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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 49 out of 1,119

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VAERS ID: 634723 (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 / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Fatigue, Injection site pain, Injection site swelling, Lethargy
SMQs:, Dementia (broad), 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? 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: US2016GSK049201

Write-up: This case was reported by a other health professional via sales rep and described the occurrence of lethargy in unspecified number of patients who received BEXSERO. On an unknown date, the patients received BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patients experienced lethargy and tiredness. On an unknown date, the outcome of the lethargy and tiredness were recovered/resolved. It was unknown if the reporter considered the lethargy and tiredness to be related to BEXSERO. Additional details received were 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 (see case US2016GSK049200) who received also BEXSERO and experienced a soft-ball like swelling at the injection site. Also mentioned about some other patients concerned in this case 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: 631558 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Male  
Location: Texas  
Vaccinated:2016-04-12
Onset:2016-04-12
   Days after vaccination:0
Submitted: 2016-04-14
   Days after onset:2
Entered: 2016-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS DF92Z / 5 RA / IM
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 153701 / 1 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Mobility decreased, Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Parkinson-like events (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament 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: None
Current Illness: None
Preexisting Conditions: NKDA
Allergies:
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Severe pain began about 1 hour after injection, now (04/14/16) came to clinic due to immobility of arm due to pain of muscles radiating from right chest to elbow per patient. Pain medication prescribed.


VAERS ID: 631647 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2016-03-30
Onset:2016-03-30
   Days after vaccination:0
Submitted: 2016-04-15
   Days after onset:16
Entered: 2016-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 149001 / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Dizziness, Local reaction, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), 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: Cetirizine, Femhrt, Maxair, Bactroban ointment
Current Illness: None
Preexisting Conditions: Bacitracin, Ibuprofen, Morphine, Peanut and Tree Nut
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Large local reaction and hives occurring few hours after vaccine. Hives noted on neck, forearm and legs. States had 2 or 3 in each area. Felt lightheaded and feverish for 3 hours post vaccine.


VAERS ID: 631693 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2016-04-08
Onset:2016-04-08
   Days after vaccination:0
Submitted: 2016-04-13
   Days after onset:5
Entered: 2016-04-15
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 149001 / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injected limb mobility decreased, Myalgia, Neck pain, Spinal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament 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? No
Previous Vaccinations:
Other Medications: CIPRODEX; Benzaclin
Current Illness: Otitis externa
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Could not lift arm on injection side for days, resolved top of neck all the way down spine hurt starting morning after injection sore muscles all over starting night of vaccine admin.


VAERS ID: 631701 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Male  
Location: Texas  
Vaccinated:2016-04-14
Onset:2016-04-14
   Days after vaccination:0
Submitted: 2016-04-15
   Days after onset:1
Entered: 2016-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Headache, Injection site pain, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (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: NO
Preexisting Conditions: NO
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Soreness at injection site, fever (103F), headache, joint aches, nausea.


VAERS ID: 631794 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2016-04-13
Onset:2016-04-14
   Days after vaccination:1
Submitted: 2016-04-16
   Days after onset:2
Entered: 2016-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH M35315 / 1 UN / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Chills, Headache
SMQs:

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: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Headaches, chills.


VAERS ID: 631831 (history)  
Form: Version 1.0  
Age: 52.0  
Sex: Female  
Location: South Dakota  
Vaccinated:2016-04-07
Onset:2016-04-07
   Days after vaccination:0
Submitted: 2016-04-15
   Days after onset:8
Entered: 2016-04-18
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 146101D / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (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:
CDC Split Type: US2016047614

Write-up: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received BEXSERO (batch number 146101D, expiry date 30th April 2016). On 7th April 2016, the patient received BEXSERO .5 ml. On 7th April 2016, less than a day after receiving BEXSERO, the patient experienced injection site pain, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site warmth and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site warmth and injection site erythema to be related to BEXSERO. Additional details were received as follows: The reporter called to report that a female adult patient received her second dose of BEXSERO on 7th April 2016 and experienced a painful, hot-to-the-touch two inch in diameter raised red mark below the injection site in the subcutaneous area. The patient called the clinic this morning, and had an appointment with the physician at the clinic on the day of reporting, and the painful event has not yet resolved.


VAERS ID: 631843 (history)  
Form: Version 1.0  
Age: 17.0  
Sex: Female  
Location: Unknown  
Vaccinated:2016-03-30
Onset:2016-04-08
   Days after vaccination:9
Submitted: 2016-04-15
   Days after onset:7
Entered: 2016-04-18
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Decreased appetite, Dizziness, Electrocardiogram normal, Fatigue, Loss of consciousness, Nausea, Syncope, Urine analysis normal
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (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? 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: 04/08/2016, Electrocardiogram, No finding; 04/08/2016, Urine analysis, No finding
CDC Split Type: US2016GSK049410

Write-up: This case was reported by a consumer and described the occurrence of passed out in a 17-year-old female patient who received BEXSERO. On 30th March 2016, the patient received BEXSERO. On 8th April 2016, 9 days after receiving BEXSERO, the patient experienced passed out (serious criteria GSK medically significant), nausea, dizziness and fainting. On 9th April 2016, the patient experienced appetite absent, stomach pain and tiredness. On an unknown date, the outcome of the passed out, nausea, dizziness, fainting, appetite absent, stomach pain and tiredness were unknown. It was unknown if the reporter considered the passed out, nausea, dizziness, fainting, appetite absent, stomach pain and tiredness to be related to BEXSERO. Additional details were received as follows: This case was reported by the patient''s mother. On 08 April 2016, 9 days after the vaccination, the patient experienced nausea, dizziness and passed out or fainted for two minutes. The mother took the patient to the emergency room. In emergency room, they did Electrocardiogram and urine test. No findings were observed. On 09 April 2016, the patient was still experiencing nausea, did not want to eat, stomach ache and very tired. In the emergency room, the mother did not remember to tell the physicians that, the patient had received a dose of BEXSERO. When she remembered the vaccine administration, she called the nurse''s line and they advised the events were from BEXSERO. The mother of the patient wanted to know how long the side effects would continue.


VAERS ID: 631868 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Illinois  
Vaccinated:2016-03-24
Onset:0000-00-00
Submitted: 2016-04-15
Entered: 2016-04-18
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 151401 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Unevaluable event
SMQs:

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: Venlafaxin
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated.


VAERS ID: 632051 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: New York  
Vaccinated:2016-04-15
Onset:2016-04-15
   Days after vaccination:0
Submitted: 2016-04-19
   Days after onset:4
Entered: 2016-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH M37314 / 1 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Cellulitis, Drug administered at inappropriate site, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
SMQs:, Drug abuse and dependence (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

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: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: She complained that the vaccine burned at the time it was given. I then noticed that it was given in the subcutaneous fatty tissue of her arm and not the deltoid muscle. Within 2 hours she was complaining that her arm hurt. The next morning (Sat) she said her arm was very painful and had a small red spot were the vaccine was given. By that evening she had a half dollar sized red area and was given Benadryl. The next day (Sun) the red area continued spreading, swelling, and was hot to the touch. The area was from her elbow and up about 6 inches. She was given more Benadryl. By that evening it had spread about 2 more inches upward and an inch more below her elbow. Her primary MD was notified and advised us to go to the ER. The ER diagnosed her with cellulitis and prescribed Keflex 4X/day Sunday around 8:00 PM. Monday the area continued spreading and had wrapped around to the back side of her arm. We elevated, iced it, and gave her more Benadryl. This morning it was about the same or maybe a little less red.


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