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Case Details (Sorted by Age)

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VAERS ID:436095 (history)  Vaccinated:2011-05-17
Age:54.0  Onset:2011-05-17, Days after vaccination: 0
Gender:Female  Submitted:2011-09-26, Days after onset: 132
Location:Foreign  Entered:2011-09-28, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported; The patient was allergic to sulfonamide.
Diagnostic Lab Data:
CDC 'Split Type': 201108877
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH3654AC UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Conjunctival hyperaemia, Laryngeal oedema, Mucosal hyperaemia, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Conjunctival disorders (narrow), Hypersensitivity (narrow)
Write-up: This case report is a part of a batch of several hundred reports associated with different products, that was received on 13 September 2011 by sanofi pasteur affiliate in a foreign country, from the "Foreign Ministry of Health" (local case reference number BR-BT2011-3722). A female patient, whose medical history and concomitant therapies were not reported, had received a dose of FLUZONE (batch number "UH3654AC", route and anatomical site of administration not reported) on 17 May 2011. The patient was allergic to sulfonamide. Less than 2 hours post-vaccination, the patient experienced severe anaphylaxis level 1. The patient experienced glottis oedema, fever at 37.8 degrees C, mucosal and conjunctival hyperemia. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. The Ministry of Health classified the adverse events on AEFI (Adverse Event Following Immunization). The "causality classification" was confirmed (the Ministry of Health assessed the adverse events as related to the vaccine). Documents held by sender: none.

VAERS ID:439654 (history)  Vaccinated:2011-09-23
Age:54.0  Onset:2011-09-23, Days after vaccination: 0
Gender:Female  Submitted:2011-10-21, Days after onset: 28
Location:Foreign  Entered:2011-10-24, 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: D1 and D2 of rabies vaccine (TOLLWUT-IMPFSTOFF), given on 09-Sep-2011 and 12-Sep-2011, due to a dog bite, were well tolerated. After D3 on 16-Sep-2011 the patient complained of mild pain in vaccinated arm for two days.
Diagnostic Lab Data:
CDC 'Split Type': E201105737
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURERE08963IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Ear pain, Hyperhidrosis, Myocardial infarction, Pain, Pain in extremity, Vaccine positive rechallenge
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)
Write-up: Case was received from a healthcare professional on 28-Sep-2011. Case is medically confirmed. A 54-year-old female patient who was bitten by a dog, received a fourth dose of TOLLWUT IMPFSTOFF (lot-no. E0896-1) IM into the left upper arm on 23-Sep-2011. A short time later, she complained of severe burning pain in the vaccinated arm spreading down to the fingers and up to shoulder and ear. She additionally suffered from sweating attacks. She was treated with Ibuprofen but had not recovered at the time of reporting. D1 and D2 of TOLLWUT IMPFSTOFF, given on 09-Sep-2011 and 12-Sep-2011, due to a dog bite, were well tolerated. After D3 on 16-Sep-2011 the patient complained of mild pain in vaccinated arm for two days. Follow-up information received on 12-Oct-2011 by phone. The case has to be upgraded. The patient had experienced a posterior myocardial infarction. The reporting physician assessed the relation to the vaccination as not related and wanted to withdraw this case. No further information will be made available. FILE CLOSED.

VAERS ID:440855 (history)  Vaccinated:2011-03-21
Age:54.0  Onset:2011-03-22, Days after vaccination: 1
Gender:Male  Submitted:2011-10-31, Days after onset: 223
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: Allergy
Diagnostic Lab Data:
CDC 'Split Type': 2011028429
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER090629502 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Muscular weakness, Neuritis, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: This health authority report (initial receipt: 04-MAY-2011) concerns a 54 year old male patient, who had known allergy and other medical conditions (unspecified). Concomitant medications included amoxicillin, fluticasone, quinapril and metformin. On 21-MAR-2011, the patient received 0.5mL dose of influenza virus vaccine inactivated (batch number: 090629502) intramuscularly. On 22-MAR-2011, the day after vaccination, the patient developed neuritis, muscle weakness and arm pain. The duration to onset of event was specified as <12 hours. The event outcome was not yet recovered. Dechallenge was unknown. No rechallenge was performed. The suspect drug was not reduced. The reporter considered event not serious and possibly related to the suspect drug. Follow-up (17-May-2011): Data correction related to duration to onset of event. Data correction (28-Oct-2011): After internal review, it was noted that listedness assessment for the events ''muscle weakness'' and ''arm pain'' and overall case were inadvertently captured. This has been corrected.

VAERS ID:444129 (history)  Vaccinated:2010-11-10
Age:54.0  Onset:2010-11-20, Days after vaccination: 10
Gender:Male  Submitted:2011-11-30, Days after onset: 375
Location:Foreign  Entered:2011-11-30
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: UNK
CDC 'Split Type': B0764721A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTIPV: DT + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER  IMRA
Administered by: Other     Purchased by: Other
Symptoms: Pulmonary fibrosis, Systemic sclerosis
SMQs:, Interstitial lung disease (narrow)
Write-up: This case was reported by a health professional via a regulatory authority (# NL-LRB-129257) and described the occurrence of systemic sclerosis in a 54-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline), TYPHERIX and DT-IPV. On 10 November 2010 the subject received unspecified dose of TWINRIX (intramuscular, left arm, unknown batch number), unspecified dose of TYPHERIX (intramuscular, right arm, unknown batch number), unspecified dose of DT-IPV (Non-GSK) (intramuscular, unknown injection site, unknown batch number). On 20 November 2010, 10 days after vaccination with DT-IPV (Non-GSK), TWINRIX and TYPHERIX, the subject experienced systemic sclerosis. In November 2010, 2 weeks after vaccination with DT-IPV (Non-GSK), TWINRIX and TYPHERIX, the subject experienced pulmonary fibrosis. The subject was hospitalised and the regulatory authority reported that the events were disabling. The subject was treated with methotrexate and naproxen. At the time of reporting the outcome of systemic sclerosis was unresolved and the outcome of pulmonary fibrosis was unspecified. The regulatory authority reported that systemic sclerosis was unlikely to be related to vaccination with TWINRIX, TYPHERIX and DT-IPV (Non-GSK).

VAERS ID:446078 (history)  Vaccinated:0000-00-00
Age:54.0  Onset:0000-00-00
Gender:Male  Submitted:2011-12-21
Location:Foreign  Entered:2011-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Type 2 diabetes mellitus
Diagnostic Lab Data: Blood amylase, 517 IU/l; Blood glucose, 39 mmol/l; Body mass index, 20.2 kg/m2; Glycosylated haemoglobin, 40 mmol/ mol; Immunology test, Significant, Neither interferon (IFN)-c nor interleukin (IL)-4 secretions from T-cells were detected in response to islet-related autoantigens such as GAD65 (glutamic acid decarboxylase), insulinB9- 23 peptide or insulin A1-15 peptide; Influenza virus test positive, Positive; Insulin C-peptide, < 0.0999 nmol/l, Low; Insulin C-peptide, < 0.0333 nmol/l, Low; Lymphocyte count, Significant, Low, Less than 21% of white blood cells; Platelet count, 105*10^9?l; Platelet count increased, 230*10^9/l, High
CDC 'Split Type': PHHY2011JP107550
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Amylase increased, Anti-GAD antibody negative, Anti-IA2 antibody, Blood glucose increased, CD8 lymphocytes decreased, Coxsackie virus test, Coxsackie virus test negative, Diabetic ketoacidosis, Fatigue, Glycosylated haemoglobin increased, Herpes simplex serology negative, Human herpes virus 6 serology negative, Hyperglycaemia, Immunology test abnormal, Influenza A virus test negative, Influenza B virus test, Influenza virus test positive, Insulin C-peptide decreased, Lymphocyte percentage decreased, Lymphopenia, Platelet count decreased, Polyuria, Thirst, Thrombocytopenia, Type 1 diabetes mellitus, Weight decreased
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Hypersensitivity (broad)
Write-up: Case number PHHY2011JP107550 is an initial spontaneous received on 08 Dec 2011: In this article the authors presented a case of fulminant Type 1 diabetes with thrombocytopenia after influenza vaccination. This report refers to a 54-year-old male patient. He had a family history of Type 2 diabetes, whereas he himself had been in good health without a history of hyperglycemia. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on an undetermined date. Four days after vaccination, he had general fatigue, thirst and polyuria, without flu-like symptoms. Seven days after vaccination he was admitted to hospital with hyperglycemia and diabetic ketosis. On admission, he had lost 4.5 kg of weight over a period of 2 days and his body mass index (BMI) was 20.2 kg/ m2. Blood glucose was 29 mmol/ l and HbA1c 40 mmol/ mol (5.9%). In addition, serum fasting and 2-hour C-peptide immunoreactivity were less than 0.0333 nmol/ l and 0.0999 nmol/ l, respectively. Anti-GAD (glutamic acid decarboxylase) and anti-IA-2 (anti-insulin antibodies) were negative. Serum amylase was increased to 517 U/l. Taking these factors into consideration, he was diagnosed as having fulminant Type 1 diabetes. Human leukocyte antigen genotypes were DRB1 0405/ 0901 and DQB1 0303/ 0401, recently reported to be susceptible to acute-onset and fulminant Type 1 diabetes. Interestingly, after the abrupt onset of diabetes, he showed mild thrombocytopenia (105 *10^9/ l) following a transient elevation of platelet count (230*10^9/ l), and relative lymphopenia (less than 21% of white blood cells), especially in CD8 T-cells. Thrombocytopenia (90-130*10^9/ l) with relative lymphopenia was observed for approximately five years after diabetes development. Furthermore, other than for influenza A, he showed no significant elevation of viral antibody titres for influenza B, coxsackie B3 and B4, herpes simplex and human herpes virus 6, even more than four weeks later. He had been treated with intensive insulin therapy, whereas he showed neither improvement of insulin secretion nor reduction of daily insulin requirement. To improve glycemic control, continuous subcutaneous insulin infusion was started recently. To directly evaluate the association with T-cell-mediated autoimmunity, enzyme-linked immunospot (ELISPOT) assay was performed using his peripheral lymphocytes. Neither interferon (IFN)-c nor interleukin (IL)-4 secretions from T-cells were detected in response to islet-related autoantigens such as GAD65 (glutamic acid decarboxylase), insulinB9- 23 peptide or insulin A1-15 peptide, although some cases of fulminant Type 1 diabetes represented T-cells reactivities. The authors concluded that this was the first description of fulminant Type 1 diabetes after influenza vaccination. Their observation suggested the possibility that influenza vaccination might trigger fulminant Type 1 diabetes.

VAERS ID:448697 (history)  Vaccinated:0000-00-00
Age:54.0  Onset:0000-00-00
Gender:Female  Submitted:2012-02-01
Location:Foreign  Entered:2012-02-02, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history reported
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201201105
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: Case retrieved form the Literature on 23 January 2012. Unique worldwide case ID: MX-SP-2012-01002. The database corresponding to the events temporarily associated with vaccination (ETAV) associated with influenza (A [H1N1] and seasonal) immunization reported between December 2009 and June 2010 was analyzed. Patient who displayed at least one ETAV after the administration of influenza A (H1N1) vaccine and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporarily criterion, i.e., appearance of the event within the 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine and requires demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine cases against influenza A (H1N1) and 18,442,171 doses against seasonal influenza vaccine were applied across the country. A total of 597corresponding to the application of the antiinfluenza A (H1N1) and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All the these cases were linked with the case 2012-01002, considered as the case of reference. A 54-year-old female patient, with no medical history nor concomitant therapy reported, had received on an unspecified date a combination of vaccine against influenza A (H1N1) (manufacturer unknown, batch number, number in series, route and site of administration not reported) and of vaccine against seasonal influenza (manufacturer unknown, batch number, number in series, route and site of administration not reported). It was not notified if vaccines contain adjuvant. On an unspecified date, the patient developed GBS (Guillain Barre syndrome) (reported as initial and final diagnosis). It was not specified if the patient was hospitalized. No corrective treatment was reported. The final outcome was not reported. It was specified that the patient was not died. This interval was reported as "11" (no unit reported). According to the author, the event was considered as "CNR" (coincidental not related). According with the author, this case was assessed as serious due to medically important condition. Fourteen confirmed cases of GBS according to Brighton Criteria were reported. All were ruled as unrelated coincidental events, given that vaccination against A (H1N1) as an antecedent occurred in seven cases (50%); immunization against seasonal influenza occurred in four cases (28.5%), and the joint administration of both vaccines occurred in three cases (21.4%). Documents held by sender: none.

VAERS ID:448768 (history)  Vaccinated:0000-00-00
Age:54.0  Onset:0000-00-00
Gender:Male  Submitted:2012-02-01
Location:Foreign  Entered:2012-02-02, 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history reported
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201201140
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Death, Pneumonia, Pneumonitis
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (narrow), Hypersensitivity (broad)
Write-up: Case retrieved from the literature on 23 January 2012. Unique worldwide case ID: MX-SP-2012-01002. The database corresponding to the events temporarily associated with vaccination (ETAV) associated with influenza (A [H1N1] and seasonal) immunization reported between December 2009 and June 2010 was analyzed. Patients who displayed at least one ETAV after the administration of H1N1 vaccine and/or seasonal influenza vaccine were included. Cases were considered to be probable vaccine-related if they met the temporality criterion, i.e., appearance of the event within the 52 days after vaccination, including immediate hypersensitivity reactions. In terms of association and biological plausibility, a causal ETAV is the one that appears after the administration of the vaccine and requires demonstration through clinical, epidemiological and laboratory findings. It would imply that the vaccine caused the event directly and undoubtedly. When causality cannot be demonstrated, the event is defined as a coincidental ETAV, which refers to medical incidents that would have taken place in the same manner, with or without the application of the vaccine. During the study period, a total of 27,048,330 vaccine doses against H1N1 and 18,442,171 doses against seasonal influenza were applied across the country. A total of 597 ETAV corresponding to the application of the anti-influenza A (H1N1) and/or anti-seasonal influenza vaccine were reported. A total of 57 events considered serious were reported during the period analyzed. 48 cases could be linked with sanofi pasteur product (manufacturer unknown). All of these cases were linked with the case 2012-01002, considered as the case of reference. A 54-year-old male patient, with no medical history nor concomitant therapy reported, had received on an unspecified date his dose of vaccine against seasonal influenza (manufacturer unknown, batch number, number in series, route and site of administration not reported). The vaccine was without adjuvant. On an unspecified date, the patient developed pneumonia (reported as final diagnosis). The initial diagnosis was pneumonitis. It was not specified if the patient was hospitalized. No corrective treatment was reported. The patient died on an unspecified date. This interval was reported as "1" (no unit reported). According to the author, the event was considered as "CNR" (coincidental not related). Documents held by sender: none.

