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Case Details (Sorted by Vaccination Date)

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VAERS ID: 275413 (history)  
Age: 1.27  
Gender: Male  
Location: Ohio  
Vaccinated:2007-03-30
Onset:2007-04-01
   Days after vaccination:2
Submitted: 2007-04-02
   Days after onset:1
Entered: 2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1813AB / 3 RL / IM

Administered by: Public       Purchased by: Public
Symptoms: Injection site erythema, Injection site rash, Similar reaction on previous exposure to drug
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~ ()~2~0.33~In Patient
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 2 days after receiving Dtap #4 mom reports tiny bumps & redness at injection site. No swelling. Pt had similar RXN after shots at 2 mos and 4 mos of age. Reported to VAERS.


VAERS ID: 275433 (history)  
Age: 51.0  
Gender: Female  
Location: Georgia  
Vaccinated:2007-03-30
Onset:0000-00-00
Submitted: 2007-04-02
Entered: 2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB068AA / - LA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z04202 / - LA / SC
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2491AA / - RA / IM
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR Z05722 / - RA / IM
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UE944AA / 0 LA / SC

Administered by: Public       Purchased by: Private
Symptoms: Hepatic enzyme abnormal, No adverse effect
SMQs:, Liver related investigations, signs and symptoms (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: Unknown
Current Illness: None
Preexisting Conditions: Osteopenia
Diagnostic Lab Data: Pt reported liver enzymes elevated prior to vaccines.
CDC Split Type:

Write-up: Pt had history of receiving Hepatitis B series several years ago. Desired vaccination with Hepatitis A and was given Twinrix. Pt concerned about liver status and wanted maximum Hepatitis A protection for trip out of country. On 4/8/07 pt denies problems.


VAERS ID: 275558 (history)  
Age: 10.0  
Gender: Male  
Location: Louisiana  
Vaccinated:2007-03-30
Onset:2007-03-31
   Days after vaccination:1
Submitted: 2007-04-03
   Days after onset:3
Entered: 2007-04-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1503F / 1 UN / SC

Administered by: Private       Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction, Refusal of treatment by relative
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: Local reaction. Mother declined for child to be seen by doctor. She described area size of a baseball, swollen, red, and warm to touch


VAERS ID: 275562 (history)  
Age: 23.0  
Gender: Female  
Location: Maine  
Vaccinated:2007-03-30
Onset:2007-04-03
   Days after vaccination:4
Submitted: 2007-04-03
   Days after onset:0
Entered: 2007-04-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0187U / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Local reaction, Urticaria
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: mIRENA iud
Current Illness: NO
Preexisting Conditions: CODEINE,SULFA,CEFZIL
Diagnostic Lab Data:
CDC Split Type:

Write-up: LOCAL REACTION WITH URTICARIA


VAERS ID: 275595 (history)  
Age: 25.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2007-03-30
Onset:2007-03-30
   Days after vaccination:0
Submitted: 2007-04-02
   Days after onset:3
Entered: 2007-04-04
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U1944BA / 0 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Pruritus, 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: Prenatal Vitamins
Current Illness: None
Preexisting Conditions: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Itching and rash started on the soles of the feet; then the itching and rash moved to the legs, knees, back, and stomach areas.


VAERS ID: 275596 (history)  
Age: 52.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-03-30
Onset:2007-04-02
   Days after vaccination:3
Submitted: 2007-04-04
   Days after onset:2
Entered: 2007-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2454AA / 0 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Headache, Malaise, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: local reaction lasting $g 3 months~Td Adsorbed (no brand name)~2~29.00~In Patient
Other Medications: Celebrex, Premarin, Lipitor, HCTZ, ASA
Current Illness: none
Preexisting Conditions: osteoarthritis, hyperlipidemia
Diagnostic Lab Data: none performed at this time
CDC Split Type:

Write-up: body aches, pain, malaise, fever 101.2, nausea, headache began approximately 72 hours after administration of vaccine. Resolved within 48 hours


VAERS ID: 275598 (history)  
Age: 39.0  
Gender: Female  
Location: California  
Vaccinated:2007-03-30
Onset:2007-03-31
   Days after vaccination:1
Submitted: 2007-04-04
   Days after onset:4
Entered: 2007-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2632AA / 0 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Lethargy, Limb discomfort, Local reaction, Malaise, Musculoskeletal pain, Oedema peripheral, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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: NO
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: RN had a significant local reaction to the TDAP shot. She also reported a fever as high as 103 and feeling very lethargic and feeling "sick" and excessively sore throughout her arm and across her shoulders after recieving the vaccine. Dr looked at her vaccination site, and told her it looked like she had developed cellulitis. Her arm is red, and swollen from her deltoid to the mid portion of her upper arm. STARTED ON BACTRIM AND RIFAMPIN


VAERS ID: 275663 (history)  
Age: 4.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2007-03-30
Onset:2007-03-30
   Days after vaccination:0
Submitted: 2007-04-04
   Days after onset:5
Entered: 2007-04-05
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B092BA / - - / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: XOPENEX, FLOVENT
Current Illness: None - immunization visit
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Extensive erythema involving LLE. Redness extended from groin to knee within 48 hours. Patient given oral antibiotics. Redness resolved within 36-48 hours.


VAERS ID: 275716 (history)  
Age: 22.0  
Gender: Male  
Location: New Hampshire  
Vaccinated:2007-03-30
Onset:2007-03-31
   Days after vaccination:1
Submitted: 2007-04-05
   Days after onset:5
Entered: 2007-04-06
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2610AA / - LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Chest pain, Fatigue, Headache, Injection site erythema, Injection site pain, Myalgia, Nausea, Palpitations
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (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: Advair, Albuterol
Current Illness: none
Preexisting Conditions: none-except environmental allergies/asthma
Diagnostic Lab Data:
CDC Split Type:

Write-up: 24 hours after injection experienced headache, chest pain, nausea, heart racing, fatigue, muscle aches, lasting about 24 hours. Also soreness at injection site lasting 5 days and redness. Heat to arm (Pt entered 4/4/07).


VAERS ID: 275958 (history)  
Age: 35.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2007-03-30
Onset:2007-03-31
   Days after vaccination:1
Submitted: 2007-04-04
   Days after onset:4
Entered: 2007-04-10
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / MASS. PUB HLTH BIOL LAB TD166 / 1 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Cellulitis, Erythema, Induration, Pain, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Evacuated in RUE 4/1/07. Temp 98.9 2" right deltoid, redness, warmth, induration and pain. Denies itchiness. No rash noted. Dx: Right arm cellulitis - ?? allergic reaction.


VAERS ID: 276198 (history)  
Age: 62.0  
Gender: Male  
Location: Foreign  
Vaccinated:2007-03-30
Onset:2007-03-30
   Days after vaccination:0
Submitted: 2007-04-12
   Days after onset:13
Entered: 2007-04-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB069BA / - RA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / - LA / IM
TD: TETANUS DIPHTHERIA (NO BRAND NAME) / AVENTIS PASTEUR - / - LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Blood bilirubin abnormal, Blood bilirubin increased, Blood pressure, Blood urine present, C-reactive protein increased, Chills, Cough, General physical health deterioration, Hyperhidrosis, Pyrexia, Transaminases, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (narrow), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad)

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: Bilirubin total 2.8, blood pressure 70/100, C-reactive protein 383, Transaminases normal, White blood cell count 19,000
CDC Split Type: D0052814A

Write-up: This case was reported by a physician and described the occurrence of bilirubin abnormal in a 62-year-old male subject who was vaccinated with Twinrix for prophylaxis. Co-suspect vaccine included Revaxis. On 30 March 2007, the subject received 2nd dose (verbally booster dose was mentioned) of Twinrix (intramuscular, right deltoid). On the same day the subject received unspecified dose of Revaxis (intramuscular, left deltoid). On 30 March 2007, 1 hour after vaccination with Twinrix and Revaxis, the subject experienced weakness, chills, fever and he broke out into sweat. General condition worsened. On 01 April 2007, blood in urine was found. Blood examples showed abnormal bilirubin (2.8), normal transminases, increased C-reactive protein (383) and increased numbers of leucocytes (19,000). Blood pressure was 70/110. The subject developed cough. This case was assessed as medically serious by manufacturer. At the time of reporting break out into sweat, chills, fever and worsening of general condition improved. At the time of reporting the outcome of other events was unspecified. The physician considered the events were possibly related to vaccination with Twinrix. Follow-up information for further examinations has been requested.


VAERS ID: 338862 (history)  
Age: 0.5  
Gender: Male  
Location: Foreign  
Vaccinated:2007-03-30
Onset:2007-04-01
   Days after vaccination:2
Submitted: 2009-02-02
   Days after onset:673
Entered: 2009-02-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA266A / - UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 23618 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Developmental delay, Encephalopathy, Psychomotor retardation, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Past therapies included PREVENAR and INFANRIX HEXA on 16-Jan-2007.
Diagnostic Lab Data: None Provided.
CDC Split Type: ITWYEG03010609

Write-up: Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 5-month-old male patient who experienced encephalopathy, psychomotor retardation and convulsions. The patient received the second dose on 30-Mar-2007. Additional suspect medication included INFANRIX HEXA. The patient experienced encephalopathy, psychomotor and convulsions on 01-Apr-2007. The events involved inpatient hospitalization. The patient was treated for convulsions with SABRIL, DEPAKIN and KEPPRA. It is reported that the patient is presently 27 months old and does not crawl, walk, does not respond to stimuli and shows convulsions many times during the day. No additional information was available at the time of this report.


VAERS ID: 348504 (history)  
Age: 0.14  
Gender: Male  
Location: Foreign  
Vaccinated:2007-03-30
Onset:2009-05-16
   Days after vaccination:778
Submitted: 2009-06-04
   Days after onset:19
Entered: 2009-06-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 0 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Bacterial DNA test positive, Bronchitis, Haemophilus infection
SMQs:

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: Hemophilus influenzae DNA test, 16May2009, HIB
CDC Split Type: B0575980A

Write-up: This case was reported by a physician and described the occurrence of haemophilus influenzae breakthrough infection in a 27-month-old male subject who was vaccinated with INFANRIX HEXA (GlaxoSmithKline), DTPa-IPV-HIB. On 30 March 2007, 2 June 2007 and 10 August 2007, the subject received 1st dose, 2nd dose and 3rd dose of INFANRIX HEXA (unknown route and injection site). On 30 December 2008, the subject received booster dose of DTPa-IPV-HIB (unknown route and injection site). The lot numbers were not available. On 16 May 2009, 4 months after vaccination with the booster DTPa-IPV-HIB, the subject experienced haemophilus influenzae breakthrough infection. On 16 May 2009, the laboratory test performed on mucus was positive for haemophilus influenzae serotype B. On 26 May 2009, the subject experienced bronchitis. The physician didn''t think that the bronchitis was related to vaccination with INFANRIX HEXA. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.


