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VAERS ID: 597708 (history)  
Form: Version 1.0  
Age: 11.0  
Sex: Male  
Location: California  
Vaccinated:2015-02-19
Onset:2015-02-19
   Days after vaccination:0
Submitted: 2015-05-15
   Days after onset:84
Entered: 2015-09-21
   Days after submission:129
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH J29203 / UNK LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Decreased appetite, Fatigue, Injection site pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature: 102.3 F , 102 F and 100.3 F
CDC Split Type: 2015076950

Write-up: This is a spontaneous report from a contactable consumer (calling on behalf of her son) and a contactable physician. An 11-year-old male patient received TURMENBA (Lot # J29203, expiration date01JUN2016), intramuscular at 0.5 ml single in left upper arm, on 19FEB2015 at 04:10 PM. Relevant medical history was none. The patient was not ill at the time of vaccination, had no adverse event following prior vaccination. Concomitant medication included a vaccine for subtype A, injection unknown manufacturer, in the left arm on 13FEB2015. The patient complained of left upper arm pain on 19FEB2015 (right after injection of a few hours later). The pain lasted for about one week and then recovered. In the early morning of 20FEB2015 the patient was feeling tired. The reporter still sent him to school, b ut by lunch time the school called and said the patient had high temperature at 100.3 degrees F. The patient didn''t want to eat anything, had no appetite. Treatment received for high temperature included Tylenol every 4 to 6 hours. When the Tylenol wore off, his temperature went to 102.3 degrees F. High temperature, feeling tired and no appetite recovered on 22FEB2015. The physician described the event fever at 102 degrees F. x2 days and also reported the event soreness at injection site on 19FEB2015 with outcome of recovered. The physician assessed the events as non-serious and possible related to suspect product. Follow-up (17MAR2015): New information received from a contactable physician includes: Lot # and expiration date, dose and time for TRUMENBA, additional event (soreness at injection site) and details of fever, outcome and physician''s assessment. Follow-up (14MAY2015): Follow-up attempts completed. No further information expected.


VAERS ID: 597711 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-15
Entered: 2015-09-21
   Days after submission:129
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Discomfort, Headache, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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: 2015078559

Write-up: This is a spontaneous report from a non-contactable consumer who reported for her roommate A female patient of unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration, on unspecified date, at single dose. Relevant medical history and concomitant medications were not reported. A couple of hours after vaccination the patient felt heavy, her body was feeling very heavy; had a really bad headache and felt very drowsy. Outcome of the reported events was unknown at the time of this report. No follow-up attempts possible. No further information expected.


VAERS ID: 597717 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Male  
Location: Nevada  
Vaccinated:2015-04-17
Onset:2015-04-18
   Days after vaccination:1
Submitted: 2015-05-15
   Days after onset:27
Entered: 2015-09-21
   Days after submission:129
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / UNK AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Chills, Dizziness, Pyrexia, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular 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? 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: 2015143453

Write-up: This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative. This pharmacist (mother) reported same event for two patients. This is the first of two reports. A 14-year-old male patient received, on 17Apr2015, TRUMENBA intramuscularly in deltoid, at 0.5 ml, single dose. Vaccines given on the same date along with TRUMENBA were none. Vaccines given within four weeks of administration of TRUMENBA were none. Relevant medical history and concomitant medications were unknown. On 18Apr2015 at 1:30 AM, the patient experienced fever, chills. In the afternoon of the same day, on 18Apr2015, the dizziness and blurred vision began. Clinical outcome of the events was unknown at time of this report.


VAERS ID: 597718 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:2015-03-27
Onset:0000-00-00
Submitted: 2015-05-15
Entered: 2015-09-21
   Days after submission:129
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (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? 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: 2015121468

Write-up: This is a spontaneous report from a contactable consumer who reported for her son. A male patient of an unspecified age and ethnicity received TRUMENBA and GARDASIL, both via an unspecified route of administration on 27Mar2015. The patient medical history and concomitant medications were not reported. On unknown date, the patient experienced little bit of redness with outcome of unknown and pain in arm with outcome of recovered. The reporter mentioned that she did not take her son to any doctor for the pain that occurred after vaccination.


VAERS ID: 597719 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Unknown  
Vaccinated:2015-03-03
Onset:2015-03-03
   Days after vaccination:0
Submitted: 2015-05-15
   Days after onset:72
Entered: 2015-09-21
   Days after submission:129
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: KELNOR
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature 100.7 F; 100.3 F
CDC Split Type: 2015084108

Write-up: This is a spontaneous report from a contactable consumer reporting for herself. This 21-year-old other ethnic group female patient received the fist single dose of TRUMENBA via an unspecified route of administration on 03MAR2015 around 4:30 PM. The patient medical history was not reported. Concomitant medication included KELNOR one capsule by mouth daily for birth control. On 03MAR2015 at 6:00 PMJ the patient experienced high temperature (100.7 degrees F) and a very intense body fatigue on her legs and her back. She administered ibuprofen for the high temperature and temperature was down to 100.3 degrees F on an unspecified date in MAR2015. It was reported that at the time of this report symptoms were still persisting. The consumer asked if it was normal to experience these events after the vaccination. Follow-up (24MAR2015): Follow-up attempts completed. No further information expected.