VAERS ID:448964 (history)  Vaccinated:2011-05-12
Age:54.0  Onset:0000-00-00
Gender:Male  Submitted:2012-02-06
Location:Foreign  Entered:2012-02-07, 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: Not reported
Diagnostic Lab Data: Not reported
CDC 'Split Type': 201201331
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3960A0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypersensitivity
SMQs:, Angioedema (broad), Hypersensitivity (narrow)
Write-up: This initial case report is part of a batch of several hundred reports associated with several products that was received on 26 January 2012 by Sanofi Pasteur affiliate, from the "Foreign Ministry of Health" through the distributor (local case reference number BR-BT2012-0253). A female patient whose medical history and concomitant therapies were not reported, had received her 1st dose of FLUZONE (batch number "114090" corresponding to Sanofi Pasteur''s batch number U3960AA, route and anatomical site of administration not reported) on 12 May 2011. On an unspecified date post-vaccination, the patient experienced "other serious events and / or unusual" as well as hyper sensitivity reaction after 2h. She was not hospitalized. The patient recovered ("cure") without sequelae. The case was assessed as non-serious by the Ministry of Health and was upgraded by the company upon internal review. The case was "confirmed" as per the Ministry of Health, i.e. related to the vaccine. The action with regards to the next vaccination was provided: "contraindication without change in the scheme". Documents held by sender: none.

VAERS ID:449461 (history)  Vaccinated:2011-10-15
Age:54.0  Onset:2011-10-27, Days after vaccination: 12
Gender:Female  Submitted:2012-02-10, Days after onset: 106
Location:Foreign  Entered:2012-02-13, 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': 2012031073
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER098621601 IMUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.G004657 02052 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Neuralgic amyotrophy
SMQs:
Write-up: This health authority report (initial receipt 07-Feb-2012) concerns a 54 year old female patient. Concomitant medications included salbutamol and fluticasone; salmeterol combination. On 15-Oct-2011, the patient received 0.5 mL of ENZIRA (batch: 0986-221601) via intramuscular route for flu prophylaxis. On the same day she also received 0.5 mL of PNEUMOVAX II (batch number: G004657 02052) via intramuscular route. On 27-Oct-2011, the patient developed a severe neuralgic amyotrophy. The event outcome was recovering. Action taken with suspect drugs was not applicable. Rechallenge was unknown. The reporter considered events serious as the event resulted in disability / incapacity. The reporter was aware of the rarity of neuralgic amyotrophy.

VAERS ID:452364 (history)  Vaccinated:2011-10-22
Age:54.0  Onset:0000-00-00
Gender:Female  Submitted:2012-03-23
Location:Foreign  Entered:2012-03-23
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: Allergic Skin Reaction; Allergy to Metals
Diagnostic Lab Data: UNK
CDC 'Split Type': B0789639A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA629DB IMUN
Administered by: Other     Purchased by: Other
Symptoms: Discomfort, Feeling hot, Inflammation, Injection site mass, Injection site pain, Skin mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a pharmacist, via a foreign regulatory authority, and described the occurrence of injection site pain in a 54-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject''s medical history included allergic skin reaction to the perfume component of make-up and an allergy to metals. Concurrent medications included NUROFEN and IBULEVE. On 22 October 2011 the subject received an unspecified dose of FLUARIX (1 injection, intramuscular, batch number AFLUA629DB). From the time of vaccination with FLUARIX, the subject experienced injection site pain, localised warm sensation and discomfort ''as when first done at all times''. It was reported that previously the subject had felt a lump under the skin. The subject experienced local inflammation when pressure was applied. The regulatory authority reported that the events were clinically significant (or requiring intervention) as the patient was in ongoing discomfort. It was reported that the subject tried ibuprofen tablets and gel as suggested by a nurse. At the time of reporting, the outcome of the injection site lump was unknown. The other events were unresolved. MHRA Verbatim Text: Painful from time of injection, localised warm sensation, discomfort as when first done at all times. Previously, felt lump under skin. Local inflammation when pressure applied. Tried ibuprofen tablets and gel out, suggestion of nurse. Medically Significant: Patient is ongoing discomfort.

VAERS ID:453584 (history)  Vaccinated:2011-09-01
Age:54.0  Onset:2011-10-21, Days after vaccination: 50
Gender:Male  Submitted:2012-04-12, Days after onset: 174
Location:Foreign  Entered:2012-04-12
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to mercury; Allergy to Piroxicam; Calcifying tendinitis of shoulder, cervicoarthrosis
Preexisting Conditions:
Diagnostic Lab Data: Electromyogram, 10Nov2011, see narrative; Electromyogram, 12Dec2011, see narrative; Nuclear magnetic resonance ima, 07Nov2011, See narrative; Upper limb X-ray, 10Nov2011, See narrative; Upper limb X-ray, 12Dec2011, See narrative
CDC 'Split Type': B0787733A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB197AY0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Electromyogram abnormal, Hemiparesis, Hypoaesthesia, Intervertebral disc degeneration, Motor dysfunction, Musculoskeletal pain, Neuralgia, Neuralgic amyotrophy, Neuropathy peripheral, Nuclear magnetic resonance imaging spinal cord abnormal, Pain, Paraesthesia, Sensory loss, Spinal fusion surgery, X-ray limb abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Osteonecrosis (broad)
Write-up: This case was reported by a physician and described the occurrence of muscle weakness right-sided in a 54-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline), ENGERIX B adult. Concurrent medical conditions included cervicoarthrosis, calcifying tendinitis of left shoulder infraspinatus, Piroxicam allergy and Merthiolate allergy. Concurrent medications included Alanerv. The subject was practicing extra-professional activities such as bodybuilding and kickboxing. On 1 September 2011, the subject received 1st dose of TWINRIX (1 ml, intramuscular, left deltoid). On 18 October 2011, when it was time for the second dose of the vaccine, the subject preferred to be vaccinated with ENGERIX B (1 ml, intramuscular, left deltoid). Initially, within 1 week after vaccination with ENGERIX B, the subject complained about neurologic pain in the right scapular area during the night. The pain was at the opposite side where the vaccine had been administered. The subject was treated with Non-Steroidal Anti-Inflammatory, but no improvement. On 21 October 2011, 3 days after vaccination with ENGERIX B adult and 50 days after vaccination with TWINRIX, the subject presented with probable Parsonage-Turneer syndrome on the right side. On 30 October 2011, 12 days after vaccination with ENGERIX B adult, the subject presented with manifestation of paresthesia and hypoesthesia on the distal terriotory of C6. The subject was treated with ETORICOXIB, PREDNISOLONE ACETATE and BROMELAIN. Relevant test results included: Cervical Spine Magnetic Resonance Imaging done on 07 November 2011: No important disk alterations on the other inter-somatic levels observed, apart from the partial fusion of the C7-T1 vertebrae. The spinal canal presents median sagittal amplitude within normal limits. In its interior there is spinal cord with preserved signal intensity in all the length observed. Absence of important alterations of note, of the signal intensity of bone marrow of the vertebrae observed, apart from the degenerative alterations predominantly on the vertebral platforms between C4 and C6. Paravertebral spaces without alterations of note. Electromyography of the upper extremity done on 10 November 2011: Isolated deficit of the motor unit voluntary action potential of the right anterior serratus muscle, without apparent involvement of the muscles that share a identical radicular distribution (C5, C6 and C7). Reduction of the amplitude of the sensory responses corresponding to the right lateral antebrachial cutaneous nerve (radicular representation C5) and mild, of the corresponding cutaneous branch of the right radial nerve (radicular representation C6). The results are compatible with the clinical context being evaluated, with isolated neuropathy of the right long thoracic nerve (or nerve bundles of the cervical nerve roots from which it originates), of etiology to be determined. Expression of Parsonage-Turner Syndrome (?). Post-traumatic (?). Although signs of active denervation were not observed, a repeat EMG in due time, will permit the ruling out of this possibility with more certainty (and characterize with more precision the nature of the lesion). Electromyography done on 12 December 2011: Results are congruent with the previous exam, from 10/11/2011, and with the presence of axonal lesion of the right Long Thoracic Nerve (or the brachial plexus structures from which it originates). Presence of spontaneous denervation activity (though scarce), confirming the axonal nature of the lesion. At the time of reporting, the events were improved. The subject refused to be vaccinated with a third. The physician considered the events were unlikely to be related to vaccination with TWINRIX and ENGERIX B adult. The reporter also wanted to inform us about two other situations that, in her opinion, were more likely to have originated the scapular neurogenic pain, than the vaccination. She stated that there might have been long thoracic nerve injury that might

VAERS ID:453952 (history)  Vaccinated:2012-04-03
Age:54.0  Onset:2012-04-03, Days after vaccination: 0
Gender:Female  Submitted:2012-04-18, Days after onset: 15
Location:Foreign  Entered:2012-04-18
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': B0796256A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB849BL0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Confusional state, Gait disturbance, Headache, Hypertension, Speech disorder
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow)
Write-up: This case was reported by a physician via a regulatory authority (# 163972) and described the occurrence of confusion in a 54-year-old female subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). On 3 April 2012, the subject received 1st dose of ENGERIX B adult (20 mcg, intramuscular, unknown injection site). On 3 April 2012, less than one day after vaccination with ENGERIX B adult, the subject experienced confusion, high blood pressure, speech difficulty, walking difficulty and headache. The subject was hospitalised. On 12 April 2012, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with ENGERIX B adult.

VAERS ID:456204 (history)  Vaccinated:2012-05-01
Age:54.0  Onset:2012-05-01, Days after vaccination: 0
Gender:Male  Submitted:2012-05-24, Days after onset: 23
Location:Foreign  Entered:2012-05-25, 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: Crohn''s disease
Diagnostic Lab Data:
CDC 'Split Type': 2012032359
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED  IDUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Arthralgia, Back pain, Condition aggravated, Crohn's disease, Myalgia, Nausea, Pain in extremity, Paranasal sinus hypersecretion, Pyrexia, Spinal pain, Tendonitis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal premalignant disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: This health authority report (initial receipt: 17-May-2012) concerns a 54-year-old male patient. On 01-May-2012 the patient received 1 dose of FLUVAX (batch number was not provided) injection intradermally (not explicity reported) for prophylactic inoculation and vaccination. On 01-May-2012 the patient experienced severe arm soreness, nausea, inflammation of Crohn''s disease (seemed to turbo charge the immune system) with associated abdominal pain and other pains connected to enthesitis (feet, hip and back pain both spine and muscle). His sinus cavities affected extreme amount of mucus flow down his throat. He also had 18 hours of fever and other joint / muscle pain. Treatment included time / rest. The event outcome was recovered on 03-May-2012.

VAERS ID:457197 (history)  Vaccinated:2012-04-21
Age:54.0  Onset:2012-04-26, Days after vaccination: 5
Gender:Male  Submitted:2012-06-08, Days after onset: 43
Location:Foreign  Entered:2012-06-12, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 2012032524
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED090633202 SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Chest pain, Electrocardiogram abnormal, Headache, Malaise, Neck pain, Pericarditis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Arthritis (broad)
Write-up: This health authority report (initial receipt 04-Jun-2012) concerns a 54 year old male patient who received a dose of FLUVAX injection on 21-Apr-2012 (reported batch number: 090633202). Two hours following FLUVAX administration, the patient had joint and neck pain, headache, chest pain that has since resolved, fevers and a general malaise feeling. The symptoms had progressively gotten worse. The patient was admitted for 2 days with a diagnosis of acute pericarditis. The patient had ECG (electrocardiograph) changes and was febrile at the GP (general practitioner). Case onset date was reported to be 26-Apr-2012. Patient outcome is recovered. Reporter comments: The reporter considered events possible to the suspect vaccine, FLUVAX, due to patient hospitalisation (caused or prolonged).

VAERS ID:460446 (history)  Vaccinated:2009-11-04
Age:54.0  Onset:2009-12-04, Days after vaccination: 30
Gender:Female  Submitted:2012-07-27, Days after onset: 965
Location:Foreign  Entered:2012-07-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; Hypertension; Migraine
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0815581A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK)GLAXOSMITHKLINE BIOLOGICALS  IMRA
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNRA
Administered by: Other     Purchased by: Other
Symptoms: Back disorder, Back pain, Monoparesis, Myelitis, Paraparesis, Sensory loss
SMQs:, Peripheral neuropathy (narrow), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: This case was reported by a physician via regulatory authority (# FI-FIMEA-20120629) and described the occurrence of myelitis in a 54-year-old female subject who was vaccinated with PANDEMRIX H1N1 (GlaxoSmithKline) and Influenza vaccine unspecified. Concurrent medical conditions included asthma, hypertension and migraine. On 4 November 2009, the subject received an unspecified dose of PANDEMRIX H1N1 (intramuscular, right arm, batch number not provided) and an unspecified dose of Influenza vaccine unspecified (route unknown, right arm, batch number not provided). On 4 December 2009, 30 days after vaccination with Influenza vaccine unspecified and PANDEMRIX H1N1, the subject experienced paresis of foot, back pain and loss of sensation especially in left foot. On 8 December 2009, the subject was slipped over on the ice. She was not fallen down but the back was somewhat snapped. In January 2010, the subject was hospitalised due to extensive myelitis of thoracic spine. Etiological explorations were remained negative. Sequel of virus myelitis was considered as an option. The subject was treated with cortisone pulse therapy during 3 days and oral cortisone in length of several months. The findings have been decreased in MRI-controls. In consequence of the myelitis, set of symptoms of paraparesis remained which had satisfied the criteria of sequel of severe injury of the spinal cord. At the time of reporting, myelitis and paraparesis were unresolved. The outcome of the events was unspecified.

VAERS ID:462275 (history)  Vaccinated:2012-07-19
Age:54.0  Onset:2012-07-19, Days after vaccination: 0
Gender:Female  Submitted:2012-08-17, Days after onset: 29
Location:Foreign  Entered:2012-08-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1208ITA004356
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.G0038860IMUN
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Laryngospasm, Type I hypersensitivity
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Dystonia (broad), Hypersensitivity (narrow)
Write-up: Case received from Health Authority (case n. 172200) (local case n. IT382/12). Initial report received on 26-Jul-2012. Case medically confirmed. A 54-year-old female patient was vaccination on 19-Jul-2012 with a first dose of PNEUMOVAX 23 (lot n. G003886, site not reported) intramuscularly and immediately she experienced mild laryngospasm and immediate hypersensitivity. The reactions lasted 3 minutes and recovered spontaneously without treatment. The patient was kept under surveillance for 45 minutes. The outcome is fully recovered on 19-Jul-2012. The case is closed.

