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Case Details

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VAERS ID:359411 (history)  Vaccinated:2009-09-28
Age:39.0  Onset:2009-09-29, Days after vaccination: 1
Gender:Female  Submitted:2009-09-29, Days after onset: 0
Location:Georgia  Entered:2009-10-05, 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: SYNTHROID 0.15; PNV; VALTREX 500g
Current Illness:
Preexisting Conditions: Pregnancy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED07249111A0IMRA
Administered by: Other     Purchased by: Private
Symptoms: Abdominal discomfort, Dizziness, Feeling hot, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Dizzy, hot, nauseated, intestinal upset, pt reported fever of 99.7 degrees.

VAERS ID:359412 (history)  Vaccinated:2009-09-22
Age:66.0  Onset:2009-09-22, Days after vaccination: 0
Gender:Male  Submitted:2009-09-30, Days after onset: 8
Location:Illinois  Entered:2009-10-05, 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: AMLODIPINE 2.5mg; OMEPRAZOLE 40mg
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS97839P2 IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.06274 IMRA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Injection site cellulitis, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Patient was in to pick up an Rx on 9/29/09. He said that after he received his vaccine last week, he reacted to the pneumonia vaccine. His arm was swollen, red and very painful. He went to CDH ER and they diagnosed it as cellulitis from the vaccine and treated. His arm is now fine.

VAERS ID:359413 (history)  Vaccinated:2009-09-22
Age:5.0  Onset:2009-09-23, Days after vaccination: 1
Gender:Male  Submitted:2009-09-28, Days after onset: 5
Location:Florida  Entered:2009-10-05, 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: None
Current Illness: Left OM; URI; Wheeze - resolved.
Preexisting Conditions: Developmental / speech delay; asthma with Illness.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2398BA4IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURD03043SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0764Y1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0927Y1SCLA
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)
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)  Vaccinated:2009-09-30
Age:36.0  Onset:2009-10-03, Days after vaccination: 3
Gender:Female  Submitted:2009-10-04, Days after onset: 1
Location:Mississippi  Entered:2009-10-04
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED05949111A0 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)
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)  Vaccinated:2009-03-04
Age:72.0  Onset:2009-03-06, Days after vaccination: 2
Gender:Female  Submitted:2009-09-29, Days after onset: 206
Location:California  Entered:2009-10-05, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.013040SCLA
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)
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)  Vaccinated:2009-09-28
Age:52.0  Onset:2009-09-28, Days after vaccination: 0
Gender:Male  Submitted:2009-09-28, Days after onset: 0
Location:California  Entered:2009-10-05, Days after submission: 7
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) (Influenza (H1N1) (Influenza A (H1N1) 2009 Monovalent)~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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS97839P10IMLA
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)
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)  Vaccinated:0000-00-00
Age:33.0  Onset:0000-00-00
Gender:Male  Submitted:2009-09-29
Location:Virginia  Entered:2009-10-05, Days after submission: 6
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
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
YF: YELLOW FEVER (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:
Write-up: None

VAERS ID:359418 (history)  Vaccinated:2009-09-23
Age:0.34  Onset:2009-09-23, Days after vaccination: 0
Gender:Female  Submitted:2009-09-24, Days after onset: 1
Location:New Mexico  Entered:2009-10-05, 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: No
Preexisting Conditions: None; NKDA; NKA
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURB109020UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHD030700UNRL
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)
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)  Vaccinated:2009-09-21
Age:1.19  Onset:2009-09-21, Days after vaccination: 0
Gender:Female  Submitted:2009-09-22, Days after onset: 1
Location:Florida  Entered:2009-10-05, Days after submission: 13
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 PASTEURC3430AA3UNRL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT3178EA1UNLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0427Y1SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0849Y1SCLA
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: Slight raised red hives at injection site. Right anterio lateral thigh.

VAERS ID:359420 (history)  Vaccinated:2009-09-11
Age:71.0  Onset:2009-09-11, Days after vaccination: 0
Gender:Female  Submitted:2009-09-29, Days after onset: 18
Location:Michigan  Entered:2009-10-05, Days after submission: 6
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) (AFLURIA)CSL LIMITED05849111A UNLA
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)
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)  Vaccinated:2009-09-21
Age:11.0  Onset:0000-00-00
Gender:Female  Submitted:2009-09-23
Location:Washington  Entered:2009-10-05, 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: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU3021AA IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B038CA IMLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: Rash @ injection site - treated with anti-histamines.

VAERS ID:359422 (history)  Vaccinated:2006-12-19
Age:0.99  Onset:2009-09-25, Days after vaccination: 1011
Gender:Female  Submitted:2009-09-28, Days after onset: 3
Location:Georgia  Entered:2009-10-05, 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)SANOFI PASTEURUT2176JA0UNRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1025F0UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08691F3UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1146F0UNRL
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)
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)  Vaccinated:2009-09-24
Age:3.0  Onset:2009-09-24, Days after vaccination: 0
Gender:Female  Submitted:2009-09-25, Days after onset: 1
Location:West Virginia  Entered:2009-10-05, 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: PENICILLINS
Diagnostic Lab Data:
CDC Split Type: WV0908
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3177BA3IMLL
Administered by: Private     Purchased by: Public
Symptoms: Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
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)  Vaccinated:2009-09-22
Age:35.0  Onset:2009-09-22, Days after vaccination: 0
Gender:Female  Submitted:2009-10-02, Days after onset: 10
Location:Kansas  Entered:2009-10-05, 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: 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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLU468AA IMRA
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)
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)  Vaccinated:2009-09-23
Age:2.0  Onset:2009-09-24, Days after vaccination: 1
Gender:Male  Submitted:2009-09-28, Days after onset: 4
Location:Michigan  Entered:2009-10-05, 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: BENADRYL PRN
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU3208AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
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)  Vaccinated:2009-09-11
Age:89.0  Onset:2009-09-11, Days after vaccination: 0
Gender:Female  Submitted:2009-09-15, Days after onset: 4
Location:Minnesota  Entered:2009-10-05, 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:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS97841P10UNLA
Administered by: Other     Purchased by: Other
Symptoms: Injection site haematoma, Injection site reaction
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
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)  Vaccinated:2009-09-21
Age:86.0  Onset:2009-09-27, Days after vaccination: 6
Gender:Female  Submitted:2009-09-28, Days after onset: 1
Location:New York  Entered:2009-10-05, Days after submission: 7
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:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS97840P110IMLA
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)
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)  Vaccinated:2009-09-25
Age:91.0  Onset:2009-09-25, Days after vaccination: 0
Gender:Male  Submitted:2009-09-28, Days after onset: 3
Location:New Jersey  Entered:2009-10-05, 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: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS97839P2 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Patient is reporting dizziness.

VAERS ID:359429 (history)  Vaccinated:2009-09-30
Age:28.0  Onset:2009-09-30, Days after vaccination: 0
Gender:Male  Submitted:2009-10-05, Days after onset: 5
Location:Missouri  Entered:2009-10-05
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
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA279AA IMLA
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)
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)  Vaccinated:2005-08-30
Age:  Onset:2006-11-29, Days after vaccination: 456
Gender:Male  Submitted:2009-10-05, Days after onset: 1040
Location:Foreign  Entered:2009-10-05
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
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS 1IMLA
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)
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 ophthal

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