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Found 502657 cases in entire database

Case Details (Sorted by Age)

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VAERS ID:223956 (history)  Vaccinated:2004-06-11
Age:49.0  Onset:2004-06-11, Days after vaccination: 0
Gender:Male  Submitted:2004-07-13, Days after onset: 32
Location:Foreign  Entered:2004-07-15, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data: Blood glucose normal; Creatinine 1.7 mg/dl
CDC Split Type: B0338661A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Dyspepsia, Glycosuria, Hepatocellular damage, Laboratory test abnormal, Malaise, Myalgia, Proteinuria, Pyrexia, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of a mild liver damage in a 49 year old male subject who had received Hepatitis B vaccine injection for prophylaxis. On 6/11/04, the patient received Hepatitis B vaccine. The same day, after vaccination, this subject was found to have mild liver damage, mild renal failure, asthenia, dyspepsia, fever, glycosuria, malaise, myalgia, and proteinuria. Subsequently, he was hospitalized. Creatinine was measured at 1.7g/dl and blood glucose level was within normal ranges. An unspecified treatment was given. At the time of this report, the events were ongoing. The regulatory authority reported that the events were possibly related to vaccination with Hepatitis B vaccine. Additional information has been requested.

VAERS ID:225298 (history)  Vaccinated:2004-04-01
Age:49.0  Onset:2004-07-01, Days after vaccination: 91
Gender:Female  Submitted:2004-08-10, Days after onset: 40
Location:Foreign  Entered:2004-08-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions: The patient''s medical history, concurrent medical conditions, and concurrent medications were not reported.
Diagnostic Lab Data: Hepatitis B surface antibody negative; July 2004: MRI revealed a broad disk protrusion on the right side of L5 and S1.
CDC Split Type: A0521220A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS5514A24UNAR
Administered by: Private     Purchased by: Other
Symptoms: Hemiparesis, Laboratory test abnormal, Myelitis transverse, Peroneal nerve palsy
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)
Write-up: This case was reported by a nurse practitioner and described the occurrence of transverse myelitis in a 49 year old female patient who received hepatitis B vaccine recombinant. On unspecified dates in 2003, the patient received the first two doses of Engerix B (lot ENG5384A2). On an unspecified date in January 2004, the patient received the third dose of Engerix-B (lot ENG5384A2). On an unspecified date in 2004, a hepatitis B surface antibody titer revealed that the patient was a non-responder. Subsequently, the patient received the fourth dose of Engerix-B on an unspecified date in March 2004 (lot number not provided). On an unspecified date in April 2004, the patient received the fifth dose of Engerix-B in the deltoid (lot ENG5514A2). Approximately three months after the fifth administration of Engerix-B, on an unspecified date in July 2004, after returning from a trip, the patient experienced transverse myelitis, right foot drop and right leg weakness. The patient was seen at a physician''s office. MRI, performed on an unspecified date in July 2004, revealed a broad disk protrusion on the right side of L5 and S1. The events were ongoing at the time of initial reporting. The nurse practitioner considered the events to be unrelated to vaccination with Engerix B. Comment: Transverse myelitis and intervertebral disc protrusion were assessed as medically serious (OMIC).

VAERS ID:226286 (history)  Vaccinated:2004-05-19
Age:49.0  Onset:2004-05-23, Days after vaccination: 4
Gender:Male  Submitted:2004-09-07, Days after onset: 107
Location:Foreign  Entered:2004-09-08, 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: Functional colopathy
Preexisting Conditions: Zona ophthalmica
Diagnostic Lab Data: Alanine aminotransferase 42 IU/L, 28 IU/L; Aspartate aminotransferase 37 IU/L, 23 IU/L; Blood glucose 1.35g/L, 1.07g/L; Body temperature 38.5 degrees C; C-reactive protein 18mg/ml, $g8mg/mL; Granulocyte count 80%; RBC SR 25/52 mm, 14mm; WBC
CDC Split Type: B0334348A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS810A6   
Administered by: Other     Purchased by: Other
Symptoms: Anorexia, Arthralgia, Asthenia, Influenza, Laboratory test abnormal, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: This case was reported by two physicians and described the occurrence of pseudo-influenza syndrome in a 49 year old male subject who was vaccinated with Havrix for hepatitis A prophylaxis. The subject''s past medical history included Zona ophthalmica in 2003. Concurrent medical conditions included a functional colopathy. Subject''s family history included type 1 diabetes mellitus in one sister and subject''s son died at 2 year old following an auto-immune disease. On 5/19/04, the subject received a first injection of Havrix at 1440 Elisa unit (batch VHA810A6). Four days later, on 5/23/04, the subject experienced a severe influenza-like syndrome with polyarthralgias, myalgias, asthenia, anorexia, and fever at 38.5 degrees C. The same day, oral treatment with ibuprofen (Nureflex) and paracetamol were started. On 5/25/04, the fever resolved. Polyarthralgias and myalgias improved but reappeared when treatment was discontinued. On 5/27/04, blood tests showed a biological inflammatory syndrome (C-reactive protein (CRP) at 18 mg/ml and red blood cell sedimentation rate at 25/52 mm), a discrete elevation of liver enzymes (alanine aminotransferase at 42 IU/L and aspartate aminotransferase at 37 IU/L), hyperglycemia at 1.35 g/L and white blood cells at 9600/mm3 with a discrete polynucleosis at 80%. On 6/15/04, all clinical signs were resolved. After an unspecified delay, blood tests normalized. On 7/28/04, blood tests were normal and showed ALAT at 28 IU/L, ASAT at 23 IU/L, CRP <8 mg/mL, SR at 14mm, and blood glucose at 1.07 g/L. The reporting physician considered the events as clinically significant and almost certainly related to vaccination with Havrix 1440. (OMIC)

VAERS ID:227487 (history)  Vaccinated:2001-02-10
Age:49.0  Onset:2002-08-11, Days after vaccination: 547
Gender:Male  Submitted:2004-10-07, Days after onset: 788
Location:Foreign  Entered:2004-10-08, 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: UNK
Current Illness: UNK
Preexisting Conditions: UNK
Diagnostic Lab Data: 08/11/02: Muscular biopsy: lesions of macrophagic myofascitis (not provided);
CDC Split Type: B0293217A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS3169B6 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Fasciitis, Pain
SMQs:
Write-up: This case was reported by the regulatory authority and described a macrophagic myofascitis in a 48 year old male subject vaccinated with Engerix-B for Hepatitis B prophylaxis. The subject belongs to an association. Medical history was unknown in this subject. Co-suspect vaccine included Genhevac B for hepatitis B prophylaxis. On 12/20/94, on 03/06/95 and on 02/12/96, he received three injections of Genhevac B, IM. On 01/29/95 and on 02/10/01, he received two injections of Engerix B 20mcg, IM. Two months after the last injection of Engerix B, on 04/10/01, he reported pains in four limbs. On 08/11/02, muscular biopsy showed lesions of macrophagic myofascitis. At the time of reporting, the outcome of the events was unknown. According to the regulatory authority, the events were disabling. No causal relationship was performed. Per follow up report received on 08/19/2005: This report was received from a regulatory authority. No further information is available.

VAERS ID:229222 (history)  Vaccinated:1995-08-08
Age:49.0  Onset:2003-04-07, Days after vaccination: 2799
Gender:Female  Submitted:2004-11-15, Days after onset: 588
Location:Foreign  Entered:2004-11-15
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: Carpal Tunnel Syndrome
Diagnostic Lab Data: Alanine aminotransferase negative; Alkaline phosphatase negative; Anti-nuclear antibody pos 1/80; Antiphospholipid antibodies negative; Aspartate aminotransferase; Bilirubin negative; Blood calcium negative; Blood creatinine negative; Blood
CDC Split Type: B0314898A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS1675C6 IM 
Administered by: Other     Purchased by: Other
Symptoms: Amnesia, Arthralgia, Disturbance in attention, Fasciitis, Fatigue, Insomnia, Laboratory test abnormal, Muscle spasms, Myalgia, Sensation of heaviness
SMQs:, Rhabdomyolysis/myopathy (broad), Dementia (broad), Dystonia (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad)
Write-up: This case was reported by a foreign regulatory authority and described a macrophagic myofascitis in a 57 year old female subject vaccinated with Engerix B and Havrix for hepatitis A-B prophylaxis. Co-suspected vaccinations included Typhim Vi on 1/16/95 and in 1/98 and DTPolio on 3/7/97. On 1/9, 2/8, and 8/8/95, the subject received an injection of Engerix B. On 1/6 and 1/12/95, she received an injection of Havrix. In 1999 and 2000, the subject complained of severe fatigue associated with recurrent and diffuse arthralgia and myalgia from scapular area to lower limb. The subject also reported memory loss and concentration difficulties (unknown starting date). From an unspecified date, she complained of agitated sleep with increased sleep needed, general body pain especially in back, shoulders and legs, cramps and heavy leg feeling. In 8/00, she received a booster injection of Engerix B. In 6/02, symptomatology aggravated. In 9/02, the subject was treated with antidepressant and anxiolytic drugs. At unspecified dates, blood cell count, ESR, C-reactive protein, blood creatinine, blood calcium and blood phosphorus were normal. Blood ionogram was normal except low blood potassium level at 3.3 (N$g3.5) and low blood sugar level at 3.9 mmol/L (N$g4.1). Transaminases level, bilirubin, GammaGT, alkaline phosphatase and creatine phosphokinase were normal. Rheumatoid factor and C3 and C3 complement factors were normal. Total hemolytic complement was increased to 135% (N<120). Immunoelectrophoresis was normal. Antinuclear antibody was mildly positive at 1/80, antithyroid, antifilagrin, and antiphospholipid antibodies were negative. AntiHBs antibody was positive at 15 IU/l (antiHBs antigen was negative): serologies of hepatitis C and HIV 1/2 were negative. TSH and androgenic hormones were normal. Vitamin E, A and Selenium levels were normal. Vitamin B12 level was increased to 570 ng/l (N<500). Seric folate level was normal. On 4/7/03, left deltoid biopsy showed lesions of macrophagic myofascitis. Antidepressant and anxiolytic tr

VAERS ID:232493 (history)  Vaccinated:2001-10-22
Age:49.0  Onset:2001-10-24, Days after vaccination: 2
Gender:Female  Submitted:2002-10-10, Days after onset: 351
Location:Foreign  Entered:2005-01-19, Days after submission: 832
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: History of allergy
Diagnostic Lab Data:
CDC Split Type: PJP200200184
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)EVANS VACCINES760659 ID 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Headache, Injection site swelling, Malaise
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: A report was received on 2/11/02 concerning a 49 year old female patient who experienced headache, local swelling at the injection site, and unwell, which were considered to be not serious after receiving a Fluvirin vaccine on 10/22/01. The patient experienced a painful swelling of 4 inches in diameter on left upper arm with headache and general malaise on 10/24/01, two days after receiving the Fluvirin vaccine. The patient recovered on 10/27/01. There was insufficient information to determine the reporter''s causality assessment.

VAERS ID:232622 (history)  Vaccinated:2004-11-11
Age:49.0  Onset:2004-11-15, Days after vaccination: 4
Gender:Female  Submitted:2005-01-17, Days after onset: 63
Location:Foreign  Entered:2005-01-21, Days after submission: 4
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: UNK
Current Illness:
Preexisting Conditions: NONE
Diagnostic Lab Data: Serum C-reactive protein 256.
CDC Split Type: WAES0501USA00952
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0421N SC 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Laboratory test abnormal, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Information has been received from a health authority concerning a 48 year old female who on 11/11/04 was vaccinated SC with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine, lot # 646492/0421N. Concomitant therapy included an influenza vaccine administered 11/11/04 into her upper arm (route not reported). On 11/15/04 the patient developed a high fever and was hospitalized. Laboratory evaluations revealed her C-reactive protein was increased at 256. On 11/19/04, the patient recovered. The events were considered to be immediately life threatening. No further information is available. The case was closed. Other business partner numbers included E200500080, 2004002266, and MA20050015.

VAERS ID:233107 (history)  Vaccinated:2004-03-18
Age:49.0  Onset:2004-06-24, Days after vaccination: 98
Gender:Female  Submitted:2005-01-31, Days after onset: 221
Location:Foreign  Entered:2005-01-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Thyroxine Sodium
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: Alanine aminotransferase 9U/l, 110U/l, 19U/l, 22U/l; Aspartate aminotransferase 22U/l; Gamma glutamyl transferase 8U/l, 42U/l, 84U/l, 41U/l; HIV antibody negative; Hepatitis C antibody negative; P24 negative. Titre control, performed on 4/6
CDC Split Type: D0045470A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS5402B6 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Gamma-glutamyltransferase increased
SMQs:, Liver related investigations, signs and symptoms (narrow)
Write-up: This case was reported by a physician and described the occurrence of increased gamma glutamyl transferase in a 49 year old female subject who was vaccinated with hepatitis B vaccine for prophylaxis. The reporting physician was also the vaccinating physician. Concurrent medications included thyroxine sodium. On 3/18/04, the subject received a booster with the fourth dose of hepatitis B vaccine, IM in the left upper arm. Approximately three months post vaccination, on 6/24/04, laboratory examinations showed slightly increased gamma glutamyl transferase. On 11/25/04, approximately 8 months post vaccination, laboratory examinations showed further increased gamma glutamyl transferase. The event resolved on an unknown date. On 11/25/04, approximately 8 months after vaccination, laboratory examinations showed also increased alanine aminotransferase (ALAT). This event was assessed as medically serious (OMIC). The event resolved about one month later on 12/21/04. Serology for anti-hepatitis C virus antibodies, anti-human immunodeficiency virus (HIV) 1 and 2 antibodies and HIV p24 antigen, performed on 12/21/04, were negative. The reporting physician considered that the events were non-serious. The reporting physician considered that the events were unlikely related to vaccination with hepatitis B vaccine.

VAERS ID:234048 (history)  Vaccinated:2001-09-18
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2005-02-18
Location:Foreign  Entered:2005-02-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 20 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: Antinuclear antibody positive; CSF test abnormal; MRI brain abnormal
CDC Split Type: B0362633A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Antinuclear antibody positive, CSF test abnormal, Hypoaesthesia, Immune system disorder, Multiple sclerosis, Nausea, Neuropathy, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Systemic lupus erythematosus (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Demyelination (narrow)
Write-up: This case was reported by a physician via an insurance company and described the occurrence of multiple sclerosis in a 49 year old female subject who had received Hepatitis B vaccine injection for prophylaxis. The subject was taking no concomitant medication and was previously healthy except for proctitis that she was having for years. On 9/26/00, the first dose of Engerix B was given. On 9/18/01, the patient received the second dose of Hepatitis B vaccine at 20mcg. In September or October 2001, she developed the first symptoms of multiple sclerosis with paresthesia and numbness of hands. On 11/19/01, she was seen by a physician who judged the event as an adverse reaction to the vaccine, possibly a neuropathy. Since then no further attacks occurred. On 4/18/03, she developed a suspected winter vomiting disease, but as the nausea persisted, she was admitted to hospital from 5/6/03 until 5/26/03. Liquor investigation showed a picture of immunopathy. An MRI of the brain showed high signal changes periventricular and one in C2 area, consistent with an immunopathy. No information regarding the activity was provided. Lab tests proved also positive antinuclear antibodies. The outcome of the events is unknown.

VAERS ID:234190 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2005-02-22
Location:Foreign  Entered:2005-02-22
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: UNK
CDC Split Type: B0371978A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Other     Purchased by: Other
Symptoms: Depression, Multiple sclerosis, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Optic nerve disorders (broad), Demyelination (narrow), Depression (excl suicide and self injury) (narrow)
Write-up: This case was reported in a newspaper article and described the occurrence of multiple sclerosis in a 49 year old female subject who had received hepatitis B vaccine injection for prophylaxis. Approximately 2 years after having received the first and second dose of Hepatitis B vaccine, this subject developed pins and needles in hands and feet as well as depression. A diagnosis of multiple sclerosis was made. This case was assessed as medically serious (OMIC). The outcome of the events is unknown. This report was received from a newspaper article. No further information is available.

VAERS ID:234620 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2005-03-02
Location:Foreign  Entered:2005-03-07, Days after submission: 5
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: UNK
Diagnostic Lab Data: UNK
CDC Split Type: WAES0502USA03438
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Depression, Multiple sclerosis, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Optic nerve disorders (broad), Demyelination (narrow), Depression (excl suicide and self injury) (narrow)
Write-up: Information has been received from a newspaper article concerning a 49 year old female doctor with no reported relevant history who was vaccinated with two doses of hepatitis B virus vaccine. Subsequently, three years after receiving the vaccinations the patient developed multiple sclerosis. She commented that she experienced pins and needles in her hands and feet and depression. She also commented that she has not been able to work full time since this occurred. The outcome of the event was not reported. This case was not medically confirmed. The reporter considered multiple sclerosis, pins and needles in her hands and feet and depression to be disabling. Other business partner numbers included: E200500729. Additional information is not expected. The case is closed.

VAERS ID:239052 (history)  Vaccinated:2000-10-02
Age:49.0  Onset:2005-05-22, Days after vaccination: 1693
Gender:Female  Submitted:2005-06-03, Days after onset: 12
Location:Foreign  Entered:2005-06-03
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: UNK
Preexisting Conditions:
Diagnostic Lab Data: Alanine aminotransferase 156U/l; Aspartate aminotransferase 110U/l; Bilirubin total 1.1mg/dl; GGT 208U/l; Sonogram normal; Transaminases normal.
CDC Split Type: D0046693A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Cholelithiasis, Drug ineffective, Gamma-glutamyltransferase abnormal, Hepatitis A, Viral infection
SMQs:, Liver related investigations, signs and symptoms (narrow), Liver infections (narrow), Acute pancreatitis (narrow), Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Biliary system related investigations, signs and symptoms (narrow), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was reported by a physician and described the occurrence of possible hep A infection (lack of efficacy) in a 53 year old female subject who was vaccinated with combined hep A, Hep B vaccine (Twinrix) for prophylaxis. Previous vaccination included combined hep A, hep B vaccine given on 04Jun1999 and 2Jul99. In Oct 2004 the transaminases had been normal. The subject had been in a foreign country in Nov 2004. On 02Oct00 the subject received 3rd dose of Twinrix adult (unk). On 22May05, 5 years after vaccination with Twinrix adult, the subject experienced upper abdominal pain. The subject was hospitalized due to suspect of gall colic. A sonogram was without pathologic findings, bile ducts were not visible in endoscopic retrograde cholangiopancreatography, so gall stones could not be excluded. On 23May05 transaminases were increased. On 24May05 hep A virus IgM antibodies were positive. A hep A infection was suspected. At the time of reporting the outcome of the events was unspecified.

VAERS ID:243142 (history)  Vaccinated:2005-07-18
Age:49.0  Onset:2005-07-19, Days after vaccination: 1
Gender:Male  Submitted:2005-08-18, Days after onset: 30
Location:Foreign  Entered:2005-08-18
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: UNK
Preexisting Conditions:
Diagnostic Lab Data: Transaminases increased.
CDC Split Type: D0047291A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSXHBVB047AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Hepatitis, Laboratory test abnormal, Meningism, Thrombocytopenia
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Noninfectious meningitis (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of meningeal irritation in a 46 year old male subject who was vaccinated with hepatitis B vaccine for prophylaxis. This report was received from a foreign regulatory authority. Previous vaccinations with hepatitis B vaccine, given on 3/10/94, 4/11/94, 9/14/94, and 5/11/98 were well tolerated. On 7/18/05, the subject received the fifth dose of hepatitis B vaccine (1ml, IM, left deltoid). Approximately one day post vaccination, on 7/19/05, the subject experienced meningeal irritation, hepatitis and thrombocytopenia. The events were confirmed by serology (date not reported0. The subject was hospitalized for an unknown period of time. Meningeal irritation and thrombocytopenia resolved after about 10 days. At the time of reporting, transaminases were still increased. Therefore the outcome of hepatitis was considered to be either unknown or unresolved.

VAERS ID:244863 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:2004-01-22
Gender:Male  Submitted:2005-09-30, Days after onset: 616
Location:Foreign  Entered:2005-10-04, 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: NONE
Diagnostic Lab Data: UNK
CDC Split Type: WAES0509USA03244
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug ineffective, Hepatitis, Jaundice, Viral infection
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Hepatitis, non-infectious (narrow), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow)
Write-up: Information has been received from a published article concerning a 49 year old male, with no reported medical history, who in 1998 was vaccinated with a first dose of hepatitis B vaccine (manufacturer unknown). On 20-DEC-2003 the pt had jaundice and on 22-JAN-2004 the pt was diagnosed with acute hepatitis B. Vaccination failure was noted. It was noted that no risk factors were found. The outcome of the acute hepatitis B was considered as favorable, but the pt''s final outcome as not reported. Acute hepatitis B was considered to be an other important medical event (OMIC) by the reporter. No further data are available. The case is closed. Other business partner numbers include: E200503735.

VAERS ID:249396 (history)  Vaccinated:2000-06-16
Age:49.0  Onset:2003-06-15, Days after vaccination: 1094
Gender:Male  Submitted:2005-12-16, Days after onset: 915
Location:Foreign  Entered:2005-12-16
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 Aug 26 2005 abnormal. On Aug 26 2005, muscle biopsy showed lesions of Macrophagic myofascitis.
CDC Split Type: B0402714A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Cleft lip and palate, Fibrosis tendinous, Laboratory test abnormal, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Congenital, familial and genetic disorders (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad)
Write-up: This case was reported and described the occurrence of myalgia in a 49 year old male subject who was vaccinated with hepatitis B vaccine (Engerix B adult) for prophylaxis. On April 8 1994 and June 16 2000, the subject received 2 doses of Engerix B at 20 mcg (intramuscular injections, batch reference not available). There was not specified if the subject received another dose of hepatitis B vaccine between these two dates. On June 15 2003, three years after the last dose of Engerix B, the subject experienced myalgia induced by palpation on calf''s and arms physical and mental asthenia with professional affects. On Aug 26 2005, a muscle biopsy was performed and showed lesions of macrophagic myofascitis. At the time of reporting myalgia and asthenia were unresolved, while the outcome of macrophagic myofasciitis was unknown. The events were disabling and unlikely related to vaccinated with Engerix B vaccine. This case is closed, no further information will be available.

VAERS ID:249402 (history)  Vaccinated:1992-09-14
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2005-12-15
Location:Foreign  Entered:2005-12-16, 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: Depressive disorder
Diagnostic Lab Data:
CDC Split Type: B0403308A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  SC 
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Arthropathy, Back pain, Hypokinesia, Malaise, Pain, Psoriasis
SMQs:, Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad)
Write-up: This case was reported and described occurrence of spondyloarthropathy in a 49 year old female subject who was vaccinated with hepatitis b vaccine Engerix B for prophylaxis. The subjects medical history included depressive disorder (NOS). On July 10 1992, Aug 6 1992, Sept 14 1992 and July 17 1993, the subject received four doses of Engerix B (subcutaneously, batch number not available. From 1993, less than one year after the third dose, the subject''s general state progressively deteriorated, associated with worsening lumbodorsal pain. In 1995, the subject developed arthralgia and flare up of psoriasis at elbows, knees, legs, abdomen and scalp level. In Sept 1996, due to intense pain and motor difficulty, the subject was definitively on sick leave. In Oct 1996, the subject was treated with phenylbutazone (Butazolidine), corticoids, amitriptyline hydrochloride (Laroxyl) and physiotherapy. In May 1997, the subject was diagnosed with spondyloarthropathy. On an unknown date, the subject was hospitalised. The subject was found HLA B 27 negative. At the time of reporting (Dec 6 2005), the events were unresolved. According to regulatory authority, the relationship between vaccination and Engerix B and the events was unlikely. No more information will be available, this case has been closed.

VAERS ID:250409 (history)  Vaccinated:1997-11-06
Age:49.0  Onset:2004-01-24, Days after vaccination: 2270
Gender:Female  Submitted:2006-01-16, Days after onset: 723
Location:Foreign  Entered:2006-01-16
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: Allergy To Vaccine. The subject vaccinal history included a booster of diphtheria, tetanus typhus, para-typhus A+B on 263 December 1968. Six injections of diphtheria and tetanus (DT) vaccine on : 02 April 1975, 02 July 1975, 09 July 1975, 23 July 1975, 24 September 1975, 09 February 1993. One booster of diphtheria, tetanus, poliomyelitis (DTP) on 02 February 1983 four injections
Diagnostic Lab Data: Anti Hbs antibody 03/16/1993 412 mIU/ml, Biopsy muscle 10/13/2004 abnormal, Creatine phosphokinase normal. On Oct 13 2004 muscular biopsy of the left deltoid, muscular fibers were normal. No necrosis nor overload. Macrophagic infiltrations
CDC Split Type: B0373813A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS1972B6 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Asthenia, Fibrosis tendinous, Laboratory test abnormal, Muscle disorder, Myalgia, Oedema peripheral, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: This case was reported via another manufacturer and described the occurrence of arthromyalgia in a 56 year old female subject who received hepatitis B vaccine (Engerix B adult) for prophylaxis. The subject''s vaccinal history included a booster injection of diphtheria, tetanus, typhus, para typhus A+B on Dec 26 1968, six injections of diphtheria and tetanus DT vaccine on 04/02/1975, 07/02/1975, 07/09/1975, 07/23/1975, 09/24/1975, 02/09/1993, one booster injection of diphtheria, tetanus poliomyelitis DTP on 02/02/1983, test for tuberculosis in 1954 and 1978 which were both strongly positive. The subjects medical history included allergy to Typhus, para typhus A+B and to smallpox vaccines. On Oct 6 1992, Nov 17 1992, Jan 11 1993 and Sept 28 1993 and Nov 6 1997,the subject received five injections doses of Engerix B vaccine, 20mcg, intramuscular with respectively batch reference 864D6, 955D6, 911D6, 1157D6, 1972B6. On March 16 1993 anti HBs antibodies were at 412m UI/ml. On 01/19/2004, she received a second booster injection of Revaxis vaccine, intramuscular, batch reference 6518. Five days after the vaccination with Revaxis and 6 years after the last dose of Engerix B adult, the subject experienced bilateral hands edema requiring the cut of marriage ring. On 02/15/2004 she developed gonalgias following by diffuse and fluctuation arthromyalgia at wrists, elbows, hands, knees and ankles level. Decreased strength, muscular fatigue and asthenia were also reported. On 10/13/2004 biopsy of left deltoid showed lesions of macrophagic myofascitis. At an unspecified date, the subject experienced paresthesia and creatine phosphokinase level was found normal. At the time of the follow up the events were unresolved. The events were disabling and dubiously related with Engerix b adult and Revaxis vaccine. This case was duplicate case of case B0375696A. Case B0375696A has been voided and all future correspondence will be added on the master case B0373813A. This case has been closed. No further information will be available.

VAERS ID:251164 (history)  Vaccinated:2005-12-19
Age:49.0  Onset:2005-12-19, Days after vaccination: 0
Gender:Male  Submitted:2006-01-24, Days after onset: 36
Location:Foreign  Entered:2006-02-02, Days after submission: 9
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: Obesity;Diabetes Mellitus insulin-dependent
Diagnostic Lab Data:
CDC Split Type: WAES0601USA03039
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR   LA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0966P0SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site abscess, Injection site hypersensitivity, Injection site inflammation, Injection site swelling, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a health professional concerning a 46 year old male, with a history of obesity and insulin-dependent diabetes mellitus, who on 19-Dec-2005 was vaccinated subcutaneously into the right upper arm with a first dose of pneumococcal 23v polysaccharide vaccine (Lot #650835/0966P, Batch #NB29850) and concomitantly with a dose of influenza virus split virion 3v vaccine inactivated (MUTAGRIP, lot # not reported) into the left upper arm. A few hours post vaccination on 19-Dec-2005, the patient developed a fever up to 40 degree C and severe injection site inflammation w/redness, swelling and warmth of the right upper arm. He was admitted to the hospital where tentative diagnosis of abscess was established. An incision was carried out, nothing was reported about the swab result. He was treated with antibiotics (Unacid) intravenously and recovered within an unspecified time. Other business partners numbers included: E2006-00368. Additional information has been requested.

