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VAERS ID: 359413 (history)  
Age: 5.0  
Gender: Male  
Location: Florida  
Vaccinated:2009-09-22
Onset:2009-09-23
   Days after vaccination:1
Submitted: 2009-09-28
   Days after onset:5
Entered: 2009-10-05
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2398BA / 4 RA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR D0304 / 3 LA / SC
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0764Y / 1 RA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0927Y / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Blister, Injection site erythema, Injection site swelling, Pain
SMQs:, Severe cutaneous adverse reactions (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Left OM; URI; Wheeze - resolved.
Preexisting Conditions: Developmental / speech delay; asthma with Illness.
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Right arm with blisters (vesicles), started with one large centralized vesicle & several smaller ones day after with pain. Right arm shoulder to elbow redness & swelling.


VAERS ID: 359414 (history)  
Age: 36.0  
Gender: Female  
Location: Mississippi  
Vaccinated:2009-09-30
Onset:2009-10-03
   Days after vaccination:3
Submitted: 2009-10-04
   Days after onset:1
Entered: 2009-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 05949111A / 0 RA / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal discomfort, Cough, Dysphagia, Fatigue, Headache, Nasal congestion, Oropharyngeal pain, Pyrexia, Rhinorrhoea, Sneezing
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), 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 (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: I am presently taking Methotrexate 4@2.5 mg per week, Nifedipine 90 mg per day, Tramadol 3x per day, Lorcet only as needed, I can''t remember all the others, this is the major medicines I take daily or weekly.
Current Illness: Chronic. On file at my physicians. Primary Raynaud''s Disease and Polyarthritis.
Preexisting Conditions: n/a
Diagnostic Lab Data:
CDC Split Type:

Write-up: I began with tiredness and upset stomach. I am sick as I write this so the it is possibly not very coherent. 1)extreme sore throat, almost cannot swallow 2)running nose, sneezing 3)cough 4)mild fever, I have not checked my fever unmedicated. 5)Nasal Congestion and I almost forgot the massive 6)Headaches I had when the symptoms were beginning. As well I do not know if I am contagious or not due to the fact that I got sick from the vaccine. Please notify me. I am taking precautions in hygiene and wearing face masks but I am not quarantined. The nurse said I would get mildly get sick, but I slept all day yesterday and can barely move today.


VAERS ID: 359415 (history)  
Age: 72.0  
Gender: Female  
Location: California  
Vaccinated:2009-03-04
Onset:2009-03-06
   Days after vaccination:2
Submitted: 2009-09-29
   Days after onset:206
Entered: 2009-10-05
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 01304 / 0 LA / SC

Administered by: Other       Purchased by: Private
Symptoms: Activities of daily living impaired, Asthenia, Back pain, Blood thyroid stimulating hormone abnormal, Chills, Fatigue, Heart rate irregular, Hyperthyroidism, Incontinence, Pyrexia, Thyroxine abnormal, Thyroxine free abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Hypothyroidism (broad), Hyperthyroidism (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: COREG, AMLODAPINE (as needed), DIOVAN, COUMADIN
Current Illness: Sinusitis/Allergy (Nasal)
Preexisting Conditions: Have a mechanical heart valve. BP - controlled, need COUMADIN
Diagnostic Lab Data: T4 and T5H = Hyperthyroidism 3/27 free T4 = T5H =
CDC Split Type:

Write-up: (2nd report) 2 days after getting shingles vaccine: chills, fever, low back pain, incontinence. Ran it''s course but exhausted. On 3/29 blood work showed hyperthyroidism - I had never ever had that. It has been difficult from the springtime, to continued exhaustion to irreg. heartbeat to lack of energy to do daily chores or get involved w/community. Have never regained health level prior to 3/6/09.


