010-05-12
Age:31.0  Onset:2010-05-13, Days after vaccination: 1
Gender:Female  Submitted:2010-10-18, Days after onset: 158
Location:Foreign  Entered:2010-10-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: not reported
CDC Split Type: 201005034
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN))UNKNOWN MANUFACTURERUH038AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash generalised, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case received from foreign Institute through the VIS (Vaccination Information Service) of sanofi pasteur on 25 August 2010 under the local reference number BR2010-396. A 32-year-old female patient, with no reported personal and family medical history, no reported previous history of adverse event to a vaccine or a drug and no reported concomitant therapies, had received her dose of H1N1 vaccine, batch number UH038AA, route and anatomical site of administration not reported, on 12 May 2010. On 13 May 2010, i.e. the following day post-vaccination, the patient experienced itchy rash throughout the body. Anaphylaxis was mentioned. It was also mentioned that the patient did not have any contact with products other than the vaccine. According to the report provided by foreign Institute, this case was confirmed and classified as "moderate". The outcome was unknown. This case was assessed as a significant medical condition. Documents held by sender: none.

VAERS ID:407689 (history)  Vaccinated:2010-10-16
Age:31.0  Onset:2010-10-16, Days after vaccination: 0
Gender:Female  Submitted:2010-11-04, Days after onset: 19
Location:Foreign  Entered:2010-11-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: History of Multiple Sclerosis (MS). No concomitant medications except for unspecified over-the-counter (o/c) medication(s).
Diagnostic Lab Data: None
CDC Split Type: 201006304
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURC3729AA IMUN
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURC3265AA IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypoaesthesia, Multiple sclerosis relapse, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Optic nerve disorders (broad), Demyelination (narrow)
Write-up: Initial report received on 02 November 2010 from a physician. A 31 year old female patient, with a history of multiple sclerosis (MS), received a 0.5 ml intramuscular injection of MENACTRA (sanofi pasteur Ltd. lot number C3729AA, which corresponds to sanofi pasteur Inc. lot number U3363AB) and a 0.5 ml intramuscular injection Td Adsorbed (lot number C3265AA) on 16 October 2010. No concomitant medications were reported except for unspecified over-the-counter (o/c) medication(s). On the evening of vaccination, 16 October 2010, the patient developed numbness and tingling in the left arm which was increasing over one week. According to the physician, the neurologist felt that this was a "flared MS". The patient received no corrective treatment. There were no relevant tests/laboratory data. The patient''s outcome was not reported.

VAERS ID:410351 (history)  Vaccinated:2010-11-06
Age:31.0  Onset:2010-11-06, Days after vaccination: 0
Gender:Male  Submitted:2010-11-29, Days after onset: 23
Location:Foreign  Entered:2010-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Unknown previous history of convulsions/allergies
Diagnostic Lab Data: UNK
CDC Split Type: B0685422A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA526AH IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Dizziness, Erythema, Injection site swelling, Yellow skin
SMQs:, Cholestasis and jaundice of hepatic origin (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a pharmacist via the regulatory authority (# GB-MHRA-ADR 20742924) and described the occurrence of swelling at injection site in a 31-year-old male subject who was vaccinated with FLUARIX. On 6 November 2010 the subject received an unspecified dose of FLUARIX (.5 ml, intramuscular). That same day on 6 November 2010, at an unspecified time after vaccination with FLUARIX, the subject experienced swelling at injection site and was feeling faint and the subject''s skin colour was changed from yellow to red then had several convulsions for over 30 seconds. The regulatory authority reported that the events were clinically significant (or requiring intervention). It was reported that the patient received Anapen. On 6 November 2010, the events were resolved. Patient had swelling at injection site and complained of feeling faint. Changed in colour from yellow to red then had several convulsions over 30 seconds. Anapen administered. Other medically significant: unknown previous history of convulsion/allergies.

VAERS ID:413022 (history)  Vaccinated:2010-11-20
Age:31.0  Onset:2010-11-20, Days after vaccination: 0
Gender:Female  Submitted:2010-12-17, Days after onset: 27
Location:Foreign  Entered:2010-12-17
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0688082A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMAR
Administered by: Other     Purchased by: Other
Symptoms: Muscular weakness, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of arm pain in a 31-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 23 October 2010, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site and batch number). On 20 November 2010 the subject received 2nd dose of CERVARIX (.5 ml, intramuscular, unknown injection site and batch number). On 20 November 2010, less than one day after 2nd dose of vaccination with CERVARIX, the subject experienced arm pain. On 21 November 2010, one day after 2nd dose of CERVARIX, the subject experienced arm weakness. The physician considered the events were disabling. At the time of reporting, arm pain was improved and the outcome for arm weakness was unspecified. The physician considered the events were almost certainly related to vaccination with CERVARIX.

VAERS ID:413716 (history)  Vaccinated:2010-12-13
Age:31.0  Onset:2010-12-13, Days after vaccination: 0
Gender:Female  Submitted:2010-12-29, Days after onset: 16
Location:Foreign  Entered:2010-12-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0689975A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness postural, Grip strength decreased, Headache, Hypoaesthesia, Metrorrhagia, Muscular weakness, Musculoskeletal stiffness, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: This case was reported by a physician and described the occurrence of metrorrhagia in a 31-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 13 December 2010, the subject received unspecified dose of CERVARIX (.5 ml, intramuscular, unknown injection site, batch number not provided). On 13 December 2010, less than one day after vaccination with CERVARIX, the subject experienced shoulder muscle stiffness, headache and brachialgia. On 14 December 2010, one day after vaccination, the subject also experienced metrorrhagia, limb numbness, grip strength decreased, lower extremity weakness and dizziness on standing. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting, the events of shoulder muscle stiffness, headache, limb numbness and brachialgia were unresolved, the outcome of the rest of the events was unspecified. The physician considered the events were almost certainly related to vaccination with CERVARIX.

VAERS ID:417182 (history)  Vaccinated:2010-10-08
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2011-02-18
Location:Foreign  Entered:2011-02-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Polymerase chain reaction, INFLUENZA A posi
CDC Split Type: D0070346A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA516AA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Cough, Influenza, Influenza A virus test positive, Pain in extremity, Polymerase chain reaction, Pyrexia, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority (DE-PEI-PEI2011003695) and described the occurrence of influenza A in a 31-year-old female subject who was vaccinated with INFLUSPLIT SSW (GlaxoSmithKline). On 08 October 2010 the subject received a dose of INFLUSPLIT (intramuscular). On an unknown date after vaccination the subject presented with fever, cough and limb pain. By means of polymerase chain reaction she was confirmed with Influenza A infection. The reporter considered this was a vaccination failure. The outcome of the events was unspecified.

VAERS ID:417643 (history)  Vaccinated:2010-07-18
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2011-02-25
Location:Foreign  Entered:2011-02-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: CIGARETTE SMOKER; PENICILLIN ALLERGY
Preexisting Conditions:
Diagnostic Lab Data: Diagnostic ultrasound, 2010, Negativeunits; Mammogram, 2010, Negativeunits
CDC Split Type: B0685618A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 0UNAR
Administered by: Other     Purchased by: Other
Symptoms: Cervical dysplasia, Lymphadenopathy, Mammogram normal, Ultrasound scan normal
SMQs:, Reproductive premalignant disorders (narrow), Uterine and fallopian tube malignant tumours (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a sales representative and described the occurrence of lymph node enlargement in a female subject of unspecified age who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. In July 2010, the subject received 1st dose of CERVARIX (unknown route and injection site, batch number not provided). In July 2010, less than some months after vaccination with CERVARIX, the subject experienced lymph node enlargement for 10 days. At the time of reporting, the outcome of the event was unspecified. Follow up was expected but could not be obtained after 2 reminders : the case has therefore been closed. Follow-up information received on 15 February 2011 by a physician: The subject medical conditions included allergy to penicillin and smoking 10 cigarettes per day. The subject received 1st dose of CERVARIX on 18 July 2010. In 2010, less than 1 year after vaccination with CERVARIX, the subject developed enlargement of lymph node (20 mm) in the armpit of the same arm of the injection. An ultrasound and a mammography were performed and showed negative results. The physician reported that the lymph node enlargement was almost certainly related to vaccination with CERVARIX. Then, the subject did not receive another dose. In December 2010, 5 months after vaccination with CERVARIX, the subject suffered from cervical intraepithelial neoplasia grade 2-3.

VAERS ID:417693 (history)  Vaccinated:2009-11-27
Age:31.0  Onset:2010-01-07, Days after vaccination: 41
Gender:Female  Submitted:2011-01-07, Days after onset: 365
Location:Foreign  Entered:2011-02-25, Days after submission: 49
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 02-MAY-2009, Date of LMP for pregnancy
Diagnostic Lab Data:
CDC Split Type: PHHY2010CH73580
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN))UNKNOWN MANUFACTURER  IJUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Caesarean section, Drug exposure during pregnancy, Premature labour
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Initial report received from a health care professional via Health Authority (2010-03049) on 29 Oct 2010: Date of last menstruation period of this pregnant patient was 02 May 2009. She received SIRDALUD at a dose of 4 mg per day for an unknown indication for 5 days in Jun 2009. She was vaccinated with H1N1 (batch number unknown) on 27 Nov 2009. On 07 Jan 2010, she gave premature birth to a male child (see the case PHHY2010CH73578) weighing 2540 g with Apgar score of 9/1, 10/5 and 10/10 by cesarean section. The child was healthy without any signs of prematurity. The outcome of the event premature birth was recovery as of 07 Jan 2010. The outcome of the other events was not reported. The reporter assessed the event premature birth s medically significant and possibly related to H1N1 and unlikely to SIRDALUD. The causality of the event drug exposure during pregnancy was possible for both H1N1 and SIRDALUD. Follow up Health Authority (2010-03049) report received from agency on 04 Jan 2011: The health authority re-confirmed that the therapy date for SIRDALUD was from Jun 2009 for 5 days. Serious spontaneous report. Premature labour, caesarean section (medically significant), assessed as unlisted according to core data sheet. The information provided in this individual case does not warrant a change to the Core data sheet text. The topic will be monitored closely. All spontaneous reports are considered suspected for reporting purposes or in accordance with national regulatory requirements. The remaining reported leading event was assessed as non-serious by Novartis Medical Safety Physician. Based on review of available reported data does not allow for a proper causality assessment. There is no known pathomechanism and no evidence from literature suggesting a causal association between the study vaccine used during pregnancy and the reported event (s).

VAERS ID:418706 (history)  Vaccinated:2011-01-10
Age:31.0  Onset:2011-01-11, Days after vaccination: 1
Gender:Female  Submitted:2011-03-11, Days after onset: 59
Location:Foreign  Entered:2011-03-14, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical history of allergies to fruits, nuts and perfume. Patient showed similar symptoms two weeks after vaccination with PANDEMRIX (GSK) in 2009. Several investigations including EEG, neurography and cranial MRI did not establish any cause. Cranial MRI only showed suspicious demyelinating focus in left medullary layer. Laboratory test revealed antinuclear antibody titer of 1:160. Diagnosis of unspecified sensory disturbance was established. Under corrective therapy with Gabapentin the patient recovered.
Diagnostic Lab Data:
CDC Split Type: E201100164
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURC3124AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Antinuclear antibody positive, Central nervous system inflammation, Demyelination, Dysaesthesia, Electroencephalogram normal, Electroneurography, Hypoaesthesia, Hypoaesthesia facial, Neurological examination abnormal, Nuclear magnetic resonance imaging brain abnormal, Pain in extremity, Paraesthesia, Reflexes abnormal, Sensory disturbance, Skin warm
SMQs:, Peripheral neuropathy (narrow), Systemic lupus erythematosus (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Case received from a healthcare professional on 13-Jan-2011. Case medically confirmed. A 31-year-old female patient with a medical history of allergies to fruits, nuts and perfume and similar symptoms after PANDEMRIX (GSK) in 2009 (at that time symptoms regressed under therapy with gabapentin) had received the booster dose of TD IMPFSTOFF MERIEUX (lot-no. C3124AA) injection route and site not reported on 10-Jan-2011. One day later, she developed paraesthesia and numbness in the right foot, numbness and hot feeling on the right side of face. Concomitant therapy included hormonal contraceptives for systemic use. At the time of reporting the patient had not recovered; neurological examination was planned. Follow-up information received on 07-Mar-2011. Report of a neurological check-up was provided. The case was upgraded to serious a chronic inflammatory CNS disease was evoked. In November 2009, similar symptoms (sensory disturbances) had occurred two weeks after vaccination with PANDEMRIX (GSK). At that time, several exams including EEG, neurography and cranial MRI did not lead to a clear diagnosis ("unspecified sensory disturbance"). Cranial MRI showed suspicious demyelinating focus in left medullary layer. Laboratory test revealed antinuclear antibody titer of 1:160. The patient had corrective therapy with Gabapentin and recovered. On 10-Jan-2011, the patient was vaccinated with TD-IMPFSTOFF MERIEUX IM into the left upper arm. The next day, she developed hypaesthesia and dysaesthesia of her right feet and right side of face, but less intensely then in 2009 after the pandemic flu vaccine. On 14-Jan-2011, she underwent neurological check-up in an outpatient department. Neurological exam showed difference of reflexes, distinctive right-sided arm reflexes and discretely right-sided leg reflexes. Diagnosis of chronic inflammatory CNS disease was made. The neurologist suspected that manifestations of a previously existing inflammatory CNS disease were triggered by the vaccinations. On 17-Jan-2011, the patient additionally complained of sharp pain in upper and lower extremities. Further inpatient diagnostic exams including lumbar puncture were recommended. The final outcome was not reported. The case is closed.