VAERS ID: 515461 (history)  
Age: 0.2  
Gender: Female  
Location: Foreign  
Vaccinated:2007-03-30
Onset:2007-04-01
   Days after vaccination:2
Submitted: 2013-12-03
   Days after onset:2438
Entered: 2013-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 0 - / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Aerophagia, Blood iron decreased, Blood test normal, Chest X-ray normal, Cold agglutinins negative, Culture stool negative, Culture urine negative, Dark circles under eyes, Decreased appetite, Glomerular filtration rate increased, Haematocrit normal, Haemoglobin normal, Helicobacter test negative, Pallor, Pharyngeal exudate, Protein C increased, Pyrexia, Red blood cell count normal, Rotavirus test negative, Streptococcus test negative, Urinary tract infection, Viral test positive, Weight increased, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test, negative; Blood test, agglu - ; Body temperature, 38.5deg C; Glomerular filtration rate, 18May2007, 32-56; Glomerular filtration rate inc, increased; Hematocrit, 18May2007, 43; Hemoglobin, 18May2007, 10.8; Iron, 18May2007, 26; Leukocyte count NOS, 18May2007, 15200; Leukocyte count NOS, 15-17000'' Pharyngeal culture positive, 18May2007, H. influenza; Protein C, 18May2007, 3; Red blood cell count, 18May2007, 3,8c/mm3; Stool culture, 18May2007, negative; Streptolysin O antibody normal, normal; Thorax x-ray, normal; Urine culture, 18May2007, negative
CDC Split Type: B0471564A

Write-up: This case was reported by a physician (via a sales representative) and described the occurrence of urinary tract infection in 3 month-old female who was vaccinated with ROTARIX (GlaxoSmithKline). On 30 March 2007, the subject received 1st dose of ROTARIX (oral). The vaccine batch number was not provided. Since the vaccination with ROTARIX, the subject presented lack of appetite. She also presented intermittent episodes of fever of about 38.5 deg C that subsided after taking antipyretics. Since vaccination the subject''s weight increased from 4.5 Kg to 5 kg.The week before Easter the subject was hospitalised during 72 hours because she did not eat anything. During this time an urinary infection was detected. The subject also presented aerophagia and bloated belly. Different analysis were performed to discharge different pathologies as thorax x-ray which was normal; protein C in blood which was positive; leulocytes count NOS (15-17000), glomerular filtration rate increased; Streptolysin O antibody which was normal. At the time of the report the results of an exudated pharynges - nasal and stool culture was pending. At the time of reporting, the outcome of the events was unspecified. Follow up received on 28 May 2007: The subject was much better and she was getting over. The same day after vaccination the subject had fever. Relevant test results included negative stool culture for Salmonella, Rotavirus and Campylobacter. On 18 May 2007 relevant test showed: red blood cell (3.8) ; hemoglobine (10.8) ; hematocrit (43) ; leukocytes (15200) ; glomerular filtration rate (32-56) , iron (26) ; C-protein (3). The nasopharyngeal culture showed H. Influenza. the urine culture was negative; aggutination in blood was negative. Furthermore in the report it was specifies that from 15 May 2007 to 24 May 2007 the subject gain 170 g on weight. On 25 May 2007 the subject received unspecified vaccine, and the following day she had fever which was solved with antipyretics. She also was pale and presented ring under the eyes. The physician was not sure about the relationship of the events with ROTARIX but she could not discharged. Follow-up information received on 25 November via a literature article: This case was also reported by a regulatory authority (ES-AGEMED-719497241).


VAERS ID: 275429 (history)  
Age: 1.56  
Gender: Female  
Location: Illinois  
Vaccinated:2007-03-31
Onset:2007-03-31
   Days after vaccination:0
Submitted: 2007-04-02
   Days after onset:2
Entered: 2007-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08681D / 3 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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:

Write-up: MOTHER STATES LEG BECAME RED THAT NIGHT. SWELLING STARTED AND BY TODAY( MONDAY) THE THIGH IS SWOLLEN AND RED FROM THE KNEE TO THE HIP. TOOK TO DR. FOR HIM TO EVAULUATE. STATES NOT INFECTED JUST A REACTION TO THE PREVNAR IMMUNIZATION. ADVISED TO GIVE BENADRYL AND IBUPROFEN BY MD.


VAERS ID: 275593 (history)  
Age: 1.23  
Gender: Female  
Location: New Jersey  
Vaccinated:2007-03-31
Onset:2007-04-04
   Days after vaccination:4
Submitted: 2007-04-04
   Days after onset:0
Entered: 2007-04-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B040BA / 3 RL / IM
HIBV: HIB (OMNIHIB) / SANOFI PASTEUR 1014F / 3 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site reaction
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Has local burn on arm- on eflex250/5 1tsp.BIDX10days and Silvadene locally to burn.
Current Illness: Burn on Rt.arm.
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Local site reaction on Rt.thigh. Hydrocortisone cream 2.5% as directed.


VAERS ID: 276011 (history)  
Age: 1.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2007-03-31
Onset:2007-04-04
   Days after vaccination:4
Submitted: 2007-04-04
   Days after onset:0
Entered: 2007-04-11
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 1009F / 0 RA / -
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 1481F / 0 LA / -

Administered by: Private       Purchased by: Unknown
Symptoms: Blood culture positive, Febrile convulsion, Full blood count
SMQs:, Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Viral URI/ early sinusitis
Preexisting Conditions: None
Diagnostic Lab Data: BC+, CBC at hosp
CDC Split Type:

Write-up: Febrile seizure on 4/4


VAERS ID: 277243 (history)  
Age: 4.0  
Gender: Female  
Location: Utah  
Vaccinated:2007-03-31
Onset:2007-04-01
   Days after vaccination:1
Submitted: 2007-04-23
   Days after onset:22
Entered: 2007-04-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2570BA / 4 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Y10322 / 3 RL / SC
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 1564F / 1 LL / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site pruritus, 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: poss. runny nose
Preexisting Conditions: poss heart murmur
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Left thigh welted, itchy, red, swollen tx''d with hot washcloths, calamine lotion


VAERS ID: 278896 (history)  
Age: 8.0  
Gender: Male  
Location: California  
Vaccinated:2007-03-31
Onset:2007-04-02
   Days after vaccination:2
Submitted: 2007-04-25
   Days after onset:23
Entered: 2007-05-17
   Days after submission:22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 130T / 1 LA / -

Administered by: Other       Purchased by: Private
Symptoms: Cellulitis, Hypersensitivity, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was described to have allergic reaction (swelling and pain) visit on 4/2/07 with F.N.P. dx: cellulitis, Rx: Keflex 250mg/ 5ml 1 tsp QID x 5 days.


VAERS ID: 280878 (history)  
Age: 46.0  
Gender: Male  
Location: Oklahoma  
Vaccinated:2007-03-31
Onset:2007-05-20
   Days after vaccination:50
Submitted: 2007-06-07
   Days after onset:18
Entered: 2007-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U1820FA / - LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Borrelia burgdorferi serology negative, Coordination abnormal, Dyspnoea, Guillain-Barre syndrome, Hyperaesthesia, Hypoaesthesia, Motor dysfunction, Muscular weakness, Paraesthesia, Sensory disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Demyelination (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None; being treated in ER for a dog bite
Preexisting Conditions: None
Diagnostic Lab Data: Tick diseases ruled out LABS: EMG/NCS was done in office prior to admission & was reported as markedly abnormal. CSF glucose 56, protein 151. Blood WBC 6.1.
CDC Split Type:

Write-up: On 5/20/07 patient noted paresthesias in hands and feet, weakness in hands and legs, decreased dexterity. Minimal amount of shortness of breath upon exertion. Some mild skin sensations in weeks before these symptoms, unable to exactly date beginning of those symptoms. Admitted for probable Guillain-Barre syndrome on 06/05/07 and treated with IVIG. 6/8/07 Received partial hospital medical records which reveal patient initially seen in ER on 3/31 for treatment of dog bite on left lower leg received in line of duty (police officer). Received wound care & Td injection. Lot # confirms VAERS report. Patient admitted to hospital 6/4/07 after experienced paresthesias of hands & feet associated w/weakness of legs & decreased dexterity & weakness of hands. Symptoms began abruptly 12 days prior to admission. Neuro exam on admit revealed areflexia throughout. LP done on admission & PICC line placed for IVIG. No D/C summary w/records. Call to med records to request d/c summary. 6/12/07 Received EMG/NCS report from neurologist which reveals very diminished peroneal amplitude & slowed tibial conduction velocity, prolonged motor latency & median sensory latency w/diminished amplitude. F wave latencies prolonged in median & ulnar nerves. Unable to determine clear tibial nerve F wave. Study felt to be c/w GBS. 1/11/2010 Continued weakness and bouts of numbness in hands and feet.


VAERS ID: 289978 (history)  
Age: 25.0  
Gender: Male  
Location: Ohio  
Vaccinated:2007-03-31
Onset:2007-04-10
   Days after vaccination:10
Submitted: 2007-08-22
   Days after onset:134
Entered: 2007-09-06
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV108 / 5 UN / SC
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020072 / 0 UN / ID
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR Z1102 / 2 UN / IM

Administered by: Military       Purchased by: Military
Symptoms: Blood test, Body temperature increased, Muscle spasms, Musculoskeletal stiffness
SMQs:, Neuroleptic malignant syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Bloodwork
CDC Split Type:

Write-up: About 1 week after received shot stiffness and cramping on left side below rib cage with 104 degree temp x 2 days; started day before cramping.


VAERS ID: 290048 (history)  
Age: 48.0  
Gender: Male  
Location: Ohio  
Vaccinated:2007-03-31
Onset:2007-03-31
   Days after vaccination:0
Submitted: 2007-04-14
   Days after onset:14
Entered: 2007-09-06
   Days after submission:145
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Military       Purchased by: Military
Symptoms: Abdominal pain, Arthralgia, Dizziness, Fatigue, Headache, Influenza, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (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: Abd pain LLQ of nephrolithiasis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Flu like symptoms (x 2 wks) myalgia, arthralgia fatigue. Myalgia/arthralgia hands, feet, ankle, knees elbows. Also had lightheaded but no vertigo. Rare HA. Abd pain but this preceded vaccine. Ibuprofen/Aleve


VAERS ID: 290078 (history)  
Age: 45.0  
Gender: Male  
Location: Ohio  
Vaccinated:2007-03-31
Onset:2007-04-15
   Days after vaccination:15
Submitted: 2007-04-28
   Days after onset:13
Entered: 2007-09-06
   Days after submission:131
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV108 / 0 LA / UN

Administered by: Military       Purchased by: Military
Symptoms: Balance disorder, Blood pressure increased, Dizziness, Feeling jittery, Nasopharyngitis, Sleep disorder
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Vestibular disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lipitor 10mg, Atenolol 50mg
Current Illness: None
Preexisting Conditions: HTN - was well controlled with med
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received 1st shot 31 Mar, 2nd on 14 Apr, on 15 Apr woke up wide awake about 0300 hrs, unable to sleep, slept about 4 hrs the night of the 16th, very jittery, felt like he "took 10 Sudafed", dizzy, off balance, cold symptoms, increased BP on 23 Apr.


VAERS ID: 365889 (history)  
Age:   
Gender: Male  
Location: New Jersey  
Vaccinated:2007-03-31
Onset:2007-04-02
   Days after vaccination:2
Submitted: 2009-11-08
   Days after onset:951
Entered: 2009-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 1106F / 1 LL / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Erythema, Rash generalised
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: PHYSICAL EXAM ONLY
CDC Split Type:

Write-up: RED AND FLESH TONE RASH ON FACE AND BODY. SKIN HAS NOT CLEARED SINCE. ADVISED NOT TO WASH W/CLOTH AND SOAP.


VAERS ID: 276700 (history)  
Age: 59.0  
Gender: Male  
Location: Foreign  
Vaccinated:2007-03-31
Onset:2007-03-31
   Days after vaccination:0
Submitted: 2007-04-17
   Days after onset:17
Entered: 2007-04-18
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0272F / - UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacteraemia, Cellulitis
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0704ARG00001

Write-up: Information has been received from a physician concerning a 59 year old male who on 31-MAR-2007 was vaccinated with Pneumovax. On 31-Mar-2007 the patient experienced bacteremia and cellulitis. The patient''s cellulitis persisted. The reporter felt that bacteremia and cellulitis were related to therapy with Pneumovax. The reporter considered the patient''s bacteremia and cellulitis to be other important medical events. Lot No. NE36810, expiring on 07/03/2008. Batch#NE36810, Lot#654796/0278F. The reporter was concerned about the lot and would like a lot check.


