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From the 11/19/2021 release of VAERS data:

Found 11,184 cases where Vaccine is MENB

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Case Details

This is page 48 out of 1,119

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VAERS ID: 631109 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Male  
Location: Unknown  
Vaccinated:2016-04-04
Onset:2016-04-04
   Days after vaccination:0
Submitted: 2016-04-11
   Days after onset:7
Entered: 2016-04-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 149001 / UNK LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Immediate post-injection reaction, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2016045645

Write-up: This case was reported by a other health professional via sale rep and described the occurrence of fainting in a 16-year-old male patient who received BEXSERO (batch number 149001, expiry date 1st September 2016). Concomitant products included MENACTRA, On 4th April 2016, the patient received BEXSERO .5 ml. On 4th April 2016, immediately after receiving BEXSERO, the patient experienced fainting. On 4th April 2016, the outcome of the fainting was recovered/resolved. It was unknown if the reporter considered the fainting to be related to BEXSERO. Additional details provided as follows. The healthcare professional reported that, the patient fainted instantly after receiving a dose of BEXSERO vaccine in the left arm once the needle was pulled out. The patient also received the MENACTRA vaccine right before the BEXSERO administration in the right arm. The patient recovered after a few moments.


VAERS ID: 631134 (history)  
Form: Version 1.0  
Age: 15.0  
Sex: Female  
Location: California  
Vaccinated:2016-04-01
Onset:2016-04-01
   Days after vaccination:0
Submitted: 2016-04-05
   Days after onset:4
Entered: 2016-04-12
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. L024993 / 3 RA / IM
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH M37314 / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Headache, Injection site pain, Pain, Urinary tract infection, Vomiting, White blood cells urine positive
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (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: MOTRIN; CLARITIN; FLONASE
Current Illness: Eczema; Allergy rhinitis; Temp 99.0
Preexisting Conditions: Panic attack Allergy rhinitis; Eczma
Allergies:
Diagnostic Lab Data: UA - bacteria few, leukocytes 3+ oer mother labs drawn and UA in ER (+) UTI 4/2/16
CDC Split Type:

Write-up: Generalised pain, particularly increase pain at injectable site, vomiting, headache.


VAERS ID: 631144 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Colorado  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-12
Entered: 2016-04-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Immediate post-injection reaction, 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), Hypersensitivity (narrow), 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: No other medications
Current Illness: Fear of injection, needle phobia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2016046390

Write-up: This case was reported by a other health professional via sales rep and described the occurrence of passed out in a 16-year-old female patient who received BEXSERO. Concurrent medical conditions included fear of needles (needle phobia). On an unknown date, the patient received BEXSERO. On an unknown date, immediately after receiving BEXSERO, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was recovered/resolved. It was unknown if the reporter considered the passed out to be related to BEXSERO. Additional details were provided as follows: This case was reported by a medical assistant (MA). The sales representative was unable to provide name of the primary reporter. Limited details were known for this report.


VAERS ID: 631159 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: New York  
Vaccinated:2016-02-27
Onset:2016-02-28
   Days after vaccination:1
Submitted: 2016-04-09
   Days after onset:40
Entered: 2016-04-12
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS L045711 / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2016044229

Write-up: This case was reported by a other health professional via call center representative and described the occurrence of facial swelling in a 16-year-old female patient who received BEXSERO (batch number L045711, expiry date 8th May 2017). Concomitant products included GARDASIL. On 27th February 2016, the patient received 1st dose of BEXSERO. In February 2016, 1 day after receiving BEXSERO, the patient experienced facial swelling. On 5th March 2016, the outcome of the facial swelling was recovered/resolved. It was unknown if the reporter considered the facial swelling to be related to BEXSERO. Additional details provided were as follows: The patient had received GARDASIL previously with no adverse reactions. The patient experienced face swelling which lasted for 1 week and which was described as severe, uncomfortable, and embarrassing. There were no other associated symptoms.


VAERS ID: 631242 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-13
Entered: 2016-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Rash erythematous
SMQs:, Anaphylactic reaction (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2016GSK049701

Write-up: This case was reported by a physician and described the occurrence of erythematous rash in unspecified number of patients who received BEXSERO. On an unknown date, the patients received BEXSERO at an unknown dose. On an unknown date, several days after receiving BEXSERO, the patients experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was unknown. It was unknown if the reporter considered the erythematous rash to be related to BEXSERO. Additional details were provided as follows: The reported stated about several reports of bilateral erythematous rash presenting on both upper deltoids of an unspecified number of patients within days after vaccination with BEXSERO. This case has been linked to case US2016GSK019838.