VAERS ID:419673 (history)  Vaccinated:2010-04-29
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2011-03-25
Location:Foreign  Entered:2011-03-28, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No reported medical history and concomitant therapies.
Diagnostic Lab Data: Not reported
CDC Split Type: 201101653
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI))SANOFI PASTEURUH039AA0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Adverse event, Headache, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case report is part of a batch of several thousand reports associated with different products, that was received on 10 March 2011 by sanofi pasteur affiliate in a foreign country, from the "foreign Ministry of Health" (local case reference number BR-BT2011-113). A female patient, whose medical history and concomitant therapies were not reported, had received her 1st primary dose of H1N1 (manufactured by sanofi pasteur, batch number UH039AA, route and anatomical site of administration not reported) on 29 April 2010. The original reported batch number was "VH039AA". On an unspecified date post-vaccination, the patient experienced fever < 39.5 degrees C, "other serious and/or unusual adverse events", headache and myalgia. 1 hour is reported but it is unknown if the information is related to the symptom onset or adverse events duration. The patient was hospitalized for 5 days. The patient''s outcome was "ignored". No further information was provided. The case was assessed as serious by the Ministry of Health due to hospitalization. The case status was "under investigation". The action taken was also mentioned: "ignored". Documents held by sender: none.

VAERS ID:419700 (history)  Vaccinated:2010-04-05
Age:31.0  Onset:2010-04-06, Days after vaccination: 1
Gender:Female  Submitted:2011-03-25, Days after onset: 353
Location:Foreign  Entered:2011-03-28, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No reported medical history and concomitant therapies.
Diagnostic Lab Data: Not reported
CDC Split Type: 201101601
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN))UNKNOWN MANUFACTURER1003085 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Headache
SMQs:, Arthritis (broad)
Write-up: This case report is part of a batch of several thousand reports associated with different products, that was received on 10 March 2011 by sanofi pasteur affiliate in a foreign country, from the "foreign Ministry of Health" (local case reference number BR-BT2011-348). A 31-year-old female patient, whose medical history and concomitant therapies were not reported, had received a dose of H1N1 vaccine during a national campaign (manufacturer unknown, batch number reported as "1003085", route and anatomical site of administration not reported) on 05 April 2010. On 06 April 2010, i.e. 1 day postimmunization, the patient experienced arthralgia and headache. The patient was hospitalized (unknown duration). The patient recovered without sequelae on an unspecified date. No further information was provided. "24 hours" is reported but it is unknown if the information is related to the symptom onset or adverse events duration. The case was assessed as serious by the Ministry of Health due to hospitalization. The Ministry of health classified the adverse events on category 1 (intensity/severity scale from 1 (less important) to 4 (more important)). The case status was confirmed (the Ministry of Health assessed the adverse events as related to the vaccine). The action taken was also mentioned: "the scheme was maintained". Documents held by sender: none.

VAERS ID:420604 (history)  Vaccinated:2010-04-29
Age:31.0  Onset:2010-04-29, Days after vaccination: 0
Gender:Female  Submitted:2011-04-07, Days after onset: 343
Location:Foreign  Entered:2011-04-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201101828
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI))SANOFI PASTEURUH039AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Headache
SMQs:
Write-up: This case report is part of a batch of several thousand reports associated with different products, that was received on 10 March 2011 by sanofi pasteur affiliate in a foreign country, from the "foreign Ministry of Health" (local case reference number BR-BT2011-501). A 31-year-old female patient, whose medical history and concomitant therapies were not reported, had received her dose of H1N1 (manufactured by sanofi pasteur, batch number UH039AA, route and anatomical site of administration not reported) on 29 April 2010. The patient had no "simultaneous" vaccine. On 29 April 2010, the patient experienced a severe headache. Symptom classification was also reported as "light/mild". The patient was hospitalized from 09 May 2010 to 14 May 2010. The outcome was not reported. No further information was provided. The case was assessed as serious by the Ministry of Health due to hospitalization. The Ministry of health classified the adverse events on category 1 [intensity/severity scale from 1 (less important) to 4 (more important)]. The case status was "confirmed" = the Ministry of Health assessed the patient''s events as related to the vaccine. Documents held by sender: none.

VAERS ID:420748 (history)  Vaccinated:2010-04-12
Age:31.0  Onset:2010-04-12, Days after vaccination: 0
Gender:Female  Submitted:2011-04-08, Days after onset: 361
Location:Foreign  Entered:2011-04-11, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201101914
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI))SANOFI PASTEURUH004AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Feeling hot, Generalised erythema, Pruritus generalised
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case report is part of a batch of several thousand reports associated with different products, that was received on 10 March 2011 by sanofi pasteur affiliate in a foreign country, from the "Foreign Ministry of Health" (local case reference number BR-BT2011-625). A 31-year-old female patient, whose medical history and concomitant therapies were not reported, had received her dose of H1N1 (manufactured by sanofi pasteur, batch number UH004AA, route and anatomical site of administration not reported) on 12 April 2010. The patient had no "simultaneous" vaccine. On 12 April 2010, the patient experienced "light/mild" itching and redness through the body, and heat. The event was classified as anaphylaxis grade 3. The patient was hospitalized on unspecified dates. The outcome was not reported. No further information was provided. The case was assessed as serious by the Ministry of Health due to hospitalization. The Ministry of Health classified the adverse events on category 1 [intensity/severity scale from 1 (less important) to 4 (more important)]. The case status was "confirmed" = the Ministry of Health assessed the patient''s events as related to the vaccine. Documents held by sender: none.

VAERS ID:420773 (history)  Vaccinated:2011-02-02
Age:31.0  Onset:2011-03-16, Days after vaccination: 42
Gender:Female  Submitted:2011-04-11, Days after onset: 26
Location:Foreign  Entered:2011-04-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Alanine aminotransferase, 16Mar2011, 77; Alanine aminotransferase, 29Mar2011, 91; Albumin, 29Mar2011, 27; Albumin, 29Mar2011, 27; Albumin abnormal, 16Mar2011, 29; Alkaline phosphatase, 16Mar2011, 66; Alkaline phosphatase, 29Mar2011, 71; Alkaline phosphatase, 29Mar2011, 71; Bilirubin, 29Mar2011, 4; Blood creatine phosphokinase a, 16Mar2011, 2469; C-reactive protein abnormal, 16Mar2011, 159; Creatine phosphokinase, 29Mar2011, 2469; ESR abnormal, 16Mar2011, 113; Eosinophil count, 16Mar2011, 0.4; Eosinophil count, 29Mar2011, 0.6; Full blood count abnormal, 16Mar2011, count distributi; Globulin, 29Mar2011, 42; Globulin abnormal, 16Mar2011, 48; Glomerular filtration rate, 16Mar2011, 60; Hemoglobin, 29Mar2011, 9.6; Hemoglobin abnormal, 16Mar2011,
CDC Split Type: B0710795A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB921CA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Anaemia, Arthralgia, Blood albumin abnormal, Blood alkaline phosphatase normal, Blood bilirubin increased, Blood creatine phosphokinase increased, Blood creatinine normal, Blood potassium normal, Blood sodium normal, C-reactive protein abnormal, Eosinophil count, Full blood count abnormal, Globulin abnormal, Glomerular filtration rate, Haematocrit decreased, Haemoglobin, Joint swelling, Lymphocyte count normal, Malaise, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell haemoglobin concentration decreased, Mean cell volume normal, Monocyte count, Myositis, Neutrophil count increased, Oedema peripheral, Pain in extremity, Platelet count, Platelet disorder, Protein total normal, Red blood cell count decreased, Red blood cell sedimentation rate abnormal, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Biliary system related investigations, signs and symptoms (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a Nurse and described the occurrence of anemia in a 31-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 2 February 2011 the subject received unspecified dose of ENGERIX B (1 injection, intramuscular). On 16 March 2011, 42 days after vaccination with ENGERIX B, the subject experienced anemia, abnormal platelets, swollen leg, thigh pain, knee pain, swelling of knees, hand pain, hand swelling, c-reactive protein abnormal, erythrocyte sedimentation rate abnormal, feeling unwell, albumin abnormal, globulin abnormal, creatine phosphokinase abnormal, myositis, full blood count abnormal. Blood tests on the 16 March 2011, showed: Hemoglobin 9.8 unknown units, platelets 706 unknown units, c-reactive protein 159 unknown units, erythrocyte sedimentation rate 113 unknown units, albumin 29 unknown units, globulin 48 unknown units, creatine phosphokinase 2469 unknown units, and a full blood count showed that blood count distribution was high. On the 3 April 2011 the patient also experienced swollen legs. This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved. Verbatim text received: On 04th April 2011, a nurse reported that a 31 year old female was administered ENGERIX B vaccine (batch number AHBVB921CA, expiry date not recorded) on 2nd February 2011. From the 16th March 2011 the patient started feeling unwell, developed Myositis, thigh, knee, hand pain and thigh, knee, hand swelling. Blood tests from the 16th of March 2011 showed anemia with hemaglobin 9.6 and full blood count showed blood count distribution was high. Also C-reactive protein (159), ESR (113), platelets (706), albumin (29), globulin (48) Creatinine kinase (2469) were all abnormal (units and normal values unknown). In addition from 3rd April the patient experienced swollen legs. No known concurrent medication or medical history. At the time of reporting the events were ongoing. No further information was available at the time of reporting.

VAERS ID:420829 (history)  Vaccinated:2010-12-30
Age:31.0  Onset:2011-01-02, Days after vaccination: 3
Gender:Female  Submitted:2011-04-08, Days after onset: 95
Location:Foreign  Entered:2011-04-11, Days after submission: 3
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHFR2011GB02394
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER107221 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Influenza like illness, Precipitate labour, Premature delivery
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Case number PHFR2011GB02394 is an initial foreign regulatory report (GB-MHRA-ADR20987681) received from the Medicines and Healthcare Products Regulatory Agency (MHRA) on 06 Apr 2011 has been transcribed from an Anonymised Single Patient Report (ASPR). This report refers to a 31-year-old pregnant female patient. The patient''s medical history and concomitant medications were not reported. On an unknown date, the patient had her last menstrual period. When she was 35 weeks pregnant, she received AGRIPPAL (batch number: 107221) on 30 Dec 2011 at dose of 0.5 ml. Exposure to AGRIPPAL occurred during the 3rd trimester. On 31 Dec 2011, the patient developed influenza like symptoms which resulted in hospitalization with premature delivery on 02 Jan 2011, three days after vaccination. The delivery was via precipitous labour and the baby was resuscitated and kept in special care baby unit for three weeks (see case: PHFR2011GB02397). The patient recovered from influenza like symptoms on 15 Jan 2011. These events were also considered serious due to being medically significant and life threatening. The physician''s causality assessment was not reported. By convention reports from the MHRA are considered to have implied causal relationship.

VAERS ID:424286 (history)  Vaccinated:2010-09-28
Age:31.0  Onset:2010-09-28, Days after vaccination: 0
Gender:Female  Submitted:2011-05-27, Days after onset: 241
Location:Foreign  Entered:2011-05-31, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Crohn''s disease
Preexisting Conditions: Pregnant; Live birth with congenital anomaly; Last menses: 01-Mar-2010; Pregnancy end date: 26-Oct-2010
Diagnostic Lab Data:
CDC Split Type: 2011028629
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Antepartum haemorrhage, Drug exposure during pregnancy, Premature delivery, Premature rupture of membranes, Retroplacental haematoma, Ultrasound scan abnormal, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: This health authority report (initial receipt on 12-May-2011) concerns a 31 year old female pregnant patient. At the time of the event the patient concomitantly suffered from Crohn''s disease and therefore needed to take the following drugs during whole pregnancy: Azathioprine oral, Mesalazine oral and rectal. Furthermore she took levothyroxine because of hypothyroidism, also long-term exposure. The patient also received concomitant medication folic acid and nifedipine. Azathioprine, Mesalazine, thyroxine, aminosalicylic acid and folate were taken from gestational week 0-34.1. The whole pregnancy she suffered from vaginal bleedings, partially severe bleedings until gestational week 20. A retro placental hematoma was documented by sonography. On 28-SEP-2010 (30.1 week of gestation) the patient received AFLURIA intramuscularly. Azathioprine was also reported as a suspect drug. The patient took azathioprine orally 100 mg/d from 01-Mar-2010 to 26-Oct-2010. In 32.3 GW (gestational weeks), premature rupture of membranes happened. For several days, tocolysis with nifedipine was given and maternal therapy to enhance fetal lung maturity with corticoids (not specified)) was completed. Simultaneously therapy with antibiotics (drug unknown) happened. Twelve days later, premature rupture of membranes delivery happened after cervical priming with misoprostol in GW 34.1. The pregnancy end date was 26-Oct-2010. The event outcome was recovered. Reporter''s comments: The reporter considered the event ''haemorrhage in pregnancy'' to be unlikely in relation to the suspect drug AFLURIA. ''Prematurity'' possible to AFLURIA vaccine (see linked child case). The reporter stated the following, ''Suppression of haemotopoetic system by azathioprine is described in the literature. If there is a relationship to the permanent uterine bleedings we cannot verify why. We do not know if there were changes in the blood count of the mother during pregnancy''. Causality of the event ''haemorrhage in pregnancy'' was considered possible to azathioprine and unlikely to Mesalazine, aminosalicylic acid, levothyroxine, folic acid and nifedipine. Prior to receiving AFLURIA and throughout whole pregnancy the patient had suffered from vaginal bleedings and a retro placental hematoma was documented by sonography, therefore ''haemorrhage in pregnancy'' and ''retro placental hematoma'' is unlikely to be related to suspect drugs. The other events are possibly related to temporal relationship. Linked case: 2011028625 (child). This individual case does not affect the benefit-risk assessment, hence no further safety-relevant measure is deemed necessary.