VAERS ID: 389499 (history)  
Age: 20.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-03-31
Onset:0000-00-00
Submitted: 2010-05-27
Entered: 2010-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB306BC / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acute lymphocytic leukaemia recurrent, Blood fibrinogen normal, Condition aggravated, Fatigue, Haematocrit decreased, Haemoglobin decreased, Lymphocyte count normal, Mean cell haemoglobin concentration increased, Mean cell haemoglobin increased, Monocyte count decreased, Neutrophil count decreased, Platelet count decreased, Red blood cell count decreased, Red blood cell sedimentation rate increased, Stem cell transplant, White blood cell count decreased
SMQs:, Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow)

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: chemotherapy, erythrocyte sedimentation rate incr, lymphoblastic leukemia
Diagnostic Lab Data: erythrocyte sedimentation rate, 01Sep2005, 22mm; erythrocyte sedimentation rate, 01Sep2005, 9mm; erythrocyte sedimentation rate, 23Feb2007, 39mm; erythrocyte sedimentation rate, 23Feb2007, 19mm; erythrocyte sedimentation rate, 18Apr2007, 120mm; erythrocyte sedimentation rate, 18Apr2007, 115mm; fibrinogen, 18Apr2007, 2.82g/l; Hematocrit, 01Sep2005, 35.2%; Hematocrit, 23Feb2007, 35.2per cent; Hematocrit, 18Apr2007, 18 per cent; hemoglobin, 23Feb2007, 11.8g/dL; hemoglobin, 18Apr2007, 6.5g/dL; leukocyte count NOS, 01Sep2005, 9060/mm3; leukocyte count NOS, 23Feb2007, 3650/mm3; leukocyte count NOS, 18Apr2007, 3130/mm3; lymphocyte count, 01Sep2005, 3080/mm3; lymphocyte count, 23Feb2007, 2519/mm3; lymphocyte count, 18Apr2007, 2473/mm3; mean cell he
CDC Split Type: B0653116A

Write-up: This case was reported by a consumer and described the occurrence of fatigue in a 20-year-old female subject who was vaccinated with hep B. A physician or other health care professional has not verified this report. The subject''s past medical history included acute lymphoblastic leukemia in 1995, treated with chemotherapy. In 2005, a haematologist considered the leukemia as resolved. In September 2005, full blood count was normal, except erythrocyte sedimentation rate at upper limit at 9 and 22 mm at one and two hours (normal upper limit: 7 and 21). On 15 February 2007, the subject received a 1st dose of hep B vaccine (batch, route and injection site unknown). Rapidly after, the subject presented with a severe fatigue. A blood work-up was thus prescribed and showed on 23 February 2007 a decrease of red blood cells (3.69 M/mm3), of hematocrit (35.2 per cent), of leukocyte count (3650/mm3), of neutrophil count (913/mm3) and of monocyte count (70/mm3). Erythrocyte sedimentation rate was increased at 19 and 39 mm at one and two hours. On 31 March 2007, the subject received a 2nd dose of hep B vaccine (batch, route and injection site unknown). Less than one month after vaccination, the subject experienced fatigue again. On 18 April 2007, blood work-up showed decreased of red blood cells (1.98 M/mm3), of hemoglobin (6.5 G/dLl), of hematocrit (18 per cent), of leukocyte count (3130/mm3), of neutrophil count (532/mm3), of monocyte count (60/mm3) and of platelet count (148 000/mm3). There was also an increase of erythrocyte sedimentation rate (115 and 120 mm at one and two hours). At that time, diagnosis of recurrent acute lymphoblastic leukemia was ruled out. In November 2007, the subject received umbilical cord blood transplantation for unspecified indication. At the time of reporting, outcome of the events was unknown. Causality relationship was not specified. Follow-up information received on 18 May 2010 from the subject: In fact, the consumer was also a paediatric nurse (case medically confirmed). In 1995, chemotherapy for leukemia included cyclosporin. Before vaccination with hep B, the subject had no fatigue. The subject had no concurrent medications at the time of hep B vaccination. On 15 February 2007, the subject received a 1st dose of ENGERIX B adult (batch AHBVB219CB, route and injection site unknown). On 31 March 2007, the subject received 2nd dose and 1st dose of ENGERIX B adult (AHBVB306BC, route and injection site unknown). In April 2007, less than one month after second vaccination with ENGERIX B adult, the subject was diagnosed with recurrence of acute lymphoblastic leukemia. After stem cell transplantation, at unspecified dates, the subject received various unspecified vaccines (except hepatitis B vaccines) without safety problems. At the time of reporting, the subject was treated with hydrocortisone to avoid stem cell transplant rejection. The subject was in remission (outcome improved). According to a physician, the causal relationship between recurrence of acute lymphoblastic leukemia and ENGERIX B vaccination was unrelated. This case was assessed as medically serious by GSK.


VAERS ID: 276581 (history)  
Age: 28.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-04-01
Onset:2007-04-02
   Days after vaccination:1
Submitted: 2007-04-10
   Days after onset:8
Entered: 2007-04-17
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV106 / 6 RA / SC

Administered by: Military       Purchased by: Military
Symptoms: Hypokinesia, Injection site reaction, Pain, Pruritus, Skin warm, Swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: NONE
Preexisting Conditions: N/A
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Received shot Sunday - symptoms visible by Monday PM; pain began Monday AM. Pain/physical charac. subsided Friday time frame. Physical charac. were: itching, swelling down to elbow - pass elbow (looked deformed), skin very hot to touch. Small welt still evident at injection site, decreased movement. Treatment: Ibuprofen (800 mg) and instant cold compresses.


VAERS ID: 276597 (history)  
Age: 24.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2007-04-12
   Days after onset:11
Entered: 2007-04-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 0 - / -

Administered by: Military       Purchased by: Military
Symptoms: Abdominal pain upper, Back pain, Injection site rash, Injection site urticaria, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: rash and welt at site
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: rash and welt at site (immediate reaction and still there) fever that lasted 2 days (began April 10, 2007) back aches (began April 10, 2007-continue) stomach pains (began April 10, 2007 and continue)


VAERS ID: 277167 (history)  
Age:   
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2007-04-20
   Days after onset:19
Entered: 2007-04-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - - / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Gaze palsy
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0704USA02668

Write-up: Information has been received from a physician concerning a 12-15 year old (exact age unknown) female patient who in April 2007, was vaccinated with a dose of Gardasil. The patient started to convulse in front of the physician and her eyes rolled back after receiving the Gardasil. The patient received medical attention. The physician''s office followed up with the patient the next day and she was doing fine. Upon internal review, convulsion was considered to be an other important medical event. The physician reported that another patient in the same age group convulsed after receiving the Gardasil. Additional information has been requested.


VAERS ID: 278376 (history)  
Age:   
Gender: Unknown  
Location: New Jersey  
Vaccinated:2007-04-01
Onset:0000-00-00
Submitted: 2007-05-09
Entered: 2007-05-11
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Oedema peripheral, Palatal disorder, Pharyngolaryngeal pain, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 200701462

Write-up: Initial report received on 27 April 2007 from a health care professional. A patient (unknown gender and age) received in on an unspecified date ("days ago") in April 2007 a dose of rabies vaccine (unknown manufacturer) for unknown indication and experienced sore throat, swelling of the hand and soft palate. Reporter denied itchiness. The patient admitted to the hospital and treated with prednisone. The patient''s outcome was unknown. No other information was provided.


VAERS ID: 278788 (history)  
Age: 12.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-04-01
Onset:2007-04-06
   Days after vaccination:5
Submitted: 2007-05-16
   Days after onset:40
Entered: 2007-05-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Blood bilirubin increased, Dysstasia, Full blood count, Hypoventilation
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (narrow), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: complete blood cell 04/06?/07 - results not reported, total serum bilirubin 04/06?/07 - bilirubin was elevated
CDC Split Type: WAES0705USA02024

Write-up: Information has been received from a mother concerning her 12 year old daughter with hypersensitivity to red dye who in February 2007, was vaccinated with a first dose of Gardasil. In April 2007, the patient was vaccinated with her second dose of Gardasil there were no concomitant medications. On approximately 06-APR-2007 the patient experienced stomach pain, difficulty standing, and shallow breathing. The patient went to the emergency room where laboratory data revealed bilirubin was elevated. At the time of the report, the patient was recovering from the stomach pain, difficulty standing, shallow breathing, and elevated bilirubin. The consumer considered stomach pain, difficulty standing, shallow breathing, and elevated bilirubin to be disabling. Additional information has been requested.


VAERS ID: 279043 (history)  
Age: 18.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2007-05-14
   Days after onset:43
Entered: 2007-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Urticaria
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? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0704USA00397

Write-up: Information has been received from a consumer concerning her daughter, an 18 year old female, who on 01-APR-2007 was vaccinated with a dose, 0.5ml, of Gardasil. There was no concomitant medication. The consumer reported that on 01-APR-2007 after receiving the vaccination, her daughter "broke out in hives." At the time of this report, the consumer''s daughter had not recovered from the hives. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 279061 (history)  
Age: 22.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2007-05-14
   Days after onset:43
Entered: 2007-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site induration, Injection site swelling, Metrorrhagia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unk
Current Illness:
Preexisting Conditions: Unk
Diagnostic Lab Data: Unk
CDC Split Type: WAES0704USA00748

Write-up: Information has been received from a nurse concerning a 22 year old female patient who in April 2007, was vaccinated with a first dose of Gardasil. The patient developed a knot and swelling at the injection site, after the vaccination. The next day the patient developed spotty vaginal bleeding. Unspecified medical attention was sought. The patient''s outcome was unknown. Follow-up from the patient''s physician stated that the patient did not feel that the vaginal bleeding was related to vaccination with Gardasil. No further details are available.


VAERS ID: 279067 (history)  
Age: 18.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2007-07-06
   Days after onset:96
Entered: 2007-05-17
   Days after submission:50
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0704USA00906

Write-up: Information has been received from a health professional (Nurse) concerning an 18 year old female patient who in approximately April 2007, was vaccinated with a first dose 0.5 mL of Gardasil. The patient experienced pain in the injection site right after receiving the injection. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information is not expected.


VAERS ID: 279235 (history)  
Age: 16.0  
Gender: Female  
Location: New York  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2007-05-14
   Days after onset:43
Entered: 2007-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Loss of consciousness, Syncope
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), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ALEVE
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0704USA03464

Write-up: Information has been received from a nurse practitioner, via a company representative, concerning a 16 year old female patient, who in April 2007, was vaccinated with a dose of Gardasil. Concomitant therapy included Menactra and Vaqta. The nurse practitioner stated that the patient "fainted after she received the Gardasil vaccination. " The "patient was given liquids to drink and something to eat, and she was fine." Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007. Initial follow up information has been received. There was no illness at the time of vaccination. The nurse practioner stated that as the patient walked from the exam room at 8:35, she felt lightheaded, passed out and fell and hit her right occipital area. The NP stated that the patient had not eaten that morning, and was given juice and a banana. The patient left the office after about 10 minutes, and recovered on the same day, 10-Mar-2007. No further information is expected.


VAERS ID: 279651 (history)  
Age: 18.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-04-01
Onset:0000-00-00
Submitted: 2007-05-14
Entered: 2007-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Menstruation irregular
SMQs:, Fertility disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0705USA00056

Write-up: Information has been received from a physician concerning an 18 year old female who sometime in April 2007 was vaccinated with her first dose of Gardasil. There was no concomitant medication. Subsequently, the patient claims that ever since she received the vaccination, she gets her "period every 13 days" as opposed to every 28 days which is considered normal for her. Unspecified medical attention was sought. The patient''s outcome was reported as unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 281653 (history)  
Age: 24.0  
Gender: Female  
Location: New York  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2007-06-13
   Days after onset:73
Entered: 2007-06-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood pressure, Chest pain, Heart rate irregular, Medical observation, Nausea, Throat tightness
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypersensitivity (broad)

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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: medical observation 04/??/07 - Blood Pressure Monitoring
CDC Split Type: WAES0706USA00814

Write-up: Information has been received from a nurse concerning a 24 year old female patient who in April 2007, "about two months ago" was vaccinated IM with a first dose of Gardasil. Within about a half an hour, the patient experienced chest pains, nausea, tightening of the throat, and an irregular heartbeat. The nurse reported that the patient has been hospitalized twice for the irregular heartbeat since receiving Gardasil. The nurse also reported that the patient has no prior history of heartbeat irregularities. Laboratory diagnostic studies included blood pressure and monitoring. At the time of this report, the patient''s outcome was unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 283146 (history)  
Age: 75.0  
Gender: Female  
Location: Kansas  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2007-06-14
   Days after onset:74
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Herpes zoster
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Herpes zoster
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0705USA00536

Write-up: Information has been received from a pharmacist and a registered nurse (clinical coordinator) concerning a 75 year old female with a history of a rash on 27-FEB-2007 and herpes zoster who in April 2007, was vaccinated with a 0.65 ml dose of Zostavax. subsequently the patient presented to the emergency room with a mild case of shingles/herpes zoster. The patient was treated with acyclovir and told to follow-up with her family physician. It was reported by the nurse that the patient had not been seen in the office since February 2007. It was reported that the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested.


VAERS ID: 283157 (history)  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2007-06-14
   Days after onset:74
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0705USA00887

Write-up: Information has been received from a physician concerning himself who in April 2007, was vaccinated with a dose of Zostavax. In April 2007, the patient experienced soreness in the arm the vaccination was administered. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.


VAERS ID: 283811 (history)  
Age: 15.0  
Gender: Female  
Location: New Mexico  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2007-06-14
   Days after onset:74
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0705USA02050

Write-up: Information has been received from a physician concerning a 15 year old female who in April 2007, was vaccinated intramuscularly with a 0.5 mL dose of Gardasil. There was no concomitant medication. Approximately 6 to 8 hours after vaccination, the patient experienced shortness of breath. Her symptoms lasted "all night long" and resolved by the next morning. Unspecified medical attention was sought. Subsequently, the patient recovered from shortness of breath. Additional information has been requested.