VAERS ID: 359416 (history)  
Age: 52.0  
Gender: Male  
Location: California  
Vaccinated:2009-09-28
Onset:2009-09-28
   Days after vaccination:0
Submitted: 2009-09-28
   Days after onset:0
Entered: 2009-10-05
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 97839P1 / 0 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Blood pressure decreased, Dizziness, Nausea, Orthostatic hypotension, Photophobia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: :Sick X 3 days~Influenza (H1N1) (H1N1 (MONOVALENT) (UNKNOWN))~UN~0.00~Patient
Other Medications: PERCOCET; MS CONTIN; Nortriptyline; Cyclobenzeprin; Cyclobenzaprine; Carvedilol; Docusate; Fish oil; ASA; PROTONIX.
Current Illness: None
Preexisting Conditions: Allergy to PCN; Bee stings
Diagnostic Lab Data:
CDC Split Type:

Write-up: Onset 0925 dizzy, photophobia, decreased blood pressure, positive orthostatic blood pressure with uncompensated heart rate. No chest pain , SOB, hives, tongue swelling, positive nausea txd with PHENERGAN. VS monitored until stable at 1130 and pt reported feeling better.


VAERS ID: 359417 (history)  
Age: 33.0  
Gender: Male  
Location: Virginia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2009-09-29
Entered: 2009-10-05
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:

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:

Write-up: None


VAERS ID: 359418 (history)  
Age: 0.34  
Gender: Female  
Location: New Mexico  
Vaccinated:2009-09-23
Onset:2009-09-23
   Days after vaccination:0
Submitted: 2009-09-24
   Days after onset:1
Entered: 2009-10-05
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR B10902 / 0 RL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH D03070 / 0 RL / UN

Administered by: Military       Purchased by: Military
Symptoms: Crying, Decreased appetite, Diarrhoea, Injection site erythema, Injection site swelling, Injection site warmth, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 0.7 ml POQ 4-6 H; Acetaminophen 100 mg/ml; Poly-Vi-Sol: dropperful PO daily
Current Illness: No
Preexisting Conditions: None; NKDA; NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Crying, decreased appetite, vomit x2, diarrhea x 4. Injection site red, raised, warm to touch, penny sized. No fever.


VAERS ID: 359419 (history)  
Age: 1.19  
Gender: Female  
Location: Florida  
Vaccinated:2009-09-21
Onset:2009-09-21
   Days after vaccination:0
Submitted: 2009-09-22
   Days after onset:1
Entered: 2009-10-05
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3430AA / 3 RL / UN
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT3178EA / 1 LL / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0427Y / 1 LL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0849Y / 1 LA / SC

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)

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:

Write-up: Slight raised red hives at injection site. Right anterio lateral thigh.


VAERS ID: 359420 (history)  
Age: 71.0  
Gender: Female  
Location: Michigan  
Vaccinated:2009-09-11
Onset:2009-09-11
   Days after vaccination:0
Submitted: 2009-09-29
   Days after onset:18
Entered: 2009-10-05
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 05849111A / - LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injected limb mobility decreased, Injection site induration, Injection site pain, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)

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:

Write-up: When she received injection it hurt her arm. She came in a few days after and complained of arm to sore to lift above shoulder. Then she came back and complained of also having tingling in arm.


VAERS ID: 359421 (history)  
Age: 11.0  
Gender: Female  
Location: Washington  
Vaccinated:2009-09-21
Onset:0000-00-00
Submitted: 2009-09-23
Entered: 2009-10-05
   Days after submission:12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3021AA / - LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B038CA / - LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)

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: None
CDC Split Type:

Write-up: Rash @ injection site - treated with anti-histamines.


VAERS ID: 359422 (history)  
Age: 0.99  
Gender: Female  
Location: Georgia  
Vaccinated:2006-12-19
Onset:2009-09-25
   Days after vaccination:1011
Submitted: 2009-09-28
   Days after onset:3
Entered: 2009-10-05
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2176JA / 0 RA / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1025F / 0 LL / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08691F / 3 LA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1146F / 0 RL / UN

Administered by: Private       Purchased by: Private
Symptoms: Rash erythematous, Rash papular, Scab
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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:

Write-up: 9/22/09 red raised papular rashes on face trunk which progressed to papulo-vesicular the vesicular & crusting lesions.