VAERS ID:424432 (history)  Vaccinated:2010-05-27
Age:31.0  Onset:2011-05-10, Days after vaccination: 348
Gender:Female  Submitted:2011-06-01, Days after onset: 22
Location:Foreign  Entered:2011-06-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: C-section due to breech presentatio
Diagnostic Lab Data: UNK
CDC Split Type: B0688910A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMRA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal wound dehiscence, Caesarean section, Drug exposure before pregnancy, Effusion, Live birth, Postoperative wound complication, Wound secretion
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: This prospective pregnancy case was reported by a physician and described occurrence of postoperative wound breakdown in a 32-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Previous vaccination included CERVARIX (GlaxoSmithKline, intramuscular, lot number not provided) given on 30 April 2010. On 27 May 2010, the subject received 2nd dose of CERVARIX (intramuscular, unknown injection site, lot number not provided). The subject experienced vaccine exposure during pregnancy. Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine during unspecified trimester. The outcome of the pregnancy was unknown. Follow-up information was received on 15 December 2010: First dose of CERVARIX was administered at the left deltoid, second dose at the right deltoid muscle. Follow-up information received on 25 May 2011: This case was upgraded to serious. The subject''s medical history included c-section due to breech presentation, no more details were provided. The subject was a non-smoking person and not a alcohol drinker. Concurrent medications included LOXONIN, FLOMOX, BIOFERMIN, Medroxyprogesterone, FOLIAMIN, CINAL, MAGMITT, Chinese medication (Chinese medicine), MUCODYNE, UTEMERIN, FERRUM, MARCAIN, ANAPEINE, Fentanyl, EPHEDRIN, ATONIN O, Cephazolin sodium, Heparin sodium, METHERGIN, MEIACT, MUCOSTA, HUSTAZOL, MUCOSOLVAN, ROPION, Atropine and DROLEPTAN. Her last menstrual period was on 17 August 2010 and estimated date of delivery was not provided. The subject was exposed to the vaccine before pregnancy. On 10 May 2011, after 38 weeks of gestation and 11 months after vaccination, the subject gave birth to a live baby girl by C-section. No birth defects were noted. The infant had an Apgar score of 8 at 1 min and 9 at 5 minutes, a height of 47 cm and a weight of 2.520 kg. On 18 May 2011, the subject experienced postoperative wound breakdown There was an oozing from caesarian section wound and a dehiscence of a part of the wound was observed. The physician considered the events were clinically significant (or requiring intervention). On 21 May 2011, the redness around wound disappeared. On 24 May 2011, effusion decreased and the subject was discharged from the hospital (managed on an outpatient basis). At the time of reporting, the events were reported as improved. The physician considered the events were related to vaccination with CERVARIX.

VAERS ID:425125 (history)  Vaccinated:2010-04-01
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2011-06-06
Location:Foreign  Entered:2011-06-09, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Cellulitis from a previous insect bite (Cellulitis), polycystic ovaries, periods cased 2 years ago (Absence of menstruation)
Diagnostic Lab Data:
CDC Split Type: 2011028676
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal distension, Arthralgia, Headache, Hypertension, Laboratory test, Oedema, Oedema peripheral, Pyrexia, Swelling face
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This spontaneous consumer report (initial receipt 23-May-2011) concerns a 31 year old female patient. The patient had a medical history of cellulitis from a previous insect bite, polycystic ovaries and her periods ceased 2 years ago. The patient had not received any other vaccinations within the last 3 months. The patient has not had recent or concurrent infection, chronic illness or previous febrile reactions to vaccination. The patient did not have any other suspected cause of fever. The patient did not have any concurrent medications. On ??-Apr-2010, the patient received FLUVAX. Two days after vaccination, the patient developed swelling in the face, high fever, headache, high blood pressure, oedema in the legs, and aching joints. The patient was taken to hospital for further tests. The symptoms continued for approximately one week after vaccination. The symptoms and laboratory tests were investigated by a physician/nephrologist at a hospital and by a rheumatologist. The patient has intermittent bouts of oedema, bloating and aching joints since the vaccination. The patient required consultation with a doctor, was reviewed in a hospital emergency department and required admission to hospital. No antipyretic treatment was administered. The reporter was unsure if the patient required any other treatment. The event outcome was recovered. Follow up #1 (27-May-2011): medically confirmed, patient hospitalised, treatment, event outcome, additional medical history, case upgraded to serious.

VAERS ID:425753 (history)  Vaccinated:0000-00-00
Age:31.0  Onset:0000-00-00
Gender:Male  Submitted:2011-06-20
Location:Foreign  Entered:2011-06-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2011AR51520
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS11625025 IJUN
Administered by: Other     Purchased by: Other
Symptoms: Malaise, Upper respiratory tract infection
SMQs:
Write-up: Case number PHHY2011AR51520 is an initial spontaneous report received from health authority (Ministry of Health: Vaccination campaign) on 07 Jun 2011. This report refers to a 31 year old male patient. He was vaccinated with FLUVIRIN (batch number: 11625025) on an unspecified date. One day after vaccination, he presented with malaise and upper respiratory tract infection. He received symptomatic treatment and recovered completely on unspecified date.

VAERS ID:426058 (history)  Vaccinated:2011-05-20
Age:31.0  Onset:2011-05-22, Days after vaccination: 2
Gender:Female  Submitted:2011-06-23, Days after onset: 32
Location:Foreign  Entered:2011-06-24, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2011028930
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED  IJUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Angioedema, Arthralgia, Blood pressure increased, Headache, Joint swelling, Oedema peripheral, Swelling face
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Oropharyngeal allergic conditions (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This health authority report (initial receipt: 14-Jun-2011) concerns a 31-year old female patient. On 20-May-2011 the patient received one dose of FLUVAX. On 22-May-2011 the patient developed swelling of face, legs, ankles, arms. She also had ? ascites (fluid in abdomen), arthralgia, headache and increased blood pressure. She had experienced 2 similar episodes since. The event outcome was not yet recovered. The reporter considered events possibly related to the suspect drug. The reporter also added ''angioedema'' as one of the Preferred Terms.

VAERS ID:427190 (history)  Vaccinated:0000-00-00
Age:31.0  Onset:2011-05-18
Gender:Male  Submitted:2011-07-12, Days after onset: 55
Location:Foreign  Entered:2011-07-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 13 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Cerebrospinal fluid protein, 09Jun2011, 1912ng/l
CDC Split Type: D0071959A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B065AE IMLA
Administered by: Other     Purchased by: Other
Symptoms: Autonomic nervous system imbalance, CSF protein increased, Computerised tomogram head, Computerised tomogram normal, Dysaesthesia, Electromyogram abnormal, Electronystagmogram abnormal, Facial paresis, Guillain-Barre syndrome, Hypertension, Immunoglobulin therapy, Reflexes abnormal, Tachycardia, Upper respiratory tract infection
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypertension (narrow), Demyelination (narrow)
Write-up: This case was reported by a regulatory authority (DE-PEI-PEI2011022421) and described the occurrence of demyelinating polyneuropathy in a 31-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). In May 2011 the subject received a dose of BOOSTRIX (intramuscular, left upper arm). On 18 May 2011, 2 weeks after vaccination with BOOSTRIX, the subject experienced dysesthesia of hands and upper respiratory tract infection on June the 1st. The subject was treated with PENICILLIN on 6 June 2011. On 7 June 2011 the subject developed facial paresis. The subject was hospitalised for 13 days from 9 till 21 June 2011. The subject also experienced monosynaptic reflexes, distally accentuated paresis, clearly affected vegetative neural pathway, tachycardia and hypertension. Diagnose included acute inflammatory demyelinating polyneuropathy based on EMG and ENG findings. Cranial computerized tomography was without pathological findings. The subject was successfully treated with immunoglobulins. The subject underwent a rehab program. At the time of reporting the subject had not completely recovered. No further information will be available.

VAERS ID:429021 (history)  Vaccinated:2011-05-05
Age:31.0  Onset:2011-05-05, Days after vaccination: 0
Gender:Male  Submitted:2011-08-05, Days after onset: 92
Location:Foreign  Entered:2011-08-08, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No reported medical history and concomitant therapy
Diagnostic Lab Data: Not reported
CDC Split Type: 201105770
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURV3928AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cough, Dysphagia, Hyperhidrosis, Hypersensitivity, Pharyngeal erythema
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Case received from a healthcare professional on 25 July 2011 under the reference number PA2011006. This case is a part of a cluster of 7 cases: 2011-05768, 2011-05770, 2011-05771, 2011-05772, 2011-05773, 2011-05775, 2011-05777. A 31-year-old male patient, with no reported medical history and concomitant therapy, had received his primary dose of FLUZONE (batch number V3928AA, route and site of administration not reported) on 05 May 2011. On 05 May 2011, the patient experienced allergic reaction, dysphagia, coughing, erythema throat and sweating. The patient was treated with CLOROTRIMETRON IV and hydrocortisone IV. The patient recovered on an unspecified date. The case was reported as non-serious. Upon internal review, it was upgraded to serious due to other important medical condition.

VAERS ID:432273 (history)  Vaccinated:2011-08-22
Age:31.0  Onset:0000-00-00
Gender:Male  Submitted:2011-08-26
Location:Foreign  Entered:2011-08-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0742156A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Paraplegia
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: This case was reported by a physician via a sales representative and described the occurrence of paraplegia in a 31-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 22 August 2011, the subject received 1st dose of HAVRIX (unknown route of administration, unknown site of injection, batch number not provided). On 22 or 23 August 2011, less than one week after vaccination with HAVRIX, the subject experienced paraplegia. On 23 August 2011, the subject went to the emergency room due to the symptom. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The HAVRIX prescriber considered that the event could be unlikely diagnosed as Guillain-Barre syndrome.

VAERS ID:434757 (history)  Vaccinated:2011-06-15
Age:31.0  Onset:2011-06-17, Days after vaccination: 2
Gender:Female  Submitted:2011-09-16, Days after onset: 91
Location:Foreign  Entered:2011-09-19, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Pregnant; Sex: Female; The patient had a medical history of gestational diabetes mellitus and pre-eclampsia; No reported concomitant therapy
Diagnostic Lab Data: Not reported
CDC Split Type: 201108595
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion, Cough, Influenza, Intra-uterine death, Maternal exposure during pregnancy, Oropharyngeal pain, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case received from the Health Authorities via another company GPO-MBP on 13 September 2011 under the reference number GPO-MBP-11-010. A 31-year-old pregnant female patient, with a medical history of gestational diabetes mellitus and pre-eclampsia and no reported concomitant therapy, had received a dose of influenza vaccine (manufacturer unknown, batch number, route and site of administration not reported) on 15 June 2011. There was no information on origin of seasonal flu vaccine. However, the influenza vaccine manufactured by GPO-MBP is routinely used in the national vaccination programme. Information about pregnancy was not reported. On 17 June 2011, the patient developed fever, cough and sore throat. Flu was diagnosed. The patient experienced abortion due to fetal death in utero. The patient was hospitalized (dates of hospitalization not reported). The patient''s outcome was not reported. This case was investigated by the regional committee and the relationship between the events and the vaccination was assessed as not related.