VAERS ID:251795 (history)  Vaccinated:2005-07-01
Age:49.0  Onset:2005-08-01, Days after vaccination: 31
Gender:Female  Submitted:2006-02-23, Days after onset: 206
Location:Foreign  Entered:2006-02-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcohol consumption, family problems, hypercholesterolemia, tiredness, weight gaining.
Preexisting Conditions: Coronary artery disease, menopausal.
Diagnostic Lab Data: Alanine aminotransferase 9/15/2005 32U/L 9/29/2005 32 U/L 11/23/2005 21 U/L 12/02/2005 21 U/L, Alkaline phosphatase 9/15/2005 91 U/L 9/29/2005 91 U/l 12/02/2005 80 U/L, Aspartate aminotransferase 9/15/2005 52 U/l, Basophil percentage 9/15/2
CDC Split Type: B0404128A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anxiety, Aspartate aminotransferase increased, Basophilia, Blood cholesterol increased, Chest discomfort, Fatigue, Gamma-glutamyltransferase increased, Haemoglobin decreased, Hepatic enzyme abnormal, Insomnia, Laboratory test abnormal, Pain, Respiratory disorder, Viral infection
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Dyslipidaemia (narrow), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Acute central respiratory depression (broad), Lipodystrophy (broad)
Write-up: This case was reported by a physician and described the occurrence of increased liver enzymes in a 49 year old female subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix), influenza virus vaccine Fluarix for prophylaxis. Concurrent medical history or family history included alcohol consumption on average two days a week, 1-3 units at a time. She had many problems with husbands daughter and she was not happy in her present job. The subjects medical history included hypercholesterolemia since 2003 for which she was given instructions at the time by the occupational health service nurse, ant the matter was left as it was. Over the lasts few years, the subjects weight had increased considerably over the last few years. In 2004, the patient menstruation ended. The subject had also a background of coronary artery disease. Previous and or concurrent vaccination included hepatitis A inactivated and hepatitis B recombinant vaccine intramuscular, unk given in June 2005. In July 2005 the subject received 2nd dose of Twin 20 mcg, intramuscular. In Aug 2005 less than one month after vaccination with Twinrix, the subject experienced unusual fatigue. On 9/07/2005, the subject was on sick leave due to flu. On 9/13/2005, the subject was very tired and explained to the doctor that she suffered from feelings of constriction episodes in the left shoulder from the thoracic vertebral area through to the front. The subject also suffered from thoracic vertebral pain and would be treated with physiotherapy. On 9/15/2005 lab test revealed elevated alanine aspartate aminotransferase 52 IU/L and elevated basophils 2%. The physician thought of a viral infection. On 9/21/2005, the gamma GT was increased at 178 U/L instead of 10 to 75 U/L for a women over 40 years of age. On 10/05/2005, the gamma GT had gone up to 197 U/L. On 12/2/2005, lab test revealed cholesterolaemia 6 mmol/l, and low density lipoprotein 3.9 mmol/l. She was treated with Oxazepam (Oxepam). On 11/3/2005, the subject received a

VAERS ID:253916 (history)  Vaccinated:1995-03-30
Age:49.0  Onset:1996-01-30, Days after vaccination: 306
Gender:Female  Submitted:2006-04-10, Days after onset: 3722
Location:Foreign  Entered:2006-04-10
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormones
Current Illness: Depression, Menopausal
Preexisting Conditions: Encephalitis, Meningitis, Toxicoderma
Diagnostic Lab Data: Anti HBc antibody negative, antinuclear antibody N, antiphospholipid antibodies N, auditory evoked potentials normal, B lymphocyte count 193/mm3, biopsy muscle 10/22/2002 abnormal, biopsy muscle 10/3/2005 abnormal, blood calcium N, blood cr
CDC Split Type: B0357348A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSENG1681C6 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Back pain, Cognitive disorder, Fasciitis, Hypokinesia, Laboratory test abnormal, Myalgia, Skin burning sensation
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of myalgia in a 51 year old female subject who was vaccinated with Engerix B for hepatitis B prophylaxis. The subject belongs to the REVAHB association. The subjects medical history included meningitis at the age of eight year old, encephalitis at twenty years old treated with phenobarbital (Gardenal) and phenytoin (Dihydan) and gravidic drug eruption. Concurrent medical condition included depression and non treated menopause. Co suspected vaccines included three injections of TPolio vaccine (tetanus poliomyelitis) between 1980 and 1987. In March, April and June 1994, the subject received three injections of Engerix B. In March 1995, she received a booster injection of Engerix B. In Sept 1996, 18 months after the last injection, the subject complained of recurrent and diffuse asthenia and myalgia, mainly localised in lower limbs and dorsalgia (on the top of back). On 6/14/2001 and or 10/22/2002, biological tests showed normal blood cell count, erythrocyte sedimentation rate, c reactive protein level, blood ionogram, blood creatinine, calcium, phosphorus and creatine phosphokinase levels, blood ferritin level was slightly decreased. Antinuclear and antiphospholipid antibodies were normal. Hepatitis B, hepatitis C and HIV serologies were negative. Anti antiHBs antibodies were positive 632 IU/l. On 6/14/2001, electromyogram was normal. On 10/22/2002, a biopsy of left deltoid showed no lesion of macrophagic myofascitis. On 10/25/2002, auditory, sensory, visual and muscular evoked potentials were normal. At the time of reporting, the events were considered resolved with sequelae. The events were disabling and dubiously related to Engerix and TPOLIO vaccine. Follow up received on 3/29/2006. Co suspect vaccine included tetanus vaccine (Tetavax) and poliomyelitis + tetanus vaccine. On 3/29/1994, 4/28/1994 and 6/22/1994, the subject was vaccinated with three dosed of Engerix B (20 mcg, batches number ENG11786B, ENG1178B6B, ENG17B6B respectively)

VAERS ID:262510 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:0000-00-00
Gender:Male  Submitted:2006-08-31
Location:Foreign  Entered:2006-09-01, 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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: B0435813A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS    
Administered by: Other     Purchased by: Other
Symptoms: Haemolytic anaemia
SMQs:, Haemolytic disorders (narrow), Systemic lupus erythematosus (broad)
Write-up: This case was reported by a physician and described the occurrence of hemolytic anemia in a 49 yr old male subject who was vaccinated with hep A vaccine (Havrix 1440) for prophylaxis. On an unspecified date the subject received unspecified dose of Havrix (unk, lot number not provided). At an unspecified date the subject received unspecified dose of Havrix 1440 (unk, lot number not provided). At an unspecified time after vaccination with Havrix 1440, the subject experienced an hemolytic anemia. This case was assessed as medically serious by manf (OMIC). At the time of reporting the outcome of the event was unspecified. The physician considered the event was unlikely to be related to vaccination with Havrix 1440.

VAERS ID:265065 (history)  Vaccinated:2006-09-20
Age:49.0  Onset:2006-09-24, Days after vaccination: 4
Gender:Female  Submitted:2006-10-23, Days after onset: 29
Location:Foreign  Entered:2006-10-23
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: MA20060794
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABIPUR)CHIRON CORPORATION 2IDUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic shock, Anxiety, Erysipelas, Headache, Injection site oedema, Medication error, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: A female pt was vaccinated for the third time with Rabipur on 9/20/06 (batch no 375011E). Four days after the third vaccination she developed swelling of injection site and of the whole arm. She was treated in hospital with Augmentin, due to suspicion of erysipelas. the pt suffered from an anaphylactic shock to Augmentin and was hospitalised for one week. No further information was provided. Addendum 10/11/06 the 49 year old female pt born on 9/26/56 was vaccinated three times Intradermally for per exposure (see also case MA20060806 and MA20060807). It was reported that she experienced headache and anxiety attacks about 5-10 hours after each vaccination. Erysipelas developed away from injection site. After treatment with Augmentin she suffered from an anaphylactic shock and was hospitalized. Swelling of arm, swelling of injection site and headache are expected after vaccination with Rabipur, Erysipelas, anxiety attacks and administration incorrect are not expected after vaccination with Rabipur. Addendum 10/12/2006 it was reported that the pt was vaccinated only two times Intradermally. (conflicting to the previous statement). WE decided to indicate all three vaccinations like initially reported. Furthermore it was mentioned that the women received 0.2 ml Rabipur, instead of the usual used 0.1 ml for Intrademal administration.

VAERS ID:267933 (history)  Vaccinated:2006-10-11
Age:49.0  Onset:2006-11-01, Days after vaccination: 21
Gender:Female  Submitted:2006-11-29, Days after onset: 28
Location:Foreign  Entered:2006-11-29
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: Interferon
Current Illness:
Preexisting Conditions: Hepatitis C; Hepatitis C RNA negative
Diagnostic Lab Data:
CDC Split Type: D0051586A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS   UN
Administered by: Other     Purchased by: Other
Symptoms: Inflammation, Pain
SMQs:
Write-up: This case was reported by a physician and described the occurrence of suspected polyradiculitis in a 49 year old female subject who was vaccinated with influenza virus vaccine for prophylaxis. The subject''s medical history included hepatitis C. Concurrent medication for the treatment of hepatitis C included interferon. At the moment, the subject seems to be hepatitis C RNA negative. On 10/11/06, the subject received an unspecified dose of Influsplit SSW 2006/2007 (0.5 ml, unknown). Approximately six weeks post vaccination with Influsplit SSW 2006/2007, since about five days prior to 11/27/06 (day of initial reporting), the subject experienced pain in cervical spine and pain in thoracic spine. The reporting physician suspected polyradiculitis of unknown origin. The subject was hospitalized at the neurological department for an unknown period of time for examinations. At the time of reporting the outcome of the events was unspecified. The reporting physician considered that the events were unlikely related ("very vaguely related") to vaccination with Influsplit SSW 2006/2007. Follow up information has been requested.

VAERS ID:270877 (history)  Vaccinated:2000-10-04
Age:49.0  Onset:2000-10-06, Days after vaccination: 2
Gender:Female  Submitted:2007-01-19, Days after onset: 2296
Location:Foreign  Entered:2007-01-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Gold sodium thiomalate, Naproxen
Current Illness: Rheumatoid Arthritis
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0454789A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IM 
Administered by: Other     Purchased by: Other
Symptoms: Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: This case was reported by a regulatory authority and described the occurrence of arm pain in a 49 year old female subject who was vaccinated with influenza virus vaccine (Influenza vaccine) for prophylaxis. Concurrent medical conditions included RA. Concurrent medications included Gold sodium thiomalate (Myocrista) and Naproxen. On 04 October 2000 the subject received unspecified dose of Influenza vaccine (0.5 ml intramuscular). On 06 October 2000, 2 days after vaccination with Influenza vaccine, the subject experienced arm pain and febrile illness. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 10 October 2000, the events were resolved. Verbatim text received: Horrendous pain in both arms-lasted 48-96 hours: pyrexial illness, suspect drug brand name was either Begrivac or Influvac.

VAERS ID:270990 (history)  Vaccinated:2006-11-24
Age:49.0  Onset:0000-00-00
Gender:Male  Submitted:2007-01-23
Location:Foreign  Entered:2007-01-24, 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: UNK
Preexisting Conditions:
Diagnostic Lab Data: C-reactive protein, 03 Jan 2007, 7.78mg/dl, low normal-0, high normal-1; C-reactive protein, 12 Jan 2007, 3.09mg/dl, low normal-0, high normal-1; Erythrocyte sedimentation rate, 03 Jan 2007, 72, low normal-0, high normal-10; Erythrocyte sed
CDC Split Type: D0051939A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: C-reactive protein increased, Erythema nodosum, Haemoglobin abnormal, Inflammation, Localised oedema, Lymphocyte count, Mean cell haemoglobin concentration, Mean cell haemoglobin normal, Mean cell volume normal, Monocyte count, Oedema peripheral, Platelet count, Red blood cell count, Red blood cell sedimentation rate increased, White blood cell count
SMQs:, Cardiac failure (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Haemorrhage laboratory terms (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a physician via a sales representative and described the occurrence of erythema nodosum in a 49 years old male subject who was vaccinated with Twinrix adult for prophylaxis. There was no concurrent medical condition or concurrent medication or any other risk factors. On 24 November 2006 and 22 December 2006 the subject received 1st dose and 2nd dose of Twinrix adult (intramuscularly into unknown deltoid muscle). Initially it was reported that some days after one of the vaccinations with Twinrix adult, the subject experienced erythema nodosum. Follow up information reported edema of legs and trunk. Increased inflammatory values were found by blood examinations. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unresolved. The physician considered the events were possibly related to vaccinations with Twinrix adult.

VAERS ID:272381 (history)  Vaccinated:2006-09-29
Age:49.0  Onset:2006-09-29, Days after vaccination: 0
Gender:Female  Submitted:2007-02-13, Days after onset: 137
Location:Foreign  Entered:2007-02-15, Days after submission: 2
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: Bronchitis asthmatic
Preexisting Conditions: Strumectomy, Fibromyalgia syndrome.
Diagnostic Lab Data: On 29-AUG-2006, before vaccianton, laboratory evaluation revealed serum alanine aminotransferase 23 U/L, serum aspartate aminotransferase 28 U/L, and C-reactive protein (CRP) 8 mg/dl. Laboratory tests were performed on 30-SEP-2006 that revealed elevated SGPT 130 U/L, SGGT 150 U/L, and CRP 8.2 mg/dl. ON 03-OCT-2006, laboratory evaluation revealed SGPT 94 U/L and SGGT 118 U/L. On 05-OCT-2006, laboratory evaluation revealed SGPT 107 U/L, SGGT 168 U/L, and CRP 1.9 mg/dl. Hepatitis screening was negative on 09-OCT-2006. On 20-NOV-2006, her SGPT was 30 U/L and SGGT was 46 U/L.
CDC Split Type: WAES0702USA01407
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER067022 UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.01135P IMGM
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Alanine aminotransferase normal, Aspartate aminotransferase increased, Aspartate aminotransferase normal, C-reactive protein, C-reactive protein increased, C-reactive protein normal, Dizziness, General physical health deterioration, Hepatitis B surface antigen negative, Pain in extremity, Pyrexia
SMQs:, Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Information has been received from the health authority agency concerning a 49 year old female with bronchial asthma treated with Symbicort turboinhaler as needed, on therapy with L-Thyroxin after a strumectomy was performed and a history of Fibromyalgia syndrome. On 29-AUG-2006, before vaccianton, laboratory evaluation revealed serum alanine aminotransferase 23 U/L, serum aspartate aminotransferase 28 U/L, and C-reactive protein (CRP) 8 mg/dl. On 29-SEP-2006, the patient was also vaccinated with Fluad (lot #067022) into the left upper arm. Concomitant therapy included L-Thyroxin and Symbicort. On 29-SEP-2006, the same day, the patient experienced fever for one day, an dizziness for four days. She complained of severe pain in the right thigh lasting for four days. Her general condition was reduced for about five weeks. The woman was admitted to the hospital two times. The first time from 30-SEP-2006 to 03-OCT-2006 (initiated by herself) and a second time from 06-OCT-2006 to 12-OCT-2006 (initiated by general practitioner). Laboratory tests were performed on 30-SEP-2006 that revealed elevated SGPT 130 U/L, SGGT 150 U/L, and CRP 8.2 mg/dl. ON 03-OCT-2006, laboratory evaluation revealed SGPT 94 U/L and SGGT 118 U/L. On 05-OCT-2006, laboratory evaluation revealed SGPT 107 U/L, SGGT 168 U/L, and CRP 1.9 mg/dl. Hepatitis screening was negative on 09-OCT-2006. On 20-NOV-2006, her SGPT was 30 U/L and SGGT was 46 U/L. At the time of reporting, the woman had recovered completely. File closed. Other business partner numbers included E2007-00705. Additional information is not expected.

VAERS ID:274840 (history)  Vaccinated:2007-02-05
Age:49.0  Onset:2007-02-14, Days after vaccination: 9
Gender:Female  Submitted:2007-03-26, Days after onset: 39
Location:Foreign  Entered:2007-03-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Potassium iodide
Current Illness: UNK
Preexisting Conditions: Hypothyroidism
Diagnostic Lab Data: UNK
CDC Split Type: D0052574A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB075AH SCLA
Administered by: Other     Purchased by: Other
Symptoms: Burning sensation, Circulatory collapse, Headache, Paraesthesia, Visual disturbance
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (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), Guillain-Barre syndrome (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a pharmacist and described the occurrence of collapse episodes in a 49-year-old female subject who was vaccinated with Twinrix adult, injection for prophylaxis. Follow-up information was received from a physician. Concurrent medications included Thyrojod for hypothyroidism. The subject was smoking 15 cigarettes per day since 30 years and was drinking alcohol occasionally. On 5 February 2007 the subject received 1st dose of Twinrix adult (subcutaneously into the left upper arm). On 14 February 2007, 9 days after vaccination with Twinrix adult, the subject experienced collapse episodes after everything went black (black spots in front of eye) as well as paresthesia in extremities with pins and needles in left arm and hand and severe headache. On 17 February 2007 the subject experienced pins and needle in both hands, both legs and face (paresthesia in extremities). On 20 February 2007 all the events were resolved. After the next vaccination with Twinrix adult the events recurred. On 27 February 2007 the subject received 2nd dose of Twinrix adult (subcutaneously into the right arm). On 28 February 2007, 1 day after vaccination with Twinrix adult, the subject experienced collapse episodes after everything went black (black spots in front of eye) which was less intense than after 1st vaccination as well as paresthesia in extremities with pins and needle in hands, legs and face. Additional she had a burning sensation (like electric shocks). On 10 March 2007, the events were resolved. The subject went to a neurologist for investigation but according to her there were no pathologic findings. The subject received no treatment. This case was assessed as medically serious. The physician considered paresthesia in extremities and collapse episode were probably related to vaccination with Twinrix adult.

VAERS ID:275435 (history)  Vaccinated:2007-02-08
Age:49.0  Onset:2007-02-09, Days after vaccination: 1
Gender:Female  Submitted:2007-04-02, Days after onset: 51
Location:Foreign  Entered:2007-04-02
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: Unknown
CDC Split Type: B0464143A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB070AE  UN
Administered by: Other     Purchased by: Other
Symptoms: Influenza like illness
SMQs:
Write-up: This case was reported by a regulatory authority and described the occurrence of influenza-like symptoms in a 49-year-old female subject who was vaccinated with Twinrix adult for prophylaxis. The subject had no concomitant medication. On 8 February 2007, the subject received unspecified dose of Twinrix adult (unknown injection site and route). On 9 February 2007, 1 day after vaccination with Twinrix adult, the subject experienced influenza-like symptoms. It was not specified if the subject received a treatment. The regulatory authority reported that the event was clinically significant (or requiring intervention). At the time of reporting the event was resolved.

VAERS ID:276318 (history)  Vaccinated:2007-03-16
Age:49.0  Onset:2007-03-16, Days after vaccination: 0
Gender:Female  Submitted:2007-04-13, Days after onset: 28
Location:Foreign  Entered:2007-04-16, 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: NUCODYNE Sep06 - Unk, NUCOSOLVAN Oct03 - Unk, PULMICORT 01Oct03 - Unk, SEREVENT Oct06 - Unk
Current Illness: Bronchitis asthmatic
Preexisting Conditions:
Diagnostic Lab Data: body temp 16Mar07 39 C, body temp 17Mar07 37 C, eosinophil count 31Mar07 9.4
CDC Split Type: WAES0704USA01052
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Eosinophil count increased, Erythema, Eye swelling, Ocular hyperaemia, Oedema peripheral, Pyrexia, Swelling face
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 49 year old female with bronchial asthma who on 16-MAR-2007 was vaccinated SC into the left upper limb with a 0.5ml dos of Pneumovax. Concomitant therapy included THEOLONG, MUCOSOLVAN, PULMICORT, montelukast sodium, SEREVENT AND MUCODYNE. On 16-MAR-2007 the patient experienced pyrexia of 39 degrees C at night and swelling of the upper limb that resolved in several days. On 17-MAR-2007 the patient''s body temperature was 37 degrees C (normal) and the swelling of the face was remarkable around the eyes with redness. On 18-MAR-2007, the patient''s body temperature was in normal range. There was no improvement in the swelling of her face. On 31-MAR-2007, the patient was seen by her physician. The patient was slightly recovering from the swelling in her face, however, the redness around her eyes persisted. Blood tests revealed a high eosinophil level of 9.4. The result of the IgE test was pending. There was no abnormal findings in other lab valves. At the time of this report, the patient was monitored with ALLELOCK 10 mg. The physician considered that swelling face was an other important medical event. The reporter felt that swelling face and swelling of upper limb were related to therapy with Pneumovax. Additional information has been requested.

VAERS ID:277409 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:2007-03-08
Gender:Female  Submitted:2007-04-25, Days after onset: 47
Location:Foreign  Entered:2007-04-26, 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: Unknown
Preexisting Conditions: ADIPOSITAS, DIABETES MELLITUS
Diagnostic Lab Data: UNK
CDC Split Type: D0053007A
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)AVENTIS PASTEUR  IMUN
TD: TD ADSORBED (TD-RIX)SMITHKLINE BEECHAMAC12B017AC IMUN
Administered by: Other     Purchased by: Other
Symptoms: Hypertension, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypertension (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of hypertension episode in 49-year-old female subject who was vaccinated with Td-RIX for prophylaxis. Concurrent medical conditions included adipositas and diabetes mellitus. Co-suspect vaccination included inactivated IPV. On unspecified dates the subject received an unspecified dose of Td-RIX (0.5 ml, intramuscular, unknown site) and an unspecified dose of IPV (0.5 ml, intramuscular, unknown site). At unspecified periods of time post vaccination with Td-RIX and IPV, on 08 March 2007, the subject experience hypertensive episode, fever and feeling unwell. The subject was hospitalised for an unknown period of time. At the time of reporting the outcome of the events was unspecified. No further information will be available.

VAERS ID:278483 (history)  Vaccinated:2007-04-16
Age:49.0  Onset:2007-04-16, Days after vaccination: 0
Gender:Male  Submitted:2007-05-10, Days after onset: 24
Location:Foreign  Entered:2007-05-14, Days after submission: 4
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: None reported.
Diagnostic Lab Data:
CDC Split Type: E200702828
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ1008 IM 
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURZ1008 IM 
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Chills, Hallucination, Hyperhidrosis
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was initially reported on 03-Mar-2007. ADR 20117063. This case concerns a 49 year old male patient. The patient received DT-IPV, Revaxis, batch number Z1008-1, and Twinrix, batch number AHABB062BC, on 06-Mar-2007, and Typhim VI, Z0982 and Twinrix, batch number AHABB065BB, on 16-Apr-2007. On 16-Apr-2007, 3-4 hours post Typhim and the second dose of Twinrix, and six weeks post Revaxis and the first dose of Twinrix, the patient experienced hallucinations, rigors, sweating and central abdominal pain. At the time of reporting the patient was recovering. Both the reporter and the agency considered the case to be serious.

VAERS ID:280228 (history)  Vaccinated:2006-10-16
Age:49.0  Onset:2006-10-16, Days after vaccination: 0
Gender:Female  Submitted:2007-06-04, Days after onset: 231
Location:Foreign  Entered:2007-06-04
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: B0473430A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA198AC SC 
Administered by: Other     Purchased by: Other
Symptoms: Eye swelling, Lip swelling, Pharyngeal oedema, Rash generalised, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of rash all over in a 49-year-old female subject who was vaccinated with Fluarix for prophylaxis. On 16 October 2006 the subject received unspecified dose of Fluarix (0.5 ml, subcutaneous, batch number AFLUA198AC). Later that same day, 16 October 2006, after vaccination with Fluarix, the subject experienced rash all over. The following day she experienced eye swelling, swelling of face, lip swelling and throat swelling. The regulatory authority reported that the events were life threatening and clinically significant (or requiring intervention). The subject was treated with antihistamine (unspecified). At the time of reporting the events were improved.

VAERS ID:285506 (history)  Vaccinated:2007-04-16
Age:49.0  Onset:2007-06-07, Days after vaccination: 52
Gender:Female  Submitted:2007-07-20, Days after onset: 43
Location:Foreign  Entered:2007-07-23, 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: None
Diagnostic Lab Data:
CDC Split Type: E200704445
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB078AC IMGM
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURZ048950IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Myelitis transverse
SMQs:, Demyelination (narrow)
Write-up: It was reported that nearly 50-year-old female patient was vaccinated into the deltoid muscle (side not reported) with a first dose of Typhim VI (lot no. Z0489-5) and concomitantly with a first dose of Twinrix (lot-no. AHABB078AC) on 16-Apr-07. About 7 weeks later on 07-Jun-07 at the age of 50-years suspicion of transverse myelitis (thoracic spine) was diagnosed. At the time of reporting just neurological examination was done (findings not given). MRI and EEG were planned. At the time of reporting the patient had not recovered. Transverse myelitis is unlisted event with typhoid vaccine, and the time to onset appears to be too long for causal role of the vaccine. It is to be noted that the diagnosis was not definitely established. In addition, infectious etiology cannot be ruled out based on available information.

VAERS ID:286447 (history)  Vaccinated:1994-01-01
Age:49.0  Onset:1994-01-01, Days after vaccination: 0
Gender:Female  Submitted:2007-08-01, Days after onset: 4959
Location:Foreign  Entered:2007-08-01
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: Anti-HBs antibody 19May2007 477, Complete blood count Mar1999 normal, Lumbar puncture Mar1999 normal, MRI brain May1999 Abnormal, In May 1999: Brain MRI evidenced several diffuse hypersignals of the white matter. Evoked potentials were foun
CDC Split Type: B0480689A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anti-HBs antibody positive, Cauda equina syndrome, Full blood count normal, Immediate post-injection reaction, Lumbar puncture normal, Multiple sclerosis, Muscle disorder, Nervous system disorder, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Somatosensory evoked potentials, Visual evoked potentials abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Liver infections (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by the regulatory authority and described the occurrence of multiple sclerosis in a 49-year-old female subject who was vaccinated with Hepatitis B vaccine, GlaxoSmithKline for prophylaxis. The subject belongs to the association under reference 2148. In 1994, reported as immediately after the vaccination (brandname and date not known), the subject experienced neurologic syndrome evoking a medullar suffering at T6. A possible multiple sclerosis was evoked. In March 1999, the subject developed paresthesia at the lower limbs and sphincter. A cauda equina syndrome was evoked. Biological tests and lumbar puncture were normal. In May 1999, brain MRI evidenced several diffuse hypersignals of the white matter. Somatosensory evoked potentials were found abnormal at the lower limbs. A multiple sclerosis was diagnosed. The subject were found abnormal at the lower limbs. A multiple sclerosis was diagnosed. The subject was treated with three infusions of methylprednisolone sodium succinate (Solumedrol) and then with prednisone (Cortancyl). Then, physical state improved. On 31 May 1999, anti-HBS antibody was at 477. At the time of reporting the events were unresolved. According to the intrinsic imputability, the events were dubiously related with Hepatitis B vaccine.

VAERS ID:288653 (history)  Vaccinated:1992-11-02
Age:49.0  Onset:2007-03-12, Days after vaccination: 5243
Gender:Female  Submitted:2007-08-22, Days after onset: 163
Location:Foreign  Entered:2007-08-22
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: Biopsy muscle 12Mar2007 Abnormal Investigations: The biopsy of the muscle revealed florid histological lesions of macrophagic myofascitis associated with presence of lymphocytes.
CDC Split Type: B0483696A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  IMRA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Asthenia, Back pain, Biopsy muscle abnormal, Dysstasia, Fatigue, Lymphocyte count, Myalgia, Myofascitis, Pain, Skin burning sensation
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: This case was reported by the regulatory authority and described the occurrence of macrophagic myofascitis in a 49-year-old female subject who was vaccinated with Engerix B, GlaxoSmithKline for prophylaxis. Co-suspect vaccination included Genhevac B, Sanofi Pasteur MSD) received on 23 November 1993. Concurrent vaccination included hepatitis B vaccine recombinant (Genhevac B, Sanofi Pasteur MSD) received on 08 September 1992 and 07 January 1993, inactivated poliomyelitis virus vaccine and tetanus toxoid (TP vaccine, manufacturer unknown) received between 1993 and 2003 and tetanus and diphtheria toxoids absorbed and inactivated poliomyelitis virus vaccine (DRP vaccine, manufacturer unknown) received between 1993 and 2003. The subject belongs to the EMM association under reference 246. On 08 September 1992, the subject received first dose of Genhevac B (intramuscular). On 02 November 1992, the subject received second dose of Engerix B (batch number not available, intramuscular). On 07 January 1993, the subject received third dose of Genhevac B (intramuscular). On 23 November 1993, the subject received fourth dose of Genhevac B (intramuscular). Between 1993 and 2003, the subject received DTP vaccine and TP vaccine. On an unspecified date after vaccination with Engerix B, the subject experienced intense asthenia with exhaustion, burning sensation skin, pain localized in level of thighs, knees, pelvis, shoulders, wrists and jawbones that required placement of splint, difficulty standing and she felt like her back was broken. On 12 March 2007, muscle biopsy was performed and revealed florid histological lesions of macrophagic myofascitis associated with presence of lymphocytes. The AFSSaPS reported that the events were disabling. At the time of reporting, the outcome of the events was unresolved. The AFSSaPS considered the events as unlikely related to vaccination with Engerix B and/or Genhevac B according to the method of imputability.

VAERS ID:289843 (history)  Vaccinated:2007-08-06
Age:49.0  Onset:2007-08-06, Days after vaccination: 0
Gender:Female  Submitted:2007-09-05, Days after onset: 30
Location:Foreign  Entered:2007-09-05
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Valerian root
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0485021A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALSAC12B015DA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site inflammation, Injection site oedema, Injection site pain, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of injection site inflammation in a 49-year-old female subject who was vaccinated with Ditanrix adult, GlaxoSmithKline for prophylaxis. The subject''s concurrent medication included valerian extract for insomnia. There was unknown prior drug reaction. On 6 August 2007 the subject received unspecified dose of Ditanrix adult (intramuscular). On 6 August 2007, within hours of vaccination with Ditanrix adult, the subject had exuberant inflammatory reaction with edema at injection site til the elbow. The subject presented also injection site warmth, injection site redness, injection site pain which lasted a few days. She developed fever for two days. The regulatory authority reported that the events were disabling (as the subject could not led her diary activities) and clinically significant (or requiring intervention). The subject was treated with ice, antipyretic and non-steroidal anti-inflammatory (Non steroids anti-inflammatory). At the time of reporting the events were resolved.

VAERS ID:293742 (history)  Vaccinated:2007-10-02
Age:49.0  Onset:2007-10-02, Days after vaccination: 0
Gender:Female  Submitted:2007-10-18, Days after onset: 16
Location:Foreign  Entered:2007-10-19, 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: Injection site swelling
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA03181
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERB0500 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC. 1UNRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Headache, Injection site swelling, Malaise, Oedema peripheral, Paraesthesia
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received from a physician concerning a 49 year old female who on 02-OCT-2007 was vaccinated with the second dose of Pneumovax 23, injection (form) into the right arm. Concomitant therapy included a dose of Flu-Vaccinol (Grippe-Impfstoff Stada, STADA, lot #B0500-1) into the left upper arm. The first vaccination with Pneumopur on 17-DEC-2002 was well tolerated, there was only a slight injection site swelling. On 02-OCT-2007, that same day at 2:30 pm, the patient experienced swelling of the whole right arm down to the wrist. She also complained about paraesthesia in the right hand and fingers. Additionally, the patient developed cephalgia and slightly increased body temperature (37.5C) and felt sick. The patient went to the emergency room and received antibiotic treatment with amoxicillin and topic anti-inflammatory treatment. Subsequently as of 08-OCT-2007, the patient present to the physicians office and had recovered from all of the symptoms. The case is closed. Swelling of the whole right arm down to the wrist, paraesthesia in the right hand and fingers, cephalgia, slightly increased body temperature (37.5C) and felt sick were considered to be other important medical events. Other business partner numbers included E2007-06694. Additional information is not expected.

