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VAERS ID: 597749 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2015-03-03
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: Glossodynia, Injection site swelling
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: 2015119602

Write-up: This is a spontaneous report from a non clinical study program for a contactable consumer who reported for her daughter. A female patient of an unspecified age and ethnicity received the first dose of TRUMENBA, via an unspecified route of administration on 03MAR2015 at single dose. The patient medical history and concomitant medications were not reported. In MAR2015, 1-2 weeks after vaccination, the patient experienced had a lot of pain in her tongue. On an unspecified date the patient developed a pea sized swelling at the injection site. The outcome of the events was unknown. Follow up (06APR2015): New information from a contactable consumer included: new event, vaccination date.


VAERS ID: 597750 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Male  
Location: Unknown  
Vaccinated:2015-03-13
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 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Muscle tightness, Neck pain
SMQs:, Retroperitoneal fibrosis (broad), Dystonia (broad), Arthritis (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: Prednisone
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015100593

Write-up: This is a spontaneous report from a non-clinical study program. A 19-year-old male patient received TRUMENBA vaccine because there was a meningitis outbreak at his school on 13MAR2015 at 4:00 PM or 5:00 PM on left arm. The following day the vaccination the patient received prednisone table for him headaches. The patient had a history of concussion, and really bad headaches two or three weeks after concussion. On unknown date after vaccination the patient experienced neck sore and tense and back soreness and tense. He did not sure if they were related to TRUMENBA or prednisone. The outcome of the events back tense and soreness was reported as recovered while the outcome of the events neck sore and tense was not recovered.


VAERS ID: 597751 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Oregon  
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 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Malaise, Peripheral swelling
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? 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: 2015094112

Write-up: This is a spontaneous report from a contactable physician through a sales representative. A female patient (a college student) of unknown age received on unknown date TRUMENBA 0.5 ml single dose, intramuscular. The patient experienced redness and swelling of the arm and general malaise that went away after one day. The outcome of the other two events was unknown. Follow-up (07MAY2015): Follow-up attempts completed. No further information expected.


VAERS ID: 597752 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Oregon  
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: Erythema, Malaise, Peripheral swelling
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? 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: 2015094110

Write-up: This is a spontaneous report from a contactable physician through a sales representative. A female patient (a college student) of unknown age received on unknown date TRUMENBA 0.5 ml single dose, intramuscular. The patient experienced redness and swelling of the arm and general malaise that went away after one day. The outcome of the other two events was unknown. Follow-up (07MAY2015): Follow-up attempts completed. No further information expected.


VAERS ID: 597754 (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: Rash pruritic
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: 2015093414

Write-up: This is a spontaneous report from a contactable physician. A female patient of an unspecified age received a 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 gradually spreading diffuse pruritic rash over several days again starting about 24 hours post the vaccination, on an unspecified date. The outcome of the reported event was unknown at the time of this report. Follow-up (06MAY2015): Follow-up attempts completed. No further information expected.


VAERS ID: 597755 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
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: Chest X-ray normal, Full blood count normal, Pyrexia, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (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: 2015093403

Write-up: This is a spontaneous report from a contactable physician. A patient of unknown age and gender received TRUMENBA single dose on unknown date. The patient experienced wheezing 24 hours post vaccination. No history of asthma or ever having wheezing. The patient also experienced a slight fever on unknown date. The patient received albuterol and QVAR as treatment for the event wheezing. Chest X-ray was clear and full blood count was unremarkable. The outcome of the events was unknown. Follow-up (08MAY2015): Follow-up attempts completed. No further information expected.


VAERS ID: 597756 (history)  
Form: Version 1.0  
Age: 22.0  
Sex: Female  
Location: Oregon  
Vaccinated:2015-03-05
Onset:2015-03-06
   Days after vaccination:1
Submitted: 2015-05-15
   Days after onset:69
Entered: 2015-09-21
   Days after submission:129
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Back pain, Chills, Fatigue, Injection site pain, Pain in extremity
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (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? 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: 2015088479

Write-up: This is a spontaneous report from a contactable consumer reporting for herself. This 22-year-old female patient received the first single dose of TRUMENBA intramuscular in the right arm on 05MAR2015 at 02:30 PM against diphtheria meningitis which was going around the campus that she was attending. The patient had not any other relevant conditions and hse had not received any concomitant medications. No other vaccine was administered in the previous eight weeks. On 05MAR2015 she had soreness at the injection site, on an unspecified date in MAR2015 (unknown if on 05MAR2015 or 06MAR2015) she experienced tiredness, on 06MAR2015 at 11 AM chills appeared, at 12 she had soreness stomach, a bad stomach ache and at an unknown time she experienced soreness on lower back, thighs and other arm. Due to the reported events, the patient did not visit medical doctor or emergency room. No relevant tests were performed. The patient did not recover from the reported events at the time of this report. Follow-up (15APR2015): Follow-up attempts completed. No further information expected.