VAERS ID: 597720 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-15
Entered: 2015-09-21
   Days after submission:129
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / UNK AR / SYR

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Balance disorder, Dizziness, Fatigue, Headache, Injection site pain, Musculoskeletal stiffness, Myalgia, Pain in extremity, Photophobia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Extravasation events (injections, infusions and implants) (broad), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (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? 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: 2015087623

Write-up: This is a spontaneous report from a Non Clinical Study Program from a contactable consumer who reported for her son. A male patient of an unspecified age received a single dose of TRUMENBA via an unspecified route of administration in the arm on an unspecified date as Meningitis vaccine. The patient medical history and concomitant medications were not reported. After the vaccination on an unspecified date the patient experienced fever, headache, stiff neck, back pain, muscle pain, he was dizzy, lot of pain in the arm and area where vaccine was injected, pain in hand, lot of fatigue, sensitivity to light, he was unstable. The reporter mentioned that her son had multiple effects and she was wondering how long these side effects would have lasted and expected to last and whether they were normal. Outcome of events was unknown. Follow-up (06MAY2015): Follow-up attempts completed. No further information expected.


VAERS ID: 597722 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2015-03-02
Onset:2015-03-03
   Days after vaccination:1
Submitted: 2015-05-15
   Days after onset:72
Entered: 2015-09-21
   Days after submission:129
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Chills, Fatigue, Pain in extremity, Vaccination site swelling
SMQs:, 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: 2015086066

Write-up: This is a spontaneous report from a contactable consumer reporting for herself. This 19-year-old female patient received the first single dose of TRUMENBA via an unspecified route of administration on 02MAR2015. The patient medical history and concomitant medications were not reported. She had stopped an unspecified antibiotic two weeks prior to the vaccination. On 03MAR2015 the patient experienced swelling and warm to touch underneath the area where she received the vaccination, tiredness, chills and her arm hurt. The patient did not recover from the events swelling and warm to touch underneath the area where she received the vaccination and arm hurt, she recovered from tiredness and chills on an unspecified day in MAR2015. Follow-up (01MAY2015): Follow-up attempts completed. No further information expected.


VAERS ID: 597723 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-15
Entered: 2015-09-21
   Days after submission:129
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / UNK AR / UN

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Peripheral swelling, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015084759

Write-up: This is a spontaneous report from a non-contactable consumer. This female patient of an unspecified age received a single dose of TRUMENBA in the arm on an unspecified date in Mar2015. The patient medical history and concomitant medications were not reported. The patient mentioned that her arm started swelling and turned red and hot to the touch on an unspecified date in Mar2015. She wanted to know if this adverse reactions were normal with TRUMENBA. Outcome of the reported events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 597724 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Male  
Location: Nevada  
Vaccinated:2015-02-14
Onset:2015-02-17
   Days after vaccination:3
Submitted: 2015-05-15
   Days after onset:86
Entered: 2015-09-21
   Days after submission:129
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH J28923 / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Decreased appetite, Nausea, Pain in extremity, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, 102 Fahrenheit
CDC Split Type: 2015084673

Write-up: This is a spontaneous report from two contactable pharmacists via a sales representative. A 13-year-old male patient received TRUMENBA (Lot # J28923, Expires 30Jun2016), intramuscular in left deltoid at 0.5 ml, single on 14Feb2015 at 20:30. The following vaccinations were schedule for 15Apr2015 and for 15Aug2015. The patient medical history was not reported. Concomitant medications were none. On 17Feb2015, the patient experienced high fever of 102 degrees F, no appetite, self nauseated and blew up and sore arms. The events resolved after 2 or 3 days without treatments. The events did not require an emergency room or physician visit. No specific tests and/or treatments were required. According to the second reporting pharmacist, there was a reasonable possibility that all the events was related to suspect product. Follow up (06Apr2015): New information from another contactable pharmacist includes: updated patient age, updated vaccine lot number, route of administration, anatomical location, vaccination date/time, following vaccination schedule. Follow-up attempts completed. No further information expected.


VAERS ID: 597725 (history)  
Form: Version 1.0  
Age: 21.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2015-05-15
Entered: 2015-09-21
   Days after submission:129
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Feeling abnormal, Feeling cold, Headache, Rash, Rash erythematous, Rash pruritic, Thinking abnormal
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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? 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: 2015084642

Write-up: This is a spontaneous report from a contactable consumer who reported for her daughter. A 21 year-old female patient of an unspecified ethnicity received the first single dose of TRUMENBA via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. The patient experienced fuzziness, dizziness, fatigue, bad headache, weakness, shivering/cold, she slept for very long time, she had rash, red rash of about 2 by 2 on her arm and it was itchy, she could not think straight, all on an unspecified date. The outcome of the events was unknown. The reporter inquired if the patient should see her doctor and if the reported symptoms could be allergic reactions. He also asked if it would be ok if the patient would miss the second and the third vaccination, and just got the first one. Follow-up (06Mar2015): New information reported from the same contactable consumer includes: patient age, vaccine dose number, reaction data (new events weakness, could not think straight, shivering/cold were added), reporter questions. Follow-up (01MAY2015): Follow-up attempts completed. No further information expected.


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