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Found 8094 cases where Vaccine is MENB

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VAERS ID: 597778 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-08-13
Entered: 2015-09-21
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Rash
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: 2015216303

Write-up: This is a spontaneous report from a non-contactable nurse. A female patient of unspecified age received the first single dose of TRUMENBA on unknown date. Medical history and concomitant medications were not provided. One day after vaccination the patient developed rash on her face, neck and her leg. Event outcome was unknown. No follow up attempts possible. No further information expected.


VAERS ID: 597786 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-08-13
Entered: 2015-09-21
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
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? 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: 2015216300

Write-up: This is a spontaneous report from a contactable Reporter who reported for a consumer. A female patient of an unspecified age and ethnicity started to receive TRUMENBA via an unspecified route of administration at unknown dose from an unspecified ate to an unspecified date for an unspecified indication. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced hives on her face and on her legs on an unspecified date with outcome of unknown. Follow-up (22JUL2015): Follow-up attempts completed. No further information expected.


VAERS ID: 597787 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-08-13
Entered: 2015-09-21
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Pain
SMQs:, Anaphylactic reaction (broad), 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015214572

Write-up: This is a spontaneous report from a non-contactable consumer who reported for his son. A male patient of unknown age and ethnicity received TRUMENBA, single dose on unknown date. After vaccination the arm was got all red which was about 10 inches long and painful. The outcome of the events was unknown. No follow up attempts possible. No further information expected.


VAERS ID: 597788 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Male  
Location: Unknown  
Vaccinated:2015-06-20
Onset:2015-06-21
   Days after vaccination:1
Submitted: 2015-08-13
   Days after onset:53
Entered: 2015-09-21
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH J28923 / 1 AR / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: 2015209951

Write-up: This is a spontaneous report from a contactable consumer (patient mother) via a non-clinical study program. This consumer reported similar events for 2 patients. This is the 2nd of 2 reports. A 19 years old male patient of an unspecified age and ethnicity received the first dose of TRUMENBA Lot number and Expiration Date: J28923, JUN2016, in the arm at 0.5 ml single on 20JUN2015. The patient was not taking any other medications and was not having any other medical conditions. On 21JUN2015, the patient experienced swelling and tenderness of lymph node under arm where vaccine was given. The events were described as tenderness at the injection site, glands at the injection site swelling under the arm. The events had resolved. The patient''s brother reported the same events after administration of the same vaccine (first dose). The patient did not undergo any lab work. No doctor was consulted. The reported stated that she decided to give ADVIL because of the tenderness at the injection site. Follow-up (22JUN2015): New information from a contactable consumer via a non-clinical study program, includes: patient age, ethnicity, height, weight, vaccination date, events details, onset date, outcome, treatment received. Follow-up (16JUL2015): New from a contactable consumer: This Consumer reported in response to the Non HCP letter sent which includes: Lot Number and Expiration Date, onset date and outcome. Follow-up (16JUL2015): This follow up report contains no new safety information.


VAERS ID: 597789 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Male  
Location: Unknown  
Vaccinated:2015-06-20
Onset:2015-06-21
   Days after vaccination:1
Submitted: 2015-08-13
   Days after onset:53
Entered: 2015-09-21
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH J28923 / 1 AR / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy
SMQs:, 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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Swelling and tenderness of lymph node under arm~Meningococcal B (Trumenba)~1~0.00~Patient
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015209925

Write-up: This is a spontaneous report from a non-clinical study program, by a contactable consumer (the mother) who reported similar events for two patients (her two sons). This is the first of two reports. A 21-year-old male patient received TRUMENBA, Lot Number and Expiration Date: J28923 JUN2016 via an unspecified route of administration at 0.5 ml, single on 20JUN2015. The patient was not having any other medical conditions and as not taking any other medications. On 21JUN2015, the patient experienced swelling and tenderness of lymph node under arm/tenderness at the injection site/glands at the injection site are swelling under the arms. Therapeutic measures taken as a result of the events included administration of ADVIL. The patient did not undergo any lab work. The outcome of the events was recovered. The patient''s brother reported the same events after administration of the same vaccine (first dose). Follow-up (22JUN2015): New information from a non-clinical study program, by a contactable consumer (mother) includes: report type from spontaneous, patient''s age, date of administration, details of the events, onset and outcome, treatment. Follow-up (16JUL2015) and 6JUL2015): New information from a non-clinical study program, by a contactable consumer (mother) includes: vaccine details, event onset and outcome.