VAERS ID:294145 (history)  Vaccinated:2007-07-12
Age:49.0  Onset:2007-09-01, Days after vaccination: 51
Gender:Male  Submitted:2007-10-23, Days after onset: 52
Location:Foreign  Entered:2007-10-23
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: Roxithromycin
Current Illness: Unknown
Preexisting Conditions: The subject had no relevant past medical and surgical history, no allergy, and took no concurrent medication. He ate seafood all the year.
Diagnostic Lab Data: Alanine aminotransferase 01Sep2007 10N; Alanine aminotransferase 07Sep2007 50N; Alkaline phosphatase 01Sep2007 Normal; Alkaline phosphatase 07Sep2007 5N; Aspartate aminotransferase 01Sep2007 10N; Aspartate aminotransferase 07Sep2007 30N; Bi
CDC Split Type: B0491235A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Bilirubin conjugated increased, Blood alkaline phosphatase increased, Blood alkaline phosphatase normal, Body temperature increased, Chills, Gamma-glutamyltransferase increased, Headache, Hepatitis A, Hepatitis A antibody negative, Hepatitis A antibody positive, Hepatocellular damage, Hyperhidrosis, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Liver infections (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (narrow), Eosinophilic pneumonia (broad)
Write-up: This case was reported by a foreign regulatory authority and described the occurrence of acute hepatitis A in a 50-year-old male subject who was vaccinated with Havrix 1440 for prophylaxis. The subject had no relevant past medical history and surgical history, no allergy and took no concurrent medication. He ate seafood all the year. Concurrent medication included Rulid. On 12 July 2007, the subject received a dose of Havrix 1440 (intramuscular, batch number not available). On 01 September 2007, 51 days after vaccination, the subject presented with fever at 40 degrees Celsius, shiver, sweating, myalgia and headache. The subject was hospitalised. Hepatic check up revealed hepatocellular injury with ASAT and ALAT at 10N. Gamma-GT and alkaline phosphatase were normal. Hepatitis A virus serology was negative. Due to a suspected atypic pneumopathy, the subject was treated with Rulid at 300 mg daily. Within several days, fever resolved. On 07 September 2007, hepatic check up showed an aggravation with ASAT at 30N, ALAT at 50N, Gamma-GT at 10N, alkaline phosphatase at 5N and an increase of total and conjugated bilirubin. On 13 September 2007, IgM and IgG were positive to hepatitis A virus. Diagnosis of acute hepatitis A was made (possible lack of efficacy). On 16 September 2007, treatment with Rulid was discontinued. At the time of reporting, hepatitis A was unresolved. Outcome of pneumopathy was unknown. The agency considered that hepatitis A was dubiously related to vaccination with Havrix. Causality relationship was not assessed for pneumopathy. This case has been closed; no more information will be available.

VAERS ID:294987 (history)  Vaccinated:2007-06-04
Age:49.0  Onset:2007-06-04, Days after vaccination: 0
Gender:Female  Submitted:2007-10-30, Days after onset: 148
Location:Foreign  Entered:2007-10-31, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710AUS00258
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.NID125 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site swelling, Lower respiratory tract infection
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Information has been received on request by the Company from the agency via a Public Case Detail form and a Case Line Listing concerning a 49 year old female who on 04-JUN-2007 was vaccinated with Pneumovax 23 (reported batch number as "NID125, exp 04/02/08" is not valid). In June 2007, the patient experienced injection site reaction (described as swelling developed at site of immunisation) and lower respiratory tract infection (described as respiratory symptoms) and was hospitalised. The patient was treated with roxithromycin. At the time of reporting on 18-JUN-2007, the patient had recovered from injection site swelling and lower respiratory tract infection. The agency considered that injection site swelling and lower respiratory tract infection were certainly related to therapy with Pneumovax 23. The original reporting source was not provided. Additional information is not expected.

VAERS ID:303343 (history)  Vaccinated:2006-02-15
Age:49.0  Onset:2006-06-20, Days after vaccination: 125
Gender:Male  Submitted:2008-01-23, Days after onset: 582
Location:Foreign  Entered:2008-01-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Nuclear magnetic resonance imaging Jan2007 normal
CDC Split Type: B0503744A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSATYAB005AB UNUN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURERATYAB005AB UNUN
Administered by: Other     Purchased by: Other
Symptoms: Facial palsy, Facial paresis, Hypoaesthesia facial, Nuclear magnetic resonance imaging normal
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: This case was reported by a healthcare professional and described the occurrence of facial numbness in a 50-year-old male subject who was vaccinated with Hepatyrix (GlaxoSmithKline) for prophylaxis. Concurrent vaccination included yellow fever vaccine, manufacturer unspecified, given on 19 February 2006. Concurrent medications included an unspecified statin. On 15 February 2006 the subject received unspecified dose of Hepatyrix (1 injection). On 20 June 2006, 4 months after vaccination with Hepatyrix, the subject experienced facial numbness, Bell''s palsy and facial weakness. This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved. Verbatim text received: On th 16th of January 2008 a nurse reported that a patient received Hepatyrix on the 15th of February 2006. On the 19th of February 2006 the patient received a yellow fever vaccine at another surgery. On the 20th of June 2006 the patient experienced facial numbness, this was diagnosed as Bell''s palsy on the 26th of July 2006. In January 2007 the patient had an MRI scan and it returned clear, there was no evidence of a stroke. The nurse stated that the patient''s facial weakness has now gone, and is fine.

VAERS ID:304151 (history)  Vaccinated:2007-12-13
Age:49.0  Onset:2007-12-13, Days after vaccination: 0
Gender:Female  Submitted:2008-01-31, Days after onset: 49
Location:Foreign  Entered:2008-02-01, 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:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: A0706120A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Chest discomfort, Dizziness, Loss of consciousness, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a healthcare professional via a representative and described the occurrence of loss of consciousness in a 49-year-old female subject who was vaccinated with Twinrix for prophylaxis. On 13 December 2007 the subject received 1st dose of Twinrix (unknown). On 13 December 2007, 20 to 30 minutes after vaccination with Twinrix, when the subject was already out of the medical office, the subject lost consciousness, and felt like there was fluid in her heart. Two weeks post vaccination, the subject experienced dizziness and her head was spinning. It was reported that afterwards, she was Ok. This case was assessed as medically serious. At the time of reporting the exact outcome of the events was not specified.

VAERS ID:304541 (history)  Vaccinated:2007-12-13
Age:49.0  Onset:2007-12-13, Days after vaccination: 0
Gender:Female  Submitted:2008-02-07, Days after onset: 56
Location:Foreign  Entered:2008-02-07
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: trimethoprim
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0506007A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB082ED2IMLA
Administered by: Other     Purchased by: Other
Symptoms: Musculoskeletal pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad)
Write-up: This case was reported by a regulatory authority via a physician and described the occurrence of arm pain in a 49-year-old female subject who was vaccinated with Twinrix adult (GlaxoSmithKline) for prophylaxis. Previous vaccination included the 1st dose of Twinrix (GlaxoSmithKline; intramuscular, unknown) given on 18 June 2006. Concurrent medication included Monotrim. On 13 December 2007, the subject received the 3rd dose of Twinrix adult (intramuscular, unknown). On 13 December 2007, less than one day after vaccination with the 3rd dose of Twinrix adult, the subject experienced pain in the arm and shoulder. the regulatory authority reported that the events were disabling. At the time of reporting the events were unresolved.

VAERS ID:304981 (history)  Vaccinated:2007-11-20
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:Foreign  Entered:2008-02-14
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: A0709441A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA020A1 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Chills, Delirium, Myalgia, Pyrexia, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad)
Write-up: This case was reported by a nurse, via a regulatory authority and described the occurrence of delirium in a 49-year-old female subject who was vaccinated with Fluviral, GlaxoSmithKline for prophylaxis. On 20 November 2007, the subject received an unspecified dose of Fluviral (unknown). Six hours after vaccination with Fluviral, the subject experienced rigors, fever, myalgia and tachycardia. At an unspecified time after vaccination with Fluviral, the subject experienced delirium. This case was assessed as medically serious by GSK. At the time of reporting, the events were resolved with sequelae.

VAERS ID:308822 (history)  Vaccinated:2004-06-21
Age:49.0  Onset:2004-06-21, Days after vaccination: 0
Gender:Male  Submitted:2008-04-02, Days after onset: 1381
Location:Foreign  Entered:2008-04-03, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 2008-03-13
   Days after onset: 1361
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: bone marrow biopsy 21Jul04 rare auto immune illness; peripheral hematopoietic stem cell ??Aug06 alpha beta hepatosplenic t-cell lymphoma was diagnosed; splenectomy 10 x normal size; body weight measurement 01Dec06 16 stone; body weight meas
CDC Split Type: WAES0803USA04707
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alopecia, Autoimmune disorder, Biopsy bone marrow abnormal, Blood stem cell transplant failure, Body temperature increased, Chemotherapy, Death, Hepatosplenic T-cell lymphoma, Influenza like illness, Laboratory test abnormal, Limb discomfort, No reaction on previous exposure to drug, Sensory loss, Splenectomy, Splenomegaly, Stem cell transplant, Syncope, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Malignant tumours (narrow), Hypotonic-hyporesponsive episode (broad), Malignant lymphomas (narrow)
Write-up: Information has been received from a physician concerning a case that was initially reported in a foreign newspaper article on 25 MAR 2008, concerning a 49 year old male who on 21-Jun-2004 was vaccinated with a third dose of Recombivax HB (manufacturer unknown) (batch number not reported). The patient had received the first dose of Recombivax HB (manufacturer unknown) on 25-MAY-2004 and a second dose of Recombivax HB (manufacturer unknown) on an unreported date, as part of a rapid dose schedule, with no adverse events reported. Following the third dose of Recombivax HB (manufacturer unknown) (the exact time to onset not reported) the patient reported knowing that his arm did not feel right. Within five days of the vaccination, the patient displayed a temperature, flu-like symptoms and within ten days was in the hospital. On 21 JUL 2004, one month post vaccination, the collapsed in his garden. The patient managed to drive himself to the local "doctor''s surgery" where he was referred to the "local causality department". Numerous tests were performed including a bone marrow removal, and a very rare auto immune illness was confirmed. The patient''s condition failed to improve. The patient''s spleen enlarged up to ten times the normal size and was subsequently removed. The nerves in the abdomen were severed in order to remove the spleen, which resulted in some loss of feeling in some parts of the body. A stem cell transplant was performed after alpha beta hepatosplenic t-cell lymphoma was diagnosed in August 2006. The stem cell transplant failed, and the patient received a course of rarely used chemotherapy (unspecified), which was very severe. The patient''s weight reduced from 16 stone to 11.5 stone between Christmas 2006 to March 2007. The patient lost his hair, regained it, and lot it again (time internal unspecified). The patient subsequently died on 13 MAR 2008. Additional information is expected.

VAERS ID:320423 (history)  Vaccinated:2007-09-24
Age:49.0  Onset:2007-10-01, Days after vaccination: 7
Gender:Female  Submitted:2008-07-25, Days after onset: 298
Location:Foreign  Entered:2008-07-25
Life Threatening? No
Died? Yes
   Date died: 2007-10-24
   Days after onset: 23
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: 1.Systemic Lupus Erythenmatosis (vs. Rheumatoid Arthritis)2. Chronic renal Insufficiency 3.Hypertension 4. s/p Cerebrovascular Accident-2003
Diagnostic Lab Data: See case summary sent to VAERS
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER050VFA121Z0SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Death
SMQs:
Write-up: See deatailed case summary sent to VAERS

VAERS ID:323068 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:2008-04-17
Gender:Unknown  Submitted:2008-08-22, Days after onset: 127
Location:Foreign  Entered:2008-08-22
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: Hepatitis B core antigen, 2008, positive; Hepatitis B e antigen, 2008, positive
CDC Split Type: D0058387A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hepatitis B, Hepatitis B core antigen positive, Hepatitis B e antigen positive, Therapeutic response decreased, Transaminases increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Liver infections (narrow), Lack of efficacy/effect (narrow)
Write-up: This case was reported by a physician and described the occurrence of hepatitis B in a 49-year-old subject of unspecified gender who was vaccinated with ENGERIX B ADULT, GlaxoSmithKline. From June 2007 on, the subject received primary course of ENGERIX B ADULT (unknown route and injection site) in correct time scheme. Basic immunization was completed. On 17 April 2008, less than one year after vaccination with ENGERIX B ADULT, the subject was not responding to therapy (titer below 10). On 28 May 2008 the subject received booster dose of ENGERIX ADULT (unknown route and injection site). On 26 June 2008, 4 weeks after vaccination with ENGERIX B ADULT, therapeutic response was decreased (titer 18). Upon examination by the family physician very high transaminases were diagnosed and parameters for Hepatitis B were positive (Hbc and Hbs positive, possible vaccination failure). This case was assessed as medically serious by GSK. At the time of reporting the outcome of hepatitis B was unspecified. Further information has been requested.

VAERS ID:327719 (history)  Vaccinated:2005-07-20
Age:49.0  Onset:2005-08-01, Days after vaccination: 12
Gender:Female  Submitted:2008-10-08, Days after onset: 1164
Location:Foreign  Entered:2008-10-09, 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: Milk allergy; Fruit allergy; Hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0808USA00778
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  UNLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Cervical root pain, Feeling hot, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Arthritis (broad)
Write-up: Initial and follow-up information has been received from an occupational health physician concerning a nearly 49 year old female with milk allergy and citrus fruit allergy who on 20-JUL-2005, was vaccinated with a dose of RECOMBIVAX HB, thimerosal free, (lot #, route, not reported) into the left arm. 14 days post vaccination, the patient experienced feeling of warmth (hot and burning) in the sternum, cervical spine, shoulders and arms. In addition, she developed paresthesia and arthralgia (not otherwise specified). The patient presented to several physicians except for a neurologist. The symptoms lasted for several months and the patient recovered. Follow-up information has been received from the occupational health physician. The patient''s history also included an allergy to panthenol and x-ray developer. The patients symptoms started about 14 days post vaccination and also included arthralgia of the hip and cervicobrachialgia which lasted for several days. No mention about previously reported symptoms and duration were in the reporting form. The patient was examined by a rheumatologist on an unknown date who didn''t find any infectious focus (no laboratory findings were provided). The rheumatologist assessed the relation to the vaccine as probably. The reporter considered the feeling of warmth, arthralgia, cervicobracgialgia, and paresthesia to be other important medical events. Other business partner numbers include E2008-07327. No further information was available. The case was closed.

VAERS ID:329057 (history)  Vaccinated:2008-01-23
Age:49.0  Onset:2008-01-24, Days after vaccination: 1
Gender:Female  Submitted:2008-10-17, Days after onset: 266
Location:Foreign  Entered:2008-10-17
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: UNK
CDC Split Type: B0541838A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB098BD IMLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site pain, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority (foreign Regulatory Authority # 28.895/0-18/09/08) and described the occurrence of musculoskeletal pain in a 49-year-old female subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). On 23 January 2008, the subject received unspecified dose of TWINRIX adult (intramuscular, left deltoid). On 24 January 2008, 1 day after vaccination with TWINRIX adult, the subject experienced injection site pain and musculoskeletal pain with pain and pressure in the left shoulder when moving. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved.

VAERS ID:332464 (history)  Vaccinated:2008-11-04
Age:49.0  Onset:0000-00-00
Gender:Male  Submitted:2008-11-14
Location:Foreign  Entered:2008-11-14
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: Subject reported that all vital signs "blood pressure, sugar, etc." were "OK". Subject reported that the Computerized Axial Tomography scan was "fine".
CDC Split Type: A0755324A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram normal, Dizziness, Nasopharyngitis, Nausea, Rash, Rash macular, Vertigo, Vital capacity normal, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a consumer and described the occurrence of nonspecific reaction in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date, the subject received unspecified dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced a "very bad reaction". At the time of reporting the outcome of the event was unspecified. Follow-up was received on 11 November 2008, from the consumer. A physician or other health care professional has not verified this report. The subject was on a rapid schedule. On 29 October 2008, the subject received 1st dose of TWINRIX. Subject was "OK" for five days. Then he experienced symptoms of a cold, vertigo, dizziness and nausea. The subject saw his physician and reported that all "vital signs (blood pressure, sugar, etc.)" were OK. Subject went to the hospital and was hospitalized for six hours. Subject was "hooked up" to an intravenous line and treated with intravenous anti-nausea medication. He was then released from the hospital and felt better. On 4 November 2008, the subject received 2nd dose of TWINRIX. Two hours after vaccination with TWINRIX, the subject had severe nausea, severe vertigo, vomiting, rash, blotchy face. He was bedridden for the next five days. The subject went to the emergency on "Sunday". More tests were done and all were "fine". Subject reported that a Computerized Axial Tomography scan was done and was "fine". The subject was discharged from the emergency and felt better. He was "released" and slowly started to feel better. But he was still not "100%". At the time of reporting, dizziness was still present. The subject will not take the "third dose".

VAERS ID:333619 (history)  Vaccinated:2008-11-03
Age:49.0  Onset:2008-11-04, Days after vaccination: 1
Gender:Female  Submitted:2008-12-01, Days after onset: 27
Location:Foreign  Entered:2008-12-02, 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: Begrivac
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0811USA03774
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0976U IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Agitation, Arthralgia, Diarrhoea, Injection site erythema, Injection site induration, Injection site swelling, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a Health Authority concerning a 49 year old female patient. The patient had no relevant medical history. The patient also received BEGRIVAC, batch number not reported on an unknown date but reported as concomitant medication by health authority. On 03-NOV-2008, the patient received a PNEUMOVAX 23, lot # 659086/0976U, batch number NG34060, intramuscularly, site not reported. On 04-NOV-2008, one day post immunisation, the patient experienced agitation, arthralgia, diarrhoea, malaise, pyrexia and injection site erythema, injection induration and injection site swelling. The patient did not receive any treatment and recovered with out sequelae. Both the reporter and the health authority considered this to be a serious reaction. No more information available, this case is closed. Other business partner number included E2008-10819 and health authority 041026.

VAERS ID:335794 (history)  Vaccinated:2008-09-20
Age:49.0  Onset:2008-10-26, Days after vaccination: 36
Gender:Male  Submitted:2008-12-22, Days after onset: 57
Location:Foreign  Entered:2008-12-19, Days after submission: 3
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: MA20083143
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABIPUR)NOVARTIS VACCINES AND DIAGNOSTICS442011A2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Computerised tomogram normal, Diplopia, Electrocardiogram normal, Nuclear magnetic resonance imaging normal, Paraesthesia, Transient ischaemic attack
SMQs:, Peripheral neuropathy (broad), Ischaemic cerebrovascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Guillain-Barre syndrome (broad), Ocular motility disorders (broad)
Write-up: We received the following information from another pharmaceutical company on 10 DEC 2008: A 49-year-old patient, born on 27 OCT 1958, was vaccinated with 1 ml RABIPUR (batch no. 442011A) into the upper arm on 20 SEP 2008, 27 SEP 2008 and 11 OCT 2008. The patient was hospitalised from 26 OCT 2008 till 30 OCT 2008. Upon admission the patient suffered from right sided tingling paraesthesia on lower leg and thigh, arm and cheek and double vision. No other pathological findings. ECG showed negative T-waves in aVR and V1. Long-term ECG presented no pathological findings. Cranial MRI was unremarkable. CCT showed no hint for intracranial bleeding. No masses, no signs for ischemia or early signs of ischemia. Doppler examination of carotides was unremarkable. The patient was hospitalised due to right sided paraesthesia of extremities and visual disturbances. Based on the history and the diagnostic findings the suspicion of transient ischaemic attack (TIA) was made. Treatment with ACETYSALICYLIC ACID was prescribed. On 30 OCT 2008 the patient was discharged free of complaints. Company assessment: Seriousness criterion: hospitalisation. Causality: not related. The strict right-sided localisation of the symptoms support the diagnosis of TIA. In addition, the onset interval of 3 to 4 weeks after vaccination is not typical for respective side effects after RABIPUR vaccination. Expecteness assessment according to SPC: TIA is unexpected after vaccination with RABIPUR. No change in benefit-risk-ratio. No measures necessary.

VAERS ID:337924 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:0000-00-00
Gender:Male  Submitted:0000-00-00
Location:Foreign  Entered:2008-12-19
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: 200813435
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED100059429 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Report received from a non-health professional reporter on 02-MAY-2008. A 49-year-old male patient received FLUVAX (batch number B090621602, expiry: 01/09) for influenza immunization on 30-APR-2008. On approximately 02-MAY-2008, the patient developed a red, hard lump at the injection site (1-2 inches in diameter). It is not known whether the patient received any treatment for the reaction. At the time of reporting, the reaction was ongoing.

VAERS ID:336470 (history)  Vaccinated:2007-01-25
Age:49.0  Onset:0000-00-00
Gender:Unknown  Submitted:2009-01-05
Location:Foreign  Entered:2009-01-05
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: D0060019A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB091AF IMLA
Administered by: Other     Purchased by: Other
Symptoms: Hepatic enzyme increased
SMQs:, Liver related investigations, signs and symptoms (narrow)
Write-up: This case was reported by a regulatory authority (foreign Regulatory Authority (vaccines, biologicals) # DE-PEI-PEI2008020081) and described the occurrence of increased liver enzymes in an approximately 50-year-old subject of unspecified gender who was vaccinated with HAVRIX 1440 (GlaxoSmithKline). On 25 January 2007 the subject received a dose of HAVRIX 1440 (intramuscular, left deltoid). At an unspecified time after vaccination with HAVRIX 1440 the subject''s liver enzymes were noticed to be "continuously" increased. At the time of reporting the outcome of the event was unspecified. This case was assessed as medically serious by GSK.

VAERS ID:339179 (history)  Vaccinated:2009-01-29
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2009-02-06
Location:Foreign  Entered:2009-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PERCOCET; Nortriptyline; Duloxetine; Lorazepam; Sodium rabeprasole; Salbutamol sulphate
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: A0766186A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a pharmacist and described the occurrence of diarrhea in a 49-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medications included PERCOCET, Nortriptyline, CYMBALTA, Lorazepam, PARIET, and SALBUTAMOL. On 29 January 2009 the subject received 1st dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced bad diarrhea for the past couple days, the subject thinks that she might have had a stomach flu. The reporting pharmacist was not sure if the events were due to vaccine or if the subject had a viral infection or a stomach flu. Pharmacist said that no hospitalization was required and that the subject was feeling better now. This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved.

VAERS ID:339481 (history)  Vaccinated:1996-06-19
Age:49.0  Onset:1996-09-01, Days after vaccination: 74
Gender:Male  Submitted:2009-02-11, Days after onset: 4546
Location:Foreign  Entered:2009-02-11
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, 12Dec2000, see lab text. On 12 December 2000, left deltoid biopsy showed histological architecture within normal limits without myocyte abnormality. There was little focal inflammatory infiltrate in epimysial sheath with la
CDC Split Type: B0530897A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS2034E61IMLA
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Asthenia, Biopsy muscle normal, Dizziness, Headache, Inflammation, Lymphocyte count, Memory impairment, Myalgia, Myofascitis, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (narrow)
Write-up: This case was reported by a physician of a foreign regulatory authority, via another manufacturer, and described the occurrence of asthenia in a 49-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject belongs to an association under reference number 262. Co-suspect vaccination included tetanus toxoid and poliomyelitis virus vaccine (manufacturer unknown). On 24 May and 07 July 1995, the subject received two doses of tetanus toxoid and poliomyelitis virus vaccine (batch number K5982 and L5103 respectively). On 22 May and 19 June 1996, he received two doses of ENGERIX B, intramuscularly, in left arm (batch reference 1908C6 and 2034E6 respectively). In September 1996, approximately two months after vaccination with ENGERIX B, the subject complained of permanent and deep asthenia, muscle pain, abdominal pain, headache, vertigo and memory disorder (he reported that he could not memorise some words and names anymore). On 12 December 2000, left deltoid biopsy showed histological architecture within normal limits without myocyte abnormality. There was a little focal inflammatory infiltrate in epimysial sheath with large cytoplasm basophile macrophages associated with a few lymphocytes, evoking a macrophagic myofasciitis lesion. No inflammatory anomaly, no vasculitis, no mitochondrial dysfunction and no overload disease were noticed. Adipose Macrophagic myofasciitis diagnosis was then made in December 2000. In March and in April 1997, the subject received the third and the fourth dose of ENGERIX B, intramuscularly, in left arm. As he did not feel well after the two first doses, he reported that he did not want to receive another injection of ENGERIX B. But because "responsible people" insisted, he agreed to be vaccinated. At the time of reporting, the outcome of the events was unknown. The reporter''s causality assessment was provided. Follow-up information was received on 02 February 2009 from the agency (number PC20090011 and PC0900011). The agency confirmed that in 2000, the subject sti

VAERS ID:339820 (history)  Vaccinated:2008-11-28
Age:49.0  Onset:2008-11-30, Days after vaccination: 2
Gender:Female  Submitted:2009-02-17, Days after onset: 79
Location:Foreign  Entered:2009-02-18, 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
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0902AUS00019
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0353U1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration, Oropharyngeal pain, Radiotherapy, Tonsillar neoplasm
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Oropharyngeal neoplasms (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Tumours of unspecified malignancy (narrow)
Write-up: Information has been received from a health professional, via CSL as part of a business agreement (manufacturer control No. 2009 02 10 LS1), concerning a 49 year old female who on 28-NOV-2008 was vaccinated with her second dose of GARDASIL (Lot # 0353U, Batch # NH00870, Expiry date 22-FEB-2010). This was inappropriate schedule of drug administration due to the patient''s age of 49 years. On 30-NOV-2008, 2-3 days after the second vaccination with GARDASIL, the patient experienced a sore throat and two weeks later, a tonsillar tumour was diagnosed. Subsequently the tonsillar tumour was removed and at the time of reporting on 10-FEB-2009, the patient was undergoing radiation treatment. Upon internal medical review, tonsillar tumour was considered an other important medical event. Additional information has been requested.

VAERS ID:347716 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2009-05-26
Location:Foreign  Entered:2009-05-28, Days after submission: 2
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: venlafaxine HCL
Current Illness: Depression
Preexisting Conditions:
Diagnostic Lab Data: blood pressure measurement, 95/60 mmHg, at presentation; blood pressure measurement, 70 mmHg, systolic blood pressure 48 hours after admission; skin biopsy, culture from a small skin lesion - organism isolated was identified as S. pyogenes
CDC Split Type: WAES0905AUS00008
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Arthralgia, Arthritis reactive, Aspartate aminotransferase increased, Aspiration joint, Biopsy skin abnormal, Blood albumin decreased, Blood alkaline phosphatase increased, Blood bilirubin increased, Blood creatinine increased, Blood culture positive, Blood potassium normal, Blood sodium decreased, Blood urea increased, Bone scan normal, Carpal tunnel decompression, Confusional state, Culture negative, Gamma-glutamyltransferase increased, HLA marker study, Heart rate increased, Histology abnormal, Hypotension, Intensive care, Joint dislocation, Joint effusion, Joint swelling, Lethargy, Ligament rupture, Myalgia, Nerve compression, Neutrophil count increased, Oedema peripheral, Platelet count decreased, Polymerase chain reaction, Renal impairment, Synovectomy, Synovitis, Thrombocytopenia, Toxic shock syndrome streptococcal, Ultrasound scan normal, Viraemia, Viral DNA test positive, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Biliary system related investigations, signs and symptoms (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Skin tumours of unspecified malignancy (broad), Chronic kidney disease (broad), Arthritis (narrow), Tumour lysis syndrome (broad)
Write-up: Information has been received in a published article, concerning a 49 year old female hospital employee who received VARIVAX vaccination (manufacturer unknown), in accordance with the guidelines for varicella-seronegative health care workers. She presented 17 days after the second vaccine dose (38 days after the first dose) with a 21 day history of joint pain and swelling, predominantly affecting the upper limbs and knees, along with myalgia and lethargy. These symptoms had worsened over the preceding 48 hours. There were no noticeable skin lesions and no local reaction at the vaccination site. The patient''s past history was unremarkable except for depression treated with venlafaxine, the only medication she was taking at the time of admission. At presentation she was afebrile, with a blood pressure of 95/60 mmHg and pulse rate of 96 beats/min. The dominant clinical finding was gross peripheral oedema of the upper limbs including the hands. Initial investigation showed raised total white cell count of 13.1x10^9/L and neutrophil count of 12.1x10^9/L and abnormal liver function (bilirubin of 51 umol/L); concentration of alanine aminotransferase (ALT of 152 u/L; aspartate amino transferase (AST) of 112 U/L; gamma glutamyltransferase (GGT) of 112 U/L; alkaline phosphatase (ALT) of 308 U/L and albumin of 32 g/L). The possibility of varicella hepatitis complicating vaccination was considered. Forty eight hours after admission, the patient became confused and hypotensive, with a systolic blood pressure of 70 mmHg. Streptococcus pyogenes was isolated from blood cultures. Her blood pressure did not increase in response to intravenous resuscitation with normal saline (1 L) and colloid (2 L). She was transferred to the intensive care unit, where she received inotropic support with noradrenaline for 22 hours. She developed streptococcal toxic shock syndrome with renal impairment (concentration of sodium of 126 mmol/L; potassium of 4.3 mmol/L; urea of 23.4 mmol/L; creatinine of 195 umol/L; thrombocytopenia (platelet count of

VAERS ID:348562 (history)  Vaccinated:2009-05-14
Age:49.0  Onset:2009-05-26, Days after vaccination: 12
Gender:Male  Submitted:2009-06-04, Days after onset: 9
Location:Foreign  Entered:2009-06-05, 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: Inflammatory bowel disease, severe to moderate pancolitis, neutrophilic leucocytosis, high P-ANCA and C-ANCA titres.
Diagnostic Lab Data:
CDC Split Type: 2009020269
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Chest pain, Chondropathy, Costochondritis, Hyperhidrosis, Immobile, Injection site anaesthesia, Injection site pain, Mobility decreased, Myalgia, Pain, Paralysis, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Arthritis (broad)
Write-up: Report received from a consumer on 28-MAY-2009. A male patient received FLUVAX (batch unknown) on 14-MAY-2009. Medical history included inflammatory bowel disease, severe to moderate pancolitis, neutrophilic leucocytosis and has high P-ANCA and C-ANCA titres. The patient was not on any other medications and has received FLUVAX on multiple occasions previously with no side effects. At unknown time after receiving FLUVAX, the patient experienced initial pain for a couple of days at the injection site and numbness at the injection site. The pain/numbness was the size of the palm of a hand. On 26-MAY, 12 days after vaccination, the patient experienced chest pain which he labelled as costocondritis. The pain has been constant and is ongoing. On the following morning (27-MAY), the patient experienced generalised pain, immobility, polyarticular pain, cartilage and muscle pain and found it impossible to get up. The patient found it extremely painful to move. The symptoms had a sudden onset and are starting to ease. A fever started on 27th May and is ongoing. The patient has been starting to sweat and has experienced paralysis. It is not known whether the patient received any treatment. The events were ongoing at the time of reporting. Follow-up received from the consumer on 01-JUN-2009: The patient is able to move half a meter in 1 minute, and it is extremely painful in his joints. The company assessed the causality as possible, however this case was not medically confirmed by the patient''s health care professional. Consent was not given. Information derived from this AE report does not change the safety profile of the product.