VAERS ID:434889 (history)  Vaccinated:2011-05-12
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2011-09-19
Location:Foreign  Entered:2011-09-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: not reported
CDC Split Type: 201108696
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3960AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Feeling hot, Local reaction, Pain
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case report is part of a batch of several hundred reports associated with different products, that was received on 13 September 2011 by sanofi pasteur affiliate in a foreign country, from the "Ministry of Health" (local case reference number BR-BT2011-3662). A female patient (born on 01 July 1979), whose medical history and concomitant therapies were not reported, had received her dose of FLUZONE (batch number U3960AA, route and anatomical site of administration not reported) on 12 May 2011. On an unspecified date post-vaccination, the patient experienced local reaction with pain, redness and "heat" (intensity classification: not severe). The case was assessed as serious by the Ministry of Health. The patient was hospitalized on unspecified dates. The Ministry of Health classified the adverse events on category 4 [intensity/severity scale from 1 (less important) to 4 (more important)]. The "causality classification" was confirmed (the Ministry of Health assessed the adverse events as related to the vaccine). Documents held by sender: none.

VAERS ID:434932 (history)  Vaccinated:2011-05-25
Age:31.0  Onset:2011-05-25, Days after vaccination: 0
Gender:Female  Submitted:2011-09-19, Days after onset: 117
Location:Foreign  Entered:2011-09-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: not reported
CDC Split Type: 201108699
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3960AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Angioedema, Cough, Dyspnoea, Headache, Maternal exposure during pregnancy, Ocular hyperaemia, Pruritus
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Glaucoma (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case report is part of a batch of several hundred reports associated with different products, that was received on 13 September 2011 by sanofi pasteur affiliate from the "foreign Ministry of Health" (local case reference number BR-BT2011-3664). A 31-year-old pregnant female patient whose medical history and concomitant therapies were not reported, had received her dose of FLUZONE (batch number U3960AA, route and anatomical site of administration not reported) on 25 May 2011. No details regarding the patient''s pregnancy were reported. Two hours post-vaccination, the patient experienced anaphylaxis level 2 with angioedema, pruritus, hyperemia in the eyes, dry cough, difficulty in breathing and headache (intensity classification: severe). The case was assessed as serious by the Ministry of Health. The patient was hospitalized on unspecified dates. The Ministry of Health classified the adverse events on category 1 [intensity/severity scale from 1 (less important) to 4 (more important)]. The "causality classification" was confirmed (the Ministry of Health assessed the adverse events as related to the vaccine). Documents held by sender: none.

VAERS ID:435052 (history)  Vaccinated:2011-05-04
Age:31.0  Onset:2011-05-04, Days after vaccination: 0
Gender:Female  Submitted:2011-09-20, Days after onset: 139
Location:Foreign  Entered:2011-09-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data:
CDC Split Type: 201108820
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3931AB UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Cough, Eye pruritus, Ocular hyperaemia, Oropharyngeal pain, Pain, Pyrexia, Sneezing, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case report is part of a batch of several hundred reports associated with different products, that was received on 13 September 2011 by sanofi pasteur affiliate, from the "Ministry of Health" (local case reference number BR-BT2011-3769). A 31-year-old female patient, whose medical history and concomitant therapies were not reported, had received a dose of FLUZONE (batch number U3931AB, route and anatomical site of administration not reported) on 04 May 2011. On 04 May 2011, the patient experienced not severe anaphylaxis level 3. She experienced pain, eye hyperemia and itching, sore throat, sneezing, closing throat sensation, dry cough and fever lower than 39.5 degrees C. The case was assessed as serious by the Ministry of Health. The patient was not hospitalized. The Ministry of Health classified the adverse events on AEFI (Adverse Event Following Immunization). The "causality classification" was confirmed (the Ministry of Health assessed the adverse events as related to the vaccine). Documents held by sender: none.

VAERS ID:435250 (history)  Vaccinated:2011-04-30
Age:31.0  Onset:2011-04-30, Days after vaccination: 0
Gender:Female  Submitted:2011-09-21, Days after onset: 144
Location:Foreign  Entered:2011-09-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: No data
CDC Split Type: 201108743
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3829AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Laryngeal oedema, Oral pruritus, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: This case report is part of a batch of several hundred reports associated with different products, that was received on 13 September 2011 by sanofi pasteur affiliate, from the "foreign Ministry of Health" (local case reference number BR-BT2011-3710). A female patient, whose medical history and concomitant therapies were not reported, had received a dose of FLUZONE (batch number U3829AA, route and anatomical site of administration not reported) on 30 April 2011. On an unspecified date, 2 hours after the vaccine administration, the patient presented with dyspnea, dry cough, pruritus in the throat, glottis edema (sensation of closing of the throat). Anaphylaxis was reported (intensity classification: severe). She was referred to the hospital, duly medicated, and presented improvement. The patient received the vaccine in previous years. "Level 2" was mentioned. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. The patient''s outcome was not reported. The Ministry of Health classified the adverse events as AEFI (Adverse Event Following Immunization). The "causality classification" was confirmed (the Ministry of Health assessed the adverse events as related to the vaccine). Documents held by sender: none.

VAERS ID:435541 (history)  Vaccinated:1992-11-23
Age:31.0  Onset:1992-12-15, Days after vaccination: 22
Gender:Female  Submitted:2011-09-23, Days after onset: 6855
Location:Foreign  Entered:2011-09-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0748092A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rheumatoid arthritis
SMQs:, Arthritis (narrow)
Write-up: This case was reported by the foreign regulatory authority (reference number PP20090007) and described the occurrence of rheumatoid polyarthritis in a 31-year-old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). The subject belonged to an association under reference 2355. The subject''s medical history and concomitant medications, if any, were not specified. On an unspecified date, the subject received first dose of hepatitis B vaccine. On 23 November 1992, the subject received second dose of hepatitis B vaccine (manufacturer, batch number, route and injection site unknown). On 15 December 1992, 22 days after vaccination with hepatitis B vaccine, the subject was diagnosed with rheumatoid polyarthritis. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. The agency''s causality assessment was not provided.

VAERS ID:435525 (history)  Vaccinated:2009-10-06
Age:31.0  Onset:2009-10-26, Days after vaccination: 20
Gender:Female  Submitted:2011-09-25, Days after onset: 699
Location:Foreign  Entered:2011-09-25
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Soreness at the site of injection, and dizziness.
Preexisting Conditions:
Diagnostic Lab Data: CTI, MRI, Xray of chest
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IJLA
Administered by: Unknown     Purchased by: Private
Symptoms: Cerebrovascular accident, Computerised tomogram, Dizziness, Headache, Injection site pain, Nuclear magnetic resonance imaging
SMQs:, Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad)
Write-up: Severe Headache - later found out was a stroke.

VAERS ID:435990 (history)  Vaccinated:2011-06-13
Age:31.0  Onset:2011-06-13, Days after vaccination: 0
Gender:Male  Submitted:2011-09-26, Days after onset: 105
Location:Foreign  Entered:2011-09-28, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported; The patient had chronic disease; She stated that she had presented similar symptoms after H1N1 vaccination last year. She also had been hospitalized and had received the same injectable medications.
Diagnostic Lab Data:
CDC Split Type: 201108876
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH365AB UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Angioedema, Dyspnoea, Oropharyngeal pain, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case report is a part of a batch of several hundred reports associated with different products, that was received on 13 September 2011 by sanofi pasteur affiliate in a foreign country, from the "Foreign Ministry of Health" (local case reference number BR-BT2011-3723). A 31-year-old male patient, whose medical history and concomitant therapies were not reported, had received a dose of FLUZONE (batch number UH365AB, route and anatomical site of administration not reported) on 13 June 2011. The patient had chronic disease (not specified). On 13 June 2011, 7 hours post-vaccination, the patient experienced severe anaphylaxis level 1. He had sore throat, sensation of closing of throat, breathing difficulty, angioedema in eyes, tongue and larynx. The patient was treated with IV hydrocortisone and FENERGAN. She stated that she had presented similar symptoms after H1N1 vaccination last year. She also had been hospitalized and had received the same injectable medications. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. The Ministry of Health classified the adverse events on AEFI (Adverse Event Following Immunization). The "causality classification" was confirmed (the Ministry of Health assessed the adverse events as related to the vaccine). Documents held by sender: none.

VAERS ID:436026 (history)  Vaccinated:2011-05-13
Age:31.0  Onset:2011-05-13, Days after vaccination: 0
Gender:Female  Submitted:2011-09-26, Days after onset: 136
Location:Foreign  Entered:2011-09-28, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: No data
CDC Split Type: 201108865
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH365AD UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Dyspnoea, Erythema, Eyelid oedema, Ocular hyperaemia
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Glaucoma (broad), Cardiomyopathy (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case report is part of a batch of several hundred reports associated with different products, that was received on 13 September 2011 by sanofi pasteur affiliate, from the "foreign Ministry of Health" (local case reference number BR-BT2011-3732). A 31-year-old female patient, whose medical history and concomitant therapies were not reported, had received a dose of FLUZONE (batch number UH365AD, route and anatomical site of administration not reported) on 13 May 2011. On 13 May 2011, 3 hours after vaccination, the patient experienced anaphylaxis level 2 (intensity classification: severe). The patient''s had difficulty breathing, edema in the eyelid, redness in the face and eyes. The patient was not hospitalized. The case was assessed as serious by the Ministry of Health i.e. other medically important condition. The Ministry of Health classified the adverse events on AEFI (Adverse Event Following Immunization). The "causality classification was confirmed (the Ministry of Health assessed the adverse events as related to the vaccine). Documents held by sender: none.

VAERS ID:436107 (history)  Vaccinated:2011-05-03
Age:31.0  Onset:2011-05-03, Days after vaccination: 0
Gender:Female  Submitted:2011-09-26, Days after onset: 146
Location:Foreign  Entered:2011-09-28, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported; She had received vaccines during previous campaigns without reaction.
Diagnostic Lab Data: not reported
CDC Split Type: 201108825
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3960AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Oropharyngeal pain, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: This case report is part of a batch of several hundred reports associated with different products, that was received on 13 September 2011 by sanofi pasteur affiliate, from the "foreign Ministry of Health" (local case reference number BR-BT2011-3797). A 31-year-old female patient, whose medical history and concomitant therapies were not reported, had received her dose of FLUZONE (batch number U3960AA, route and anatomical site of administration not reported) on 03 May 2011. She had received vaccines during previous campaigns without reaction. On 03 May 2011, 3 hours post-vaccination, the patient experienced anaphylaxis with sore throat, breathing difficulty, dry cough, dyspnea and vomiting (intensity classification: severe). She received medical care in the hospital where she worked. The case was assessed as serious by the Ministry of Health. The patient was not hospitalized. The Ministry of Health classified the adverse events on AEFI (Adverse Event Following Immunization). The "causality classification" was confirmed (the Ministry of Health assessed the adverse events as related to the vaccine). Documents held by sender: none.

VAERS ID:440901 (history)  Vaccinated:2008-12-15
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2011-10-31
Location:Foreign  Entered:2011-11-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GAVISCON ADVANCE; ferrous fumarate
Current Illness: Pregnancy NOS (LMP = 23Nov08); Gastrooesophageal reflux; Anaemia
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES1110USA03911
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Caesarean section, Labour complication, Labour induction, Maternal exposure during pregnancy, No adverse event, Prolonged pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: This case of pregnancy follow up was received from the Health Protection Agency on 20-OCT-2011. HPA ref 0046. This case was linked to infant report E2011-06427 (WAES#1110USA03911B1). This case was medically confirmed. A 31 year old female patient received an injection of MMR (manufacturer and batch number not reported) on 15-DEC-2008. The patient was found to be pregnant. Her last menstrual period (LMP) was 23-NOV-2008 and her estimated delivery date (EDD) was 30-AUG-2009. The patient had no adverse reaction following vaccination. The patient was a teacher and was susceptible to measles, mumps and rubella according to her vaccine history and was vaccinated in response to a local outbreak. The patient had no previous pregnancies. The patient was taking concomitant GAVISCON ADVANCE 5-10 mls for reflux starting on 17-APR-2009 and ferrous fumarate 210 mg for anaemia starting on 11-JUN-2009. The patient had no pregnancy complications or illness or medical conditions or diagnostic tests. The patient had an induction of labour for post-maturity (41 +6/40) and unspecified labour complications resulting in an emergency caesarean section. The patient had a live birth at 42 weeks gestation of a female infant weighing 3460g. The infant did not have any congenital anomalies. The infant did have reflux diagnosed and was found to be positive for faecal reducing substances although the significance of this was not known. The infant was referred to paediatric outpatients on 20-OCT-2009. The infant would be followed up after one year as standard. The infant also had a cow''s milk protein allergy with a positive patch test. The patient outcome was not reported. Upon internal medical review the events were considered to be medically significant. Other business partner number included: E2011-06424. No further information is available.

VAERS ID:442957 (history)  Vaccinated:2008-08-18
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2011-11-10
Location:Foreign  Entered:2011-11-14, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Immunoglobulin Equine antirabies
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201110764
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURER075306C0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Adverse event
SMQs:
Write-up: This case report is part of a batch of several hundred reports associated with Rabies Vaccine, that was received on 27 October 2011 by sanofi pasteur affiliate, from the "Ministry of Health" (local case reference number BR-BT-2011-4341). A female patient whose medical history and concomitant therapies were not reported, had received her 1st dose of Rabies Vaccine and Rabies Serum (manufacturer not reported, batch number "075306-C", route and anatomical site of administration not reported) on 18 August 2008. The patient had received more than one concomitant vaccine (manufacturer and batch numbers not reported). The suspect vaccine was reported as "RB", i.e. Rabies Serum and "RV", i.e. Rabies Vaccine/Vero. On an unspecified timeframe post-vaccination, the patient experienced other serious or unexpected adverse events. The patient''s symptoms lasted for 2 days. She recovered without sequelae. The case was assessed as serious by the Ministry of Health due to other important medical condition. The patient was reported as hospitalized for 0 days. The recommended "conduct" was "schedule maintained". Documents held by sender: none.

