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Case Details (Sorted by Vaccination Date)

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VAERS ID:442594 (history)  Vaccinated:2011-11-15
Age:15.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-15, Days after onset: 0
Location:Kentucky  Entered:2011-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illnesses noted.
Preexisting Conditions: No illnesses documented on consent.
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS11015011IMRA
Administered by: Other     Purchased by: Public
Symptoms: Injection site pruritus
SMQs:
Write-up: Began complaining of itching at injection site. Took off bandaid and cleaned area. After 40 minutes of injection, itching subsided. No med given.

VAERS ID:442597 (history)  Vaccinated:2011-11-15
Age:18.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Male  Submitted:2011-11-15, Days after onset: 0
Location:Virginia  Entered:2011-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH505AB1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0840AA1IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Foaming at mouth, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Observed pt. have an syncope episode with legs tremors and foaming at the mouth.

VAERS ID:442600 (history)  Vaccinated:2011-11-15
Age:41.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Male  Submitted:2011-11-15, Days after onset: 0
Location:Colorado  Entered:2011-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: PCN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALS 0IMLA
Administered by: Other     Purchased by: Other
Symptoms: Chest discomfort, Headache, Lacrimation increased, Myalgia, Ocular hyperaemia, Wheezing
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Glaucoma (broad), Eosinophilic pneumonia (broad), Lacrimal disorders (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: Wheezing, tightness in chest, red watery eyes, headache, muscle soreness.

VAERS ID:442609 (history)  Vaccinated:2011-11-15
Age:11.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-15, Days after onset: 0
Location:Florida  Entered:2011-11-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Loratadine
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1397AA1UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4243AA0UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0710AA1UNRA
Administered by: Private     Purchased by: Public
Symptoms: Malaise, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: 20 minutes after receiving the 3 vaccines & while leaving the office building, patient told her mom, I don''t feel good, turned very pale & fainted, once laying down she was conscious, smiling but very pale, mom said that she didn''t eat breakfast.

VAERS ID:442659 (history)  Vaccinated:2011-11-15
Age:39.0  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:Texas  Entered:2011-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Allergies to fruits
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS11092P IMLA
Administered by: Other     Purchased by: Private
Symptoms: Anxiety, Blood pressure increased, Chest pain, Chills, Dyspnoea, Injection site erythema, Injection site pruritus
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad)
Write-up: Pt was having chest pain, itching on injection site, redness, shortness of breath, chills, increased B/P, anxiety.

VAERS ID:442744 (history)  Vaccinated:2011-11-15
Age:0.2  Onset:2011-11-15, Days after vaccination: 0
Gender:Unknown  Submitted:2011-11-16, Days after onset: 1
Location:Colorado  Entered:2011-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B300BA0UNRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0640AA0UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH9165990UNLL
Administered by: Private     Purchased by: Public
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever.

VAERS ID:442749 (history)  Vaccinated:2011-11-15
Age:0.5  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-16, Days after onset: 1
Location:Texas  Entered:2011-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: white cells 24.6; negative urine
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B300BA2UNLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4119BA0UNRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9166182UNRL
Administered by: Private     Purchased by: Public
Symptoms: Crying, Pyrexia, Urine analysis normal, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient began with fever, excessive crying, elevated white count at 24.6. Received ROCEPHIN IM following AUGMENTIN x 10 days.

VAERS ID:442762 (history)  Vaccinated:2011-11-15
Age:49.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-15, Days after onset: 0
Location:Virginia  Entered:2011-11-16, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VALIUM 5 mg last nite
Current Illness: None
Preexisting Conditions: Chronic kidney stones-non functioning (R) kidney
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1150Z0IMUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC528071CA0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Feeling abnormal, Heart rate increased, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)
Write-up: Became trembly, shaky, rapid heartbeat, thought I was going to black out.

VAERS ID:442791 (history)  Vaccinated:2011-11-15
Age:10.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Male  Submitted:2011-11-16, Days after onset: 1
Location:South Dakota  Entered:2011-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH478AB IMRA
Administered by: Other     Purchased by: Public
Symptoms: Contusion, Dizziness, Erythema, Fall, Head injury, Headache, Immediate post-injection reaction, Pallor, Peripheral coldness, Swelling face, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Client had just received his flu shot in the right deltoid muscle by School Nurse. Fluzone vaccine by Sanofi, Lot # UH478AB, Exipration 6/30/12. He stood up after receiving the injection and immediately fainted, falling to the floor and hit his head on the hard gym floor. School Nurse assisted the client to lie on his back but stay lying down. This nurse was called over with the Emergency Kit. This nurse''s assessment showed the client awake, alert, and orientated. His skin was pale in color and cool to the touch. He complained of his head hurting. A large bump approximately 1 and 1/4 inch in diameter with redness and contusion was noted to the left forehead and eyebrow area. No other injury noted. Client was able to move all exremities by command. Vital signs at 1615 hours by this nurse: Blood Pressure 98/64, Pulse 70, Respirations 24. His pupils reacted to light quickly equal and bilaterally. A cold pack was applied to the client''s forehead. Client was encouraged to take slow deep breaths and to stay resting on the floor for another five minutes. Repeat vital signs at 1620 hours by this nurse: Blood Pressure 100/64, Pulse 64, Respirations 20. His skin color was still pale, but improving. Client was assisted to a sitting, and then a standing position. He walked across the gym with assistance to side wall. He sat down on a mat and still complained of being dizzy, so was laid down on the mat to rest. His grandmother had accompanied him to the flu clinic, so the client''s mom was notified of the incident at this time. His mom stated she would come to get him. Repeat vital signs at 1632 hours by School Nurse: Blood Pressure 90/54, Pulse 64, Respirations 20. Client still complained of his head hurting and feeling dizzy, so he continued to stay lying down on the mat. This nurse left to resume flu clinic duties as School Nurse stayed with the client to monitor him. Per School Nurse there was no change in the client''s condition. Per School Nurse she spoke with the client''s family about monitioring for any signs of complications and recommended seeing a doctor for any concerns. When the client''s mom arrived they left the clinic to rest at home. 11/16/11 0800 hours Per School Nurse she spoke with the client''s father this morning. He stated to her that the client does have the large bump on his forehead, but is fine otherwise and had no complications overnight.

VAERS ID:442793 (history)  Vaccinated:2011-11-15
Age:14.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Female  Submitted:2011-11-16, Days after onset: 0
Location:Virginia  Entered:2011-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0469AA1IMLA
Administered by: Unknown     Purchased by: Public
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Whelp the size of a quarter at the location the vaccination given.

VAERS ID:442795 (history)  Vaccinated:2011-11-15
Age:11.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-16, Days after onset: 1
Location:South Dakota  Entered:2011-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH478AB IMRA
Administered by: Other     Purchased by: Public
Symptoms: Pallor, Peripheral coldness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Client had just received a flu shot in the right deltoid muscle by Nursing Student. Fluzone vaccine by Sanofi, Lot # UH478AB, Exipration 6/30/12. Client leaned forward in a faint, but was caught and lowered to the floor by Student Nurse. This nurse was then called over with the Emergency Kit. This nurse''s assessment showed the client awake, alert, and orientated. Her skin was pale and cool to the touch. She stated she felt "fine" and had no complaints. Vital signs at 1755 hours by this nurse: Blood Pressure 110/70, Pulse 60, Respirations 16. Client was encouraged to stay resting and lying on the floor. Vital signs at 1804 hours by this nurse: Blood Pressure 110/72, Pulse 60, Respirations 16. Client was assisted into a reclined sitting position resting against her mom. Mom reported the client had just finished playing basketball before coming to get her flu shot and had not eaten yet. The client''s mom gave the client a Fruit Punch Powerade to sip on. Client stated still no complaints, but was still pale in color and cool to the touch. Client was assisted up to sit in a nearby chair. Vital signs at 1815 hours by this nurse: Blood Pressure 110/70, Pulse 60, Respirations 16. Client''s mom gave her a granola bar to eat. Client stated still no complaints and her color was still a little pale, but was improving. Client was assisted to stand. She stayed standing without difficulty. Client left the clinic with her mom, but was escorted to their car by Student Nurse. 11/16/11 1040 hours This nurse called to follow up on the client''s condition today, but had to leave a message. This nurse also spoke with Dr''s. to report the incident.

VAERS ID:442807 (history)  Vaccinated:2011-11-15
Age:46.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-16, Days after onset: 1
Location:Pennsylvania  Entered:2011-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR 1UNLA
Administered by: Other     Purchased by: Other
Symptoms: Chills, Cough, Dyspnoea, Oropharyngeal pain, Pyrexia, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Wheezing, shortness of breath, cough, sore throat, fever and chills.

VAERS ID:442811 (history)  Vaccinated:2011-11-15
Age:3.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Female  Submitted:2011-11-16, Days after onset: 0
Location:Washington  Entered:2011-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data: not indicated
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH478AB1IMLL
Administered by: Public     Purchased by: Public
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash on trunk and face.

VAERS ID:442812 (history)  Vaccinated:2011-11-15
Age:72.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Male  Submitted:2011-11-16, Days after onset: 0
Location:North Carolina  Entered:2011-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC061AA1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site discharge, Injection site induration, Injection site vesicles
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Blister and the drainage with slight induration directly over site of injection.

VAERS ID:442813 (history)  Vaccinated:2011-11-15
Age:0.3  Onset:2011-11-15, Days after vaccination: 0
Gender:Male  Submitted:2011-11-16, Days after onset: 1
Location:Colorado  Entered:2011-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Premature, Acid Reflux
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPIHI: DT+IPV+HIB+HEPB (NO BRAND NAME)UNKNOWN MANUFACTURER 1 LG
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 1 LG
RVX: ROTAVIRUS (NO BRAND NAME)UNKNOWN MANUFACTURER 1 UN
Administered by: Unknown     Purchased by: Other
Symptoms: Diarrhoea, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: High fever 103.6 and diarrhea.

VAERS ID:442827 (history)  Vaccinated:2011-11-15
Age:15.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-16, Days after onset: 1
Location:Pennsylvania  Entered:2011-11-16
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Anaphylaxis~Varicella (no brand name)~1~~Patient
Other Medications: ranitidine 150 mg; trazodone 150 mg; ZOLOFT 50 mg
Current Illness: None
Preexisting Conditions: varicella allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1008Z SCLA
Administered by: Private     Purchased by: Public
Symptoms: Dyspnoea, Injection site pruritus, Rhinorrhoea, Sneezing, Vaccine positive rechallenge, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Itching at injection site, sneezing, rhinorrhea, audible wheeze, labored breathing, given a dose of injectable Diphenhydramine 50mg/mL and a dose of injectable Epinephrine 1:1000 (1mg/mL) also given O2 at 4 liters. Ambulance was called pt transferred to medical center.

VAERS ID:442983 (history)  Vaccinated:2011-11-15
Age:4.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Male  Submitted:2011-11-16, Days after onset: 0
Location:Iowa  Entered:2011-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (KINRIX)GLAXOSMITHKLINE BIOLOGICALSAC20B171BA IMLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT491AB6IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0403AA1SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0823AA1SCLL
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: On the am of 11-16-11, care taker noticed a baseball size, bright red, swollen hot area on child''s (L) leg. Recc. to mark area with pen to track size expansion. Recc warm compress to notify pediatrician for further care.

VAERS ID:442815 (history)  Vaccinated:2011-11-15
Age:31.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-17, Days after onset: 2
Location:Maryland  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: diabetes, hypertension
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TETANUS DIPHTHERIA (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMRA
Administered by: Public     Purchased by: Private
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (broad)
Write-up: Pain around site. Hard to lift right arm that it was administered in. Pain on right side of neck. Tetanus shot.

VAERS ID:442849 (history)  Vaccinated:2011-11-15
Age:10.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Male  Submitted:2011-11-17, Days after onset: 2
Location:Ohio  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: kidney defect repair at 3 mos - nor current issues
Diagnostic Lab Data: PMD dx as reaction to varicella vaccine
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH476AB IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0864AA1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Developed rash on opposite arm of injection within several hours. Parent took child to PMD. Dx hives had cortisone inj & prednisone rx.

VAERS ID:442854 (history)  Vaccinated:2011-11-15
Age:66.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-17, Days after onset: 2
Location:Florida  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0595AA1IMLA
Administered by: Public     Purchased by: Private
Symptoms: Breast tenderness, Injection site erythema, Injection site pain, Injection site reaction, Rash macular, Tenderness
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Tenderness to site -woke her during night when laying on affected side (left deltoid). Next day area red with blotchy area that spread to inner aspect of left arm by that night (Wed 11/16). Tenderness to touch that extended to left breast and neck. Took Cipro and Benadryl --- by next morning Thursday 11/17 area still red and blotchy with some tenderness but improved from day before.

VAERS ID:442857 (history)  Vaccinated:2011-11-15
Age:11.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-17, Days after onset: 2
Location:Oklahoma  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.06366AA1IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURE09050 IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSA100541IMRA
TD: TETANUS DIPHTHERIA (NO BRAND NAME)UNKNOWN MANUFACTURER03007DA2IMLA
Administered by: Public     Purchased by: Public
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: S/S lightheadedness and dizziness.

VAERS ID:442859 (history)  Vaccinated:2011-11-15
Age:65.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Male  Submitted:2011-11-17, Days after onset: 2
Location:New Jersey  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEUR 1 LA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.   RA
Administered by: Other     Purchased by: Other
Symptoms: Chills, Cough, Dyspnoea, Heart rate increased, Palpitations, Pyrexia, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Began wheezing, cough, palpitations. initially. Progressed to fever, chills and shortness of breath and extremely rapid heart beat. Temperature taken at 5:35PM was 102.2F.

VAERS ID:442860 (history)  Vaccinated:2011-11-15
Age:3.0  Onset:2011-11-17, Days after vaccination: 2
Gender:Female  Submitted:2011-11-17, Days after onset: 0
Location:Indiana  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pharyngitis (viral) URI
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF136360IMLL
Administered by: Private     Purchased by: Public
Symptoms: Injection site urticaria, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Hives, starting at injection site (left thigh) spread all over body.

VAERS ID:442870 (history)  Vaccinated:2011-11-15
Age:46.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Female  Submitted:2011-11-17, Days after onset: 1
Location:Texas  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: omeprazole; NEXIUM
Current Illness: Chest pain; esophagitis
Preexisting Conditions: Allergic to LEVAQUIN
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.00006494300 SYRAR
Administered by: Private     Purchased by: Private
Symptoms: Injection site swelling, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Swelling around injection site and spreading to elbow; red rash; patient took BENADRYL.

VAERS ID:442874 (history)  Vaccinated:2011-11-15
Age:80.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Female  Submitted:2011-11-17, Days after onset: 1
Location:Ohio  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH469AB0IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0595AA0IMLA
Administered by: Other     Purchased by: Public
Symptoms: Dizziness, Pain in extremity, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: Severe drowsiness x 2 days. Severe dizziness x 2 days. Pain in arm x 2 days.

VAERS ID:442882 (history)  Vaccinated:2011-11-15
Age:70.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Female  Submitted:2011-11-17, Days after onset: 1
Location:Massachusetts  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURUH452AC0IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Head discomfort, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever of 99.9, slight body aches, "head felt strange" - she took 3 baby ASA - completely resolved in 48 hrs.

VAERS ID:442896 (history)  Vaccinated:2011-11-15
Age:10.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-17, Days after onset: 2
Location:Indiana  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: CAT scan & x-rays of head
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3517AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B056BB0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0718Z1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Computerised tomogram, Dizziness, Fall, Head injury, Headache, Hypoaesthesia, Loss of consciousness, Paraesthesia, Syncope, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Syncopal episode with loss of consciousness in the parking lot. Mother states child fell from car & hit head on asphalt. Complained of head pain, dizziness, numbness/tingling in both arms & knees.

VAERS ID:442904 (history)  Vaccinated:2011-11-15
Age:29.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Female  Submitted:2011-11-17, Days after onset: 1
Location:California  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: N/A
Preexisting Conditions: N/A
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV2863IMLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Grip strength decreased, Limb discomfort, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Redness, swelling, hot to touch, red streaking, hard to make fist, uncomfortable feeling in whole side of left arm.

VAERS ID:442905 (history)  Vaccinated:2011-11-15
Age:2.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Male  Submitted:2011-11-17, Days after onset: 1
Location:New York  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: URI symptoms
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEUR 3  
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR 0  
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 3  
Administered by: Private     Purchased by: Other
Symptoms: Febrile convulsion, Postictal state, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever $g102 degrees. Febrile Seizure. Duration uncertain. Post-ictal upon evaluation in office.

VAERS ID:442924 (history)  Vaccinated:2011-11-15
Age:36.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Male  Submitted:2011-11-17, Days after onset: 2
Location:California  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NO KNOWN DRUG ALLERGIES PPD CONVERTER
Diagnostic Lab Data: VITAL SIGNS BP 121/79, P 83, R 16, TEMP, 97.7 DEGREES ORALLY, PAIN 3/10 IN RIGHT ARMPIT
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4099AA2IMRA
Administered by: Military     Purchased by: Military
Symptoms: Axillary pain, Dyspnoea, Eye irritation, Injection site pain, Sluggishness
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Corneal disorders (broad)
Write-up: SLUGGISH, INJECTION SITE WAS SORE AND TENDER TO TOUCH, ARMPIT WAS SORE, SHORTNESS OF BREATH, FEELS LIKE EYES BURN

VAERS ID:442937 (history)  Vaccinated:2011-11-15
Age:1.3  Onset:2011-11-16, Days after vaccination: 1
Gender:Male  Submitted:2011-11-17, Days after onset: 1
Location:Arizona  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3932AB0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0336AA0SCRA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Inflammation, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Localized inflammatory response, redness, heat, (L) arm.

VAERS ID:442938 (history)  Vaccinated:2011-11-15
Age:22.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-17, Days after onset: 2
Location:North Carolina  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH486AF0UNRA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Feeling hot
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: About 45 minutes after the vaccine was given, the patient became dizzy and felt faint. She was given a chair to sit in, and her blood pressure was checked (87/54 mmHg). She said she was hot, so she was given water, Ginger Ale & crackers. She sat for about 1 hour before being picked up and taken home.

VAERS ID:442990 (history)  Vaccinated:2011-11-15
Age:49.0  Onset:2011-11-17, Days after vaccination: 2
Gender:Male  Submitted:2011-11-18, Days after onset: 1
Location:Minnesota  Entered:2011-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Bactrim, Codeine, Iodine, Levaquin, PCN
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4147AA4IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1071AA0SCLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3989AA0IMRA
Administered by: Private     Purchased by: Other
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Redness and Erythema.

VAERS ID:443007 (history)  Vaccinated:2011-11-15
Age:41.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Female  Submitted:2011-11-18, Days after onset: 2
Location:Massachusetts  Entered:2011-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergy to ASPIRIN, Grape Juice BiPolar, Cocaine abuse, PTSD, GERD, Hyperlipidemia, Obesity
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.09855AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site swelling, Joint range of motion decreased, Local swelling, Pain, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Localized erythema, warmth and swelling about 5cm x 5cm with one hive, altered ROM specifically difficulty with abduction, increased pain, day two additional sweling and redness below site of original redness aprox 2cm x 3 cm all on left arm where vaccine given.