VAERS ID:350450 (history)  Vaccinated:2005-05-25
Age:49.0  Onset:2008-12-30, Days after vaccination: 1315
Gender:Female  Submitted:2009-06-29, Days after onset: 180
Location:Foreign  Entered:2009-06-30, 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: Blood culture, positive; serotype 8
CDC Split Type: WAES0906USA04849
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood culture positive, Pneumonia, Serology positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad)
Write-up: Information was obtained on request by the company from the agency via a public case details form concerning a 49 year old female patient who on 25-MAY-2005 was vaccinated with a dose of PNEUMOVAX 23, subcutaneously. It was reported that on 30-DEC-2008 a vaccination failure was noted. It was reported that the patient developed pneumonia with blood culture positive-serotype 8 and the patient was hospitalized. The agency considered that vaccination failure was possibly related to vaccination with PNEUMOVAX 23. The original reporting source was not provided. Additional information is not expected.

VAERS ID:352525 (history)  Vaccinated:2009-06-08
Age:49.0  Onset:2009-06-09, Days after vaccination: 1
Gender:Male  Submitted:2009-07-27, Days after onset: 48
Location:Foreign  Entered:2009-07-27
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: DESCRATCHP000172
Vaccination
Manufacturer
Lot
Dose
Route
Site
JEV1: JAPANESE ENCEPHALITIS (IXIARO)INTERCELL AGJEV08E11B IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Encephalitis, Headache, Neck pain, Pain in extremity, Performance status decreased, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow)
Write-up: The 49-year-old male was vaccinated with IXIARO into the right deltoid on 08 June 2009 (batch number JEV08E11B). Patient developed headache and neck pain on 09 June 2009. On 10 June 2009 headache and neck pain increased and pain in limbs, pyrexia (38.3 C), diarrhea, severe decrease of performance status occurred. Therapy on that day included ibuprofen and paracetamol, but did not alleviate patient''s condition. Patient improved by evening of 11 June 2009, and was recovered by 12 June 2009. Diagnostic: Mild encephalitis.

VAERS ID:356347 (history)  Vaccinated:1997-02-14
Age:49.0  Onset:1997-03-01, Days after vaccination: 15
Gender:Female  Submitted:2009-09-02, Days after onset: 4567
Location:Foreign  Entered:2009-09-02
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: DRUG ADDICTION
Preexisting Conditions:
Diagnostic Lab Data: Anti-La antibody, Dec2004, negative; Anti-Ro antibody, Dec2004, negative; Anticardiolipin antibodies, Dec2004, negative; CSF test, Dec2004, see text; Nuclear antibody negative, Dec2004, negative; Nuclear magnetic resonance imaging, Nov2004,
CDC Split Type: B0590051A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS1856A6 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anti-thyroid antibody, Anti-thyroid antibody negative, Antibody test negative, Antinuclear antibody negative, CSF oligoclonal band present, CSF test abnormal, Cardiolipin antibody negative, Gait disturbance, Hemianopia, Multiple sclerosis, Myalgia, Myelitis, Nuclear magnetic resonance imaging abnormal, Optic nerve disorder, Papilloedema, Paraesthesia, Smooth muscle antibody negative, Vision blurred, Visual acuity reduced, Visual acuity tests abnormal, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hypothyroidism (broad), Hyperthyroidism (broad)
Write-up: This case was reported by a foreign regulatory authority (MA20091320 and 09-2732) and described the occurrence of multiple sclerosis in a 49-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included drug addiction (nos). ENGERIX B (unspecified formulations, intramuscular, injection site unknown) was administered on 07 December 1995 (batch unknown), 10 January 1996 (batch 1856A6), 06 February 1996 (batch 1856A6) and 14 February 1997 (batch 1856A6). In March 1997, one month after last vaccination with ENGERIX B, the subject complained of left eye visual disorder and limbs myalgia. In 1999, a check-up showed visual acuity decreased at 02/10 with papilledema and optic nerve hypertrophy. The subject received unspecified corticoid treatment for 3.5 years. In November 2004, encephalic MRI showed bilateral T2 and flair white matter hypersignals and medullary MRI revealed T2 hypersignals at cervical and thoracic levels. Functional signs included blurred vision and gait disturbance. There was no urinary disorder. From 13 to 17 December 2004, she was hospitalized for further investigations. Neurological examination showed upper bilateral quadrantic hemianopia, left adiadochokinesy, increased wide based gait and difficulty to walk along a line. Romberg sign was negative. Anti-cardiolipin and anti-beta 2-GP1, anti-elastin peptide, anti-thyroid peroxidase and anti-thyroglobulin antibodies were negative. Anti nuclear antibodies were negative, included Anti-Sm, Anti SSA/Ro, anti-SSB/Lq (as reported, coded anti La antibodies), anti-ribonucleoprotein antibodies. Cerebrospinal fluid analysis evidenced an IgM specific of oligoclonal profile and intra-thecal immunoglobulins synthesis. Those results were suggestive of auto-immune myelitis in favour of multiple sclerosis. On 19 January 2005, the subject was hospitalised for left hemiface paresthesia, a probable multiple sclerosis flare up according to the reporter. She was treated with Solumedrol at 1g daily during five days. Pa

VAERS ID:366914 (history)  Vaccinated:2009-10-30
Age:49.0  Onset:2009-10-30, Days after vaccination: 0
Gender:Female  Submitted:2009-11-12, Days after onset: 13
Location:Foreign  Entered:2009-11-12
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: Body temperature, 30Oct2009, 39deg C
CDC Split Type: B0601860A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA502AF IMLA
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Feeling cold, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: This case was reported by a physician was the subject herself and described the occurrence of tremor in a 49-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject was healthy before vaccination. On 30 October 2009 the subject received unspecified dose of FLUARIX (intramuscular, left upper deltoid). On 30 October 2009, 14 hours after vaccination with FLUARIX, the subject experienced tremor due to cold feeling and fever (39 deg C). The subject had no local symptoms. No symptoms of influenza was detected. The physician considered the events were clinically significant (or requiring intervention). The subject was treated with dipyrone (Novamidazophenum) and abundant fluid intake. On 31 October 2009, the events were resolved. The physician considered the events were almost certainly related to vaccination with FLUARIX.

VAERS ID:368654 (history)  Vaccinated:2009-10-24
Age:49.0  Onset:2009-10-25, Days after vaccination: 1
Gender:Female  Submitted:2009-11-18, Days after onset: 24
Location:Foreign  Entered:2009-11-19, 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: Candesartan cilexetil; Metformin; Simvastatin
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0911USA02360
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  IJUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Extensive swelling of vaccinated limb, Pain in extremity, Rash generalised
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a foreign Health Authority (20519559) concerning a 49 year old female patient. Details of the patient''s medical history have not been reported. The patient was receiving candesartan cilexetil, metformin and simvastatin for unreported indications. On 24-OCT-2009, the patient received an influenza virus split virion 3v vaccine inactivated (manufacturer, batch number and route were not reported) in the right arm and PNEUMOVAX 23 (manufacturer and batch number not reported) in the left arm. On 25-OCT-2009, one day post immunizations, the patient experienced a generalized rash, and a massive swelling and pain in the left arm. Patient outcome has not been reported. Both the agency and the reporter considered this to be serious reaction due to disability/incapacity. No more information is expected, this case is closed.

VAERS ID:369535 (history)  Vaccinated:2009-11-09
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2009-11-23
Location:Foreign  Entered:2009-11-23
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Simvastatin
Current Illness: Insulin-dependent diabetes mellitus
Preexisting Conditions: Took antihistamine, paracetamol, ibuprofen. IDDM
Diagnostic Lab Data: UNK
CDC Split Type: B0604342A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERE0542 IJLA
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Arthralgia, Chest discomfort, Chills, Death, Influenza like illness, Mouth ulceration, Pain, Pruritus, Swollen tongue
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Systemic lupus erythematosus (broad), Dementia (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: This case was reported by the regulatory authority (# GB-MHRA-FLU 00027480) and described the occurrence of death (nos) in a 49-year-old female patient who was vaccinated with influenza virus vaccine (manufacturer unspecified). Concurrent medical conditions included insulin-dependent diabetes mellitus. Previous and/or concurrent vaccination included influenza virus vaccine (manufacturer unspecified; unknown) given on an unspecified date. Concurrent medications included Simvastatin. On 09 November 2009 the patient received a dose of Influenza virus vaccine (1 injection, unknown). At an unspecified time after vaccination with Influenza virus vaccine, the patient experienced flu like symptoms, joint pain, chest tightness, pain, itching, swelling of tongue, mouth ulcer and rigors. The regulatory authority reported that the events were disabling. The reaction severity was bad enough to affect every day activities. The patient was treated with Antihistamines, Paracetamol and Ibuprofen. At an unspecified time after vaccination with Influenza virus vaccine, the patient died from unknown cause of death. It was unknown whether an autopsy was performed. Verbatim Text : Reaction Severity: Bad enough to affect every day activities, Caused death.

VAERS ID:371423 (history)  Vaccinated:2009-09-20
Age:49.0  Onset:2009-10-10, Days after vaccination: 20
Gender:Female  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: B0607545A
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 50-year-old female subject who was vaccinated with ENGERIX B ADULT (GlaxoSmithKline). Concurrent medical conditions included tobacco use. On 26 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). 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:374105 (history)  Vaccinated:2009-06-12
Age:49.0  Onset:2009-06-13, Days after vaccination: 1
Gender:Female  Submitted:2009-12-18, Days after onset: 188
Location:Foreign  Entered:2009-12-18
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: B0616703A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALSXC12B19P1 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site inflammation
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority (ES-AGEMED-621963341) and described the occurrence of injection site inflammation in a 49-year-old female subject who was vaccinated with DITANRIX adult, (GlaxoSmithKline). On 12 June 2009, the subject received unspecified dose of DITANRIX adult (intramuscular, right deltoid). On 13 June 2009, 1 day after vaccination with DITANRIX adult, the subject experienced injection site inflammation. The regulatory authority reported that the event was clinically significant (or requiring intervention). The subject was treated with antihistamine during 4 days. The event lasted 6 days. On 18 June 2009, the event was resolved. The vaccination course with DITANRIX adult was discontinued. The regulatory authority reported that the event was probably related to vaccination with DITANRIX adult.

VAERS ID:376903 (history)  Vaccinated:2009-11-04
Age:49.0  Onset:2009-11-09, Days after vaccination: 5
Gender:Female  Submitted:2010-01-14, Days after onset: 66
Location:Foreign  Entered:2010-01-14
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: Bronchial asthma; cardiomyopathy; Hypertension arterial; Ischemic heart disease; Maxillary sinusitis; Obesity; Pulmonary embolism
Preexisting Conditions: Cholecystecomy
Diagnostic Lab Data: UNK
CDC Split Type: B0624111A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUAU77C SCUN
Administered by: Other     Purchased by: Other
Symptoms: Acute respiratory failure, Brain oedema, Circulatory collapse, Hypotonic-hyporesponsive episode, Intensive care, Loss of consciousness, Pneumonia, Pyrexia, Septic shock
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Agranulocytosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), 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), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority (# PL-URPL-OCR-20100105001) and described the occurrence of brain edema in a 49-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject''s medical history included status post cholecystectomy. Concurrent medical conditions included bronchial asthma, cardiomyopathy, hypertension arterial, ischemic heart disease, maxillary sinusitis, obesity and pulmonary embolism. On 4 November 2009 the subject received unspecified dose of FLUARIX (subcutaneous). On 9 November 2009, 5 days after vaccination with FLUARIX, the subject experienced, hypotonic-hyporesponsive episode and fever. The subject was transferred to the intensive care unit where she was hospitalized for acute respiratory-circulatory failure, septic shock, pneumonia, brain edema and loss of consciousness. The information gathered from the subject showed that she was vaccinated against influenza during an ongoing infection. The subject received antibiotic therapy after which the subject''s general conditions improved. At the time of reporting the events were resolved. No further information was available as this was all the information that regulatory authorities had.

VAERS ID:377283 (history)  Vaccinated:2009-11-25
Age:49.0  Onset:2010-01-03, Days after vaccination: 39
Gender:Male  Submitted:2010-01-15, Days after onset: 12
Location:Foreign  Entered:2010-01-18, Days after submission: 3
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: EVANS syndrome
Preexisting Conditions: Splenectomy
Diagnostic Lab Data: Hemoglobin, 18Nov09, 14.3 g/dL; Platelet count, 18Nov09, 352 k/uL; Hemoglobin, 03Jan10, 3.7 g/dL: Platelet count, 03Jan10, 10 k/uL; Direct antiglobulin test, 03Jan10, Normal range: negative, comment; 4+; Hemoglobin, 08Jan10, 12.7g/dL; Platelet count, 08Jan10; 95 k/uL
CDC Split Type: WAES1001TWN00005
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood product transfusion, Coombs direct test, Haemoglobin decreased, Haemolytic anaemia, Platelet count decreased, Thrombocytopenia
SMQs:, Haemolytic disorders (narrow), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (narrow)
Write-up: Information has been received from a pharmacist concerning a 49 year old male with Evans syndrome and a history of splenectomy who on 25-NOV-2009 was vaccinated with PNEUMOVAX vaccine. His hemoglobin and platelet were within normal range after splenectomy in 2009 Jan, and his medications were discontinued after June 2009. On 03-JAN-2010 the patient experienced hemolytic anemia (Hb=3.7 g/dL) and thrombocytopenia (PLT=10 k/uL) and was hospitalized. He received blood transfusion on Jan 3 and intravenous immunoglobulin during Jan 5 to Jan 8. The patient''s Hb recovered to 12.7 g/dL and PLT recovered to 95 k/uL on Jan 8. The reporter felt that hemolytic anemia and thrombocytopenia were related to therapy with PNEUMOVAX vaccine. No further information is available.

VAERS ID:384731 (history)  Vaccinated:2010-03-29
Age:49.0  Onset:2010-03-30, Days after vaccination: 1
Gender:Female  Submitted:2010-04-08, Days after onset: 9
Location:Foreign  Entered:2010-04-08
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: B0645786A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALSXC12B023F1 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority (# ES-AGEMED-222301341) and described the occurrence of injection site induration in a 49-year-old female subject who was vaccinated with DITANRIX adult (GlaxoSmithKline). On 29 March 2010, the subject received unspecified dose of DITANRIX adult (.5 ml, intramuscular, unknown injection site). On 30 March 2010, 1 day after vaccination with DITANRIX adult, the subject experienced injection site induration (10x15 cm), injection site pain, injection site inflammation and vaccination site erythema. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 30 March 2010, at the time of reporting, the events were unresolved. No further information was expected, this case was therefore closed.

VAERS ID:384736 (history)  Vaccinated:2010-03-23
Age:49.0  Onset:2010-03-23, Days after vaccination: 0
Gender:Female  Submitted:2010-04-08, Days after onset: 16
Location:Foreign  Entered:2010-04-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Loin Pain
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 23Mar2010, 40deg. C
CDC Split Type: B0645705A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALSXC12B020J1 IMAR
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Depressed mood, Dizziness, Fatigue, Hypotension, Malaise, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad)
Write-up: This case was reported by a regulatory authority (#ES-AGEMED-222283341) and described the occurrence of malaise in a 49-year-old female subject who was vaccinated with DITANRIX adult (GlaxoSmithKline). Concurrent medical conditions included loin pain which was treated with TRAMADOL and OMEPRAZOL since 1st October 2009. On 23 March 2010, the subject received unspecified dose of DITANRIX adult (intramuscular, unknown injection site). On 23 march 2010, 30-45 minutes after vaccination with DITANRIX adult, the subject experienced malaise and dizziness. The subject also presented hypotension which surmounted spontaneously. Although, malaise and fatigue persisted. During the afternoon, the subject presented a spike of temperature (40 deg. C) that decreased with antipyretics. The subject continued without fever but presented malaise and depressed mood. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the fever and the hypotension were resolved but the others events were unresolved. The regulatory authority reported that the events were probably related to vaccination with DITANRIX adult. No further information was expected, this case was therefore closed.

VAERS ID:387023 (history)  Vaccinated:2009-11-19
Age:49.0  Onset:2009-11-28, Days after vaccination: 9
Gender:Female  Submitted:2010-05-07, Days after onset: 159
Location:Foreign  Entered:2010-05-10, 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: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2010AT28731
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURER095902A UNUN
Administered by: Other     Purchased by: Other
Symptoms: Multiple sclerosis, Myelitis, Osteomyelitis
SMQs:, Optic nerve disorders (broad), Demyelination (narrow), Osteonecrosis (broad)
Write-up: Initial foreign health authority report received on 03 May 2010: The patient was vaccinated with SANDOVAC (batch number 095902A) on 20 Oct 2009 and CELVAPAN (batch number VNV9J014A) on 19 Nov 2009. The patient presented with acute myelitis, osteomyelitis and primary manifestation of multiple sclerosis on 28 Nov 2009. The events were assessed as medically significant by health authority and suspected for both CELVAPAN and SANDOVAC.

VAERS ID:389587 (history)  Vaccinated:2010-03-29
Age:49.0  Onset:2010-03-29, Days after vaccination: 0
Gender:Female  Submitted:2010-05-26, Days after onset: 58
Location:Foreign  Entered:2010-05-28, 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:
Diagnostic Lab Data:
CDC Split Type: 2010023508
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED090626901 IJUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hyperventilation, Hypoaesthesia, Hypoaesthesia facial, Immediate post-injection reaction, Injection site anaesthesia, Palpitations, Paraesthesia, Paraesthesia oral, Rash, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Report received from the Regulator on 20-May-2010 (case number: 266763). A 49 year old female patient received a single dose of FLUVAX injection (influenza vaccine, batch 090626901) on 29-Mar-2010. The medical history and concomitant medication were not specified. On 29-Mar-2010, immediately after receiving FLUVAX vaccination, the patient developed numbness and tingling of arm and hand on the injection side. The patient was also hyperventilating. A few minutes later, the patient developed tingling lips, itchy throat and felt like her heart was racing (pulse was <90). A rash developed on her chest and neck. She was taken to the Emergency Department and given phergan, prednisolone and zantac. Most symptoms resolved except left sided facial numbness which still existed. The outcome of these events is unknown. Reporter assessed the causality as possible in relation to the suspect drug, FLUVAX. This case was considered serious due to medical significance. The company considered events possibly related to FLUVAX. Information derived from this AE report does not change the current safety profile of the product.

VAERS ID:393101 (history)  Vaccinated:1999-12-20
Age:49.0  Onset:0000-00-00
Gender:Male  Submitted:2010-07-19
Location:Foreign  Entered:2010-07-19
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Nephrolithiasis
Preexisting Conditions:
Diagnostic Lab Data: NMR, Abnormal
CDC Split Type: B0664262A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test normal, Chronic inflammatory demyelinating polyradiculoneuropathy, Nuclear magnetic resonance imaging abnormal, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: This case was reported by a regulatory authority (DHH-N2010-51145) and described the occurrence of chronic inflammatory demyelinating polyneuropathy in a 51-year-old male subject who was vaccinated with ENGERIX B ADULT (GlaxoSmithKline), TWINRIX ADULT. Concurrent medical conditions included exotic nephrolithiasis. Previous and/or concurrent vaccination included 2 doses of hepatitis B vaccine recombinant; GlaxoSmithKline; intramuscular; given in 1996. On 20 December 1999, the subject received 3rd dose of ENGERIX B ADULT (intramuscular, unknown injection site), lot number not provided. In 2001, approximately 2 years after vaccination with the 3rd of ENGERIX B ADULT, the subject experienced a progressive ascending paresthesia from toes to feet. On 9 December 2002 and on 2 December 2004, the subject received 4th dose of ENGERIX B ADULT (intramuscular, unknown injection site) and 5th dose of TWINRIX ADULT (intramuscular, unknown injection site). The lot numbers were not provided. In 2007, approximately 5 years after vaccination with the 4th dose of ENGERIX B ADULT and 3 years after vaccination with TWINRIX ADULT, the paresthesia in feet had worsened. The paresthesia had reached the entire foot and posterior part of the legs as well as the end of the fingers. In 2008, the subject visited a neurologist. The NMR of the cervical roots showed a typical image C5-C8 and the diagnosis of chronic inflammatory demyelinating polyneuropathy was made. With the blood tests results, the other causes were excluded. The regulatory authority reported that the events were disabling. At the time of reporting the events were unresolved.

VAERS ID:395353 (history)  Vaccinated:2009-09-15
Age:49.0  Onset:2009-09-15, Days after vaccination: 0
Gender:Female  Submitted:2010-08-16, Days after onset: 335
Location:Foreign  Entered:2010-08-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcoholism (not abuse)
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0665379A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB682BC0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Headache, Impaired work ability, Influenza like illness, Malaise, Myalgia, Sensation of heaviness, Vaccine positive rechallenge
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad)
Write-up: This case was reported by a nurse and described the occurrence of feeling unwell in a 50-year-old female subject who was vaccinated with ENGERIX B. The patient had no other medical conditions and was not on any other medication. On 15 September 2009 and on an unknown date in October 2009, the subject received 1st dose and 2nd dose of ENGERIX B (1 injection, intramuscular). At an unspecified time after the 1st vaccination with ENGERIX B, the subject felt unwell for more than two days. The patient experienced muscle ache, headache and felt like she was coming down with the flu but had no pyrexia. After the second dose of ENGERIX B the patient experienced the same symptoms as after the first dose but this time the symptoms were worse and lasted more than a week and the patient had to take time off work. The patient''s limbs also felt very heavy after the second dose. The nurse decided not to give the third dose based on the side effects the patient experienced and the fact that it was not a risk patient. At the time of reporting the patient was reported to be fine and all symptoms had resolved. Verbatim text: On the 14th July 2010, a nurse reported that a 50 year old female patient was administered the first dose of ENGERIX B on the 15th September 2009 and the second dose of ENGERIX B one month later. After the first dose of ENGERIX B the patient felt unwell for more than two days. The patient experienced muscle ache, headache and felt like she was coming down with the flu but had no pyrexia. After the second dose of ENGERIX B the patient experienced the same symptoms as after the first dose but this time the symptoms were worse and lasted more than a week and the patient had to take time off work. The patient''s limbs also felt very heavy after the second dose. The nurse decided not to give the third dose based on the side effects the patient experienced and the fact that it was not a high risk patient. At the time of reporting the patient was reported to be fine and all symptoms had resolved. The patient had no other medical conditions and was not on any other medication. There was no further information available at the time of reporting. Follow-up received on 05 Aug 2010: Patient demographics were received and updated. Concurrent medical conditions included alcoholism (not abuse) as the subject would drink 1 glass of wine per week. Other than this, the subject was reported as being a fit and healthy individual. On 15 September 2009 and 14 October 2009 the subject received 1st dose and 2nd dose of ENGERIX B (1 injection, intramuscular). On 15 September 2009, after vaccination with 1st ENGERIX B, the subject experienced feeling unwell, muscle pain, headache, and influenza like illness. The events were resolved on 18 September 2009. On 14 October 2009 after administration of 2nd dose ENGERIX B the symptoms re-appeared and were worse. The events were considered clinically significant (or required intervention). It was noted that the subject had to take time off work for 1 week to recover. The vaccination course with ENGERIX B was discontinued. The second episode of events were resolved on 21 October 2009.

VAERS ID:404434 (history)  Vaccinated:2010-08-04
Age:49.0  Onset:2010-08-08, Days after vaccination: 4
Gender:Female  Submitted:2010-10-18, Days after onset: 71
Location:Foreign  Entered:2010-10-20, 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: congenital platelet storage pool disease; autoimmune deficiency syndrome
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1010USA01205
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Haematoma, Injection site haemorrhage, Oedema peripheral, Platelet transfusion
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This case was received by a general practitioner on 07-OCT-2010 under the reference number MedInfosys no: 97295. This case was medically confirmed. A 49 year old female patient developed injection site bleeding, swollen injected arm and haematoma in injected arm after she had received a dose of PNEUMOVAX 23 (Batch # not reported), intramuscularly in the arm on 04-AUG-2010. The patient had a medical history a platelet storage pool disease and possible subtle antibody deficiency. It was not known if the patient was receiving any concomitant medication. No information was reported about prior exposure. On 08-AUG-2010, four days post vaccination, the patient developed injection site bleeding, a swollen injected arm, and a haematoma in the injected arm. The patient was hospitalized. The patient had corrective treatment with platelet transfusion. The patient continued to receive platelets as treatment and every time the platelets are stopped the bleeding starts again. At the time of reporting the patient had not yet recovered and remained in hospital. Other business partner numbers included E2010-06057. No further information is available.

VAERS ID:407028 (history)  Vaccinated:2010-03-09
Age:49.0  Onset:2010-03-09, Days after vaccination: 0
Gender:Female  Submitted:2010-10-19, Days after onset: 223
Location:Foreign  Entered:2010-10-20, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
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: 201005326
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Fatigue, Headache, Hyperhidrosis, Hypertension, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (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 BR2010626). A 49-year-old female patient, with no reported medical history, no reported concomitant therapy and "no other vaccine", had received her dose of H1N1 vaccine (manufacturer and batch number unknown, route and anatomical site of administration not reported) on 09 March 2010. On 09 March 2010, 30 minutes post-vaccination, the patient experienced sweating, fatigue and hypertension (BP 15 x 11). On 11 March 2010, the patient developed headache and "maintained hypertension" (148 x 107). He was reevaluated at the medical service the same day. The patient received corrective therapies with analgesics and antihypertensive drugs. On 12 March 2010, there was a new medical assessment (rest of the information was cut on the source document). The patient was hospitalized on unspecified dates. The patient finally experienced unexpected sudden death on an unspecified date. This case was considered as "severe". Documents held by sender: none.

VAERS ID:407945 (history)  Vaccinated:2010-04-15
Age:49.0  Onset:2010-04-16, Days after vaccination: 1
Gender:Male  Submitted:2010-11-11, Days after onset: 209
Location:Foreign  Entered:2010-11-11
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic rhinitis; hypertension arterial
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0658383A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALSAC12B025AA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Conjunctivitis, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (broad)
Write-up: This case was reported by a regulatory authority (# PT-INFARMED-L201004-1197) and described the occurrence of conjunctivitis in a 49-year-old male subject who was vaccinated with DITANRIX ADULT (GlaxoSmithKline). It was unknown whether there was a previous history of adverse reaction to this or other drugs. On 15 April 2010, the subject received unspecified dose of DITANRIX ADULT (.5 ml, intramuscular, unknown injection site). On 16 April 2010, 1 day after vaccination with DITANRIX ADULT, the subject experienced conjunctivitis, myalgia and fever. It was unknown if a specific treatment of adverse reaction was given. On 18 April 2010, the events were resolved. No further information is expected, the regulatory Authority has provided GSK with all the available information for the time being, if they ever get any further information they will send it to GSK. Follow-up information received on 04 November 2010: This case was upgraded to serious. The regulatory authority reported that the events were disabling (motivated by 1 day of sick leave). Concurrent medical conditions included allergic rhinitis and hypertension arterial. Concurrent medications included Losartan potassium, AERIUS and NASOMET. The regulatory authority reported that the events were probably related to vaccination with DITANRIX ADULT. No further information is expected, the regulatory Authority has provided GSK with all the available information for the time being, if they ever get any further information they will send it to GSK. The case has been closed.

VAERS ID:412944 (history)  Vaccinated:2010-11-25
Age:49.0  Onset:2010-12-05, Days after vaccination: 10
Gender:Male  Submitted:2010-12-14, Days after onset: 9
Location:Foreign  Entered:2010-12-16, 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: The patient had received a course of rabies vaccine (manufacturer and batch number not reported) in 2009 with no adverse effect.
Diagnostic Lab Data:
CDC Split Type: E201007637
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURERE0715 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspepsia, Eye pruritus, Eye swelling, Hypersensitivity, Rash generalised, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Gastrointestinal nonspecific dysfunction (narrow), Hypersensitivity (narrow)
Write-up: This case was received from a nurse in a foreign country on 06-Dec-2010. This case is medically confirmed. A 49 year old male patient received a booster of rabies vaccine BP Pasteur Merieux (batch number E0715-1, expiry 06/2012) on 25-Nov-2010. On 05-Dec-2010, ten days post vaccination, the patient experienced an allergic reaction. The patient had received a course of rabies vaccine (manufacturer and batch number not reported) in 2009 with no adverse effect. The patient experienced indigestion, an itchy rash on his body including palms, and swollen and itchy eyes. The patient was prescribed antihistamines as this was considered to be an allergic reaction. At the time of reporting the patient had not yet recovered. The reporter considered the events to be medically significant.

VAERS ID:412953 (history)  Vaccinated:2010-11-30
Age:49.0  Onset:2010-11-30, Days after vaccination: 0
Gender:Male  Submitted:2010-12-15, Days after onset: 15
Location:Foreign  Entered:2010-12-16, 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: Medical history of unspecified allergies, treated with antiallergics. Unspecified time prior to vaccination the patient developed an unspecified exanthema (ongoing at the time of AE). The patient drank contaminated water and took expired analgesics on an unspecified date prior to vaccination.
Diagnostic Lab Data:
CDC Split Type: E201007445
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERC3547AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Condition aggravated, Hypersensitivity, Rash, Sensation of foreign body
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Hypersensitivity (narrow)
Write-up: Case received from a general practitioner in a foreign country on 01-Dec-2010. Case medically confirmed. A 49-year-old male patient, with a medical history of multiple allergies and unspecified exanthema at the time of vaccination, had received a booster dose of COVAXIS (lot-no. C3547AA) IM into the left upper arm on 30-Nov-2010. 45 minutes later exanthema aggravated and he developed globus feeling in pharynx. The physician suspected an allergic reaction type 1. The patient received corrective treatment with prednisolone (IV) and Fenistil (IV). Subsequently the patient recovered (exanthema reached the same level as before vaccination, respectively). It was pointed out by the reporter that the patient had drunken bacterial contaminated water and had taken in expired analgesics prior to the vaccination. CASE IS CLOSED.

VAERS ID:413366 (history)  Vaccinated:2010-12-04
Age:49.0  Onset:2010-12-04, Days after vaccination: 0
Gender:Female  Submitted:2010-12-21, Days after onset: 17
Location:Foreign  Entered:2010-12-21
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: A0899591A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHBB188AC0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Nausea, Pallor, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a nurse and described the occurrence of vagal shock in a 49-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). On 4 December 2010 the subject received 1st dose of TWINRIX (unknown). On 4 December 2010, three to four minutes after vaccination with TWINRIX, the subject experienced vagal shock, fainting, nausea and pallor. The events lasted for forty-five minutes to one hour. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. This case is linked to case A0899592A same reporter. (Same events associated with 2 lots number AHBB188AC and AHBB188AA, the reporter did not know which lot was used for which subject).

