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Found 7716 cases where Vaccine is MENB

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VAERS ID: 571849 (history)  
Form: Version 1.0  
Age: 29.0  
Sex: Female  
Location: Unknown  
Vaccinated:2015-02-24
Onset:2015-03-08
   Days after vaccination:12
Submitted: 2015-03-30
   Days after onset:21
Entered: 2015-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Abortion spontaneous, Blood test abnormal, Exposure during pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Propylthiouracil; Prenatal vitamins
Current Illness: Unknown
Preexisting Conditions: Basedow''s disease
Allergies:
Diagnostic Lab Data: 03/04/2015, Blood test, Abnormal, Significant, Non-viable
CDC Split Type: PHEH2015US005313

Write-up: Case number PHEH2015US005313, is an initial spontaneous report from a consumer (patient) received on 17 Mar 2015 and with follow up information received from the quality assurance department (QA reference number: 358730) on 20 Mar 2015 and a follow up received from nurse on 20 Mar 2015, with the follow-up information received from Quality Assurance Department (reference number: 358730) on 26 Mar 2015. This report refers to a 29 years old female pregnant patient. Past medical history included Graves'' disease. Concomitant medications included propylthiouracil and prenatal vitamins. The patient was vaccinated with BEXSERO (batch number: unknown) on 24 Feb 2015. On 04 Mar 2015, the patient underwent blood test which confirmed non-viable (not further specified). The patient''s pregnancy was confirmed by quantitative lab work (possible chemical pregnancy). However, no ultrasound was done to confirm the pregnancy. The patient''s last menstrual period (LMP) was on 28 Jan 2015 and expected date of delivery (EDD) was 04 Nov 2015. On 08 Mar 2015, the patient had a miscarriage. The patient''s pregnancy was not associated with any contraception failure and the patient did not discontinue any drugs due to the pregnancy. The patient had now recovered and was now having regular menses. Seriousness and causality of the events was not reported. Seriousness assessment of miscarriage was upgraded based on the NVS-IMS list. On the basis of the review performed it is possible to confirm that BEXSERO manufacturing process is under control. From a technical and quality point of view, neither any objection nor discrepancy has been identified nor was any cause identified for the reported adverse event. Non-significant follow up information received from the quality assurance department (QA reference number: 358730) on 20 Mar 2015: Updated QA reference number. Follow up received from nurse on 20 Mar 2015: updated patient demographics, medical history, concomitant medications, LMP, EDD and other clinically relevant information in the narrative. Follow-up information received from the Quality Assurance Department (reference number: 358730) on 26 Mar 2015: Updated BEXSERO batch review report.


VAERS ID: 572183 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: Unknown  
Vaccinated:2014-09-06
Onset:2014-09-06
   Days after vaccination:0
Submitted: 2015-03-24
   Days after onset:199
Entered: 2015-03-31
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Alanine aminotransferase increased, Antibody test negative, Aspartate aminotransferase increased, Blood culture negative, Borrelia test negative, CSF culture negative, CSF glucose normal, CSF protein normal, CSF test normal, CSF white blood cell count negative, Differential white blood cell count normal, Ehrlichia test, Immunology test normal, Infection, Laboratory test normal, Malaise, Musculoskeletal stiffness, Myalgia, Parasitic blood test negative, Platelet count normal, Pyrexia, Typhus rickettsia test, Urine analysis normal, West Nile virus test negative, White blood cell count normal
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data: 09/06/2014, Alanine aminotransferase, 71; 09/06/2014, Aspartate aminotransferase, 46; 09/06/2014, Blood culture, normal, Showed no growth; 09/06/2014, Body temperature, 101-102 Degree Fahrenheit; 09/06/2014, CSF test, normal, CSF WBC-1, glucose was normal, protein-normal and culture showed no growth. It was reported that the results were not consistent with meningitis; 09/06/2014, Ehrlichia test, Negative; 09/06/2014, Ehrlichia test, negative, Antibody IgG titre <1:64.; 11/07/2014, Ehrlichia test, negative, showed negative for Ehrlichia Chaffeensis IgG antibodies; 11/07/2014, Human ehrlichiosis, Negative; 11/07/2014, Immunology test, negative; 02/27/2015, Immunology test, Negative, Showed negative result, ruled out tick-borne illness; 11/07/2014, Investigation, negative; 11/07/2014, Parasite blood test, negative; 09/06/2014, Platelet count, Normal; 09/06/2014, Urine analysis, Normal; 09/06/2014, West Nile virus test negative, Showed negative for both IgG and IgM; 09/06/2014, White blood cell count, Normal with normal differential
CDC Split Type: PHHO2015US004372