VAERS ID: 283932 (history)  
Age: 14.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-04-01
Onset:2007-05-01
   Days after vaccination:30
Submitted: 2007-06-14
   Days after onset:44
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC Split Type: WAES0705USA02180

Write-up: Information has been received from a certified medical assistant and a physician (patient''s dermatologist) concerning a 14 year old female student who was vaccinated in April 2007 with her third dose of Gardasil in the left arm and developed an injection site reaction. There was no concomitant medication. In May 20007 the patient developed left arm swelling, redness, tenderness and warm and firm to touch. The patient noted this did not happen with the first and second injections. The patient had recovered three weeks post injection. The patient''s OB/GYN office who administered the Gardasil was not concerned. The patient''s mother was concerned and took her to a dermatologist. Cool compresses were recommended for the patient. Additional information has been requested.


VAERS ID: 283978 (history)  
Age: 15.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2007-06-14
   Days after onset:74
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 RA / IM

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Penicillin allergy: Allergic reaction to antibiotics
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0705USA03012

Write-up: Information has been received from a registered nurse concerning a female under 18 years old who in approximately April 2007 was vaccinated with the first dose of Gardasil. Subsequently the patient experienced a rash on her complete torso. The patient was prescribed an unknown cream as treatment. The rash did not resolve by 5 days but may have resolved by now. Medical attention was sought. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a registered nurse concerning a 15 year old female student with PENICILLIN, AMOXICILLIN and CECLOR allergies who on 19-APR-2007 at 16:23 was vaccinated intramuscularly into the right deltoid with the first dose of GARDASIL (Lot # 654702/0011U). On 22-APR-2007, the patient felt "cold and achy" which persisted until the p.m. of 23-APR-2007 when itchiness and a rash on her complete torso, knees and back of hands developed. The patient was prescribed CLARINEX and LOTRISONE cream as treatment. The rash did not resolve by 5 days. The patient''s mom called on 01-MAY-2007 and reported that the symptoms persisted. No further information had been received since then. Additional information is not expected.


VAERS ID: 284179 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2007-04-01
Onset:0000-00-00
Submitted: 2007-06-14
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / -

Administered by: Other       Purchased by: Other
Symptoms: Amenorrhoea, Urine human chorionic gonadotropin negative
SMQs:, Fertility disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: beta-human chorionic - negative, beta-human chorionic - negative
CDC Split Type: WAES0705USA04044

Write-up: Information has been received from a medical assistant concerning herself who was vaccinated with two doses of Gardasil. Subsequently she experienced amenorrhea after each of the 2 doses of Gardasil she received. The first time the patient didn''t have her menses for 6 to 8 weeks and now she has not had her menses since her most recent injection in April 2007. The patient took home pregnancy tests both times and was not pregnant. Lot number was not provided. It was reported that the patient sought unspecified medical attention. The patient has not recovered. No further details were provided. The medical assistant also reported that another patient had a similar experience which is reported in WAES # 0705USA04921. Additional information has been requested.


VAERS ID: 284492 (history)  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2007-06-14
   Days after onset:74
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - - / -

Administered by: Unknown       Purchased by: Unknown
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: WAES0705USA05033

Write-up: Information has been received from a physician concerning a 15 year old female who in April 2007, was vaccinated with Gardasil. There was no concomitant medication. In April 2007, the patient fainted after receiving the vaccine. It was reported that the patient''s blood pressure was taken. No further details were provided. Additional information has been requested.


VAERS ID: 284522 (history)  
Age: 21.0  
Gender: Female  
Location: Maryland  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2007-06-14
   Days after onset:74
Entered: 2007-06-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Headache
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVORA
Current Illness: Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0705USA05672

Write-up: Information (and additional information on 23-OCT-2007) has been received from a physician concerning her 21 year old daughter with a penicillin allergy who in January 2007, was vaccinated with a first dose of Gardasil. Concomitant therapy included Levora. In April 2007, the patient was vaccinated with a second dose of Gardasil. The patient was vaccinated in the morning and by the evening had developed a headache. The patient sought unspecified medical attention. The headache lasted 4 hours and was treated with TYLENOL. The vaccination was not administered at the physician''s office. The patient picked up the vaccine at the pharmacy, and her mother, who was a physician, administered the vaccine at home. The patient did not develop a headache afte rthe first injection. Additional information has been requested.


VAERS ID: 284785 (history)  
Age: 5.0  
Gender: Male  
Location: Connecticut  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2007-07-06
   Days after onset:96
Entered: 2007-07-13
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. - / - UN / SC

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0704USA03193

Write-up: Information has been received from a health professional concerning a 5 year old male who, "last week," in April 2007, was vaccinated with a 0.5 ml subcutaneous dose of ProQuad. "Last week," in April 2007, the patient developed a rash on her right arm, 4 by 3 inches, at the injection site. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 284912 (history)  
Age: 13.0  
Gender: Female  
Location: California  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2007-07-06
   Days after onset:96
Entered: 2007-07-13
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA00557

Write-up: Information has been received from a physician, via a company representative, concerning a 13 year old female patient, who in April 2007, was vaccinated with the first dose of GARDASIL. Since the injection in April 2007, the patient has had a small lump at the injection site. At the time of this report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/6/2007. Initial and follow-up information has been received from a physician, concerning a 13 year old female patient, who in April 2007, was vaccinated with the first dose of GARDASIL. Since the injection in April 2007, the patient has had a small lump at the injection site. Follow up information from the physician confirmed there had been no further contact with the patient, however, she added that the patient had "moved or flinched and tightened her muscle during the vaccination." The area was described as a slight induration, about 1 inch in diameter. At the time to this report, it was unknown if the patient had recovered from the event. The patient sougth unspecified medical attention. Additional information has been requested.


VAERS ID: 285054 (history)  
Age: 12.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2007-07-06
   Days after onset:96
Entered: 2007-07-13
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Nausea
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA01198

Write-up: Information has been received from a physician concerning a female between the age of 12 and 16, who, a "couple months ago" was vaccinated with a 0.5mL dose of Gardasil. Concomitant therapy included Menactra. Twenty-four hours after being vaccinated with Gardasil the patient experienced nausea and weakness. The patient sought unspecified medical attention. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 285138 (history)  
Age: 0.25  
Gender: Unknown  
Location: Texas  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2007-07-16
   Days after onset:106
Entered: 2007-07-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. - / - UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 0 - / PO

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707USA00084

Write-up: Information has been received from a physician concerning an approximately 4-month-old patient who in approximately April 2007, was vaccinated PO with the first dose of Rotateq. Concomitant vaccinations administered on that same day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of COMVAX, a dose of poliovirus vaccine inactivated and a dose of PREVNAR. The physician reported that in approximately April 2007, a day after being vaccinated, the patient developed vomiting and diarrhea. The patient subsequently recovered. It was noted that the patient''s mother refused the second dose. Additional information has been requested.


VAERS ID: 285433 (history)  
Age: 16.0  
Gender: Female  
Location: Maryland  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2007-07-16
   Days after onset:106
Entered: 2007-07-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Menstruation irregular
SMQs:, Fertility disorders (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLEGRA
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA02380

Write-up: Information has been received from a Medical Assistant concerning a 16 year old female patient who in approximately April 2007, was vaccinated with her first dose of Gardasil. Concomitant therapy included ALLEGRA. The reporter indicated that the patient "has not had regular menstrual cycles since receiving her first dose of GARDASIL". The patient was not pregnant. Medical attention was sought. At the time of reporting the event was ongoing. Additional information has been requested.


VAERS ID: 285798 (history)  
Age: 18.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-04-01
Onset:2007-04-07
   Days after vaccination:6
Submitted: 2007-07-16
   Days after onset:100
Entered: 2007-07-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Nausea, Pruritus generalised, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0706USA04185

Write-up: Information has been received from a physician concerning an 18 year old female with "unremarkable" medical history who in April 2007, was vaccinated with a first dose of Gardasil. Subsequently, the patient experienced welts, itching all over body, and nausea. The patient sought unspecified medical attention. The patient recovered from welts, itching all over body and nausea approximately 3 days after initial injection. The physician did plan on administering further doses of Gardasil to this patient. Additional information has been requested.


VAERS ID: 285936 (history)  
Age: 25.0  
Gender: Female  
Location: Vermont  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2007-07-16
   Days after onset:106
Entered: 2007-07-18
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA05340

Write-up: Information has been received from a 25 year old female who in April 2007, was vaccinated with a 0.5 ml second dose of Gardasil. Subsequently in April 2007 the patient fainted and had a moderate amount of injection site pain. Unspecified medical attention. Subsequently that same day, the patient recovered from the fainting and moderate amount of injection site pain. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow-up information has been received from a 25 year old female and the doctors office, who in April 2007, was vaccinated with a 0.5 ml second dose of GARDASIL. Subsequently in April 2007 the patient fainted and had a moderate amount of injection site pain. Unspecified medical attention was sought. Subsequently that same day, the patient recovered from the fainting and moderate amount of injection site pain. Additional information is not expected.


VAERS ID: 286009 (history)  
Age: 77.0  
Gender: Female  
Location: Indiana  
Vaccinated:2007-04-01
Onset:2007-06-01
   Days after vaccination:61
Submitted: 2007-07-25
   Days after onset:54
Entered: 2007-07-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Ankle fracture, Eye pain, Fall, Herpes zoster, Pain
SMQs:, Accidents and injuries (narrow), Glaucoma (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: VICODIN; FOSAMAX; calcium (unspecified); SYNTHROID; TOPROL XL TABLETS; PAXIL; CRESTOR
Current Illness: Osteoporosis; Blood pressure high; Drug hypersensitivity
Preexisting Conditions: Osteoporosis; Blood pressure high; Drug hypersensitivity
Diagnostic Lab Data: None
CDC Split Type: WAES0707USA03065

Write-up: Information has been received from a 77 year old female with osteoporosis, high blood pressure and amoxicillin allergy who in April 2007, was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included SYNTHROID, alendronate sodium (MSD), calcium (unspecified), TOPROL XL TABLETS, CRESTOR, PAXIL and VICODIN. IN end of June 2007, the patient experienced fractured ankle and was hospitalized. It was reported that the in end of June 2007 patient was walking down steps and fell resulting in a broken ankle. The patient was currently in a rehabilitation hospital and having daily physical therapy. The patient''s son thought the fall was because she was taking VICODIN. on approximately 27-JUN-2007 the patient developed shingles on her face from her cheekbone into her hair line. The patient stated that the pain was excruciating and her eyeball hurts. No diagnostic laboratory tests were performed. At the time of report the patient was not recovered. A product quality complaint was not involved. Additional information has been requested.


VAERS ID: 288311 (history)  
Age: 0.33  
Gender: Female  
Location: Unknown  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2007-08-14
   Days after onset:135
Entered: 2007-08-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 0 - / PO

Administered by: Private       Purchased by: Other
Symptoms: Tongue discolouration
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707USA00569

Write-up: Information has been received from a registered nurse concerning an approximately 4 month old female who in April 2007 (about two and a half months ago), was vaccinated with the first dose of Rotateq, 2 mL, oral. On an unspecified date in 2007, the patient received the second dose of Rotateq. Concomitant medication was reported as none. On an unspecified date in 2007, after the patient received both the first and second dose of Rotateq, she experienced a greenish tint to the tongue. The patient sought unspecified medical attention. Subsequently on an unspecified date, the patient recovered completely from the greenish tint to tongue. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 294322 (history)  
Age: 70.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-04-01
Onset:2007-06-15
   Days after vaccination:75
Submitted: 2007-09-24
   Days after onset:101
Entered: 2007-09-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Herpes zoster, Pain
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: [therapy unspecified]; LORTAB; ELAVIL; SINEMET
Current Illness: Parkinson''s disease
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0706USA02816

Write-up: Information has been received from a 70 year old male with Parkinson''s disease and no allergies who on 01-APR-2007 was vaccinated with a dose of Zostavax (Oka/Merck). Concomitant therapy included LORTAB, amitriptyline hydrochloride (MSD) and "LIQUIP.". On 15-JUN-2007, the patient developed breakthrough shingles. The shingles were on the left side of his head and neck. The scabs went away but the pain was still present. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been received from a nurse who reported that the patient recovered on an unspecified date. No further information is expected.