VAERS ID: 359423 (history)  
Age: 3.0  
Gender: Female  
Location: West Virginia  
Vaccinated:2009-09-24
Onset:2009-09-24
   Days after vaccination:0
Submitted: 2009-09-25
   Days after onset:1
Entered: 2009-10-05
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3177BA / 3 LL / IM

Administered by: Private       Purchased by: Public
Symptoms: Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: PENICILLINS
Diagnostic Lab Data:
CDC Split Type: WV0908

Write-up: About 1-2 hours after receiving vaccine patient called with description of red spots on right upper arm. No shortness of breath , no palpitations, no tachycardia, no altered mental status. Patient''s mom concerned.


VAERS ID: 359424 (history)  
Age: 35.0  
Gender: Female  
Location: Kansas  
Vaccinated:2009-09-22
Onset:2009-09-22
   Days after vaccination:0
Submitted: 2009-10-02
   Days after onset:10
Entered: 2009-10-05
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLU468AA / - RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Eye swelling, Hypersensitivity, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Calcium; MVI (doesn''t take regularly)
Current Illness: None except allergies
Preexisting Conditions: Seasonal nasal allergies - CLARITIN usually daily from August until first
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Took IM flu vaccine at approx, 1:30 pm. Employee is a counselor. Had client session from 2-3 pm. When came out of session at 3:00 PM, (L) eye was swollen shut, lower (L) side of face swelled later. No resp. problems. Psychiatrist said "looks like allergic reaction." Took CLARITIN at 3pm and BENADRYL PO at 6:30pm and 10 pm - Swelling resolved by 9/23 AM and no further problems.


VAERS ID: 359425 (history)  
Age: 2.0  
Gender: Male  
Location: Michigan  
Vaccinated:2009-09-23
Onset:2009-09-24
   Days after vaccination:1
Submitted: 2009-09-28
   Days after onset:4
Entered: 2009-10-05
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U3208AA / 0 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENADRYL PRN
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Rash developed on face then spread to trunk and limbs pt took BENADRYL with no relief of sx-rash began about 24 hours after receiving influenza vaccine. RX- watch and wait.


VAERS ID: 359426 (history)  
Age: 89.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2009-09-11
Onset:2009-09-11
   Days after vaccination:0
Submitted: 2009-09-15
   Days after onset:4
Entered: 2009-10-05
   Days after submission:20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 97841P1 / 0 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site haematoma, Injection site reaction
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

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:

Write-up: Local, injection site reaction resulting in a 3-4 inch bruise surrounding injection site beginning night of vaccination. No allergic reaction reported. No other adverse effects reported and hospitalization was not necessary.


VAERS ID: 359427 (history)  
Age: 86.0  
Gender: Female  
Location: New York  
Vaccinated:2009-09-21
Onset:2009-09-27
   Days after vaccination:6
Submitted: 2009-09-28
   Days after onset:1
Entered: 2009-10-05
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 97840P1 / 10 LA / IM

Administered by: Unknown       Purchased by: Public
Symptoms: No reaction on previous exposure to drug, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: rash~Influenza (Seasonal) (Fluvirin)~1~86.00~Patient
Other Medications: DIOVAN, METOPROLOL, NIASPAN, ACTOS, OMEPRAZOLE, SERTRALINE, CALCIUM
Current Illness: Not ill
Preexisting Conditions: Diabetes, HTN; allergic to codeine & LOTREL
Diagnostic Lab Data:
CDC Split Type:

Write-up: Rec''d influenza vaccine 9/21, broke out in rash on neck 9/27, only on (L) side of neck shoulder (1 week after FLUVIRIN, w/o reaction to any flu imm. in past).


VAERS ID: 359428 (history)  
Age: 91.0  
Gender: Male  
Location: New Jersey  
Vaccinated:2009-09-25
Onset:2009-09-25
   Days after vaccination:0
Submitted: 2009-09-28
   Days after onset:3
Entered: 2009-10-05
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 97839P2 / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

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:

Write-up: Patient is reporting dizziness.