Write-up: Case number PHHO2015US004372, is an initial report received on 16 Mar 2015, from clinical study. This 18-year-old male subject was enrolled in a study. The subject''s medical history included asthma. Concomitant medications were not reported. On 06 Sep 2014 at 09:33, the subject received the study vaccine MenB. It was reported that the subject had just returned from a 5-day camping trip with other college students. Approximately at 18:50 hrs the subject was taken to the ER room due to fever, myalgia, malaise and mild neck stiffness. In the emergency room, the subject recovered from the event neck stiffness. The subject was noted with temperature of 101-102 F. ER physician suspected possible meningitis. On the same day lumbar puncture was performed and CSF analysis was not consistent with meningitis. CSF showed WBC-1, glucose was normal, protein was normal and culture showed no growth. On the same day the subject was admitted to the hospital for overnight observation. The other investigations included WBC: normal with normal differential, platelets: normal, ALT was 71, AST was 46 (mildly elevated), blood culture showed no growth, urine analysis was normal, Lyme disease antibody titre was negative, Wright''s stain for Ehrlichia showed negative, Ehrlichia IgG antibody titre was <1:64, blood smear showed normal and West Nile virus IgG and IgM antibodies showed negative. On 07 Sep 2014, the subject was discharged from the hospital with a diagnosis of likely tick borne illness and was prescribed with doxycycline as a treatment. On 07 Nov 2014, a follow up serology for tick-borne illness was performed (considering subject''s history of a recent camping trip), which included Lyme EIA test which returned negative, Rickettsia rickettsii IgG showed negative, Ehrlichia chaffeensis IgG showed negative, Anaplasma phagocytophilum IgG was negative and Babesia microti AB IFA was negative. It was reported that these negative antibody results, 8 weeks following symptom onset argue against the earlier presumptive diagnosis of a tick-borne illness and hence the symptoms myalgia, malaise and fever were considered as serious (hospitalization). The event mild neck stiffness was considered as non-serious. It was reported that as per the hospital admission notes that the neck stiffness had resolved in the emergency room and it was not included in the treating physician''s assessment as an important factor in the clinical decision making and was not indicated as a reason for the hospital admission. The investigator did suspect a causal relationship between the events and study vaccine. Investigator stated that since all antibody tests for tick-borne illness were negative, this suggests that the subject''s symptoms were possibly related to rMenB vaccine based on the timing of onset and the absence of an identified alternative cause. Follow up received on 23 Mar 2015, prior to the circulation of previous report: Clinical information related to the seriousness of the event neck stiffness was updated.


VAERS ID: 572934 (history)  
Form: Version 1.0  
Age: 71.0  
Sex: Male  
Location: Oregon  
Vaccinated:2015-03-20
Onset:2015-03-21
   Days after vaccination:1
Submitted: 2015-03-30
   Days after onset:9
Entered: 2015-04-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH J29203 / 1 RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Muscular weakness, Pain, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Got meningococcal vaccine on 3/10/15. Rash (band across arm formed on day 2. Pain formed day 2, worsened to affect muscle strength with pain (no numbness or tingling). Pain noticeable Kw/use. Sore/weaker today. Sent doctor email today. No other tx.


VAERS ID: 573752 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Oregon  
Vaccinated:2015-04-10
Onset:0000-00-00
Submitted: 2015-04-13
Entered: 2015-04-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 146101 / 2 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Erythema, Pain, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Swelling, redness, had pain/tender 4 x 7cm area for 4 days.


VAERS ID: 576678 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Male  
Location: Texas  
Vaccinated:2015-04-09
Onset:2015-05-04
   Days after vaccination:25
Submitted: 2015-05-04
   Days after onset:0
Entered: 2015-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 146101 / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Eye inflammation, Sudden visual loss
SMQs:, Corneal disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Inflamed and no vision to left eye sudden presentation.


VAERS ID: 577922 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Oregon  
Vaccinated:2015-03-03
Onset:2015-03-03
   Days after vaccination:0
Submitted: 2015-05-12
   Days after onset:69
Entered: 2015-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / 1 LA / UN

Administered by: Public       Purchased by: Other
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fainting, nausea, muscle weakness
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Passed out while leaving the mass vaccination for meningitis B (Trumenba Vaccine).