VAERS ID:446017 (history)  Vaccinated:0000-00-00
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2011-12-21
Location:Foreign  Entered:2011-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0769369A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inflammation
SMQs:
Write-up: This case was reported by a regulatory authority (# GB-MHRA-EYC 00076503) and described the occurrence of inflammation localized in a 31-year-old female subject who was vaccinated with Influenza virus vaccine (unspecified). On an unspecified date the subject received unspecified dose of Influenza vaccine (unspecified) (1 IU Axa). At an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced inflammation localized. The regulatory authority reported that the event was clinically significant (or requiring intervention). At the time of reporting the event was unresolved. The patient experienced localised inflammation.

VAERS ID:446389 (history)  Vaccinated:0000-00-00
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2011-12-27
Location:Foreign  Entered:2011-12-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHFR2011GB007214
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Inflammation
SMQs:
Write-up: Case number PHFR2011GB007214 is an initial spontaneous report received from the health authority (reference number: GB-MHRA-EYC-00076503/ADR21384915) on 15 Dec 2011. This case refers to a 31-year-old female patient. She was vaccinated with influenza vaccine (manufacturer and batch number: unknown) on an unspecified date. She experienced localized inflammation on an unspecified date. The outcome the event was reported as not recovered. The health authority assessed this case was medically significant.

VAERS ID:448219 (history)  Vaccinated:2011-10-19
Age:31.0  Onset:0000-00-00
Gender:Male  Submitted:2012-01-26
Location:Foreign  Entered:2012-01-27, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201200883
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH365AC0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This initial case report is part of a batch of several hundred reports associated with several products that was received on 17 January 2012 by Sanofi Pasteur affiliate in a foreign country, from the "foreign Ministry of Health" (local case reference number BR-BT2012-0039). A "31-year-05-month-08-day" old male patient, whose medical history and concomitant therapies were not reported, had received his 1st dose of FLUZONE (batch number UH365AC, route and anatomical site of administration not reported) on 19 October 2011. FLUZONE was associated with more than one vaccine. On an unspecified date post-vaccination, the patient experienced fever lower than 39.5 degrees C. The patient recovered ("cure") without sequelae. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. The case was "confirmed" as per the Ministry of Health, i.e. related to the vaccine. It was also reported that this case was "causality 1", i.e. "confirmed" corresponding to any clinical event that has linked plausible temporal association with administration of a vaccine and can not be explained by concurrent disease or administration of other drugs or chemicals. The Ministry of Health classified this case in category 1, i.e. Adverse Reaction Following Immunization (ARFI). Documents held by sender: none.

VAERS ID:448705 (history)  Vaccinated:0000-00-00
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2012-02-01
Location:Foreign  Entered:2012-02-02, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201201093
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN))UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: Case retrieved form the literature on 23 January 2012. Unique worldwide case ID: MX-SP-2012-01002. The database corresponding to the events temporarily associated with vaccination (ETAV) associated with influenza (A [H1N1] and seasonal) immunization reported between December 2009 and June 2010 was analyzed. Patient who displayed at least one ETAV after the administration of influenza A (H1N1) vaccine and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporarily criterion, i.e., appearance of the event within the 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine and requires demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine cases against influenza A (H1N1) and 18,442,171 doses against seasonal influenza vaccine were applied across the country. A total of 597corresponding to the application of the antiinfluenza A (H1N1) and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. A 31-year-old female patient, with no reported medical history and concomitant therapy, had received on an unspecified date her dose of vaccine against influenzaA (H1N1) (manufacturer unknown, batch number, number in series, route and site of administration not reported). The vaccine was without adjuvant. On an unspecified date, the patient developed GBS (Guillain Barre syndrome) (reported as initial and final diagnosis). It was not specified if the patient was hospitalized. No corrective treatment was reported. The final outcome was not reported. It was specified that the patient was not died. This interval was reported as "39" (no unit reported). According to the author, the event was considered as "CNR" (coincidental not related). According with the author, this case was assessed as serious due to medically important condition. Fourteen confirmed cases of GBS according to Brighton Criteria were reported. All were ruled as unrelated coincidental events, given that vaccination against A (H1N1) as an antecedent occurred in seven cases (50%); immunization against seasonal influenza occurred in four cases (28.5%), and the joint administration of both vaccines occurred in three cases (21.4%). Documents held by sender: none.

VAERS ID:449004 (history)  Vaccinated:2010-08-04
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2012-02-03
Location:Foreign  Entered:2012-02-06, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201201228
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)SANOFI PASTEUR  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This initial case report is part of several hundred reports associated with several products that was received on 26 January 2012 by Sanofi Pasteur affiliate, from the "Foreign Ministry of Health" through the distributor (local case reference number BR-BT2012-0226). A female patient whose medical history and concomitant therapies were not reported, had received her dose of H1N1 vaccine (manufactured by Sanofi Pasteur, batch number, route and anatomical site of administration not reported) on 04 August 2010 during a vaccination campaign. On an unspecified date post-vaccination, the patient experienced fever (<39.5 deg C). The patient recovered ("cure") without sequelae. The case was assessed as serious by the Ministry of Health. The patient was hospitalized on unspecified dates. The case was "confirmed" as per the Ministry of Health, i.e. related to the vaccine. The action with regards to the next vaccination was provided: "no conduct". Documents held by sender: none.

VAERS ID:449019 (history)  Vaccinated:2011-05-31
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2012-02-03
Location:Foreign  Entered:2012-02-06, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201201180
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3961AA UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Angioedema, Hypersensitivity
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This initial case report is part of a batch of several hundred reports associated with several products that was received on 26 January 2012 by Sanofi Pasteur affiliate, from the "Ministry of Health" through the distributor (local case reference number BR-BT2012-0197). A female patient, whose medical history and concomitant therapies were not reported, had received her dose of FLUZONE (batch number reported as 1104091 corresponding to Sanofi Pasteur''s batch number U3961AA, route and anatomical site of administration not reported) on 31 May 2011 during a vaccination campaign. On an unspecified date post-vaccination, the patient experienced hypersensitivity reaction until 2 hours and angioedema. The patient recovered ("cure") without sequelae. The case was assessed as serious by the Ministry of Health. The patient was hospitalized on unspecified dates. The case was "confirmed" as per the Ministry of Health, i.e. related to the vaccine. The action with regards to the next vaccination was provided: "contraindication without change of scheme". Documents held by sender: none.

VAERS ID:451023 (history)  Vaccinated:2012-02-18
Age:31.0  Onset:2012-02-18, Days after vaccination: 0
Gender:Male  Submitted:2012-03-02, Days after onset: 13
Location:Foreign  Entered:2012-03-02
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0784502A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Electrocardiogram ST-T change, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority (# GB-MHRA-EYC 00080817) and described the occurrence of fit (non-epileptic) in a 31-year-old male subject who was vaccinated with TWINRIX, (non-gsk) TYPHIM VI. Concurrent medications included ibuprofen. On 18 February 2012 the subject received unspecified dose of TWINRIX (1 ml, intramuscular) and an unspecified dose of TYPHIM VI (0.5 ml, intramuscular). On 18 February 2012, at an unspecified time after vaccination with TWINRIX and TYPHIM VI, the subject experienced fit (non-epileptic), respiratory arrest and electrocardiogram ST-T change. The regulatory authority reported that the events were life threatening. On 18 February 2012, the events; fit (non-epileptic) and respiratory arrest were resolved. Verbatim Text: The patient experienced ECG nonspecific ST-T change, fit (non-epileptic) and respiratory arrest.

VAERS ID:451335 (history)  Vaccinated:2011-02-06
Age:31.0  Onset:2011-11-01, Days after vaccination: 268
Gender:Male  Submitted:2012-03-08, Days after onset: 128
Location:Foreign  Entered:2012-03-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Pertussis IgA, positive; Pertussis IgG, positive; Pertussis serology, 16Feb2012, positive; Polymerase chain reaction, 16Feb2012, pertussis: negat
CDC Split Type: B0781757A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Bordetella test, Bordetella test positive, Pertussis, Polymerase chain reaction, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)
Write-up: This case was reported by a healthcare professional (nurse) via a sales representative and described the occurrence of whooping cough in 32-year-old male subject whow as vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of BOOSTRIX (unknown route of administration, unknown site of injection, batch number not provided). At an unspecified time after vaccination with BOOSTRIX, the subject experienced whooping cough (vaccination failure). This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified. This case was linked to B0781755A and is one out of the 3 cases reported by the same nurse. The nurse reported all staff members at the facility had been vaccinated with BOOSTRIX but three staff members who were vaccinated experienced whooping cough. Follow-up information received on 27 February 2012: The subject details were added. The vaccine was administered on 10 February 2011. In November 2011, 9 months after vaccination with BOOSTRIX, the subject experienced whooping cough for 3 weeks. The reporter considered the events as clinically significant (or intervention required). On 16 February 2012, a serology test was performed and was positive for pertussis. The PCR test was negative. The subject was treated with antibiotics. At the time of reporting, the event was resolved. Follow-up information received on 2 March 2012: No medical history was available. Previous vaccinations included PRIORIX and ENGERIX B given on 1 July 2011. B Pertussis IgG and B Pertussis IgA were detected. Results of culture of B Pertussis was negative. The subject was also treated with azithromycin for 5 days.

VAERS ID:451561 (history)  Vaccinated:2012-01-04
Age:31.0  Onset:2012-01-04, Days after vaccination: 0
Gender:Female  Submitted:2012-03-12, Days after onset: 67
Location:Foreign  Entered:2012-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: C-reactive protein, 12Jan2012, 2mg/l; Hematocrit, 12Jan2012, 42%; Hemoglobin, 12Jan2012, 13.9g/dl; MCH, 12Jan2012, 30.2pg/Ery; MCHC, 12Jan2012, 33.3g/dl; MCV, 12Jan2012, 90.7fl; Platelet count, 12Jan2012, 176Tsd/mcl; Red blood cell analysis, 12Jan2012, 4.61Mio/mcl; White blood cell count, 12Jan2012, 6.9Tsd/mcl
CDC Split Type: D0074646A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B074AD0UNLA
Administered by: Other     Purchased by: Other
Symptoms: Angioedema, C-reactive protein normal, Eczema, Haematocrit normal, Haemoglobin normal, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Platelet count normal, Red blood cell count normal, Urticaria, Vaccination site pain, White blood cell count normal
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician via regulatory authority (# DE-PEI-PEI2012006229) and described the occurrence of quincke''s edema in a 31-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Previous vaccinations included 4 doses of tetanus toxoid and reduced diphtheria toxoid vaccine given in 1980 and 1981, 1 dose of tetanus toxoid vaccine given in 1993, 1 dose of reduced diphtheria toxoid vaccine given in 1997, 1 dose REVAXIS (other manufacturer) given on an unspecified date, 5 doses of polio vaccine given in 1980, 1981 and 1997, 1 dose of Bacille Calmette-Guerin vaccine given in 1980, 3 doses of FSME-immune given in 1986 and 1987, 1 dose of INFLUSPLIT SSW given in 2002, 3 doses of Hepatitis A and B given in 2001 and 2002, 1 dose of INFLUSPLIT SSW given in 2003 as Past medical history were not provided. On 4 January 2012 the subject received 1st dose of BOOSTRIX (unknown route, left upper arm). On 4 January 2012, less than one day after vaccination with BOOSTRIX, the subject experienced vaccination site pain, eczema and possible injury to cutaneous sensory nerve and upper limb. On 6 January 2012 the subject experienced generalized urticaria and quincke''s edema. This case was assessed as medically serious by GSK. Vaccination site pain and eczema resolved after 3 days. Generalized urticaria and quincke''s edema resolved after 7 days. On 17 February 2012, possible injury to cutaneous sensory nerve and upper limb was reported to be unresolved. No further information will be available.