VAERS ID: 294888 (history)  
Age: 76.0  
Gender: Female  
Location: Arizona  
Vaccinated:2007-04-01
Onset:2007-07-27
   Days after vaccination:117
Submitted: 2007-09-24
   Days after onset:59
Entered: 2007-09-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / - UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Herpes zoster
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PLAVIX; SYNTHROID; ZOCOR
Current Illness: Hypertension; Hypothyroidism
Preexisting Conditions: Shingles
Diagnostic Lab Data: None
CDC Split Type: WAES0708USA00066

Write-up: Information has been received from a 76-year-old female with hypertension, hypothyroidism and no allergies, who in April 2007, was vaccinated with a subcutaneous "single 0.65 injection" of Zostavax (Oka/Merck). Concomitant therapy included PLAVIX, simvastatin (MSD) and SYNTHROID. On 27-JUL-2007 the patient developed shingles. It is unknown if she had a previous history of herpes zoster. Unspecified medical treatment was sought. No diagnostic or laboratory test were ordered. The outcome is reported as not recovered. No product quality complaint was involved. Additional information has been requested. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Follow-up information received from the consumer states "I got the worst case of shingles I ever had over the past 15 years, after I had the shot." Additional information has been requested.


VAERS ID: 293739 (history)  
Age: 25.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-04-01
Onset:0000-00-00
Submitted: 2007-10-18
Entered: 2007-10-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Pregnancy NOS (LMP = 7/9/2007)
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0708USA04042

Write-up: Initial and follow-up information has been received through the Merck pregnancy registry from a 25 year old female, who in approximately April 2007, was vaccinated with a second dose of Gardasil. There was no concomitant medication. Subsequently the patient became pregnant. The patient''s last menstrual period was 09-Jul-2007, with an estimated date of delivery was 14-Apr-2008. Subsequently, on an unspecified date, the patient had a miscarriage at 10 weeks. Upon internal review, miscarriage was considered to be an other important medical event. Additional information is not expected.


VAERS ID: 299688 (history)  
Age:   
Gender: Female  
Location: New Jersey  
Vaccinated:2007-04-01
Onset:0000-00-00
Submitted: 2007-11-14
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Concussion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA05267

Write-up: Information has been received from a physician concerning a female with no prior history of fainting who in approximately April 2007, "about six months ago, " was vaccinated IM with the first dose of Gardasil. It was reported that after receiving her first dose of Gardasil the patient fainted and has fainted several times since the injection. On one occasion the patient developed a concussion. The patient''s outcome was unknown. Additional information has been requested.


VAERS ID: 300192 (history)  
Age: 15.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-04-01
Onset:2007-06-01
   Days after vaccination:61
Submitted: 2007-11-14
   Days after onset:166
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Formication, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Plaquenil
Current Illness:
Preexisting Conditions: Medical History: glomerulonephritis; Idiopathic thrombocytopenic purpura; Raynaud''s Syndrome; Lupus erythematosus
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA03097

Write-up: Information has been received from a nurse concerning a 16 year old female with a history of glomerulonephritis, idiopathic thrombocytopenic purpura, Raynaud''s syndrome and possible lupus erythematosus, who in April 2007 was vaccinated with Gardasil vaccine. Concomitant therapy included Plaquenil. In June 2007, the patient experienced asthenia, paresthesia. The patient experienced pin-prick sensations along the right thigh and a crawling sensation in the middle of her back. It was reported that the patient sought unspecified medical attention. The patient''s paresthesia and crawling like sensation in the middle of her back persisted. The patient''s asthenia has improved. Additional information has been requested.


VAERS ID: 300199 (history)  
Age: 21.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-04-01
Onset:2007-04-03
   Days after vaccination:2
Submitted: 2007-11-14
   Days after onset:225
Entered: 2007-11-15
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

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

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0710USA03194

Write-up: Information has been received from a medical assistant concerning a 21 year old female who in approximately April 2007, "6 months ago", was vaccinated with the first dose of Gardasil vaccine (lot# not reported). There was no concomitant medication. In approximately April 2007, "2 days after vaccination", the patient developed bruised skin and skin atrophy at the injection site. The patient sought unspecified medical attention. No laboratory diagnostic testes were performed. Subsequently, the patient recovered from bruised skin but the indentation from skin atrophy is still noticeable on her arm. There was no product quality complaint. Additional information has been requested.


VAERS ID: 306891 (history)  
Age: 4.0  
Gender: Unknown  
Location: Washington  
Vaccinated:2007-04-01
Onset:0000-00-00
Submitted: 2007-04-16
Entered: 2008-03-06
   Days after submission:325
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2552AA / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site mass, Injection site swelling, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: 200701121

Write-up: Initial report received from a health care professional on 10 April 2007. A 4-year-old, patient (gender not reported) experienced an entire upper arm that became swollen, painful and warm to the touch after receiving Daptacel (lot number C2552AA, route and site of administration not reported) on 01 April 2007. As of 09 April 2007, most of the swelling had resolved, but a "hard lump" at the injection site remains. It was not reported if the patient recovered.


VAERS ID: 315968 (history)  
Age: 7.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2008-05-14
   Days after onset:409
Entered: 2008-05-23
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Drug administration error, Erythema, Injection site swelling, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Medication errors (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:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: A0647298A

Write-up: This case was reported by a physician and described the occurrence of erythema in a 7-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Dtpa, manufacturer unspecified) for prophylaxis. In April 2007 the subject received an unspecified dose of Dtpa (.5 ml, unknown, left arm). At an unspecified time after vaccination with Dtpa, the subject experienced erythema, extensive swelling of vaccinated limb, itching and drug maladministration. A physician reported that during a conversation he heard another physician mention that they vaccinated a female subject who was 7 years and 4 months old with a diphtheria, tetanus and pertussis (Dtpa) vaccine. At the site of administration, the subject developed swelling (extensive swelling of vaccinated limb) and redness in a 4 by 6 inch area. The physician stated that he did not think the subject received any other vaccinations on the same day that Dtpa was administered. However, the reporting physician was not the physician who administered the vaccine, nor was it administered at his practice. Unspecified medical attention was required at the physician''s office.


VAERS ID: 317514 (history)  
Age: 5.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-04-01
Onset:0000-00-00
Submitted: 2008-05-28
Entered: 2008-06-18
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA00019

Write-up: Information has been received from a registered nurse concerning a 5-year-old female, who in approximately April or May 2007 at 10:30 AM, was vaccinated IM with a 0.5mL dose of hepatitis A vaccine (inactive). Concomitant vaccinations included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (MSD), and a dose of diphtheria toxoid (+) Hib conj vaccine (unspecified) (+) pertussis vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine (unknown) (IPOL). At 3:00 PM, the same day of vaccination, the patients'' mother called and reported facial swelling. Unspecified medical attention was sought. Subsequently the patient recovered. No product quality complaint was involved. This information is one of several reports from the same source. Additional information has been requested.


VAERS ID: 319442 (history)  
Age:   
Gender: Male  
Location: Florida  
Vaccinated:2007-04-01
Onset:0000-00-00
Submitted: 2008-06-24
Entered: 2008-07-11
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Herpes zoster
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805USA00385

Write-up: Information has been received from a physician concerning a male patient who in approximately April 2007 was vaccinated with zoster vaccine live (Oka/Merck) (Dose, route, and lot number were not reported). On an unspecified date soon after vaccination, the patient developed a mild shingles-like rash. The physician reported that the patient did not experience post herpetic neuralgia. Subsequently, the patient recovered from the shingles like rash. Further information was requested.


VAERS ID: 319579 (history)  
Age: 72.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-04-01
Onset:2007-07-01
   Days after vaccination:91
Submitted: 2008-06-24
   Days after onset:359
Entered: 2008-07-11
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Pain, Ultrasound kidney normal
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Hypercholesterolaemia, Drug hypersensitivity
Diagnostic Lab Data: renal ultrasound - negative
CDC Split Type: WAES0805USA02131

Write-up: Information has been received from a 72-year-old female with hypercholesterolaemia and an allergy to LIPITOR (muscles aches all over body, the muscle aches resolved when the medication was discontinued-years ago) who in April 2007, was vaccinated with a single dose of zoster vaccine live (Oka/Merck). In July 2007, the patient developed pain in her right side. The distribution of the pain was from the right side of the torso, at waist level, radiating round to the middle of her back. The patient''s physician suspected a possible case of shingles. No rash developed. The patient was referred for a renal ultrasound, which was negative. The pain resolved 6-7 weeks after onset with treatment. A product quality complaint was not involved. Additional information has been requested.


VAERS ID: 319619 (history)  
Age: 70.0  
Gender: Female  
Location: Minnesota  
Vaccinated:2007-04-01
Onset:2008-02-18
   Days after vaccination:323
Submitted: 2008-06-24
   Days after onset:126
Entered: 2008-07-11
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Herpes zoster
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: (therapy unspecified); vitamins (unspecified)
Current Illness:
Preexisting Conditions: Breast cancer; Radiotherapy; Shingles
Diagnostic Lab Data: None
CDC Split Type: WAES0804USA01458

Write-up: Information has been received from a 71-year-old female consumer with a history of breast cancer with radiation about 8 years ago and "previously in her 50''s had developed the shingles and eventually had recovered" who in April 2007, was vaccinated with a "single dose series" of zoster vaccine live (Oka/Merck). Concomitant therapy included vitamins (unspecified) and "abalide." On 18-FEB-2008, the patient noticed that she started to have pain in her right shoulder. The consumer reported that later on that night she noticed she had developed the shingles again which were located on her right side on the upper body around her breast area and her upper back. The consumer reported that her shingles did not have any puss sores, but she had pain. She did see a physician who gave her medication to treat the shingles. There were no laboratory tests performed. The consumer reported that the shingles have faded, but she still can see some of the lesions, and that her pain that she had associated with the shingles first went away in the front and then around 02-Apr-2008, the pain on her back had gone away. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 321970 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-04-01
Onset:2007-09-23
   Days after vaccination:175
Submitted: 2008-08-12
   Days after onset:324
Entered: 2008-08-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Caesarean section, Drug exposure during pregnancy, Epidural anaesthesia, Foetal disorder, Heart rate increased, Labour induction, Pregnancy test positive, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 9/23/2007)
Preexisting Conditions:
Diagnostic Lab Data: beta-human chorionic - positive
CDC Split Type: WAES0710USA06167

Write-up: Initial and follow-up information has been received from a 23 year old female for the pregnancy registry for GARDASIL who in APR 2007 was vaccinated with the first dose of GARDASIL. No information was received concerning the second dose of GARDASIL. In OCT 2007 the patient was vaccinated intramuscularly with the third dose of GARDASIL. The patient states that she discovered she was pregnant about 1 week after receiving the third dose of GARDASIL (LMP=23-SEP-2007). The pregnancy was confirmed with a pregnancy test. No adverse events were reported. The patient sought unspecified medical attention. On 01-AUG-2008 the patient reported that her pregnancy was fine, no complications. Per the patient, she delivered an healthy and normal boy on 03-JUL-2008 at 40 weeks 5 days by cesarean section. The patient had an elective induction with pitocin and an epidural and progressed to 8cm dilation, at which time she had developed a fever - though she wasn''t sure why as there was no infection and both she and the baby had elevated heart rates and the decision for a cesarean section was made at that time. Her son weighed 8 lbs, 3.3 oz. At that time of reporting, the infant was almost one month old and doing well. The patient, reported that she was recovering well - no problems at all. Upon internal review, the patient''s fever and increased heart rate and the fetal increased heart rate were considered other important medical events as the events lead to the delivery via cesarean section. Additional information has been requested.


VAERS ID: 329610 (history)  
Age: 19.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-04-01
Onset:0000-00-00
Submitted: 2008-10-14
Entered: 2008-10-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Pap test, HPV
CDC Split Type: WAES0809USA01952

Write-up: Information has been received from a consumer concerning her daughter a 19 year old female who on 04-OCT-2006 was vaccinated with the first dose of GARDASIL. In December 2006, the patient was vaccinated with a second dose of GARDASIL. In April 2007, she was vaccinated with a third dose of GARDASIL. Concomitant therapy included hormonal contraceptives (unspecified). The patient received an abnormal pap smear. The abnormal cells were diagnosed as HPV. The patient sought unspecified medical attention. At the time of reporting the patient had not recovered from HPV. The patient''s physician plans to retest in 3 months. Additional information has been requested.


VAERS ID: 330731 (history)  
Age: 23.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-04-01
Onset:2008-09-23
   Days after vaccination:541
Submitted: 2008-10-14
   Days after onset:21
Entered: 2008-10-30
   Days after submission:16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Smear cervix abnormal
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Pap test, 09/23/2008, positive
CDC Split Type: WAES0810USA00048

Write-up: Information has been received from a consumer concerning her 23 year old daughter who on an unknown dates was vaccinated with the three doses of GARDASIL was given in April 2007. There was no concomitant medications. On approximately 23-Sep-2008, the patient had a Papanicolaou test positive. As of 29-Sep-2008, the patient had not recovered. Further testing must be done pertaining to positive PAP test. The patient sought unspecified medical attention. No additional information is expected.