VAERS ID:464445 (history)  Vaccinated:2011-07-31
Age:54.0  Onset:2011-09-30, Days after vaccination: 61
Gender:Female  Submitted:2012-09-06, Days after onset: 342
Location:Foreign  Entered:2012-09-07, 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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 2012033272
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED090628502 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abasia, Gait disturbance, Paraesthesia, Paralysis
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: This health authority report (initial receipt 29-Aug-2012) concerns a 54-year-old female patient. On 31-Jul-2011, the patient received FLUVAX (batch no. 090628502). On 30-Sep-2011, 2 months after receiving FLUVAX the patient felt paralysis in her chest, lower back and both feet. She had tingling in both legs/paraesthesia and was unable to walk/gait disturbance. The events lasted about 2.5 weeks however after this time she still did not feel 100%. She still had some tingling in her feet. Reporter''s comment: On 07-Aug-2012 the health authority considered the events as possible in relation to FLUVAX. Batch record review of lot number 090628502 received on 06-Jun-2011 noted: On completion of this investigation, it has been determined that all deviations related to the manufacture of this lot were assessed as having no impact on product quality, all QC testing was satisfactory with no out of specification results reported, there are no outstanding issues related to this lot that would potentially affect product quality. In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse drug reaction reported.

VAERS ID:464620 (history)  Vaccinated:2011-10-20
Age:54.0  Onset:2011-10-24, Days after vaccination: 4
Gender:Male  Submitted:2012-09-10, Days after onset: 322
Location:Foreign  Entered:2012-09-11, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Malignant tumour excision
Diagnostic Lab Data:
CDC 'Split Type': PHFR2011GB007198
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis
SMQs:, Noninfectious encephalitis (narrow), Demyelination (narrow)
Write-up: Case number PHFR2011GB007198, is a spontaneous report received initially from Health authority (reference number: 21383259) on 15 Dec 2011 and with a follow up received on 29 Aug 2012 and a follow up information received from a physician via health authority on 07 Sep 2012. This case refers to 54-year-old male patient. Medical history included squamous cell carcinoma excision and his concomitant medications were not reported. He was vaccinated with influenza vaccine (manufacture and batch number unknown) intramuscularly, on 20 Oct 2011. On 24 Oct 2011, he experienced acute demyelinating encephalomyelitis (acute disseminated encephalomyelitis). It was reported that he was admitted to hospital (date of admission and duration of hospitalization was not reported). The outcome of the events was reported as recovering. The causality of the events was not reported. Following an internal review on 29 Aug 2012 of the information received on 20 Aug 2012. The case PHFR2012GB004576, was found to be duplicate of PHFR2011GB007198. All the information from the case PHFR2012GB004576 was merged with PHFR2011GB007198 and the case PHFR2012GB004576 would be deactivated. Updated the vaccination date. Follow up information received on 07 Sep 2012: Reporter and vaccination route updated. Event recoded to acute disseminated encephalomyelitis.

VAERS ID:465863 (history)  Vaccinated:2012-08-13
Age:54.0  Onset:0000-00-00
Gender:Female  Submitted:2012-09-20
Location:Foreign  Entered:2012-09-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No information reported on the patient''s medical history. No history of allergy. Primary series of rabies vaccine in July 2009 intradermally in the right upper arm: uneventful.
Diagnostic Lab Data: Primary series of rabies vaccine in July 2009 intradermally in the right upper arm: uneventful.
CDC 'Split Type': E201205806
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURERH1287 IDUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Malaise, Oedema peripheral, Respiratory disorder
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Case of misuse received from a physician on 29-Aug-2012 and on 30-Aug-2012. This case is linked to case serious E2012-05725 (same reporter, same vaccine: Rabies HDCV). Case medically confirmed. A female patient of unspecified age received a dose of inactivated rabies HDC Vaccine (batch number not reported, 0.1 mL) via the intracutaneous route in the right arm in Aug-2012, during the week of 16-Aug-2012. Six days later, she developed a red and swollen arm. This happened after she took a sunbed. According to the reporter, the vaccination center always advised not to take a sunbed/solarium for 2 days after vaccination. The patient had no history of allergy. All possible causes for the reaction were excluded except the vaccination. Primary series of rabies vaccine 3 to 4 years before the booster dose of administered uneventfully. The outcome was not reported. At the time of reporting no further information was available. Follow-up information received on 06-Sep-2012: Case upgraded into serious (hospitalization). The patient was 55 years old. She had received a dose of inactivated rabies HDC Vaccine (batch number H1287-2) probably on 13-Aug-2012. Seven or eight days after vaccination, she had a sunbed session and subsequently her right arm became red and swollen, and later in the night she began to feel unwell and was sent to hospital with breathing problems. The hospital physician thought that it was probably an allergic reaction to cleaning products used on the sunbed. The patient had never had any problems before and was used to sunbed sessions on an regular basis. Primary series of rabies vaccine in July 2009 intradermally in the right upper arm: uneventful.

VAERS ID:470504 (history)  Vaccinated:2011-11-17
Age:54.0  Onset:2011-12-13, Days after vaccination: 26
Gender:Male  Submitted:2012-10-19, Days after onset: 310
Location:Foreign  Entered:2012-10-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Flat foot; Hypercholesterolemia; Hypertriglyceridemia
Preexisting Conditions: Cholecystectomy; Induration penis plastica
Diagnostic Lab Data: Blood triglycerides, 04Jul2012, 289mg/dl; CSF cell count, 05Jul2012, 5/ul; CSF immunoglobulin increased, 05Jul2012, IgA: 0.89mg/dl; Cerebrospinal fluid protein, 05Jul2012, 89mg/dl; Electrocardiogram, 04Jul2012, at rest: normal; Electroencephalogram, 06Jul2012, normal; Nerve conduction studies abnor, Jul2012, decreased; Somatosensory evoked potential, 05Jul2012, pathologic; Vitamin B12, 05Jul2012, above 2000pg/ml
CDC 'Split Type': D0077317A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB886AP UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood folate normal, Blood glucose normal, Blood triglycerides increased, CSF cell count normal, CSF immunoglobulin increased, CSF protein increased, Chronic inflammatory demyelinating polyradiculoneuropathy, Decreased vibratory sense, Electrocardiogram normal, Electroencephalogram normal, Glycosylated haemoglobin normal, Hypoaesthesia, Immunoelectrophoresis, Inflammation, Nerve conduction studies abnormal, Neurological examination abnormal, Nuclear magnetic resonance imaging spinal cord abnormal, Paraesthesia, Peripheral sensorimotor neuropathy, Pleocytosis, Polyneuropathy, Somatosensory evoked potentials abnormal, Thermohypoaesthesia, Thyroid function test normal, Vitamin B12 increased, Walking disability
SMQs:, Dyslipidaemia (narrow), Peripheral neuropathy (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Lipodystrophy (broad)
Write-up: This case was reported by a regulatory authority (# DE-PEI-PEI2012032072) and described the occurrence of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) in 55-year-old male subject who was vaccinated with ENGERIX-B adult (GlaxoSmithKline). The case was reported to the regulatory authority via agency (# 157351) by a physician. The subject''s medical history included cholecystectomy and induration penis plastica (IPP) since 2011. Concurrent medical conditions included flat foot (treated with corrective insole, hypercholesterolemia and hypertriglyceridemia (with previous values above 500 mg/dl). The subject did not smoke, did not drink alcohol and did not abuse any drugs. The subject was very sportive (running on a treadmill; swimming). The subject was slim and well in training. On 17 November 2011 the subject received an unspecified dose of ENGERIX-B adult (1 ml, unknown). Approximately 26 days post vaccination with ENGERIX-B adult, on 13 December 2011, the subject experienced first signs of progressive polyneuropathy. The subject experienced symmetric numbness of both feet in the area of the forefoot, more at the sole of the foot than at the back of the foot, sometimes ascending with stocking like distribution. At rest and after acupuncture the numb feeling was improved. Paresthesia at the feet has occurred for the first time after a long-distance flight but this may have been just coincidental. Intermittently the subject also experience numbness at the fingertips. Magnetic resonance tomogram (MRT) of the lumbar spine has showed suspicious results (not further specified). Approximately seven months post vaccination with ENGERIX-B adult, on 03 July 2011, the subject was diagnosed with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) with peripheral sensorimotor neuropathy. From 04 July 2012 to 07 July 2012 the subject was hospitalised for four days for examinations. Clinical neurological examinations showed discrete symptoms of polyneuropathy with bimalleolar pallhypesthesia (5/8), slight disability to walk at the heel both sides, and subjective feeling of numbness and thermohypoesthesia in the area of both forefeet with an emphasis towards the sole of the forefeet. Neurological examinations including somatosensory evoked potential (SSEP), nerve conduction velocity and motor evoked potential (MEP) were consistent with mixed senso-motor polyneuropathy of the legs. Laboratory examinations, including thyroid gland parameters, folic acid, immunoelectrophoresis and HbA1C, were normal. Vitamin B12 was severely increased under substitution. Blood glucose profile was normal and showed no signs of diabetes mellitus (which may have explained also previous experienced induration penis plastica (IPP)). Cerebrospinal fluid (CSF) examinations showed minimal pleocytosis and distinctly increased CSF protein as signs of a chronic inflammatory reaction but no signs of a specific infection (e.g. Borreliosis). In conclusion the subject was diagnosed with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The subject was treated with high-dose KORTISON, intravenously, for two days at 1000 mg and 500 mg, respectively, followed by KORTISON, orally at 100 mg daily plus tapering. The subject reported subjective improvement of numb feeling. On 07 July 2012 the subject was discharged from hospital in unchanged condition. At the time of reporting to the agency, on 18 July 2012, the events were unresolved. The reporting physician considered that the events were causally related to vaccination with ENGERIX-B adult. At the moment no further information was available.

VAERS ID:473707 (history)  Vaccinated:0000-00-00
Age:54.0  Onset:0000-00-00
Gender:Female  Submitted:2012-11-08
Location:Foreign  Entered:2012-11-08
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: No medical history in her family. No tobacco use.
Diagnostic Lab Data: Nuclear magnetic resonance ima, See text; MRI: demyelinating plaques (date unspecified)
CDC 'Split Type': B0842120A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Demyelination, Multiple sclerosis, Nuclear magnetic resonance imaging normal, Sensory loss
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Optic nerve disorders (broad), Demyelination (narrow)
Write-up: This case was reported by a consumer and described the occurrence of multiple sclerosis in a 54-year-old female subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. There was no medical history in her family. The subject was not a tobacco user. Concomitant medications, if any, were not specified. In 1995, the subject received three primary doses of hepatitis B vaccine recombinant following unknown vaccine schedule (manufacturer, batch number, route and site unknown). In 2007, 12 years after vaccination with Hepatitis B vaccine, the subject experienced decreased sensory in arms and legs which resolved after treatment with corticosteroids (nos). On unspecified date, MRI evidenced demyelinating plaques. In 2009, the diagnosis of multiple sclerosis was made. Since 2007, she had not had a flare up. This case was assessed as medically serious by GSK.

VAERS ID:479091 (history)  Vaccinated:2012-11-29
Age:54.0  Onset:2012-11-29, Days after vaccination: 0
Gender:Female  Submitted:2012-12-21, Days after onset: 22
Location:Foreign  Entered:2012-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Acetylsalicylic acid allergy; Allergy to nifedipine; Climacteric Disturbance; Iodine allergy
Preexisting Conditions: Headache
Diagnostic Lab Data: Heart rate, 29Nov2012, 89/min; Increased blood pressure, 29Nov2012, 180/100mmHg; Increased blood pressure, 29Nov2012, 190/105mmHg; Oxygen saturation, 29Nov2012, 93%
CDC 'Split Type': D0078113A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA700IA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Blood pressure increased, Chest discomfort, Electrocardiogram normal, Heart rate irregular, Hypertension, Hypertensive crisis, Palpitations, Tachycardia, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypersensitivity (broad)
Write-up: This case was reported by a physician and described the occurrence of hypertensive crisis in a 54-year-old female subject who was vaccinated with INFLUSPLIT SSW (GlaxoSmithKline). Concurrent medical conditions included ASS allergy and iodine allergy. Concomitant medications included a Beta blocker. On an unspecified date in 2012 the subject received a dose of INFLUSPLIT SSW (0.5 ml, unknown). Less than one day post vaccination with INFLUSPLIT SSW, on an unspecified date in 2012, the subject experienced tachycardia and severe hypertension with blood pressure of 190/105 mmHg for approximately two hours. At the time of reporting the outcome of the events was unspecified. Follow-up information, including an emergency ambulance report from a hospital, was received on 30 December 2012 from the reporting physician. The case was upgraded to serious. The subject''s medical history included headache on treatment with NIFEDIPIN / possible allergy to nifedipine. Concurrent medical conditions included known allergies to ASS and iodine and climacteric disturbances. Concomitant medications included Bisoprolol and PHYTO-STROL. Previous annual vaccinations with INFLUSPLIT SSW (GlaxoSmithKline) have been well tolerated. On 29 November 2012 the subject received a dose of INFLUSPLIT SSW (.5 ml, intramuscular, left deltoid). Less than one day post vaccination with INFLUSPLIT SSW, on 29 November 2012 in the evening, the subject reported severe heart palpitation felt up to the throat. On 29 November 2012 at around 21:30 the subject experienced severe irregular heartbeat, chest tightness, throat tightness and severe hypertension with blood pressure of 190/105 mmHg. The subject was treated at an emergency ambulance report from a hospital for hypertensive crisis and possible paroxysmal supraventricular tachycardia (PSVT) post vaccination with INFLUSPLIT SSW. This case was assessed as medically serious by GSK criteria. The subject showed no signs of apnea, dyspnea, cephalgia or neurologic deficiencies. The subject was awake. Examinations on admission were all normal. Relevant test results included blood pressure of 180/100 mmHg, heart rate of 89 /min and oxygen saturation of 93%. Electrocardiogram (ECG) was normal and showed no signs of disturbance of repolarisation. After about two hours, on 29 November 2012 at around 21:30, all events were resolved. The reporting physician considered that the event was the events were possibly related to vaccination with INFLUSPLIT SSW. No further information will be available.

VAERS ID:482349 (history)  Vaccinated:2012-09-21
Age:54.0  Onset:2012-10-09, Days after vaccination: 18
Gender:Male  Submitted:2013-01-23, Days after onset: 106
Location:Foreign  Entered:2013-01-23
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: Alanine aminotransferase, 15Oct2012, 3470U/L; Serum ferritin, 15Oct2012, above 2000mcg/l
CDC 'Split Type': B0861471A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC054AH2IMAR
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase increased, Hepatitis, Influenza like illness, Jaundice, Laboratory test, Pyrexia, Serum ferritin increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Hepatitis, non-infectious (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow)
Write-up: This case was reported by a health professional via a regulatory authority (# NL-LRB-148643) and described the occurrence of hepatitis in a 54-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concomitant medication was not reported. The subject had no known medical history nor past drug therapy. On 21 September 2012, the subject received 3rd dose of ENGERIX B (20 mcg, intramuscular, unknown arm). On 9 October 2012, 18 days after vaccination with 3rd dose of ENGERIX B, the subject experienced fever and influenza like symptoms. On 14 October 2012, 23 days after vaccination with ENGERIX B, the subject experienced icterus. Hepatitis was reported. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 15 October 2012, laboratory tests were performed. No diagnosis could be made. At the time of reporting, the events were resolved. The regulatory authority reported that the events were unlikely to be related to vaccination with ENGERIX B.