VAERS ID: 597790 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Unknown  
Vaccinated:2015-03-04
Onset:2015-03-04
   Days after vaccination:0
Submitted: 2015-08-13
   Days after onset:161
Entered: 2015-09-21
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / 1 AR / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Fatigue, Grip strength decreased, Injected limb mobility decreased, Injection site pain, Mobility decreased, Muscular weakness, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (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: Seasonal allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015209572

Write-up: This is a spontaneous report from a contactable consumer via a non-clinical study program. A 21-year old female patient (weight was between 166 pounds to 170 pounds) received first dose of TRUMENBA on 04MAR2015 at single dose in arm after an outbreak of meningitis. Medical history included ongoing seasonal allergy. Concomitant medications were not reported. On 04MAR2015, after receiving the vaccine, she felt a little tired and nauseated and her arm started feeling really weak; initially her arm was sore where shot was received (on 04MAR2015), then the soreness spread on unspecified date in MAR2015. She could not sleep on the side she received the vaccine because it was sore and kept her awake. On 05MAR2015 she could not lift her arm very far, she could not lift her wrist, elbow or shoulder for about a week after getting the vaccine. On 06MAR2015 she did not have enough strength in her arm to move it around. She stated she did not remember if her arm felt heavy and if it did, it was not very much. On an unknown date all limbs were weak, she could move fingers but they were weak. She could not clinch her hand to hold stuff. No hospitalization was required. She was treated with acetaminophen for soreness on the site of vaccination which helped a little bit. No treatment was received for the other events. Fatigue resolved on 07MAR2015, felt nauseated resolved on 05MAR2015. The other reported events resolved on an unspecified date. She did not receive her second dose of TRUMENBA which was scheduled in MAY2015. Follow-up attempts completed. No further information expected. Follow up (30JUN2015). This is a follow up spontaneous report from a contactable consumer. The same contactable consumer reported in response to the telephone follow-up activities that included: events outcomes and details. Follow-up attempts completed. No further information expected.


VAERS ID: 597791 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Male  
Location: Unknown  
Vaccinated:2015-06-16
Onset:2015-06-16
   Days after vaccination:0
Submitted: 2015-08-13
   Days after onset:58
Entered: 2015-09-21
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH J29203 / 1 UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Fatigue, Malaise, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: 2015206390

Write-up: This is a spontaneous report from a contactable consumer (father). A 12-year-old male patient of unknown ethnicity received the first dose of TRUMENBA, lot number J296203 at 0.5 ml single dose on 16JUN2015. Medical history and concomitant medications were not reported. Approximately 12 hours from receiving the injection, on 16JUN2015, the patient developed a temperature of 37.6, fatigue, nausea. The patient also got sick overnight (16JUN2015). Temperature returned to normal with ibuprofen, then on 17JUN2015, the patient vomited and temperature reached highest point of 38.7C. Outcome was unknown. Follow-up attempts completed. No further information expected.


VAERS ID: 597792 (history)  
Form: Version 1.0  
Age: 18.0  
Sex: Female  
Location: Texas  
Vaccinated:2015-06-11
Onset:2015-06-11
   Days after vaccination:0
Submitted: 2015-08-13
   Days after onset:63
Entered: 2015-09-21
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH J29203 / 1 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Body temperature increased, Chills, Headache, Injection site pain, Injection site swelling, Nausea, Rash, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: ALEVE
Current Illness: Unknown
Preexisting Conditions: 2009, Appendectomy; 05/30/2013, Urticaria; AMOXIL, Hypersensitivity
Allergies:
Diagnostic Lab Data: 06/11/2015, Body temperature, rising; 06/12/2015, Full blood count, elevation of white blood count; 06/12/2015, Laboratory test
CDC Split Type: 2015201325