VAERS ID: 334787 (history)  
Age: 21.0  
Gender: Female  
Location: Montana  
Vaccinated:2007-04-01
Onset:0000-00-00
Submitted: 2008-11-14
Entered: 2008-11-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Smear cervix abnormal
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Hormonal contraceptives; PAXIL
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Pap test, normal; Pap test, positive for HPV
CDC Split Type: WAES0810USA03824

Write-up: Information has been received from a consumer concerning her 21 year old daughter with no pertinent medical history or known allergies who in approximately April 2007, was vaccinated with the third dose of GARDASIL 0.5 ml, IM. Concomitant therapy included PAXIL and hormonal contraceptives (unspecified). It was reported that after the patient received GARDASIL, had a Papanicolaou test positive for HPV. The patient did not know which strain of the virus it is from. There were no Papanicolaou test done during the series, so she did not know if she would have tested positive before or after it was reintroduced. It was reported that a Papanicolaou test done before the vaccination series was "normal". The reporter did not know where the series begun. At the time of the report, the patient had not recovered. Additional information has been requested.


VAERS ID: 337025 (history)  
Age: 75.0  
Gender: Female  
Location: Georgia  
Vaccinated:2007-04-01
Onset:2008-11-07
   Days after vaccination:586
Submitted: 2008-12-23
   Days after onset:46
Entered: 2008-12-29
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Laboratory test, Paraesthesia, Pruritus, Rash, Tenderness, X-ray normal
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR; COZAAR
Current Illness: Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: X-ray - fine; diagnostic laboratory - rib study fine
CDC Split Type: WAES0811USA02939

Write-up: Information has been received from a 77 year old female registered nurse (R.N.) with codeine allergy who in April 2007, was vaccinated with a dose of ZOSTER (Oka/Merck). Concomitant therapy included LIPITOR and MSD. On 07-NOV-2008 the patient began experiencing soreness and tingling/itching under skin at her ribcage. She then started to break out with a larger rash surrounded by what "looks like 3 spider bites"


VAERS ID: 337388 (history)  
Age: 74.0  
Gender: Female  
Location: Illinois  
Vaccinated:2007-04-01
Onset:2008-08-26
   Days after vaccination:513
Submitted: 2008-12-23
   Days after onset:119
Entered: 2008-12-29
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Herpes zoster, Laboratory test, Pain
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: (Therapy unspecified)
Current Illness: Blood cholesterol abnormal
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA01841

Write-up: Information has been received from a 75 year old female patient with blood cholesterol abnormal who in April or May 2007 was vaccinated with ZOSTAVAX. On 26-AUG-2008, the patient developed shingles on her upper right corner of her face. Routine lab tests were done, but results not reported. The pain and rash was healed about 10 days after her diagnoses. No further information was provided.


VAERS ID: 344321 (history)  
Age: 18.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2009-04-16
   Days after onset:746
Entered: 2009-04-17
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Drug exposure during pregnancy, Foetal disorder, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamins (unspecified)
Current Illness: Pregnancy NOS (LMP = 5/9/2007); Migraine
Preexisting Conditions:
Diagnostic Lab Data: Beta-human chorionic, ?/?/07, pregnant
CDC Split Type: WAES0904USA01551

Write-up: Information has been received from an 18 year old female with migraine and no allergies for GARDASIL, a Pregnancy Registry product, who in February 2007, was vaccinated with the first dose of GARDASIL (lot# not reported). Concomitant therapy included vitamins (unspecified). In April 2007, the the patient received her second dose of GARDASIL (lot# not reported) 0.5 mL when she was 2 weeks pregnant. The patient requested a pregnancy test before receiving the shot of second dose however it was never given to her. On 13-FEB-2008, the patient delivered a baby. It was reported that the baby experienced unexplained fever almost every other day as well as seizures. The baby was also congested all the time and was diagnosed with asthma. The reporter felt that the baby''s unexplained fever, seizures and asthma were related to therapy with GARDASIL. Unspecified medical attention was sought. Upon internal review, seizure was considered to be an other important medical event. No further information is available.


VAERS ID: 347347 (history)  
Age:   
Gender: Female  
Location: North Carolina  
Vaccinated:2007-04-01
Onset:0000-00-00
Submitted: 2009-05-15
Entered: 2009-05-21
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0440N / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Varicella post vaccine
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0810USA03770

Write-up: Information has been received from a registered nurse concerning a female patient who in April 2007, was vaccinated with a dose of VARIVAX (Merck) (Lot # 645579/0440N) and developed a chicken pox rash as per the father''s report. The registered nurse reported the patient had not been by the physician and no follow up appointment is scheduled. At the time of reporting the patient was recovering from "chicken pox rash". The registered nurse mentioned that the patient received MMRII + VARIVAX (Merck) (Lot # 656941/0227U) on 15-AUG-2003 without any incidence. It was reported that the patient sought for medical attention by a phone call. Additional information has been requested.


VAERS ID: 347895 (history)  
Age: 5.0  
Gender: Female  
Location: California  
Vaccinated:2007-04-01
Onset:0000-00-00
Submitted: 2009-05-15
Entered: 2009-05-21
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0115U / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Varicella, Varicella post vaccine
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0806USA01539

Write-up: Information has been received from a physician concerning a 5 year old female patient with no pertinent medical history and drug reactions/allergies who in January 2003, was vaccinated with the first dose of VARIVAX (Merck) (lot number, route and site of administration not reported). In April 2007, the patient was vaccinated with the second dose of VARIVAX (Merck) (lot number 656572/0115U) (route and site of administration not reported). On an unspecified date the patient had a breakthrough of VARIVAX. The patient had about 12 lesions. The patient had completely recovered from this event. The patient sought medical attention. Additional information has been requested.


VAERS ID: 351665 (history)  
Age: 74.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-04-01
Onset:2009-04-10
   Days after vaccination:740
Submitted: 2009-06-24
   Days after onset:75
Entered: 2009-07-13
   Days after submission:19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Herpes zoster
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0904USA04180

Write-up: Information has been received from a physician concerning a "74 year old" female who in April 2007, was vaccinated with a single dose of ZOSTAVAX (Merck) (dose, route and lot number unspecified). There was no concomitant therapy. A "couple of weeks ago" (approximately 10-APR-2009), the patient came down with shingles. The patient sought unspecified medical attention. The outcome of the patient was unknown. Additional information has been requested.


VAERS ID: 385707 (history)  
Age: 90.0  
Gender: Unknown  
Location: South Dakota  
Vaccinated:2007-04-01
Onset:0000-00-00
Submitted: 2010-04-21
Entered: 2010-04-22
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Herpes zoster
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1004USA02508

Write-up: Information has been received from a physician concerning a 90 year old patient who in April 2007, "3 years ago", was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not reported). The patient was currently hospitalized with a diagnosis of shingles. It was unknown if the patient sought medical attention. At the time of the report, the outcome of the patient was unknown. Additional information has been requested.


VAERS ID: 399688 (history)  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-04-01
Onset:2008-04-01
   Days after vaccination:366
Submitted: 2010-08-04
   Days after onset:855
Entered: 2010-09-08
   Days after submission:35
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Insulin resistance, Weight increased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Lipodystrophy (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1004USA03566

Write-up: Information has been received from a nurse concerning her 17 year old daughter who three years ago, in April 2007 was vaccinated with doses of GARDASIL IM. One year after vaccination, in April 2008, the patient gained 25 lbs. One year later, in April 2009, the patient gained another 25 lbs. The patient sought unspecified medical attention. She had been diagnosed with insulin resistance. At the time of the report, the patient had not recovered. No further information is available.


VAERS ID: 400084 (history)  
Age: 15.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-04-01
Onset:0000-00-00
Submitted: 2010-08-04
Entered: 2010-09-08
   Days after submission:35
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dysmenorrhoea, Menstrual disorder
SMQs:

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Allergic reaction to antibiotics
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0908USA04453

Write-up: Information has been received from mother concerning her 17 year old daughter with allergic reaction to CECLOR and no pertinent medical history who in 2007 completed the series of the GARDASIL. Concomitant therapies were not reported. The mother reported that ever since her daughter finished the series, she has been having permanent problems with her menstrual cycle. The mother stated that her daughter has been in excruciating pain every time she gets her monthly period. The patient sought unspecified medical attention. At the time of the reporting, the outcome of the events were unknown. Additional information has been requested.


VAERS ID: 521728 (history)  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2007-04-01
Onset:0000-00-00
Submitted: 2014-02-04
Entered: 2014-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, White blood cell count increased
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)

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: Unspecified test (unknown date): Elevated white blood cell count
CDC Split Type: WAES1402USA000903

Write-up: This spontaneous report as received from a other health professional (physician assistant) who was mother of patient via company representative refers to a female patient of unknown age. In April 2007 the patient was vaccinated with GARDASIL dose 1. Approximately in 2007 the patient experienced seizure (medically significant) sometime after the first vaccination. Unspecified Laboratory test was done on an unknown date with result of elevated white blood cell count after the vaccination. The outcome of seizure and elevated white blood cell count was unknown. The relation between the event and the vaccine was unknown. It was reported that the series of vaccination has been completed. Upon internal review event seizure was considered medically significant. Additional information has been requested.


VAERS ID: 614590 (history)  
Age: 18.0  
Gender: Female  
Location: Illinois  
Vaccinated:2007-04-01
Onset:2007-04-02
   Days after vaccination:1
Submitted: 2015-12-13
   Days after onset:3177
Entered: 2015-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - - / -

Administered by: Other       Purchased by: Other
Symptoms: Pain, Paraesthesia, Peripheral swelling, Vaccination complication
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Swelling in hands and feet~ ()~~0.00~Patient
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: I had an adverse reaction to the Gardasil vaccination when I received the second and third vaccines in the series. My hands and feet tingled and swelled, building up slowly over the course of several days until I woke up one morning and was unable to close my hand because it was so swollen, and it hurt to walk on my feet. I painstakingly made it to the clinic and was given numerous medications and a large shot of Benadryl. It was not until I started to feel the tingling feeling again a day or so after my third vaccination that the connection was made between the vaccine and my reaction.


VAERS ID: 285315 (history)  
Age: 43.0  
Gender: Male  
Location: Foreign  
Vaccinated:2007-04-01
Onset:2007-04-20
   Days after vaccination:19
Submitted: 2007-07-20
   Days after onset:91
Entered: 2007-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / - RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Anti-HBs antibody negative, Aspartate aminotransferase increased, Aspartate aminotransferase normal, Asthenia, Blood creatine phosphokinase normal, Blood lactate dehydrogenase normal, C-reactive protein normal, Gamma-glutamyltransferase, Hepatitis B surface antigen negative, Muscle spasms, Myalgia, Myositis, Neck pain, Rhabdomyolysis, Thyroid neoplasm, Transaminases
SMQs:, Rhabdomyolysis/myopathy (narrow), Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological tumours of unspecified malignancy (narrow)

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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Alanine aminotranferase 04May2007 71; Anti-HBs antibody 04May2007 198IU/L; Aspartate aminotranferase 04May2007 108; C-reactive protein 04May2007 15; Creatine phosphokinase 8171; Creatine phosphokinase 30May2007 167; Gamma GT 04May2007 34; Hepatitis B surface antigen 17Apr2007 Negative; Lactate dehydrogenase 04may2007 674; Transaminases 30May2007 Normal
CDC Split Type: B0479457A

Write-up: This case was reported by a physician and described the occurrence of rhabdomyolysis in a 43-year-old male subject who was vaccinated with Engerix B adult for prophylaxis. The subject had no relevant medical history. No concomitant medication was noted. In April 2007, as the subject presented with negative anti-HBs antibody (see case B0479457B), the subject received a booster dose of Engerix B adult (unknown batch reference). On 17 April 2007, hepatitis b surface antigen was negative. On 20 April 2007, a few days after the vaccination with Engerix B adult, the subject presented with asthenia, myalgia and cramps associated with cervical constrictive pains. On 04 May 2007, biological tested evidenced severe increase of CPK level (at 8171, unspecified units), increased LDH and transaminases levels. Then, the subject was hospitalised. On 23 may 2007, pain was resolved. On 30 may 2007, CPK and transaminases levels normalised. Presence of thyroid node was also reported. Inflammatory myositis and rhabdomyolysis from an unknown etiology were diagnosed. In May 2007, the events were resolved. The physician''s causality assessment was unspecified.