VAERS ID:443034 (history)  Vaccinated:2011-11-15
Age:75.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Male  Submitted:2011-11-16, Days after onset: 1
Location:Texas  Entered:2011-11-18, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None listed
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURUH459AB0IMAR
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1159AA0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Chills, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Temperature, chills, fever, shaking. Went to ER & stayed overnight.

VAERS ID:443047 (history)  Vaccinated:2011-11-15
Age:11.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-18, Days after onset: 3
Location:New York  Entered:2011-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH477AD2IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B074CA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: RD injection site 3 hrs after swelling & redness x 2 days. Day 3 also warm to touch. Initially Tx ice & BENADRYL. 11-18-11 seen in office - rec elevate, ice if not improved will take KEFLEX.

VAERS ID:443074 (history)  Vaccinated:2011-11-15
Age:33.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Male  Submitted:2011-11-18, Days after onset: 3
Location:Minnesota  Entered:2011-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Tetracyclins
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA675AA0IJLA
Administered by: Other     Purchased by: Private
Symptoms: Confusional state, Dizziness, Fatigue, Pyrexia, Sluggishness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Dizziness and confusion, followed at approximately 8pm by fever (un-measured). Sluggishness and tiredness continued through 11/18/2011.

VAERS ID:443084 (history)  Vaccinated:2011-11-15
Age:31.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Male  Submitted:2011-11-19, Days after onset: 4
Location:Hawaii  Entered:2011-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT499AA0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Chest discomfort, Dyspnoea, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Patient was given Fluzone vaccine (Lot UT499AA Exp 6/30/12) IM at approximately 11:35am at a worksite health fair. This was his first time receiving a flu vaccination. After approximately 10 minutes, patient reported having a heaviness in his chest and tightness in his throat. He also complained of feeling short of breath. No signs of rash, swelling of tongue or throat, and patient was alert. We had him sit for a few minutes and monitored his symptoms. At approximately 11:55am, the ambulance was called, and patient was taken to hospital. He was treated with prednisone and Allegra, then released. I was not able to reach the patient for further follow up.

VAERS ID:443097 (history)  Vaccinated:2011-11-15
Age:54.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-20, Days after onset: 5
Location:Michigan  Entered:2011-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: allergies to fish, mushrooms, tetanus vaccine, nutrasweet; has asthma, pituitary ademnoma, GERD, peripheral neuropathy r/t reconstruction of scalp
Diagnostic Lab Data: none done
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL)SANOFI PASTEUR 0IDLA
Administered by: Public     Purchased by: Other
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling, Muscle spasms, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Dystonia (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Pain at site, muscle cramps; proceeded to swelling size of 50 cent piece with tenderness at site, continued muscle cramps, pain/redness/itching at site; on 11/18/2011 slight elevation of temp to 99, continued pain/itchy/red/elevated hard at site, muscle cramps and pain, fatigue; seen in Employee Health at Hospital.

VAERS ID:443111 (history)  Vaccinated:2011-11-15
Age:5.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Female  Submitted:2011-11-21, Days after onset: 5
Location:Maryland  Entered:2011-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: questionable/unknown per mom~Vaccine not specified (no brand name)~UN~0.00~Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: Hx of seizures in past. Hx from mom not clear. Reports last episode 2009. After incident - mom reports as many as 9.
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B121BB1IMLA
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVC032AA1IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURD10861IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0446AA1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Body temperature increased, Convulsion, Crying, Pallor, Skin discolouration
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Pt received vaccination at facility 11/15/11 at 9:30AM. Mother reported one seizure in 2009. Clinician was contacted at previous visit and stated no connections to vaccination. Mother reports no adverse rxn after previous vaccination. School nurse calls 11/16/11 to report that student had febrile seizure at 11:15AM. Pt. temp was 98 degrees F - 102 degrees F within 30 min. Ambulance was called and pt. taken to hospital. Nurse states that pt. was found at lunch pale, dusky color. Returned at nurse office. Seizing & whimpering x30 min.

VAERS ID:443216 (history)  Vaccinated:2011-11-15
Age:68.0  Onset:2011-11-18, Days after vaccination: 3
Gender:Female  Submitted:2011-11-21, Days after onset: 3
Location:Virginia  Entered:2011-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None at the time
Preexisting Conditions: Allergic to Codeine, Simvastatin, and ACE-I inhibitors. Dx: DM, BCC/SCC, Hypertension, Osteoarthritis, Hyperlipidemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1254AA0SCLA
Administered by: Unknown     Purchased by: Other
Symptoms: Injection site erythema, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness and itching to immunization site.

VAERS ID:443225 (history)  Vaccinated:2011-11-15
Age:55.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Male  Submitted:2011-11-21, Days after onset: 5
Location:Washington  Entered:2011-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA636AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Influenza like illness, Myalgia, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Achy flu-like symtoms, entire body, especially muscle aches.

VAERS ID:443400 (history)  Vaccinated:2011-11-15
Age:18.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-16, Days after onset: 1
Location:New Mexico  Entered:2011-11-21, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1102701 IJRA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Red, swollen, painful from site of injection to elbow, fever. Reaction occurred within a few hours of vaccination. Recommended ice & Ibuprofen, ER if worsens, call in AM for follow-up. On follow-up - pt feeling better. Swelling decreasing - no ER needed.

VAERS ID:443402 (history)  Vaccinated:2011-11-15
Age:11.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Male  Submitted:2011-11-21, Days after onset: 5
Location:Delaware  Entered:2011-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None - healthy child
Diagnostic Lab Data: None; Meds given 11/18/2011 BENADRYL q 6 hours; Prednisolone 15mg/mL
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH454AD0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4025AA0IMUN
TDAP: TDAP (ADACEL)SANOFI PASTEURC3837BA0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Headache, Pyrexia, Rash, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Mom reported fever on 11/16/2011 of 102.2 and rash. Pt still with rash despite BENADRYL x 24 hours fever resolved. Pt seen 11/18/2011, Pt reports headache, fever & rash 1 day after vaccine. Rash itchy, generalized fever and HA resolved after 24 hours 11/21/011 Mom reports rash is completely resolved. No fever. No HA''s.

VAERS ID:443349 (history)  Vaccinated:2011-11-15
Age:1.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-22, Days after onset: 7
Location:Texas  Entered:2011-11-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE (WELL CHECK VISIT)
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type: TX20110094PU
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB477BA0 RL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0398AA0 RL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0139AA0 LL
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: WELP ON LEFT THIGH, REDNESS, SWELLING. PLACED COOL COMPRESS ON PATIENT AND GAVE BENADRYL / TYLENOL.

VAERS ID:443411 (history)  Vaccinated:2011-11-15
Age:43.0  Onset:2011-11-17, Days after vaccination: 2
Gender:Female  Submitted:2011-11-22, Days after onset: 5
Location:Ohio  Entered:2011-11-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergies
Preexisting Conditions: Seasonal allergies; Shellfish; Sulf.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH462AB15IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Injected limb mobility decreased, Injection site reaction, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Limited range of motion & muscle pain following influenza vaccination in left upper arm/shoulder.

VAERS ID:443425 (history)  Vaccinated:2011-11-15
Age:5.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Male  Submitted:2011-11-19, Days after onset: 4
Location:Ohio  Entered:2011-11-22, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU3492CA4UNRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG10684UNRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0103AA1SCLA
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF100674UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1705Z1SCRA
Administered by: Private     Purchased by: Other
Symptoms: Unevaluable event
SMQs:
Write-up: None stated.

VAERS ID:443497 (history)  Vaccinated:2011-11-15
Age:36.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-22, Days after onset: 7
Location:Colorado  Entered:2011-11-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH456AB IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Lymphadenopathy
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: - Local erythema, swelling, warmth, pain at injection site. - (R) axillary lymphadenopathy (large).

VAERS ID:443498 (history)  Vaccinated:2011-11-15
Age:50.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Oregon  Entered:2011-11-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH493AA IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1072AA IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness, Ear discomfort, Eyelid pain, Headache, Oropharyngeal pain, Swelling face, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 2 hrs after getting shots (flu & pneumo) she became dizzy, light headed, both ears starting burning deep inside, throat started hurting, headache, painful to open eyes, facial swelling, throat closing.

VAERS ID:443649 (history)  Vaccinated:2011-11-15
Age:0.8  Onset:2011-11-15, Days after vaccination: 0
Gender:Male  Submitted:2011-11-16, Days after onset: 1
Location:Rhode Island  Entered:2011-11-22, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CBC; diff; UA all normal
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4196AA0UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9166172UNLL
Administered by: Private     Purchased by: Public
Symptoms: Body temperature increased, Convulsion, Differential white blood cell count normal, Febrile convulsion, Full blood count normal, Urine analysis normal
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Pt has seizure to 104.6 F the evening of the vaccine and had febrile seizure at home.

VAERS ID:443653 (history)  Vaccinated:2011-11-15
Age:36.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-17, Days after onset: 2
Location:Unknown  Entered:2011-11-22, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Currently breastfeeding. Probably allergic to FLEXERIL -sp?-, broke out into itchy rash the two times I took it.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3989AA IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Muscle spasms, Muscle twitching, Pain in extremity
SMQs:, Dyskinesia (broad), Dystonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Had ADACEL injection approx 3pm on 11/15/11 - lot # C3989AA -. Arm progressively got more sore throughout evening -expected probably would be sore to some degree-. Approx 9pm same evening started having very noticeable muscle spasms/twitching below injection site -approx. 4" x 3" area- that was quite visible through my loose T-shirt. Strongest spasms lasted about 15-20 minutes, finally stopped after approx one hour. Wasn''t quite as sore after spasms quit. Didn''t feel great, but hard to say if injection to blame. Arm still sore - figured this degree of soreness might last couple days, anyway-. Never had anything like this before.

VAERS ID:443733 (history)  Vaccinated:2011-11-15
Age:12.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-16, Days after onset: 1
Location:Vermont  Entered:2011-11-22, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Physical
Preexisting Conditions: Asthma; Seasonal allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4197B8IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0692AA0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4008AA0IMLA
Administered by: Private     Purchased by: Public
Symptoms: Chest discomfort, Dyspnoea, Rash erythematous, Rash pruritic, Sensory loss
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Had below imms on 11/15/11. That eve - red, itchy rash bil hands. Then chest tight. Took to ER - given BENADRYL. They thought possibly viral. Slept well. Next AM SOB, chest tight, no feeling (R) hand. Rash continues. On BENADRYL and her albuterol (has asthma). Site of injection WNL, no erythema, no edema.

VAERS ID:443749 (history)  Vaccinated:2011-11-15
Age:15.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Male  Submitted:2011-11-15, Days after onset: 0
Location:Rhode Island  Entered:2011-11-22, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.YK2014 IN 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Condition aggravated, Erythema, Pruritus generalised, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Felt generalized itching. (Has hx of itching has rashy spots on forearms - itching previous) but the face became reddened and he reported increased itching.

VAERS ID:443878 (history)  Vaccinated:2011-11-15
Age:63.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:California  Entered:2011-11-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: General body pain
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.115020IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0620AA0SCRA
Administered by: Other     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Red, swollen around Pneumonia injection site. Pain above left elbow. Fever of 101-102 for 2 days. Tried Ibuprofen, no relief. Pt had complained of body ache before receiving immunization but still wants Pneumonia shot.

VAERS ID:443468 (history)  Vaccinated:2011-11-15
Age:3.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Male  Submitted:2011-11-23, Days after onset: 8
Location:Virginia  Entered:2011-11-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.501117P0IN 
Administered by: Private     Purchased by: Private
Symptoms: Rash, Swelling face, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient started with rash/hives to face appoximately 2 1/2 hours after receiving FluMist. Pt given Benadryl and instructed to take every 8 hrs as needed and see allergist. The rash increased to facial swelling and spread to arms and legs. Rash lasted for 48 hrs pt was then put on Orapred (an oral steroid).

VAERS ID:443626 (history)  Vaccinated:2011-11-15
Age:7.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Male  Submitted:2011-11-18, Days after onset: 2
Location:California  Entered:2011-11-23, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4124AA1IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Erythema, Injection site erythema, Injection site oedema, Oedema peripheral
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)
Write-up: Mom reports pt developed (R) LE edema, erythema from shoulder to forearm 1 day after INFLUENZA vaccine. Taken to ED was given IV abx. Improved after 3 d.

VAERS ID:443516 (history)  Vaccinated:2011-11-15
Age:68.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-25, Days after onset: 10
Location:New York  Entered:2011-11-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: sea food allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURAH498AB2IMRA
Administered by: Public     Purchased by: Other
Symptoms: Asthenia, Fatigue, Pruritus
SMQs:, Anaphylactic reaction (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Extreme itching, fatigue, weakness.

VAERS ID:443522 (history)  Vaccinated:2011-11-15
Age:48.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-25, Days after onset: 10
Location:North Dakota  Entered:2011-11-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH460AC0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Cough, Eye discharge, Pharyngeal oedema, Pruritus, Sneezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: At 3pm began sneezing, coughing, itchy, goopy eyes and throat swelling.

VAERS ID:443644 (history)  Vaccinated:2011-11-15
Age:4.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Female  Submitted:2011-11-25, Days after onset: 9
Location:Washington  Entered:2011-11-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC3957AA4UNLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG10833UNRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.047AA1UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1089Z1UNRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Had ER visit on 11/16/11 for large hive 14 x 15 cm on (L) anterior thigh post vaccine (MMR & tetanus) on 11/15/11. Treated w/NSAIDS, BENADRYL.

VAERS ID:443547 (history)  Vaccinated:2011-11-15
Age:36.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-26, Days after onset: 11
Location:Alabama  Entered:2011-11-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Hypothyroidism
Diagnostic Lab Data: I have no health insurance so I have not been to the doctor. I don''t know the outcome yet, because I still have symptoms.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  IJAR
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Fatigue, Headache, Injection site urticaria, Insomnia, Lethargy, Lymphadenopathy, Movement disorder, Muscle spasms, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)
Write-up: Extreme fatigue lasting 1 week+, falling asleep in public, etc. Loss of muscle control and extreme muscle spasms: in arm and face, primarily on side where flu shot was administered lasting 1 week+. Slight fever lasting 1 day. Cyst or swollen lymph node in armpit on side where shot was administered, approx. 1 inch in diameter- lasting 1 week+. Hives, primarily around area of flu shot, lasting 1 week+. Dizziness, lethargy lasting 1 week+. Headache- lasting 2 days. Intermittent morning insomnia lasting 1 week +. I have no health insurance so I have not been to the doctor. I don''t know the outcome yet, because I still have symptoms.

VAERS ID:443689 (history)  Vaccinated:2011-11-15
Age:6.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Male  Submitted:2011-11-28, Days after onset: 12
Location:Kentucky  Entered:2011-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Wart on left heel
Preexisting Conditions: No known allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B101AA IMRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB517CA IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUREO9502 IMLL
Administered by: Military     Purchased by: Military
Symptoms: Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling and pain in left leg following immunizations given the day before.

VAERS ID:443711 (history)  Vaccinated:2011-11-15
Age:74.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Male  Submitted:2011-11-28, Days after onset: 13
Location:California  Entered:2011-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEUR  IMRA
Administered by: Other     Purchased by: Other
Symptoms: Chills, Muscle spasms
SMQs:, Dystonia (broad)
Write-up: Severe Chills - Muscle cramps.

VAERS ID:443712 (history)  Vaccinated:2011-11-15
Age:18.0  Onset:2011-11-23, Days after vaccination: 8
Gender:Male  Submitted:2011-11-28, Days after onset: 5
Location:Washington  Entered:2011-11-28
Life Threatening? Yes
Died? Yes
   Date died: 2011-11-28
   Days after onset: 5
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None listed and all AHLTA meds not active. Was given doxycycline for malaria prophylaxis on SRP note--but would not have taken it until 2 days prior to deployment.
Current Illness: None recorded
Preexisting Conditions: allergy to primaquine and G6PD deficient
Diagnostic Lab Data: Leukocytosis, thrombocytosis, decreased fibrinogen and prolonged PT/PTT, elevated liver enzymes, Increased Cr, Increased CKs, transient elevated TNIs
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV2940UNUN
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV040003A0 UN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURB10260UNUN
Administered by: Military     Purchased by: Military
Symptoms: Activated partial thromboplastin time prolonged, Blood creatine phosphokinase increased, Blood creatinine increased, Blood fibrinogen decreased, Body temperature increased, Cardioversion, Disseminated intravascular coagulation, Encephalopathy, Hepatic enzyme increased, Intensive care, Leukocytosis, Loss of consciousness, Pain, Prothrombin time prolonged, Renal failure, Rhabdomyolysis, Thrombocytosis, Troponin I increased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (narrow), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)
Write-up: Per records, patient was in 5 mile run and passed out--HR$g180s and T~102.9 - adenosine and cardioversion with IVF-admitted to ICU-placed on broad spectrum Abx and Cx drawn. Progressive, rhabdomyolysis, DIC, renal failure, pain, and encephalopthy. Tx with cryo, ffp, fluids, pressors and ultimately transferred to another facility.

VAERS ID:443913 (history)  Vaccinated:2011-11-15
Age:21.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Male  Submitted:2011-11-21, Days after onset: 6
Location:Maryland  Entered:2011-11-28, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergic - LAMICTAL -$g lips swollen, ears red with blisters, hives on chest
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH477AD5IMRA
Administered by: Public     Purchased by: Private
Symptoms: Abdominal pain upper, Ear discomfort, Feeling abnormal, Sinus congestion, Swelling
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Approx 45 min. after receiving vaccine pt''s head got stuffy/swollen. Took BENADRYL & was seen at ER. "Ears felt like were about to pop & his throat felt funny" & "stomach really hurt".

VAERS ID:443897 (history)  Vaccinated:2011-11-15
Age:46.0  Onset:2011-11-18, Days after vaccination: 3
Gender:Male  Submitted:2011-11-29, Days after onset: 11
Location:Oklahoma  Entered:2011-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Had been sick 2 wks prior
Preexisting Conditions: Hx of asthma; Bronchitis - 2 wks prior; Hx: eczema, psoriasis
Diagnostic Lab Data: None; Given p.o. KEFLEX by ER doc 11/21
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH507AB0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: The employee developed a 10mm raised area on the left deltoid. Dime size area circumference with fluid-filled area. Tender, red & sore to touch.

VAERS ID:443979 (history)  Vaccinated:2011-11-15
Age:42.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-18, Days after onset: 3
Location:Missouri  Entered:2011-11-30, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None - yearly flu vaccine
Preexisting Conditions: allergic to latex; PCN; COMPAZINE
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH477AD IMLA
Administered by: Other     Purchased by: Private
Symptoms: Unevaluable event
SMQs:
Write-up: None stated.

VAERS ID:444015 (history)  Vaccinated:2011-11-15
Age:52.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Florida  Entered:2011-11-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None (Here for PE)
Preexisting Conditions: prednisone - rash slurred speech
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA652B0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52ZB073B IMRA
Administered by: Private     Purchased by: Private
Symptoms: Paraesthesia oral, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad)
Write-up: Pt states after receiving flu and TDAP injection that she felt tingling sensation in mouth and then as time progressed she felt her throat "tighten" but did not keep her from breathing did not seek any medical attention. First time getting flu vaccine 11-15-11 3:00 pm visit.