VAERS ID:413437 (history)  Vaccinated:2010-11-03
Age:49.0  Onset:2010-11-05, Days after vaccination: 2
Gender:Female  Submitted:2010-12-20, Days after onset: 45
Location:Foreign  Entered:2010-12-22, 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:
Current Illness: BECHTEREW''s disease
Preexisting Conditions:
Diagnostic Lab Data: ultrasound, 05Nov10, a thickened cutis and subcutis but no inflammation and no abscess or muscle involvement
CDC Split Type: WAES1012USA02601
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pyrexia, Skin hypertrophy, Skin warm, Ultrasound scan abnormal
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Case received from a health authorities under reference number 2010-03557 via the local site. Case medically confirmed. A 49 year old female received a dose of PNEUMOVAX 23 (0.5ml, batch number not provided), TWINRIX (1ml, batch number not provided), BOOSTRIX (0.5ml, batch number not provided) and INFLEXAL (0.5ml, batch number not provided). All the vaccinations were administered on 03-NOV-2010 in the left upper arm, via IM route. Two days later (05-NOV-2010) the patient''s left arm became hot, reddened, (limited and tapering cubitally), painful and swollen. Ultrasonography showed a thickened cutis and subcutis but no inflammation and no abscess or muscle involvement. Half a day later she also developed fever which regressed after the administration of PANADOL. On day 7 after the vaccination, the patient was treated with amoxicillin (+) clavulanate 3x 625mg/d. The patient then recovered completely without any injury. To be noted that the patient had medical history of BECHTEREW''s disease disease (ankylosing spondylitis). Upon medical review, the company judged relevant to code the following adverse events: pain localized, redness and skin warmth which were mentioned by the CA in the narrative but not coded. Other business partner number included E2010-07748. No further information is available.

VAERS ID:414042 (history)  Vaccinated:2010-10-20
Age:49.0  Onset:2010-10-23, Days after vaccination: 3
Gender:Female  Submitted:2011-01-04, Days after onset: 73
Location:Foreign  Entered:2011-01-05, 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: Asthma
Preexisting Conditions: Epilepsy; Influenza
Diagnostic Lab Data:
CDC Split Type: 2011027268
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER098616101 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Burning sensation, Chills, Dizziness, Impaired work ability, Myalgia, Neuropathy peripheral, Pain, Paraesthesia, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad)
Write-up: This regulatory report (initial receipt 21-DEC-2010) concerns a 49 year old female patient, who had a medical history of epilepsy and influenza in 2007. At the time of the event the patient concomitantly suffered from asthma (since 2007). She developed asthma after a flu three years ago. Concomitant medication included levothyroxine sodium. On 20-OCT-2010, the patient received ENZIRA (batch number: 098616101) at a dose of 0.5mL intramuscularly for flu vaccination. Three to four days post vaccination the patient felt woozy and developed achy joints and muscles. A week later, tingling started in her feet and legs, from then it gradually spread and now affecting most of her body. Her condition was particularly troublesome at night and disturbed her sleep. It felt like a painful shiver with burning in legs. It was worst in hands and legs. The patient was seen by a consultant neurologist and diagnosed with post immunisation neuropathy. She was prescribed with amitriptyline 10mg nocte. The patient was last seen four days ago with continued symptoms and still off work as a result. The patient had not recovered from the events.

VAERS ID:416996 (history)  Vaccinated:2011-02-11
Age:49.0  Onset:2011-02-12, Days after vaccination: 1
Gender:Female  Submitted:2011-02-16, Days after onset: 4
Location:Foreign  Entered:2011-02-16
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: Body temperature, 12Feb2011, 39Deg C
CDC Split Type: D0070303A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B062AJ UNUN
Administered by: Other     Purchased by: Other
Symptoms: Chills, Circulatory collapse, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of circulatory collapse in a 49-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 11 February 2011 at 11:00 the subject received a dose of BOOSTRIX. 15 hours later, on 12 February 2011 at 02:00 the subject developed fever of 39 deg C and shivers. The following morning the subject developed circulatory collapse. At the time of reporting, on 14 February 2011 the subject was still suffering from poor circulation. The physician considered the events were life threatening.

VAERS ID:421945 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2011-04-29
Location:Foreign  Entered:2011-04-29
Life Threatening? No
Died? No
Permanent Disability? Yes
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: Computerized tomogram, see text units; Lymphocytes, high or low units; Thrombocyte count, low units; X-ray, see text
CDC Split Type: B0715759A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Apnoea, Breast neoplasm, Computerised tomogram abnormal, Dyspnoea, Lymphocyte count decreased, Lymphocyte count increased, Mammogram abnormal, Mechanical ventilation, Monoplegia, Platelet count decreased, Post procedural complication, Surgery, Thymoma
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tumours of unspecified malignancy (narrow), Breast tumours of unspecified malignancy (narrow)
Write-up: This case was reported by a consumer and described the occurrence of breast tumor in a 49-year-old female subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Hep a/b vaccine, manufacturer unspecified). A physician or other health care professional has not verified this report. The subject was in good health before receiving the vaccine. Her doctor never confirmed that the tumor was due to vaccination. In 2007, the subject received unspecified dose of Hepatitis A and B vaccine (unknown trade name, unknown route of administration, unknown site of injection, batch number not provided). In 2007, less than one week after vaccination with Hep a/b vaccine, the subject experienced paralysis of arm and difficulty to breath. She did not remember which arm was affected. After three days, it decreased. 2 months later, the subject went to a pneumologist and everything was normal. 6 - 7 months later, the subject experienced problems again and a tumor was discovered in her breast by a specialist for X-ray. Afterwards, a computerized tomogram was performed and a thymoma was diagnosed. The subject underwent surgery. Afterwards she experienced after-effects. During surgery, they have operated too much away (muscles). And so, the subject had breathing breaks (apnea) in the night, therefore she needed a breathing machine (mask) during the night. Thrombocytes were low (alternate 140 and 90) and lymphocytes were alternate high and low. The subject was hospitalised and was severely disabled. At the time of reporting, the events were resolved with sequelae. The company of the subject wanted her to receive a booster for hepatitis B vaccination, but she refused.

VAERS ID:423201 (history)  Vaccinated:2010-11-05
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2011-05-18
Location:Foreign  Entered:2011-05-19, 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:
Diagnostic Lab Data:
CDC Split Type: 2011028501
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED16449411A IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Biopsy skin abnormal, Eczema, Neurodermatitis, Pruritus generalised
SMQs:, Anaphylactic reaction (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Skin tumours of unspecified malignancy (broad), Hypersensitivity (narrow)
Write-up: This health authority report (initial receipt on 09-May-2011) concerns a 49-year-old female patient. Past medical history was not provided. On 05-Nov-2010 the patient received AFLURIA (lot no. 16449411A) in the right upper arm. At an unspecified date in November 2010, the patient presented with eczematous dermatitis with generalized pruritus. Skin biopsy revealed lichen simplex. A contact eczema was excluded. The patient was hospitalized but not recovered. More information has been requested. This individual case does not affect the benefit-risk assessment, hence no further safety-relevant measure is deemed necessary.

VAERS ID:424020 (history)  Vaccinated:2008-03-13
Age:49.0  Onset:2011-05-01, Days after vaccination: 1144
Gender:Male  Submitted:2011-05-25, Days after onset: 24
Location:Foreign  Entered:2011-05-25
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: Creatinine, 19May2011, 79.0mg/dl; Gamma glutamyl transpeptidase, 19May2011, 1.24U/l; Hemoglobin, 19May2011, 8.90g/dl; Mean cell hemoglobin concentra, 19May2011, 20g/dl; Mean corpuscular hemoglobin, 19May2011, 1.93pg; Examinations: Test on 19 May 2011: BPWBA: negative; BPWBG: negative
CDC Split Type: D0071362A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B025BI0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Bacterial test negative, Blood creatinine increased, Bordetella test, Bordetella test positive, Cough, Differential white blood cell count, Full blood count, Gamma-glutamyltransferase decreased, Haemoglobin decreased, Laboratory test normal, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin decreased, Pertussis, Platelet count, Productive cough, Respiration abnormal, Sputum discoloured, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Lack of efficacy/effect (narrow), Haemorrhage laboratory terms (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of pertussis in a 53-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date in 2008 the subject received unspecified dose of BOOSTRIX (unknown route and application site). Approximately in May 2011, approximately 2 years after vaccination with BOOSTRIX, the subject experienced pertussis (vaccination failure). An unspecified test for pertussis was positive. This case was assessed as medically serious by GSK. Follow-up was received from the physician on 23 May 2011, including a questionnaire and a Targeted Follow Up Questionnaire. According to the questionnaire, concurrent medications included JODID, L-THYROXIN and Citalopram. On 13 March 2008 the subject received 1st dose of BOOSTRIX (intramuscular, right upper arm). The subject was treated with erythromycin. At the time of reporting the event was resolved. According to the Targeted Follow Up Questionnaire, on 6 May 2011 pertussis IgA was 107 U/ml (range less 15.0), pertussis IgG was 68.9 U/ml (range less 20.0) and pertussis IgM was less 1.0 U/ml (range less 9.0). The subject developed Pertussis. Since February 2011 the subject experienced paroxysmal coughing in the morning with yellow Sputum. Cardiac sounds were loud/rhythmic. Vesicular respiration. The subject was treated with erythromycin 500 mg 3 times daily over 10 days. The subject presented cough and paroxysmal cough. The subject did not present fever, vomiting, cyanosis, apnea, rhinitis, enlarged lymph nodes, ? pseudomembranes, dysphagia, muscular rigidity, trismus or opistotonus. The subject did not have a wound within 3 weeks before symptoms. It was unspecified whether the following tests were performed: anti-adenyl cyclase hemolysin antibodies, anti-hemaglutinin filamentous antibodies, PCR on B. Pertussis, Culture of B. Pertussis or other serology. Complete blood count, differential, and platelet count were performed. No other diagnostic tests were performed. There was no relevant past medical history. Relevant Vaccination History was not provided. No further information will be available.

VAERS ID:425756 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:0000-00-00
Gender:Female  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? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2011AR50825
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS11625025 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Gastrointestinal disorder, Headache, Influenza like illness, Malaise, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: Case number PHHY2011AR50825 is an initial spontaneous report from Ministry of Health received on 07 Jun 2011. This report refers to a 49-year-old female patient. She received FLUVIRIN (batch no: 11625025) on an unknown date. Two days after vaccination, she experienced fever, malaise, headache, gastrointestinal symptoms, myalgia, arthralgia and flu-like syndrome which led to hospitalization from an unknown date. The event outcome was reported as complete recovery.

VAERS ID:430170 (history)  Vaccinated:2011-07-11
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2011-08-17
Location:Foreign  Entered:2011-08-18, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arthritis; Enteritis; Colitis; Monarthritis; Oral aphthae; Rheumatoid arthritis; Behcet''s syndrome; Joint swelling
Preexisting Conditions:
Diagnostic Lab Data: WBC count, 14Jul11, 18000; serum C-reactive protein, 14Jul11, 180 mg/l; WBC count, 14000; serum C-reactive protein, 125
CDC Split Type: WAES1107USA04051
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0888Y IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthritis, C-reactive protein increased, Expired drug administered, Injection site pain, Injection site reaction, Injection site swelling, Local reaction, Pregnancy test urine, Pyrexia, Rash, Vaccination complication, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (narrow)
Write-up: Case of misuse received from a physician on 13-JUL-2011 via the local site. Case medically confirmed. A 49-year old female patient had been administered an expired dose of PNEUMOVAX 23 (lot number: 665745/0888Y, batch number NM00040) (expiry date May 2011) intramuscularly in the left deltoid on 11-JUL-2011 and 30 hours later she experienced fever and exanthema, swelling and pain at the site of injection. Her axillary lymph nodes were not swollen. At the time of reporting, the patient had not recovered. The patient had a history of arthritis and chronic enteritis/colitis. A urine pregnancy test was performed: results not reported. Lab tests showed serum C-reactive protein test CRP: 125 and Leukocytes: 14000. Follow-up information received on 05-AUG-2011: The case was upgraded to serious because the patient was hospitalized. The patient had a medical history of arthritis, chronic enteritis and colitis, monoarthritis and recurrent oral aphthae. She was suspected to have Behcet''s disease or rheumatoid arthritis. On 14-JUL-2011, the patient had swollen inflammatory talocrural joint since about three weeks. The physician decided to vaccinate the patient with PNEUMOVAX 23 before starting a therapy with methotrexate. Further investigations to diagnose rheumatism were also made. The differential diagnosis of the reporting physician was: - massive reaction to vaccination because of a suspicion of an unknown pneumococcal infection in the patient''s childhood - reaction on junctions - local infection. The patient was given ibuprofen and CECLOR as corrective treatment 2 days after vaccination. On 14-JUL-2011, the patient was hospitalized. On the same day lab tests showed CRP increased up to 180mg/l and Leukocytes increased up to 18000. The vital parameters were normal. During hospitalization the patient was given as corrective treatment antibiotics via intravenous route first and nonsteroidal antiinflammatory drugs for rheumatism per os for 10 days. On 19-JUL-2011, the patient had fully recovered and was discharged. It was of note that the hospitalization was organized by the reporting physician because he went on holidays soon after the notice of the non serious adverse events. The patient was hospitalized for observation, further investigation and therapy during the physician''s absence. On 05-AUG-2011, the physician confirmed that the adverse events have to be classified as not serious and that the hospitalization was organized only to be sure that the patient was well followed-up. After the reporter''s holiday, the patient had no more inflammatory signs and on her deltoid there was no abscess, no symptoms. Other business partner numbers included: E2011-04524. No further information is available.

VAERS ID:438800 (history)  Vaccinated:2011-07-20
Age:49.0  Onset:2011-07-21, Days after vaccination: 1
Gender:Unknown  Submitted:2011-10-17, Days after onset: 88
Location:Foreign  Entered:2011-10-17
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: UNK
CDC Split Type: B0755805A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBV970BK IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Chills, Dysaesthesia, Hypotonia, Myalgia, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (broad)
Write-up: This case was reported by a regulatory authority (# PL-URPL-OCR-20110928038) via a physician and described the occurrence of decreased muscle tone in a 49-year-old subject of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On 20 July 2011 the subject received unspecified dose of ENGERIX B (intramuscular, unknown). On 21 July 2011, 1 day after vaccination with ENGERIX B, the subject experienced decreased muscle tone, arthralgia, myalgia, dysesthesia, chills and vertigo. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified.

VAERS ID:440928 (history)  Vaccinated:2011-10-03
Age:49.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-10-31, Days after onset: 28
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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2011030189
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Neuropathy peripheral, Pain, Pain in extremity, Vaccination site pain
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad)
Write-up: This health authority report (initial receipt: 26-Oct-2011) concerns a 49-year old female patient. On 03-Oct-2011 the patient received a dose of influenza vaccine in deltoid. On 03-Oct-2011, the same day as vaccination, the patient experienced vaccination site soreness. On 05-Oct-2011, two days post vaccination, she had severe pain in the arm and suspected nerve aggravation. She also had a severe pain in the vaccinated deltoid radiating up into the neck and down to the thumb and forefinger. She could not move her arm without severe pain. The General Practitioner was querying nerve aggravation. It was unknown if the events were treated. The patient had not recovered at the time of reporting. The outcome for ''vaccination site soreness'' was unknown. Action taken with drug was not applicable. Rechallenge was unknown. The reporter considered events to be serious as the events was considered medically significant.

VAERS ID:441689 (history)  Vaccinated:2011-10-03
Age:49.0  Onset:2011-10-03, Days after vaccination: 0
Gender:Female  Submitted:2011-11-04, Days after onset: 32
Location:Foreign  Entered:2011-11-04
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: No information reported
Diagnostic Lab Data: UNK
CDC Split Type: B0758071A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNAR
Administered by: Other     Purchased by: Other
Symptoms: Neck pain, Neuralgia, Pain, Pain in extremity, Vaccination site pain
SMQs:, Peripheral neuropathy (narrow), Arthritis (broad)
Write-up: This case was reported by the foreign regulatory authority and described the occurrence of neuralgia in a 49-year-old female subject who was vaccinated with Influenza vaccine. On 3 October 2011 the subject received unspecified dose of Influenza vaccine. On 3 October 2011, the same day as the vaccination, the subject experienced vaccination site soreness in the deltoid. On 05 October 2011, she had severe pain in the vaccinated deltoid radiating up into the neck and down to the thumb and fore finger. She could not move her arm without severe pain. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. Verbatim Text: This case was received from a Pharmacist on 06-Oct-11 under the reference number 07124. This case is medically confirmed. A 49 year old female patient with an unreported medical history and concomitant medication received a dose of an influenza vaccine (batch number not reported) route in the deltoid on 03-Oct-11. On 03-Oct-11, the same day as the vaccination, the patient experienced vaccination site soreness and two days post vaccination had severe pain in the arm and suspected nerve aggravation. Initially the patient had injection site soreness in the deltoid. On 05-Oct-11, she had severe pain in the vaccinated deltoid radiating up into the neck and down to the thumb and fore finger. She cannot move her arm without severe pain. The General Practitioner is querying a nerve aggravation. The reporter considered the events of suspected nerve aggravation and severe pain to be serious and has reported these events to the agency. At the time of reporting the patient has not recovered.

VAERS ID:441697 (history)  Vaccinated:2011-08-25
Age:49.0  Onset:2011-09-13, Days after vaccination: 19
Gender:Female  Submitted:2011-11-07, Days after onset: 55
Location:Foreign  Entered:2011-11-07
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: mesalazine; duloxetine; unknown
Current Illness: Hereditary non-polyposis colorectal; Morbus Crohn disease
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 13Sep2011, 39.6degC
CDC Split Type: D0073088A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Polymyalgia rheumatica, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vasculitis (narrow)
Write-up: This case was reported by a hospital physician and described the occurrence of fever of undetermined origin in a 50-year-old female subject who was vaccinated with HAVRIX 1440 (GlaxoSmithKline). Concurrent medical conditions included Morbus Crohn disease. On 25 August 2011 the subject received an unspecified dose of HAVRIX 1440 (1 ml, unknown). Approximately 19 days post vaccination with HAVRIX 1440, on 13 September 2011, the subject experienced fever of undetermined origin of 39.6 degC. The subject was hospitalised for an unknown period of time. At the time of reporting the outcome of the event was unspecified. Follow-up information was received on 28 October 2011 from the reporting hospital physician. The reported dates of the events were not consistent with initial report. Concurrent medical conditions included Morbus Crohn disease and hereditary non-polyposis colorectal cancer (HNPCC) syndrome with detection of heterozygote mutation of pRS2 locus. Concomitant medications included SALOFALK, YENTREVE and a not readable medication. On 25 August 2011 the subject received an unspecified dose of HAVRIX 1440 (1 ml, unknown). According to follow-up information, approximately 39 days later, on 03 October 2011, the subject experienced fever of undetermined origin. Furthermore, on an unknown date in 2011, the subject was diagnosed for the first time with polymyalgia rheumatica. On an unknown date in 2011 the subject was hospitalised for an unknown period of time for focus diagnostics. The subject was treated with Antibiotic and later on replaced by oral Prednisolon. At the moment no further vaccination with HAVRIX 1440 was necessary. At the time of reporting, on 26 October 2011, fever was resolved and the subject was discharged from hospital.

VAERS ID:443268 (history)  Vaccinated:2011-10-05
Age:49.0  Onset:2011-10-08, Days after vaccination: 3
Gender:Male  Submitted:2011-11-22, Days after onset: 45
Location:Foreign  Entered:2011-11-22
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: Body temperature, 08Oct2011, more than 39Deg.; C-reactive protein, 12Oct2011, 16.85mg/dl; Lymphocytes, 12Oct2011, 17%; Lymphocytes, 12Oct2011, 1.5G/l; Monocytes, 12Oct2011, 1.0G/l; Monocytes, 12Oct2011, 11%; White blood cells, 12Oct2011, 9.49G/l
CDC Split Type: B0759731A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: C-reactive protein increased, Chills, Diarrhoea, Headache, Lymphocyte percentage decreased, Monocyte count, Monocyte percentage increased, Nausea, Pain, Pain in extremity, Pyrexia, White blood cell count
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a physician and described the occurrence of diarrhea in a 49-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 5 October 2011, the subject received unspecified dose of FLUARIX (unknown route of administration, unknown site of injection, batch number not provided). On 7 October 2011, 2 days after vaccination with FLUARIX, the subject experienced diarrhea, limb pain, headache, fever and had a value of 16.86 mg/dl for C-reactive protein. At the time of reporting, the outcome of the events was unspecified. Follow up information received on 9 November 2011 and 15 November 2011: The reporter considered the events as clinically significant (or intervention required). Clarifications regarding the onset date of the events have been provided. On 8 October 2011, 3 days after vaccination with FLUARIX, the subject experienced fever over 39 Deg.C, chills, mild nausea, mild shooting pains, diarrhea, limb pain and headache. On 12 October 2011, 7 days after vaccination with FLUARIX, the subject experienced increased of C-reactive protein with a value of 16.86 mg/dl. The subject was treated with MEXALEN 1000 mg to lower body temperature and with AUGMENTIN 1g twice daily over a period of 7 days. On 12 October 2011, result for white blood cells was 9.49 G/l, for lymphocytes was 17 % and 1.5 G/l and for monocytes was 11% and 1.0 G/l. On 16 October 2011, the events were resolved. The reporter considered the events were probably related to vaccination with FLUARIX.

VAERS ID:445104 (history)  Vaccinated:2011-10-21
Age:49.0  Onset:2011-10-21, Days after vaccination: 0
Gender:Female  Submitted:2011-12-08, Days after onset: 48
Location:Foreign  Entered:2011-12-09, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test, normal; CSF culture, No organisms grown
CDC Split Type: PHFR2011GB006971
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test normal, CSF culture negative, Chest pain, Neuropathy peripheral, Pain, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: Case number PHFR2011GB006971 is an initial report from Regulatory Agency (21369707) received on 02 Dec 2011: This report has been transcribed from an Anonymised Single Patient report (ASPR). All reports received from the regulatory authority are considered to be serious. The report refers to a 49-year-old female patient. She was vaccinated with influenza virus vaccine seasonal (batch no: and manufacturer: unknown) on 21 Oct 2011. One hour after received vaccination, the patient developed shooting pains down left arm. On 22 Oct 2011, one day later, the patient developed pins and needles and shooting pain in both feet and hands. The patient was hospitalised on an unknown date. Over four weeks gradual progression of symptoms in an ascending fashion. Patient had onset of pain in chest from an unknown date. There was no weakness in limbs noticed. It was reported that the patient had suspected small fibre neuropathy or possible Guillain-Barre Syndrome. The events were considered life threatening by the reporter. The event outcome of chest pain was unknown whilst the other events were reported as not recovered. The reporter did not provide a causality assessment. By convention reports from the regulatory authority are considered to have implied causal relationship.

VAERS ID:445125 (history)  Vaccinated:2011-10-21
Age:49.0  Onset:2011-10-21, Days after vaccination: 0
Gender:Female  Submitted:2011-12-09, Days after onset: 49
Location:Foreign  Entered:2011-12-12, Days after submission: 3
Life Threatening? Yes
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:
Diagnostic Lab Data:
CDC Split Type: 2011030473
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood test normal, CSF culture negative, Chest pain, Neuropathy peripheral, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: This health regulator report (initial receipt 02-Dec-2011) concerns a 49-year old female patient. On 21 Oct-2011 the patient received influenza vaccine intramuscularly. On 21-Oct-2011, one hour after receiving flu vaccine, the patient developed shooting pains down her left arm. One day later, she developed pins and needles and shooting pain in both feet and hands. Over 4 weeks she had gradual progression of symptoms in an ascending fashion and with onset of pain in chest. No weakness in limbs noticed. The patient had suspected small fibre neuropathy or possible Guillain Barre Syndrome. All blood tests performed were normal. CSF (cerebrospinal fluid) showed no organisms grown. The event outcome was not recovered except for ''pain in chest'' which was reported as unknown. Action taken with drug was not applicable. Rechallenge was unknown. The reporter considered events to be serious as the events caused hospitalisation, was life-threatening and medically significant. The reporter also added ''pain'' as one of the Preferred Terms.

VAERS ID:445244 (history)  Vaccinated:2011-10-21
Age:49.0  Onset:2011-10-21, Days after vaccination: 0
Gender:Female  Submitted:2011-12-12, Days after onset: 52
Location:Foreign  Entered:2011-12-12
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: Fit and well.
Diagnostic Lab Data: Blood test, all tests perfor; CSF culture, no organisms gro
CDC Split Type: B0766511A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blood test, CSF culture negative, Chest pain, Neuropathy peripheral, Pain, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)
Write-up: This case was reported by a regulatory authority (GB-MHRA-EYC 00075777) and described the occurrence of peripheral neuropathy in a 49-year-old female subject who was vaccinated with INFLUENZA (split virion, inactivated). On 21 October 2011 the subject received unspecified dose of INFLUENZA (split virion, inactivated) (intramuscular). On 21 October 2011, 1 hour after vaccination with INFLUENZA (split virion and inactivated), the subject experienced shooting pains down left arm. One day later developed pins and needles and shooting pain in both feet and hands. Over 4 weeks gradual progression of symptoms in an ascending fashion, with onset of pain in chest. No weakness in limbs noticed. Suspected small fibre neuropathy or possible Guillain Barre Syndrome. The subject was hospitalized and the regulatory authority reported that the events were life threatening. At the time of reporting the events were resolved. One hour after receiving flu vaccine developed shooting pains down left arm. One day after developed pins and needles and shooting pain in both feet and hands. Over 4 weeks gradual progression of symptoms in an ascending fashion, with onset of pain in chest. No weakness in limbs notices. Suspected small fibre neuropathy or possible Guillain Barre Syndrome.

VAERS ID:446175 (history)  Vaccinated:2011-11-22
Age:49.0  Onset:2011-11-23, Days after vaccination: 1
Gender:Female  Submitted:2011-12-22, Days after onset: 29
Location:Foreign  Entered:2011-12-22
Life Threatening? No
Died? No
Permanent Disability? Yes
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: A0957202A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA705AA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Anxiety, Arthritis, Injected limb mobility decreased, Injection site inflammation, Muscle spasms, Myositis, Pain, Pain in extremity, Rotator cuff syndrome, Skin warm
SMQs:, Rhabdomyolysis/myopathy (broad), Systemic lupus erythematosus (broad), Dementia (broad), Dystonia (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of injection site inflammation in a 49-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 22 November 2011 the subject received unspecified dose of FLULAVAL (.5 ml, intramuscular, left arm). This case was reported by a healthcare professional via a sales representative and described the occurrence of injection site inflammation in a 49-year-old female subject who was vaccinated with FLUVIRAL (GlaxoSmithKline). On an unspecified date the subject received a dose of FLUVIRAL (unknown route, unknown arm). At an unspecified time after vaccination with FLUVIRAL, the subject experienced inflammation at the site of injection and some reduced mobility in her arm (the arm that she got the vaccine). The subject saw her physician who prescribed some Physiotherapy. At the time of reporting the outcome of the events was unspecified. Follow-up information was received on 8 December 2011 from the healthcare professional via sales representative. The subject also experienced inflammation in her shoulder that reduced her mobility. The outcome of the events was unspecified. Follow-up information was received on 10 December 2011 from a healthcare professional via sales representative. Additional events of anxiety, hotness at injection site and injection arm pain were reported. At the time of reporting, the subject was two and a half weeks after vaccination and was very anxious. The vaccination and events occurred in 2011. In that time, she had missed work for one day. Her physician told her to continue to move while the physiotherapist told her to move less because the inflammation and the pains are constant. The subject felt the post vaccination heat in her arm and the pain were still intense. Follow-up was received on 12 December 2011 from the healthcare professional. The subject saw her physician on 25 November 2011 and went to a private clinic on 3 December 2011 due to the pain. She has another appointment on 23 December 2011. As of 12 December 2011, the pain was always present and she was anxious about the course and effects of this pain. At the time of reporting, the events were unresolved. Follow-up was received on 16 December 2011 from the healthcare professional that upgraded the case to serious. The healthcare professional reported pain left arm as the primary event. Additional events of shooting arm pain, spasm in arm, persistent pain, inflammation arm muscle and impingement syndrome were reported. On 22 November 2011 the subject received a dose of FLUVIRAL (.5 ml, intramuscular, left arm). On 23 November 2011, 1 day after vaccination with FLUVIRAL, the subject experienced pain left arm. On 24 November 2011, she experienced intense shooting pain. On 28 November 2011, she experienced spasm with touch. On 3 December 2011, she experienced persistent pain. On unspecified dates, she experienced muscle inflammation in deltoid and compensatory impingement syndrome. The subject was treated with anti-inflammatory since 28 November 2011. On 3 December 2011, she started physiotherapy. The event of arm pain and persistent pain were unresolved. Shooting pain was resolved with sequelae. The outcome of the event of spasm was unknown. The outcomes of events inflammation arm muscle and impingement syndrome were not reported. The healthcare professional considered the events were disabling. The healthcare professional considered the events of arm pain and shooting pain, spasm and persistent pain as probably related to vaccination with FLUVIRAL. The healthcare professional did not provide causality assessments for the other events. As of 15 December 2011, the pain was still present.

VAERS ID:447020 (history)  Vaccinated:2007-03-05
Age:49.0  Onset:0000-00-00
Gender:Male  Submitted:2012-01-06
Location:Foreign  Entered:2012-01-09, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Blood culture, positive strep pneumo serotype 19A
CDC Split Type: WAES1201USA00295
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood culture positive, Pneumonia streptococcal
SMQs:
Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail form (local ref # AUS/12/0013, OPR293457), concerning a currently 49 year old male patient who was on 29-MAY-2000 was vaccinated SC with a dose of PNEUMOVAX 23 (lot number not reported). On 05-MAR-2007, the patient was vaccinated SC with another dose of PNEUMOVAX 23 (lot number not reported). On an unspecified date, the Patient developed pneumonia with blood culture positive strep pneumo serotype 19A and was hospitalized. On an unspecified date, the patient had recovered. The agency considered that the adverse events were probably related to therapy with PNEUMOVAX 23. The original reporting source was not provided. Additional information is not expected.

VAERS ID:448527 (history)  Vaccinated:2011-10-20
Age:49.0  Onset:2011-10-22, Days after vaccination: 2
Gender:Female  Submitted:2012-02-01, Days after onset: 102
Location:Foreign  Entered:2012-02-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0777605A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB235AI0IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERAC39B033BP IMUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC39B033BP IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthritis, Arthritis bacterial, Joint swelling
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow)
Write-up: This case was reported by a physician via regulatory authority (114858) and described the occurrence of arthritis in a 49-year-old female subject who was vaccinated with BOOSTRIX-POLIO (GlaxoSmithKline) and TWINRIX. On 20 October 2011, the subject received unspecified dose of BOOSTRIX-POLIO (intramuscular, unknown injection site) and 1st dose of TWINRIX (intramuscular, unknown injection site). On 22 October 2011, 2 days after vaccination with BOOSTRIX-POLIO and TWINRIX, the subject experienced left ankle swelling. An orthopedist was visited and the subject was hospitalised due to a suspicion of septic arthritis. The diagnosis could not confirm and the subject was discharged the next day. At the time of reporting the events were resolved. On 18 November 2011, the subject received the second dose of TWINRIX, without any reported adverse event. The regulatory authority reported that the events were possibly related to vaccination with BOOSTRIX-POLIO and TWINRIX.