VAERS ID: 291486 (history)  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-04-01
Onset:2007-06-19
   Days after vaccination:79
Submitted: 2007-09-26
   Days after onset:99
Entered: 2007-09-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain, Lymphadenopathy, Pharyngolaryngeal pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA02976

Write-up: Information has been received from a gynecologist concerning a 16 year old female who on 12-JUN-2007 was vaccinated IM in the deltoid (unspecified) with a second dose of GARDADIL (lot #654948/0903F/ batch #NE35170). On 19-JUN-2007, the patient complained of abdominal pain and throat pain and had developed lymphadenopathy in her neck and groin. Subsequently, the patient was hospitalized. Appendicitis was ruled out. The patient''s outcome was unknown. It was reported that the first vaccination of GARDASIL in April 2007 was well tolerated. No further information is available. Other business partner numbers included E2007-06150.


VAERS ID: 295026 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2007-04-01
Onset:2007-05-01
   Days after vaccination:30
Submitted: 2007-10-31
   Days after onset:183
Entered: 2007-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC37B024BD / 0 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)

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: UNK
CDC Split Type: B0493216A

Write-up: This case was reported by a sales representative and described the occurrence of Guillain-Barre syndrome in a female subject of unspecified age who was vaccinated with (DTPa (Refortrix), GlaxoSmithKline ) for prophylaxis. A physician or other health care professional has not verified this report. In April 2007, the subject received 1st dose of DTPa (Refortrix) (unknown route and injection site). In May 2007, 1 month after vaccination with DTPa, the subject experienced Guillain-Barre syndrome. This case was assessed as medically serious by GSK. At the time of reporting the event was resolved. A medical evaluation was recommended to the subject.


VAERS ID: 303184 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2008-01-18
   Days after onset:292
Entered: 2008-01-22
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTOX: DIPHTHERIA TOXOIDS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / - UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Back pain, Laboratory test normal, Local swelling, Malaise, Pyrexia
SMQs:, Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (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: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: diagnostic laboratory test Comment: biochemical results normal
CDC Split Type: WAES0801USA03229

Write-up: Information has been received from a health care professional concerning a female (age not reported) with no relevant medical history. In April 2007, the patient was vaccinated with a dose of RECOMBIVAX HB (thimerosol free) (batch number, route and site of administration not reported). Suspect vaccination included a dose of REVAXIS (batch number, route and site of administration not reported). It is not known if the patient was receiving any concomitant medication. In April 2007, three days post immunization, the patient experienced a fever, started to feel unwell and then developed a lump in the groin and excruciating stomach pain radiating to the back. The patient was seen by the general practitioner but no details were available. Biochemical results were normal. The patient has almost recovered from the lump in the groin but the patient still occasionally experiences stomach pains. It is not known if the patient has recovered from the fever. The reporter did not provide an assessment of the seriousness of the reaction. The reporter considered lump in the groin and the stomach pain to be other important medical events. Other business partner numbers include: E2008-00230.


VAERS ID: 303913 (history)  
Age: 0.3  
Gender: Female  
Location: Foreign  
Vaccinated:2007-04-01
Onset:2008-01-01
   Days after vaccination:275
Submitted: 2008-01-29
   Days after onset:28
Entered: 2008-01-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Cellulitis orbital, Pneumococcal bacteraemia, Serology test
SMQs:, Ocular infections (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: The patient is a healthy infant.
Diagnostic Lab Data: Blood culture (results: detection of pneumococci of serotype 7F) was done in Jan-2008.
CDC Split Type: DEWYEG00926508

Write-up: This case was considered medically important. Information regarding Prevenar was received from a healthcare professional regarding a 13-month-old female patient who experienced pneumococcal bacteraemia without focus and orbital cellulitis. The patient received the third dose in Apri-2007. The patient experienced pneumococcal bacteraemia without focus and orbital cellulitis in Jan-2008. Pneumococci of serotype 7F were detected. The patient recovered completely.


VAERS ID: 304282 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2008-02-04
   Days after onset:309
Entered: 2008-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTIPV: DT + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Back pain, Lymphadenopathy, Malaise, Mass, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0506138A

Write-up: This case was reported by a regulatory authority and described the occurrence of mass nos in a female subject of unspecified age who was vaccinated with HBvaxPRO for prophylaxis. In April 2007 the subject received unspecified dose of HBvaxPRO. In April 2007, at an unspecified time after vaccination with HBvaxPRO, the subject experienced mass nos, stomach pain, fever and feeling unwell. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. Fever, abdominal pain and feeling unwell have been described following the two vaccines. However, in this case, the time of onset of three days and the association with a lump in the groin are not suggestive of a role played by the two vaccines. Verbatim Text: Three days post immunisation, the patient experienced a fever, started to feel unwell and then developed a lump in the groin and excruciating stomach pain radiating to the back. The patient was seen by the general practitioner but no details were available. Biochemical results were normal. The patient has almost recovered from the lump in the groin but the patient still occasionally experienced stomach pains. It is not known if the patient has recovered from the fever. Reporter Comment: Fever, abdominal pain and feeling unwell have been described following the two vaccines. However, in this case, the time of onset of three days and the association with a lump in the groin are not suggestive of a role played by the two vaccines.


VAERS ID: 311231 (history)  
Age: 27.0  
Gender: Male  
Location: Foreign  
Vaccinated:2007-04-01
Onset:0000-00-00
Submitted: 2008-04-29
Entered: 2008-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Alanine aminotransferase increased, Antibody test positive, Inappropriate schedule of drug administration
SMQs:, Liver related investigations, signs and symptoms (narrow), Vasculitis (broad), Hypersensitivity (broad), Medication errors (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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0518372A

Write-up: This case was reported by a pharmacist and described the occurrence of alanine aminotransferase increased in a 27-year-old male subject who was vaccinated with Engerix B (GlaxoSmithKline). On April 2007, June 2007 and December 2007 the subject received 1st dose, 2nd dose and 3rd dose of Engerix B (20 mcg, unknown). At an unspecified time after vaccination with Engerix B, the subject experienced alanine aminotransferase increased and inappropriate schedule of vaccine administered. This case was assessed as medically serious by manufacturer. At the time of reporting the outcome of the events were was unspecified. Verbatim text: On the 25th April 2008 a pharmacist reported that a patient had been following the 0,1 and 6 month Engerix B schedule. The first Engerix B vaccination had been administered in April 2007, the second dose had been administered in June 2007 and the third dose had been administered in December 2007. The pharmacist stated that the vaccinations had been administered when mutually convenient between the occupational health department and the patient and thus an out of a licensed schedule may have been used. A test in November 2007 had shown the patient''s ALT level to be 47 and a test in February 2008 had shown the patient''s ALT level to be 68. An antibody test in February 2008 had stated positive. No further information was available at the time of reporting.


VAERS ID: 339607 (history)  
Age: 53.0  
Gender: Male  
Location: Foreign  
Vaccinated:2007-04-01
Onset:2008-04-01
   Days after vaccination:366
Submitted: 2009-02-13
   Days after onset:318
Entered: 2009-02-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Anti-HBs antibody negative, Hepatitis B surface antigen positive
SMQs:, Liver infections (narrow)

Life Threatening? Yes
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: Anti-HBs antibody, Apr2008, Negative; Hepatitis B surface antigen, Apr2008, Positive
CDC Split Type: B0558384A

Write-up: This case was reported by a physician and described the occurrence of hepatitis B surface antigen positive in a 53-year-old male subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). Patient had no risk factors: a pastor (no history of promiscuity), no history of blood transfusion or surgical procedure. Prior to vaccination, the subject was HBs Ag negative. On February 2007, March 2007 and April 2007 the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX adult (intramuscular, unknown deltoid, lot number not provided). In April 2008, 12 months after vaccination with 3rd dose of TWINRIX adult, 13 months after vaccination with 2nd dose of TWINRIX adult, 14 months after vaccination with 1st dose of TWINRIX adult, the subject experienced hepatitis B surface antigen positive and anti-HBs antibody negative (verified in 2 hospitalis). No clinical symptoms. The physician considered the events were potentially life threatening. At the time of reporting the events were unresolved. The physician considered the events were possibly related to vaccination with TWINRIX adult.


VAERS ID: 345522 (history)  
Age: 0.47  
Gender: Male  
Location: Foreign  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2009-04-30
   Days after onset:760
Entered: 2009-05-04
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CA205A / 0 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 25470 / 0 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Body height, Cerebral palsy, Cytogenetic analysis normal, Developmental delay, Hypotonia, Neurological examination normal, Ophthalmological examination abnormal, Posture abnormal, Speech disorder, Ultrasound scan normal
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Congenital, familial and genetic disorders (narrow), Dystonia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Optic nerve disorders (broad), Corneal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness: The patient''s concurrent illness includes milk allergy.
Preexisting Conditions: The patient''s concurrent illness includes milk allergy with a past history of maternal therapy to enhance foetal lung maturity. The patient has a 6-year-old sister who is a healthy child. The patient was born after the 40th week of pregnancy per sectio and breech presentation with APGAR of 6/8/10. The patient has been breastfeeded for 6 months. The patient did not suffer from any teething problems. Maternal therapy to enhance foetal lung maturity
Diagnostic Lab Data: Body height (results: birth body height: 52 cm) was done on 13-Oct-2006. Cytogenetic analysis (results: exclusion of fragile X syndrome and happy puppet syndrome) was done in 2007. Physical examination (results: muscle strength reflex: bilateral equal and present) was done on 23-Jan-2009. Additionally, the following tests were done on an unspecified date: neurological examination (results: friendly and responsive child who answers adequate with laughing or crying, upper and lower limbs: hypotonia; for the rest: without any pathological findings); physical examination (results: internistic examination: without any pathological findings); physical examination (results: eating and drinking without any problems, urine and stool continence norma
CDC Split Type: DEWYEG03562209

Write-up: Information regarding PREVENAR was received from a healthcare professional via a regulatory authority (PEI) regarding a 6-months old male patient who experienced distinctive developmental delay, postural function retardation and severe muscular hypotonia which led to the diagnosis of hypotonic infantile cerebral palsy. The patient received the first dose in Apr-2007. After the patient received the first doses of PREVENAR and INFANRIX HEXA in April 2007, he experienced distinctive developmental delay and postural function retardation. The patient was not able to turn himself and he did not tolerate abdominal position. Since the 10th months of life the patient has received physiotherapy and osteopathy. When the patient was of approximately 1 year of age, the paediatrician diagnosed muscular hypotonia and therefore the patient was hospitalized for diagnostic investigations. At hospital generalized muscular hypotonia without spasticity was confirmed. Several diagnostic tests did not reveal any diagnoses, focal-neurological deficiencies could not be found. Signs of moving disorders like spasticity or a primary muscle disease could not be detected, too. Neither perinatal nor genetic reasons were found. The patient did not experience any seizures "or something like this". Afterwards the patient received Bobath therapy once weekly, physiotherapy once weekly, early advancement therapy once weekly, electroneutraltherapy twice weekly and rota therapy which was performed by the patient''s mother. The patient began to crawl at the age of 21 months and could sit at the age of 18 months. He was able to say 4 words (mom, dad, grandma and grandpa) but he could not form two-word-sentences. The speech comprehension was good. The patient''s mother initiated several alternative treatments and on 14-Oct-2008 the patient has received rehabilitation treatment for 7 weeks. During these 7 weeks the patient showed an uncomplicated rehabilitation course. Treatment included conductive advancement (Peteau therapy), neurophysiological therapies according to the Padovan concept and additionally adequate sports like swimming, music therapy and animal-supported psychomotoric therapies. At the end of rehabilitation therapy, Vojta-therapy was initiated that was resulted in good reflex improvements. All in all, the patient''s condition improved during rehabilitation treatment. The effect of Peteau therapy was especially emphazised. On 23-Jan-2009 the patient was again hospitalized and the reported events were diagnosed in terms of hypotonic infantile cerebral palsy. The attending clinician considered a degree of disability of 80% as adequate. The patient was not recovered until the time of initial reporting. The patient mother''s assessment of relatedness between the adverse event and PREVENAR and INFANRIX HEXA was possibly related. The reporting physician''s assessment of relatedness between the adverse events and PREVENAR and INFANRIX HEXA was unknown because he just stated that he did not want imply a causality correlation between the adverse events and PREVENAR and INFANRIX HEXA with the report. This case is being treated according to the Protection against Infection Act.