VAERS ID:444095 (history)  Vaccinated:2011-11-15
Age:62.0  Onset:2011-11-17, Days after vaccination: 2
Gender:Female  Submitted:2011-11-18, Days after onset: 1
Location:Louisiana  Entered:2011-11-30, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No acute illness
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1158AA UNLA
Administered by: Other     Purchased by: Private
Symptoms: Arthralgia, Musculoskeletal stiffness
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: 11/15/2011 - Injection given. 11/17/2011 - Pt called to report increase in arthritic pain & stiffness. No change in regular regimen.

VAERS ID:444108 (history)  Vaccinated:2011-11-15
Age:72.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-23, Days after onset: 8
Location:Pennsylvania  Entered:2011-11-30, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: A-fib; CAD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR 0UNUN
Administered by: Other     Purchased by: Unknown
Symptoms: Chills, Diarrhoea, Headache, Heart rate increased, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Also on 11/24 on top of or along lips chills, diarrhea, headache, vomiting, fast heart beat. Time course - from 9pm on 11/23/11 - 3 am 11/24/11.

VAERS ID:444246 (history)  Vaccinated:2011-11-15
Age:37.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Male  Submitted:2011-11-16, Days after onset: 1
Location:Massachusetts  Entered:2011-12-02, Days after submission: 16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: HTN; hypothyroidism
Diagnostic Lab Data: 11/23/11 450 spoke to pt''s wife who states pt has fully recovered.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH487AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Hyperhidrosis, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Pt called on 11-16-11 at 830 am stating he felt feverish, sweaty, and had body aches at 7pm on 11-15-11 pt states he took TYLENOL pm with no relief, pt was unable to take his temp (no thermometer) no reaction at site of injection. Pt advised to push fluids, take MOTRIN & call if symptoms persist.

VAERS ID:444591 (history)  Vaccinated:2011-11-15
Age:30.0  Onset:2011-11-26, Days after vaccination: 11
Gender:Male  Submitted:2011-12-05, Days after onset: 9
Location:Hawaii  Entered:2011-12-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Chest X-ray, Ultrasound of lower extremities, CBC, PT, PTT.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV2940IMRA
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0IDLA
Administered by: Military     Purchased by: Military
Symptoms: Activated partial thromboplastin time, Chest X-ray, Chills, Ecchymosis, Full blood count, Oedema, Pain in extremity, Prothrombin time, Pyrexia, Ultrasound scan, Vasculitis
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vasculitis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: PT experienced fever, chills, and pain at 8 of 10 in bilateral calves that lasted 1-2 hours then +3 pitting edema and ecchymosis of bilateral lower extrimities set in. PT was medevac''d to Hospital and spent 2 days in the hospital DX with vasculitis. Released 29 Nov 11 Fit for Full Duty Asymptomatic.

VAERS ID:444772 (history)  Vaccinated:2011-11-15
Age:3.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Male  Submitted:2011-11-17, Days after onset: 1
Location:Utah  Entered:2011-12-07, Days after submission: 20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Atopic dermatitis
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT447AA4IMLL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: One day after administration of the INFLUENZA vaccine in the left anterior thigh the patient experienced swelling of the leg, a red hive like rash that covered the leg. There was no itching or tenderness. BENADRYL was given by parents and this reduced the erythema. Leg was still swollen at office visit.

VAERS ID:444779 (history)  Vaccinated:2011-11-15
Age:67.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-29, Days after onset: 14
Location:Texas  Entered:2011-12-07, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain upper, Activities of daily living impaired, Asthenia, Dyskinesia, Fatigue, Hypotension, Oedema peripheral, Pain, Pain in extremity, Poor quality sleep, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 11/15/11 1:00 PM Became tired in few hours. Began ache all over and muscle jerks and arm pain around 6:00 PM. Fever began at 10 PM and lasted 12 hrs (always over 100 degrees). Blood pressure lowside from 54 to 92. Awake every other hr. In bed 2 1/2 days off work. Stomach cramps, swollen arm - exhausted. Weak for 5 days. Call Dr. 2nd day early. Returned call 4:00. BENADRYL.

VAERS ID:444800 (history)  Vaccinated:2011-11-15
Age:4.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Male  Submitted:2011-11-23, Days after onset: 8
Location:Missouri  Entered:2011-12-07, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4003AA4IMUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG10833IMUN
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, 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)
Write-up: Redness & tenderness to (L) deltoid - 8-10 cm - fever 103.

VAERS ID:444801 (history)  Vaccinated:2011-11-15
Age:56.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-29, Days after onset: 14
Location:Connecticut  Entered:2011-12-07, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None indicated
Preexisting Conditions: None indicated
Diagnostic Lab Data: None. No medical intervention sought.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH460AA IMLA
Administered by: Public     Purchased by: Private
Symptoms: Dry mouth, Dysphagia, Panic reaction, Pharyngeal oedema
SMQs:, Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Shot given at approximately 12:00 noon. At 2 pm noticed very dry mouth, harder to swallow, felt a little swollen, mild panic feeling. No swelling, dizziness or hives. Lasted 3 1/2 hours until 5:30 pm.

VAERS ID:444804 (history)  Vaccinated:2011-11-15
Age:0.8  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-11-30, Days after onset: 15
Location:Louisiana  Entered:2011-12-07, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: seizures; aqueduct stenosis
Preexisting Conditions: hydrocephalus; s/p vp shunt; development delay; FTT; hip subluxation
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4159BB0IMLL
Administered by: Private     Purchased by: Private
Symptoms: Chills, Irritability, Muscle twitching, Vomiting
SMQs:, Acute pancreatitis (broad), Dyskinesia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypoglycaemia (broad)
Write-up: 3 pm fussy. 5 pm MOTRIN. 7 pm large emesis. 8 pm shivering. Twitching of (L) arm. Small emesis. 11:30 pm fussy. MOTRIN. Next day - without problems.

VAERS ID:444949 (history)  Vaccinated:2011-11-15
Age:37.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Male  Submitted:2011-12-08, Days after onset: 22
Location:Minnesota  Entered:2011-12-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B068BA0IMLA
Administered by: Other     Purchased by: Public
Symptoms: Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Tdap vaccine resulted in extreme soreness and unusual swelling of left medial deltoid.

VAERS ID:445195 (history)  Vaccinated:2011-11-15
Age:54.0  Onset:2011-11-18, Days after vaccination: 3
Gender:Female  Submitted:2011-12-12, Days after onset: 24
Location:Florida  Entered:2011-12-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA686AA IMRA
Administered by: Other     Purchased by: Private
Symptoms: Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Right arm pit swollen.

VAERS ID:445515 (history)  Vaccinated:2011-11-15
Age:45.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Female  Submitted:2011-11-16, Days after onset: 0
Location:Georgia  Entered:2011-12-15, Days after submission: 29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH486AE1UNRA
Administered by: Other     Purchased by: Unknown
Symptoms: Asthenia, Joint stiffness, Malaise, Oropharyngeal pain, Pain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Patient''s husband came to pharmacy asking about getting the flu from taking the flu shot. He said patient woke up this morning with a sore throat, aching, feeling weak, and joints were stiff. He said she is pretty tough and it is unusual for anything to get her down like this, but she is really sick. I explained to him that the vaccine is a killed virus and unlikely to cause the flu. I suggested that she to to the doctor and get checked.

VAERS ID:446489 (history)  Vaccinated:2011-11-15
Age:60.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Male  Submitted:2011-12-29, Days after onset: 44
Location:New York  Entered:2011-12-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydochlorothiazide 25mg Spironolactone 50mg Atenolol 50mg Lisinopril 40mg Testosterone cypionate 75mg/wk Adderall 10mg
Current Illness: none
Preexisting Conditions: polycythemia secondary testicular hypofunction hypertension carpal tunnel peripheral neuropathy
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1420AA SYRLA
Administered by: Unknown     Purchased by: Private
Symptoms: Chills, Fatigue, Injection site pain, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)
Write-up: 11/15 significant arm pain, chills, nausea, fatigue. 11/16 to 11/27 arm pain and fatigue gradually decreased. 11/28 to 12/29 arm tender to touch at injection site, very slight ache in upper arm, fatigue would come and go sometimes severe. 12/29 injection site painful to touch, upper arm aches, severe fatigue.

VAERS ID:446494 (history)  Vaccinated:2011-11-15
Age:63.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Male  Submitted:2011-12-30, Days after onset: 45
Location:D.C.  Entered:2011-12-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none. I am the patient, not the physician. The flu shot was administered by the employee health program. I reported the arm disability at the student health office. They suggested I see my doctor. I can contact them for information regard
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: rotator cuff tendonosis and biceptical tenonitis
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT427AA SYRLA
Administered by: Other     Purchased by: Public
Symptoms: Activities of daily living impaired, Disability, Mobility decreased, Myalgia, Tendon disorder, Tendonitis
SMQs:, Rhabdomyolysis/myopathy (broad), Dementia (broad), Parkinson-like events (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (narrow)
Write-up: Severe muscle pain, loss of use of upper arm, inability to complete normal tasks, disability continues, sought medical care in December. Rotator cuff tendonosis and biceptical tendonitis. 4 week of therapy ahead.

VAERS ID:446552 (history)  Vaccinated:2011-11-15
Age:52.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-01-01, Days after onset: 47
Location:Virginia  Entered:2012-01-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: no
Preexisting Conditions: Latex, Pentazocine, Fosamax
Diagnostic Lab Data: 6 weeks out still unable to lift left arm over head-remains sore and painful with movement.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4178BA2IMLA
Administered by: Unknown     Purchased by: Other
Symptoms: Chest discomfort, Dysphonia, Dyspnoea, Fatigue, Injected limb mobility decreased, Injection site pain, Ocular hyperaemia, Pain, Pyrexia, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Glaucoma (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Bloodshot eyes, hoarse voice, scratchy throat, extreme fatigue, fever, achy, soreness at injection site, chest tightness, shortness of breath.

VAERS ID:447826 (history)  Vaccinated:2011-11-15
Age:26.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Female  Submitted:2012-01-03, Days after onset: 48
Location:Pennsylvania  Entered:2012-01-23, Days after submission: 20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hx of asthma & allergies
Preexisting Conditions: Asthma; Allergies; Tachycardia
Diagnostic Lab Data: WBC''s 27, 000
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1158AA UNLA
TD: TETANUS DIPHTHERIA (TENIVAC)SANOFI PASTEURC3989AA UNLA
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Chills, Erythema, Headache, Nausea, Oedema peripheral, Pain, Pain in extremity, Pyrexia, Rash, White blood cell count increased
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)
Write-up: Per patient on 11/10/11 she woke up with chills, fever, body aches. Headaches and nausea. Arm pain and swelling, redness, rash. Admitted to hospital for cellulitis on 11/18/11 and D/C on 11/21/11 IV antibiotics.

VAERS ID:449831 (history)  Vaccinated:2011-11-15
Age:15.0  Onset:2011-12-30, Days after vaccination: 45
Gender:Female  Submitted:2012-02-13, Days after onset: 45
Location:Texas  Entered:2012-02-20, Days after submission: 7
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0692AA0UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:
Write-up: None stated.

VAERS ID:450353 (history)  Vaccinated:2011-11-15
Age:5.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2011-12-02, Days after onset: 17
Location:Connecticut  Entered:2012-02-23, Days after submission: 83
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0014041
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.YL2001 IN 
Administered by: Other     Purchased by: Other
Symptoms: Eye swelling, Swelling face, Upper respiratory tract infection, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: A non-serious spontaneous report of facial swelling manifested with upper cheeks swelling, eye swelling, URI and wheezing has been received from a health professional concerning a five-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 15-Nov-2011. On 15-Nov-2011, three hours later receiving FLUMIST the patient experienced facial swelling in upper cheeks and eyes. Also had wheezing then went to emergency room and was diagnosed with upper respiratory infection. The patient was not hospitalized. The patient was prescribed diphenhydramine, prednisolone, azithromycin and ipratropium bromide & albuterol sulfate. At the time of reporting, the patient was ok with no symptoms. The outcome of events facial swelling manifested with upper cheeks swelling, eye swelling, URI and wheezing was resolved.

VAERS ID:450820 (history)  Vaccinated:2011-11-15
Age:61.0  Onset:2011-11-25, Days after vaccination: 10
Gender:Female  Submitted:2012-02-27, Days after onset: 94
Location:Arkansas  Entered:2012-02-29, Days after submission: 2
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 40 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Quadriplegic/high level functioning
Diagnostic Lab Data: Spinal tap - nerve conduction tests
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA683BA UNUN
Administered by: Private     Purchased by: Private
Symptoms: Asthenia, Eating disorder, Hypoaesthesia, Hypoaesthesia oral, Immunoglobulin therapy, Lumbar puncture, Nerve conduction studies, Paraesthesia, Plasmapheresis
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad)
Write-up: Extreme weakness - 10 days after shot tingling & numb tongue, mouth - Dec. 7 eating became difficult - numbness in body & hands - Dec. 18-24. Received plasmapheresis & IV/IG in Jan.

VAERS ID:451395 (history)  Vaccinated:2011-11-15
Age:2.0  Onset:2011-11-16, Days after vaccination: 1
Gender:Male  Submitted:2012-03-09, Days after onset: 114
Location:Oregon  Entered:2012-03-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4184BA0IMRL
Administered by: Other     Purchased by: Public
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Unsure as to when other than he got a rash. It was reported 2 1/2 months after it happened.

VAERS ID:451617 (history)  Vaccinated:2011-11-15
Age:34.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-03-13, Days after onset: 118
Location:Louisiana  Entered:2012-03-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CYMBALTA; ATIVAN; vimoro; propanolol; furosemide; ZANAFLEX
Current Illness: None
Preexisting Conditions: Arthritis; thyroid disease; depression; irregular heart beat; Back & neck injury; gastric bypass surgery
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITEDN561060IMRA
Administered by: Private     Purchased by: Private
Symptoms: Arthropod bite, Hypersensitivity, Rash, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: On 11/15/11 at 09:35 patient received flu vaccine, on 11/16/11 reported to employee wellness with rash to neck & what appeared to be flea or insect bites all over her legs. Sent to occupational health MD. He treated an allergic reaction to flu vaccine.

VAERS ID:453401 (history)  Vaccinated:2011-11-15
Age:0.8  Onset:2011-11-15, Days after vaccination: 0
Gender:Unknown  Submitted:2012-03-29, Days after onset: 134
Location:South Dakota  Entered:2012-04-10, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1111USA02268
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 2PO 
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Information has been received from a registered nurse concerning a 9 month old patient who on 26-APR-2011 and 27-JUN-2011 was vaccinated orally with the first dose and the second dose of 2ml ROTATEQ (Lot# not reported) respectively. On 15-NOV-2011, the patient received the third dose of 2ml ROTATEQ (Lot# not reported) orally, late. The nurse reported that the patient was 9 months old instead of 8 months old when the patient received the third dose of ROTATEQ. No adverse effects were reported. It was unknown if the patient sought medical attention. Additional information has been requested.

VAERS ID:458449 (history)  Vaccinated:2011-11-15
Age:1.3  Onset:2012-05-23, Days after vaccination: 190
Gender:Male  Submitted:2012-06-27, Days after onset: 35
Location:Wisconsin  Entered:2012-06-29, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject''s medical history was not reported. The subject''s vaccination history included 3 doses of PENTACEL; received on 08 October 2010, 08 December 2010 and 11 February 2011 (lot numbers not reported).
Diagnostic Lab Data:
CDC Split Type: 201206237
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEUR 3UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Apnoea, Cough, Nasopharyngitis, Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Respiratory failure (narrow)
Write-up: Initial report received on 18 June 2012 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 21-month-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of PENTACEL; received on 08 October 2010, 08 December 2010, 11 February 2011 and 15 November 2011 (lot number, routes and sites of administration not reported). The subject developed cold-like symptoms and cough on 23 May 2012, approximately six months after the dose. On 01 June 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 07 June 2012. Corrective treatments consisted of azithromycin starting on 07 June 2012 for 5 days. The subject was not hospitalized. At the final contact on 11 June 2012, the subject''s cough had resolved. The duration of the cough was reported at that time as 15 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.

VAERS ID:462289 (history)  Vaccinated:2011-11-15
Age:60.0  Onset:2012-06-28, Days after vaccination: 226
Gender:Male  Submitted:2012-08-06, Days after onset: 39
Location:Unknown  Entered:2012-08-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1208USA000105
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1124AA SCUN
Administered by: Other     Purchased by: Other
Symptoms: Blister, Rash vesicular, Scab, Skin lesion
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This spontaneous report as received from a Doctor of pharmacy refers to a 62 years old male patient with no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with lot # (671452/1124AA expiration date 12-OCT-2012), with a 0.65 ml dose of ZOSTAVAX on 15-NOV-2011. No other co-suspects were reported. Concomitant medications included bupropion hydrochloride, magnesium oxide, potassium (unspecified), naproxen, trazodone hydrochloride, multivitamins, simvastatin (manufacturer unknown), gabapentin, vitamin D (unspecified), docusate sodium, CETRIZIN and ropinirole. The pharmacist reported that on approximately 28-JUN-2012, "about 2 - 4 weeks ago", the patient developed varicella - like rash. The patient had about 20-30 lesions, raised rash on his back and legs, which would blister, then form scabs and fell off over the time. No treatment information was given. There were no Lab diagnosis or studies performed. The patient sought unspecified medical attention. The outcome of varicella - like rash was reported as not recovered/not resolved. Additional information has been requested.

VAERS ID:461887 (history)  Vaccinated:2011-11-15
Age:2.0  Onset:2012-07-05, Days after vaccination: 233
Gender:Female  Submitted:2012-08-10, Days after onset: 36
Location:Wisconsin  Entered:2012-08-14, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The subject had previously received three doses of PENTACEL; lot number C3338AA received on 11 January 2010, lot number C3404AA received on 09 March 2010 and lot number C3494AA received on 11 May 2010.
Diagnostic Lab Data:
CDC Split Type: 201207423
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU3497BA2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis, Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)
Write-up: Initial report received on 08 August 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received three doses of PENTACEL; lot number C3338AA received on 11 January 2010, lot number C3404AA received on 09 March 2010 and lot number C3494AA received on 11 May 2010; and one dose of TRIPEDIA; lot number U3497BA received on 15 November 2011 (routes and sites of administration not reported). The subject developed a cough on 05 July 2012, approximately seven months after the last dose of pertussis vaccine. On 07 July 2012, the subject developed cold-like symptoms and paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 08 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 08 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 26 July 2012, the subject''s cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.

VAERS ID:476816 (history)  Vaccinated:2011-11-15
Age:34.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2012-12-04, Days after onset: 385
Location:D.C.  Entered:2012-12-06, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient has an allergy to cats, and she had previously received many doses of FLUZONE in the past.
Diagnostic Lab Data: Not reported
CDC Split Type: 201211470
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT427AA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthma, Dyspnoea, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Initial report was received 29 November 2012 from a consumer, who is also the patient. A 35-year-old female patient with a history of a cat allergy, had received an intramuscular left deltoid injection of FLUZONE, lot number UT427AA (also reported as UT427AAI) and on the day of vaccination, she experienced an asthmatic reaction, trouble breathing and wheezing 6-8 hours after the vaccine. The patient took BENADRYL and was fine after that. An event outcome was not reported. The patient had not been taking any concomitant medications and she had previously received many doses of FLUZONE in the past. Documents held by sender: None.