VAERS ID:452633 (history)  Vaccinated:2011-03-03
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2012-03-26
Location:Foreign  Entered:2012-03-29, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Miscarriage; Previous caesarean section
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1203USA00382
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1761X SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arrested labour, Caesarean section, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: This case of pregnancy follow up was received from the Health Protection Agency on 23-FEB-2012 HPA ref 0488. This case was medically confirmed. A 31 year old female patient received an injection of MMR II (lot # 663925/1761X, batch # NK41820, expiry April 2011), route and site not reported, on 03-MAR-2011. The patient was pregnant at the time of vaccination. Her last menstrual period was on 11-FEB-2011 and her estimated delivery date was 19-NOV-2011. The patient had a sero negative test result at antenatal screening on 15-SEP-2012 and so was susceptible to rubella and this was the reason for vaccination. The patient did not experience an adverse event reaction following vaccination. The patient had three previous pregnancies. One went to full term and two resulted in a miscarriage in week seven of pregnancy. There were no birth defects. Follow up received from the health authority on 15-MAR-2012: the patient had a past history of a caesarian section for her last baby. The patient was taking folic acid for an unreported indication. The patient underwent an emergency lower section caesarian section due to a failure to progress to the first stage. The patient had no medical conditions, diagnostic tests. The patient gave birth to a live female baby on an unreported date, weighing 3320 g at 40 weeks gestation with no abnormalities. It was not known if the baby had any cutaneous skin scarring, limb hypoplasia, eye abnormalities, neurological deficits, cardiac abnormalities, microcephaly, intrauterine growth retardation or other symptoms. The patient''s mother had moved GP practice and the GP had not seen the baby however no abnormalities had been noted on the hospital discharge summary. Upon internal review this case was upgraded to serious. Failure to progress to the first stage and emergency LSCS were considered to be an other important medical events by the agency. Other business partner numbers include: E2012-01470. No further information is available.

VAERS ID:455999 (history)  Vaccinated:2011-10-18
Age:31.0  Onset:2012-02-18, Days after vaccination: 123
Gender:Male  Submitted:2012-05-22, Days after onset: 93
Location:Foreign  Entered:2012-05-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0802751A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB849BT1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Lymphadenopathy mediastinal, Pulmonary sarcoidosis, Pyrexia
SMQs:, Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority (# 165158) and described the occurrence of pulmonary sarcoidosis in a 31-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 18 October 2011 the subject received 2nd dose of ENGERIX B (intramuscular, unknown injection site). On 18 February 2012, 4 months after vaccination with ENGERIX B, the subject experienced pulmonary sarcoidosis, arthralgia, lymphadenopathy mediastinal and fever. This case was assessed as medically serious by GSK. The subject was treated with cortisone. At the time of reporting the events were improved.

VAERS ID:457671 (history)  Vaccinated:2012-05-04
Age:31.0  Onset:2012-05-04, Days after vaccination: 0
Gender:Female  Submitted:2012-06-19, Days after onset: 46
Location:Foreign  Entered:2012-06-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0075807A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB886AH0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Chills, Diarrhoea, Dyspnoea, Hypotension, Pyrexia, Tachycardia, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of fever in an approximately 31-year-old female subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). On an unspecified date the subject received 1st dose of ENGERIX B adult (unknown route and application site). In May 2012, less than one month after vaccination with ENGERIX B adult, the subject experienced severe fever and shivers. The subject was hospitalised. At the time of reporting the outcome of the events was unspecified. Follow-up information has been requested. Written follow-up was received on 14 June 2012 from a physician. On 4 May 2012 the subject received 1st dose of ENGERIX B adult (intramuscular left upper arm). On 4 May 2012, one hour after vaccination with ENGERIX B adult, the subject experienced preshock, tachycardia, dyspnea, vomiting and diarrhea. An ambulance was called. The events preshock, tachycardia, dyspnea, vomiting and diarrhea lasted approximately for four hours. At the time of reporting, all events were resolved, as reported. The vaccination course with ENGERIX B adult was discontinued. The physician considered the events, preshock, tachycardia, dyspnea, vomiting and diarrhea were probably related to vaccination with ENGERIX B adult.

VAERS ID:458430 (history)  Vaccinated:2012-04-05
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2012-06-28
Location:Foreign  Entered:2012-06-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 09Apr12)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1206USA04107
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.G0151190IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Maternal exposure before pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Case of pregnancy follow-up received from Health Authorities via a Nurse on 15-JUN-2012 under the reference number L201206-661. Case medically confirmed. A 31 year old female patient had received a first dose of MMR II (batch number G015119 during validation process), via intramuscular route (administration site not reported) on 05-APR-2012. The reporter stated that vaccination with the suspected vaccine occurred in the 3 months before the patient became pregnant. Her last menstrual period was on 09-APR-2012. The patient had no known clinical history; she had no known previous reactions to other drugs. There was no suspicion of drug interaction. There was no specific treatment. The same vaccine was not reintroduced. At the time of reporting, the outcome was unknown. The Health Authorities considered the case to be serious due to "other medically important condition". The other business numbers included E2012-03946. No further information is available.

VAERS ID:462682 (history)  Vaccinated:2012-07-14
Age:31.0  Onset:2012-07-14, Days after vaccination: 0
Gender:Male  Submitted:2012-08-21, Days after onset: 38
Location:Foreign  Entered:2012-08-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0822166A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB197 IMUN
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER657542 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Hyperthermia
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority (# 173417) and described the occurrence of convulsion in a 31-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline) and (non-gsk) STAMARIL. On 14 July 2012, the subject received unspecified dose of TWINRIX (intramuscular, administration site unknown) and an unspecified dose of STAMARIL (intramuscular, unknown). On 14 July 2012, less than one day after vaccination with STAMARIL and TWINRIX, the subject experienced convulsion and hyperthermia. This case was assessed as medically serious by GSK. The subject received to be hospitalised. At the time of reporting, the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with TWINRIX and STAMARIL.

VAERS ID:463037 (history)  Vaccinated:2012-07-02
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2012-08-23
Location:Foreign  Entered:2012-08-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 07/14/2012, CSF cell count increased; 07/142012, CSF protein increased, 0.63; 07/14/2012, CSF test
CDC Split Type: WAES1208DEU000700
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood brain barrier defect, Body temperature, CSF cell count increased, CSF protein increased, CSF test, Chills, Decreased activity, Headache, Influenza like illness, Meningism, Meningitis viral, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Eosinophilic pneumonia (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (broad), Tendinopathies and ligament disorders (broad)
Write-up: Case was received from a pharmacist in a foreign country on 20-Jul-2012. Case is medically confirmed. A female patient of unspecified age received a dose of GARDASIL (lot-no. not reported) on an unspecified date. Eleven days later she developed flu-like symptoms with headache and chills and a general deceleration. The outcome was not reported. Follow-up information received on 31-Jul-2012. The reporting form was provided including detailed information about the patient, adverse event, laboratory results and therapy. The patient, received a dose of GARDASIL on 02-Jul-2012. Eleven days later, on 13-Jul-2012, the patient developed headache, meningism, subfebrile temperature, chills and myalgia leading to hospitalisation on an unspecified date. On 14-Jul-2012 CSF showed increased cell count (13), increased protein (0.63 g/l) and moderate intrathecal barrier disorder. Diagnosis of viral meningitis was assumed. After treatment with Aciclovir, analgesics and "antivertiginosa" the patient recovered completely after two days. According to the reporter, the reaction was possibly related to the vaccination. CASE IS CLOSED.

VAERS ID:465092 (history)  Vaccinated:2012-07-31
Age:31.0  Onset:2012-07-31, Days after vaccination: 0
Gender:Unknown  Submitted:2012-09-14, Days after onset: 45
Location:Foreign  Entered:2012-09-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0828600A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA0918A IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Diarrhoea, Hypopnoea
SMQs:, Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow)
Write-up: This case was reported by the regulatory authority and described the occurrence of joint pain in a 31-year-old subject of unspecified gender who was vaccinated with CERVARIX (GlaxoSmithKline). On 31 July 2012, the subject received an unspecified dose of CERVARIX (0.5 ml, intramuscular, batch number AHPVA0918A). On 31 July 2012, less than one day after vaccination with CERVARIX, the subject experienced a few reactions including aching of all joints, diarrhoea once, and difficulty taking a full breath (not breathless). The regulatory authority reported that the events were clinically significant (or requiring intervention). On 2 August 2012, the events were resolved. A few reactions after vaccination ached all joints. Diarrhoea x1. Difficulty taking full breath (not breathless) - lasted.

VAERS ID:467780 (history)  Vaccinated:2005-11-01
Age:31.0  Onset:2010-01-15, Days after vaccination: 1536
Gender:Female  Submitted:2012-10-04, Days after onset: 992
Location:Foreign  Entered:2012-10-05, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 2012-07-12
   Days after onset: 908
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2UNLA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Biopsy stomach abnormal, Chemotherapy, Gastrectomy, Gastric cancer, Metastases to ovary, Radiotherapy
SMQs:, Acute pancreatitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Non-haematological malignant tumours (narrow)
Write-up: In 11/2009, subject reported onset of severe epigastralgia and was examined and biopsied on 01/15/2010. After receiving Dx of gastric cancer, had complete gastrectomy on 2/9/2010 and 45 day hospital stay. Was also hospitalized in 4/2010 for chemotherapy and radiotherapy, and discharged on 5/26/2010. Followed up with specialist, chemotherapy, and metoclopramide daily. Mother reported subject received Dx of ovarian metastasis in 4/2011, and additional chemotherapy was not successful.

VAERS ID:468209 (history)  Vaccinated:2012-07-12
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2012-10-05
Location:Foreign  Entered:2012-10-08, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No relevant patient''s medical history reported.
Diagnostic Lab Data:
CDC Split Type: E201206334
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG05310UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Blood culture positive, Campylobacter gastroenteritis, Campylobacter test positive, Culture stool positive, Diarrhoea, Pyrexia, Salmonella test positive, Typhoid fever, Vaccination failure, Weight decreased
SMQs:, Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This TYPHIM batch was identified as at-risk of an antigen (purified VI capsular polysaccharide) content below specifications. Batch recall in Sept 2012. Case received from a healthcare professional on 27-Sep-2012. Case medically confirmed. A 31-year-old female patient (weight, height not reported) with no relevant medical history was vaccinated with a first dose of TYPHIM VI (lot no. G0531-2 route and site of administration not reported) on 12-Jul-2012. On an unknown date the patient traveled abroad. Two days prior to hospitalisation, in Aug-2012, she developed fever up to 40 degrees C. She also experienced diarrhoea and weight loss while being abroad leading to hospitalisation on 25-Aug-2011 (short hospital report was forwarded). Examinations of stool culture and blood culture, performed on unspecified dates, were positive for Campylobacter and Salmonella typhi, respectively. The patient was diagnosed with typhoid fever and Campylobacter diarrhoea. Treatment with IV high-dose CRAVIT (750 mg every 24 hours) and ZITHROMAX (3 days) for Campylobacter diarrhoea was initiated. Fever improved after one week. The patient was discharged on 04-Sep-2012 and was told to continue CRAVIT to finish 2 weeks course of antibiotic. When back home, patient''s stool check up was negative for pathogenic germs. She was last seen by her General Practitioner on 19-Sep-2012. Patient had been feeling better, her weight had stabilised, she had already recovered from other symptoms, but she had not recovered from asthenia which began on an unknown date. Upon medical review the company considered relevant to code the LLT term "vaccination failure". CASE IS CLOSED.

VAERS ID:473703 (history)  Vaccinated:2012-09-10
Age:31.0  Onset:2012-09-10, Days after vaccination: 0
Gender:Male  Submitted:2012-11-08, Days after onset: 59
Location:Foreign  Entered:2012-11-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Circulatory collapse
Diagnostic Lab Data: UNK
CDC Split Type: D0077157A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB240AE0IMLA
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURERG1430IMRA
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure decreased, Circulatory collapse, Condition aggravated, Syncope
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), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician via a sales representative and described the occurrence of syncope in a 31-year-old male subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). Co-suspect vaccinations included unspecified Rabies Vaccine (non-GSK) (unknown manufacturer). On an unspecified date the subject received an unspecified dose of TWINRIX adult (1 ml, unknown) and an unspecified dose of Rabies Vaccine (unknown), contralaterally. At an unspecified time post vaccination with TWINRIX adult and Rabies Vaccine, on an unknown date, the subject experienced syncope. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 31 October 2012 from the reporting physician. The case was upgraded to serious. Co-suspect vaccinations included TOLLWUT-IMPFSTOFF (sanofi Pasteur MSD). The subject''s medical history included one episode of postvaccinal circulatory collapse in the youth. The subject received no concomitant medication. On 10 September 2012 the subject received the first dose of TWINRIX adult (1 ml, intramuscular, left deltoid) and the first dose of TOLLWUT-IMPFSTOFF (1 ml, intramuscular, right deltoid), contralaterally. At an unspecified time post vaccination with TWINRIX adult and TOLLWUT-IMPFSTOFF, most likely on 10 September 2012, the subject experienced circulatory collapse, syncope and decreased blood pressure. This case was assessed as medically serious by GSK criteria. The subject was treated for the symptoms. Treatment included lying down, autotransfusion position (Trendelenburg position) and later on infusion therapy with volume substitution. After an unknown period of time, most likely on 10 September 2012, all events were resolved. After the next vaccinations with TWINRIX adult and TOLLWUT-IMPFSTOFF the events did not recur. A second follow-up was received on 31 October 2012 by phone by the sales representative. It was agreed that the reporting physician will contact the other manufacturer (Sanofi Pasteur MSD) directly to report the events. No further information will be available.