VAERS ID:483662 (history)  Vaccinated:2013-01-26
Age:54.0  Onset:2013-01-26, Days after vaccination: 0
Gender:Female  Submitted:2013-02-06, Days after onset: 11
Location:Foreign  Entered:2013-02-07, 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: NORVASC; LIPITOR; TWYNSTA
Current Illness:
Preexisting Conditions: Hypertension; Influenza vaccine, No adverse event
Diagnostic Lab Data: Dengue and Typhoid exam (unknown date): normal result; Stool exam (unknown date): normal result; Body temperature (27Jan2013): 38-40 Celsius.
CDC 'Split Type': 2013042743
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Bacterial test negative, Blister, Chills, Decreased appetite, Diarrhoea, Flushing, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Mobility decreased, Pyrexia, Rash, Rash erythematous, Stool analysis normal, Tenderness, Viral test negative
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow)
Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative. This 54-year-old female patient received PREVENAR 13 intramuscular, single dose on 26Jan2013. Concurrent condition includes hypertension. Concomitant medications included TWYNSTA, NORVASC and LIPITOR, all for hypertension, dosage and route unknown. Past drug history was unspecified. On 26Jan2013, the patient seek consultation, due to hypertension as a regular check up. The physician recommended PREVENAR 13 and she was vaccinated by her daughter, who is also a physician and was with them during the check up. The night after vaccination, the patient experienced: warmth at the injection site, redness, hardness and pain aft the injection site, and flashing of face. The following day, on 27Jan2013, the patient was febrile at 38-40 degree Celsius and the fever persisted. On the same day, the patient had also diarrhea. The patient was hospitalised on 27Jan2013. On 28Jan2013, erythema was already present, swelling at the injection site that bulges out and quickly expanded to 4cm at deltoid part, and tenderness on the outer part and hardness near the injection site were evident. Fever was present during daytime. On 31Jan2013, blisters were already evident and burn-like effect was seen; also limitation of arm movement, decreased appetite, chills, and rashes were present. The patient had also joint pain. The patient had normal results for dengue and typhoid exam, stool examination was normal. The patient had no reaction to flu vaccine. It was first time that the patient received pneumococcal vaccine and that experienced the above mentioned adverse events. At the time of the report, the outcome of the events was unknown. The physician believed that the adverse events were related to pneumococcal vaccine.

VAERS ID:486436 (history)  Vaccinated:0000-00-00
Age:54.0  Onset:0000-00-00
Gender:Male  Submitted:2013-03-05
Location:Foreign  Entered:2013-03-07, 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:
Preexisting Conditions: Not reported
Diagnostic Lab Data:
CDC 'Split Type': 201303428
Vaccination
Manufacturer
Lot
Dose
Route
Site
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: CSF test, Flavivirus test positive, HIV test negative, Meningitis, Musculoskeletal stiffness, Neurological symptom, Pain, Parasitic blood test negative, Polymerase chain reaction, Viral test negative, Yellow fever vaccine-associated neurotropic disease
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Arthritis (broad)
Write-up: Case retrieved from the literature on 22 February 2013. A total of 22 cases were created corresponding to the cases classified as possible Yellow Fever (YF) vaccine reactions. This case is linked with the reference case 2013-03410. Abstract: "BACKGROUND Serious, but rare adverse events following immunization (AEFI) have been reported with yellow fever (YF) 17D vaccine, including severe allergic reactions, FY vaccine-associated neurologic disease (YEL-AND) and YF-vaccine-associated viscerotropic disease (YEL-AVD). The frequency with which YEL-AND and YEL-AVD occur in YF endemic countries is mostly unknown. METHOD: From 2007 to 2010, eight countries - implemented large-scale YF preventive vaccination campaigns. Each country established vaccine pharmacovigilance systems that included standard case definitions, procedures to collect and transport biological specimens, and National Expert Committees to review data and classify cases. Staff in all countries received training and laboratory capacity expanded. RESULTS: In total, just over 38 million people were vaccinated against YF and 3116 AEFIs were reported of which 164 (5%) were classified as serious. Of these, 22 (13%) were classified as YF vaccine reactions, including 11 (50%) hypersensitivity reactions, six (27%) suspected YEL-AND, and five (23%) suspected YEL-AVD. The incidence per 100,000 vaccine doses administered was 8.2 for all reported AEFIs, 0.43 for any serious AEFI, 0.058 for YF vaccine related AEFIs, 0.029 for hypersensitivity reactions, 0.016 for YELAND, and 0.013 for YEL-AVD. Our findings were limited by operational challenges, including difficulties in obtaining recommended biological specimens leading to incomplete laboratory evaluation, unknown case ascertainment, and variable levels of staff training and experience. CONCLUSIONS: Despite limitations, active case-finding in the eight different countries did not find an incidence of YF vaccine associated AEFI''s that was higher than previous reports. These data reinforce the safety profile of YF vaccine and support the continued use of attenuated FY vaccine during preventive mass vaccination campaigns in YF endemic areas." Study design and setting: "From 2007 to 2010, active surveillance of serious AEFIs was undertaken during preventive YF vaccination campaigns. All countries were included in the analysis due to unavailability of the national database. Both the 17D-204 and 17DD YF substrain vaccines were 73 used." The present case described a 54-year-old male patient, with no reported medical history and concomitant therapy, who had received a dose of Yellow fever vaccine (manufacturer unknown, batch number, route and site of administration not reported) on an unspecified date. Less than 1 day post-vaccination, the patient developed pain and cervical stiffness as primary symptoms. Three days post-vaccination, the patient had her first clinical evaluation. The diagnosis was yellow fever vaccine-associated neurotropic disease (YEL-AND) with neurologic reaction and meningitis; Brighton aseptic meningitis case definition was not fulfilled. Human immunodeficiency virus (HIV) and malaria tests were negative. No further tests to evaluate other etiologies were done. Results of lab tests performed on acute serum or plasma sample taken at onset of symptoms showed IgM (1:10) and IgG (1:100) positive (positive detection of anti-YFV antibodies or genome). Results of IgM level measured on convalescent serum sample (sample taken at 21-35 days after onset of symptoms) and cerebro-spinal fluid (CSF) were not available. Results of YF real-time reverse transcription-quantitative polymerase chain reaction (YF RT-qPCR) in CSF, serum, blood or plasma and urine were not available. Results of reciprocal neutralization titer (1:x) were not available. Results of total IgE was not available. The time between vaccination and sample collection for the analyses to be conducted at the Institute was 4 days. The patient recovered on an unspecified

VAERS ID:487108 (history)  Vaccinated:2012-10-23
Age:54.0  Onset:0000-00-00
Gender:Female  Submitted:2013-03-15
Location:Foreign  Entered:2013-03-15
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0872848A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA4744AB SCUN
Administered by: Other     Purchased by: Other
Symptoms: VIIth nerve paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: This case was reported by a regulatory authority (# GB-MHRA-ADR 22031860) and described the occurrence of Bell''s palsy in a 54-year-old female subject who was vaccinated with FLUARIX. On 23 October 2012 the subject received unspecified dose of FLUARIX (1 IU Axa, subcutaneous). At an unspecified time after vaccination with FLUARIX, the subject experienced Bell''s palsy. The regulatory authority reported that the event was disabling. At the time of reporting the event was unresolved. Verbatim Text: Bell''s palsy.

VAERS ID:487286 (history)  Vaccinated:2012-11-27
Age:54.0  Onset:2013-03-02, Days after vaccination: 95
Gender:Female  Submitted:2013-03-19, Days after onset: 16
Location:Foreign  Entered:2013-03-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy; Hypertonus; Thyroid adenoma
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 02Mar2013, 39.8deg C; C-reactive protein, increased; H1N1 influenza PCR, 04Mar2013, negative; Influenza A virus test, 04Mar2013, PCR positive; Influenza B virus test, 04Mar2013, PCR negative; Polymerase chain reaction, 04Mar2013, Influenza A positive; Smear, 04Mar2013, positive; White blood cell count, normal
CDC 'Split Type': D0079146A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA7521AB IMUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, C-reactive protein increased, Cough, General physical condition abnormal, Headache, Influenza, Influenza A virus test negative, Influenza A virus test positive, Influenza B virus test, Influenza like illness, Nasopharyngitis, Oral herpes, Oropharyngeal pain, Pain in extremity, Polymerase chain reaction, Pyrexia, Rhinitis, Smear site unspecified abnormal, Vaccination failure, White blood cell count normal
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad)
Write-up: This case was reported by a health professional via a regulatory authority (# DE-PEI-PEI2013014620) and described the occurrence of influenza A virus infection in a 54-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included allergy, hypertonus and thyroid adenoma. On 27 November 2012 the subject received a dose of INFLUSPLIT SSW (intramuscular, unknown). 95 days after vaccination with INFLUSPLIT SSW, on 02 March 2013, the subject developed signs of an infection with influenza A, which included common cold, herpes labialis, rhinitis, cough, irritative cough, throat pain, fever, weakness, headache, limb pain and an abnormal general physical condition. On 04 March 2013 the subject was confirmed positive for Influenza A by means of PCR (vaccination failure). She was negative for Influenza A H1N1 and Influenza B. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by GSK.

VAERS ID:487727 (history)  Vaccinated:0000-00-00
Age:54.0  Onset:0000-00-00
Gender:Male  Submitted:2013-03-25
Location:Foreign  Entered:2013-03-25
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Hypertension arterial
Preexisting Conditions:
Diagnostic Lab Data: Diagnostic ultrasound, subacromial burs; Physical examination, see text; X-ray, no abnormalities
CDC 'Split Type': B0876403A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Arthritis, Arthrogram, Bursitis, Injected limb mobility decreased, Injection site joint pain, Injection site pain, Joint range of motion decreased, Periarthritis, Tenderness, Ultrasound joint, Ultrasound scan normal, X-ray normal
SMQs:, Systemic lupus erythematosus (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (narrow)
Write-up: This case was reported in a literature article and described the occurrence of frozen shoulder syndrome in a 54-year-old male subject who was vaccinated with Influenza vaccine (manufacturer unspecified). Concurrent medical conditions included hypertension arterial for which the subject was treated with unknown (unspecified) medication. On an unspecified date, the subject received unspecified dose of Influenza vaccine (intramuscular, left deltoid). At hours, after vaccination with Influenza vaccine, the subject experienced shoulder pain in injection arm. The shoulder pain increased progressively after the vaccination and the injected limb mobility decreased. The events were considered disabling. Clinical examination showed a maximal abduction of 80 degrees, a 110 degrees flexion, an absent external rotation and an internal rotation limited to the hip. Frozen shoulder syndrome was diagnosed. Radiological examination showed no abnormalities and ultrasound revealed a subacromial bursitis with an intact rotator cuff. The subject was treated with physical therapy and distension arthrography after which the pain relief immediately and the mobility improved. After 3 months of treatment, the mobility was almost normal and the pain resolved. Further treatment was discontinued. Summary of the literature article: The frozen shoulder syndrome was often related with metabolic disorders. Secondary forms were preceded by an injury or surgical procedure. Frozen shoulder syndrome was characterized by an adhesive capsular inflammation of the glenohumeral joint. This initially leads to a painful shoulder, followed by a freezing phase with a progressive decrease in both active and passive glenohumeral mobility and then a thawing phase with a decreased in tenderness and a partial recovery of range of motion. The cause of frozen shoulder syndrome was unknown in most cases, although it can be preceded by minor trauma. The above case reported a subject with severe frozen shoulder after an intramuscular vaccination in the deltoid muscle. A distension arthrography resulted in good pain relief and improved mobility. Frozen shoulder syndrome can be a severe manifestation of vaccination related shoulder dysfunction. Correct intramuscular administration was crucial to prevent post vaccination frozen shoulder and on the other hand, physicians awareness was needed to recognize this feature early on. Even if the exact causes were unknown the pathology of frozen shoulder syndrome included an inflammatory response and fibroblastic proliferation, possibly immunomodulated. The trigger of this process of adhesive capsulitis was unspecified, although metabolic disorders like diabetes were often associated with frozen shoulder syndrome. The authors suggested that injections on the upper third of the deltoid muscle were at risk of intrabursal leakage; cause of severe local immune inflammatory response. Inflammatory process and an autoimmune pathway may be implicated in the post-vaccination frozen shoulder; as vaccination were known to trigger autoimmune diseases. The weakness of this report was that the subject could not recall the exact site of infiltration. Frozen shoulder syndrome was diagnosed on clinical ground. There was no underlying pathology and no serious underlying shoulder abnormalities were seen. The good outcome after distension arthrography opposed to the calcifications on its own as a cause of the shoulder pain. Early diagnosis of frozen shoulder syndrome could be challenged. The supine abduction exorotation test could help in rapid clinical diagnosis. With this article the authors wanted to enhance the awareness of possible post vaccination frozen shoulder syndrome in subjects with persistent shoulder pain after intramuscular deltoid infiltration. In idiopathic frozen shoulder a careful history should exclude recent vaccination. By a correct intramuscular deltoid vaccination the shoulder frozen syndrome could be prevented, deep infiltration in the upp

VAERS ID:490523 (history)  Vaccinated:2013-03-27
Age:54.0  Onset:2013-03-27, Days after vaccination: 0
Gender:Male  Submitted:2013-04-30, Days after onset: 34
Location:Foreign  Entered:2013-05-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 2013035629
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITEDB090637501 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Hot flush, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)
Write-up: This health authority report (initial receipt 22-Apr-2013) concerns a 54-year-old male patient. On 27-Mar-2013, the patient received FLUVAX (batch number: B0906-37501) intramuscularly. On 27-Mar-2013, 5 minutes after vaccination the patient experienced mild lightheadedness. He also developed a hot flush and pins and needles sensation under the skin in head area only. The patient was reviewed and monitored for signs of vasovagal and anaphylaxis which were nil. At 12.30pm his blood pressure (BP) was 154/96 and pulse was 84. At 13.15pm his BP was 176/98 and pulse was 91. The patient had not eaten for 5 hours; he had a sugary drink and the symptoms improved. The final outcome was unknown. Reporter''s comment: The health authority considered the events as possible in relation to influenza vaccine and serious due to incapacity/disability.

