|
VAERS ID: |
597795 (history) |
Form: |
Version 1.0 |
Age: |
|
Sex: |
Unknown |
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: 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: 2015198212
Write-up: This is a spontaneous report obtained from a contactable nurse through a sale representative. A patient of an unspecified age, gender and ethnicity received, on an unknown date, TRUMENBA, single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced rash on the arm which was larger n size (its got 4 inches big) than usual size. Clinical outcome was unknown at time of this report. Follow-up attempts completed. No further information expected. |
|
VAERS ID: |
597796 (history) |
Form: |
Version 1.0 |
Age: |
18.0 |
Sex: |
Unknown |
Location: |
New York |
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 |
AR / IM |
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR |
- / UNK |
AR / IM |
Administered by: Private Purchased by: Private 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: 2015189888
Write-up: This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A 18-year-old patient of unspecified gender and ethnicity received first dose of TRUMENBA, intramuscular in the arm, on an unspecified date, at 0.5 ml single, for MENACTRA, intramuscular in the arm, on an unspecified date, at 1DF single. Relevant medical history and concomitant medications were not reported. On an unspecified date the vaccines were administered intramuscularly in the same arm during the same visit. On an unspecified date the patient allegedly developed a rash. Outcome of the reported events was unknown at the time of this report. Follow-up (01AUG2015): Follow-up attempts completed. No further information expected. |
|
VAERS ID: |
597797 (history) |
Form: |
Version 1.0 |
Age: |
|
Sex: |
Unknown |
Location: |
Unknown |
Vaccinated: | 0000-00-00 |
Onset: | 0000-00-00 |
Submitted: |
2015-07-13 |
Entered: |
2015-09-21 |
Days after submission: | 70 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH |
- / UNK |
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: 2015185599
Write-up: This is a spontaneous report from a non-contactable consumer via a non-clinical study program. A patient of unspecified age and gender received TRUMENBA at single dose, on unknown date. Medical history and concomitant medications were not provided. The patient got a rash on an unknown date after vaccine injection. Event outcome was unknown. No follow up attempts possible. No further information expected. |
|
VAERS ID: |
597798 (history) |
Form: |
Version 1.0 |
Age: |
|
Sex: |
Unknown |
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 |
AR / UN |
Administered by: Other Purchased by: Other Symptoms: Injection site pain,
Rash SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (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: 2015184763
Write-up: This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age, ethnicity and gender received TRUMENBA, via an unspecified route of administration in the arm, on an unspecified date, at single dose. Relevant medical history and concomitant medications were not reported. The patient experienced rash on the arm and burning on the site on an unspecified date. Outcome of the reported events was unknown at the time of this report. Follow-up (24JUL2015): Follow-up attempts completed. No further information expected. |
|
VAERS ID: |
597799 (history) |
Form: |
Version 1.0 |
Age: |
15.0 |
Sex: |
Male |
Location: |
Unknown |
Vaccinated: | 2015-05-15 |
Onset: | 2015-05-18 |
Days after vaccination: | 3 |
Submitted: |
2015-08-13 |
Days after onset: | 87 |
Entered: |
2015-09-21 |
Days after submission: | 39 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH |
- / 1 |
UN / SYR |
Administered by: Other Purchased by: Other Symptoms: Headache,
Myalgia,
Pyrexia,
Urticaria SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), 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: ZOLOFT; VYVANSE; Caltrate select Current Illness: Preexisting Conditions: Asperger''s disorder, diagnosed several years ago, maybe in 2012 Allergies: Diagnostic Lab Data: CDC Split Type: 2015173059
Write-up: This is a spontaneous report from a contactable consumer reporting on behalf of her son. A 15 years old male patient received first dose of TRUMENBA on 15May2015 at 4:45 P.M. at 0.5 ml single to prevent meningitis. Medical history included Asperger''s disorder diagnosed several years ago, maybe in 2012 (before that they thought it was ADHD). Concomitant medications included ZOLOFT at 250 mg, VYNASE at 60 mg and calcium carbonate, CALTRATE SELECT gummies daily and gummy laxative do not know brand. On 18May2015 the patient experienced muscle ache in neck, headache, low fever, hives on both arms. The mother was sick for the last 4 days; she thought he had received a cold from her. The patient was recovering from hives. Outcome of the other reported events was not resolved. Follow-up (15JUL2015): Follow-up attempts completed. No further information expected. |
|
VAERS ID: |
597801 (history) |
Form: |
Version 1.0 |
Age: |
|
Sex: |
Female |
Location: |
California |
Vaccinated: | 2015-05-05 |
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 / 1 |
UN / UN |
Administered by: Private Purchased by: Public Symptoms: Asthenia,
Lymphadenopathy,
Mobility decreased,
Pain,