VAERS ID:450492 (history)  Vaccinated:2011-04-05
Age:49.0  Onset:2011-04-05, Days after vaccination: 0
Gender:Female  Submitted:2012-02-24, Days after onset: 325
Location:Foreign  Entered:2012-02-27, 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:
Diagnostic Lab Data:
CDC Split Type: 2012031210
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER090629501 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest discomfort, Flushing, Paraesthesia, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad)
Write-up: This health authority report (initial receipt: 14-Feb-2012) concerns a 50 year old female patient. On 05-Apr-2011 the patient received 0.5mL dose of influenza virus vaccine inactivated (batch number: 090629501) intramuscularly. On 05-Apr-2011 (1-59 minutes later) the patient experienced chest tightness, throat tightness, flushing and paraesthesia. The event outcome was recovered without sequelae. Upon dechallenge the events showed definite improvement. No rechallenge was performed. The suspect drugs were not reduced. The reporter considered events to be serious (due to intervention) and probable in relation to the suspect drugs.

VAERS ID:450914 (history)  Vaccinated:2009-10-22
Age:49.0  Onset:2009-11-01, Days after vaccination: 10
Gender:Male  Submitted:2012-03-01, Days after onset: 851
Location:Foreign  Entered:2012-03-01
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension Arterial; Lumbar Spondyloarthrosis
Preexisting Conditions:
Diagnostic Lab Data: CSF cell count, Dec2009, 4Mpt/l; Cerebrospinal fluid protein, Dec209, 339mg/l; Electrocardiogram, 18Dec2009, normal; Electroneurography, Dec2009, consistent with; Neurography (18Dec2011): consistent with guillain barren syndrome; nerve potentials of tibial nerves: decreased; nerve conduction velocities of radial and sural nerves: decreased; Magnetic and somatosensory evoked potentials (18Dec2011): increased latencies for both motor and sensory nerves; results consistent with demyelinization
CDC Split Type: D0074549A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA453AB IMLA
Administered by: Other     Purchased by: Other
Symptoms: Areflexia, CSF cell count, CSF protein increased, Demyelination, Electrocardiogram normal, Electroneurography, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Intervertebral disc protrusion, Monoclonal gammopathy, Mycoplasma infection, Nuclear magnetic resonance imaging spinal cord abnormal, Pain, Paraesthesia, Paraparesis, Polyneuropathy, Sciatica, Somatosensory evoked potentials abnormal, Spondylitis
SMQs:, Peripheral neuropathy (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related conditions (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Arthritis (narrow)
Write-up: This case was reported by a physician via a regulatory authority (DE-PEI-PEI2012003703) and described the occurrence of suspected guillain barre syndrome in a 49-year-old male subject who was vaccinated with INFLUSPLIT SSW (GlaxoSmithKline). The authority provided structured information, a questionnaire completed by the original reporter and a hospital reported. Concurrent medical conditions included arterial hypertension. Previous vaccinations with unspecified influenza virus vaccines were well tolerated. On 22 October 2009, the subject received dose of INFLUSPLIT SSW (intramuscular, left deltoid). The following month, in November 2009 (on 23 or 30), the subject experienced symptoms which subsequently were suspected to be signs of guillain barre syndrome (differential diagnosis: polyneuropathy due to monoclonal gammapothy of uncertain significance). According to the questionnaire signs of guillain barre syndrome started on 23 November 2009. According to the hospital report on 30 November 2009 the subject suddenly developed lumbioschialgia. Treatment with ibuprofen and prednisolone lead to an improvement of the associated pain, but paresthesia of both lower legs and finger tips on both sides were persisting. On 18 December 2009 the subject was hospitalized. At the time of hospitalization there were observed signs of bilateral leg paresis (weakness of foot levator, hallux levator, foot pronation and foot supination as well as absent reflexes) and hypesthesia/hypoalgesia of both lower legs. By means of magnetic resonance imaging spondyloarthritis and mild protrusion of lumbar spines 4 and 5 were observed, but intervertebral disc prolapse could be excluded as an origin of the symptoms. In cerebrospinal fluid, protein level and cell counts were normal. Results from neurography (18 December 2011) were consistent with guillain barre syndrome. Nerve potentials of tibial nerves were decreased and nerve conduction velocities of radial and sural nerves were decreased. By means of magnetic and somatosensory evoked potentials (18 December 2011) there were found increased latencies for both motor and sensory nerves. Results were considered consistent with demyelinization. Based on serological testing there was suspected an acute mycoplasma infection. It was not reported whether there were symptoms of infections preceding the neurological symptoms. The subject was treated with ibuprofen, Prednisolon, normal immunoglobulin and Doxycyclin as well as physiotherapy. Signs of leg paresis improved. After fourteen days, on 31 December 2009, the subject was discharged from the hospital. According to the original reporter the events were disabling. It was reported that the patient had not recovered and there were permanent sequelae.

VAERS ID:452685 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2012-03-29
Location:Foreign  Entered:2012-03-29
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: B0791848A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Glaucoma, Intraocular pressure increased, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (narrow), Lens disorders (broad), Retinal disorders (broad)
Write-up: This case was reported in a literature article and described the occurrence of glaucoma in a 49-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 of administration, unknown site of injection, batch number not provided). 4 days after vaccination with ENGERIX B ADULT, the subject experienced increasing ocular pressure and blurred vision related to glaucoma. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the events was unspecified. The vaccination course with ENGERIX B ADULT was discontinued.

VAERS ID:452855 (history)  Vaccinated:2012-03-08
Age:49.0  Onset:2012-03-08, Days after vaccination: 0
Gender:Female  Submitted:2012-04-02, Days after onset: 24
Location:Foreign  Entered:2012-04-03, 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: Previous allergies to dust mites; Previous allergy to grass seed; Previous allergy to crustaceans; Allergic to dust; Allergic to grass
Diagnostic Lab Data:
CDC Split Type: 2012031702
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED090631502 IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Feeling hot, Headache, Hyperhidrosis, Immediate post-injection reaction, Neck pain, Oropharyngeal pain, Pruritus
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: This medically confirmed spontaneous report (initial receipt: 20-Mar-2012) concerns a 49 year old female patient with a medical history of allergies to dust, dust mites, grass, grass seed and crustaceans. She was well on the day of vaccination, had not have a severe reaction following any vaccine, did not suffer from any medical conditions or taking any medications, no history of Guillain-Barre syndrome or paralysis, not pregnant and had not been vaccinated against the flu in previous years. On 08-Mar-2012 at 14:00 the patient received one dose of FLUVAX (batch number: 090631502) intramuscularly in left upper arm for ''flu". The suspect drug was stored in cooled conditions (refrigerator, 2-8 degrees Celsius/35.6-46.4 degrees Fahrenheit). The storage temperature remained the same during storage at reporting site. Immediately (within 30 minutes) after receiving the injection the patient felt pain and sweating at the base of her neck. She became hot and itchy. She waited until 14:00 (as reported) to return to clinic. She complained of abdominal pain with sore throat and headache at based skull. The patient followed up with her nurse and doctor on the same day. Her BP (blood pressure) was 120/60 and 120/70. P (pulse) was 88 (strong). She was given oral cortisone and a referral to an allergy specialist. Following treatment with cortisone the symptoms abated immediately. The nurse called the patient the next day. She was no longer concerned. On 09-Mar-2012 the event outcome was recovered. Dechallenge, rechallenge and previous treatment with the suspect drug were not applicable. Follow up (28-Mar-2012): patient initials, suspect drug (storage condition, route of administration, one dose, indication for use, time of administration, site of administration), additional AE terms, reporter''s seriousness and causality assessment, event outcome, dechallenge, rechallenge, previous treatment with suspect drug, time to onset, event summary description, AE stop date, medical history, case upgraded to serious by company.

VAERS ID:454220 (history)  Vaccinated:2011-06-15
Age:49.0  Onset:2011-06-15, Days after vaccination: 0
Gender:Female  Submitted:2012-04-23, Days after onset: 313
Location:Foreign  Entered:2012-04-23
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: D0075314A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB230AE3IMLA
Administered by: Other     Purchased by: Other
Symptoms: Burning sensation, Pain, Paraesthesia, Vaccination site pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of puncture site pain in a 49-year-old female subject who was vaccinated with TWINRIX ADULT (GlaxoSmithKline). Concurrent medications included LYRICA (3 to 4 times per day). On 15 June 2011 the subject received 4th dose of TWINRIX ADULT (0.5 ml, intramuscular, left upper arm). On 15 June 2011, less than one day after vaccination with TWINRIX ADULT, the subject experienced puncture site pain, possible lesion of a cutaneous nerve upper arm, burning (nos), stitching, throbbing pain and paresthesia. The physician considered the events were clinically significant (or requiring intervention). The subject was treated with ambulatory analgetic therapy. At the time of reporting the events were unresolved. No further information will be available.

VAERS ID:455065 (history)  Vaccinated:2011-10-13
Age:49.0  Onset:2011-11-01, Days after vaccination: 19
Gender:Female  Submitted:2012-05-04, Days after onset: 185
Location:Foreign  Entered:2012-05-04
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: Travel to foreign country
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 01NOv2011, up to 39degC
CDC Split Type: D0075433A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB490AE0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Alopecia, Diarrhoea, Gastroenteritis, Gastrointestinal infection, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a foreign regulatory authority (DE-PEI-PEI2012012896) and described the occurrence of gastroenteritis in a 49-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Past medical history was not provided. Concurrent medical conditions included travel to foreign country. On 13 October 2011 the subject received the first dose of HAVRIX (1 ml, intramuscular, unknown). 19 days after vaccination with HAVRIX, on 01 November 2011, the subject experienced gastroenteritis, severe diarrhea, fever up to 39 degC and diffuse alopecia. The subject was hospitalised for an unknown period of time. In hospital gastrointestinal infection (post travel to a foreign country) and diffuse alopecia were confirmed. Malaria and acute hepatitis were excluded by differential diagnosis. The subject experienced severe diarrhea and fever up to 39 degC for about 14 days. At the time of reporting, on 02 March 2012, the subject had not recovered. The vaccination course with HAVRIX was discontinued. No further information will be available.

VAERS ID:456853 (history)  Vaccinated:2012-04-26
Age:49.0  Onset:2012-04-26, Days after vaccination: 0
Gender:Male  Submitted:2012-06-05, Days after onset: 40
Location:Foreign  Entered:2012-06-06, 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:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1205USA05548
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.G016320 IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature, Lower respiratory tract infection, Nausea, Rales, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was received from a health care professional on 16-MAY-2012. This case is medically confirmed. A 49 year old male received an injection of RECOMBIVAX HB (batch number G016320), route and site not reported, on an unreported date. On an unreported date, following vaccination, the patient stated that he had had a chest infection and fainted. The patient outcome was not report. Follow up received from the initial reporter on 29-MAY-2012: This case has been upgraded to serious. The patient''s date of birth was provided. The patient had no known medical history and was not taking concomitant medication. The patient received two of RECOMBIVAX HB, 1ml, IM in the arm, on 26-APR-2012. On 26-APR-2012, the same day as vaccination, the patient experienced a temperature, collapse, chest crackles and nausea. The patient required first aid treatment in a supermarket. At the time of reporting the patient had not yet recovered and stated that he had "lingering symptoms" on 15-MAY-2012. The events were considered to be serious due to persistent or significant disability or incapacity. They were considered to be severe and it was unknown whether they were related to vaccination. The reporter did not inform the agency. Other business partner numbers included E2012-03365.

VAERS ID:459901 (history)  Vaccinated:2012-07-06
Age:49.0  Onset:0000-00-00
Gender:Male  Submitted:2012-07-20
Location:Foreign  Entered:2012-07-23, 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: None reported.
Diagnostic Lab Data:
CDC Split Type: E201204747
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Diarrhoea, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was received from the health authority on 18-Jul-2012. GB-MHRA-ADR 21756139. The primary reporter is a consumer. This case is not medically confirmed. A 49 year old male patient who was taking concomitant omeprazole for an unknown indication received an injection of TYPHIM VI (batch number not reported), route and site not reported, on 06-Jul-2012. On an unreported date, post vaccination, the patient experienced diarrhoea, was nauseous and had a temperature elevation. At the time of reporting the patient was recovering. The events were considered to be serious due to disability/incapacity.

VAERS ID:460115 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2012-07-24
Location:Foreign  Entered:2012-07-25, 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? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201206912
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEUR  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Gait disturbance, Peripheral sensory neuropathy
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad)
Write-up: Initial information received from a search on the database under reference number 000404135 on 12 July 2012. A 49-year-old female patient had received a 0.5 mL intramuscular injection of Td Adsorbed, sanofi pasteur Ltd. (lot number, site and date of administration not reported). An unspecified amount of time later, the patient experienced gait disturbance and peripheral sensory neuropathy which lasted for 48 hours. The patient was hospitalized (dates not reported). No further information was available at the time of the report. The patient''s outcome was recovered. Documents held by sender: None.

VAERS ID:462510 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2012-08-17
Location:Foreign  Entered:2012-08-20, 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: No other medications
Current Illness: Unknown
Preexisting Conditions: Renal failure chronic, At age 33 she had haematuria, proteinuria, and biopsy proven IgAN that progressed to end-stage renal failure (ESRF), without features of HSP, over 6 years; Renal transplant, Living-related donor renal transplantation occurred at age 41.
Diagnostic Lab Data: Biopsy kidney, Significant, IgA nephropathy, Renal biopsy showed active IgAN with focal crescent formation; Biopsy skin, Significant, Skin biopsy showed leukocytoclastic vasculitis with positive immunofluorescence for IgA; Blood creatinine 100 micromol/L, Normal; Blood creatinine, 102 micromol/L, normal; Blood pressure, 132/77 mmHg; Blood pressure, High, 148/96 mmHg; Glomerular filtration rate, Low, 51 ml/min/1.73 m^2; Glomerular filtration rate, Low, 50 ml/min/1.73 m^2; Urine analysis, 10x10^6/L WBC & RBC, Urinalysis revealed less than 10x10^6/L white and red blood cells (RBC''s), no casts, and total protein creatinine ratio (TPCR) 17.8 g/mol; Urine protein/creatinine ratio, High, 17.8 g/mol; Urine protein/creatinine ratio, High, 658.1 g/mo
CDC Split Type: PHHY2012NZ070904
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Biopsy kidney abnormal, Biopsy skin abnormal, Blood creatinine increased, Coagulation test normal, Glomerular filtration rate decreased, Haematuria, Henoch-Schonlein purpura, Hypertension, IgA nephropathy, Immunology test, Leukocytoclastic vasculitis, Platelet count normal, Proteinuria, Purpura, Red blood cells urine positive, Renal function test normal, Urinary casts present, Urine protein/creatinine ratio increased, White blood cells urine positive
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Hypertension (narrow), Vasculitis (narrow), Skin tumours of unspecified malignancy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad)
Write-up: Case number PHHY2012NZ070904 is an initial literature report received on 15 Aug 2012. Authors presented a case of Henoch-Schonlein Purpura (HSP) and recurrent IgA nephropathy (IgAN) in an renal transplant recipient following influenza vaccination. This case refers to a 49-year old female patient. At age 33 she had hematuria, proteinuria, and biopsy proven IgAN that progressed to end-stage renal failure (ESRF), without features of HSP, over 6 years. She underwent renal transplantation (living-related donor) and at age 41. She was vaccinated with influenza vaccine (manufacturer and batch number: unknown, hence it was considered as influenza unknown INN) on an unspecified date. Ten days after vaccination, she presented with a progressive, palpable purpuric rash. On presentation blood pressure was 132/77 mmHg, serum creatinine 100 micromol/L, and estimated glomerular filtration rate (eGFR) 51 ml/min/1,73 m^2 (Modification of Diet in Renal Disease (MDRD) formula). Urinalysis revealed less than 10x10^6/L white and red blood cells (RBC''s), no casts, and total protein creatinine ratio (TPCR) 17.8 g/mol. Platelet count, coagulation profile, and rapid vasculitis screen were unremarkable. Skin biopsy showed leukocytoclastic vasculitis with positive immunofluorescence for IgA. A diagnosis for HSP was made. Seven weeks later, microscopic hematuria (50-100 x 10^6/L RBC''s) was noted, which persisted at six months, along with development of cellular casts, dysmorphic RBC''s, nephrotic range proteinuria (urine TPCR 658.1 g/mol), and hypertension (148/96 mmHg). Renal function remained stable (creatinine 102 micromol/L, eGFR 50 ml/min/1.73 m^2). Renal biopsy showed active IgAN with focal crescent formation. Influenza vaccination was considered the trigger for HSP, followed by recurrent IgAN. The outcome and seriousness was not reported. Authors concluded that nephrologists should be cognizant of the potential for allograft dysfunction following influenza vaccination in renal transplant recipients whose primary cause of ESRF was HSP or IgAN.

VAERS ID:467716 (history)  Vaccinated:2012-09-19
Age:49.0  Onset:2012-09-19, Days after vaccination: 0
Gender:Female  Submitted:2012-10-04, Days after onset: 15
Location:Foreign  Entered:2012-10-04
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: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHFR2012GB005179
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM10147 IMAR
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Infection, Local reaction, Oedema peripheral, Pain
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Case number PHFR2012GB005179 is an initial spontaneous report received from a pharmacist on 27 Sep 2012: This report refers to an adult female patient. She was vaccinated with MENVEO (batch number: X10147/M10147) intramuscularly in to the deltoid on 19 Sep 2012. On the same day after vaccination, her arm had swelled and it had become red. She met a general practitioner who indicated that she had become infected from injection and started her on antibiotics. The reporter commented that this was more likely to be a local reaction causing pain, resulting in dependent edema in hand. It was suggested that she could continue antibiotics treatment. No further information about causality, outcome and seriousness was provided.

VAERS ID:470895 (history)  Vaccinated:2012-08-24
Age:49.0  Onset:2012-08-25, Days after vaccination: 1
Gender:Female  Submitted:2012-10-22, Days after onset: 58
Location:Foreign  Entered:2012-10-23, 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:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0839038A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B082BB0SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis, Generalised erythema, Oedema, Vaccination site swelling, Vaccination site warmth
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: This case was reported by a health professional via a regulatory authority (ES-AGEMED-025512341) and described the occurrence of cellulitis in a 49-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 24 August 2012, the subject received 1st dose of BOOSTRIX (unknown route and injection site). On 25 August 2012, 1 day after vaccination with BOOSTRIX, the subject experienced vaccination site swelling. In August 2012, less than one week after vaccination with BOOSTRIX, the subject experienced cellulitis, edema, generalized erythema over the whole limb and vaccination site warmth. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with URBASON (100mg IM) and physical measures. At the time of reporting the vaccination site swelling was unresolved and the outcome of cellulitis, edema, generalized erythema and vaccination site warmth was unspecified. The vaccination course with BOOSTRIX was discontinued. The regulatory authority reported that the events were possibly related to vaccination with BOOSTRIX.

VAERS ID:473142 (history)  Vaccinated:2012-10-16
Age:49.0  Onset:2012-10-16, Days after vaccination: 0
Gender:Female  Submitted:2012-11-01, Days after onset: 16
Location:Foreign  Entered:2012-11-02, Days after submission: 1
Life Threatening? Yes
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: 2012033801
Vaccination
Manufacturer
Lot
Dose
Route
Site
LYME: LYME (NO BRAND NAME)UNKNOWN MANUFACTURER23049411A IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dry throat, Malaise, Nausea, Pruritus
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad)
Write-up: This health authority report (initial receipt 26-Oct-2012) concerns a 49-year-old female patient, who had vaccines before with no problem. She was given the same vaccine in last years flu campaign. On 16-Oct-2012, the patient received ENZIRA (batch number: ''230494411A'') at a dose of 0.5 mL intramuscularly. On 16-Oct-2012, 2 minutes after vaccination, the patient started feeling itchy in the palm of her hands. She then started feeling unwell, nausea and dry throat. Oxygen was administered, cannula was put in arm and intravenous PIRITON and metoclopramide were administered by an attending doctor. The event outcome was recovered on 16-Oct-2012. Reporter''s comment: The reporter considered events to be serious as they were considered life-threatening.

VAERS ID:476020 (history)  Vaccinated:2012-10-15
Age:49.0  Onset:2012-10-16, Days after vaccination: 1
Gender:Male  Submitted:2012-12-03, Days after onset: 48
Location:Foreign  Entered:2012-12-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: METOJECT; SALAZOPYRIN
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: CRP: 130; Leukocytes:13,3; CRP: 39 (21-Oct-2012); C-reactive protein, 130; 10/21/2012, C-reactive protein, 39; White blood cell count, 13.3
CDC Split Type: WAES1211FIN010976
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: C-reactive protein increased, Erysipelas, Erythema, Pain in extremity, Pyrexia, Skin warm, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad)
Write-up: Serious case reported on 21-Nov-2012 by Health Authority (HA ref. FI-FIMEA-20121282). The primary reporter is a physician. The case is medically confirmed. It was reported that a 49-years old male patient (initial unknown) was vaccinated with PNEUMOVAX (batch number G014487) on the 15-Oct-2012. As a basic disease the patient has spondylarthritis ancyclopoetica. As a basic medication for that the patient has METOJECT (dosage not reported) and SALAZOPYRIN. One day after from vaccination (16-Oct-2012) the patient experienced fever and had redness, hotness and pain in his left arm. The patient was hospitalized from 18-Oct-2012 to 21-Oct-2012. At the time of the beginning of the hospitalization the patient had large redness and hotness in his left arm on area of 5 x 10 cm. During the hospitalization the CRP values was 130 (units not reported) as highest and Leukocytes was 13,3 (units not reported) as highest. The patient was administered ZINACEF (dosage not reported) three times daily intravenously and his basic medication METOJECT and sulphasalzine was put on hold for not reported period. On 21-Oct-2012 patient''s CRP was 39 (units not reported). As home treatment, the patient was prescribed KEFEXIN treatment (dosage not reported). HA has coded medical term "Erysipelas", but this is not mentioned as such in HA case narrative. In additional to HA medical codes, MA-holder has coded "Fever". The outcome is reported as "Not recovered/Not resolved" by HA. The case is closed.

VAERS ID:478926 (history)  Vaccinated:2012-11-29
Age:49.0  Onset:2012-11-29, Days after vaccination: 0
Gender:Female  Submitted:2012-12-20, Days after onset: 21
Location:Foreign  Entered:2012-12-20
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: D0078198A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC062AB IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure increased, Dizziness, Flushing, Pain, Renal pain, Respiratory distress
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Hypertension (narrow), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: This case was reported by a physician via a regulatory authority (# DE-PEI-PEI2012064265) and described the occurrence of increased blood pressure in a 49-year-old female subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). The subject did not drink or smoke and did not take any concurrent medication. On 29 November 2012 at 13:00 the subject received a dose of ENGERIX B adult (1 ml, intramuscular). In the late evening of the same day, on 29 November 2012, the subject developed increased blood pressure, dizziness, flushing, pain, renal pain and respiratory distress. The subject was hospitalised immediately. At the time of reporting the subject was still at the hospital and the events were unresolved. According to the reporting physician the events were unrelated to vaccination with ENGERIX B adult.

VAERS ID:479496 (history)  Vaccinated:2010-03-03
Age:49.0  Onset:2010-03-03, Days after vaccination: 0
Gender:Female  Submitted:2012-12-21, Days after onset: 1024
Location:Foreign  Entered:2012-12-27, Days after submission: 6
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: Personal medical history: hypothyroidism; Family medical history: not reported.
Diagnostic Lab Data: Not reported
CDC Split Type: 201212291
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Arthralgia, Back pain, Chest pain, Chills, Diarrhoea, Headache, Malaise, Nasopharyngitis, Pyrexia, Rhinorrhoea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Noninfectious diarrhoea (narrow)
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. A 49-year-old female patient, with a medical history of hypothyroidism, had received a dose of H1N1 (manufacturer unknown, batch number, route and anatomical site of administration not reported) on 03 March 2010. The AE start date was reported as 03 March 2010. The patient was initially diagnosed with rhinopharyngitis. The final diagnosis was rhinopharyngitis. The following additional AEs were reported: arthralgia, cephalea, diarrhoea, abdominal and thoracic pain, chills, fever, low back pain, general malaise and rhinorrhea. The patient''s outcome was not reported. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. The clinical classification was reported as moderate. The causality as concluded by the Ministry of Health was coincidental. Documents held by sender: None.

VAERS ID:479497 (history)  Vaccinated:2010-02-24
Age:49.0  Onset:2010-02-24, Days after vaccination: 0
Gender:Male  Submitted:2012-12-21, Days after onset: 1031
Location:Foreign  Entered:2012-12-27, Days after submission: 6
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: Personal medical history of systemic arterial hypertension and diabetes mellitus
Diagnostic Lab Data: Not reported
CDC Split Type: 201212314
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Cough, Local reaction, Myalgia, Pneumonia, Pneumonitis, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Arthritis (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 49-year-old male patient, with a medical history of systemic arterial hypertension and diabetes mellitus, had received a dose of H1N1 vaccine (manufacturer unknown, batch number, route and anatomical site of administration not reported) on 24 February 2010. The AE start date was reported as 24 February 2010. The patient was initially diagnosed with pneumonitis. The final diagnosis was pneumonitis. The following additional AEs were reported: arthralgia, fever, myalgia, pneumonia, local reaction and cough. The patient''s outcome was not reported. The clinical classification was reported as moderate. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. The causality as concluded by the Ministry of Health was coincidental. Documents held by sender: None.

VAERS ID:479914 (history)  Vaccinated:2010-01-20
Age:49.0  Onset:2010-01-26, Days after vaccination: 6
Gender:Male  Submitted:2012-12-26, Days after onset: 1065
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: No past medical history.
Diagnostic Lab Data: Not reported
CDC Split Type: 201212418
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)SANOFI PASTEURUP07244 UNUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER2526090831 UNUN
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER428180738 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Laryngospasm, Local reaction, Lymphadenopathy, Pyrexia, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Hypersensitivity (narrow), Arthritis (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 1/29/2010). A 49-year-old male patient, with no past medical history, had received a dose of pandemic influenza vaccine (Sanofi Pasteur), batch number UP07244 with an expiration date of May 2011, Hepatitis B vaccine (Probiomed), batch number 2526090831 with an expiration date of February 2011 and diphtheria and tetanus toxoids (Birmex), batch number 428180738 with an expiration date of September 2010 (route and anatomical site of administration not reported) on 20 January 2010. The AE start date was reported as 26 January 2010. The patient was initially diagnosed with laryngospasm and arthralgia. The final diagnosis was laryngospasm. The following additional AEs were reported: adenopathy, arthralgia, laryngeal spasm, fever, local reaction, and rhinorrhea. The patient''s outcome was not reported. The case was assessed as serious by the Ministry of Health. The patient was not hospitalized. The causality as concluded by the Ministry of Health was coincidental (not related to the vaccine) Documents held by sender: None.

VAERS ID:487918 (history)  Vaccinated:2012-10-22
Age:49.0  Onset:2013-03-01, Days after vaccination: 130
Gender:Female  Submitted:2013-03-27, Days after onset: 25
Location:Foreign  Entered:2013-03-27
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: B0873680A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA748AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Chills, Cough, Eye pain, Headache, Influenza, Malaise, Myalgia, Nasal congestion, Rhinorrhoea, Sneezing, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Glaucoma (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: This case was reported by a physician who is also the subject and described the occurrence of influenza in a 49-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). In December 2012, the subject received unspecified dose of FLUARIX (administration site and route unknown, batch number not provided). In March 2013, 3 months after vaccination with FLUARIX, the subject experienced influenza. This case was assessed as medically serious by GSK due to vaccination failure. At the time of reporting, the events were unresolved. The physician considered the event was probably related to vaccination with FLUARIX. Follow-up information received in 19 March 2013: On 22 October 2012, the subject received unspecified dose of FLUARIX. On 3 March 2013, 4 months after vaccination with FLUARIX, the subject experienced influenza. The symptoms started with sneezing, little rhinorrhea, nasal congestion and headache. On 4 March 2013, the nasal congestion intensified and it was associated to a general unwell feeling, light retro-ocular pain, generalized myalgia, dry cough and shivering. The body temperature was not registered. On 5 March 2013, the symptoms persisted with marked myalgia and cough. The subject was treated with paracetamol, NOLOTIL and diclofenac. On 8 March 2013, the events were improved. On 15 March 2013, dry cough was still unresolved.

VAERS ID:489879 (history)  Vaccinated:2013-04-04
Age:49.0  Onset:2013-04-05, Days after vaccination: 1
Gender:Male  Submitted:2013-04-24, Days after onset: 19
Location:Foreign  Entered:2013-04-24
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: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1304DEU013552
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H015504 UNLA
Administered by: Other     Purchased by: Other
Symptoms: Circulatory collapse, Hypersensitivity, Infection, Injection site pain, Injection site swelling, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Case was received from the Health Authorities on 18-Apr-2013 (reference no. PEI2013021192). Case is medically confirmed. A 49-year-old male patient received a dose of PNEUMOVAX 23 (lot-no. H015504) into the left upper arm on 04-Apr-2013. 24 hours later, on 05-Apr-2013, he developed an allergic reaction (not otherwise specified) lasting for 3 days. Less than 24 hours p.v. he experienced circulatory collapse, fever, infection, swelling and pain of the left arm and shoulder. The patient was hospitalised. At the time of reporting to local Health Authorities on 08-Apr-2013 he had not recovered from circulatory collapse, fever, infection (not otherwise specified), swelling and pain of the left arm and shoulder. He had recovered from allergic reaction.