VAERS ID:490908 (history)  Vaccinated:1996-03-27
Age:54.0  Onset:0000-00-00
Gender:Male  Submitted:2013-05-03
Location:Foreign  Entered:2013-05-06, 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: Patient had received one dose of TYPHIM on 21-Dec-1994 (lot K084), four doses of ENGERIX on 24-Mar-1994 (batch no. 1281B6), on 27-Apr-1994 (lot 1296B6), on 06-Jun-1994 (batch no. 1224B6), on 16-May-1994 (batch no. 1677D6), one dose of poliomyelitis vaccine on 27-Apr-1994 (batch no. J1139).
Diagnostic Lab Data:
CDC 'Split Type': E201303203
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTIPV: DT + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Biopsy muscle abnormal, Chronic fatigue syndrome, Myalgia, Myofascitis, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad)
Write-up: Initial case received on 25-Apr-2013 from the agency (Agency number PC20130241). Case is medically confirmed. Information was provided by the reference center for neuromuscular disease. . A 62-year-old male patient, was vaccinated with one dose of DT POLIO MERIEUX (batch not reported) on 27-Mar-1996; 2 doses of TYPHIM on 21-Dec-1994 (lot K084) and on 14-Feb-2000 (TYPHIM VI); 5 doses of ENGERIX on 24-Mar-1994 (batch no. 1281B6), on 27-Apr-1994 (lot 1296B6), on 06-Jun-1994 (batch no. 1224B6), on 16-May-1994 (batch no. 1677D6) and 19-Dec-2000 (ENGERIX B); one dose of T POLIO, batch no. W0059) on 24-Mar-1994; 2 doses of poliomyelitis vaccine on 27-Apr-1994 (batch no. J1139) and 06-Jun-1994 (batch no. J1139); one dose of HAVRIX (batch no. 437B6B) on 16-May-1995. All these drugs were considered as suspect vaccines. The routes of administration (intramuscular or subcutaneous) were not reported. On 13-Sep-2004, the patient experienced macrophagic myofasciitis. The patient visited a neurologist on 03-Oct-2008 for chronic fatigue syndrome and muscle pain, which a muscle biopsy had shown a macrophagic myofasciitis lesions. For the past 3 years, the patient had no intercurrent disease. There were still some fluctuations in both pain and asthenia with a score between 2 and 3 for the good periods and between 6 and 7 for the more intense symptoms. There was an increase in the symptoms on exertion and after consumption of certain substance like alcohol or acidic foods. The clinical examination is very satisfying and showed no muscular deficit, no pain on the palpation of several areas and no contractures or tone disorders. Results of the muscle biopsy performed on 13-Sep-1999: Left deltoid muscle, fascia and panniculus fragments were examined on cryosections and after fixation in parafin. The sections were stained with Hematoxylin Eosin, Masson''s trichrome, NADHTR, Cox, PAS and Susan black. The examined fragment showed an inflammatory infiltrate, localized in the perifascicular endomysium, composed of cohesive basophilic macrophages, not forming giant multinucleated cells, with collagen deposite between the macrophages. Presence of lymphocyte in the macrophagic infiltrate. The histological appearance corresponded to macrophagic myofasciitis lesions and was indicative of the persistence of aluminum hydroxide after intramuscular injection of a substance containing this compounds as an adjuvant. There were no significant myocytic lesions except for an atrophy in the myocytes enclosed in the macrophagic infiltrate. There was no histological evidence of mitochondrial dysfunction or an overload disorder. The fascia and the perimuscular adipose panniculus were normal in appearance. Conclusion: macrophagic myofasciitis histological lesions. The patient had not recovered. The Health Authorities assessed the causal relationship between the reported reaction and vaccination as doubtful (C1 S1 Il) according to the method of assessment. Upon medical review the company judged relevant to cod "muscular pain, fatigue and asthenia" which were mentioned by the agency in the narrative but not coded.

VAERS ID:492646 (history)  Vaccinated:2013-04-12
Age:54.0  Onset:2013-05-01, Days after vaccination: 19
Gender:Female  Submitted:2013-05-28, Days after onset: 27
Location:Foreign  Entered:2013-05-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Lumbar puncture, Investigational, Normal, Negative result for neuroinfection; Nuclear magnetic resonance imaging, Investigational, Significant, White matter with demyelinating lesions
CDC 'Split Type': PHHY2013CO052605
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)NOVARTIS VACCINES AND DIAGNOSTICS128702 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, Computerised tomogram head normal, Consciousness fluctuating, Convulsion, Demyelination, Encephalopathy, Headache, Lumbar puncture normal, Nausea, Pyrexia, Viral infection, Vomiting, White matter lesion
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Demyelination (narrow), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad)
Write-up: Case number PHHY2013CO052605 is a combined initial and follow-up report received from a physician and nurse on 22 May 2013. This report refers to a 54-year-old female patient. She was vaccinated with AGRIPPAL (batch number: 128702, expiry date: 30 Nov 2013) at a dose of 1ml intramuscularly on 12 Apr 2013. On 01 May 2013, she presented with persistent fever, global headaches, nauseas and emesis. She was hospitalized on unspecified date. The patient was suspected to have viral infection and was treated with analgesics and antiemetics. However, the patient showed no response. Therefore a pathological lumbar puncture was performed but it was not conclusive for neuro-infection. Simple cerebral TAC (computerized axial tomography) was performed which did not show any findings. An initial nuclear magnetic resonance imaging showed no findings but later revealed punctate lesions in white matter with features suggestive of demyelinating lesions. Two weeks prior to reporting the patient began to show fluctuations in her consciousness. The patient was diagnosed with acute disseminated encephalomyelitis after vaccination, encephalopathy and convulsive syndrome. The events were reported as serious (hospitalization, disability and medically significant). The outcome of the events was reported as condition deteriorated. The causality was reported as unknown.

VAERS ID:494496 (history)  Vaccinated:2013-04-24
Age:54.0  Onset:2013-04-24, Days after vaccination: 0
Gender:Female  Submitted:2013-06-18, Days after onset: 55
Location:Foreign  Entered:2013-06-19, 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:
Diagnostic Lab Data:
CDC 'Split Type': 2013036520
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED  SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alphavirus test, Arthralgia, Blood test normal, Gait disturbance, Impaired driving ability, Rheumatoid factor negative
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Arthritis (broad)
Write-up: This health authority report (initial receipt 05-Jun-2013) concerns a 54 year old female patient. On 24-Apr-2013, the patient received one dose of FLUVAX injection (batch unspecified) via subcutaneous route in the left deltoid. On the same day, the patient developed initial pain in the right knee joint. Within 13 hours, the pain was severe. Following morning, the patient was unable to walk easily, pain severe. Following 48 hours, the patient was unable to drive a car due to pain and limited capacity to apply brakes if and when required. Pain then began both elbow joints, the left knee joint, both wrist joints and left ankle joint. Pain subsided on 28-Apr-2013. The GP (general practitioner) recommended blood test to determine other causes, such as rheumatoid arthritis and Ross river virus. Test were negative for these. The event outcome was recovered. Reporter''s comments: The reporter considered events possible in relation to the suspect drug.

VAERS ID:497840 (history)  Vaccinated:2013-07-22
Age:54.0  Onset:2013-07-22, Days after vaccination: 0
Gender:Female  Submitted:2013-07-26, Days after onset: 4
Location:Foreign  Entered:2013-07-26
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 07/22/2013, Heart rate, 62
CDC 'Split Type': WAES1307CAN014968
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.J000841 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incoherent, Nausea, Stridor, Tremor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad)
Write-up: This spontaneous report as received from a pharmacist refers to a 54 year old female patient. On 22-JUL-2013 the patient was vaccinated with ZOSTAVAX lot # J000841, expiry date: 22-JUL-2014. No other co-suspects were reported. No concomitant medications were reported. Twelve minutes after the patient was vaccinated, she complained she wanted to throw up. She had the shakes, stridorous breathing (life threatening), her pulse at 62. She became incoherent. The nurse gave her an injection with an EPIPEN and the stridors subsided and she was able to at least get up and walk to the stretcher. She was then taken to the hospital and they have no update yet. The nurse will try to contact the patient. The outcome of she wanted to throw up, incoherent, pulse at 62 and shakes is unknown. The outcome of stridorous breathing was reported as recovered/resolved. The reporter considered she wanted to throw up, incoherent, pulse at 62, stridorous breathing and shakes to be related to ZOSTAVAX. Additional information has been requested.

VAERS ID:498889 (history)  Vaccinated:2013-05-01
Age:54.0  Onset:0000-00-00
Gender:Female  Submitted:2013-08-07
Location:Foreign  Entered:2013-08-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Decreased appetite; Rheumatic fever; Depression; Anxiety; Insomnia, Before the treatment with clonazepam; Abdominal discomfort; Systemic lupus erythematosus; Eye pain; Fatigue
Preexisting Conditions: Memory impairment; Abdominal pain upper; Fibromyalgia 4 years ago; Vision blurred; Carbamazepine 200 mg (unspecified manufacturer), twice a day, more or less 5 years
Diagnostic Lab Data:
CDC 'Split Type': PHHY2013BR064461
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic shock, Body height decreased, Chest pain, Decreased appetite, Dyspepsia, Eye swelling, Fall, Fatigue, Heart rate decreased, Hypotension, Kidney infection, Ligament sprain, Malaise, Memory impairment, Ocular discomfort, Pain in extremity, Skin discolouration, Syncope, Urinary tract infection, Vision blurred, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Osteoporosis/osteopenia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Case number PHHY2013BR064461, is an initial report received from a consumer (patient) via patient oriented program on 20 Jun 2013 and follow up report received from consumer via program on 09 Jul 2013 and follow up report received from a consumer (patient) on 31 Jul 2013: This report refers to a 54-year-old female patient. The patient''s current conditions included lupus erythematosus, rheumatic fever, depression, anxiety, insomnia (had it before the treatment with clonazepam, it was reported that the patient always experienced insomnia; however the doses of clonazepam increased. The insomnia was persisting), stomach disorder, lack of appetite, blurred vision, pain in the eyes and tiredness. The patient''s medical history included fibromyalgia (4 years ago) and stomach ache. The patient also had forgetfulness in past. The patient''s concomitant medications included omeprazole, fluoxetine, carbamazepine and clonazepam. The patient received treatment with GILENYA (Lot no: S0034) on 09 May 2013 at a dose of one tablet daily for multiple sclerosis. In May 2013, she was vaccinated with influenza vaccine (manufacturer and batch number unknown, coded with seasonal influenza vaccine INN). On an unknown date, the patient experienced strong urinary infection. It was reported that she experienced urinary infection previously and it was treated in a simple way, because no one cared. The patient also had kidney infection frequently and took unspecified medication for it. From 20 Jun 2013, the patient was treated with ciprofloxacin 500 mg (unspecified manufacturer) for urinary infection and with unknown antibiotic for kidney problem (unspecified). The patient also experienced the following events: reduced 2 cm of her height, memory a little bit weak, low blood pressure, very low cardiac beat, tiredness, fainted, twisted the foot, foot was sore and black, anaphylactic shock, blood pressure decreased, felt unwell, fall, blood pressure alteration, chest pain, strong burning sensation on stomach, lack of appetite, weight loss, worsening of forgetfulness (see case PHHY2013BR047478), blurred sight, swollen eye, eye discomfort (see case PHHY2013PBR064480). The outcome of urinary infection was condition improving and worsening for kidney infection. On 31 Jul 2013 the patient received the hepatitis vaccine. According to the reporter it was prescribed 2 tablets of fluoxetine and 2 tablets of clonazepam, however the patient used only 1 tablet. Treatment with GILENYA was ongoing. The event seriousness was not reported. The reporting consumer did not relate the causality of the event urinary infection to GILENYA while causality for kidney infection was not reported. Follow up report received from consumer via agency on 09 Jul 2013: Information related to current condition (pain in eyes, tiredness, lack of appetite) and new events (kidney infection) and its outcome (condition worsened) was updated. Follow up report received from a consumer (patient) on 31 Jul 2013: Information regarding medical history, concomitant medication and co suspect (influenza vaccine) and event outcome was updated.

VAERS ID:500860 (history)  Vaccinated:2013-02-12
Age:54.0  Onset:2013-02-12, Days after vaccination: 0
Gender:Male  Submitted:2013-08-29, Days after onset: 197
Location:Foreign  Entered:2013-08-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hepatocellular carcinoma
Preexisting Conditions: Hepatitis B virus test positive; 04/16/2011, Liver transplant
Diagnostic Lab Data:
CDC 'Split Type': PHHY2013FR092025
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICS 1SCUN
Administered by: Other     Purchased by: Other
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Case number PHHY2013FR092025 is an initial spontaneous report received from health authority (reference number: PC20130496) on 22 Aug 2013: This report refers to a 54-year-old male patient. His medical history included liver transplantation on 16 Apr 2011 and hepatocellular carcinoma due to hepatitis B virus. The patient started treatment with co-suspect oral tacrolimus (manufacturer unknown) and oral prednisone (manufacturer unknown) on 16 Apr 2011. He was vaccinated with two doses of MENVEO (batch number: unknown) subcutaneously on 28 Nov 2012 and 12 Feb 2013. Serotypes were performed before and after the vaccinations for serogroups A, C, Y and W135. After MENVEO injections on 12 Feb 2013, the patient presented immunization against serogroup C and there was only seroconversion against serogroup Y. Outcome of the event was reported as ongoing and seriousness was assessed as medically significant. The health authority reported this as drug ineffective. The health authority assessed the causal relationship between the adverse event and MENVEO as possible and possible interaction between tacrolimus and prednisone.

VAERS ID:502691 (history)  Vaccinated:2013-08-06
Age:54.0  Onset:2013-08-10, Days after vaccination: 4
Gender:Female  Submitted:2013-09-16, Days after onset: 37
Location:Foreign  Entered:2013-09-16
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': B0922214A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B093CE IMAR
Administered by: Other     Purchased by: Other
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth, Tenderness
SMQs:, Angioedema (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 nurse via a regulatory authority (# 133093) and described the occurrence of allergy in a 54-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 6 August 2013, the subject received unspecified dose of BOOSTRIX (.5 ml, intramuscular, unknown arm). On 10 August 2013, 4 days after vaccination with BOOSTRIX, the subject experienced allergy and tenderness in the arm but after some days also had increasing difficulties with itch and redness at the injection site along with swelling, increased warmth and stiffness around the area. 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. The regulatory authority reported that the events were possibly related to vaccination with BOOSTRIX. No further information was 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. Therefore the case has been closed.

VAERS ID:511163 (history)  Vaccinated:0000-00-00
Age:54.0  Onset:0000-00-00
Gender:Female  Submitted:2013-11-04
Location:Foreign  Entered:2013-11-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 2013038687
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED098624603 SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthma, Diarrhoea, Dizziness, Headache, Malaise
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow)
Write-up: This medically confirmed, spontaneous report (initial receipt 21-Oct-2013) involves a 54-year-old female patient. Concomitant medications included levothyroxine 100 and estradiol 75 mg. It was reported that the patient had received influenza in the past and it was tolerated; the patient had never received H1N1 and no other immunisations had been given within the past three months. On an unreported date, the patient received one dose of AFLURIA (batch: 0986-24603). Approximately 1.5 hours post injection the patient experienced an asthma attack. Between 1.5 to 2 hours post injection, the patient experienced headache, diarrhoea, dizziness, felt unwell and had her reaction ability was decreased. On an unreported date, the patient experienced a slightly increased temperature. Diarrhoea, dizziness and headache lasted for three days. Outcome for the other events was not reported.