Peripheral swelling,
Vomiting SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (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: Unknown Preexisting Conditions: Allergies: Diagnostic Lab Data: CDC Split Type: 2015163589
Write-up: This is a spontaneous report from a contactable physician via representative and from a contactable pharmacist. A 18 year old female patient received first single dose TRUMENBA (lot J29203, expiry date JUN2016) on 05MAY2015. Medical history and concomitant medications were not provided. The patient experienced vomiting, limited arm movement, body weakness, swelling of arm, pain and swollen lymph under arms on unknown date. THe events did not require an emergency room or physician visit or hospitalization. No specific tests and/or treatment were required. The physician wanted to know information about the immune response after the first dose because the patient did not want to receive the succeeding shots because of these reactions. Events outcome was not provided. Causality assessment was unknown. Follow-up (19JUN2015): New information from a contactable pharmacist includes: vaccine dose number, lot number, expiry date,, vaccination date, additional event. |
|
VAERS ID: |
597802 (history) |
Form: |
Version 1.0 |
Age: |
22.0 |
Sex: |
Female |
Location: |
Unknown |
Vaccinated: | 2015-05-15 |
Onset: | 2015-05-15 |
Days after vaccination: | 0 |
Submitted: |
2015-08-13 |
Days after onset: | 90 |
Entered: |
2015-09-21 |
Days after submission: | 39 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH |
- / 2 |
UN / UN |
Administered by: Other Purchased by: Other Symptoms: Erythema,
Pain in extremity,
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), 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: APRI Current Illness: Unknown Preexisting Conditions: Allergies: Diagnostic Lab Data: CDC Split Type: 2015168588
Write-up: This is a spontaneous report from a contactable consumer. This 22-year-old female patient received the second dose of TRUMENBA via an unspecified route of administration on 15MAY2015. The patient medical history was not reported. Concomitant medication included APRI tablet as oral contraceptive. The patient had previously received the first dose of TRUMENBA in MAR2015. On 15MAY 2015 the patient had a lot of swelling in her arm, it was really red and really warm, it was sore like/was very painful. None investigation was reported. The outcome of the reported events was unknown. Follow-up (15JUL2015): Follow-up attempts completed. No further information expected. |
|
VAERS ID: |
597803 (history) |
Form: |
Version 1.0 |
Age: |
|
Sex: |
Male |
Location: |
Unknown |
Vaccinated: | 2015-05-14 |
Onset: | 2015-05-14 |
Days after vaccination: | 0 |
Submitted: |
2015-08-13 |
Days after onset: | 91 |
Entered: |
2015-09-21 |
Days after submission: | 39 |
Vaccination / Manufacturer |
Lot / Dose |
Site / Route |
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH |
- / 2 |
UN / UN |
Administered by: Other Purchased by: Other Symptoms: Altered state of consciousness,
Asthenia,
Dizziness,
Pain,
Tremor SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? 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: 2015168256
Write-up: This is a spontaneous report from a contactable consumer. This male patient of an unspecified age and ethnicity received the second single dose of TRUMENBA via an unspecified route of administration on 14MAY2015. The patient medical history and concomitant medications were not reported. On 14MAY2015 the patient felt achy, really shaky and as he was going to faint and to pass out, dizzy, lightheaded and weak. His head hurt a little bit. The patient was not recovered at the time of this report. Follow-up attempts completed. No further information expected. |
|
VAERS ID: |
597804 (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: Malaise 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: Unknown Preexisting Conditions: Allergies: Diagnostic Lab Data: CDC Split Type: 2015166846
Write-up: This is a spontaneous report from a contactable reporter (patient''s brother). The reporter has reported similar events for one other patient. This is the 2nd of 2 reports. A female patient of an unspecified age received TRUMENBA, NDC, lot number, or expiration date unknown) via an unspecified route of administration at an unspecified dose on an unspecified date. The medical history was not reported. The concomitant medications were not reported. On unknown date the patient experienced sick symptoms after the vaccine was administered. Follow-up attempts completed. No further information expected. |
|
VAERS ID: |
597805 (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: Nausea 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: 2015166110
Write-up: This is a spontaneous report from a contactable consumer. A female patient of unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration, on an unspecified date, at unspecified dose. Relevant medical history and concomitant medications were not reported. After a couple of hours from vaccination the patient was not looking too good and was super nauseous. Outcome of the events was unknown at the time of this report. Follow-up (10JUL2015): Follow-up attempts completed. No further information expected. |
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