VAERS ID:490609 (history)  Vaccinated:2001-03-30
Age:49.0  Onset:0000-00-00
Gender:Male  Submitted:2013-04-30
Location:Foreign  Entered:2013-04-30
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: Biopsy muscle, 20Jan2003, see lab text; 20JAN2003, Left deltoid muscle biopsy, tissues frozen, embedded in paraffin with immunohistochemical staining (including hematein eosine, Masson Trichrome, oxidative reaction to NADHTR, mitochondria cox reaction, PAS and black Sudan): histological muscle structure at the limit of normality without obvious myocytic abnormality, inflammatory infiltrate or vascularitis, no evidence of mitochondrial overload or dysfunction, 2 dense macrophagic infiltrates in fascia with a nodule aspect, strongly PAS positive and in their periphery other infiltrates of macrophage and lyphocytes, presence of some giant cells related to a foreign matter in one nodular macrophagic infiltrate. Conclusion: Lesions of macrophagi
CDC Split Type: B0887224A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Biopsy muscle abnormal, Myofascitis
SMQs:, Rhabdomyolysis/myopathy (broad), Malignancy related therapeutic and diagnostic procedures (narrow)
Write-up: This case was reported by the regulatory authority (reference PC20130219) and described the occurrence of macrophagic myofasciitis in a 51-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline), GENHEVAC B (non-gsk), rabies vaccine (non-gsk), TYPHIM VI (non-gsk), MENINGITEC (non-gsk), REVAXIS (non-gsk) and DTPOLIO (non-gsk) and IXIARO (non-gsk). Medical conditions if any were not specified. Vaccinal history included: HAVRIX on 15 June 1994, 15 July 1994 (drug dose interval too short), 12 July 1995 and 30 March 2001 (extra dose) GENHEVAC B on 13 April 1994, 11 May 1994, 15 June 1994, 12 July 1995 and 09 April 2001. TYPHIM VI on 11 May 1994, 25 July 1994 and 30 March 2001). MENINGITEC on 13 April 1994, 25 July 1997 (batch A041-2) and 09 April 2001. Rabies vaccine on 13 April 1994 and 11 May 1994. IXIARO on 08 August 1994 and 22 August 1994. DTPOLIO in June 1991 and on 25 July 1994. REVAXIS on 09 April 2001. For all vaccines, batch number (if not specified) and route of administration (intramuscular or subcutaneous). HAVRIX on 15 June 1994, 15 July 1994 (drug dose interval too short), 12 July 1995 and 30 March 2001 (extra dose) GENHEVAC B on 13 April 1994, 11 May 1994, 14 June 1994, 12 July 1995 and 09 April 2001 TYPHIM VI on 11 May 1994, 25 July 1994 and 30 March 2001, MENINGITEC on 13 April 1994, 25 July 1997 (batch A041-2) and 09 April 2001. Rabies vaccine on 13 April 1994 and 11 May 1994. IXIARO on 08 August 1994 and 22 August 1994. DTPOLIO in June 1991 and on 25 July 1997. REVAXIS on 09 April 2001. For all vaccines, batch number (if not specified) and route of administration (intramuscular or subcutaneous) were unspecified. On 20 January 2003, a left deltoid muscle biopsy showed lesions of macrophagic myofasciitis. The regulatory authority reported that the event was disabling. At the time of reporting the event was unresolved. According to the agency, based on the method of assessment, the macrophagic myofasciitis was dubiously related to vaccination with HAVRIX, GENHEVAC B, TYPHIM VI, MENINGITEC, Rabies vaccine, IXIARO and REVAXIS.

VAERS ID:490911 (history)  Vaccinated:2001-04-09
Age:49.0  Onset:2003-01-20, Days after vaccination: 651
Gender:Male  Submitted:2013-05-03, Days after onset: 3755
Location:Foreign  Entered:2013-05-06, 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: The patient had received the following vaccines: One dose of DT POLIO MERIEUX, batch number not reported) in Jun-1991; four doses of GENHEVAC (batch number not reported) on 13-Apr-1994, 11-May-1994, 15-Jun-1994, 12-Jul-1995; One dose of VACCIN RABIQUE MERIEUX (batch number not reported) on 13-Apr-1994; Two doses meningococcal vaccine C or A+C (MFR UNK) on 13-Apr-1994, 25-Jul-1997 (batch number AO41 -2); Two doses of TYPHIM VI (batch number not reported) on 11-May-1994, 25-Jul-1997; Three doses of HAVRIX (batch number not reported) on 15-Jun-1994, 15-Jul-1994, 12-Jul-1995; One dose of IXIARO (batch number not reported) on 08-Aug-1994
Diagnostic Lab Data:
CDC Split Type: E201303173
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTIPV: DT + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 4UNUN
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Biopsy muscle abnormal, Myofascitis
SMQs:, Rhabdomyolysis/myopathy (broad), Malignancy related therapeutic and diagnostic procedures (narrow)
Write-up: Initial case received on 25-Apr-2013 from the agency (Agency number PC20130219). Case is medically confirmed. Information was provided by the reference center for neuromuscular disease. A 51-year-old male patient, was vaccinated with two doses of DT POLIO MERIEUX (batch number not reported) in Jun-1991 and on 25-Jul-1997, five doses of GENHEVAC (batch number not reported) on 13-Apr-1994, 11-May-1994, 15-Jun-1994, 12-Jul-1995 and 09-Apr-2001, two doses of VACCIN RABIQUE MERIEUX (batch number not reported) on 13-Apr-1994 and 11-May-1994, three doses of groups a and c neisseria meningitis vaccine (OTHER MFR) on 13-Apr-1994, 25-Jul-1997 (batch number A041 -2) and 09-Apr-2001, three doses of TYPHIM VI (batch number not reported) on 11-May-1994, 25-Jul-1997 and 30-Mar-2001, four doses of HAVRIX (batch number not reported) on 15-Jun-1994, 15-Jul-1994, 12-Jul-1995 and 30-Mar-2001, two doses of IXIARO (batch number not reported) on 08-Aug-1994 and 22-Aug-1994 and a dose of REVAXIS (batch number not reported) on 09-Apr-2001. All these vaccine were considered as suspect. It is not specified if the vaccines were administered via intramuscular or subcutaneous route. In 2003 the patient experienced macrophagic myofasciitis. In 20-Jan-2003: a muscle biopsy was performed. Left deltoid muscle, fascia and panniculus fragments were examined on cryosections and after fixation of parafin. The cryosections were stained with Hematoxylin Eosin, Masson''s trichrome, NADHTR, Cox, PAS and Sudan black. In the examined fragment, the muscle presented a histological architecture within normal limits, without myocyte anomaly. No inflammatory infiltrate or vasculitis was observed. No histological evidence of overload pathology or mitochondria dysfunction. Presence in the fascia of two dense macrophagic infiltrates with a nodular appearance which were highly positive with the PAS strain. Presence of others macrophagic and lymphocytic infiltrates around these two lesions. Presence of a giant cell related to a foreign body within nodular macrophagic infiltrate. These findings are characteristic of macrophagic myofasciitis lesions. Occlusion: Muscle with normal histological appearance. Macrophagic myofasciitis lesion was present within fascia. The patient has not recovered. According to the method assessment, the causal relationship was assessed as C1S1 doubtful for all suspect vaccines. To be noted that there is an inconsistency for the meningococcal vaccine. MENINGITEC is reported and also MENINGO A+C.

VAERS ID:491585 (history)  Vaccinated:2012-08-13
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2013-05-15
Location:Foreign  Entered:2013-05-15
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: Immunisation; Acromegaly; Pituitary tumour benign; Rheumatic disorder
Preexisting Conditions: 04/12/2012, GARDASIL, Alopecia; 04/12/2012, GARDASIL, Arthralgia; 04/12/2-12, GARDASIL, Weight decreased; 04/12/2012, GARDASIL, Fluid retention; 02/02/2012, GARDASIL, Alopecia; 02/02/2012, GARDASIL, Arthralgia; 02/02/2012, GARDASIL, Weight decreased; 02/02/2012, GARDASIL, Fluid retention
Diagnostic Lab Data:
CDC Split Type: WAES1305DEU007304
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alopecia, Arthralgia, Fluid retention, Vaccination complication, Weight increased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)
Write-up: Case was received from a physician on 07-May-2013. Case is medically confirmed. A 49-year-old female patient with a medical history of rheumatism, pituitary adenoma and acromegaly, had received the third dose of GARDASIL (lot no., route, administration site not reported) on 13-Aug-2012. On an unspecified date after vaccination the patient developed water retention with an increase of weight up to 7kg. joint pain and hair loss. The patient was hospitalized for an unspecified time. According to the hospital physicians, the reaction was related to vaccination. The patient had experienced similar symptoms (water retention, weight decreased, joint pain and hair loss) after D1 of GARDASIL given on 02-Feb-2012 and D2 given on 12-Apr-2012. The outcome was not reported.

VAERS ID:492813 (history)  Vaccinated:2013-05-01
Age:49.0  Onset:2013-05-01, Days after vaccination: 0
Gender:Female  Submitted:2013-05-29, Days after onset: 28
Location:Foreign  Entered:2013-05-30, 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:
Diagnostic Lab Data:
CDC Split Type: 2013036233
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED090635682 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bradycardia, Face injury, Loss of consciousness, Malaise, Respiratory rate decreased, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This health authority report (initial receipt 17-May-2013) concerns a 49-year-old female patient. On 01-May-2013, the patient received FLUVAX (batch number: 090635682, incorrect batch number) 1 dose unspecified intramuscularly. On 01-May-2013, 5 minutes after vaccination the patient stated that she didn''t feel well and fainted face first onto the floor. She was unconscious for 2-3 minutes and developed bradycardia and slow breathing. The patient was put on her side and treated with oxygen. She was transferred by ambulance to hospital. No further information was provided. The outcome of the event was unknown. Reporter''s comment: The health authority considered the events as possible in relation to FLUVAX.

VAERS ID:495682 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2013-07-01
Location:Foreign  Entered:2013-07-02, 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: Ciclosporin; Prednisone; Azathioprine; Diltiazem; Ranitidine
Current Illness:
Preexisting Conditions: Hypertension; Gastro-oesophageal reflux disease; IgA Nephropathy (that progressed to end-stage renal failure); Kidney transplant
Diagnostic Lab Data: Glomerular filtration rate, 51 ml/min/l. 73m^2; Red blood cells 50-100x10^6 /L; Serum creatinine, 100, umol/L; Total urine protein: creatinine ratio, 658.1 g/mol; Total urine protein: creatinine ratio, 17.8 g/mol; Urinalysis, Red blood cells, <10x10^6 /L; White blood cells, <10x10^6 /L
CDC Split Type: 2013036717
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Antineutrophil cytoplasmic antibody negative, Biopsy skin abnormal, Blood creatinine increased, Coagulation test normal, Condition aggravated, Coombs direct test, Coombs indirect test, Glomerular filtration rate decreased, Glomerulonephritis, Haematuria, Henoch-Schonlein purpura, Hypertension, IgA nephropathy, Kidney fibrosis, Laboratory test normal, Leukocytoclastic vasculitis, Oedema, Palpable purpura, Proteinuria, Purpura, Rash, Red blood cell morphology abnormal, Red blood cells urine positive, Streptococcus test negative, Urinary casts, Urine protein/creatinine ratio, White blood cells urine positive
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Vasculitis (narrow), Skin tumours of unspecified malignancy (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Myelodysplastic syndrome (broad), Tumour lysis syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad)
Write-up: This literature report (initial receipt 18-Jun-2013) concerns a 49-year-old female patient. Medical history included hypertension, gastro-oesophageal reflux disease and biopsy-proven Immunoglobulin A Nephropathy (IgAN) at age 33 that progressed to end-stage renal failure (ESRF) over 6 years, without features of Henoch-Schonlein purpura (HSP). At age 41, she underwent uncomplicated 3/6 human leucocyte antigen mismatch, living-related donor, kidney transplant. Baseline creatinine after transplant was 90-105 mol/L, without microscopic haematuria or proteinuria. She had previously received ''FLUVAC'' after transplantation without incident. Concomitant medications included cyclosporin A 75 mg twice daily, prednisone 10 mg daily, azathioprine 125 mg daily, diltiazem 360 mg daily, and ranitidine 150 mg daily. The patient received annual seasonal influenza vaccination ''FLUVAC'' (manufacturer and batch number not specified). 10 days after vaccination she presented with a progressive, palpable, purpuric rash involving the limbs. There was no arthralgia, fever, abdominal pain, haematuria, recent infection, or overseas travel. She was afebrile, normotensive (132/77mmHg) with no other examination abnormalities. On initial presentation, full blood count and coagulation profile were normal. Serum creatinine was 100 mol/L, and the estimated glomerular infiltration rate (eGFR) was 51 mL/min/1.73 m^2 [Modification of Diet in Renal Disease (MDRD) formula]. Urinalysis revealed <10x10^6/L white blood cells and <10x10^6/L red blood cells (RBCs), no casts and total urine protein: creatinine ratio (TPCR) 17.8 g/mol. Anti-neutrophil cytoplasmic antibodies, antiglobulins and streptococcal serology were unremarkable. Skin biopsy revealed leucocytoclastic vascultis with positive immunofluorescence for IgA. A diagnosis of HSP was made. Purpura resolved at 4-months follow-up. Seven weeks after the onset of purpura, there was microscopic haematuria (50-100x10^6/L RBCs) which persisted for 6 months, along with the development of cellular casts, dysmorphic RBCs, nephrotic range proteinuria (urine TPCR 658.1 g/ml), oedema and worsening hypertension (148/96 mmHg). Renal function remained stable [creatinine 102 mol/L, eGFR (MDRD) 50 mL/min/ 1.73 m^2]. Allograft biopsy showed active IgAN, with focal cellular or fibrocellular crescents in 4 of 25 glomeruli and moderate (2+) mesangial staining for IgA. There was minor interstitial fibrosis and no features of rejection. Cilazapril 1 mg daily and frusemide 40 mg daily were introduced for hypertension, proteinuria and oedema. Influenza vaccination was considered to be the trigger of HSP with subsequent development of IgAN. Microscopic haematuria and proteinuria persisted for 12 months without deterioration in renal function. ''Fluvac'' successfully prevented influenza infection, but she was advised to avoid future influenza vaccination. At the 12 month follow-up, the patient had evidence of active glomerulonephritis with enduring microscopic haematuria and proteinuria. Reporter''s comment: The author stated that The temporal relationship (10 days) between vaccination and purpura was consistent with the reported latency of 11.7 days (range 1-22 days).

VAERS ID:496196 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2013-07-04
Location:Foreign  Entered:2013-07-05, 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: Cyclosporin; Prednisone; Azathioprine; Diltiazem; Ranitidine
Current Illness:
Preexisting Conditions: Medical history included hypertension, gastro-oesophageal-reflux disease and biopsy-proven IgAN at age 33 that progressed to end-stage renal failure (ESRF) over 6 years, without features of Henoch-Schonlein purpura (HSP). At age 41, she underwent uncomplicated 3/6 human leucocyte antigen mismatch, living-related donor, kidney transplant. Medications included cyclosporin A 75 mg twice daily, prednisone 10 mg daily, azathioprine 125 mg daily, diltiazem 360 mg daily, and ranitidine 150 mg daily. Baseline creatinine after transplant was 90-105 umol/L, without microscopic haematuria or proteinuria. She had previously received ''FLUVAC'' after transplantation without incident.
Diagnostic Lab Data: On initial presentation, full blood count and coagulation profile were normal. Serum creatinine was 100 umol/L, and the estimated glomerular filtration rate (eGFR) was 51 mL/min/1.73m2 (Modification of Diet in Renal Disease MDRD) formula). Urinalysis revealed <10x10^6/L white and <10x10^6/L red blood cells (RBCs), no casts and total urine protein: creatinine ratio (TPCR) 17.8 g/mol. Anti-neutrophil cytoplasmic antibodies, antiglomerular basement membrane antibody, anti-nuclear antibody, rheumatoid factor, complement, serum cryoglobulins and streptococcal serology were unremarkable. Skin biopsy revealed leucocytoclastic vasculitis with positive immunofluorescence for IgA. Seven weeks after the onset of purpura, there was microscopic haematu
CDC Split Type: 201307385
Vaccination
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Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anti-glomerular basement membrane antibody negative, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Biopsy kidney abnormal, Biopsy skin abnormal, Blood creatinine increased, Complement factor normal, Condition aggravated, Creatinine urine normal, Cryoglobulins absent, Full blood count normal, Glomerular filtration rate normal, Haematuria, Henoch-Schonlein purpura, Hypertension, IgA nephropathy, Immunology test abnormal, Leukocytoclastic vasculitis, Oedema, Palpable purpura, Proteinuria, Red blood cells urine positive, Rheumatoid factor negative, Urinary casts present, Urine protein/creatinine ratio, Urine protein/creatinine ratio increased, White blood cells urine positive
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Vasculitis (narrow), Skin tumours of unspecified malignancy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad)
Write-up: Case retrieved from the literature on 25 June 2013. A 49-year-old female patient presented with a progressive, palpable, purpuric rash involving the limbs, 10 days after ''FLUVAC'' (manufacturer unknown, batch number, route and site of administration not reported) on an unspecified date. There was no arthralgia, fever, abdominal pain, haematuria, recent infection, or overseas travel. She was afebrile, normotensive (132/77 mmHg) with no other examination abnormalities. Medical history included hypertension, gastro-oesophageal-reflux disease and biopsy-proven IgAN at age 33 that progressed to end-stage renal failure (ESRF) over 6 years, without features of Henoch-Schonlein purpura (HSP). At age 41, she underwent uncomplicated 3/6 human leucocyte antigen mismatch, living-related donor, kidney transplant. Medications included cyclosporin A 75 mg twice daily, prednisone 10 mg daily, azathioprine 125 mg daily, diltiazem 360 mg daily, and ranitidine 150 mg daily. Baseline creatinine after transplant was 90-105 umol/L, without microscopic haematuria or proteinuria. She had previously received ''FLUVAC'' after transplantation without incident. On initial presentation, full blood count and coagulation profile were normal. Serum creatinine was 100 umol/L, and the estimated glomerular filtration rate (eGFR) was 51 mL/min/1.73m2 (Modification of Diet in Renal Disease (MDRD) formula). Urinalysis revealed <10x10^6/L white and <10x10^6/L red blood cells (RBCs), no casts and total urine protein: creatinine ratio (TPCR) 17.8 g/mol. Anti-neutrophil cytoplasmic antibodies, antiglomerular basement membrane antibody, anti-nuclear antibody, rheumatoid factor, complement, serum cryoglobulins and streptococcal serology were unremarkable. Skin biopsy revealed leucocytoclastic vasculitis with positive immunofluorescence for IgA. A diagnosis of HSP was made. Purpura resolved at 4-months follow-up. Seven weeks after the onset of purpura, there was microscopic haematuria (50-100x10^6/L RBCs) which persisted for 6 months, along with the development of cellular casts, dysmorphic RBCs, nephrotic range proteinuria (urine TPCR 658.1 g/mol), oedema and worsening hypertension (148/96 mmHg). Renal function remained stable (creatinine 102 umol/L, eGFR (MDRD) 50 mL/min/1.73 m2). Allograft biopsy showed active IgAN, with focal cellular or fibrocellular crescents in 4 of 25 glomeruli, and moderate (2+) mesangial staining for IgA. there was minor interstitial fibrosis and no features of rejection. Cilazapril 1 mg daily and frusemide 40 mg daily were introduced for hypertension, proteinuria and oedema. Influenza vaccination was considered to be the trigger of HSP with subsequent development of IgAN. Microscopic haematuria and proteinuria persisted for 12 months without deterioration in renal function. ''FLUVAC'' successfully prevented influenza infection, but she was advised to avoid future influenza vaccination. The case was considered as serious due to other important medical condition.

VAERS ID:498691 (history)  Vaccinated:2013-03-22
Age:49.0  Onset:2013-03-22, Days after vaccination: 0
Gender:Female  Submitted:2013-08-06, Days after onset: 137
Location:Foreign  Entered:2013-08-07, 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: Atorvastatin; Citalopram; Amlodipine; Bendrofluazide
Current Illness:
Preexisting Conditions: Known allergy; Other medical conditions
Diagnostic Lab Data:
CDC Split Type: 2013037120
Vaccination
Manufacturer
Lot
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Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED090636101 SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: VIIth nerve paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: This health authority report (initial receipt 24-Jul-2013) concerns a 49 year old female patient with known allergy and other medical conditions. Concomitant medications included atorvastatin, citalopram for depression, amlodipine and bendrofluazide for essential (primary) hypertension. On 22-Mar-2013, the patient received influenza virus vacc - seasonal (batch: 0906-36101) via subcutaneous route at a dose of 0.5 ml. On 22-Mar-2013, within 12 hours after vaccination, the patient developed Bells Palsy. There was definite improvement on dechallenge. Rechallenge was not performed. The event outcome was not yet recovered. Reporter''s comments: The reporter considered events non serious and possible in relation to the suspect drug.

VAERS ID:499753 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2013-08-16
Location:Foreign  Entered:2013-08-19, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: She had no significant past medical history or family history of muscle problems. There was no history of recent trauma. She was not on any medications including herbal or over the counter medications or supplements. She reports completion of childhood vaccinations with previous tetanus vaccination more than 10 years ago. She had not received Tdap vaccination earlier.
Diagnostic Lab Data: Initial investigations revealed rhabdomyolysis with a serum CK level of 91,000 U/L, and alanine aminotransferase of 306 U/L. Urinalysis showed no leucocytes, no erythrocytes, and 3b blood products. Urine myoglobin was significantly elevated at 51,306 mg/L. Full blood count showed an elevated white cell count with a neutrophils of 19.8x10&^9/L, low calcium 2.03 mmol/L and an elevated C reactive protein 78 mg/L. Autoimmune screen revealed a low titre antinuclear antibody (ANA) although double stranded DNA, extractable nuclear antigen (ENA), and myositis-specific autoantibodies were all negative. Erythrocyte sedimentation rate (ESR), serum complements (C3 and C4), blood cultures, urine cultures and CXR were normal. Serology for cytomegalovirus
CDC Split Type: 201309441
Vaccination
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Site
TDAP: TDAP (ADACEL)SANOFI PASTEUR  SYRLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Antinuclear antibody negative, Asthenia, Autoantibody negative, Blood calcium decreased, Blood creatine phosphokinase increased, Blood culture negative, C-reactive protein increased, Chest X-ray normal, Chromaturia, Complement factor C3, Complement factor C4, Complement factor normal, Cytomegalovirus test negative, Double stranded DNA antibody, Dysstasia, Epstein-Barr virus test negative, Fatigue, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Legionella test, Malaise, Muscular weakness, Myalgia, Mycoplasma test, Myoglobin urine present, Neutrophil count increased, Oedema peripheral, Pain, Red blood cell sedimentation rate normal, Rhabdomyolysis, Swelling, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (narrow), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad)
Write-up: Case retrieved from literature on 06 August 2013. "A 49-year-old female patient was admitted with severe myalgia, proximal weakness, and dark urine. She had undergone a pre-employment immunization, 11 days prior to admission, with 0.5 mL of ADACEL (Sanofi Pasteur, batch number not reported) into her left deltoid. She reports generalized and predominantly proximal myalgia, felt generally unwell and noted some difficulty rising from a chair about 8 days after the vaccination. Her symptoms progressed over the next 3 days with increasing pain, swelling, and weakness of both her lower limbs with dark colored urine. She reported no specific symptoms including sore arm at the injection site in the first 7 days after vaccination, except feeling a bit tired. She had no significant past medical history or family history of muscle problems. There was no history of recent trauma. She was not on any medications including herbal or over the counter medications or supplements. She reports completion of childhood vaccinations with previous tetanus vaccination more than 10 years ago. She had not received Tdap vaccination earlier. Clinical examination was unremarkable apart from minor pedal edema and with normal tone but decreased power (Medical Research Council (MRC) Grade 4 of 5) in both the upper and lower limbs. There was no localized swelling or tenderness at the site of immunization. There was no skin rash or cutaneous features suggestive of dermatomyositis. Initial investigations revealed rhabdomyolysis with a serum CK level of 91,000 U/L, and alanine aminotransferase of 306 U/L. Urinalysis showed no leucocytes, no erythrocytes, and 3b blood products. Urine myoglobin was significantly elevated at 51,306 mg/L. Full blood count showed an elevated white cell count with a neutrophils of 19.8x10&^9/L, low calcium 2.03 mmol/L and an elevated C reactive protein 78 mg/L. Autoimmune screen revealed a low titre antinuclear antibody (ANA) although double stranded DNA, extractable nuclear antigen (ENA), and myositis-specific autoantibodies were all negative. Erythrocyte sedimentation rate (ESR), serum complements (C3 and C4), blood cultures, urine cultures and CXR were normal. Serology for cytomegalovirus (CMV), Epstein-Barr virus (EBV), Influenza A and B, Parainfluenza, Mycoplasma, and Legionella was negative. MRI and muscle biopsy were not performed with ongoing symptomatic improvement and limited therapeutic benefit of the procedure. Despite intravenous hydration with normal saline, CK rose and peaked at 225,000 U/L after 24 hours of admission, although serum creatinine remained unchanged at 69 mmol/L. CK decreased over the next 4 days. She improved clinically with reduction of fatigue and was discharged home 5 days after admission with a CK of 63,420 U/L. Repeat testing 6 days later showed the CK had reduced to 1,971 U/L. Her arm strength returned to normal at 3 months and clinical examination and laboratory tests at 6 months remained normal. Application of the Naranjo probability scale revealed probable causality between the vaccination and rhabdomyolysis (Total Score 5)."

VAERS ID:506981 (history)  Vaccinated:2013-09-24
Age:49.0  Onset:2013-09-24, Days after vaccination: 0
Gender:Female  Submitted:2013-10-10, Days after onset: 16
Location:Foreign  Entered:2013-10-11, 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: Cetirizine; Gabapentin; Levothyroxine; Dihydrocodeine w/paracetamol
Current Illness: Cow''s milk intolerance, Diarrhoea on consumption; Food allergy, Diarrhoea on consumption; Drug hypersensitivity, Allergic reaction to Penicillin containing product administered intravenously
Preexisting Conditions: Antacids, Drug intolerance; Lansoprazole, Drug intolerance; Proton pump inhibitors, Drug intolerance
Diagnostic Lab Data:
CDC Split Type: PHFR2013GB005661
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Injection site pruritus, Injection site reaction, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Case number PHFR2013GB005661 is an initial spontaneous report received from a consumer via Health Authority (reference number: ADR 22261133) on 08 Oct 2013. This report refers to a 49-year-old female patient. Her medical history included egg and dairy intolerance (with diarrhea on consumption) and allergic reaction to a Penicillin containing product if administered intravenously. Her historical drugs included lansoprazole, antacid and proton pump inhibitor (unspecified) which resulted in intolerance to these three drugs. Her concomitant medication included cetirizine, gabapentin, levothyroxine and paracetamol/dihydrocodeine. She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on 24 Sep 2013. On 24 Sep 2013, after vaccination, she experienced tingling (localized) and itching at injection site. On 25 Sep 2013, she experienced diarrhea. The outcome was reported as not yet recovered. Health Authority considered the case as serious (medically significant). The causality of the events was not reported.

VAERS ID:508003 (history)  Vaccinated:2011-10-13
Age:49.0  Onset:2011-10-31, Days after vaccination: 18
Gender:Male  Submitted:2013-10-14, Days after onset: 714
Location:Foreign  Entered:2013-10-15, 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: No patient''s medical history reported.
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2013SA101377
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Depression, Diplopia, Headache, Neck pain, Paraesthesia, Polyneuropathy, Tinnitus
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (narrow), Hearing impairment (narrow), Ocular motility disorders (broad), Arthritis (broad)
Write-up: Initial report received from SPMSD (reference number: DE-157727295-E2013-07429). Case was received from a consumer via the Health Authorities on 30-Sep-2013 (reference no. PEI2013056016). Case is not medically confirmed. A 49-year-old male patient received a dose of influenza (manufacturer and lot-no. not reported) on 13-Oct-2011. On 31-Oct-2011 the patient developed headache. On 07-Nov-2011 tinnitus on both sides, on 18-Nov-2011 paraesthesia of the feet with polyneuropathy as an alternative explanation. On 18-Nov-2011 he additionally developed neck pain, on 10-Feb-2012 depression and on 02-Apr-2013 double vision when looking left, right and during convergence. At the time of reporting, the outcome was unknown. During medical review the company considered to code the adverse event of polyneuropathy, which was mentioned by HA, but was not coded as an adverse event by the HA. Upon medical judgement the company assessed this case as serious due to the adverse event of polyneuropathy. This case was assessed as not serious by local HA.

VAERS ID:509131 (history)  Vaccinated:2013-09-24
Age:49.0  Onset:2013-09-24, Days after vaccination: 0
Gender:Female  Submitted:2013-10-21, Days after onset: 27
Location:Foreign  Entered:2013-10-23, 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: Hydrocodone/Paracetamol; Cetirizine; Gabapentin; Levothyroxine; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Dairy intolerance; Egg allergy; Penicillin allergy; The patient''s medical history included diarrhoea on dairy consumption, diarrhoea on egg consumption, allergic reaction to a penicillin containing product administered intravenously, drug intolerance to antacid, lansoprazole and proton pump inhibitor.
Diagnostic Lab Data: Not reported
CDC Split Type: 2013SA104530
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Injection site pruritus, Injection site reaction, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was received from the health authority on 08-Oct-2013. GB-MHRA-ADR 22261133. This case is not medically confirmed as it was reported by a consumer. A 49-year-old female patient was vaccinated on 24-Sep-2013 with a dose of influenza vaccine (manufacturer, batch n. not reported), dose, route, dose in series and site of administration not reported, and on the same day she experienced tingling and itching at injection site. Then, one day later, on 25-Sep-2013, she experienced diarrhea. The patient''s medical history included diarrhoea on dairy consumption, diarrhoea on egg consumption, allergic reaction to a penicillin containing product administered intravenously, drug intolerance to antacid, lansoprazole and proton pump inhibitor. Concomitant treatment included cetirizine, gabapentin, levothyroxine and paracetamol/dihydrocodeine. At the time of reporting the patient had not recovered. The regulatory authority considered this case to be serious as an other medically important condition.