VAERS ID:520788 (history)  Vaccinated:2011-11-15
Age:  Onset:2011-11-15, Days after vaccination: 0
Gender:Unknown  Submitted:2014-01-27, Days after onset: 804
Location:Unknown  Entered:2014-01-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA009178
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0869AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 15-NOV-2011, the patient was administered with a dose of VARIVAX (merck) (Lot # 0869AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.

VAERS ID:520790 (history)  Vaccinated:2011-11-15
Age:  Onset:2011-11-15, Days after vaccination: 0
Gender:Unknown  Submitted:2014-01-27, Days after onset: 804
Location:Unknown  Entered:2014-01-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA009177
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0869AA UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Information has been received from a registered nurse regarding a patient of unknown age and gender. On 15-NOV-2011, the patient was administered with a dose of VARIVAX (merck) (Lot # 0869AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.

VAERS ID:569318 (history)  Vaccinated:2011-11-15
Age:65.0  Onset:2011-11-15, Days after vaccination: 0
Gender:Female  Submitted:2014-02-24, Days after onset: 832
Location:Unknown  Entered:2015-02-12, Days after submission: 353
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2011US010118
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSX11022 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:, Medication errors (narrow)
Write-up: Case number PHEH2011US010118, is an initial spontaneous report received from a nurse on 21 Nov 2011 and a follow up received on 17 Dec 2013. This report refers to 65-year-old female patient. Her medical history and concomitant medications were not reported. She had no history of vaccination. She inadvertently received MENVEO (batch number X11022) at a dose of 0.5 ml intramuscularly into the left deltoid on 15 Nov 2011. No adverse event occurred following this administration. Follow-up was received from the nurse on 17 Dec 2013: Updated vaccination history, batch number, site and route of MENVEO.

VAERS ID:580213 (history)  Vaccinated:2011-11-15
Age:60.0  Onset:2012-06-26, Days after vaccination: 224
Gender:Male  Submitted:2012-07-26, Days after onset: 30
Location:South Dakota  Entered:2015-06-02, Days after submission: 1041
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Brimonidine; Bupropion; Magnesium oxide; Potassium chloride; Naproxen; Trazodone; Multivitamin; Simvastatin; Gabapentin; Loperamide; Cholecalciferol; Docusate; Cetirizine; Ropinirole; Flunisolide
Current Illness: Vaccination given at discharge from the hospital after treatment for pneumonia.
Preexisting Conditions: Anxiety disorder NOS; Cognitive disorder NOS; Depression NOS; Diabetes; Alcohol dependence in remission; Posttraumatic Stress Disorder; Unspecified hypertrophic and atrophic conditions of skin; Insomnia; Osteoarthritis NOS; Impotence; Allergic rhinitis; Hypotension; Quadriplegia, C1-C4, Incomplete; Hyperlipidemia; Neck pain; Neurogenic Bladder NOS; Primary Open Angle Glaucoma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH438AA1UNRA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1124AA1UNLA
Administered by: Other     Purchased by: Other
Symptoms: Blister, Rash, Rash erythematous, Scab
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Calls with complaint of a red slightly raised rash on his back and legs. This rash started after he had the shingles shot a month ago. The rash on his legs has formed small blister like areas, then scabs that are now falling off. They are not painful or itchy. he has not run a fever.

VAERS ID:650961 (history)  Vaccinated:2011-11-15
Age:  Onset:2011-11-15, Days after vaccination: 0
Gender:Unknown  Submitted:2016-08-29, Days after onset: 1748
Location:Oregon  Entered:2016-08-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1608USA013473
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0138AA1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Incorrect product storage, No adverse event
SMQs:, Medication errors (narrow)
Write-up: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX, dose route and frequency unknown. On 15-NOV-2011 the patient was vaccinated with second dose of VARIVAX lot # 669601/0138AA which was improperly stored. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.

VAERS ID:442747 (history)  Vaccinated:2011-11-16
Age:65.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Male  Submitted:2011-11-16, Days after onset: 0
Location:Louisiana  Entered:2011-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SAVELLA; CELEBREX
Current Illness:
Preexisting Conditions: Hx Fibromyalgia; HTN; OA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0760AA0SCLA
Administered by: Other     Purchased by: Other
Symptoms: Feeling abnormal
SMQs:, Dementia (broad)
Write-up: 3-5mins after vaccine (ZOSTAVAX) administered she complained of "funny feeling" to (R) ant neck radiating to (R) of her nose. BENADRYL & EPI administered to some relief. Pt went to ER via EMS walked to stretcher.

VAERS ID:442801 (history)  Vaccinated:2011-11-16
Age:10.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Male  Submitted:2011-11-16, Days after onset: 0
Location:Ohio  Entered:2011-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Allergy to Omnicef
Diagnostic Lab Data: None Was administered Prednisone and Pepcid and cleared within 2 hours.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 1 LA
Administered by: Private     Purchased by: Other
Symptoms: Auricular swelling, Chest pain, Erythema, Eye swelling, Lacrimation increased, Rash generalised, Rash pruritic, Rhinorrhoea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Lacrimal disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: First chest pain followed by vomiting. Then 15 minutes later on the ride home, bright red skin, swollen eyes, swollen ears, itchy rash from head to toe, watery nose and eyes.

VAERS ID:442806 (history)  Vaccinated:2011-11-16
Age:2.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Male  Submitted:2011-11-16, Days after onset: 0
Location:North Carolina  Entered:2011-11-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Runny nose
Preexisting Conditions: N/A
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1047AA0 RL
HEPA: HEP A (VAQTA)MERCK & CO. INC.1005AA0IMRL
Administered by: Unknown     Purchased by: Private
Symptoms: Fall, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Child passed out in chair, hit the floor and continued to lose conciousness for 15 seconds.

VAERS ID:442883 (history)  Vaccinated:2011-11-16
Age:43.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-17, Days after onset: 1
Location:Florida  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: ?UTI
Preexisting Conditions: TORECAN; DARVOCET; Ketorolac
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS11093P2IMRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Rash generalised
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 4 hours post inj had sm red area on RD. later in the day became a rash all over the body. SOLU-MEDROL 40 mg inj. given. BENADRYL, Prednisone, Promethazine for N/V.

VAERS ID:442900 (history)  Vaccinated:2011-11-16
Age:2.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Male  Submitted:2011-11-17, Days after onset: 1
Location:Washington  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0IJRL
Administered by: Private     Purchased by: Public
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: At approx 8:05 pm, He began vomiting, no other symptoms of illness had been present. Vomiting continued every 30-90 minutes through the night until approx. 7:30 AM, 11/17/2011.

VAERS ID:442907 (history)  Vaccinated:2011-11-16
Age:12.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Male  Submitted:2011-11-17, Days after onset: 1
Location:New York  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: Allergy to eggs and peanuts
Diagnostic Lab Data: Pulse Oximetry 99% Temperature 98.4 BP 95/60 pain 6/10
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4119AA1IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Chest pain, Headache, Injection site erythema, Injection site haematoma, Injection site swelling, Lethargy, Myalgia, Nausea, Throat irritation
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: Chest pain, lethargy, myalgias, headache, nausea, erythema around injection site, scratchy throat, swelling and bruising at injection site. R arm 3/4", L arm 3/4".

VAERS ID:442917 (history)  Vaccinated:2011-11-16
Age:3.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Male  Submitted:2011-11-17, Days after onset: 1
Location:North Carolina  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.YK20871IN 
Administered by: Unknown     Purchased by: Private
Symptoms: Crying, Epistaxis, Immediate post-injection reaction
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow)
Write-up: Patient given Flumist. Immediately after administering in each nostril, child started crying and nose began to bleed. Pressure applied to nose by mom, bleeding lasted approx 2 min.

VAERS ID:442920 (history)  Vaccinated:2011-11-16
Age:0.8  Onset:2011-11-16, Days after vaccination: 0
Gender:Male  Submitted:2011-11-17, Days after onset: 1
Location:Missouri  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Blood, urine and CSF cultures negative. Normal BMP.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME)SANOFI PASTEURC3930AA2UNLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4196AA0UNLA
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0893AA2UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9163042UNRL
Administered by: Public     Purchased by: Other
Symptoms: Blood culture negative, CSF culture negative, Convulsion, Culture urine negative, Metabolic function test normal, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Fever with seizure. Seizure lasting at least 20 minutes requiring IV medications to stop.

VAERS ID:442939 (history)  Vaccinated:2011-11-16
Age:1.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-17, Days after onset: 1
Location:Texas  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.1005AA0UNRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0664AA0UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9153473UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0710AA0UNRL
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Injection site erythema, Injection site rash, Papule
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Yesterday (11/16/11) began with rash to (L) thigh. Today has pink/red macular rash to (L) thigh, lower abdomen, (B) axilla with scattered pink/red papules to abdomen, upper thighs & arms.

VAERS ID:442946 (history)  Vaccinated:2011-11-16
Age:50.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-17, Days after onset: 1
Location:Louisiana  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS11161P IMAR
Administered by: Other     Purchased by: Private
Symptoms: Blood pressure increased, Eye swelling, Lip swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Hypertension (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Hives, increased blood pressure, swollen eyes & lips. Pt went to emergency room.

VAERS ID:442950 (history)  Vaccinated:2011-11-16
Age:83.0  Onset:2011-11-17, Days after vaccination: 1
Gender:Male  Submitted:2011-11-17, Days after onset: 0
Location:Ohio  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: See attached.
Current Illness: None.
Preexisting Conditions: Allergy = Sulfa; See attached for remaining
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT499AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pain at injection site radiates up to neck behind (L) ear & down to fingers. Edema (L) arm & wrist sl. edema in (L) hand. Started 11-16-11. No fever no numbness. Some pain behind ear approximately 10 mins. after injection woke up at 2:00AM with other symptoms.

VAERS ID:443460 (history)  Vaccinated:2011-11-16
Age:0.2  Onset:2011-11-16, Days after vaccination: 0
Gender:Male  Submitted:2011-11-17, Days after onset: 1
Location:Florida  Entered:2011-11-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: KUB x-ray
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3723AA0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF100650IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1557Z0PO 
Administered by: Private     Purchased by: Public
Symptoms: Crying, Urinary system X-ray
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: Incessant crying about 2 hrs after vaccines. Rechecked in our office at 2:00 p.m., examined KUB ordered.

VAERS ID:442932 (history)  Vaccinated:2011-11-16
Age:22.0  Onset:2011-11-17, Days after vaccination: 1
Gender:Female  Submitted:2011-11-18, Days after onset: 1
Location:Georgia  Entered:2011-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: POST PARTUM
Preexisting Conditions: NKA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B075AA0IMUN
Administered by: Public     Purchased by: Private
Symptoms: Chills, Muscular weakness, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Fever, chills, limb weakness.

VAERS ID:442986 (history)  Vaccinated:2011-11-16
Age:39.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-18, Days after onset: 2
Location:Virginia  Entered:2011-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None but she did see a NP who put her on Benadryl 50mg po.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH469AA0IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Hypoaesthesia oral, Lip swelling, Oedema mouth, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Her lips started swelling and inside of her mouth also began swelling. Lips felt numb and she experienced some wheezing.

VAERS ID:442989 (history)  Vaccinated:2011-11-16
Age:54.0  Onset:2011-11-17, Days after vaccination: 1
Gender:Female  Submitted:2011-11-18, Days after onset: 1
Location:Wisconsin  Entered:2011-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: NO
Diagnostic Lab Data: n/a
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0IJLA
Administered by: Public     Purchased by: Other
Symptoms: Induration, Injection site swelling, Injection site warmth, Local swelling, Oedema peripheral, Tenderness
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: INJECTION SITE SWOLLEN, HOT, looked like a bull''s eye, neck/shoulder/clavicle swollen, tender with hardened lymph node.

VAERS ID:443010 (history)  Vaccinated:2011-11-16
Age:1.3  Onset:2011-11-17, Days after vaccination: 1
Gender:Male  Submitted:2011-11-18, Days after onset: 1
Location:Pennsylvania  Entered:2011-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Prematurity, Reflux, Chronic Lung Disease
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0 LA
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER 5 RL
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0 RA
Administered by: Unknown     Purchased by: Other
Symptoms: Blood test normal, Convulsion, Lethargy, Muscle twitching, Screaming, Staring
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Screaming (was sleeping), lethargy, staring, twitching/seizing (leg, arm, head); lasted about 15-20 minutes; transferred to ER; bld work normal; suggested EEG for follow-up.

VAERS ID:443017 (history)  Vaccinated:2011-11-16
Age:4.0  Onset:2011-11-18, Days after vaccination: 2
Gender:Male  Submitted:2011-11-18, Days after onset: 0
Location:Texas  Entered:2011-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B140CA4IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG10833SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0405AA1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0450AA1SCLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Red, swollen injection site; Fever 99.3.

VAERS ID:443037 (history)  Vaccinated:2011-11-16
Age:11.0  Onset:2011-11-17, Days after vaccination: 1
Gender:Female  Submitted:2011-11-18, Days after onset: 1
Location:New York  Entered:2011-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3674AA0UNRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3540AA0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Cellulitis, Hypersensitivity, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt went to ER for evaluation of painful swollen arms where immunizations were given. No fever no chills. Diagnosis in ER - acute allergic reaction vs. cellulitis.

VAERS ID:443048 (history)  Vaccinated:2011-11-16
Age:10.0  Onset:2011-11-17, Days after vaccination: 1
Gender:Female  Submitted:2011-11-18, Days after onset: 1
Location:Washington  Entered:2011-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Runny nose; cough
Preexisting Conditions: Type I Diabetic
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH478AB0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU4006AA0IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1158AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: - upper (R) arm red/swollen at injection site and warm to touch. - tender to touch. - fever noted 11/17/2011

VAERS ID:443050 (history)  Vaccinated:2011-11-16
Age:33.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-18, Days after onset: 2
Location:Florida  Entered:2011-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None yet
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH476AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Axillary pain, Injection site erythema, Injection site induration, Injection site warmth, Lymphadenopathy
SMQs:, Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Redness, warmth, induration about 10 cm diameter about injection site & lymphadenopathy in axilla & pain.

VAERS ID:443059 (history)  Vaccinated:2011-11-16
Age:21.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-18, Days after onset: 2
Location:New Jersey  Entered:2011-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Diagnostic Lab Data: Urine analysis, CBC,
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0692AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Abdominal pain, Dizziness, Full blood count, Headache, Urine analysis, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Headache, Vomiting, Abdominal Pain, Dizziness. Was seen at ER and given IV fluids and antinausea medication.

VAERS ID:443062 (history)  Vaccinated:2011-11-16
Age:65.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-18, Days after onset: 2
Location:New York  Entered:2011-11-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: All the info on the flu shot is: Fluzone, high-dose 2011-12(PF) NCD: 49281-0389-65, Qt - 0.5
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEUR49281038965  LA
Administered by: Other     Purchased by: Public
Symptoms: Chills, Eye irritation, Influenza like illness, Lacrimation increased, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Corneal disorders (broad), Lacrimal disorders (narrow)
Write-up: Eyes burned and watered, got sick to stomach - was throwing up for about 2 hours, chills, felt flu like symptoms.

VAERS ID:443054 (history)  Vaccinated:2011-11-16
Age:71.0  Onset:2011-11-17, Days after vaccination: 1
Gender:Female  Submitted:2011-11-19, Days after onset: 2
Location:Kansas  Entered:2011-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: LAMISIL allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH477AD0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Injection site induration, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient''s left arm was red that wrapped around the arm and was warm to the touch. Injection site was hard. Received vaccine on 11/16/11 and reported the event on 11/18/11. Redness had reduced by then.

VAERS ID:443087 (history)  Vaccinated:2011-11-16
Age:66.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-19, Days after onset: 3
Location:California  Entered:2011-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH463AB0IMLA
Administered by: Other     Purchased by: Public
Symptoms: Dizziness, Fatigue, Vertigo
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (narrow)
Write-up: Started with dizziness around 5 PM. The next morning when I awoke at 7 AM I experienced extreme vertigo. Dizziness & fatigue continued throughout the day into the night, for a total of 40 hours. After that I was fine.

VAERS ID:443095 (history)  Vaccinated:2011-11-16
Age:24.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-19, Days after onset: 3
Location:Kentucky  Entered:2011-11-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 1  
Administered by: Unknown     Purchased by: Other
Symptoms: Headache, Lymphadenopathy, Musculoskeletal pain, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Headache, body ache, sore arm and shoulder. 11/19/2011 - noticed swollen lymph node at collar bone and continued pain and headache.

VAERS ID:443114 (history)  Vaccinated:2011-11-16
Age:0.6  Onset:2011-11-17, Days after vaccination: 1
Gender:Unknown  Submitted:0000-00-00
Location:Georgia  Entered:2011-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: 1) lumbar puncture; 2) CBC; 3) blood/CSF culture
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3615AA IMRL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4119BA IMLL
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB842AA IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH916617 IMLL
Administered by: Private     Purchased by: Public
Symptoms: Blood culture, CSF culture, Dyskinesia, Full blood count, Lumbar puncture, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Parents observed jerky movements and child was taken to the ER. This was the day after vaccination. Also had a fever, low grade.

VAERS ID:443147 (history)  Vaccinated:2011-11-16
Age:29.0  Onset:0000-00-00
Gender:Female  Submitted:2011-11-21
Location:Ohio  Entered:2011-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0SCLA
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 0SCRA
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Injection site warmth, Puncture site induration, Puncture site pain, Rash maculo-papular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Presented to employee health services on 11/18/11 with raised erythematous maculopapular area 25 x 40 mm on right arm. Indurated, painful & warm w/central puncture mark. BENADRYL 25 mg tabs given w/directions to take tid-qid prn.

VAERS ID:443226 (history)  Vaccinated:2011-11-16
Age:65.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-21, Days after onset: 5
Location:Kentucky  Entered:2011-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Allergies: demerol, codeine, and pyridium. No birth defects known. Medical conditions: panic disorder, anxiety, and GERD.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1101601 IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1256AA0SCRA
Administered by: Other     Purchased by: Private
Symptoms: Blister, Erythema, Oedema peripheral, Pruritus
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient''s arm was red, swollen, itching with blisters and progressively got worse the next day. Patient still having problems with itching.

VAERS ID:443273 (history)  Vaccinated:2011-11-16
Age:0.8  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-21, Days after onset: 5
Location:Illinois  Entered:2011-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Congenital Heart disease (VSD); Sacral dimple; Coarctation of the aorta
Diagnostic Lab Data: Elevated glucose, B/P, low CO2, tachycardia, prolonged cap refill. CT Head WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4196AA0IMLL
Administered by: Public     Purchased by: Public
Symptoms: Blood glucose increased, Blood pressure increased, Body temperature increased, Capillary nail refill test abnormal, Carbon dioxide decreased, Computerised tomogram head, Computerised tomogram normal, Febrile convulsion, Tachycardia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt presented to ER 11/17/11 0009 by EMS with T 102.9 (R) with new onset febrile seizure Mtr. had given TYLENOL per hx Mtr in after hr T 100 - due to abnormal labs, elevated B/P, seizure hx, transported to another hospital 0200.