VAERS ID: 631258 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-13
Entered: 2016-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Encephalitis, Pharyngitis streptococcal
SMQs:, Agranulocytosis (broad), Oropharyngeal infections (narrow), Noninfectious encephalitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FLUVIRIN
Current Illness: Headache
Preexisting Conditions: Asplenia; Spherocytic anaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2016GSK046308

Write-up: This case was reported by a physician and described the occurrence of meningoencephalitis in a 11-year-old patient who received BEXSERO. The patient''s past medical history included asplenia and spherocytosis. Concurrent medical conditions included headache. Concomitant products included FLUVIRIN. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced meningoencephalitis (serious criteria hospitalization and GSK medically significant) and streptococcal pharyngitis. On an unknown date, the outcome of the meningoencephalitis and streptococcal pharyngitis were unknown. It was unknown if the reporter considered the meningoencephalitis and streptococcal pharyngitis to be related to BEXSERO. Additional details were provided as follows: In July 2014, the patient had undergone splenectomy. The patient had headache prior to vaccination with BEXSERO. The patient experienced aseptic meningoencephalitis and Group A strep pharyngitis. The patient was receiving not any penicillin prophylaxis at the time of reporting. Follow up information was received on 6th April 2016: It was concluded that the symptoms experienced by the patient were very unlikely related to BEXSERO and that the patient should receive the 2nd dose of the vaccine.


VAERS ID: 631264 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Arizona  
Vaccinated:2016-04-08
Onset:2016-04-09
   Days after vaccination:1
Submitted: 2016-04-11
   Days after onset:2
Entered: 2016-04-13
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH M51858 / 2 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR M37315 / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Pain, Rash erythematous, Rash macular
SMQs:, Anaphylactic reaction (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: BENADRYL
Current Illness:
Preexisting Conditions: Hearing loss
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Red, blotchy rash from elbow to shoulder. Extreme soreness.


VAERS ID: 631267 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: California  
Vaccinated:2016-03-31
Onset:2016-04-04
   Days after vaccination:4
Submitted: 2016-04-13
   Days after onset:9
Entered: 2016-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. L026602 / 2 LA / IM
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH M37315 / 2 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Axillary pain, Blood creatine phosphokinase, CSF cell count, CSF culture, CSF glucose, CSF protein, Full blood count, Gram stain, Headache, Laboratory test, Lipase, Lymphadenopathy, Muscular weakness, Nausea, Photosensitivity reaction, Urine analysis, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: URINE TEST, CBC, CHEM PANEL, LIPASE, CK TOTAL, CELL COUNT, CSF CULTURE AND GRAM, GLUCOSE CSF, PROTEIN CSF
CDC Split Type:

Write-up: HEADACHE, NAUSEA, VOMITING, PHOTOSENSITVITY AND BILATERAL LEG WEAKNESS, LEFT AXILLARY LYMPHADENOPATHY WITH ASSOCIATED PAIN.


VAERS ID: 631323 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-12
Entered: 2016-04-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Activities of daily living impaired, Fatigue, Injection site pain, Lethargy
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2016046410

Write-up: This case was reported by a other health professional via sales rep and described the occurrence of lethargy in a female patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, 1 day after receiving BEXSERO, the patient experienced lethargy, tiredness and injection site pain. On an unknown date, the outcome of the lethargy, tiredness and injection site pain were recovered/resolved. It was unknown if the reporter considered the lethargy, tiredness and injection site pain to be related to BEXSERO. Additional details were received as follows: Medical Science Liaison indicated that an office manager contacted her to report that a female patient (not much info known), no lot, no expiration date, no vaccination date, or age of the patient was vaccinated with BEXSERO, and then the next morning, could not get up, was lethargic and tired for two days; pain at the injection site; stayed home from school for two days. After two days the symptoms resolved. Office manager then mentioned that another patient (see case US2016GSK049200) who received BEXSERO and experienced a softball-like swelling at the injection site. Also mentioned about some other patients (see case US2016GSK049201) who also received a dose of BEXSERO vaccine and felt tired and lethargic for about two days, then the symptoms were resolved. The office manager indicated that she would be happy to be contacted by GSK for more information gathering if needed.


VAERS ID: 631331 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2016-04-12
Entered: 2016-04-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Injection site pain, Injection site swelling, Lethargy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypoglycaemia (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US2016GSK049200

Write-up: This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site swelling to be related to BEXSERO. Additional details were received as follows: Medical Science Liaison indicated that an office manager contacted her to report that a female patient (not much info known), no lot, no expiration date, no vaccination date, or age of the patient was vaccinated with BEXSERO, and then the next morning, could not get up, was lethargic and tired for two days; pain at the injection site; stayed home from school for two days (see case US2016046410). Office manager then mentioned that another patient concerned in this case who received also BEXSERO and experienced a softball-like swelling at the injection site. Also mentioned about some other patients (see case US2016GSK049201) who also received a dose of BEXSERO vaccine and felt tired and lethargic for about two days, then the symptoms were resolved. The office manager indicated that she would be happy to be contacted by GSK for more information gathering if needed.


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