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Found 8368 cases where Vaccine is MENB

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VAERS ID: 611780 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-11
Entered: 2015-11-25
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / UNK AR / UN

Administered by: Other       Purchased by: Other
Symptoms: Mobility decreased, Pain in extremity
SMQs:, Parkinson-like events (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015359073

Write-up: This is a spontaneous report from a contactable physician, who reported similar events for 3 patients. This is second of three reports. A patient of unspecified age and gender received a single dose of TRUMENBA on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced arm so sore that he/she could no move it on an unspecified date. The outcome of the event was unknown.


VAERS ID: 611781 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-11
Entered: 2015-11-25
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Mobility decreased, Pain in extremity
SMQs:, Parkinson-like events (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015359074

Write-up: This is a spontaneous report from a contactable physician, who reported similar events for 3 patients. This is third of three reports. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced arm so sore that he/she could not move it on an unspecified date. The outcome of the event was unknown.


VAERS ID: 611783 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-11
Entered: 2015-11-25
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia
SMQs:, Arthritis (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: 2015364329

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced joint pain (severe) on an unspecified date. Outcome was recovered in 2 days.


VAERS ID: 611784 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-11
Entered: 2015-11-25
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015364330

Write-up: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender received a single dose of TRUMENBA via an unspecified route of administration on an unspecified date. Medical history and concomitant medications were not reported. The patient experienced nausea and vomiting on an unspecified date with outcome of unknown.


VAERS ID: 611785 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-11
Entered: 2015-11-25
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Flushing, Injection site erythema, Injection site pain
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (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: 2015364402

Write-up: This is a spontaneous report from a contactable physician who reported for his son. A male patient of unspecified age received TRUMENBA on unspecified date, at single dose. Medical history and concomitant medications were not provided. The patient experienced redness and pain at the injection site and flushing feelings on an unknown date after vaccination. Events outcome was unknown.


VAERS ID: 611786 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-11
Entered: 2015-11-25
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / UNK UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Haematuria, Laboratory test normal, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tubulointerstitial diseases (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Laboratory test, normal
CDC Split Type: 2015368443

Write-up: This is a spontaneous report from a contactable Pfizer Sales Representative who reported on behalf of a Physician for a patient. A 16-years-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on an unspecified date in 2015 at single dose, on the same day the patient also received human papilloma vaccine, via an unspecified route of administration, and MENACTRA, via an unspecified route of administration. The patient medical history and concomitant medications were unknown. The patient went to the emergency room on an unknown date with nausea, body pain and neon red bloody urine which they diagnosed as hematuria which went away on its own within a day or two. The reporter did not believe that the patient has not taken any treatment for that, and at the emergency room they just monitored her for what the doctor said and then it just went away on its own. The patient underwent lab tests and procedures which included laboratory test with normal results. The outcome of the events nausea and body pain were unknown.


VAERS ID: 611787 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-11-11
Entered: 2015-11-25
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015254861

Write-up: This spontaneous report from a Pfizer sales representative who reported on behalf of a contactable physician for a patient. A patient of an unspecified age, ethnicity and gender started to receive TRUMENBA. The start date, dose and frequency were not provided. Medical history, concomitant drugs and laboratory test were not provided. Pfizer sales representative reported on behalf of the doctor the adverse event severe pain at the injection site and arm pain for TRUMENMA. Pfizer sales representative mentioned that she did not have ant details of the patient, she only knew that there was pain at the injection site for 3 days and then the patient took Naproxen. Pfizer sales representative mentioned that the patient was not suffering from the pain as of 29Jul2015 after taking Naproxen, and it was only for 3 days; patient had it no more and the patient was fine. The action taken was not provided. The events outcome was recovered. Causality was not provided. Follow-up (06SEP2015): Follow-up attempts complete. No further information expected.


VAERS ID: 611788 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Unknown  
Vaccinated:2015-06-05
Onset:2015-06-05
   Days after vaccination:0
Submitted: 2015-11-11
   Days after onset:159
Entered: 2015-11-25
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (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: minimal pain at the injection site~Meningococcal B (Trumenba)~1~20.00~Sibling
Other Medications: No other medications
Current Illness: Asthma; Hypersensitivity, for entire life
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015263291

Write-up: This is a spontaneous report from a contactable consumer who reported for his 2 daughters. These patients experienced the same events after first and second dose of vaccine. This is the first of 2 reports for patient 1. A 20-year-old female patient received, on 05Jun2015, the first single dose of TRUMENBA. The patient had ongoing asthma chronic and allergy for entire life. Concomitant medications included birth control pills and inhaler as needed for asthma. On 05Jun2015, the patient experienced minimal pain at the injection site. No treatment was provided. Laboratory tests were not performed. The patient recovered on 05Jun2015. The same reaction occurred to her sister after first vaccination with MenB performed on 05Jun2015. Follow up (07Aug2015): New information received from the same contactable consumer includes: details of patient. Follow-up (13-SEPT-2015): Follow-up attempts are completed. No further information is expected.