VAERS ID:473909 (history)  Vaccinated:2012-10-19
Age:31.0  Onset:2012-10-19, Days after vaccination: 0
Gender:Female  Submitted:2012-11-09, Days after onset: 21
Location:Foreign  Entered:2012-11-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0077605A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERA07 IMLA
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB256AL IMLA
Administered by: Other     Purchased by: Other
Symptoms: Haematoma, Injection site pain, Pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority (DE-PEI-PEI2012054123) and described the occurrence of hematoma in a 31-year-old female subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). The case was reported to the regulatory authority via the Drug Commission of the Medical Association (# 159293) by an unknown hospital physician. Co-suspect vaccinations included INFLUVAC (Abbott). Concomitant medication was not reported. On 19 October 2012 the subject received an unspecified dose of TWINRIX adult (1 ml, intramuscular, left deltoid) and an unspecified dose of INFLUVAC (0.5 ml, intramuscular, left deltoid). Less than one day post vaccination with TWINRIX adult and INFLUVAC, on 19 October 2012, the subject experienced hematoma and prolonged pain at rest and on movement of the injected muscle. The subject was hospitalised for an unknown period of time. At the time of reporting, on 26 October 2012, the events were still unresolved. The reporting physician reported the events as possible vaccination complication which was causally related to vaccination with TWINRIX adult and INFLUVAC. No further information will be available.

VAERS ID:473933 (history)  Vaccinated:2012-10-10
Age:31.0  Onset:2012-10-13, Days after vaccination: 3
Gender:Female  Submitted:2012-11-10, Days after onset: 28
Location:Foreign  Entered:2012-11-12, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2012AT103389
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABIPUR)NOVARTIS VACCINES AND DIAGNOSTICS496011E1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abnormal sensation in eye, Conjunctivitis, Pupil fixed, Pupillary disorder
SMQs:, Severe cutaneous adverse reactions (broad), Corneal disorders (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (broad)
Write-up: Case number PHHY2012AT103389 is an initial spontaneous report received from a physician via Health Authority (reference number: AT-BASAGES-122897) on 09 Nov 2012. This report refers to a 31-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with the second booster dose of RABIPUR vaccine (batch number: 496011E, expiration date: May 2015) on 10 Oct 2012. On 13 Oct 2012, she experienced conjunctivitis NOS in left eye, pupillary disorder (fixed pupil) and sensation of pressure above the eyes on both sides. The event sensation of pressure and pupillary disorder was lasting for 1 week until 21 Oct 2012. She had recovered from all the events on unspecified dates. The physician considered these events as medically significant. The agency reported the events were suspected to RABIPUR.

VAERS ID:475312 (history)  Vaccinated:2012-10-19
Age:31.0  Onset:2012-10-19, Days after vaccination: 0
Gender:Female  Submitted:2012-11-26, Days after onset: 38
Location:Foreign  Entered:2012-11-27, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Pregnant: Yes; Result: Spontaneous abortion; Pregnancy end date: 21-Oct-2012
Diagnostic Lab Data:
CDC Split Type: 2012034003
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER24149411A SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Exposure during pregnancy, Feeling abnormal
SMQs:, Dementia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: This health authority report (initial receipt 19-Nov-2012) concerns a 31-year-old female pregnant patient. On 19-Oct 2012, the patient received influenza vaccine split virion inactivated (batch number: 24149411A) subcutaneously for ''pregnant''. On 21-Oct-2012, within 2 days flu jab, the patient started ''lost'' symptoms of pregnancy. Miscarriage was identified later. The patient obviously concerned that the death of the fetus was related to the flu jab. The event outcome was unknown. Report''s comment: On 19-Nov-2012 the health authority considered the event to be serious as it was life-threatening.

VAERS ID:475459 (history)  Vaccinated:2012-10-19
Age:31.0  Onset:2012-10-21, Days after vaccination: 2
Gender:Female  Submitted:2012-11-27, Days after onset: 37
Location:Foreign  Entered:2012-11-27
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0845902A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER24149411A SCUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion spontaneous, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: This prospective pregnancy case was reported by a consumer, via a healthcare professional, via the foreign regulatory authority (# GB-MHRA-EYC 00095541) and described the occurrence of a miscarriage in a 31-year-old female subject who was vaccinated with influenza virus vaccine during pregnancy. On 19 October 2012 the subject received an unspecified dose of influenza vaccine (subcutaneous; batch details unknown). Her last menstrual period date and estimated date of delivery were not provided. The subject was exposed to influenza vaccine in an unknown trimester. On 21 October 2012, at an unspecified time after vaccination with the influenza vaccine, the subject experienced a miscarriage. The regulatory authority reported that the event was life threatening. It was reported that the subject was concerned that the death of the fetus was related to the flu jab. At the time of reporting the outcome of the event was unspecified. Agency Verbatim Text: As above- patient is obviously concerned that the death of the fetus was related to the flu jab. Missed miscarriage identified later but lost symptoms of pregnancy within 2 days of flu jab.

VAERS ID:476035 (history)  Vaccinated:2012-10-26
Age:31.0  Onset:2012-10-26, Days after vaccination: 0
Gender:Female  Submitted:2012-11-30, Days after onset: 35
Location:Foreign  Entered:2012-11-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test, not provided; Diagnostic ultrasound, not provided
CDC Split Type: B0847522A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA744AA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Blood test, Delivery, Exposure during pregnancy, Jaundice, Live birth, Liver injury, Premature labour, Ultrasound abdomen normal
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This retrospective pregnancy case was reported by a physician via a regulatory authority (DK-DKMA-EFO3697) and described the occurrence of liver damage in a 31-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 26 October 2012, the subject received an unspecified dose of FLUARIX (intramuscular, unknown injection site) while she was pregnant. Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine during the third trimester. On 26 October 2012, 15 days after vaccination with FLUARIX, the subject experienced severe abdominal pain, liver damage and icterus. Pre-eclampsia was not likely. Gallstone was suspected but not seen on ultrasound. The subject also experienced premature labor. The subject was hospitalised in pregnancy week 36 + 1. At the time of reporting, events were improved. On an unspecified date, the subject gave birth to a live infant, by unknown delivery method.

VAERS ID:476198 (history)  Vaccinated:2012-10-09
Age:31.0  Onset:2012-11-14, Days after vaccination: 36
Gender:Female  Submitted:2012-12-03, Days after onset: 19
Location:Foreign  Entered:2012-12-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure normal
Preexisting Conditions:
Diagnostic Lab Data: Alanine aminotransferase, Nov2012, increased; Bilirubin, Nov2012, increased
CDC Split Type: B0849186A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA744AA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Blood bilirubin increased, Exposure during pregnancy, Liver injury, Malaise, Pain, Pre-eclampsia
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Biliary system related investigations, signs and symptoms (narrow), Accidents and injuries (narrow), Hypertension (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This prospective pregnancy case was reported by a physician via a regulatory authority (DK-DKMA-EFO3698) and described the occurrence of liver damage in a 31-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included blood pressure normal. The subject''s history of vaccinations was unknown. No concomitant medication was reported. On 9 October 2012, the subject received unspecified dose of FLUARIX (intramuscular, unknown site of injection). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The subject was exposed to the vaccine during third trimester. On 14 November 2012, 36 days after vaccination with FLUARIX and after 37 weeks and 3 days of gestation, the subject was hospitalised with general feeling of sickness, pain under right curvature and liver damage. On suspicion on pre-eclampsia, liver numbers were measured, blood samples tests were performed and showed very increased alanine aminotransferase and increased bilirubin, which were not values associated to pre-eclampsia. At the time of reporting, the events were improved.

VAERS ID:479874 (history)  Vaccinated:2010-02-08
Age:31.0  Onset:2010-02-10, Days after vaccination: 2
Gender:Female  Submitted:2012-12-26, Days after onset: 1050
Location:Foreign  Entered:2012-12-31, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Not reported
CDC Split Type: 201212429
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN))UNKNOWN MANUFACTURER  UNUN
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Local reaction, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This initial case report is part of a batch of several reports associated with several products that was received on 13 December 2012 by the Sanofi Pasteur affiliate who received the report from the Ministry of Health (reference number not reported). A 31-year-old female, with no medical history, and whose concomitant therapies were not reported, had received on 08 February 2010 a dose of H1N1 vaccine (manufacturer name and lot number not reported), a dose of Td vaccine (manufacturer name and lot number not reported), and a dose of Hib vaccine (manufacturer name and lot number not reported). The AE start date was reported as 10 February 2010. The initial diagnosis was local reaction and fever, and the final diagnosis was local reaction. The following additional AEs were reported: fever and cellulitis. Onset dates of these events were not reported. The patient was not hospitalized. Outcome was not reported. Additional comments: None. The case was assessed as mild by the Ministry of Health, but was assessed as serious by Sanofi Pasteur. The causality as concluded by the Ministry of Health was casual (related to the vaccine). Causality was not reported by the expert review committee. Documents held by sender: None.

VAERS ID:480368 (history)  Vaccinated:2012-12-27
Age:31.0  Onset:2012-12-30, Days after vaccination: 3
Gender:Female  Submitted:2013-01-04, Days after onset: 5
Location:Foreign  Entered:2013-01-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 01/02/2013, Hyperthyroidism
Diagnostic Lab Data:
CDC Split Type: WAES1301KOR000699
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Paraesthesia, Vaccination site pain
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)
Write-up: This spontaneous report as received from a nurse refers to 31 years old female patient. The patient has a medical history of hyperthyroidism and it was resolved at the time of report. The patient had fever after the first dose of GARDASIL vaccination (date unknown) but there was no pain at the time. On 27-DEC-2012 in the morning, the patient was vaccinated with the second dose of GARDASIL 0.5 ml (Intramuscular injection) for the prevention of cervical cancer (lot# and dose not reported). On 30-DEC-2012, the patient experienced dizziness (also reported as 27-Dec-2012) after the second vaccination, so TYLENOL (2T BID) was taken. From 30-DEC-2012, the patient experienced pain on the vaccination site and symptom became worse, so the patient visited the hospital on 02-JAN-2013. After the treatment, the patient was hospitalized in the emergency room, and as time passed the hands tingling became worse. The outcome of the events was unknown. The relatedness of the event with GARDASIL was not provided. Additional information is not expected.

VAERS ID:480532 (history)  Vaccinated:2012-12-14
Age:31.0  Onset:0000-00-00
Gender:Male  Submitted:2013-01-08
Location:Foreign  Entered:2013-01-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 12/07/2012, HBVAXPRO, Immunisation, The patient had a history of first dose of HBVAXPRO (batch number H000618, expiry date. Apr-2014) intramuscularly, on 07-Dec-2012.
Diagnostic Lab Data:
CDC Split Type: WAES1301GBR000606
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)
Write-up: This misuse case (inappropriate scheduled of administration) was received from a healthcare professional on 17-Dec-2012 under the reference of Pivotal number 12930. This case is medically confirmed. A 32 year old male patient with the history of first dose of HBVAXPRO (batch number not reported) with no reported route and site of administration, on 07-Dec-2012, received a second dose of HBVAXPRO (batch number not reported) with no reported route and site of administration, on 14-Dec-2012. The vaccine had been given to the patient on inappropriate scheduled of vaccine administration. No adverse effect reported. Follow up received from initial reporter on 02-Jan-2013. The patient had history of first dose of HBVAXPRO (batch number. H000618, expiry date. Apr-2014, dose 10 mcg/ml) intramuscularly in unknown site. The patient received second dose of HBVAXPRO (dose. 10 mcg/ml, batch number not reported) intramuscularly in unknown right site. The reporter stated that, after administration of first dose of HBVAXPRO the patient had been administered second dose by another partitioner one week later, but error not been noted until after administration. The reporter considered this case to be serious.

VAERS ID:480734 (history)  Vaccinated:0000-00-00
Age:31.0  Onset:0000-00-00
Gender:Male  Submitted:2013-01-08
Location:Foreign  Entered:2013-01-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0856835A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Diplopia, Multiple sclerosis, Ophthalmoplegia, Vaccine positive rechallenge
SMQs:, Guillain-Barre syndrome (broad), Optic nerve disorders (broad), Demyelination (narrow), Ocular motility disorders (narrow), Hypoglycaemia (broad)
Write-up: This case was reported in a literature article and described the occurrence of multiple sclerosis in a 31-year-old male subject who was vaccinated with HepB (manufacturer unspecified). On an unspecified date, the subject received 1st booster of HepB (unknown route and injection site, batch number not provided). At an unspecified time after vaccination with 1st booster of HepB, at the age of 31 years, the subject experienced continuous horizontal diplopia. The event resolved spontaneously after 2-3 weeks without recourse to medical support. On an unspecified date, the subject received 2nd booster of HepB (unknown route and injection site, batch number not provided). At an unspecified time after vaccination with 2nd booster of HepB, the continuous horizontal diplopia recurred. Internuclear ophthalmoparesis was observed at the hospital. Until that date, there was no diagnostic criteria for multiple sclerosis. At the age of 37 years, the subject experienced a new episode of internuclear ophthalmoparesis without any relationship to vaccination or infection. This was a diagnostic criteria for multiple sclerosis. This case was assessed as medically serious by GSK. At the time of reporting (subject was 38-year-old), the outcome of the multiple sclerosis and internuclear ophthalmoparesis was unspecified but the continuous horizontal diplopia was resolved. The relationship between vaccination, natural infection and multiple sclerosis has been a source of growing concern among patients, the medical community and general population. Despite the pathogenic fundamentals are not yet fully understood, there is an unequivocal evidence of exacerbations of multiple sclerosis in infectious episodes, potentially vaccine-preventable. However, the safety of active immunization in patients with multiple sclerosis has been the subject of some concern. More recent published studies seem to deny the latest relationship between active immunization and risk of multiple sclerosis or multiple sclerosis exacerbations. However, it is not impossible to guess that an active immunization process, inducing a stimulation of the immune system can trigger autoimmune processes in susceptible individuals.