VAERS ID:443284 (history)  Vaccinated:2011-11-16
Age:50.0  Onset:2011-11-18, Days after vaccination: 2
Gender:Male  Submitted:2011-11-21, Days after onset: 3
Location:New York  Entered:2011-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Denies
Current Illness: Denies. Treatment (L) wrist laceration
Preexisting Conditions: Denies hx meds allergies or prior vaccine reaction
Diagnostic Lab Data: ER visit 11/20/11
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4103CA0UNLA
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis, Injection site erythema, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: ADACEL tdap (L) deltoid 11/16/11 - increased pain redness to site starting 11/18/11. ER eval 11/20/11 -$g Dx cellulitis 5 1/2 cm x 9 cm (at widest width) to (L) UE. 11/20/11 started oral antibiotics (thinks it is cephalexin 500 mg po 4 x daily) - Pt to verify abx given by ER.

VAERS ID:443330 (history)  Vaccinated:2011-11-16
Age:25.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-21, Days after onset: 5
Location:California  Entered:2011-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA664AA1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Chills, Oedema, Pruritus, Pyrexia, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt c/o rash covering arms & legs with itching day of vaccine, followed by fevers/chills & +1 pitting edema.

VAERS ID:443376 (history)  Vaccinated:2011-11-16
Age:1.3  Onset:2011-11-17, Days after vaccination: 1
Gender:Male  Submitted:2011-11-22, Days after onset: 5
Location:California  Entered:2011-11-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC218280AB1 RL
Administered by: Public     Purchased by: Public
Symptoms: Injection site discolouration, Injection site induration, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Local reaction at site of injection (right thigh). 2cm brownish pigment on skin with underlying 3 cm area of induration.

VAERS ID:443422 (history)  Vaccinated:2011-11-16
Age:31.0  Onset:2011-11-17, Days after vaccination: 1
Gender:Female  Submitted:2011-11-22, Days after onset: 5
Location:Oklahoma  Entered:2011-11-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC3921AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Burning sensation, Erythema, Mass, Oedema peripheral, Pruritus, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Left arm, red, swollen, knot, fever in arm, burning, itching, started 11-17-11.

VAERS ID:443458 (history)  Vaccinated:2011-11-16
Age:54.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-21, Days after onset: 5
Location:California  Entered:2011-11-22, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT443AA0IMAR
Administered by: Other     Purchased by: Private
Symptoms: Heat rash
SMQs:
Write-up: Pt. states she had heat rash on her arm 2 hours after receiving flu vaccine. She took OTC BENADRYL & rash went away. She feels fine. No other problems were reported.

VAERS ID:443830 (history)  Vaccinated:2011-11-16
Age:11.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Male  Submitted:2011-11-16, Days after onset: 0
Location:Pennsylvania  Entered:2011-11-22, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.YK2015 IN 
HEPA: HEP A (VAQTA)MERCK & CO. INC.1068AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1333Y0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM100570IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURU3979BA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0450AA1SCLA
Administered by: Public     Purchased by: Public
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: After receiving all vaccines client experienced a syncope episode. No more than 2 min. after vaccine 3rd min. Fainted for about 3 sec.

VAERS ID:443591 (history)  Vaccinated:2011-11-16
Age:63.0  Onset:2011-11-17, Days after vaccination: 1
Gender:Female  Submitted:2011-11-22, Days after onset: 5
Location:Idaho  Entered:2011-11-25, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Hospital ER - not available to us.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1102701 UNLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.15072 SCRA
Administered by: Other     Purchased by: Other
Symptoms: Blister, Lymph node pain, Rash
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Received vaccine Wednesday 11/16. Next day rash appeared and blisters formed on Sat. Blisters were white and some had broken. She also had a sore arm and shoulder and pain in lymph nodes. Went to hospital ER on Sat. AM - no fever.

VAERS ID:443546 (history)  Vaccinated:2011-11-16
Age:61.0  Onset:2011-11-20, Days after vaccination: 4
Gender:Male  Submitted:2011-11-26, Days after onset: 6
Location:Massachusetts  Entered:2011-11-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0IDLA
Administered by: Private     Purchased by: Private
Symptoms: Insomnia, Myalgia, Nasopharyngitis, Pain in extremity, Respiratory tract infection
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Muscles in legs ached, developed a respiratory infection over the next day, and unable to sleep for two nights because of pain in my legs. Felt like a bad cold. My son who is thirty three came to visit me on 11/21/2011 the next day and slept in my bed and on 11/24/2011 develop a rash on his face, back and chest. On 11/26/2011 he went to emergency room and they diagnosed his rash as consistent with herpes zoster infection and it looks exactly like the chicken pox.

VAERS ID:443734 (history)  Vaccinated:2011-11-16
Age:26.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-18, Days after onset: 2
Location:Maryland  Entered:2011-11-28, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH478AB0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Dyspnoea, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad)
Write-up: Pt experienced throat tightness and difficulty breathing within 1 hour after receiving flu vaccine. She took BENADRYL and symptoms resolved.

VAERS ID:443735 (history)  Vaccinated:2011-11-16
Age:22.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-18, Days after onset: 2
Location:Unknown  Entered:2011-11-28, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Healthy
Preexisting Conditions:
Diagnostic Lab Data: Normal B/P; B/G
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH486AE UNRA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Feeling abnormal, Feeling hot, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (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)
Write-up: Pt came very close to passing out was in and out of conscious thought/communication. Felt like she was "not here" & was very hot. EMS checked her vitals, BG = Fine.

VAERS ID:444177 (history)  Vaccinated:2011-11-16
Age:1.2  Onset:2011-11-17, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Pennsylvania  Entered:2011-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Possible viral illness
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR  UNUN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Febrile convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt had MMR, VARIVAX and flu vaccine on 11/16/11. Pt developed fever night (11/16/11) and had febrile sz on 11/17/11.

VAERS ID:443801 (history)  Vaccinated:2011-11-16
Age:27.0  Onset:2011-11-26, Days after vaccination: 10
Gender:Male  Submitted:2011-11-29, Days after onset: 3
Location:Virginia  Entered:2011-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV04003A0 LA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH109AA1SCLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema of eyelid, Eyelid oedema, Papule, Secretion discharge
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Member was properly educated and received smallpox vaccine on 11/16/2011. Vaccine was checked with a major reaction on 11/23/2011. He came to medical on 11/28/2011 with c/o of a small papule under left eye which was covered with a bandage. Clear drainage, redness, and mild swelling under left aspect of eye. No treatment necessary. Educated patient on smallpox aftercare given.

VAERS ID:443843 (history)  Vaccinated:2011-11-16
Age:1.1  Onset:2011-11-27, Days after vaccination: 11
Gender:Female  Submitted:2011-11-29, Days after onset: 2
Location:South Carolina  Entered:2011-11-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4176AA0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF136363IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0573AA0IMRL
Administered by: Private     Purchased by: Public
Symptoms: Dermatitis
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Dermatitis all over body.

VAERS ID:443959 (history)  Vaccinated:2011-11-16
Age:5.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-22, Days after onset: 6
Location:Massachusetts  Entered:2011-11-30, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.   UN
Administered by: Private     Purchased by: Unknown
Symptoms: Rash erythematous, Rash macular, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Itchy red rash in blotches on lower back and legs. Lasted off & on for 3 days. BENADRYL given.

VAERS ID:443983 (history)  Vaccinated:2011-11-16
Age:1.1  Onset:2011-11-16, Days after vaccination: 0
Gender:Male  Submitted:2011-11-22, Days after onset: 6
Location:Mississippi  Entered:2011-11-30, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4197CA0UNRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB533BA0UNRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0446AA0UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0768AA0UNLL
Administered by: Private     Purchased by: Public
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Child has fever 102 or more for about a week with each set of shots per mom.

VAERS ID:443998 (history)  Vaccinated:2011-11-16
Age:15.0  Onset:2011-11-17, Days after vaccination: 1
Gender:Female  Submitted:2011-11-30, Days after onset: 13
Location:Texas  Entered:2011-11-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH506AB IMLA
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB972EA3IMRA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: PATIENT STATES LEFT ARM WAS RED, SWOLLEN, HOT TO TOUCH, AND PAINFUL AT AND AROUND SITE OF INJECTION. AREA MEASURED APPROXIMATELY 50MM.

VAERS ID:444030 (history)  Vaccinated:2011-11-16
Age:26.0  Onset:0000-00-00
Gender:Female  Submitted:2011-11-30
Location:Illinois  Entered:2011-11-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: clonazepam; DEPO-PROVERA; LEXAPRO; TOPAMAX; LAVISONE
Current Illness: c/o sore throat & ankle pain
Preexisting Conditions: anxiety; bipolar; depression; NKDA
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH486AF IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0595AA0IMRA
Administered by: Other     Purchased by: Private
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)
Write-up: Complained that arm "hurt" after a couple hours after injection given (specified it was the PNEUMOVAX vaccine which was given in the right arm). Pt applied warm compresses was not seen in clinic for follow up, just called to complain.

VAERS ID:444105 (history)  Vaccinated:2011-11-16
Age:  Onset:0000-00-00
Gender:Female  Submitted:0000-00-00
Location:Ohio  Entered:2011-11-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illness reported
Preexisting Conditions: None specified
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0615AA0SCLA
Administered by: Unknown     Purchased by: Private
Symptoms: Epistaxis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: Pt received ZOSTAVAX on 11/16/11, called on 11/22/11 to report a nosebleed. Pt said she did not change her routine other than receiving this vaccine. She is not sure whether this is related to the vaccine or not. She has not contacted her PCP regarding this.

VAERS ID:444119 (history)  Vaccinated:2011-11-16
Age:77.0  Onset:2011-11-17, Days after vaccination: 1
Gender:Female  Submitted:2011-11-18, Days after onset: 1
Location:Illinois  Entered:2011-11-30, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH469AB0IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0614AA0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Local swelling
SMQs:, 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)
Write-up: Erythema and swelling in localized area of right arm day after administration. Secondary to PNEUMOVAX injection.

VAERS ID:444298 (history)  Vaccinated:2011-11-16
Age:38.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-18, Days after onset: 2
Location:Michigan  Entered:2011-12-01, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None per patient
Preexisting Conditions: None per patient
Diagnostic Lab Data: None known
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH453AC0IMRA
Administered by: Public     Purchased by: Private
Symptoms: Chills, Hyperhidrosis, Injection site vesicles, Joint swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Shot given at same time PPD skin test placed. Around 6 hours following vaccination, client felt "feverish". She also experienced chills and sweating. The client expressed a strong sensitivity to band-aids. On (R) deltoid she got a blister where the band-aid was. The client woke up today 11/18 and noticed a bump on (R) wrist and at joint of right of right pointer finger/hand.

VAERS ID:444274 (history)  Vaccinated:2011-11-16
Age:67.0  Onset:2011-11-17, Days after vaccination: 1
Gender:Female  Submitted:2011-11-25, Days after onset: 8
Location:Arizona  Entered:2011-12-02, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Stage 3 chronic kidney disease; HTN
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEUR  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Chills, Fatigue, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 11/17 - Severe chills & couldn''t get warm 230 am. 11/17 - Headache, backache (lumbar) fatigue, continued chills, fever 100.8 degrees developed as day progressed.

VAERS ID:444318 (history)  Vaccinated:2011-11-16
Age:52.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Male  Submitted:2011-12-02, Days after onset: 16
Location:Mississippi  Entered:2011-12-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: Received stitches as a part of an emergency room visit.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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TTOX: TETANUS TOXOID (NO BRAND NAME)UNKNOWN MANUFACTURER  IJLA
Administered by: Public     Purchased by: Other
Symptoms: Arthralgia, Drug administered at inappropriate site, Injected limb mobility decreased, Injection site mass, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Medication errors (narrow)
Write-up: Pain at injection site (left arm above the deltoid in the shoulder joint area), dimished function of left arm. Nurse gave vaccine while standing with patient in the sitting position. Felt as though needle hit cartilage or bone in the shoulder region. I''ve had pain in the shoulder joint for over two-weeks now, but seems to be subsiding. It is not waking me during the night as much and I do not have the sharp pains from lateral movement and weight bearing activities. Still tender with a small marble/kernel area at the injection site. No treatments seeked yet, but pain does still persist.

VAERS ID:444486 (history)  Vaccinated:2011-11-16
Age:56.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-12-05, Days after onset: 19
Location:Minnesota  Entered:2011-12-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ASA 81 mg; calcium with D 600-200; COZAAR 100 mg; fluoxetine 20 mg; glucagon prn; HUMALOG 100 unit/ml; LIPITOR 20 mg; SINGULAIR 10 mg; AUGMENTIN; lisinopril
Current Illness: None
Preexisting Conditions: Hypercholesterolemia; hypertension; Type I DM
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1241AA1IMRA
Administered by: Private     Purchased by: Private
Symptoms: Hypersensitivity, Injection site pain, Injection site swelling, Local reaction
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: After receiving vaccine booster, patient ended up going to ED for a local reaction. Swelling and pain at site of injection. Dx''d as mild allergic reaction, discharged to home with allergy treatment plan.

VAERS ID:445014 (history)  Vaccinated:2011-11-16
Age:17.0  Onset:2011-11-18, Days after vaccination: 2
Gender:Female  Submitted:2011-12-02, Days after onset: 14
Location:Mississippi  Entered:2011-12-09, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: thyroid; NKDA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS11026010UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSM100470UNLA
Administered by: Other     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 11/16/11 Flu & meningococcal vaccine in (L) deltoid - same arm. (L) deltoid 7 x 12 cm induration 11-18-11 erythema. No systemic signs or sxs. Localized - responded to BENADRYL.

VAERS ID:445018 (history)  Vaccinated:2011-11-16
Age:69.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-28, Days after onset: 12
Location:Illinois  Entered:2011-12-09, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1102701 IMLA
Administered by: Other     Purchased by: Other
Symptoms: Pain
SMQs:
Write-up: Soreness when moving arm for about 2 weeks now worse at night and when lifting arm to move the muscle.

VAERS ID:445087 (history)  Vaccinated:2011-11-16
Age:34.0  Onset:2011-11-20, Days after vaccination: 4
Gender:Male  Submitted:2011-12-09, Days after onset: 19
Location:Montana  Entered:2011-12-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ZOLOFT
Current Illness: None
Preexisting Conditions: Allergy; bee stings; aspirin
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
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HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB223CA1IMRA
Administered by: Public     Purchased by: Private
Symptoms: Eye irritation, Hypoaesthesia, Hypoaesthesia eye, Hypoaesthesia oral, Muscle twitching, Superficial injury of eye, VIIth nerve paralysis
SMQs:, Peripheral neuropathy (broad), Dyskinesia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Corneal disorders (broad), Hearing impairment (broad)
Write-up: 11/20/11 Reports twitching & numbness of lip on (R) side. 11/21/11 (R) eye burning, irritated & numbness. 11/22/11 (R) side face numb & eye & lip drooping. Went to ER. Started on anti-viral med and steroids, eye drops. Allergy to eye drops. 11/20/11 Follow up with optometrist for cornea scratch 12/5/11. Numbness & drooping lasted for 2 weeks. 12/9/11 (R) eye still being treated at this time.

VAERS ID:445225 (history)  Vaccinated:2011-11-16
Age:22.0  Onset:2011-11-19, Days after vaccination: 3
Gender:Female  Submitted:2011-12-12, Days after onset: 23
Location:Arizona  Entered:2011-12-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Public     Purchased by: Unknown
Symptoms: Cellulitis, Erythema, Induration, Tenderness
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: (R) arm cellulitis - erythema firm - tender -$g course few days post injection -$g worsening over month.

VAERS ID:445335 (history)  Vaccinated:2011-11-16
Age:26.0  Onset:0000-00-00
Gender:Female  Submitted:2011-12-07
Location:Vermont  Entered:2011-12-13, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PPD
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B066AA SCLA
Administered by: Private     Purchased by: Public
Symptoms: No adverse event
SMQs:
Write-up: TDAP administered subcutaneously on 11-16-2011. Site evaluated 11-19-2011 in follow-up and no problems noted. Pt contacted 12-2-2011 in follow-up, she reports no long-term effects.

VAERS ID:445721 (history)  Vaccinated:2011-11-16
Age:55.0  Onset:0000-00-00
Gender:Female  Submitted:2011-12-16
Location:Virginia  Entered:2011-12-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAIR 10mg po qd.
Current Illness: None
Preexisting Conditions: NKA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB493AA1IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURG1068 SCRA
TDAP: TDAP (ADACEL)SANOFI PASTEURU4104AA0IMLA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUH139AA0SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Flushing, Palmar-plantar erythrodysaesthesia syndrome, Pruritus, Sneezing, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient complains of reported symptoms of itchy red palms and soles of feet & facial flushing occurring 3 times since vaccination. Episodes lasts 45 min to 1 hour. First noticed 11/27 or 12/4/11. Also complains of severe hives to thigh, abdomen, groin, & buttocks once lasting a couple of hours after exercising 1 week ago sneezing (12/9/11).

VAERS ID:445704 (history)  Vaccinated:2011-11-16
Age:0.6  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-12-18, Days after onset: 32
Location:North Carolina  Entered:2011-12-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER    
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Hives on back.

VAERS ID:445757 (history)  Vaccinated:2011-11-16
Age:9.0  Onset:2011-12-11, Days after vaccination: 25
Gender:Male  Submitted:2011-12-13, Days after onset: 2
Location:Illinois  Entered:2011-12-19, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Throat culture and blood tests, throat culture negative
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURE012314IMRA
Administered by: Public     Purchased by: Public
Symptoms: Blood test, Body temperature increased, Culture throat negative, Headache, Lymphadenopathy, Neck pain, Viral infection
SMQs:, Neuroleptic malignant syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient received an IPV on 11/16/11 with no adverse events following injection. On 12-11-11 he developed headache, neck pain, temp of 105 and swollen neck glands. Sx continued thru 12-13-11. Throat culture was negative. Dr suspected virus but advised H.D. be contacted re: IPV reaction.

VAERS ID:445988 (history)  Vaccinated:2011-11-16
Age:24.0  Onset:2011-12-04, Days after vaccination: 18
Gender:Female  Submitted:2011-12-20, Days after onset: 16
Location:Illinois  Entered:2011-12-20
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Prenatal vitamins; Ketorolac trometamol; PERCOCET
Current Illness: Endometriosis
Preexisting Conditions: Cesarean delivery; Live birth; Pregnancy; The subject had no adverse events following previous vaccinations including flu shots.
Diagnostic Lab Data: Lumbar puncture, Dec2011, negative; Nuclear magnetic resonance ima, Dec2011, brain swelling
CDC Split Type: A0958679A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT426AA UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B080DA UNLA
Administered by: Public     Purchased by: Private
Symptoms: Brain oedema, Lumbar puncture normal, Nuclear magnetic resonance imaging brain abnormal, Vision blurred, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of brain swelling in a 24-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline), (non-gsk) FLUZONE. The subject''s medical history included Cesarean delivery, live birth and pregnancy. Concurrent medical conditions included endometriosis. Concurrent medications included Prenatal vitamin, TORADOL and PERCOCET. On 16 November 2011 at 11:30 the subject received a dose of BOOSTRIX (.5 ml, unknown route, left arm). On 16 November 2011 the subject received a dose of FLUZONE (unknown route). On 4 December 2011, 18 days after vaccination with BOOSTRIX and FLUZONE, the subject experienced brain swelling, vision disturbance including "could not see side of face", and cloudy vision. The pharmacist reported that on 14 November 2011, prior to the administration of the vaccines, the subject gave birth to a baby by Cesarean delivery. The subject was hospitalized for 7 days due to the events and the pharmacist considered the events were disabling and clinically significant (or requiring intervention). The pharmacist explained that the subject was hospitalized at another facility for the adverse events. Relevant test results included nuclear magnetic resonance imaging that showed brain swelling and a lumbar puncture that was negative. The subject was treated with Corticosteroids. At the time of reporting the events were improved.