Write-up: This is a spontaneous report from a contactable pharmacist who reported for her daughter, and then from a contactable physician. A 18-year-old female patient received first dose of TRUMENBA (lot # J29203x6116), intramuscular in left deltoid, on 11Jun2015 at 03:30 pm, at 0.5 ml single. Relevant medical history included appendectomy in 2009, urticarial on 30May2013 and allergy to AMOXIL. Concomitant medication included ALEVE as needed when she had her cycle. On 11Jun2015 injection site was hurting and it swelled up very bad, it was very painful, the patient had chills and temperature rising (it had not hit 100, she did not measure at that time, she had broken out in rash and had also elevation of white blood count. Nausea and really bad headache developed on 12Jun2015 at 02:00 am. The patient was taken to the Emergency Room at the hospital because headache was so bad and the temperature did not go down. The patient had unspecified laboratory work in the emergency room on 12Jun2015 that revealed she did not had any infection. Full blood count on 12Jun2015 revealed elevation of white blood count. The patient was then discharged. On an unknown date the patient also experienced urticarial. The patient too ADVIL on 12Jun2015 at 07:00 am but it did not help for headache and put little bit of liquid in. The patient was given also BENADRYL, and TYLENOL. Rash went away and swelling went down and she was pretty sure that she was reacting to vaccine. The doctor put her on prednisone when she was returning to normal. Pharmacist mentioned that eh patient was recovering. The pharmacist mentioned that all the side effects (tenderness, swelling, nausea, headache, chills and temperature rising) that the patient had were all because of vaccine. The patient was brought to the pediatrician on `3Jun2015 and he also agreed that the meningitis vaccine did it. The physician considered that meningococcal group b rlp2-086 had a causal effect to the adverse events and that there were no adverse reactions related to ibuprofen. Follow-up (29Jun2015): New information from a contactable physician included: reporter''s assessment. Follow up (06Jul2015): new information received from a contactable physician includes: TRUMENBA lot# updated, treatment updated, medical history updated, causal relationship updated. Follow-up attempts. No further information expected.


VAERS ID: 597793 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Male  
Location: Nevada  
Vaccinated:2015-06-10
Onset:0000-00-00
Submitted: 2015-08-13
Entered: 2015-09-21
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. L001312 / UNK RA / IM
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH J29203 / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Fatigue, Influenza like illness
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: flu like symptom, fatigue~Meningococcal B (Trumenba)~0~16.00~Sibling
Other Medications: No other medications
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015200009

Write-up: This is a spontaneous report from a contactable other HCP via Pfizer sales representative. This reporter reported for 2 patients. This is 2nd of 2 reports. A 14-year-old male patient of an unspecified ethnicity received TRUMENDA (lot J29203, exp. date Jun2016, NDC number: 300050100102) intramuscular in left deltoid 15:03 at 0.5 ml single dose, and GARDASIL (lot L001312, exp. date 24Feb2017, NDC number: 0006412102) intramuscular on right deltoid at 0.5 ml single dose, both on 10Jun2015 3:30 pm (flu like symptoms). The patient medical history was not reported. Concomitant medication were not reported. The patient experienced fatigue on 11Jun2015 and flu like symptom on an unspecified date. The AEs did not require an emergency room or physician visit. The patient did not recover from the event fatigue but the outcome of the event flu like symptom was unknown. The final action taken with the products was to continue to monitor the child. This patient had a sister that received the same vaccine on 10Jun2015 and experienced the same adverse events. The reporter was provided with the information regarding the adverse events by the patient. The reporter considered the Pfizer product had a causal effect to the adverse event. The reporter was willing to be contacted again by Pfizer on the reported adverse events. Follow-up attempts completed. No further information expected. Follow-up (23Jul2015): New information received from a contactable other-HCP on behalf of physician includes: HPV-9 set as suspect; TRUMENDA and HPV-9 indication and vaccination date; reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability.


VAERS ID: 597794 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Nevada  
Vaccinated:2015-06-10
Onset:0000-00-00
Submitted: 2015-08-13
Entered: 2015-09-21
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH J29203 / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Fatigue, Influenza like illness
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: No other medications
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015199979

Write-up: This is a spontaneous report from a contactable other HCP via Pfizer sales representative. This reporter reported for two patients. This is first of two reports. A 16-year-old female patient of an unspecified ethnicity received TRUMENBA (lot J29203, exp. date 30Jun2016, NDC number: 300050100102), intramuscular in left deltoid on 10Jun2015 at 15:03 at 0.5 ml single dose. The patient medical history was not reported. Concomitant medication included MENVEO (lot A14091, exp. date 30Nov2015, NDC number: 46028020801), intramuscular in right deltoid at 0.5ml single doss on unknown date in 2010. The patient experienced fatigue on 11Jun2015 and flu like symptoms on an unspecified date. The outcome of the event fatigue was not recovered, while the outcome of the event flu like symptom was reported as unknown. This patient had a brother that received the same vaccine on 10Jun2015 and experienced the same adverse events. Follow-up (23Jul2015): New information received from a contactable other-HCP includes: Vaccines Lot # and expiration date updated. Follow-up attempts completed. No further information expected.


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