VAERS ID: 359429 (history)  
Age: 28.0  
Gender: Male  
Location: Missouri  
Vaccinated:2009-09-30
Onset:2009-09-30
   Days after vaccination:0
Submitted: 2009-10-05
   Days after onset:5
Entered: 2009-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLULAVAL) / GLAXOSMITHKLINE BIOLOGICALS AFLLA279AA / - LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Incorrect route of drug administration, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Seasonal Allergy; Concomitant medications were unknown. The subject had previously received influenza vaccinations and no adverse events were reported. No adverse events were reported following receipt of prior immunizations.
Diagnostic Lab Data: UNK
CDC Split Type: A0810057A

Write-up: This case was reported by a healthcare professional and described the occurrence of itching in a 28-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). The subject''s medical history included seasonal allergy. On 30 September 2009 at 09:30 the subject received unspecified dose of FLULAVAL (unknown, left arm). On 30 September 2009, less than one day after vaccination with FLULAVAL, the subject experienced itching, erythema and inappropriate route of vaccination. It was reported the nurse inadvertently gave vaccine intradermally and the subject reported itching and redness. The healthcare professional considered the events were disabling. At the time of reporting the erythema and itching were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.


VAERS ID: 359430 (history)  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:2005-08-30
Onset:2006-11-29
   Days after vaccination:456
Submitted: 2009-10-05
   Days after onset:1040
Entered: 2009-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug exposure during pregnancy, Foetal distress syndrome, Neonatal disorder, Placental insufficiency
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Neonatal disorders (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Folic acid; Iron salt
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Apgar score, 29Nov2006, 9-9
CDC Split Type: B0421566B

Write-up: This 20-year-old female subject was enrolled in a blinded study for the prophylaxis of cervical intraepithelial neoplasia (CINII) associated with human papillomavirus (HPV) - 16 and/or HPV-18 in healthy young females. The subject received intramuscular investigational product single dose on 2 May 2005 and on 30 August 2005, after negative urine pregnancy tests. She did not receive the 3rd dose. Site of injection was the left deltoid. On 02 May 2005 and 30 August 2005, the subject received the 1st and 2nd intramuscular injection of blinded study vaccine in the left deltoid. The subject had been randomized to receive the active control in this trial, an investigational formulation of HAVRIX vaccine containing 720 ELISA units of hepatitis A antigen and 500 ul AL(OH)3. The lot number was not provided. The serious adverse event described below was not experienced by a study subject but by her offspring. The study subject or mother was exposed to vaccine before conception. The mother took folic acid and iron as concomitant medications during her pregnancy. On 29 November 2006, the mother underwent a C-section due to acute fetal distress secondary to fetal placental unit insufficiency (See case B0421566A for more details). On 29 November 2006, 15 months after the study participant''s 2nd dose of Blinded vaccine, this male child was born by C-section and it was later determined that he had left eye strabismus. The event was a congenital anomaly. At the time of reporting, the child was attending follow-up with the specialist. The investigator reported the left eye strabismus as possibly related to investigational product due to the time elapsed between the last dose of study vaccine and the last menstrual period (LMP). Investigator comments: On 25 September 2009, during the study participant''s 48 months visit, she reported that her son, who was born on 29 November 2006 (Male baby, weight 2800g, Apgar score 9-9, length 47cm, term newborn, adequate for the gestational age), was attending follow-up appointments with a ophthalmologist because when he was about 4-months-old, he presented with left eye lateral deviation. The mother expected that this alteration would have resolved with his growth, but it did not disappear. Approximately on 23 April 2009, the doctor of the local primary center referred him to the ophthalmologist (participant brought the medical reference). Approximately on 15 July 2009, he attended an appointment with the ophthalmologist, but he was not attended. Appointments were scheduled (for 14 October 2009 and to perform surgery on 04 January 2010). The study participant gave this information today because she forgot to mention it on 20 February 2007, when she reported the resolution of her pregnancy. The hospital chart was pending review. Diagnosis: Left eye strabismus in the participant''s son.