VAERS ID:445999 (history)  Vaccinated:2011-11-16
Age:32.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Male  Submitted:2011-12-21, Days after onset: 35
Location:New Jersey  Entered:2011-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: NO
Preexisting Conditions: Heart Surgery 2010
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA689AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypoglycaemia (broad)
Write-up: Patient Received 0.5mL Flulaval in left deltoid at 12:45 PM. 1:15 PM one of patient''s friends states that patient was feeling dizzy. Nurse spoke with patient and stated was feeling a little dizzy and shaky but no complaints of swelling in the mouth or throat or shortness of breath. BP 117/76, P 72, R 21. 1:30 PM patient said still feeling a little dizzy and shaky and at this point did not feel the need to seek medical attention. Patient added that his shift was over at 2:00 PM and he would be going home and would seek medical attention if still felt dizzy.

VAERS ID:446075 (history)  Vaccinated:2011-11-16
Age:60.0  Onset:2011-11-17, Days after vaccination: 1
Gender:Male  Submitted:2011-12-08, Days after onset: 21
Location:Montana  Entered:2011-12-21, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Allergies: Enoxaparin, Hydrocodone & APAP Meds:; PMH: Obstructive Sleep Apnea; Tobacco use disorder; Cardiomyopathy; Hypertrophic; Postsurgical Status of Automatic Implantable Cardiac Defibrillator in Situ; Depression; Posttraumatic Stress Disorder; Obesity; GERD; Addiction Pathological gambling; Unspecified drug dependence, in remission; Restless Legs; Counseling for marital and partner problems, unspecified; Hypertension; Obstructive Sleep Apnea; Chronic Obstructive Pulmonary Disease; Unspecified Psychosocial Circumstance; Dermatitis or Eczema; Mood Disorder due to a General Medical Condition; Tobacco Use Disorder, Continuous; SH--lives alone, worked here as cashier once. Smokes, denies alcohol abuse.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH493AA1UNLA
Administered by: Other     Purchased by: Other
Symptoms: Neck pain
SMQs:, Arthritis (broad)
Write-up: Left sided neck pain, worse with swallowing.

VAERS ID:446296 (history)  Vaccinated:2011-11-16
Age:65.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-21, Days after onset: 5
Location:Washington  Entered:2011-12-27, Days after submission: 36
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Amlodipine; CELEBREX; KEFLEX all rash/allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0630AA0SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Chills, Injection site erythema, Nausea, Pain, Vaccination site induration
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Pt stated Sx within hours of vaccine. Chills, body aches, nausea, redness and induration of site of vaccine.

VAERS ID:446376 (history)  Vaccinated:2011-11-16
Age:0.2  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-12-28, Days after onset: 42
Location:North Carolina  Entered:2011-12-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC4027AA UNUN
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0491AA UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHP25578 UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1311AA UNUN
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Faeces discoloured, Fatigue, Irritability, Mucous stools
SMQs:, Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)
Write-up: Patient started having VERY frequent, VERY runny VERY green mucousy stools. This diarrhea and generally tired & grouchy baby continued for over two weeks. Exclusively breast fed baby had always had mustard opaque stools before the vaccine. Stools eventually returned to mustard & opaque (not slimy) after about 18 days.

VAERS ID:446432 (history)  Vaccinated:2011-11-16
Age:26.0  Onset:2011-11-25, Days after vaccination: 9
Gender:Male  Submitted:2011-12-29, Days after onset: 34
Location:Georgia  Entered:2011-12-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None reported
Preexisting Conditions: None reported
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV2861IMRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURE057610IMRA
Administered by: Military     Purchased by: Military
Symptoms: Body temperature increased, Erythema, Infection, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Infection following vaccination. Arm developed increased redness, swelling and temperature. Treated with Bactrim.

VAERS ID:446537 (history)  Vaccinated:2011-11-16
Age:82.0  Onset:2011-11-17, Days after vaccination: 1
Gender:Female  Submitted:2011-12-29, Days after onset: 42
Location:Massachusetts  Entered:2011-12-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergies - eggs, milk, mold, sulfa
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1169AA0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Nausea, Pain in extremity, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Nausea, dizziness, fever, severe arm pain.

VAERS ID:447321 (history)  Vaccinated:2011-11-16
Age:42.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2012-01-12, Days after onset: 57
Location:Oklahoma  Entered:2012-01-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Thyroid Nodule; Allergic Rhinitis
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH467AA11IMRA
Administered by: Private     Purchased by: Private
Symptoms: Chest discomfort, Electrocardiogram, Pruritus, Tremor
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Pruritus, internal tremors, began 2 hours after injection - BENADRYL 12.5mg IM, DECADRON IM - then c/o chest discomfort. EKG done.

VAERS ID:447681 (history)  Vaccinated:2011-11-16
Age:0.2  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2012-01-16, Days after onset: 61
Location:Georgia  Entered:2012-01-20, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Thrush - newborn
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC3952AA0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF100650IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0677AA0PO 
Administered by: Private     Purchased by: Public
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash on pt''s face. Breathing fine. All vital signs WNL. CDC called. Pt monitored 20 minutes. Rash diminished at this time.

VAERS ID:447981 (history)  Vaccinated:2011-11-16
Age:1.0  Onset:0000-00-00
Gender:Male  Submitted:2012-01-18
Location:Florida  Entered:2012-01-25, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT4114AA0IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH9172443IMRL
Administered by: Private     Purchased by: Unknown
Symptoms: Malaise
SMQs:
Write-up: Mom states pt was "sick" x 1 1/2 wks after flu vaccine.

VAERS ID:448097 (history)  Vaccinated:2011-11-16
Age:53.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Male  Submitted:2012-01-23, Days after onset: 68
Location:Pennsylvania  Entered:2012-01-26, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Lumbago; Adult ADHD; Lyme disease; ALLEGRA, WELLBUTRIN, EFFEXOR, Morphine
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH469AA IMLA
Administered by: Private     Purchased by: Other
Symptoms: Arthralgia, Chills, Feeling cold, Feeling hot, Headache, Ocular hyperaemia, Pain, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Glaucoma (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Cold chills, shock all over (started 6-7 hours after shot was given). Episode last 1-2 hours. Headache, body aches, feverish w/o temperature. Lasted 36 hrs. (approx). Redness in eyes & joints achy.

VAERS ID:449121 (history)  Vaccinated:2011-11-16
Age:1.2  Onset:2012-01-17, Days after vaccination: 62
Gender:Male  Submitted:2012-02-08, Days after onset: 22
Location:Kentucky  Entered:2012-02-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: Unknown if ER did any tests
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB492AA0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0512AA0SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0778AA0SCLA
Administered by: Public     Purchased by: Public
Symptoms: Varicella post vaccine
SMQs:
Write-up: Pt had Varicella vaccine 11-16-2011. Mom took pt to ER 1st week of January & was diagnosed with chickenpox - pox drying but continues - returned to ER Saturday & DR again diagnosed chickenpox.

VAERS ID:449661 (history)  Vaccinated:2011-11-16
Age:24.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Male  Submitted:2012-02-15, Days after onset: 91
Location:Florida  Entered:2012-02-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.50111P0IN 
Administered by: Military     Purchased by: Military
Symptoms: Abdominal pain, Diarrhoea, Nausea
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Sharp abdominal pain, nausea, diarrhea.

VAERS ID:450089 (history)  Vaccinated:2011-11-16
Age:73.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2012-02-22, Days after onset: 98
Location:Minnesota  Entered:2012-02-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None known
Preexisting Conditions: Medication: SULFONAMIDES - joint pain CODEINE - nausea PENICILLINS - rash NITROFURANTOIN - rash, fever, lung infiltrates IODINE - Unknown VANCOMYCIN - hives/erythema Non-Medication/Food: LATEX - Unknown Radiology: **NO KNOWN CONTRAST MEDIA**
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURUH459AC IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC3989AA IMLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Chills, Injection site erythema, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This patient had shaking chills and temperature of 100.4 five hours after Tdap and High dose influenza. This patient also reports a pink to red band around her right upper arm 6 inches below the injection site for the high dose flu vaccine. The band is 4 inches wide and goes around but does not completely encircle the arm. Patient will observe this, it is not painful. Patient''s primary provider is notified.

VAERS ID:450894 (history)  Vaccinated:2011-11-16
Age:64.0  Onset:2011-11-17, Days after vaccination: 1
Gender:Female  Submitted:0000-00-00
Location:Unknown  Entered:2012-03-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: BERNA20110548
Vaccination
Manufacturer
Lot
Dose
Route
Site
TYP: TYPHOID LIVE ORAL TY21A (VIVOTIF)BERNA BIOTECH, LTD3002119 PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blister, Erythema, Pruritus, Swelling
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This spontaneous report from a nurse was received on 21.Nov.2011 and concerns a 64-year-old female patient, who received VIVOTIF (batch no: 3002119). No concomitant medication was reported. On 16.Nov.2011, the patient received the third dose of oral VIVOTIF. On the 04.Nov.2011 the patient already received unspecified hepatitis a vaccine (manufacturer and batch not reported, tetanus-diphtheria-pertussis vaccine (manufacturer and batch not reported) and polio vaccine (manufacturer and batch not reported). On 17.Nov.2011, the patient began to feel an itchy sensation on her left forearm. This then became red and raised, eventually turned into fluid filled sores. This then occurred on her left help also. A similar reaction was described to previous exposure to poison ivy. The patient hadn''t sought medical treatment as of 21.Nov.2011, when the provider, that dispensed VIVOTIF, was contacted. At the time of this report, the patient had not yet recovered. The event was considered non-serious.

VAERS ID:451421 (history)  Vaccinated:2011-11-16
Age:59.0  Onset:2011-12-01, Days after vaccination: 15
Gender:Male  Submitted:2012-03-02, Days after onset: 92
Location:Virginia  Entered:2012-03-09, Days after submission: 7
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: COZAAR (100 mg); PREVARID (20 mg); CRESTOR (20 mg); CITRUCEL (500 mg)
Current Illness: None, good health
Preexisting Conditions: None
Diagnostic Lab Data: Extensive lab work for other possibilities, all negative. Nerve test in neurologist''s office, spinal tap in hospital
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUH487AA IMRA
Administered by: Other     Purchased by: Private
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Laboratory test normal, Lumbar puncture, Nerve conduction studies, Paraesthesia
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: Good health and active up until 1st of December 2011. Received the flu shot 11/16/2011. Started feeling tingling in hands & feet, nose, left ear and then all over. Had an electrified feeling all over. Went to doctor 12/14/11. Emergency room 12/17/11, neurologist 12/29/11, hospital 12/30/11. Was released on 1/3/12. Treated for "GBS" with "IVIG" drug. Still have most of the tingling all over.

VAERS ID:455491 (history)  Vaccinated:2011-11-16
Age:24.0  Onset:2011-12-12, Days after vaccination: 26
Gender:Male  Submitted:2012-05-03, Days after onset: 142
Location:Colorado  Entered:2012-05-14, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 11 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: Post nasal drainage; sleep apnea
Preexisting Conditions: NKDA; Elevated blood pressure
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA687AA UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B066AA UNLA
Administered by: Public     Purchased by: Private
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Disability, Immunoglobulin therapy, Muscular weakness, Nuclear magnetic resonance imaging spinal cord abnormal, Paraesthesia, Spinal cord operation, Tethered cord syndrome
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow)
Write-up: 24 yo male with initial visit to clinic on 11/16/11 began having lower extremity weakness and tingling approximately 2 weeks after vaccination. With continued weakness had MRI that was abnormal. Went to OR 2/27/12 for release of tethered spinal cord. Lower extremity symptoms persisted and a diagnosis of CIDP was made 4/10/12. Pt underwent IVIG x 5 days. Still with significant disability.

VAERS ID:457729 (history)  Vaccinated:2011-11-16
Age:69.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2012-06-12, Days after onset: 208
Location:South Carolina  Entered:2012-06-19, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEUR  UNAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)
Write-up: Soreness still in am. I was told at pharmacy a nerve could have been hit.

VAERS ID:474709 (history)  Vaccinated:2011-11-16
Age:56.0  Onset:2011-11-18, Days after vaccination: 2
Gender:Female  Submitted:2012-09-21, Days after onset: 307
Location:Illinois  Entered:2012-10-17, Days after submission: 26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to erythromycin; Allergy to PROZAC; Allergy to the metal nickel; Allergy to wool; Hypothyroidism; Menopausal; Urinary tract infection
Preexisting Conditions: There were no concurrent vaccinations. The subject had no adverse events following previous vaccinations.
Diagnostic Lab Data: UNK
CDC Split Type: A0955323A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  UNLA
Administered by: Other     Purchased by: Private
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a consumer (also the subject) and described the occurrence of hive in a 56-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to erythromycin, allergy to PROZAC, allergy to the metal nickel, allergy to wool, hypothyroidism, menopausal and urinary tract infection. Concurrent medications included SYNTHROID, CELEXA and MICROBID. On 16 November 2011 at 16:00 the subject received a dose of BOOSTRIX (unknown route, left arm). The subject reported that she received Tdap vaccine by GSK. On 18 November 2011, 2 days after vaccination with BOOSTRIX, the subject experienced hive. The subject went to an emergency room. The subject was treated with prednisone, ZYRTEC and SINGULAIR. At the time of reporting the event was improved.

VAERS ID:510323 (history)  Vaccinated:2011-11-16
Age:22.0  Onset:2011-12-05, Days after vaccination: 19
Gender:Female  Submitted:2013-10-30, Days after onset: 694
Location:Minnesota  Entered:2013-10-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Diagnostic Lab Data: 10/19/2011, Viral test, Non immune; 01/17/2012, Viral test, Equivocal
CDC Split Type: WAES1112USA01189
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBV009AA0IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0037AA0SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1682Z0SCLA
Administered by: Private     Purchased by: Private
Symptoms: Antibody test negative, Blister, Injection site urticaria, Rash pruritic, Rash vesicular, Skin lesion, Urticaria, Viral test negative
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a registered nurse concerning a 22 year old female patient with no pertinent medical history and no known drug allergies who on 16-NOV-2011 was vaccinated SC with a dose of VARIVAX (Merck) (lot number: 669230/1682Z, exp. Date: 09-DEC-2012), 0.5 ml. There was no concomitant medication. On approximately 04-DEC-2011, about 2.5 weeks after administration of VARIVAX (Merck), the patient developed 5 to 6 varicella like lesions on head and body after administration of VARIVAX (Merck). The patient also developed urticaria at injection site. Unspecified antihistamine was given for the treatment of the adverse event. The patient sought medical by an office visit. No lab test was performed. At the time of the report, the patient''s outcome was unknown. Follow up information has been received from the registered nurse concerning the student with no illness at the time of vaccination, no adverse events following prior vaccinations and not immune to varicella zoster (on 19-OCT-2011) who on 16-NOV-2011 at 10:41am, was vaccinated subcutaneously in the left arm with the first 0.5 ml dose of VARIVAX (Merck) (lot number: 669230/1682Z, exp. Date 09-DEC-2012). Secondary suspect vaccines included the first dose of MMR II (lot number 669517/0037AA, exp. date 01-FEB-2013), subcutaneously in the right arm on 16-NOV-2011, at 10:41am. Concomitant vaccines included the first dose of ENGERIX-B (lot number: AHBV009AA) intramuscularly in the left deltoid on 16-NOV-2011, at 10:41am. The registered nurse reported that on 05-DEC-2011 the patient developed itchy rash, 2 lesions on scalp, 2 lesions on chest, several vesicles on forehead, 3 cm urticarial type lesion on left arm and all spots were itchy and painful. The patient was given ZYRTEC for 10 days and advised to avoid contact with high risk people. On 17-JAN-2012 lab diagnostic tests were performed and the results were varicella zoster equivocal. The patient did not seek medical attention (previously reported by the registered nurse as sought medical attention by an office visit). At the time of the report the patient recovered from the event. Follow up information has been received from another registered nurse reported that "in 2011" the patient received the second dose of VARIVAX (merck) (lot number, expiry date and route was not reported) and on an unknown date developed "a varicella like syndrome with rash". She stated that it was like chicken pox. She stated it might have been reported at that time. An unspecified treatment was given for the event. The outcome of the event was recovered on an unknown date. The patient sought medical attention. It has been determined that case # {1309USA013858} is a duplicate of case # {1112USA01189} therefore, case # {1309USA013858} is being deleted from our files and the cases consolidated into case# {1112USA01189}. Additional information is not expected.

VAERS ID:513662 (history)  Vaccinated:2011-11-16
Age:24.0  Onset:2011-12-09, Days after vaccination: 23
Gender:Male  Submitted:2013-11-19, Days after onset: 711
Location:Florida  Entered:2013-11-19
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prozac, Vyvanse, Xanax, INDOMETHACIN CAP 25MG, ITRACONAZOLE CAP 100MG, ZALEPLON CAP 10MG
Current Illness: Social Anxiety, OCD/ADD, Herniated Disc lower lumbar, Depression.
Preexisting Conditions: Social Anxiety, OCD/ADD, Herniated Disc lower lumbar, Depression. Previous infection 5/2011.
Diagnostic Lab Data: XRay of elbow, Referral to hand surgeon, diagnosed as ulnar neuropathy. EEG nerve test conducted. Also contracted further infection requiring itraconazole and other antibiotics. Had HPV 1st dose on 10-23-2011, Meningococcal Vaccine on 9-21-2011 along with Flu Vaccine on same day of 9-21-2011.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0408Z SYRRA
Administered by: Private     Purchased by: Other
Symptoms: Arthralgia, Electroencephalogram, Hypoaesthesia, Infection, Muscle spasms, Neuropathy peripheral, Pain in extremity, X-ray limb
SMQs:, Peripheral neuropathy (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Went to ER due to numbness in left arm and hand. Neuropathy of half of hand up to elbow with elbow and hand pain, with spasms.