VAERS ID:510364 (history)  Vaccinated:2013-09-07
Age:49.0  Onset:2013-09-13, Days after vaccination: 6
Gender:Male  Submitted:2013-10-29, Days after onset: 46
Location:Foreign  Entered:2013-10-30, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Previous doses of rabies vaccine were given IM on 17-Aug-2013 (D1, lot-no. J1248-2) and IM on 24-Aug-2013 (D2, lot-no. J1248-2). Both vaccinations were well tolerated.
Diagnostic Lab Data: lab test, UNK, Actinomyces neuii positive
CDC Split Type: 2013SA109050
Vaccination
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Lot
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Site
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURERJ12482IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Decreased immune responsiveness, Injury, Laboratory test abnormal, Necrotising fasciitis, Scrotal swelling
SMQs:, Angioedema (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Hypersensitivity (broad)
Write-up: This case was received from an agency (E2013-08170). Case received from the Health Authorities in a foreign country on 21-Oct-2013 (reference PEI2013060741). Case was medically confirmed. A 49-year-old male patient received the third dose of rabies vaccine (lot-no. J1248-2) IM on 07-Sep-2013. Previous doses of rabies vaccine were given IM on 17-Aug-2013 (D1, lot-no. J1248-2) and IM on 24-Aug-2013 (D2, lot-no. J1248-2). Both vaccinations were well tolerated. Six days later on 13-Sep-2013, the patient developed Fournier''s gangrene and decreased immune responsiveness. A severe inflammation of the left scrotum following a minor injury was noted. The patient was hospitalized. Laboratory test (not specified) was positive for Actinomyces neuii. The patient''s condition was considered as life-threatening. At the time of reporting to HA on 09-Oct-2013, the patient had not recovered.

VAERS ID:513947 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:2013-11-02
Gender:Male  Submitted:2013-11-19, Days after onset: 17
Location:Foreign  Entered:2013-11-19
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: Metformin hydrochloride; Aspirin; Int./long-acting insulin; Liraglutide
Current Illness: Diabetes Mellitus Type 2
Preexisting Conditions: No known allergies.
Diagnostic Lab Data: UNK
CDC Split Type: B0942069A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood glucose fluctuation, Hypersensitivity, Pruritus generalised, Rash erythematous, Rash generalised, Tremor, Viral infection, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a consumer, via the MHRA (GB-MHRA-EYC 00105636) and described the occurrence of vomiting in a 49-year-old male subject who was vaccinated with influenza virus vaccine. Concurrent medical conditions included diabetes mellitus type 2. On previous exposure to influenza virus vaccine in 2012, the patient experienced the same adverse events. Concurrent medications included Metformin, Rosuvastatin, Aspirin (Coated aspirin), LANTUS and Liraglutide. On an unspecified date the subject received unspecified dose of Influenza vaccine (unspecified). On 2 November 2013, at an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced violent vomiting, itch all over body including soles of feet, palms of hands and scalp, bright red rash all over body starting under the arms, groin area and head. The subject experienced diarrhea 30 minutes after onset of the symptoms. Vomiting recurred 2 hours after onset and sweat running off body 45 minutes after onset. Nothing had changed in the patient''s diet or day to day routine except the flu jab. The subject was told that it was an unknown virus or severe allergic reaction and advised to take antihistamines then. The subject was given the same diagnosis this time. On an unknown date (s), the patient also experienced tremor and blood sugar level fluctuation. The subject sought advice for the violent shaking, blood sugar spiking, red rash and uncontrollable itching. The subject was hospitalised. At the time of reporting the outcome of vomiting, itch all over and red rash was improved, tremor, blood sugar level fluctuation, allergic reaction and viral infection was unknown and all other events were unresolved. MHRA Verbatim Text: Violent vomiting, all over body itching including soles of feet, palms of hands and scalp, bright red rash all over body starting under the arms, groin area and head. Diarrhea followed 30 minutes after onset of symptoms. Vomiting recurred 2 hours after onset, sweat running off of body 45 minutes after onset. The same reaction occurred the same time last year. Nothing had changed in the diet or day to day routine except the flu jab. Told it was unknown virus/severe allergic reaction and to take antihistamine then. Same diagnosis given this time. Flu jab was only thing that is the same in both circumstances. Seek Advice Details: Violent shaking, blood sugar levels spiking. Red rash and uncontrollable itching.

VAERS ID:514658 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:2013-11-02
Gender:Male  Submitted:2013-11-22, Days after onset: 20
Location:Foreign  Entered:2013-11-25, 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: Allergic reaction, diarrhea, rash erythematous~Influenza (Seasonal) (no brand name)~0~0.00~Patient
Other Medications: Aspirin; LANTUS; Liraglutide; Metformin; Rosuvastatin
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHFR2013GB006412
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Blood glucose fluctuation, Diarrhoea, Hyperhidrosis, Hypersensitivity, Pruritus generalised, Rash erythematous, Rash generalised, Tremor, Viral infection, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Case number PHFR2013GB006412 is an initial spontaneous report received from the consumer via health authority (reference number: 22306975) on 12 Nov 2013. This report refers to a 49-year-old male patient. His medical history was not reported. His concomitant medications included aspirin coated, LANTUS, liraglutide, metformin and rosuvastatin. His vaccination history included influenza vaccine on an unspecified date in 2012 after he experienced severe allergic reaction, blood sugar level fluctuation, diarrhea, itching all over, rash erythematous, shaking, sweating and vomiting (see case number: PHFR2013GB006566). He was again vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on an unspecified date. On 02 Nov 2013, he experienced violent vomiting, itching all over the body including soles of feet, palms of hands and scalp, bright red rash all over body starting under arms, groin area and head. Diarrhoea followed 30 minutes after the onset of events and sweat was running off of body 45 minutes after event onset. Vomiting recurred 2 hours after onset. The patient went for advice regarding violent shaking, blood sugar levels spiking, and red rash with uncontrollable itching. Nothing had changed in the diet or day to day routine except the flu vaccine. The patient was told it was a virus/severe allergic reaction (same as reaction in 2012) and was advised to take antihistamine. The event outcome for itching all over, rash erythematous, and vomiting was condition improving. The event outcome for diarrhea and sweating was condition unchanged. The event outcome for allergic reaction, blood sugar level fluctuation, shaking, and viral infection was unknown. The events were assessed as serious (hospitalization and medically significant). The causality was not reported.

VAERS ID:515753 (history)  Vaccinated:2013-09-06
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2013-12-05
Location:Foreign  Entered:2013-12-05
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine sodium
Current Illness: Immunisation
Preexisting Conditions: Hypothyroidism
Diagnostic Lab Data:
CDC Split Type: WAES1312GBR001205
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1739AA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Autoimmune disorder, Balance disorder, Hemiparesis, Hypoaesthesia, Nasopharyngitis, Pain, Vaccination complication
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (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 (narrow), Vestibular disorders (broad)
Write-up: This case was received from the health authority on 27-Nov-2013. GB-MHRA-ADR 22323347. Information has been received from Sanofi Pasteur (manufacturer control # GB-1577272925-E2013-10039) on 27-NOV-2013. This case is medically confirmed as it was reported by a physician. A 49 year old female patient, with a medical history of hypothyroidism, received on 06-Sep-2013 an injection of MMRVAXPRO (batch number H013428, lot number 1739AA), 0.5 mL intramuscularly, dose in series and site of administration not reported. Seven days later, on 13-Sep-2013, the patient experienced left sided weakness, pain and numbness. One week after vaccination, the patient also had a cold. She saw a neurologist who felt that this is an autoimmune reaction secondary to her vaccination. The patient also received a concomitant treatment with levothyroxine on an unreported date. At the time of reporting, the patient was recovering from muscle weakness, numbness, pain and strength loss, she has not recovered from balance difficulty and the patient''s outcome was unknown for autoimmune disorder and cold. The MHRA considered that case serious due to the patient''s disability.

VAERS ID:517291 (history)  Vaccinated:2013-11-01
Age:49.0  Onset:2013-11-27, Days after vaccination: 26
Gender:Female  Submitted:2013-12-20, Days after onset: 23
Location:Foreign  Entered:2013-12-20
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: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1312GBR008457
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster, Occupational exposure to product
SMQs:
Write-up: This case of occupational exposure was received from health authority on 11-DEC-2013, GB-MHRA ADR 22341312, via Sanofi Pasteur (MFC# GB-1577272925-E2013-10718) on 17-DEC-2013, as part of a business agreement. The case is not medically confirmed. This case concerned a 49 years old female patient (59.42 kg), with no medical history reported, who developed shingles on 27-Nov-2013. The Health Authority reported an occupational exposure to ZOSTAVAX (batch number not reported) dose in series, route and site of administration not reported on 01-Nov-2013 but did not provide any details regarding what happened exactly. At the time of reporting, the patient had recovered from shingles. The regulatory authority considered that case serious due to be medically significant.

VAERS ID:521872 (history)  Vaccinated:2014-01-14
Age:49.0  Onset:2014-01-14, Days after vaccination: 0
Gender:Female  Submitted:2014-02-05, Days after onset: 22
Location:Foreign  Entered:2014-02-05
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1402GBR000571
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Headache, Hypersensitivity, Local reaction, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Angioedema (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Information has been received from Sanofi Pasteur MSD (mfr # GB-1577272925-E2014-00775) on 31-JAN-2014. This case was received from the health authority in a foreign country on 29-Jan-2013. GB-MHRA-ADR 22399322. This case is medically confirmed as it was reported by a health professional. A 49 year old female patient, with no medical history reported, received on 14-Jan-2014 an injection of HBVAXPRO (batch number J009599, thimerosal free) 1 mL, dose in series, route and site of administration not reported. Within minutes of vaccination, on 14-Jan-2014, the patient experienced a local reaction. Within 4 hours of immunisation, the same day, the patient also had a systemic reaction and noted to suffer from myalgia, arthralgia and headache since 14-Jan-2014 which were deteriorating. However, no breathing or swallowing issues were noted. It was also reported that no symptoms of tingling or altered sensation on lips, tongue or mouth were detected. At the time of reporting, the patient has not recovered from the adverse events.The MHRA considered that case serious due to the patient''s disability.

VAERS ID:522698 (history)  Vaccinated:2013-11-11
Age:49.0  Onset:2013-11-11, Days after vaccination: 0
Gender:Male  Submitted:2014-02-14, Days after onset: 95
Location:Foreign  Entered:2014-02-14
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: B0963381A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB286BB0SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site pruritus, Pain in extremity, Vaccination site exfoliation
SMQs:, Hypersensitivity (narrow)
Write-up: This case was reported by a physician via a sales representative and described the occurrence of vaccination site exfoliation in a 49-year-old male subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). On an unspecified date, the subject received 1st dose of TWINRIX adult (unknown route, injection site and batch number). At an unspecified time after vaccination with TWINRIX adult, the subject experienced strong itch and flaking skin at vaccination site and arm pain. Size of skin reaction was 2.5 - 3 cm. Pain in arm lasted for approximately 1 week and injection site pruritus lasted for 2 weeks. On an unspecified date, flaking skin at vaccination site was resolved. Follow-up information received on 5 February 2014 by a physician: The case was upgraded to serious by GSK due to vaccination site exfoliation. On 11 November 2013, the subject received 1st dose of TWINRIX adult (batch number was provided). On 11 November 2013, less than one day after vaccination with TWINRIX adult, the subject experienced the events. The case was assessed as medically serious by GSK. On 18 November 2013, arm pain was resolved and on 25 November 2013, the rest of the events was resolved. The physician considered the events were probably related to vaccination with TWINRIX adult.

VAERS ID:525617 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:0000-00-00
Gender:Male  Submitted:2014-03-12
Location:Foreign  Entered:2014-03-12
Life Threatening? No
Died? No
Permanent Disability? Yes
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: D0083141A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Neuritis, Nuclear magnetic resonance imaging normal, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad)
Write-up: This case was reported by a regulatory authority (DE-PEI-PEI2014011472) and described the occurrence of lumbar neuritis in a 49-year-old male subject who was vaccinated with INFLUSPLIT (GlaxoSmithKline). Since 2006 the subject received several vaccinations with unspecified influenza vaccine, including INFLUSPLIT and other manufacturer''s vaccines. Since 2012 the subject suffered from increasing lumbar neuritis and paresthesia of all four extremities. The condition worsened after each vaccination. By means of nuclear magnetic resonance imaging tunnel syndrome and mechanical origin were excluded. The subject was hospitalised and the health care professional reported that the events were disabling. At the time of reporting the events were still unresolved.

VAERS ID:526521 (history)  Vaccinated:2013-11-18
Age:49.0  Onset:2013-11-19, Days after vaccination: 1
Gender:Male  Submitted:2014-03-21, Days after onset: 121
Location:Foreign  Entered:2014-03-21
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: B0978686A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Arthritis, Osteonecrosis
SMQs:, Systemic lupus erythematosus (broad), Osteonecrosis (narrow), Arthritis (narrow)
Write-up: This case was reported by a physician via a regulatory authority (# AT-BASGAGES-140870) and described the occurrence of arthritis in a 49-year-old male subject who was vaccinated with HAVRIX adult (GlaxoSmithKlie). No relevant medical history and concurrent conditions were reported. The subject had no known concomitant medication. On 18 November 2013, the subject received unspecified dose of HAVRIX adult (intramuscular, unknown injection site; lot number not provided). On 19 November 2013, 1 day after vaccination with HAVRIX adult, the subject experienced arthritis and avascular necrosis femoral head. The subject was hospitalised. At the time of reporting the events were unresolved.

VAERS ID:527245 (history)  Vaccinated:2014-02-26
Age:49.0  Onset:2014-02-27, Days after vaccination: 1
Gender:Female  Submitted:2014-04-01, Days after onset: 32
Location:Foreign  Entered:2014-04-01
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: No known relevant medical history.
Diagnostic Lab Data: UNK
CDC Split Type: B0979409A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB679BB IMUN
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURERJ5227 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dysphonia, Erythema, Prurigo, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Parkinson-like events (broad), Hypersensitivity (narrow)
Write-up: This case was reported by the regulatory authority (ANSM reference NY20140550) and described the occurrence of pruriginous rash in a 49-year-old female subject who was vaccinated with HAVRIX (Adults 1440 U/l mL, GlaxoSmithKline) and STAMARIL (non GSK). The subject had no known relevant medical history. On 26 February 2014, the subject received an unspecified dose of HAVRIX Adults (batch AHAVB679BB, intramuscular, injection site unknown) and one dose of STAMARIL (batch J5227, intramuscular, injection site unknown). During the night from 26 to 27 February 2014, less than one day after vaccination with HAVRIX and STAMARIL, the subject presented with urticaria and dysphonia. She was hospitalized (no other information specified) and received symptomatic treatment. Symptoms improved partially but a migrating pruriginous erythema persisted on 05 March 2014 according to the reporter. The subject had no fully recovered. At the time of reporting, dysphonia was resolved and pruriginous rash was unresolved. According to method of assessment, the events were unlikely related to the vaccination with HAVRIX and or STAMARIL.

VAERS ID:527780 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2014-04-04
Location:Foreign  Entered:2014-04-07, 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: hematuria; proteinuria; IGA NEPHROPATHY; END STAGE RENAL FAILURE; RENAL TRANSPLANT
Diagnostic Lab Data: Confirmatory Tests: Patient''s Urine TPCR revealed 658.1 g/mol. blood pressur, 132/77 MMHG; serum creatinine, 100 MCMOL/L; EGFR status assay, 51ML/MIN/1.73M2; Urinalysis, LESS THAN 10; Urine protein/creatinine ratio, 17.8; blood pressure, 148/96 MMHG; creatinine, 102 MCMOL/L; EGFR status assay; Skin biopsy; Renal biopsy; urinalysis; Urine protein/creatinine ratio
CDC Split Type: 2014SA041974
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Biopsy kidney abnormal, Biopsy skin, Blood creatinine increased, Condition aggravated, EGFR status assay, Haematuria, Henoch-Schonlein purpura, Hypertension, IgA nephropathy, Proteinuria, Purpura, Red blood cells urine, Renal function test normal, Urinary casts, Urine analysis, Urine protein/creatinine ratio
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Hypertension (narrow), Vasculitis (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad)
Write-up: Initial report was received from the literature abstract on 27 March 2014. A 49-year old female presented with progressive, palpable purpuric rash, 10 days after influenza vaccination. At age 33, she had hematuria, proteinuria and biopsy given IgAN that progressed to end-stage renal failure (ESRF), without features of HSP, over 6 years. Living related donor renal transplantation occurs in 41. On presentation blood pressure was 132/77 mm of hg, serum creatinine was 100umol/L, and estimated glomerular filtration rate (EGFR) 51ml/min/1.73m2 (Modification of Diet in Renal Disease (MDRD formula). Urinalysis revealed <10 X 10E6/L. White blood cells (RBC), no casts and protein-creatinine ratio (TPCR) 17.8 g/mol. Platelet count coagulation profile and rapid vasculitis screen were unremarkable. Skin biopsy showed leukocytoclastic vasculitis with positive immunogluorescence for IgA. A diagnosis of HSP was made. Seven weeks later microscopic hematuria (50-100 x 10^6/L RBCs) was noted, which persisted for six months along with the development of cellular casts, dysmorphic RBCs, nephrotic range proteinuria (Urine TPCR 658.1 g/mol) and hypertension 148/96 mm hg. Renal function remained stable, creatinine 102 u/mol, eGFR 50 ml/min/1.73 mE2). Renal biopsy showed active IgAN, with focal crescent formation. Influenza vaccination was considered the trigger for HSP, followed by recurrent IgAN. Conclusion: This is the first reported case of HSP and recurrent IgAN in a renal transplant recipient following influenza vaccination. Although rare, nephrologist should be cognizant of the potential for the allograft dysfunction following influenza vaccination in renal transplant recipients whose primary cause of ESRF has HSP or IgAN. On an unknown date, the patient received INFLUENZA VACCINE (batch number, dose, route and anatomical site of administration not reported) and developed recurrent IgAN, microscopic haematuria, Henoch-Schonlein purpura, progressive, palpable purpuric rash and hypertension. The outcomes of events were unknown. The list of documents held by sender: None.

VAERS ID:534191 (history)  Vaccinated:2007-05-16
Age:49.0  Onset:2014-02-01, Days after vaccination: 2453
Gender:Female  Submitted:2014-06-18, Days after onset: 136
Location:Foreign  Entered:2014-06-18
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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Biopsy (unspecified date in 2014) result: condyloma acuminatum (injury associated to human papillomavirus (HPV)) on vulvas skin.
CDC Split Type: WAES1405MEX000786
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anogenital warts, Biopsy vulva abnormal, Colposcopy, Vulval disorder
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow)
Write-up: This spontaneous report was received from a gynecologist referring to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL, 0.5 ml, single (dose not reported). No other concomitant therapies reported. On an unknown date the patient experienced vulvar lesion. It was unknown if the patient completed the vaccination schedule. The outcome of vulvar lesion was unknown. The causality of the event was unspecified. This is one of several reports from the same source. Follow-up information was received on 11-JUN-2014 from a physician regarding a 49 year old non pregnant female patient (occupation reported as: administrator). Patient''s concurrent conditions and medical history were not reported. On 16-MAY-2007 the patient was vaccinated with the first dose of GARDASIL, intramuscular. The stop date for the therapy of GARDASIL was reported as 20-NOV-2007. The patient found some vulvar lesions on unspecified date, reason why she went to a clinical visit where she underwent a colposcopy. A biopsy was performed and the result was: condyloma acuminatum (injury associated to human papillomavirus (HPV) on vulvas skin in February 2014. In March 2014 (exact date not reported) the patient recovered from the event (also reported that: the event duration was 3 months). There was prescription drug treatment required for the event. There was no previous exposure to this or related drug. The relatedness between the event and the therapy with GARDASIL was not reported. The event required medical/surgical intervention to prevent one of the outcomes listed. Upon internal review the event of condyloma acuminatum (injury associated to human papillomavirus (HPV)) on vulvas skin was determined to be medically significant. Additional information has been requested.

VAERS ID:537723 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2014-07-24
Location:Foreign  Entered:2014-07-24
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: Alanine aminotransferase, 312 U/L; Antinuclear antibody, more or equal 1; Aspartate aminotransferase, 363 U/L; Biopsy muscle, inclusion body m; Bronchoscopy, negative; C-reactive protein, 22 mg/l; Chest X-ray, normal; Colonoscopy, negative; Computerized tomogram abdomen, negative; Computerized tomogram thorax, see text; Creatine kinase, 115 ng/ml; Creatinine phosphokinase, 5401 U/L; Electrocardiogram, normal; Electromyogram, see text; Erythrocyte sedimentation rate, 43 mm/h; Esophagogastroduodenoscopy, negative; Extractable nuclear antibody, 20; Fibrinogen, 502 mg/dl; Lactate dehydrogenase, 953 U/L; Mammogram, negative; Transvaginal ultrasound scan, negative; Troponin I, 0.12 ug/l; Myoglobin: 3614 ng/ml; D-Dimer: 1390 ug/l; Anti-dsDNA: 1:14
CDC Split Type: B1016988A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Antinuclear antibody, Antinuclear antibody negative, Arthralgia, Arthropathy, Aspartate aminotransferase increased, Biopsy muscle abnormal, Blood creatine phosphokinase increased, Blood fibrinogen increased, Blood lactate dehydrogenase increased, Bronchoscopy normal, C-reactive protein increased, Chest X-ray normal, Colonoscopy normal, Computerised tomogram abdomen normal, Computerised tomogram thorax abnormal, Double stranded DNA antibody positive, Electrocardiogram normal, Electromyogram, Erythema, Fibrin D dimer increased, Inclusion body myositis, Joint swelling, Mammogram normal, Myalgia, Myoglobin blood increased, Neurone-specific enolase, Oesophagogastroduodenoscopy normal, Papule, Rash erythematous, Red blood cell sedimentation rate increased, Troponin normal, Ultrasound scan vagina
SMQs:, Rhabdomyolysis/myopathy (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: This case was reported in a literature article and described the occurrence of inclusion body myositis in a 49-year-old female subject who was vaccinated with Influenza vaccine (manufacturer unspecified). No information regarding the subject''s medical history, concurrent conditions or medication has been provided. On an unspecified date, the subject received a dose of an unspecified influenza vaccine (manufacturer, dose and route unknown). On an unknown date, at an unspecified time after receiving the unspecified influenza vaccine, the subject presented with diffuse myalgias and a non-pruritic erythematous rash similar to small papules on her limbs. Bilateral swelling, redness and pain in the metacarpophalangeal and proximal interphalangeal joints with functional limitation were noted on physical examination. Please note that the subject reported that the vaccination had occurred recently. Chest X-ray and echocardiogram results were normal but a CT chest scan revealed diffuse areas of parenchymal consolidation with ground-glass appearance in the peripheral regions and thickening of the interlobular septa at the basal level. An electromyography revealed alterations compatible with myositis. Abdomen-CT scan, esophagogastroduodenoscopies, a colonoscopy, a mammography, a transvaginal ultrasound and a fibrobronchoscopy were negative so a paraneoplastic origin was excluded. Muscle biopsy showed the presence of nuclear and cytoplasmic eosinophilic granular inclusions which was compatible with Inclusion Body Myositis. The subject was hospitalised. The subject was treated with steroid boluses infusion for three days (1 g/day) followed by oral steroids (1mg/kg/day) associated with oral mycophenolate. The authors reported that the clinical and biohumoral improvement only started after the third week of oral therapy which confirmed the previously described resistance of the clinical variant of Inclusion Body Myositis. The authors did not comment on the causal relationship with the vaccine.

VAERS ID:539974 (history)  Vaccinated:0000-00-00
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2014-08-14
Location:Foreign  Entered:2014-08-14
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: Rituximab; Prednisone; Methylprednisolone sodium succinate
Current Illness: Immunisation; Prophylaxis; Systemic lupus erythematosus
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1408FRA008754
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Pneumonia
SMQs:, Eosinophilic pneumonia (broad)
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # FR-1577272925-E2014-06881) on 13-AUG-2014. Case retrieved from the literature on 06-Feb-2014 and received from our contractual partner Sanofi Pasteur. This case is linked to cases E2014-06882 and E2014-06854 (same literature article, same vaccine, similar adverse event, different patient). This case relates to a study which main goal was to identify the risk factors for the serious bacterial infectious events (SIEs) occurring within 12 months after the first RITUXIMAB (RTX) administration in any course of RTX. A course of RTX was defined as IV infusions of either 2x1,000 mg given 2 weeks apart or 4 x 375 mg/m2 given 4 weeks apart. At each RTX infusion, 100-mg methylprednisolone was systematically administered intravenously to prevent perfusion reactions. SIES were defined as any infection which led to hospitalization. RTX was mostly given to patients considered to be refractory to conventional therapy including corticosteroids and at least one immunosuppressive drug or to patients who were dependent on a high dose of corticosteroid (i.e. prednisone 20mg or more per day) for the purpose of corticosteroid sparing. Forty-three patients had received pneumococcal vaccination. Twelve patients experienced at least one SIE during or after an RTX course. A 49-year-old female patient who had been diagnosed with systemic lupus erythematosus, had initiated a course of RTX and had received a dose of pneumococcal vaccine (manufacturer unknown, batch number not provided) on unspecified dates. Six months after the RTX course she developed pneumonia. Other suspect drug included prednisone (more than 15mg/day). At the time of reporting the patient had recovered.

VAERS ID:539993 (history)  Vaccinated:2012-05-29
Age:49.0  Onset:2014-07-01, Days after vaccination: 763
Gender:Female  Submitted:2014-08-14, Days after onset: 44
Location:Foreign  Entered:2014-08-15, 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. No information regarding the patient''s medical history was provided.
Diagnostic Lab Data: Pertussis IgA, 16JUL2014, positive; Pertussis IgG, 16JUL2014, positive; Western blot test, 16JUL2014, IgG positive; Western blot test, 16JUL2014, band pattern FHA positive; Western blot test, 16JUL2014, PT-100 negative; Western blot test, 16JUL2014, PT positive
CDC Split Type: 2014SA109372
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERC3859AD UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bordetella test positive, Immunology test abnormal, Pertussis, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Hypersensitivity (broad)
Write-up: This case was received from SP MSD under the reference number E2014-06957. Case of vaccination failure was received from the Health Authorities on 06-Aug-2014 (reference no. PEI2014052930). Case is medically confirmed. A 49-year-old female patient received a dose of COVAXIS (lot-no. C3859AD) on 29-May-2012. Two years later on 01-Jul-2014 at the age of 51 years, she developed pertussis with pronounced clinical symptoms. Blood test was performed on 16-Jul-2014 with following results: Bordetella pertussis/Parapertussis IgA and IgG positive, Immunoblot IgG positive, band pattern filamentous hemagglutinin (FHA) positive, pertussis toxin (PT) positive and PT-100 negative. The outcome was not reported. Vaccination failure was concluded by the reporter.

VAERS ID:543162 (history)  Vaccinated:2014-05-15
Age:49.0  Onset:0000-00-00
Gender:Male  Submitted:2014-09-09
Location:Foreign  Entered:2014-09-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Gamma-glutamyltransferase increased
Preexisting Conditions:
Diagnostic Lab Data: Gamma-glutamyltransferase incr, 2014, 245U/l; Gamma-glutamyltransferase incr, 2014, 90U/l
CDC Split Type: D0085317A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB302AB2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Autoimmune hepatitis, Gamma-glutamyltransferase increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow)
Write-up: This case was reported by a physician via a sales representative and described the occurrence of autoimmune hepatitis in a 49-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). Concurrent medical conditions included slightly increased GGT. Prior to vaccination with TWINRIX GGT has been 90U/l. On 15 May 2014 the subject received the third dose of TWINRIX (1 ml, unknown). At an unspecified time post vaccination with TWINRIX, on an unspecified date between 15 May 2014 (date of vaccination) and 04 September 2014 (date of reporting), the subject experienced worsening of elevated GGT to 245 U/l. The subject was examined by a gastroenterologist who diagnosed possible autoimmune hepatitis. The subject was otherwise healthy and showed no symptoms. This case was assessed as medically serious by GSK criteria. At the time of reporting, on 04 September 2014, the outcome of the events was unspecified. Follow-up information has been requested.

VAERS ID:544487 (history)  Vaccinated:2013-04-18
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2014-09-19
Location:Foreign  Entered:2014-09-19
Life Threatening? Yes
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: D0085486A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHBB269AB3SYRLA
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Erythema multiforme, Impaired work ability, Inappropriate schedule of drug administration, Lipomatosis, Mobility decreased, Myalgia, Pruritus, Skin hypertrophy, Skin reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Parkinson-like events (broad), Eosinophilic pneumonia (broad), Lipodystrophy (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: This case was reported by a regulatory authority (# DE-PEI-PEI2014061077) and described the occurrence of erythema exsudativum multiforme in a 49-year-old female subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). Concurrent medication conditions or concurrent medications or any other risk factors were not reported. Previous vaccination included TWINRIX adult given on 10 April 2003, 16 May 2003 and 19 September 2003 (inappropriate schedule of vaccine administered at the age of 40 years). The subject had no adverse event following receipt of prior immunisation. On 18 April 2013 the subject received 4th dose of TWINRIX adult (unknown route, left upper arm). Approximately 4-5 days after vaccination the subject experienced severe skin reactions - erythema exsudativum multiforme. The subject experienced severe increase in restriction of mobility through muscle pain and joint pain and increase in palpable thickening of both upper arms and in whole body. Since 02 May 2013 the subject was unable to work. Follow up information was received on 18 September 2014 and entered together with initial. Beside erythema exsudativum multiforme and severe muscle and joint pain, on 11 September 2014 lipomatosis was diagnosed. Diagnosis was performed by attending physician (dermatologist, hospitalist, rehabilitation doctors). Rheumatism and polyarthritis were excluded. Additionally the subject experienced daily itching. The subject was treated ambulatorily and was hospitalised. According to reporter the events were life threatening. The subject received no therapy because of unclear clinical picture. At the time of reporting the events were unresolved. Erythema exsudativum multiforme was mitigated. No further information will be available. The case was identified as duplicate of case D0085495A which was voided.

VAERS ID:544582 (history)  Vaccinated:2010-02-24
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2014-09-19
Location:Foreign  Entered:2014-09-19
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: Fatigue; Flu-like symptoms; Leg pain
Diagnostic Lab Data: Allergy test, 2011, See text; Blood test, Fluctuating live; RAST, 30Apr2012, Normal; Tryptase, Elevated 13-16; Ultrasound scan, 16Jan2014, Little fluid aro; In 2011, allergy testing showed allergy to food with high levels of histamine. On 30 April 2014, RAST analysis for a variety of foods (not further described) were normal. A study on 25 September 2012 showed that the subject had severe MCS (Multiple Chemical Sensitivity) after exposure to mold on the basis of her symptoms. Study of allergies, respiratory sensitisers and food (not further specified) all were normal. Rheumatological examination showed no abnormality. Clearing of mast cell syndrome showed no abnormality.
CDC Split Type: B1033897A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Allergy test positive, Back pain, Blood test, Condition aggravated, Delusion, Dry eye, Dysgeusia, Dyspnoea, Eating disorder, Echocardiogram abnormal, Exposure to mould, Food allergy, Fungal infection, Headache, Hyperhidrosis, Influenza like illness, Malaise, Memory impairment, Multiple chemical sensitivity, Nausea, Ocular hyperaemia, Oral discomfort,