VAERS ID:513811 (history)  Vaccinated:0000-00-00
Age:54.0  Onset:2011-10-20
Gender:Male  Submitted:2013-11-13, Days after onset: 755
Location:Foreign  Entered:2013-11-19, Days after submission: 6
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Type 2 diabetes mellitus
Preexisting Conditions: Allergy to arthopod sting; Oral neoplasm; Surgery, Had an operation a month earlier to remove the small cancerous mouth tumor
Diagnostic Lab Data:
CDC 'Split Type': PHFR2013GB006373
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Acute disseminated encephalomyelitis, Intensive care, Mechanical ventilation, Mobility decreased, Paraplegia, Sensory loss
SMQs:, Peripheral neuropathy (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Case number PHFR2013GB006373 is an initial spontaneous report received from a consumer via MHRA, health authority (reference number: ADR 22305298-001) on 11 Nov 2013: This report refers to a 54-year-old male patient. His medical history included allergic reaction to wasp sting, small cancerous mouth tumor, operation to remove the mouth tumor about a month ago and type II diabetes mellitus which was being controlled by diet alone and no medication was being used at the time of reporting. His concomitant medications were not reported. He was vaccinated with an influenza vaccine (manufacturer and batch number: unknown) on an undetermined date. On 20 Oct 2011 after vaccination, he was diagnosed with acute disseminated encephalitis and spent four months in intensive care being ventilated and with limited movement. He was then moved to a specialist neurologist hospital for rehab where he stayed for 11 months. His upper body movement had recovered but he was paraplegic with no feeling or movement in lower body. Final outcome of all the events was reported as condition unchanged. The reporter assessed these events as serious leading to hospitalization and life threatening. No further information about causality was reported.

VAERS ID:515285 (history)  Vaccinated:2010-02-10
Age:54.0  Onset:2013-07-26, Days after vaccination: 1262
Gender:Male  Submitted:2013-12-02, Days after onset: 129
Location:Foreign  Entered:2013-12-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: B Culture (26-JUL-2013): Positive streptococcus pneumonia serotype 12F.
CDC 'Split Type': WAES1311AUS011752
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC. 2SCUN
Administered by: Other     Purchased by: Other
Symptoms: Pneumonia pneumococcal, Streptococcus test positive
SMQs:
Write-up: Information was obtained on a request by the Company from the agency via a Public Case Details (OPR No. 327522) concerning a 54 year old male patient. On 13-NOV-1997 the patient was vaccinated with the first dose of PNEUMOVAX 23 (lot number and expiration date not reported) subcutaneous. On 23-MAR-2005 the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot number and expiration date not reported) subcutaneous. On 10-FEB-2010 the patient was vaccinated with the third dose of PNEUMOVAX 23 (lot number and expiration date not reported) subcutaneous (1 dose, 3 times). On 26-JUL-2013 the patient developed Pneumonia with B culture positive streptococcus pneumonia serotype 12F. It was reported that the event caused or prolonged inpatient hospitalisation. On 30-JUL-2013 the patient recovered from the event. Pneumonia streptococcal was considered to be possible related with PNEUMOVAX 23. The original reporting source was reported as State/Territory Health Dept. Additional information is not expected.

VAERS ID:517008 (history)  Vaccinated:0000-00-00
Age:54.0  Onset:0000-00-00
Gender:Female  Submitted:2013-12-13
Location:Foreign  Entered:2013-12-18, 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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Gene mutation identification test, Abnormal, Significant, Showed a typical deletion, confirming the diagnosis of hereditary neuropathy with liability to pressure palsies (HNPP)
CDC 'Split Type': PHHY2013BE145411
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURER  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Cytogenetic analysis abnormal, Hereditary neuropathy with liability to pressure palsies, Immunoglobulin therapy
SMQs:, Congenital, familial and genetic disorders (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: Case number PHHY2013BE145411 is an initial literature report received on 10 Dec 2013: In this article, the authors have discussed a case of chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) associated to hereditary neuropathy with liability to pressure palsies (HNPP) which was revealed after influenza A H1N1 vaccination. This report refers to a 54-year-old female patient. She was vaccinated with an AH1N1 (manufacturer and batch number: unknown) on an undetermined date. Five weeks after vaccination, she developed chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). She had no previous neurological history, but neurophysiological features led to suspect an underlying hereditary neuropathy. PMP22 gene analysis showed a typical deletion, confirming the diagnosis of hereditary neuropathy with liability to pressure palsies (HNPP). A significant clinical and neurophysiological improvement of the neuropathy after intravenous immunoglobulin treatment was observed. No further information pertaining to this case was available. This was, to the author''s knowledge, the first reported case of CIDP potentially triggered by AH1N1 vaccination. This and previous observations suggested that genetic-determined neuropathies could predispose to the occurrence of immune-mediated neuropathies. The authors commented that the possibility of a superimposed hereditary neuropathy like HNPP in patients with a clinical presentation of CIDP must be considered, especially when positive family history or unexpected neurophysiological features are present.

VAERS ID:520635 (history)  Vaccinated:0000-00-00
Age:54.0  Onset:0000-00-00
Gender:Female  Submitted:2014-01-23
Location:Foreign  Entered:2014-01-24, 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: Unknown
Current Illness:
Preexisting Conditions: Hereditary Neuropathy with Liability to Pressure Palsies; PMP22 Gene Analysis showed typical delection, confirming the diagnosis; Diabetes mellitus
Diagnostic Lab Data: Blood tests disclosed no abnormalities (including cell count, CRP, liver enzyme, renal function, electrophoresis, IgM level, hepatitis, HIV, IgG and IgM Borrelia Burgdorferi serologies, ANA, ANCA, anti-ganglioside and anti-sulfatide antibodies). Cerebrospinal fluid protein, UNK, 0.74 G/L
CDC 'Split Type': 2014SA007134
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anti-ganglioside antibody negative, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Blood count normal, Blood immunoglobulin G normal, Borrelia test negative, C-reactive protein normal, CSF protein, Chronic inflammatory demyelinating polyradiculoneuropathy, Electrophoresis normal, HIV test negative, Hepatitis viral test negative, Immunoglobulin therapy, Liver function test normal, Renal function test normal
SMQs:, Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: Initial case received via a search of the scientific literature on 15 January 2014. Abstract: "Neurological complications of AH1N1 vaccination such as Guillain-Barre syndrome were described in the previous years. Several reports suggested that hereditary neuropathies may be a predisposing factor for immune-mediated neuropathies. We report the case of a 54-year-old female who developed chronic inflammatory demyelinating polyradiculoneuropathy (CIPD) 5 weeks after AH1N1 vaccination. She had no previous neurological history, but neurophysiological features led us to suspect an underlying hereditary neuropathy. PMP22 gene analysis showed a typical deletion, confirming the diagnosis of hereditary neuropathy with liability to pressure palsies (HNPP). We observed a significant clinical and neurophysiological improvement of the neuropathy after intravenous immunoglobulin treatment. This is, to our knowledge, the first reported case of CIDP potentially triggered by AH1N1 vaccination. This and previous observations suggest that genetic-determined neuropathies could predispose to the occurrence of immune-mediated neuropathies. One must recall the possibility of a superimposed hereditary neuropathy like HNPP in patients with a clinical presentation of CIDP, especially when positive family history or unexpected neurophysiological features are present." Additional information has been requested.

VAERS ID:25347 (history)  Vaccinated:1990-05-02
Age:55.0  Onset:1990-05-02, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:California  Entered:1990-07-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 1ST AND 2ND IMMUNIZATIONS WITH RECOMBIVAX HB WERE UNEVENTFUL.
Other Medications: POSSIBLY TAKES VASOTEC FOR HYPERTENSION
Current Illness:
Preexisting Conditions: HYPERTENSION
Diagnostic Lab Data: N/A
CDC 'Split Type': EBU900156
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM59184 IM 
Administered by: Private     Purchased by: Private
Symptoms: Dehydration, Eye pain, Headache, Influenza, Malaise, Pharyngitis, Pyrexia
SMQs:, Agranulocytosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Glaucoma (broad)
Write-up: FOUR HRS AFTER INJECTION PT EXPER PAIN BEHIND EYES, FEVER, OCCIPITAL HEADACHE, GENERAL MALISE, SORE THROAT, FLU LIKE SYMPTOMS AND DEHYDRATION. NO TREATMENT GIVEN. AS OF 02-MAY-90, CYMPTOMS CONTINUED.

VAERS ID:25390 (history)  Vaccinated:1989-10-30
Age:55.0  Onset:1989-10-30, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Minnesota  Entered:1990-07-10
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': EBU890010
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM587A4 IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dysphonia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad)
Write-up: Pt received Engerix-B 10 days later experienced severe hoarseness, transient tingling of arms & legs. No treatment was given for the events.

VAERS ID:25630 (history)  Vaccinated:1990-06-11
Age:55.0  Onset:1990-06-12, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Unknown  Entered:1990-08-06
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES90070941
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.  IM 
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site oedema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt vaccinated w/Hepatitis B vaccine developed painful edema & erythema of the legs. Transaminases and ESR were increased. Aft 3 wks of conservative treatment and immobilization, pt recovered. MD felt edema, erythema & pain were vac relat

VAERS ID:26383 (history)  Vaccinated:1990-05-17
Age:55.0  Onset:1990-05-19, Days after vaccination: 2
Gender:Female  Submitted:0000-00-00
Location:Arkansas  Entered:1990-10-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Dyazide, Feldene, Voltaren
Current Illness:
Preexisting Conditions: Arthritis.
Diagnostic Lab Data:
CDC 'Split Type': EBU900220
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM585A4   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Pt vaccinated with Engerix-B developed itching, rash , sores.

VAERS ID:26509 (history)  Vaccinated:1989-12-13
Age:55.0  Onset:1990-02-13, Days after vaccination: 62
Gender:Female  Submitted:0000-00-00
Location:New York  Entered:1990-10-04
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: Antibody titer on 3JUL90-neg
CDC 'Split Type': EBU900290
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM620A4 IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Pt received 1st dose of vax. Antibody titer on 3Jul90 was neg

VAERS ID:26564 (history)  Vaccinated:1990-02-22
Age:55.0  Onset:1990-04-27, Days after vaccination: 64
Gender:Male  Submitted:0000-00-00
Location:New Jersey  Entered:1990-10-04
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': EBU900354
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM586A4 IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Pt vaccinated with Engerix-B antibody titer non-reactive.

VAERS ID:26839 (history)  Vaccinated:0000-00-00
Age:55.0  Onset:1990-11-12
Gender:Male  Submitted:1990-11-16, Days after onset: 4
Location:Arizona  Entered:1990-11-28, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Nasalide, Zejtril
Current Illness: HTN
Preexisting Conditions: Duricef, Novacain, Feldene, Reglan
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Face oedema, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Pt vaccinated developed swelling-lips, face lt arm & lt hand. Seen in ER 13NOV90. Vsikeril injection in ER Hydroxyzine pam 50mg TID x 7 days. Seen in MD office 15NOV90 for f/u

VAERS ID:27833 (history)  Vaccinated:1990-10-24
Age:55.0  Onset:0000-00-00
Gender:Male  Submitted:0000-00-00
Location:Iowa  Entered:1991-01-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Rec''d Recombivax-HB 15SEP88, 19OCT88, 29MAR89.
Current Illness:
Preexisting Conditions: Hx of alcoholism
Diagnostic Lab Data:
CDC 'Split Type': EBU900576
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Pt given Engerix-B booster on 24OCT90, following nonresponse to 3 doses of Recombivax-HB & still has no antibodies.

VAERS ID:27852 (history)  Vaccinated:1990-06-13
Age:55.0  Onset:1990-09-13, Days after vaccination: 92
Gender:Female  Submitted:0000-00-00
Location:Illinois  Entered:1991-01-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': EBU900544
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM587A4 IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Vaccinee experienced "...failure to achieve antibody titers p/3 doses of Engerix-B."

VAERS ID:27871 (history)  Vaccinated:1990-09-20
Age:55.0  Onset:1990-10-22, Days after vaccination: 32
Gender:Female  Submitted:0000-00-00
Location:South Dakota  Entered:1991-01-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': EBU900571
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM586A42IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Rec''d Engerix-B inject 21FEB90, 21MAR90 & 20SEP90. On 22OCT90, Hepatitis B S Antibody was negative.

VAERS ID:27909 (history)  Vaccinated:1990-08-03
Age:55.0  Onset:0000-00-00
Gender:Male  Submitted:0000-00-00
Location:South Carolina  Entered:1991-01-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': EBU900487
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM597   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Vaccinee rec''d the 3rd in a series of Engerix-B (Deltoid) 23AUG90 & was a "non responder."

VAERS ID:28817 (history)  Vaccinated:1991-01-15
Age:55.2  Onset:1991-01-25, Days after vaccination: 10
Gender:Female  Submitted:1991-02-12, Days after onset: 18
Location:New York  Entered:1991-03-04, Days after submission: 20
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
RUB: RUBELLA (MERUVAX II)MERCK & CO. INC.1761S0 LA
Administered by: Public     Purchased by: Unknown
Symptoms: Arthralgia, Osteoarthritis, Pain, Paraesthesia, Pyrexia, Rash maculo-papular
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: 10 days p/vax low grade fever x 2 days, macular papular rash on face, generalized knee pain & swelling x 2 days. Severe pain & swelling from elbow to hands x 5 days; 2.5 wk later paresthesia of finger present; non immune to Rubella prior.

VAERS ID:29624 (history)  Vaccinated:1989-11-28
Age:55.0  Onset:1989-12-01, Days after vaccination: 3
Gender:Female  Submitted:0000-00-00
Location:Illinois  Entered:1991-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: premarin, provera
Current Illness:
Preexisting Conditions: history of urticaria
Diagnostic Lab Data: NA
CDC 'Split Type': WAES90020661
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1595R IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Influenza, Sinusitis, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: 28nov89 pt vax hepta B. late dec pt ex flu-like illness & sinusitis. 28dec89 pt vax 2nd hepta B. Treatment was initiated w/ PCE Dispertab & Augmentin. pt devel hives on 19jan90. See worm...

VAERS ID:29640 (history)  Vaccinated:1990-02-10
Age:55.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:Alabama  Entered:1991-03-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NA
CDC 'Split Type': WAES90021088
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1648R   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Headache, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: W/in 24 to 48 hrs developed h/a, fever & rash; Tx DPH & advised by her MD not to receive additional doses;

VAERS ID:30663 (history)  Vaccinated:1990-05-01
Age:55.0  Onset:1990-05-01, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Indiana  Entered:1991-03-12
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: NA
Diagnostic Lab Data: NA
CDC 'Split Type': WAES90070786
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Eye pain, Headache
SMQs:, Glaucoma (broad)
Write-up: may90 pt vax hepta B. pt ex h/a for few days. 01jun90 pt 2nd vax. pt ex h/a for month, dull ache in right eye. treated w/ pres. drug.