VAERS ID: 577932 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Male  
Location: Illinois  
Vaccinated:2015-04-27
Onset:2015-04-27
   Days after vaccination:0
Submitted: 2015-05-11
   Days after onset:14
Entered: 2015-05-13
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. L004601 / UNK LA / IM
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH J29203 / UNK RA / IM

Administered by: Private       Purchased by: Other
Symptoms: Chills, Dizziness, Fatigue, Feeling abnormal, Gait disturbance, Headache, Injected limb mobility decreased, Injection site pain, Muscular weakness, Nausea, Neurological examination, Pain in extremity, Pallor, Pyrexia, Seizure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (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 (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Neurological examination
CDC Split Type: 2015150884

Write-up: This is a spontaneous report from a contactable pediatrician and nurse via a Pfizer sales representative. A 13-year-old male patient received first dose (three dose series) of TRUMENBA (Lot# J29203, Exp date 01Jun2016), intramuscular in right arm, on 27Apr2015 at approximately 03:15 pm, at 0.5ml single. He left the reporter''s office at 3:30 pm feeling fine. The patient was otherwise healthy, no other medical conditions. Concomitant medication included first dose (three dose series) of HPV vaccine (Lot# L004601, Exp date 04Nov2016), intramuscular in the left arm, on 27Apr2015 at approximately 03:15 pm, at unspecified dose and frequency. On 27Apr2015 the patient experienced pain at the injection site, headache, fatigue, nausea, extreme dizziness, right arm feeling sore or painful, pallor and chills. The patient came back to see the doctor on 28Apr2015 at 11:45 am for extreme dizziness and other side effects. At doctor''s visit he could barely lift his right arm. The patient was running into corners of the wall when he had the dizziness. Patient stated he felt like blood rushing through him fast (Apr2015). On 29Apr2015 the patient experienced trouble walking: needed to go down stairs on his back, and could not walk down the stairs because of weakness in legs. On an unspecified date the patient experienced fever. The patient was completely checked out and examined at hospital and was diagnosed with convulsion disorder, for which received treatment. He was brought to the emergency room (ER), where full neurological work up was performed. Outcome of events trouble walking, weakness in legs and extreme dizziness was not recovered at the time of this report. Outcome of the other mentioned events was unknown. The reporting physician did not think side effects had anything to do with the HPV vaccine, he thought they were from TRUMENBA. Follow-up (05May2015): new information received from a contactable pediatrician via a Pfizer sales representative includes: event "Convulsion disorder" added, lab data added.


VAERS ID: 578898 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: Puerto Rico  
Vaccinated:2015-05-09
Onset:2015-05-10
   Days after vaccination:1
Submitted: 2015-05-13
   Days after onset:3
Entered: 2015-05-20
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH J28923 / 1 UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M14069 / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood urine present, Chromaturia, Injection site pain, Protein urine absent, Pyrexia, Urine bilirubin increased
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Nasal Allergies
Allergies:
Diagnostic Lab Data: U/A-protein-moderate, 1+ protein; Bili small-resolved in 24 hr
CDC Split Type:

Write-up: R/O rhabdomyolysis. Orange urine with moderate blood, fever and painful (R) arm site of injection.


VAERS ID: 579037 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Male  
Location: Oregon  
Vaccinated:2015-05-13
Onset:2015-05-13
   Days after vaccination:0
Submitted: 2015-05-20
   Days after onset:7
Entered: 2015-05-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood glucose decreased, Chills, Delirium, Feeling abnormal, Feeling cold, Gait disturbance, Headache, Increased appetite, Influenza like illness, Malaise, Nausea, Pain in extremity, Shock, Shock hypoglycaemic, Thirst
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Sick symptoms~Meningococcal B (Trumenba)~1~18.00~Sibling
Other Medications: No other medications
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015166824

Write-up: This is a spontaneous report from a cont actable consumer. A 21-year-old male patient received the second dose of TRUMENBA at 0.5 ml single dose on 13May2015 18:00, intramuscular on left arm for immunization. The patient experienced that his body went into shock because of low blood sugar, was delirious, he was cold, shivering, he was very sensitive, had flu like symptoms, nausea, his right leg was in a lot of pain and he could not walk on it, experienced appetite and thirst excessive and headache. The patient''s sister received the first dose of the same vaccine at 18-year-old and experienced sick symptoms. The outcome of the events was reported as recovering.


VAERS ID: 579779 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: New York  
Vaccinated:2015-05-27
Onset:2015-05-27
   Days after vaccination:0
Submitted: 2015-05-29
   Days after onset:2
Entered: 2015-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K014191 / 3 RA / IM
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 146101 / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Sickle C disease s/p bone marrow transplant complicated by GVH dz and asthma
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient developed small urticarial lesions proximal to injection site up towards neck. No respiratory symptoms or other signs of an allergic reaction.


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