VAERS ID: 611789 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Female  
Location: Unknown  
Vaccinated:2015-06-05
Onset:2015-06-05
   Days after vaccination:0
Submitted: 2015-11-11
   Days after onset:159
Entered: 2015-11-25
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (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: 2015, Conjunctivitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015263351

Write-up: This is a spontaneous report from a contactable consumer who reported for his 2 daughters. These patients experienced the same events after first and second dose of vaccine. This is first of 2 reports for patient 2. A 20-year-old female patient received, on 05Jun2015, the first single dose of TRUMENBA. Relevant medical history included pink eye form 2015 (ongoing). Had no allergies. Concomitant medications included birth control pills and antibiotic for Pink eye. On 05Jun2015, the patient experienced minimal pain at the injection site. No treatment was provided. Laboratory tests were not performed. The patient recovered from the adverse event on 05Jun2015. The same reactions occurred to her sister after first and second vaccination with TRUMENBA performed respectively on 05Jun2015 and 04Aug2015.


VAERS ID: 611790 (history)  
Form: Version 1.0  
Age: 12.0  
Sex: Male  
Location: Kansas  
Vaccinated:2015-08-07
Onset:2015-08-07
   Days after vaccination:0
Submitted: 2015-11-11
   Days after onset:96
Entered: 2015-11-25
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH J29203 / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Incorrect dose administered, Injection site erythema, Injection site swelling, Rash erythematous, Syringe issue
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Medication errors (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: None
Preexisting Conditions: 12/2014, Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015269081

Write-up: This is a spontaneous report from a contactable physician and from a contactable nurse. A 12-year-old male patient of unspecified ethnicity received TRUMENBA (Lot# J29203, Exp date Jun2016), intramuscular in left deltoid, on 07Aug2015 at 11:45, at 0.5 ml single. Concomitant medications were not reported. At time of vaccination the patient was healthy. Last time he received a vaccine (unspecified) was in Dec2014. While the vaccine was administered on 07Aug2015 the liquid came out from the back side of the syringe, it spilled out (the patient did not receive the full dosage, infill was wasted onto the floor and the patient did not get the medication). The reporter was not sure how much vaccine was actually administered and how much fell on the floor. The reporter mentioned that syringe was not functional. On 07Aug2015, the patient had localized redness and little bit of swelling at the site of injection that disappeared within 5 minutes. On 07Aug2015 the patient experienced also a small local red rash. Red rash happened right after the injection. Small local red rash went away in about a minute. The patient recovered completely from redness, swelling and rash on 07Aug2015. The events did not require an emergency room or physician visit. No treatments were required. No lab tests were performed. The reporter considered there was a reasonable possibility the events were related to the suspect vaccine. Product quality investigation results for lot J29203: An initial reserve review of 368 reserve samples was carried out on 11Sep2015 for Lot J56434 under the current complaint. All samples were inspected for ''Physical damage to container'' as per SOP-76241 "Reserve Retention Sample Reviews for Customer Complaints Investigations". No defects were identified. Refer to PCOM for the reserve evaluation form. Complaint Confirmed: No, as no sample has been returned for this complaint it has not been possible to determine the cause of the reported leak. It is not clear from the description where the leak occurred. If the sample is received at a later date the complaint will be re-opened in order that evaluation can be added as a supporting document to the PCOM record. This investigation will only be amended if the evaluation changes the original root cause and conclusion. A batch document review was completed. There were no planned deviations that could have caused the reported defect. The 3 incidents which occurred during the packaging of this lot were fully investigated and approved by a Qualified Person prior to release. Based on the evidence available it is concluded that this is not potentially attributable to a facility based root cause or a third party supplier quality issue and this complaint is unconfirmed. This complaint is unconfirmed and therefore no CAPA is required. Complaints of this type will continue to be monitored and investigated. Component: Packaged Lot; Lot Number J29203; Manufacturing site; Date of manufacture: N/A; Quantity: N/A. Component: Filled Batch; Lot Number: J56434; Manufacturing site; Date of Manufacture: 31Jul2014; Quantity released: 237,545 pre-filled syringes. Fill lot J56434 was packed into packaged lots: J28923, J29757, and J29203. A review for prior complaints related to these packaged lots was performed in PCOM on the 30Sep2015. An evaluation of the complaint history confirms that this is the third complaint received for investigation for fill lot J56434. This is the first complaint received for complaint subclass; container broken/cracked/leaking during prep/use. The sample was not returned prior to completion of this report. If the sample is received at a later date the complaint will be reopened and the investigation will be re-evaluated. This investigation will only be amended if the evaluation changes the conclusions of the investigation. No evidence was found to indicate the complaint occurred as a result of activities conducted at Pfizer therefore it was deemed that a regulatory notification is not required. Monitor complaints for this fill lot will continue. No further action is required at this time. Follow-up (07Aug2015): New information received from contactable physician includes: suspect drug details, reaction data and reporter details. Follow-up (21Aug2015, 21Aug2015, 21Aug2015): new information received from a contactable nurse includes: patient''s details, events "Small local red rash" and "syringe was not functional" added, vaccination details, causality assessment for event "Small local red rash", medical history. Follow-up (15Sep2015): New information from the same contactable nurse includes: updated vaccination date and time, updated events onset/stop date and events details. Follow-up (05Oct2015): New information received from product quality complaint group includes: investigation results for lot J29203.


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