VAERS ID:480754 (history)  Vaccinated:2011-03-14
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2013-01-09
Location:Foreign  Entered:2013-01-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sertraline hydrochloride
Current Illness: Immunisation; Asthma
Preexisting Conditions: Abortion spontaneous; M-M-R II
Diagnostic Lab Data:
CDC Split Type: WAES1203USA01843
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER1745X1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Caesarean section, Exposure during pregnancy, Genital herpes, Laboratory test normal, Labour complication, Prenatal screening test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: This case of pregnancy follow up with associated adverse events was received from the Health Protection Agency on 05-Mar-2012. HPA REF 0493. This case is medically confirmed. A 31 year old female patient received dose two of MMRVAXPRO (batch number NK45890, expiry 05-2011), route and site not reported, on 14-Mar-2011. The patient was pregnant at the time of vaccination. Her LPM was 04-Feb-2011 and her EDD was 18-Nov-2011. The patient''s vaccination history indicated that she was susceptible to measles, mumps and rubella and as she was a healthcare worker this was the reason for vaccination. The patient did not experience any adverse reaction following vaccination. The patient did not experience any adverse reaction following vaccination. The patient was taking concomitant sertraline for an unknown indication throughout the pregnancy. The patient had concurrent asthma. The patient had three previous pregnancies, two of which went to full term with no birth defects and one resulted in a miscarriage. The patient had no abnormal antenatal tests and no diagnostic tests. On 26-Aug-2011, 23 weeks post vaccination, the patient experienced genital herpes and was treated with acyclovir. The patient also experienced labour complications described as elective lower segment caesarean section (LSCS) due to previous LSCS. The patient had a live birth of a male infant weighing 3670g. There were no congenital anomalies. The patient outcome was not reported. Follow up received from the HPA on 20/Dec/2012: The infant did not experience any deafness.

VAERS ID:481777 (history)  Vaccinated:2012-10-04
Age:31.0  Onset:2012-10-12, Days after vaccination: 8
Gender:Female  Submitted:2013-01-17, Days after onset: 97
Location:Foreign  Entered:2013-01-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 12Oct2012, 39.8degC; Nuclear magnetic resonance ima, 2012, pathologic
CDC Split Type: D0077800A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA692CA0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Benign intracranial hypertension, Cerebrovascular disorder, Dizziness, Headache, Herpes virus infection, Nuclear magnetic resonance imaging abnormal, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a foreign regulatory authority (DE-PEI-PEI2012057292) and described the occurrence of high fever in a 32-year-old female subject who was vaccinated with INFLUSPLIT (GlaxoSmithKline). Concomitant medications was not reported. Previous vaccinations with vaccines not further specified have been well tolerated. On 04 October 2012 the subject received the first dose of INFLUSPLIT (0.5 ml, intramuscular, right deltoid). Approximately eight days post vaccination with INFLUSPLIT, on 12 October 2012, the subject experienced high fever with 39.8 degC. Another two days later, approximately 10 days post vaccination with INFLUSPLIT, on 14 October 2012, the subject experienced severe nasolabial herpes which was treated topically and with acyclovir orally. Additionally, approximately 10 days post vaccination with INFLUSPLIT, on 14 October 2012, the subject experienced persistent headache pressure on back of head with light-headedness. Cranial magnetic resonance tomogram (cMRT), performed prior to 07 November 2012 (date of reporting), showed pseudotumor cerebri with disturbance of cerebral blood flow. Additional ophthalmological examinations for papilloedema were not performed at the date of reporting. This case was assessed as medically serious by GSK criteria. The subject was treated ambulatory. At the time of reporting, on 07 November 2012, the outcome of the events was unknown. No further information will be available.

VAERS ID:484337 (history)  Vaccinated:2012-08-17
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2013-02-11
Location:Foreign  Entered:2013-02-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient''s personal and family medical history was unknown.
Diagnostic Lab Data: A faecal test was conducted on 10 January 2013. Results were negative for shigella, giardia and cryptosporidium. There were no results for salmonella typhi.
CDC Split Type: 201301426
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  IMRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURG0461 UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bacterial test negative, Diarrhoea, Giardia test negative, Irritable bowel syndrome, Typhoid fever, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Case received from an Healthcare professional through the local affiliate on 30 January 2013. TYPHIM batch number G0461-2 was identified as at-risk of an antigen (purified Vi capsular polysaccharide) content below specifications. This batch was recalled on 25 September 2012. A 32-year-old female patient, with an unknown personal and family history, has received a dose of TYPHIM VI (lot number: G0461-2, route of administration unknown) in the left arm concomitantly with an intramuscular dose of HAVRIX (other manufacturer) in the right deltoid on 17 August 2012. After vaccination, the patient travelled to another country. During this period, she informed that she was hospitalised from 28 November 2012 to 03 December 2012 and was diagnosed with typhoid fever. She was treated with antibiotics. Vaccination failure was suspected. On her return, she presented to the clinic on 07 January 2013 with diarrhoea. A faecal test was conducted on 10 January 2013. Results were negative for shigella, giardia and cryptosporidium. The nurse informed that there were no results for salmonella typhi. The doctor diagnosed post-infectious irritable bowel syndrome. The patient declined to provide the clinical reports from the hospital. List of documents held by sender: none.

VAERS ID:484431 (history)  Vaccinated:2011-11-30
Age:31.0  Onset:2011-12-01, Days after vaccination: 1
Gender:Female  Submitted:2013-02-13, Days after onset: 440
Location:Foreign  Entered:2013-02-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0867382A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB199BD IMUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Induration, Inflammation, Pain
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician via a regulatory authority (# ES-AGEMED-518359243) and described the occurrence of pain in a 31-year-old female subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). On 30 November 2011, the subject received an unspecified dose of TWINRIX adult (intramuscular, unknown injection site). On 1 December 2011, 1 day after vaccination with TWINRIX adult, the subject experienced erythema, inflammation and induration. On 2 December 2011, 2 day after vaccination with TWINRIX adult, the subject experienced pain. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 4 December 2011, the events were resolved. The regulatory authority reported that the events were probably related to vaccination with TWINRIX adult. No further information was expected. Case was closed.

VAERS ID:484517 (history)  Vaccinated:2012-03-20
Age:31.0  Onset:0000-00-00
Gender:Female  Submitted:2013-02-13
Location:Foreign  Entered:2013-02-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201302075
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURER11030560UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Feeling hot, Pain
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This initial case report is part of a batch of reports associated with several products that was received on 04 February 2013 by the Sanofi Pasteur affiliate who received the report from the Ministry of Health. A female patient (age reported as "31-year-old"), whose medical history and concomitant therapies were not reported, had received her first dose of Rabies vaccine, manufacturer unknown, lot number 1103056, (route and anatomical site of administration not reported) on 20 March 2012. On an unspecified date post-vaccination the patient experienced pain, redness and heating. The patient''s outcome was recovered without sequelae. The case was assessed as serious by the Ministry of Health. The patient was hospitalized on unspecified dates. The agency indicated that the resolution of the case was confirmed. The evolution was reported as "schedule maintained". Documents held by sender: None.

VAERS ID:485036 (history)  Vaccinated:2012-01-13
Age:31.0  Onset:2012-01-18, Days after vaccination: 5
Gender:Female  Submitted:2013-02-20, Days after onset: 399
Location:Foreign  Entered:2013-02-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Parathyroid disorder
Preexisting Conditions: CIFLOX, parathyroid disorder
Diagnostic Lab Data: 01/19/2012, Ear, nose and throat examination, Abnormal, Significant, ENT examination showed left cophosis and instability feeling during movements; 01/19/2012, Viral test, Positive, Significant, It showed Cytomegalovirus and Epstein Barr virus primary infection
CDC Split Type: PHHY2013FR014768
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICS  IMUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Cytomegalovirus infection, Cytomegalovirus test positive, Dizziness, Ear, nose and throat examination abnormal, Epstein-Barr virus infection, Epstein-Barr virus test positive, Gait disturbance, Nausea, Sudden hearing loss, Tinnitus, Vestibular nystagmus
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (broad), Ocular motility disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Case number PHHY2013FR014768, is an initial spontaneous report received from a health care professional via foreign Health Authority (reference number: RN20130112) on 12 Feb 2013. This report refers to a 31-year-old female patient. The medical history of the patient included parathyroid disorder (not specified) from Dec 2011 to Jan 2012 and historical drug included CIFLOX for parathyroid disorder. Her concomitant medication was not reported. She was vaccinated with MENVEO (batch number: unknown) intramuscularly and also with TYPHIM VI (other manufacturer, batch number: unknown) intramuscularly on 13 Jan 2012. On 18 Jan 2012, at 10 PM, she experienced left sudden deafness associated with tinnitus for about 1 hour. On 19 Jan 2012, around 1.00 AM, two hours after the stop of tinnitus, she experienced dizzy spells with nausea but without vomiting. On the same day, she was hospitalized and ENT examination was performed, which showed left cophosis and instability feeling during movements. She had no spontaneous nystagmus but had mild left head-shaking nystagmus. She also had virological work up on the same day of hospitalization, which showed Cytomegalovirus and Epstein Barr virus primary infection. It was reported that no deviation was noted for Romberg test, Index test and Fukudas'' stepping test. She received corticosteroid, CARBOGENE and ZELITREX as a treatment for the events. On 26 Jan 2012, she was discharged from the hospital without clear improvement. Only sudden deafness, tinnitus, dizzy spells and nausea were coded as events by the foreign Health Authority and assessed the causal relationship with MENVEO and TYPHIM VI as unlikely. The outcome of the events was not reported.

VAERS ID:487564 (history)  Vaccinated:2012-05-10
Age:31.0  Onset:2013-02-07, Days after vaccination: 273
Gender:Female  Submitted:2013-03-22, Days after onset: 42
Location:Foreign  Entered:2013-03-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1207DEU000333
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0790AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Breech presentation, Caesarean section, Exposure during pregnancy, Live birth, No adverse event, Premature rupture of membranes
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Case of pregnancy follow-up was received from a healthcare professional on 22-Jun-2012. Case is medically confirmed. A 31-year-old female patient received a dose of M-M-RVAXPRO (batch-no. G016279, lot number 671544/0790AA) on 10-MAY-2012, injection route and site not reported. At the date of reporting on 22-Jun-2012 she was found to be pregnant in 5th (+3) gestational week. Last menstrual period was on 14-May-2012, estimated birth date is 18-Feb-2013. No adverse effect occurred up to the time of reporting. Follow-up information received on 14-Mar-2013. The reporter was contacted by phone. Case was upgraded to serious (caesarian section). After normal course of pregnancy the patient (primipara) gave birth to a healthy female child by cesarean section due to breech presentation and premature rupture of membranes on 07-Feb-2013. The reporter did not see a causal relation between the events and the vaccination.

VAERS ID:487723 (history)  Vaccinated:0000-00-00
Age:31.0  Onset:0000-00-00
Gender:Male  Submitted:2013-03-25
Location:Foreign  Entered:2013-03-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Anal fissure
Preexisting Conditions:
Diagnostic Lab Data: Blood glucose, 3.10mmol/L; Blood glucose, 4.00mmol/L; Blood immunoglobulin A, 650mg/L; Blood immunoglobulin G, 40mg/L; Blood pressure, 110/65mmHg; Blood test, Normal; Body temperature, unspecified; Body temperature, 37.5Deg. C; CSF myelin basic protein, 0.33mcg/L; Chloride, 113mmol/L; Chloride, 123mmol/L; Cytomegalovirus antibody, Positive (1:80); Electromyogram, 13Mar2009, see text; Epstein-Barr virus test, 0.22; HIV test, Negative; Heart rate, 80bpm; Nuclear magnetic resonance ima, 18Mar2009, No abnormalities; Nuclear magnetic resonance ima, 18Mar2009, See text; Nuclear magnetic resonance ima, 18Mar2009, See text; Protein, 370mg/L; Protein, 580mg/L; Respiratory rate, 20bpm; Serum immunoglobulin G, 10.70g/L'' Somatosensory evoked potential,
CDC Split Type: B0875237A
Vaccination
Manufacturer
Lot
Dose
Route
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