VAERS ID: 597757 (history)  
Form: Version 1.0  
Age: 19.0  
Sex: Female  
Location: Oregon  
Vaccinated:2015-03-03
Onset:2015-03-05
   Days after vaccination:2
Submitted: 2015-05-15
   Days after onset:70
Entered: 2015-09-21
   Days after submission:129
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Eye irritation, Fatigue, Feeling hot, Headache, Hyperhidrosis, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Corneal disorders (broad), Vestibular disorders (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: Microgestin; Fluticasone
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015086555

Write-up: This is a spontaneous report obtained from a contactable consumer. A 19 year-old female patient received on 03MAR2015, TRUMENBA intramuscular on left arm, single dose. No other vaccines were received. Relevant medical history was unknown. Concomitant medications included oral MICROGESTIN, 1/20 tables) once a daily, for birth control and fluticasone (nasal spray) as needed used to relieve stuffy (caused by an allergy). On 05MAR2015, the patient experienced lightheadedness, fatigue, dizziness, feeling of warmth, sweating, nausea, irritation of eyes, and headache. On an unspecified date, the patient was feeling like she was going to faint. No hospitalization was required. The patient was recovering from the event, nausea. Clinical outcome of the event "felt faint" was unknown; while clinical outcome of the other events was reported as not recovered. Follow-up (01MAY2015): Follow-up attempts completed. No further information expected.


VAERS ID: 597758 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2015-03-03
Onset:2015-03-04
   Days after vaccination:1
Submitted: 2015-05-15
   Days after onset:71
Entered: 2015-09-21
   Days after submission:129
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH - / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Rash macular, 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 (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Not Ill
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2015086172

Write-up: This is a spontaneous report from a contactable consumer reporting for herself. This 19-year-old female patient of unknown ethnicity received at school first single dose of TRUMENBA on 03MAR2015 16:30 intramuscular injection in left upper arm. Once of the students at the school previously died from meningitis, so the school offered vaccines to the other students. Concomitant medications were none, no other vaccines were given on the same date or within four weeks. The patient never had adverse events with prior vaccinations, nor her siblings had adverse events with prior vaccinations. The patient had not a relevant medical history. No relevant testing. The patient was not ill at time of vaccination. On 04MAR2015 the patient experienced left arm a little swollen, 2 red non-raised blotches in left arm (described as one blotch about 3 inches below the injection site, and the second blotch about nickel size, to the right of the first one), soreness in left arm at level 4 on 1-10 scale and left arm warm to touch. The patient went to the school health clinic where she was instructed to draw a circle around the red areas and if the areas got bigger than to go back to health clinic. The event 2 red non-raised blotches in left arm was noticed on 04MAR2015 at about 17:30. The red blotches were bigger on the following morning on 05MAR2015. As of 05MAR2015, outcome of the events left arm a little swollen and 2 red non-raised blotches in left arm was not recovered, while outcome of soreness in left arm at level 4 on 1-10 scale and left arm warm to the touch was unknown. Follow-up (01MAY2015): Follow-up attempts completed. No further information expected.


VAERS ID: 597777 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:2015-07-01
Onset:2015-07-02
   Days after vaccination:1
Submitted: 2015-08-13
   Days after onset:42
Entered: 2015-09-21
   Days after submission:39
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH J29203 / UNK LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Injection site erythema, Pyrexia, Vomiting
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), 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: ORTHO TRI-CYCLEN
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Pyrexia, 100.1
CDC Split Type: 2015225715

Write-up: This is a spontaneous report from a contactable physician. A 18-year-old female patient received TRUMENBA (lot # J29203, Exp date JUN2016 NDC# 100000008535) via an unspecified route of administration in left deltoid, on 01JUL2015 at 11:00 AM. The patient had no significant medical history. Concomitant medications included ORTHO TRI-CYCLEN, oral at 35 ug daily. The patient experienced fever of 100.1, vomiting and significant redness at injection site on 02JUL2015. Fever of 100.1 and vomiting recovered on 03JUL2015, outcome of significant redness at injection site was unknown.


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