VAERS ID:522711 (history)  Vaccinated:2011-11-16
Age:1.1  Onset:2011-11-16, Days after vaccination: 0
Gender:Male  Submitted:2014-02-11, Days after onset: 818
Location:Illinois  Entered:2014-02-14, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: UNK
Preexisting Conditions: The patient received a 1st dose of FLUZONE intramuscularly Batch U4159BB on 21 September 2011. The patient was on a delayed schedule of other vaccines but by 21 September 2011 had at least 3 DTaP, polio, hib, chickenpox, hep B (did not have Hep A) and no MMR. The patient was not ill at time of vaccination or had any pre-existing physician diagnosed medical conditions or allergies.
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA014472
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4159BB1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Cognitive disorder, Emotional poverty, Feeling abnormal, Lethargy, Social avoidant behaviour, Speech disorder developmental
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)
Write-up: Initial information received from a consumer who is the patient''s parent on 03 February 2014. A 12 month old male patient was vaccinated on 16 November 2011 with FLUZONE Batch U4159BB intramuscularly, site of administration unknown. The reporter denied that the patient had any illness at the time of vaccination and pre-existing medical conditions and allergies were reported as none. The patient had received a 1 dose of FLUZONE vaccine intramuscularly on 21 September 2011, batch U4159BB, site unknown. At an unspecified time on 16 November 2011, the patient was withdrawn and zombie like after the vaccine. He was less vocal, lethargic, with no emotion and less babbling. He never "snapped out of it". The patient is speech delayed and has processing issues. He was on a delayed schedule of other vaccines, but by 21 September 2011 he had at least 3 DTaP, polio, hib, chickenpox and Hep B vaccines. He did not receive a Hep A or MMR vaccine. The patient required an ER/doctor visit on an unreported date. Concomitant medications were not reported. Further details at the time of this event were not reported. The outcome was not reported. Documents held by sender: none.

VAERS ID:539092 (history)  Vaccinated:2011-11-16
Age:4.0  Onset:2011-11-24, Days after vaccination: 8
Gender:Female  Submitted:2014-08-06, Days after onset: 985
Location:Minnesota  Entered:2014-08-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DT: DT ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURERV3327AB0UNAR
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Convulsion, Decreased interest, Headache, Irritability
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: 11-24-11 complained of head pain before bed. Went to check on her after she fell asleep. Had seizure during sleep. I woke her right away. Temp 100.5 degrees, Gave her TYLENOL. Watched her closely all night. Next 3 days complained of headache. Was "clingy" for following 2 months. Not interested in usual activities. Eventually recovered.

VAERS ID:622022 (history)  Vaccinated:2011-11-16
Age:0.9  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2016-02-05, Days after onset: 1542
Location:Unknown  Entered:2016-02-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2015US157419
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL)SANOFI PASTEURC381899 IMUN
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERUT41199 IMUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH916599 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered at inappropriate site, Febrile convulsion
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Medication errors (narrow)
Write-up: Case number PHHY2015US157419, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 596564) website on 24 Nov 2015. This report refers to a 9 months old female patient. Past medical history and concomitant medications were not reported. Vaccination history included administration of first dose of Hepatitis B vaccine (manufacturer unknown) and PREVNAR 13. The patient had no allergies or relevant family history. She was vaccinated with seasonal influenza vaccine (other manufacturer and batch number: UT41199), PENTACEL (batch number: C381899), Hepatitis b vaccine (manufacturer unknown and batch number: 15172) and PREVNAR 13 (batch number: 916599) all received intramuscularly on 16 Nov 2011. On the same day after the vaccination, the patient experienced febrile seizure (several) for which she was taken to the emergency room for evaluation. Treatment of event included TYLENOL. The patient was evaluated on 17 Nov 2011 by the physician at a follow up visit with no treatment. Outcome of the events reported as recovered without sequelae. Event was reported as non serious and causality was not reported. Seriousness of the event febrile convulsion was upgraded based on the available information in the source document. Following an internal review done 29 Jan 2016, it was confirmed that, previously reported batch number (UT41199) belongs to other manufacturer (invalid Novartis vaccine batch number). Hence, this case will be deactivated.

VAERS ID:443837 (history)  Vaccinated:2011-11-16
Age:13.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-28, Days after onset: 12
Location:Foreign  Entered:2011-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: CAT, 16Nov2011, Normal; Lumbar puncture, 16Nov2011, Normal; Neurological examination, 16Nov2011, Normal
CDC Split Type: B0764830A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA057DD0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram head, Computerised tomogram normal, Convulsion, Dizziness, Dyskinesia, Dysstasia, Gait disturbance, Headache, Lumbar puncture normal, Muscle contractions involuntary, Muscle spasms, Myalgia, Nausea, Neurological examination normal, Paraesthesia, Pyrexia, Tremor, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician, a newspaper, a pharmacist and by another health professional via a regulatory authority (# ES-AGEMED-608009345) and described the occurrence of involuntary leg movements in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject had no relevant medical history. On 16 November 2011, the subject received 1st dose of CERVARIX (intramuscular, injection site unknown). On 16 November 2011, less than one day after vaccination with CERVARIX, the subject experienced headache, dizziness and uncontrolled contracture in legs. The article mentioned seizures. The movements were described by the pharmacist as muscular spasms with tremor in legs and instability that was bigger when standing up. The regulatory authority added myalgia, fever, nausea and paresthesia which later involving in leg fasciculations. She had no loss of consciousness. The subject went to the emergency room. A neurological examination and brain CAT were performed and showed normal results and a lumbar puncture was also done where encephalitis was discharged. The subject was hospitalised on 18 November 2011 with cephalea, dizziness and uncontrolled movements of the legs. And the regulatory authority reported that the events were clinically significant (or requiring intervention). The events showed a good evolution. And the neurologist has not been able to see the movements of the legs in this subject. The subject was initially treated with RIVOTRIL (withdrawn), and after with paracetamol (1g/8h) and ibuprofen (600mg/8h) with good response. On 18 November 2011, headache, dizziness, leg fasciculation, paresthesias, fever, nausea and myalgia were resolved. On 23 November 2011, the other events were improved, but the subject vomited. At the time of reporting the outcome of vomiting was unspecified. The reporters described 2 other similar cases. Please see case B0764827A for details about the other subjects.

VAERS ID:443840 (history)  Vaccinated:2011-11-16
Age:13.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-11-28, Days after onset: 12
Location:Foreign  Entered:2011-11-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Anorexia nervosa; Recurrent headache; Vaccine reaction
Diagnostic Lab Data: CAT, 16Nov2011, Normal; Lumbar puncture, 16Nov2011, Normal; Neurological examination, 16Nov2011, Normal
CDC Split Type: B0764827A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA057DD0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram normal, Convulsion, Coordination abnormal, Dizziness, Dyskinesia, Headache, Lumbar puncture normal, Muscle contractions involuntary, Muscle contracture, Muscle spasms, Muscular weakness, Myalgia, Nausea, Neurological examination normal, Paraesthesia, Pyrexia, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician, a newspaper, a pharmacist and by another health professional via a regulatory authority (# ES-AGEMED-508008345) and described the occurrence of involuntary leg movements in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject''s medical history included anorexia nervosa, recurrent headache since the age of 4 years and reaction to the allergy vaccines. On 16 November 2011, the subject received 1st dose of CERVARIX (intramuscular, injection site unknown). On 16 November 2011, less than 1 day after vaccination with CERVARIX, the subject experienced heavy headaches, dizziness and uncontrolled movements in both legs. The physician reported bilateral muscular weakness and continuous muscular contracture in legs. The article mentioned seizures. The movements were described by the pharmacist as muscular spasms with tremor in legs and instability that was bigger when standing up. The regulatory authority added myalgia, fever, nausea and paresthesia which later involving in leg fasciculations. She had no loss of consciousness. The subject went to the emergency room. A neurological examination and brain CAT were performed and showed normal results and a lumbar puncture was also done where encephalitis was discharged. The subject was hospitalised on 18 November 2011 with cephalea, dizziness and uncontrolled movements of the legs. And the regulatory authority reported that the events were clinically significant (or requiring intervention). The events showed a good evolution. The subject was initially treated with RIVOTRIL (withdrawn), and after with paracetamol (1g/8h) and ibuprofen (600mg/8h). At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the leg fasciculation, paresthesia, myalgia, fever and nausea were probably related to vaccination with CERVARIX. The reporters described 2 other similar cases. Please see cases B0764830A and B0764836A for details about the other subjects.

VAERS ID:444021 (history)  Vaccinated:2011-11-16
Age:0.2  Onset:2011-11-16, Days after vaccination: 0
Gender:Male  Submitted:2011-11-29, Days after onset: 13
Location:Foreign  Entered:2011-11-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 16Nov2011, 39.6deg.C
CDC Split Type: B0764402A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSYHIBC497BA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Bronchopneumonia, Febrile convulsion
SMQs:, Neuroleptic malignant syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician via a sales representative and described the occurrence of bronchopneumonia in a 3-month-old male subject who was vaccinated with HIBERIX (GlaxoSmithKline). On 16 November 2011, the subject received unspecified dose of HIBERIX (intramuscular, injection site unknown). On 16 November 2011, less than one day after vaccination with HIBERIX, the subject experienced febrile convulsion (body temperature max 39.6 deg.C). The initial diagnosis was bronchopneumonia. The subject was hospitalised. At the time of reporting, the outcome of the events was unspecified.

VAERS ID:444619 (history)  Vaccinated:2011-11-16
Age:0.6  Onset:2011-11-16, Days after vaccination: 0
Gender:Male  Submitted:2011-12-01, Days after onset: 15
Location:Foreign  Entered:2011-12-02, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2011289141
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSA21CB118A2IMLG
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHPAA0128422IMLG
Administered by: Unknown     Purchased by: Unknown
Symptoms: Eyelid oedema, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This is a spontaneous report downloaded from the web-portal of a foreign Health Authority. Regulatory Authority report number DE-PEI-PEI2011039155. A 6-month-old male patient received the third dose of PREVENAR 13 (lot number PAA012842) and the third dose of INFANRIX for vaccination on 16Nov2011. PREVENAR 13 and INFANRIX were administered in thigh, one product in the right thigh and one product in the left thigh. It was unknown which product was administered in which thigh. Route of administration was intramuscular. Past vaccinations included the first two doses of PREVENAR 13 and INFANRIX on 29Jul2011 and 26Sep2011 which had been well tolerated. On 16Nov2011 the patient experienced urticarial exanthema at face with the suspicion of eyelid oedema. The events lasted for about six hours. The patient was hospitalized but the events were not considered to be life-threatening. The patient recovered by an unknown date. No follow-up attempts needed, follow-up automatically provided by PEI$g

VAERS ID:444538 (history)  Vaccinated:2011-11-16
Age:13.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-12-05, Days after onset: 19
Location:Foreign  Entered:2011-12-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: CAT, 18Nov2011, Normal; Lumbar puncture, 18Nov2011, Normal; Neurological examination, 18Nov2011, Normal
CDC Split Type: B0764836A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA057DD IMUN
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram normal, Convulsion, Dizziness, Dyskinesia, Headache, Lumbar puncture normal, Muscle contractions involuntary, Muscle contracture, Muscular weakness, Myalgia, Nausea, Neurological examination normal, Paraesthesia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician, a newspaper, a pharmacist and by a regulatory authority (# ES-AGEMED-608009345) and described the occurrence of involuntary leg movements in a 13-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject had no relevant medical history. On 16 November 2011, the subject received unspecified dose of CERVARIX (route and injection site unknown). On 16 November 2011, less than one day after vaccination with CERVARIX, the subject experienced headaches, dizziness and uncontrolled movements in both legs. The physician reported bilateral muscular weakness and continuous muscular contracture in legs. The article mentioned seizures. The regulatory authority added myalgia, fever, nausea, paresthesia and leg fasciculation. She did not loss of consciousness at any time. On 18 November 2011, the subject went to the emergency room: a neurological examination and brain CAT were performed and showed normal results. A lumbar puncture was also done: encephalitis was ruled out. The subject was treated with RIVOTRIL and paracetamol with good response and was discharged. On 18 November 2011, according to the regulatory authority leg fasciculation, headache, paresthesia, dizziness, fever, nausea and myalgia were resolved. The subject was hospitalised on 22 November 2011 and the regulatory authority considered the events were clinically significant (or requiring intervention). However the events were improved (according to the pharmacist), the subject was hospitalised for assessment due to 2 similar cases reported. The neurologist has not been able to see the movements of the legs in this subject. At the time of reporting, leg fasciculation, headache, paresthesia, dizziness, fever, nausea and myalgia were resolved and the other events were improved. Follow-up information received on 28 November 2011 from regulatory authority: At the time of follow-up, leg fasciculation, headache, paresthesia, dizziness, fever, nausea and myalgia were unresolved. The reporters described 2 other similar cases. Please see case B0764827A for details about the other subjects.

VAERS ID:444870 (history)  Vaccinated:2011-11-16
Age:38.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-12-07, Days after onset: 21
Location:Foreign  Entered:2011-12-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: No known allergies.
Diagnostic Lab Data: UNK
CDC Split Type: B0765691A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERH8300 IDUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of acute anaphylaxis in a 38-year-old female subject who was vaccinated with Influenza vaccine. Historic medications included Pandemrix. On 16 November 2011 the subject received unspecified dose of Influenza vaccine (.5 ml, intradermal). On 16 November 2011, at an unspecified time after vaccination with Influenza vaccine, the subject experienced acute anaphylaxis. The healthcare professional considered the event was clinically significant (or requiring intervention). On 19 November 2011, the event was resolved. Verbatim Text: Treatment required in accident and emergency department on two occasions. Required oxygen, Piriton and Prednisolone.

VAERS ID:445257 (history)  Vaccinated:2011-11-16
Age:15.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Female  Submitted:2011-12-12, Days after onset: 26
Location:Foreign  Entered:2011-12-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 16Nov2011, 90/60mmHg
CDC Split Type: B0768365A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cold sweat, Hypotension, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician via a sales representative and described the occurrence of fainting in a 19-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 16 November 2011, the subject received 2nd dose of CERVARIX (unknown route, unknown injection site). Lot number not provided. On 16 November 2011, less than one day after vaccination with CERVARIX, the subject experienced fainting, cold sweat and low blood pressure (90/60 mmHg). The physician considered the events were clinically significant (or requiring intervention). After 5 minutes, the events were improved. On 16 November 2011, the subject had fully recovered. The physician considered the events were probably related to vaccination with CERVARIX.

VAERS ID:445404 (history)  Vaccinated:2011-11-16
Age:78.0  Onset:2011-11-23, Days after vaccination: 7
Gender:Female  Submitted:2011-12-13, Days after onset: 20
Location:Foreign  Entered:2011-12-14, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 2011-11-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOHRUS
Current Illness: Osteoporosis; Hypertension
Preexisting Conditions: Craniotomy
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1112USA01111
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1577Z SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Autopsy, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)
Write-up: Information has been received from a physician concerning a 78 year old female patient with hypertension, osteoporosis and a history of craniotomy who on 16-NOV-2011 was subcutaneously vaccinated with a dose of PNEUMOVAX 23 (batch number: 9MN01R; lot number: 670142/1577Z) (injection site and dose not reported). Concomitant medications included MOHRUS TAPE (There was a possibility that other medications had been prescribed by a neurosurgery hospital). On 23-NOV-2011, the patient was found dead at home. No information on autopsy was provided. An autopsy seemed to have been performed after her death but details were unknown because the autopsy was not performed at the reporting physician''s institution. There was no further information. The reporting physician felt that sudden death was definitely related to PNEUMOVAX 23. The reporting physician considered sudden death to be serious due to death. A standard lot check investigation has been finalized. All in-process quality checks for lot number 670142/1577Z were satisfactory. The lot met the requirements of the Center for Drug Evaluation and Research and was released. Additional information has been requested.

VAERS ID:446030 (history)  Vaccinated:2011-11-16
Age:16.0  Onset:2011-11-16, Days after vaccination: 0
Gender:Male  Submitted:2011-12-20, Days after onset: 34
Location:Foreign  Entered:2011-12-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient did not have any medical history of epilepsy, and no previous reactions to these vaccines or any other drugs were known.
Diagnostic Lab Data:
CDC Split Type: E201108165
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER  SCUN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Disorientation, Hypotension, Loss of consciousness, Muscle spasticity, Neck pain, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Hypoglycaemia (broad)
Write-up: Case received from the Health Authorities in a foreign country (which received it from a nurse) on 14-Dec-2011 under the reference number N201112-678 via the local site Sanofi Pasteur. Case medically confirmed. A 16-year-old male patient had simultaneously received an injection of TYPHIM VI (batch number not reported) and an injection of meningococcal vaccine via subcutaneous route (MFR unknown, batch number not reported) on 16-Nov-2011 in the context of the recommended traveler''s medical visit, and seven minutes after vaccinations he experienced syncope with loss of consciousness, moderate spasticity and disorientation in time and space, as well as convulsions. As a result, the patient stayed under observation for three hours, trying several time to sit down without any success. During this period of time, he developed neck pain, appeared very pale and hypotensive. To be noted that the patient did not have any medical history of epilepsy, and that no previous reactions to these vaccines or any other drugs were known. There was no suspicion of interaction between drugs. It is noteworthy that the medical center where the patient was vaccinated thought to refer him to hospital but his mother refused and both left the unit. At the time of reporting, the outcome was unknown.

VAERS ID:446173 (history)  Vaccinated:2011-11-16
Age:0.3  Onset:2011-11-16, Days after vaccination: 0
Gender:Unknown  Submitted:2011-12-22, Days after onset: 36
Location:Foreign  Entered:2011-12-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0770718A
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CA930B IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHPAA013526 IMUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA255AD UNUN
Administered by: Other     Purchased by: Other
Symptoms: Apnoea, Cyanosis, Hemiparesis, Hypotonia, Hypotonic-hyporesponsive episode, Loss of consciousness, Pallor, Respiratory disorder, Urinary tract infection
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician via a regulatory authority (PL-URPL-OCR-20111214015) and described the occurrence of apnea in a 4-month-old subject of unspecified gender who was vaccinated with INFANRIX HEX (GlaxoSmithKline), ROTARIX and (non-gsk) PREVENAR 13. The subject was rehabilitated because of malposition (asymmetry). In neurological examination, discrete left-side paresis was stated. On 16 November 2011, the subject received an unspecified dose of INFANRIX HEXA (intramuscular, administration site unknown), an unspecified dose of ROTARIX (unknown) and an unspecified dose of PREVENAR 13 (intramuscular, unknown). On 16 November 2011, 12 hours after vaccination with INFANRIX HEXA, PREVENAR 13 and ROTARIX, the subject experienced apnea, cyanosis, loss of consciousness, hypotonic-hyporesponsive episode and muscle tone flaccid. The events were short-lived. Next, paleness of skin and irregular breath during a couple of minutes were observed. The subject was hospitalised. No distressing manifestations were observed. After 6 days, the subject was discharged in good general condition. The subject was treated with antibiotics due to suspicion of urinary tract infection. At the time of reporting, the events were resolved.

VAERS ID:446506 (history)  Vaccinated:2011-11-16
Age:0.3  Onset:2011-11-16, Days after vaccination: 0
Gender:Unknown  Submitted:2011-12-28, Days after onset: 42
Location:Foreign  Entered:2011-12-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No reported medical history and concomitant therapy
Diagnostic Lab Data: not reported
CDC Split Type: 201112464
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20909003A SCUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA72CA659A IMUN
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEURE5985 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying
SMQs:, Depression (excl suicide and self injury) (broad)
Write-up: Case received from the Health Authorities in a foreign country on 20 December 2011 under the reference number 2011/0385 (HA''s number PLURPLOCR20111212013). A 03-month-old patient, with no reported medical history and concomitant therapy , had received an intramuscular dose of IMOVAX POLIO (batch number E5985, site of administration not reported), a subcutaneous dose of DTP VACCINE (other manufacturer, batch number 20909003A, site of administration not reported) and an intramuscular dose of HIBERIX (other manufacturer, batch number A72CA659A, site of administration not reported) on 16 November 2011. On 16 November 2011, the patient experienced uncontrollable crying. The patient recovered on an unspecified date. The case was assessed as serious due to other medical important condition. The Health Authorities coded crying uncontrollable.