VAERS ID:29277 (history)  Vaccinated:1991-02-12
Age:55.0  Onset:1991-02-13, Days after vaccination: 1
Gender:Female  Submitted:1991-02-20, Days after onset: 7
Location:Indiana  Entered:1991-03-22, Days after submission: 30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NONE
Other Medications: Estrace 2mg/day; Lorazepam 1mg-3times per wk; Lanoxin 0.25mg/day;
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)PFIZER/WYETH49082410SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site hypersensitivity, Oedema, Rash maculo-papular
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Given TD 12FEB91 p/being cut on finger while cleaning a meat slicer; Returned 13FEB91 & arm was sl. reddened; Instructed to use Tylenol & cold packs for discomfort; 14FEB91 lt upper arm was edematous & reddened w/blisters; Benadryl & Medrol

VAERS ID:32089 (history)  Vaccinated:1990-07-23
Age:55.0  Onset:1990-09-25, Days after vaccination: 64
Gender:Male  Submitted:0000-00-00
Location:North Carolina  Entered:1991-03-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Hx of hiatal hernia & back problems.
Diagnostic Lab Data: 12Dec90 Titer 1.8RU; 25Sep titer - 1.8RU
CDC 'Split Type': EBU900643
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM587A42IMA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Pt vax w/ 3 hepta B; testing 2 months after 3rd dose indicated titer neg. After 2 boosters titer still neg.

VAERS ID:32221 (history)  Vaccinated:1990-04-17
Age:55.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:Minnesota  Entered:1991-03-28
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 relevant hx
Diagnostic Lab Data: none
CDC 'Split Type': EBU910104
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 0  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pt recvd 1st hep B vax 17APR90 & exp pain @ inject site that burned down to elbow & lasted 2-4 hours.

VAERS ID:32719 (history)  Vaccinated:1990-03-06
Age:55.0  Onset:1990-04-11, Days after vaccination: 36
Gender:Female  Submitted:0000-00-00
Location:Michigan  Entered:1991-03-28
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: Vitamins
Diagnostic Lab Data: AUSAB EIA neg for HBSAB on both 11APR90 & 19JUN90.
CDC 'Split Type': EBU910018
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM585A4   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Pt recvd 1st 2 hep B vax w/Recombivax & 3rd dose 06MAR90 w/ Energix-B.Test results 11APR90 neg for HBSAB.Addt''l Energix-B dose given & test results again neg for HBSAB.

VAERS ID:33090 (history)  Vaccinated:1990-09-17
Age:55.0  Onset:1990-09-17, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:New Jersey  Entered:1991-03-28
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: JUL89 1st/2nd/3rd degree burns w/minor infect;allergy-tetanus
Diagnostic Lab Data:
CDC 'Split Type': EBU900407
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM587A40IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Headache, Myalgia, Rash, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: Pt recvd 1st dose vax; same day exp h/a; later exp joint pains, rash, hives; felt tired, exp itching; sx abated w/o treatment

VAERS ID:30087 (history)  Vaccinated:1988-10-05
Age:55.7  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:Iowa  Entered:1991-04-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Smoker, sl overweight
Diagnostic Lab Data: 28DEC90 HBSAg-negative; 27NOV90 Anti-HBs-negative; 28DE90 Anti-Hbs positive;
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 0IMLA
Administered by: Public     Purchased by: Other
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: 28DEC90 HBs Ag - negative; 27NOV90 Anti-HBs - negative; 28DEC90 ANti HBs positive; Given 5 doses vax 5OCT88, 2NOV88, 21APR89, 30NOV90, 3JAN91 fr lot#s 1893P, 1880R, 1238S, 1st & 2nd dose not recorded;

VAERS ID:33327 (history)  Vaccinated:1990-12-12
Age:55.8  Onset:1991-02-21, Days after vaccination: 71
Gender:Female  Submitted:0000-00-00
Location:Michigan  Entered:1991-07-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Dyazide, tagamet
Current Illness: NONE
Preexisting Conditions: Hx of hypertensive & stomach problems; allergic to IV dye;
Diagnostic Lab Data: 21FEB91 HBSAB 0.020 EIA;negative
CDC 'Split Type': EBU910209
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM630A42IMA
Administered by: Private     Purchased by: Private
Symptoms: Unevaluable event
SMQs:
Write-up: Pt recvd series of 3 doses of Engerix-B vax; 3rd dose given 12DEC90; It was determined that pt was not immune to Hep B; Reporter stat pt recvd 2 more injects & is still not serum converted;

VAERS ID:33743 (history)  Vaccinated:1990-04-28
Age:55.0  Onset:1991-02-25, Days after vaccination: 303
Gender:Female  Submitted:0000-00-00
Location:Alabama  Entered:1991-07-01
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: Hepatitis B surface antibody s/n ratio=2.6(2.1-10.0 = reduced immunity).
CDC 'Split Type': EBU910244
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 0IMA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:
Write-up: Pt did not acquire high levels of immunity p/ 3 doses of hep B vax on 0,1 & 6 months schedule.

VAERS ID:33767 (history)  Vaccinated:1990-11-01
Age:55.0  Onset:1991-02-20, Days after vaccination: 111
Gender:Male  Submitted:0000-00-00
Location:New Jersey  Entered:1991-07-01
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: NKA
Diagnostic Lab Data: 20FEB91 HBSAB-neg
CDC 'Split Type': EBU910268
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM606A42IM 
Administered by: Private     Purchased by: Private
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Pt recvd 3 doses of Engerix-B, 3rd dose given 1NOV90 & it was determined that pt did not convert to protective surface antibody level;

VAERS ID:34042 (history)  Vaccinated:1991-06-04
Age:55.0  Onset:1991-07-01, Days after vaccination: 27
Gender:Female  Submitted:0000-00-00
Location:Oregon  Entered:1991-07-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: hx of breast cancer;
Diagnostic Lab Data:
CDC 'Split Type': EBU910406
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM631A43IMA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bone neoplasm, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow), Tumours of unspecified malignancy (narrow)
Write-up: Pt recvd Engerix-B given 25JUL90, 24AUG90, 4FEB91; There was non-response to the 3 dose series of Engerix-B vax; tx plan to administer 2 addtl doses of vax;P/ 2 add''l vaxs metastic bone disease was DX.

VAERS ID:34511 (history)  Vaccinated:1991-05-15
Age:55.9  Onset:1991-05-15, Days after vaccination: 0
Gender:Female  Submitted:1991-05-23, Days after onset: 8
Location:Nevada  Entered:1991-09-03, Days after submission: 103
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NA
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Nausea, Rash, Vasodilatation
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Pt c/o being really hot, for about 1/2 hr, then sick on stomach, walked outside for lunch for air, went home 130; found rash all over top part of legs, very tired;

VAERS ID:35192 (history)  Vaccinated:1990-09-09
Age:55.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:Texas  Entered:1991-09-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NA
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC 'Split Type': EBU910594
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM6182IMA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Pt recvd 3 doses of Engerix-B on 07MAR90, 13APR90, & 09SEP90 & it was determined that pt failed to seroconvert;

VAERS ID:35351 (history)  Vaccinated:1991-04-22
Age:55.0  Onset:1991-06-01, Days after vaccination: 40
Gender:Female  Submitted:0000-00-00
Location:Maryland  Entered:1991-09-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: APR91 test for antibodies for HBSAG= no response;
CDC 'Split Type': EBU910658
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM  IMA
Administered by: Public     Purchased by: Other
Symptoms: Unevaluable event
SMQs:
Write-up: Pt recvd series of 3 EngerixB vax 22FEB91, 22MAR91, 22APR91; Antibody test done 2 months p/last dose indicated pt was a non-responder; later tests indicated pt seroconverted;

VAERS ID:35399 (history)  Vaccinated:1991-02-21
Age:55.0  Onset:0000-00-00
Gender:Female  Submitted:1991-08-05
Location:Unknown  Entered:1991-09-30, Days after submission: 56
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Provera, Synthroid
Current Illness:
Preexisting Conditions: Thyroid illness;
Diagnostic Lab Data:
CDC 'Split Type': EBU910707
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 2IMA
Administered by: Public     Purchased by: Private
Symptoms: Unevaluable event
SMQs:
Write-up: Pt recvd series of 3 Engerix-B vax on 20AUG90, 21SEP90, & 21FEB91 & was a non-responder;

VAERS ID:35443 (history)  Vaccinated:1991-05-03
Age:55.0  Onset:0000-00-00
Gender:Female  Submitted:1991-09-12
Location:Ohio  Entered:1991-09-30, Days after submission: 18
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': EBU910755
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM638A42  
Administered by: Other     Purchased by: Other
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Pt recvd 3 doses of Engerix-B 31OCT90, 30NOV90, & 03MAY91 & it was determined that pt did not seroconvert;

VAERS ID:35773 (history)  Vaccinated:1990-12-28
Age:55.6  Onset:1990-12-30, Days after vaccination: 2
Gender:Female  Submitted:1991-01-11, Days after onset: 12
Location:Wisconsin  Entered:1991-10-07, Days after submission: 268
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data: Td lot# 4908043 was examined & found satisfactory w/no anomalies noted;
CDC 'Split Type': 891031017B
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)PFIZER/WYETH4908043 IMRA
Administered by: Other     Purchased by: Private
Symptoms: Injection site hypersensitivity, Injection site oedema, Vasodilatation
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Pt devel erythema, warmth, & swelling of the entire upper arm @ site of inject p/receiving Td;

VAERS ID:35774 (history)  Vaccinated:1991-01-07
Age:55.1  Onset:0000-00-00
Gender:Female  Submitted:1991-01-11
Location:Wisconsin  Entered:1991-10-07, Days after submission: 268
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data: Td lot# 4908043 was examined & found satisfactory w/no anomalies noted;
CDC 'Split Type': 891031018B
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)PFIZER/WYETH4908043 IMLA
Administered by: Other     Purchased by: Private
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site oedema, Vasodilatation
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Pt devel erythema, warmth, & swelling of the entire upper arm @ the site of inject p/receiving Td; Pt MD was consulted for another reason, felt had cellulitis;

VAERS ID:35526 (history)  Vaccinated:1990-11-09
Age:55.8  Onset:1990-11-24, Days after vaccination: 15
Gender:Female  Submitted:1991-06-07, Days after onset: 194
Location:Wisconsin  Entered:1991-10-16, Days after submission: 131
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NONE
Other Medications: Pt recvd Hep B vax on 28SEP90 & 29OCT90;
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: A review of the batch record for lot# 4908194 was satisfactory w/no anomalies noted;
CDC 'Split Type': 890354001B
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)PFIZER/WYETH4908194   
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Guillain-Barre syndrome, Hypertension, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (narrow), Hypertension (narrow), Demyelination (narrow)
Write-up: Pt devel GBS p/receiving influenza vax; sx included numbness & tingling in hands, feet, & lt side of face; weakness in limbs; & elevation in BP; pt hospitalized on 24NOV90 & treated w/meds;

VAERS ID:36479 (history)  Vaccinated:1990-10-31
Age:55.0  Onset:1990-11-14, Days after vaccination: 14
Gender:Female  Submitted:1991-01-16, Days after onset: 63
Location:California  Entered:1991-11-19, Days after submission: 307
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE
Other Medications: Premarin/Provera, Inderal
Current Illness: NONE
Preexisting Conditions: Hypertension, migraines, tremor in lt hand for 15 hrs controlled by inderal;
Diagnostic Lab Data: LP x 1 28NOV MRI head/neck in hosp; 23DEC MRI head, to be repeated in April, Blood test in hosp thinks Ca & K was low; pt doesn''t have results;
CDC 'Split Type': CA91126
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)CONNAUGHT LABORATORIES112220 LA
Administered by: Public     Purchased by: Public
Symptoms: Asthenia, Guillain-Barre syndrome, Hyperaesthesia, Hypotension, Myalgia, Paraesthesia, Speech disorder, Visual disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Optic nerve disorders (broad), Demyelination (narrow), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad)
Write-up: 14NOV90 tingling & cold hands & feet; 16NOV90 Seen by MD tingling, hypersensitive to touch, no response to knee reflex, tired; 22NOV90 unable to eat much, trouble ambulating, slurred speech, vision problems; poss GBS, backache, low BP;

VAERS ID:36484 (history)  Vaccinated:1991-10-31
Age:55.3  Onset:1991-11-04, Days after vaccination: 4
Gender:Male  Submitted:1991-11-05, Days after onset: 1
Location:California  Entered:1991-11-19, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Clonidine, Calan, Coumadin, Tenormin
Current Illness: Hypertension myocardial infarct
Preexisting Conditions:
Diagnostic Lab Data: Elevated K+
CDC 'Split Type': CA91131
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)PFIZER/WYETH49181700IMLA
Administered by: Public     Purchased by: Public
Symptoms: Dyspnoea, Hyperkalaemia, Nausea, Pallor, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad)
Write-up: Nauseated, dry "heaves", dyspnea, paleness wife called EMT transported to ER; stay approx 2 hrs-released home saw pvt MD later same day;

VAERS ID:36735 (history)  Vaccinated:1991-11-08
Age:55.2  Onset:1991-11-10, Days after vaccination: 2
Gender:Female  Submitted:1991-11-19, Days after onset: 9
Location:Wisconsin  Entered:1991-12-02, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Feldene, Capazid, arthritis meds;
Current Illness: NONE
Preexisting Conditions: PCN; Bactrim; Motrin; inc BP (on meds);
Diagnostic Lab Data: UA-8-10 white cells-trace leukocytes; CBC-WBC 5,900;HGB-12.9; sed rate-24; Glu-20;
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)PFIZER/WYETH49181350IMLA
Administered by: Public     Purchased by: Public
Symptoms: Myasthenic syndrome, Pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Malignancy related conditions (narrow), Guillain-Barre syndrome (broad)
Write-up: 10NOV91 burning pain, numbness, sl weakness lt leg; 11NOV91 numbness, sl weakness lt arm; 12NOV91 seen by MD;

VAERS ID:36774 (history)  Vaccinated:1991-11-21
Age:55.2  Onset:1991-11-21, Days after vaccination: 0
Gender:Female  Submitted:1991-11-22, Days after onset: 1
Location:New Hampshire  Entered:1991-12-03, Days after submission: 11
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':
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX)PASTEUR MERIEUX INST.E05252IM 
Administered by: Other     Purchased by: Public
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Vasodilatation
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Local rxn-red, hot, hard swollen painful-area of inject; duration 21NOV91-24NVO91 dec in sx as time passed;