VAERS ID: 359431 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2006-01-24
Onset:2006-12-08
   Days after vaccination:318
Submitted: 2009-10-05
   Days after onset:1031
Entered: 2009-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug exposure during pregnancy, Neonatal disorder
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Folic acid; Iron salt; Oral contraceptive
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Apgar score, 08Dec2006, 9
CDC Split Type: B0421587B

Write-up: This 24-year-old female subject was enrolled in a study (580299 009) for the prophylaxis of cervical intraepithelial neoplasia (CINII) associated with human papillomavirus (HPV) - 16 and/or HPV-18 in healthy young females. The subject received intramuscular investigation product single dose on 16 August 2005, 29 September 2005 and on 24 January 2006, after negative urine pregnancy tests. Site of injection was the left deltoid. On 16 August 2005, 29 September 2005, and 24 January 2006, the subject received the 1st, 2nd, and 3rd intramuscular injection of study vaccine in the left deltoid. The subject had been randomized to received the active control in this trial, and investigational formulation of HAVRIX containing 720 ELISA units of hepatitis A antigen and 500 ug Al (OH)3. The lot number was not provided. The serious adverse event described below was not experienced by a study subject but her offspring. The study subject or mother was exposed to vaccine before conception. The mother took folic acid and iron salt as concomitant medications during her pregnancy. She used oral contraceptives as a birth control method before getting pregnant. On 08 December 2006, the mother had a normal vaginal delivery (see case id B0421587A for more details). On 08 December 2006, 10 months after the study participant''s 3rd dose of vaccine, this female child was born by normal vaginal delivery and had an Apgar score of 9, a weight of 3.3 Kg, a height of 49 cm. It was later determined that the child had bilateral strabismus. The event was a congenital anomaly. At the time of reporting, the child was under medical control at the hospital. The investigator reported the bilateral strabismus as possibly related to investigational product due to the time elapsed between the last dose of vaccine and the last menstrual period (MLP). Investigator comments: On 28 September 2009, during the 48 months visit, the study participant reported that when her daughter was approximately one and a half year old, they noticed strabismus, for which she was taken to a private clinic and later referred to hospital, where she was currently under medical control. She has been wearing glasses for two months. The mother reported that her child has relatives with with this same disease. The medical chart will be reviewed. Diagnosis: Bilateral strabismus in participant''s daughter.


VAERS ID: 359432 (history)  
Age: 12.0  
Gender: Female  
Location: Foreign  
Vaccinated:2009-09-15
Onset:2009-09-15
   Days after vaccination:0
Submitted: 2009-10-05
   Days after onset:20
Entered: 2009-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB692DC / 0 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Chills, Dizziness, Nausea, Product quality issue, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Rhinitis
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 15Sep2009, 114/78; Heart rate, 15Sep2009, 90-101
CDC Split Type: B0593372A

Write-up: This case was reported by a physician and described the occurrence of rigors in a 12-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 15 September 2009, the subject received 1st dose of ENGERIX B (intramuscular, unknown deltoid). On 15 September 2009, 45 minutes after vaccination with ENGERIX B, the subject experienced rigors, nausea, dizziness and fever (37,3 deg C). The subject was hospitalised. Blood pressure was measured during one hour: 130/90; 115/70; 133/87; 114/78. Heart rate was 90 and then 101. At the time of reporting the events were improved. The physician considered the events were possibly related to vaccination with ENGERIX B. This case has been associated with a product complaint. This is 1 of 2 cases reported by the same school where the vaccination was done with the product from the same batch. Follow up information received on 17 September 2009:The subject stayed at hospital for 6 hours under observation. The events disappeared completely. The patient was discharged in the evening. On 15 September 2009, the events were resolved. The next day, she returned to school. This case has been reported to a regulatory agency. Follow up information received on 22 September 2009 from regulatory authority: The treatment given was: giving a patient a lot of liquid; blood pressure monitoring; pulse monitoring and temperature control- done at hospital. The school doctor confirmed that the patient did not have any known allergy. When the report from Authority will be available, additional information will be send to us. Follow up information received on 25 September 2009 from regulatory authority: It was confirmed that the subject did not have any chronic disease and was not known for any allergies. One week before vaccination the subject did have rhinitis. The adverse events lasted from 9.15 until 11.30 AM. In addition to body temperature, blood pressure and pulse, the oxygen saturation had also been monitored at hospital. No value or results provided. Follow up information received on 29 September 2009: Technical assessment of QA department was provided with the following conclusion: based on the fact that no precise technical problem was reported, no technical investigation has been performed accordingly; GlaxoSmithKline Biologicals considers this complaint has not verified.


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