VAERS ID:446842 (history)  Vaccinated:2011-11-16
Age:0.3  Onset:2011-11-16, Days after vaccination: 0
Gender:Unknown  Submitted:2012-01-03, Days after onset: 48
Location:Foreign  Entered:2012-01-05, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Neurological exam (Nov2011): slight left-sided paresis
CDC Split Type: 2011314781
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CA930B IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHPAA013526 IMUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA255AD IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Apnoea, Cyanosis, Hemiparesis, Hypotonia, Hypotonic-hyporesponsive episode, Loss of consciousness, Neurological examination abnormal, Pallor, Respiratory disorder, Urinary tract infection
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)
Write-up: This is a spontaneous report from a non-contactable physician via a foreign HA URPL. Regulatory authority report number N1114/2011 and PL-URPL-OCR-20111213015. A 3-month-old patient (unspecified ethnicity and gender) received a dose of PREVENAR 13 intramuscularly along with a dose of INFANRIX HEXA and a dose of ROTARIX intramuscularly on 16Nov2011 for immunisation. Relevant medical history concomitant medications were not reported. The patient experienced hypotonic-hyporesponsive episode, apnea, cyanosis, loss of consciousness, and muscle tone flaccid at 23:00 on 16Nov2011, approximately twelve hours after vaccination. The episode was short. Then the patient experienced pallor of skin with a period of irregular breathing for a few minutes on 16Nov2011. The patient was hospitalized and no disturbing symptoms were observed during hospitalization. The child was rehabilitated by a physiotherapist due to asymmetric presentation., The patient underwent laboratory tests and procedures including a neurological exam, which showed slight left-sided paresis. A lower urinary tract infection was also suspected. The patient received an antibiotic for six days due to suspicion of urinary tract infection. The patient recovered from the events and was discharged home in good condition after six days of observation. No follow-up attempts possible. No further information expected.

VAERS ID:446966 (history)  Vaccinated:2011-11-16
Age:12.0  Onset:2011-12-21, Days after vaccination: 35
Gender:Female  Submitted:2012-01-06, Days after onset: 16
Location:Foreign  Entered:2012-01-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0773785A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA133BO2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hypertonia, Loss of consciousness, Syncope, Trismus
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (narrow), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician via a regulatory authority (155355) and described the occurrence of short loss of consciousness in a 12-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 16 November 2011, the subject received 3rd dose of CERVARIX (.5 ml, unknown route of administration, unknown site of injection). On 21 December 2011, 35 days after vaccination with CERVARIX, the subject experienced syncope, short loss of consciousness, mild hypertonia and trismus. The subject was hospitalised. At the time of reporting, the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with CERVARIX.

VAERS ID:447803 (history)  Vaccinated:2011-11-16
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2012-01-23
Location:Foreign  Entered:2012-01-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0774863A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Fatigue, Headache, Pruritus, Visual acuity reduced
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority (GB-MHRA-ADR 21433475) and described the occurrence of decreased vision in a 12-year-old female subject who was vaccinated with CERVARIX. On 19 October 2011 and 16 November 2011 the subject received 1st and 2nd dose of CERVARIX (intramuscular). At an unspecified time after vaccination with CERVARIX, the subject experienced decreased vision, headache, tiredness and itching. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. MHRA Verbatim Text: Mum reports: eyesight deterioration, headaches, tiredness and itching hands. GP referred to Paediatrician for follow up. Unsure if vaccine related but mum thinks so. Mum reports optician feels eyesight has deteriorated rapidly, mum reports onset of headaches since injection. I have been unable to clarify further with mum.

VAERS ID:454885 (history)  Vaccinated:2011-11-16
Age:15.0  Onset:2011-12-08, Days after vaccination: 22
Gender:Female  Submitted:2012-05-02, Days after onset: 145
Location:Foreign  Entered:2012-05-03, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Ultrasound, 08Dec11, There was finding visible, but abscess excluded; Ultrasound, 12Dec11, unlimited spindle district 7x26 mm with partially preserved muscle structure, control; Ultrasound, 02Jan12, unlimited spindle district 5x15 mm
CDC Split Type: WAES1201USA03535
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site oedema, Injection site pain, Pain in extremity, Ultrasound scan normal
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician (local reference ID # CZE12/018) concerning a female patient who was vaccinated with a dose of GARDASIL (lot number, dose and site of administration were not reported). On 08-DEC-2011, the patient experienced local reaction in site where vaccine was administered occurred with the following symptoms: oedema of arm, oedema in site of administration and pain in whole arm. On approximately 08-DEC-2011, an ultrasonography was performed: there was finding visible, but abscess excluded. Patient got as the treatment for this event IBALGIN, cool and calm limbs. At the time of the report, the patient''s outcome was unknown. Follow up information has been received from the physician concerning the 15 year old patient who after GARDASIL vaccine experienced vaccine administration oedema, pain and palpable resistance, as per ultrasonography resistance persisted, the patient had symptomatic therapy IBALGIN, cool compresses. An ultrasonography was performed on 12-DEC-2011 and showed unlimited spindle district 7x26 mm with partially preserved muscle structure, control ultrasonography performed on 02-JAN-2012 with the following findings: unlimited spindle district 5x15 mm. At the time of the report, the patient''s outcome was unknown. Vaccine administration oedema, pain and palpable resistance in administration site were considered to be other important medical events by the physician. Additional information is not expected.

VAERS ID:455500 (history)  Vaccinated:2011-11-16
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2012-05-11
Location:Foreign  Entered:2012-05-14, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1205USA00789
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NF260801IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hyperthyroidism
SMQs:, Hyperthyroidism (narrow)
Write-up: This case was received from a Health Authority on 02-MAY-2012 (reference number 2012-011170). This case was medically confirmed. A 17 year old female patient with no relevant medical history or concurrent conditions and was not receiving any concomitant medication, received the second dose of GARDASIL (batch No. reported as NP26080, this is an invalid batch number for HPV rL1 6 11 1 18 VLP vaccine, intramuscularly, site not reported on 16-NOV-2011. In March 2012, also reported as 5 months post vaccination by the Health Authority, the patient was diagnosed with hyperthyroidism. The patient attended for her third dose of GARDASIL on an unknown date, when she informed the reporter that she had been diagnosed with hyperthyroidism in March 2012. The patient is receiving corrective treatment with NEOMERCAZOLE. At the time of the reporting, the patient has not recovered. The Health Authority considered the event to be serious due to other medically important condition requiring intervention. Other business partner numbers include: E2012-02856. Additional information has been requested.

VAERS ID:494937 (history)  Vaccinated:2011-11-16
Age:0.4  Onset:2013-02-18, Days after vaccination: 460
Gender:Male  Submitted:2013-06-21, Days after onset: 122
Location:Foreign  Entered:2013-06-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: 10/14/2011, ROTATEQ, No adverse event; 09/13/2011, ROTATEQ, No adverse event
Diagnostic Lab Data: Erythrocyte sedimentation rate: High erythrocyte sedimentation rate increased; Adenovirus test, Negative; Body temperature, 39 degrees; 02/18/2013, C-reactive protein, 9.39 mg/dL; 02/20/2013, C-reactive protein, 2.64 mg/dL; 02/18/2013, Giardiasis, Negative; Polymerase chain reaction, Norovirus, Negative; 02/18/2013, Red blood cell sedimentation rate, Increased; 02/20/2013, Red blood cell sedimentation rate, 33 mm first hour mm/hr; 02/18/2013, Rotavirus test, Positive
CDC Split Type: WAES1306DEU008220
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0993AA2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Adenovirus test, C-reactive protein increased, Condition aggravated, Conjunctivitis, Dehydration, Diarrhoea, Gastroenteritis rotavirus, General physical health deterioration, Giardia test, Otitis media, Pharyngitis, Polymerase chain reaction, Pyrexia, Red blood cell sedimentation rate increased, Rotavirus test positive, Skin turgor decreased, Tonsillar hypertrophy, Tonsillitis, Tympanic membrane hyperaemia, Upper respiratory tract infection, Viral test
SMQs:, Severe cutaneous adverse reactions (broad), Agranulocytosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case was received from a health care professional on 14-Jun-2013. Case is medically confirmed. This case is linked with not serious case E2013-04468 (same reporter, same product, similar reaction). Master case: A male patient (weight 12 kg, height 85 cm) received the complete immunisation series with three doses of ROTATEQ, starting at the age of 11 weeks on 13-Sep-2011 (D1, batch no. 0451AA, lot No. 670009/0451AA, exp 30-NOV-2012), on 14-Oct-2011 (D2, batch-no. 0451AA, lot No. 670009/0451AA, exp 30-NOV-2012) and on 16-Nov-2011 (D3, batch-no. 0993AA, lot No. 671102/0993AA exp. 31-MAR-2013). 15 months after vaccination on 15-Feb-2013, the patient developed diarrhoea and fever up to 39 degrees C. An already existing upper respiratory infection with pharyngitis and tonsillitis worsened. On 17-Feb-2013 otitis media was diagnosed. General condition worsened on 17-Feb-2013 and therapy with Amoxicillin was started on 18-Feb-2013. Insufficient food supply and dehydration lead to hospitalization on 18-Feb-2013. On admission, the patient presented with reduced turgor, active bowel sounds, enlarged palatine tonsil, a red left eardrum and conjunctivitis. On 18-Feb-2013 a rotavirus gastroenteritis was confirmed by laboratory results (EIA). Analysis of giardia lamblia on 18-Feb-2013 was negative. Stool test for adenovirus (EIA) and PCR for norovirus were negative as well. The laboratory test on 18-Feb-2013 showed C-reactive protein 9.39 mg/dl and increased blood sedimentation rate. On 20-Feb-2013 C-reactive protein was 2.64 mg/dl and blood sedimentation rate 33 mm/h. The patient was treated with fluid, amoxicillin and cefuroxime and the general condition improved. On 22-Feb-2013 the patient was discharged from hospital. Vaccination failure was concluded by the reporter. At the time of reporting the patient had recovered.

VAERS ID:501369 (history)  Vaccinated:2011-11-16
Age:0.4  Onset:2011-11-20, Days after vaccination: 4
Gender:Male  Submitted:2013-09-02, Days after onset: 651
Location:Foreign  Entered:2013-09-04, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: 09-MAY-2012, Haemoglobin, 11.8 g/dl; 11-JUL-2012, Haemoglobin, 11.5 g/dl; 26-SEP-2012, Haemoglobin, 12.8 g/dl; 09-MAY-2012, Lymphocyte count, 5500 /mm3; 11-JUL-2012, Lymphocyte count, 4300 /mm3; 26-SEP-2012, Lymphocyte count, 4500 /mm3; 22-NOV-2011, Neutrophil count, 230 /mm3; 02-FEB-2012, Neutrophil count, 1040 /mm3; 09-MAY-2012, Neutrophil count, 100 /mm3; 01-JUL-2012, Neutrophil count, 5300 /mm3; 11-JUL-2012, Neutrophil count, 100 /mm3; 26-SEP-2012, Neutrophil count, 4100 /mm3; 31-JAN-2013, Neutrophil count, 560 /mm3; 09-MAY-2012, Platelet count, 341000 /mm3; 11-JUL-2012, Platelet count, 334000 /mm3; 26-SEP-2012, Platelet count, 352000 /mm3; 22-NOV-2011, White blood cell count, 9680 /mm3; 09-MAY-2012, White blood cell count, 6700 /mm3; 1
CDC Split Type: 2013135764
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CB219A IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF43114 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Acid base balance normal, Adenovirus test, Amylase normal, Anti-thyroid antibody negative, Anti-transglutaminase antibody negative, Antibody test negative, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Blood immunoglobulin A normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Cardiolipin antibody negative, Constipation, Cough, Cytomegalovirus test negative, DNA antibody negative, Epstein-Barr virus test negative, Faeces hard, Gastrooesophageal reflux disease, Haemoglobin normal, Hyperpyrexia, Idiopathic neutropenia, Lymphocyte count increased, Middle insomnia, Monocyte count normal, Neutropenia, Neutrophil count decreased, Parvovirus B19 test negative, Platelet count normal, Pyrexia, Restlessness, Smooth muscle antibody negative, Upper respiratory tract infection, Upper respiratory tract inflammation, White blood cell count decreased
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This is a spontaneous report received from the foreign Regulatory Authority; regulatory authority report number 202025. A specialized physician (contactable through Regulatory Authority only) reported that a 5-month-old male patient received, at the age of 4-month-old, PREVENAR 13 (Lot Number: F43114; Expiration Date: 28Feb2014) and INFANRIX HEXA (Lot Number: A21CB219A; Expiration Date: 31Oct2013), both administered intramuscularly on 16Nov2011. Relevant medical history and concomitant medications were unknown. The patient was born at term by dystocia delivery (application of suction cup), after normal pregnancy. Birth weight 3870 g, length 51 cm, 35 cm CC. Breastfeeding up to 8 months of life. Weaning at 6 months, well tolerated. Height-weight growth within the reference percentiles. Free diet and varied. Eupeptic. Patient tend to be constipated (hard stools, goat every 1-2 days). Urination normal. Sleep-wake rhythm characterized by frequent nocturnal awakenings and restlessness as young as 6 months of life (attempted treatment with anti-acids for suspected gastroesophageal reflux, without benefit). Two episodes of inflammation of the upper respiratory tract, one of which was treated at home with antibiotics and aerosol therapy. No family history of onco-hematological diseases. Grandmother showed brain aneurysm. On 20Nov2011, the patient experienced hyperpyrexia (reported as higher than 40 degrees Celsius), and on 22Nov2011, the patient experienced neutropenia. On 22Nov2011 a full blood count (CBC) was performed for reported night restlessness which showed monocyte count at 1.45, white blood cells 9680/mm3 and neutrophils 230/mm3 with hemoglobin and platelets normal. Neutropenia was also confirmed in subsequent checks on 23Nov2011, 14Dec2011, 01Jan2012 and 14Jan2012 (during ongoing fever of unknown origin). On 02Feb2012 (during upper respiratory tract infection and fever), the neutrophils were increased to 1040/mm3. The patient was visited on 07Mar2012 and appeared in good condition, with normal cardio-thoracic-abdominal objectivity. On 09May 2012 blood count showed the persistence of neutropenia (white blood cells 6700/mm3, neutrophils 100/mm3, lymphocytes 5500/mm3, hemoglobin 11.8 g/dl, platelets 341000/mm3, also on the same date the following examinations were performed: first indirect detection of antibodies anti neutrophil IgG and IgM: negative; dose IgG, IgA and IgM: normal; Ab anti-transglutaminase IgA negative; serology for CMV infection, parvovirus B19, EBV and Adenovirus: negative; amylase and evaluation of acid-base venous: normal. On 01Jul2012 the patient was taken to the emergency room for fever and Neutrophils were 5300/mm3. On 11Jul2012 were performed the following tests: white blood cells 5300/mm3, neutrophils 100/mm3, lymphocytes 4300/mm3, hemoglobin 11.5 g/dl, platelets 334000/mm3 and second indirect detection of antibodies IgG and IgM anti neutrophils: negative. On 26Sep2012, the patient was visited for cough and fever and examinations carried out on the same day confirmed a good response to the infectious stimulus: white blood cells 10400/mm3, neutrophils 4100/mm3, lymphocytes 4500/mm3, hemoglobin 12.8 g/dl, platelets 352000/mm3, third indirect detection of antibodies anti-neutrophil IgG and IgM negative, smooth muscle antibodies, antinuclear extractable (ENA), anti-neutrophil cytoplasmic antibodies (ANCA), anti-cardiolipin, anti-thyroglobulin, anti-native DNA and anti nucleus on fabric and Hep2 cells: negative. On 23Nov2012 chronic idiopathic neutropenia with good response to infectious stimuli was diagnosed. On 31Jan2013 the white blood cells were 6640/mm3 and neutrophils 560/mm3. On 12Mar2013, the patient was in good general condition. Weight 15,350 kg, length 89.5 cm, no deformities, no skin changes, or back, normal head, fountain ossified, tonsillar tissue present, pharyngeal hyperemia, teeth normal for age. Heart normal, protruding abdomen and manageable, no organomegaly, normal male genitals, testic

VAERS ID:524406 (history)  Vaccinated:2011-11-16
Age:81.0  Onset:2011-12-22, Days after vaccination: 36
Gender:Female  Submitted:2014-02-27, Days after onset: 798
Location:Foreign  Entered:2014-03-03, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 20 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: 01/11/2012, Rehabilitation therapy; Hypertension
Preexisting Conditions: Hip arthroplasty, post total hip replacement condition.
Diagnostic Lab Data:
CDC Split Type: PHHY2014HR006503
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Guillain-Barre syndrome, Paralysis flaccid
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Case number PHHY2013HR006503 is an initial spontaneous report received from a physician via health authority (reference number: 2012-01732) on 23 Jan 2013 and a follow up information received from a literature on 19 Feb 2014. In the article, the author evaluated 10 cases of Guillain Barre syndrome (GBS) reported following influenza vaccination. Brighton collaborations''s case definitions for analyzing cases of GBS reported to the agency for the period Jul 2012 to Jul 2013 were used. The time window at risk was set at 6 weeks after vaccine administration. This case refers to an 81-year-old female patient. Her concurrent conditions included arterial hypertension and post total hip replacement condition. Her concomitant medications were not reported. Her vaccination history included administration of influenza vaccine every year. She was vaccinated with FLUIMUM (batch number: "6/6") at a dose of 0.5 ml intramuscularly on 16 Nov 2011. On 22 Dec 2011 she developed flaccid paralysis and Guillain-Barre syndrome. The patient was hospitalized in the department of neurology from 22 Dec 2011 till 10 Jan 2012. The patient underwent spa rehabilitation from 11 Jan 2012 till 04 May 2012. She received medical treatment (not specified) for the events. The patient had significant disability due to these events. The final outcome was reported as recovered with sequelae (disability). The causality assessment between the reported events and vaccine was assessed as possible. The author concluded that the benefits of influenza vaccination outweigh potential risks associated with it and hence special care should be taken in order to inform patients about benefits and risk of influenza vaccination in order to facilitate informed decision. Follow up information received from a literature on 19 Feb 2014: Updated report type, literature details, article ID and author''s conclusion.

VAERS ID:545787 (history)  Vaccinated:2011-11-16
Age:1.0  Onset:0000-00-00
Gender:Male  Submitted:2014-09-26
Location:Foreign  Entered:2014-09-30, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRIORIX, 09-MAR-2012
Current Illness:
Preexisting Conditions: 11-MAR-2011, DITEKIPOL/ACTHIB, first dose, batch number: 0123A/E9513; 09-MAY-2011, DITEKIPOL/ACTHIB, second dose batch number: 0124A/E9513
Diagnostic Lab Data: Skin test
CDC Split Type: 2014262042
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTPPHIB: DTP + IPV + ACT-HIB (NO BRAND NAME)UNKNOWN MANUFACTURERE95702IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF242412IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Allergy to metals, Erythema,