VAERS ID:37968 (history)  Vaccinated:1991-11-08
Age:55.8  Onset:1991-11-10, Days after vaccination: 2
Gender:Female  Submitted:1991-11-15, Days after onset: 5
Location:Mississippi  Entered:1991-12-16, Days after submission: 31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: NONE
Other Medications:
Current Illness: NONE
Preexisting Conditions: hx of hypertension, arthritis hip & arm
Diagnostic Lab Data: NONE
CDC 'Split Type': MS9152
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)PFIZER/WYETH4918153 IMLA
Administered by: Public     Purchased by: Public
Symptoms: Arthralgia, Headache, Injection site hypersensitivity, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: "Egg size red area @ site of inject", swelling in neck on side inject was given; joint pain on side inject given; dull h/a; relieved by analgesics but returns;

VAERS ID:38221 (history)  Vaccinated:1991-07-31
Age:55.0  Onset:0000-00-00
Gender:Female  Submitted:1991-12-09
Location:Illinois  Entered:1991-12-23, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hygroton, Kolyum, Lasix, Postssium
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data: 24JUL91 tested for Anti-HBS again found non-reactive;
CDC 'Split Type': EBU910872
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM719B44IMA
Administered by: Private     Purchased by: Private
Symptoms: Drug ineffective, Vertigo
SMQs:, Lack of efficacy/effect (narrow), Vestibular disorders (narrow)
Write-up: Pt recvd 3 dose of Engerix-B 10OCT90, 20NOV90 & 23APR91; 4JUN91 tested for Anti-HBS & found to be non-reactive; 11JUN91 recvd 4th dose; 5th Engerix-B dose given on 31JUL91; devel vertigo;

VAERS ID:38512 (history)  Vaccinated:0000-00-00
Age:55.0  Onset:0000-00-00
Gender:Female  Submitted:1991-11-05
Location:Pennsylvania  Entered:1991-12-23, Days after submission: 48
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': EBU911110
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM638A4 IMA
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Eructation, Headache, Hyperhidrosis, Nausea, Tachycardia, Vasodilatation
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Pt recvd a dose of Engerix-B & exp h/a, dizziness, & nausea;

VAERS ID:38556 (history)  Vaccinated:1991-09-21
Age:55.0  Onset:0000-00-00
Gender:Female  Submitted:1991-12-04
Location:Unknown  Entered:1991-12-23, Days after submission: 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: 19AUG91 HBSAB-neg;
CDC 'Split Type': EBU911156
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 3  
Administered by: Other     Purchased by: Other
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Pt recvd 3 doses of Engerix-B 7JAN91, 7FEB91 & 11JUL91 & reporter indicated due to neg HBSAB titer result, 4th dose of Engerix-B was required 21SEP91;

VAERS ID:38568 (history)  Vaccinated:0000-00-00
Age:55.0  Onset:0000-00-00
Gender:Female  Submitted:1991-12-02
Location:Pennsylvania  Entered:1991-12-23, Days after submission: 21
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': EBU911168
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 2  
Administered by: Public     Purchased by: Public
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: 3 pts were non-responders p/receiving Engerix-B;

VAERS ID:38705 (history)  Vaccinated:1991-09-11
Age:55.0  Onset:1991-11-01, Days after vaccination: 51
Gender:Male  Submitted:1991-11-25, Days after onset: 24
Location:New Hampshire  Entered:1991-12-23, Days after submission: 28
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': EBU911267
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM600A42IMA
Administered by: Private     Purchased by: Private
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Pt recvd series of 3 Engerix-B vax on 6MAR91, 10APR91 & 11SEP91; following the series NOV91 did not respond plan is to revax;

VAERS ID:38205 (history)  Vaccinated:1991-11-21
Age:55.9  Onset:1991-11-21, Days after vaccination: 0
Gender:Female  Submitted:1991-11-22, Days after onset: 1
Location:Texas  Entered:1992-01-03, Days after submission: 42
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': TX91165
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)CONNAUGHT LABORATORIES1F212230IMLA
PPV: PNEUMO (PNU-IMUNE)LEDERLE LABORATORIES3089130IMRA
Administered by: Public     Purchased by: Public
Symptoms: Ecchymosis, Injection site hypersensitivity, Injection site mass, Injection site oedema, Injection site pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Rt arm swelling around inject site occurred 1 hr p/inject given; bruising, swelling area approx 5-6 cm in size; area tender & sore reddened & bruised on outside of induration;

VAERS ID:38723 (history)  Vaccinated:1991-10-04
Age:55.4  Onset:1991-10-05, Days after vaccination: 1
Gender:Female  Submitted:1991-12-30, Days after onset: 86
Location:Pennsylvania  Entered:1992-01-10, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Ceclor
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': PA91389
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)PFIZER/WYETH4918170  LA
Administered by: Public     Purchased by: Public
Symptoms: Asthenia, Chills, Myalgia, Pruritus, Urticaria, Vasodilatation
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: 5OCT91 itchy; wheals, felt hot & cold; 6OCT91 taken to ER rx Pred & DPH; also exp muscle aches; no energy;

VAERS ID:38873 (history)  Vaccinated:1991-10-09
Age:55.0  Onset:1991-10-12, Days after vaccination: 3
Gender:Female  Submitted:1991-12-30, Days after onset: 79
Location:Colorado  Entered:1992-01-17, Days after submission: 18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: nausea, fever
Preexisting Conditions: PCN allergy
Diagnostic Lab Data: lab showed elevated liver function test which resolved by 22OCT91;
CDC 'Split Type': CO9203
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)PFIZER/WYETH4918169 IMA
Administered by: Private     Purchased by: Private
Symptoms: Hepatic function abnormal, Pyrexia, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: 9OCT91 pt recvd flu vax; 15OCT91 vomiting, high fever seen by MD initial labs showed elevated liver function tests which resolved by 22OCT91;

VAERS ID:39729 (history)  Vaccinated:1991-11-05
Age:55.4  Onset:1991-11-06, Days after vaccination: 1
Gender:Male  Submitted:1991-11-26, Days after onset: 20
Location:Utah  Entered:1992-02-28, Days after submission: 94
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: NONE
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC 'Split Type': UT92002
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNU-IMUNE)LEDERLE LABORATORIES3069100 LA
Administered by: Public     Purchased by: Public
Symptoms: Oedema, Pain, Vasodilatation
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)
Write-up: Arm swelled from shoulder to elbow became very red, hot & painful; MD administered ATB & antiinflammitory; pt improved in couple of days;

VAERS ID:39834 (history)  Vaccinated:1991-01-25
Age:55.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:Florida  Entered:1992-03-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen
Current Illness:
Preexisting Conditions: arthritis
Diagnostic Lab Data: No relevant data;
CDC 'Split Type': WAES91020544
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 0  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pain
SMQs:
Write-up: Pt recvd 1st dose of Recomb on 25JAN91 & devel severe shoulder pain;

VAERS ID:39848 (history)  Vaccinated:1991-02-25
Age:55.0  Onset:1991-02-25, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:New York  Entered:1992-03-02
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Estorgen
Current Illness:
Preexisting Conditions: allergy codeine
Diagnostic Lab Data: No relevant data;
CDC 'Split Type': WAES91021176
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0789S0IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Chest pain, Dizziness, Dysphagia, Dyspnoea, Injection site hypersensitivity, Injection site oedema, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Pt recvd 1st dose Recomb 25FEB91 & following vax pt devel rash & swelling @ inject site, dizziness, & numbness in both hands; few min later lips felt numb; 5 to 10 mins later pt had difficulty swallowing & breathing, tightness in chest;

VAERS ID:40496 (history)  Vaccinated:1991-10-21
Age:55.9  Onset:1991-10-21, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:New York  Entered:1992-03-02
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: No relevant data;
CDC 'Split Type': WAES91101630
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0957T2IM 
Administered by: Other     Purchased by: Other
Symptoms: Nausea, Paraesthesia, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)
Write-up: Pt recvd 3 doses of Hep B vax-3rd dose on 21OCT91; Immediately p/vax pt devel nausea; p/returning home pt stated that rt arm & hand became numb & devel spots on rt hand; also advised to see MD next day but declined because was asymptomatic;

VAERS ID:40669 (history)  Vaccinated:1991-07-23
Age:55.2  Onset:1991-07-25, Days after vaccination: 2
Gender:Female  Submitted:0000-00-00
Location:California  Entered:1992-03-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Premarin, APAP, Advil
Current Illness:
Preexisting Conditions: allergies nos; rhinitis
Diagnostic Lab Data: No relevant data;
CDC 'Split Type': WAES91090411
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1238S0IM 
Administered by: Public     Purchased by: Other
Symptoms: Petechiae, Rash
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hypersensitivity (narrow)
Write-up: Pt recvd 1st dose of Hep B vax on 23JUL91 & 1 to 2 days p/vax pt devel a rash & petechiae on lower extremities; Pt had no angioedema, fever, or arthralgias; pt later recovered;

VAERS ID:40710 (history)  Vaccinated:1991-07-10
Age:55.8  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:New York  Entered:1992-03-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: pt exp malaise @ 55 y/o w/Recomb doses 1, 2, 3 & 4; pt exp no drug effect p/#3;
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: No relevant data;
CDC 'Split Type': WAES91091365
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0098S4  
Administered by: Private     Purchased by: Other
Symptoms: Malaise
SMQs:
Write-up: Pt recvd 5 doses of Hep B vax on 28SEP88 & OCT88 & 14MAR89, & 7JUN91 & 10JUL91 & exp malaise;

VAERS ID:40882 (history)  Vaccinated:1991-12-04
Age:55.7  Onset:1991-12-07, Days after vaccination: 3
Gender:Male  Submitted:0000-00-00
Location:Pennsylvania  Entered:1992-03-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Tenormin
Current Illness:
Preexisting Conditions: allergy PCN
Diagnostic Lab Data: No relevant data;
CDC 'Split Type': WAES91120614
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 0  
Administered by: Public     Purchased by: Other
Symptoms: Herpes zoster, Pain, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Pt recvd 1st dose of Hep B vax on 4DEC91 & on 7DEC91 devel pain on rt side; seen in ER & herpes zoster was suspected; next day pt devel itching; lesions broke out on rt side & on 17DEC91 sx w/herpes zoster of abd wall; later pt recovered;

VAERS ID:40888 (history)  Vaccinated:1991-08-05
Age:55.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:New York  Entered:1992-03-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Pt exp exacerbation of arthritis @ 55 y/o w/Recombivax dose 1 & 2;
Other Medications: Pred
Current Illness:
Preexisting Conditions: arthritis, rheumatoid
Diagnostic Lab Data: OCT91-anti-HBs neg;
CDC 'Split Type': WAES91120307
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0412T2  
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Pt recvd 3 doses of Hep B vax 4JAN91, 10FEB91, & 5AUG91 & following each dose of vax pt had an exacerbation of arthritis; pt was placed on steroids & anti-inflammatory meds; lab eval approx OCT91 revealed a neg titer for HBSAB;

VAERS ID:39774 (history)  Vaccinated:1991-11-13
Age:55.0  Onset:1991-11-16, Days after vaccination: 3
Gender:Female  Submitted:1991-12-19, Days after onset: 33
Location:California  Entered:1992-03-03, Days after submission: 75
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid, Premarin, Glucatral
Current Illness: NONE
Preexisting Conditions: NONE x/diabetes, non-insulin
Diagnostic Lab Data: tests for infection, Lupis, rheumatoid arthritis-all neg;
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM827A40  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Hypokinesia, Influenza, Oedema peripheral, Osteoarthritis, Pyrexia, Serum sickness
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: 3 days p/Hep B vax pt exp flu like muscle soreness & low grade fever 99; 7 days p/inject had swollen & painful hands & foot, & knee joints; high fever 103.5 w/h/a; On 8th day devel rash on feet & legs & forearms that lasted x 5 days;

VAERS ID:39908 (history)  Vaccinated:1990-12-26
Age:55.0  Onset:1990-12-29, Days after vaccination: 3
Gender:Female  Submitted:0000-00-00
Location:North Carolina  Entered:1992-03-06
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 flu vax prior to this one
Diagnostic Lab Data: JAN91 Sed rate-100; 20FEB91 sed rate=50; SMAC=WNL; ANA=neg;
CDC 'Split Type': 914090013
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUOGEN)PARKE-DAVIS  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypertonia, Red blood cell sedimentation rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad)
Write-up: Muscle tightness is reported in pt who recvd flu vax & 3 days p/flu shot, pt devel tightness of neck & shoulder muscles; event lasted 3-4 wks & for past 3-4 wks pt has tightness of posterior of thighs & hip muscles;

VAERS ID:41059 (history)  Vaccinated:0000-00-00
Age:55.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:Alabama  Entered:1992-03-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: allergy, gamma globulin
Diagnostic Lab Data: No relevant data;
CDC 'Split Type': WAES91100636
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (FOREIGN)MERCK & CO. INC. 0IM 
Administered by: Other     Purchased by: Other
Symptoms: Dyspnoea, Injection site hypersensitivity, Injection site pain, Pruritus
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Pt recvd Hep B vax in 1986 & on the same day as inject pt exp SOB & devel redness, itching & burning @ inject site; It was noted that exp necessitated a visit to either an ER or MD office;

VAERS ID:41062 (history)  Vaccinated:1986-02-21
Age:55.0  Onset:1987-01-28, Days after vaccination: 341
Gender:Female  Submitted:0000-00-00
Location:North Carolina  Entered:1992-03-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Antivert, Seldane
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: 28MAY85 Anti-HBc-neg prevax; 28JAN87 Anti-HBc-pos; 4FEB88 Anti-HBc-pos; 3OCT91 Anti-HBe-pos;
CDC 'Split Type': WAES91100921
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (FOREIGN)MERCK & CO. INC. 2IM 
Administered by: Private     Purchased by: Private
Symptoms: Drug ineffective, Hepatitis, Infection
SMQs:, Hepatitis, non-infectious (narrow), Lack of efficacy/effect (narrow)
Write-up: Pt recvd 3 doses of Hep B vax on 16AUG85, 16SEP85, & 21FEB86 & following a blood donation on 28JAN87 pt was notified of pos test for Hep B core antibody; On 4FEB88, donated blood again & was notified of pos results for Hep B core antibody;

VAERS ID:36836 (history)  Vaccinated:1990-11-27
Age:55.0  Onset:1991-10-01, Days after vaccination: 308
Gender:Female  Submitted:1992-03-03, Days after onset: 154
Location:Virginia  Entered:1992-04-02, Days after submission: 30
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: 1OCT91 HBSAB to surface antigen titer=0.7;
CDC 'Split Type': EBU920440
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)SMITHKLINE BEECHAM 2IMA
Administered by: Other     Purchased by: Other
Symptoms: Drug ineffective
SMQs:, Lack of efficacy/effect (narrow)
Write-up: Pt recvd 3 doses of Engerix-B & 1OCT91 found to be a non-seroconverter;

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