VAERS ID: 426446 (history)  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:2007-04-01
Onset:0000-00-00
Submitted: 2011-06-29
Entered: 2011-06-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Drug exposure during pregnancy, Labour complication, Neonatal disorder, Shoulder dystocia, Total bile acids increased
SMQs:, Liver related investigations, signs and symptoms (narrow), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GAVISCON ANTACID TABLETS; amoxicillin
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1106USA03258B1

Write-up: This case of pregnancy with associated adverse events was reported by the Health Protection Agency (HPA Reference 0011) on 16-JUN-2011. This case is linked to mother case E2011-03746. The patient''s mother had one previous pregnancy. The patient''s mother''s LMP was not provided, the estimated delivery date was 20-JAN-2008. The patient received MMR II, batch and manufacturer not reported on 01-APR-2007 transplacentally. It was not known if the patient''s mother had experienced an adverse reaction following vaccination. The patient''s mother had no pregnancy illness, medical conditions, or diagnostic tests. The patient''s mother experienced raised bile acids on an unreported date with an unreported outcome and labour complications on an unreported date as the patient had shoulder dystocia. The patient weighed 3.88kg at birth after 40 weeks gestation. The patient had no abnormalities, cutaneous skin scarring, limb hypoplasia, eye abnormalities, neurological deficits, cardiac abnormalities, microcephaly or congenital anomalies. On an unreported date the patient had skin tags in front of the ears, the patient outcome was not reported. The patient''s mother was taking concomitant medications of GAVISCON, for an unreported indication and Amoxicillin 250mg three times per day for an unreported indication, started on 07/Jun/2008. Upon internal company review, this case was considered serious as an other important medical event. Other business partner numbers include E2011-03750. No further information is available.


VAERS ID: 429153 (history)  
Age: 1.6  
Gender: Male  
Location: Foreign  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2011-08-07
   Days after onset:1589
Entered: 2011-08-09
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / - UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Electrolyte imbalance, Endocrine disorder, Neurological symptom, Speech disorder developmental
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (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: Allergy (Hypersensitivity)
Diagnostic Lab Data:
CDC Split Type: 2011175726

Write-up: This is spontaneous report from a contactable consumer via the Medical Information Team (Medical Information No. Pre/08-11/257). A 19-month-old male patient received a dose of PREVENAR on an unspecified date in Apr2007. Relevant history included allergy, and the patient''s development was reported as correct in every aspect until the age of 19 months. In Apr2007, since the age of 19 months, the patient started to have various neurological problems (including seizures) as a result of total deregulation of his body due to electrolyte imbalance. By that time, the patient also stopped speaking. A diagnosis could not be made. It was reported that the most reliable thesis, due to distinct coincidence of the disorders with vaccination (April2007), indicated the neuroinfectious reaction as the reason for disorders in neurological development and endocrinological disorder. The vaccine was purchased by the parents from a pharmacy. The patient''s parents reported that they do not recollect being informed that some of the medical clinics deny vaccination of children with vaccines bought by parents due to possible improper storage which could cause complications upon purchasing the vaccine. At the time of this report, at the age of almost 6 years, the patient was still unable to speak actively. The outcome of the neurological problems, seizures, endocrinological disorder and electrolyte imbalance was unknown. The parents reported that it was highly probable that PREVENAR caused their son''s disorders.


VAERS ID: 497913 (history)  
Age:   
Gender: Female  
Location: Foreign  
Vaccinated:2007-04-01
Onset:2007-04-01
   Days after vaccination:0
Submitted: 2013-07-29
   Days after onset:2311
Entered: 2013-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / - RL / IM

Administered by: Other       Purchased by: Other
Symptoms: Acid fast bacilli infection, Aspiration, Biopsy lung, Chest X-ray normal, Granuloma, Injection site swelling, Mycobacterium test positive, Red blood cell sedimentation rate normal, Tuberculosis, Ultrasound abdomen normal, X-ray of pelvis and hip normal
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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: Acid fast stain, Apr2007, Positive for bac; Aspiration biopsy, Apr2007, See text; Erythrocyte sedimentation rate, Apr2007, No evidence of t; Ultrasound abdomen, Apr2007, No evidence of t; X-ray, Apr2007, See text
CDC Split Type: B0910928A

Write-up: This case was reported in a literature article and described the occurrence of tuberculous abscess in a 8-month-old female subject who was vaccinated with combined diphtheria, tetanus, pertussis (A or W not known) vaccine (manufacturer unspecified). Historic vaccination included bacillus calmette-guerin vaccine (non-gsk) given in 2006. In April 2007, the subject received unspecified dose of Diphtheria tetanus pertussis (A or W not known) (intramuscular, right thigh, batch number not provided). In April 2007, within 5 days after vaccination with Diphtheria tetanus pertussis (A or W not known), the subject experienced swelling at the site of intramuscular DPT injection. It was 3.5x1.5 cm in size, not warm, non-tender, fluctuant, non-pulsatile and in the subcutaneous plane. Fine needle aspiration cytology (FNAC) of the swelling showed caseating granulomas suggestive of tuberculosis. Staining for acidfast bacilli was positive. This child had no history of contact with tuberculosis. X-ray of hip joints, thigh and spine showed no bony abnormality or evidence of chronic osteomyelitis. On further detailed investigations (Chest X-ray, gastric aspirate for AFB, erythrocyte sedimentation rate, and ultrasound abdomen), no evidence of tuberculosis at any other site was found and, screening of caregivers was also non-contributory. Primary tuberculous abscess was the final diagnosis. This case was assessed as medically serious by GSK. Antitubercular therapy was started with four drugs but the swelling did not subside over the next six weeks. Antigravity drainage of the swelling was done. Antitubercular therapy was continued for six months and follow up examination showed no swelling and a wellthriving child with adequate weight gain.


VAERS ID: 277117 (history)  
Age: 46.0  
Gender: Male  
Location: California  
Vaccinated:2007-04-02
Onset:2007-04-03
   Days after vaccination:1
Submitted: 2007-04-19
   Days after onset:16
Entered: 2007-04-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0889F / 1 - / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / - UN / -

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Chills, Erythema, Hyperhidrosis, Induration, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Type I diabetes mellitus
Preexisting Conditions:
Diagnostic Lab Data: temperature measurement 04/04/07 100.4F, temperature measurement 04/06/07 98F, temperature measurement 04/04/07 103F
CDC Split Type: WAES0704USA02289

Write-up: Information has been received from a licensed practical nurse concerning a 46 year old male with type 1 diabetes mellitus, and no history of drug reactions/allergies. In 1994, the patient received first vaccination with Pneumovax 23. On 02-APR-2007, the patient was vaccinated with second dose of Pneumovax 23 (lot # 655152/0889F) 0.5 ml IM in the left deltoid. Concomitant therapy included ADACEL also given on 02-APR-2007 in the right arm. On 03-APR-2007, the patient experienced muscle aching and called the office. On 04-APR-2007, the patient was seen in the office with a fever of 100.4 degrees Fahrenheit (F). His left arm had a 8x8 area of induration. His fever had risen to 103 F with chills and sweating. He was placed on cephalahexin for 7 days. When he called the office on 06-APR-2007, his temperature had decreased to 98 F and the redness was decreased. On 10-APR-2007, at the time of reporting, he had recovered. The nurse reported that the muscle aching, fever, induration, chills, sweats, and redness were other Important Medical Events and they were disabling because the patient missed work. Additional information has been requested.


VAERS ID: 277924 (history)  
Age: 8.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-04-02
Onset:2007-04-03
   Days after vaccination:1
Submitted: 2007-04-04
   Days after onset:1
Entered: 2007-05-04
   Days after submission:30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1060F / 1 LL / SC

Administered by: Private       Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), 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: TX07031

Write-up: Varivax administered 04/02/2007. On 4/3/07, notice redness @ injection site @ (R) thigh area, size of a silver dollar, slightly raised. Area doubled in size by this morning. Area warm, red, tender to touch. Mom administered Ibuprofen 200mg last night and this AM


VAERS ID: 278272 (history)  
Age: 7.0  
Gender: Female  
Location: Texas  
Vaccinated:2007-04-02
Onset:2007-04-02
   Days after vaccination:0
Submitted: 2007-05-08
   Days after onset:36
Entered: 2007-05-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0637R / 1 RA / SC

Administered by: Private       Purchased by: Public
Symptoms: Blood glucose decreased, Blood pressure decreased, Computerised tomogram normal, Convulsion, Urinary incontinence, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (narrow)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Rhinitis allergic, Tubular vision; Esotropia
Preexisting Conditions: Syncope
Diagnostic Lab Data: Blood pressure 04/02/07 60/48, head computed axial - normal, blood glucose 04/02/07 42
CDC Split Type: WAES0704USA00503

Write-up: Information has been received from a registered nurse concerning a 7 year old female who is cross sighted with estopia and who fainted previously with no other known allergies or medical history who on 02-APR-2007 in the AM was vaccinated SC in the right arm with 0.5 ML second dose of Varivax (Lot # 647532/0637R). At the time of vaccination, the patient was noted to have allergic rhinitis. There was no concomitant medication. On 02-APR-2007 the patient experienced seizure about 15 minutes after vaccination while she was sitting in the waiting room. The seizure lasted about 4 minutes. The patient hit her head on the wall without apparent injury. She was taken to the emergency room and the patient''s blood glucose was42 when she was evaluated by a physician. It was reported that she only ate a small amount of "fruit loops" cereal that day. During the seizure, the patient had vomited and urinated. She had fainted on a previous occasion. As of 04-Apr-2007, the patient had recovered. Follow up information received from a physician indicated that on 02-APR-2007 in the AM the patient developed a generalized seizure in the waiting room after receiving the second dose of Varivax. The patient has head on the wall, vomiting once, and voided. The blood pressure was 60/48. The patient was awake by the time EMS transported her to the hospital. A CT of the head was normal. The patient recovered on 02-APR-2007. The reporter considered the events to be other important medical events. No additional information is expected.


VAERS ID: 279037 (history)  
Age: 23.0  
Gender: Female  
Location: Indiana  
Vaccinated:2007-04-02
Onset:2007-04-02
   Days after vaccination:0
Submitted: 2007-05-14
   Days after onset:42
Entered: 2007-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 - / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0704USA00315

Write-up: Information has been received from a medical assistant concerning a 23 year old female with no pertinent medical history who on approximately 02-FEB-2007 was vaccinated with a first dose of Gardasil. On 02-APR-2007, the patient was vaccinated, intramuscularly, with a second dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). On 02-APR-2007, within a few hours of the vaccination, the patient experienced shortness of breath and nausea. She called the physician''s office and the physician prescribed Benadryl. There were no laboratory or diagnostic tests performed. The patient''s outcome was unknown. Additional information has been requested.


VAERS ID: 279161 (history)  
Age: 21.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-04-02
Onset:2007-04-05
   Days after vaccination:3
Submitted: 2007-05-14
   Days after onset:39
Entered: 2007-05-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0136U / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Rash generalised
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0704USA01001

Write-up: Information has been received from a physician, via a company representative, concerning a 21 year old female patient, who on 05-FEB-2007 was vaccinated IM, with the first dose of Gardasil, and on 02-APR-2007 with the second dose of Gardasil (Lot #654535/0136U). Concomitant therapy included an antibiotic containing sulfa (unspecified). On 05-APR-2007, three days later after the second dose was administered, the patient developed a red rash from her chin to her toes. The physician indicated he believed "the antibiotic containing sulfa" was "the cause of the rash." At the time of the report, it unknown if the patient had recovered. The patient sought unspecified medical attention. Additional information has been requested.


VAERS ID: 280882 (history)  
Age: 15.0  
Gender: Female  
Location: New York  
Vaccinated:2007-04-02
Onset:2007-04-02
   Days after vaccination:0
Submitted: 2007-06-07
   Days after onset:66
Entered: 2007-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0689F / 0 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: ASTHMA
Diagnostic Lab Data:
CDC Split Type:

Write-up: COMPLAINTS OF FEVER OF 102.0 FOR 2 DAYS AND VOMITING


VAERS ID: 289857 (history)  
Age: 1.3  
Gender: Male  
Location: Oklahoma  
Vaccinated:2007-04-02
Onset:2007-04-30
   Days after vaccination:28
Submitted: 2007-06-29
   Days after onset:60
Entered: 2007-09-05
   Days after submission:68
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B08683H / 3 LL / IM

Administered by: Public       Purchased by: Public
Symptoms: Skin hypertrophy
SMQs:

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 done
CDC Split Type:

Write-up: Client received vaccine 4/3/07. End of April, mother noted a small dimple on (R) upper thigh; continued to get bigger throughout May. No redness or inflammation noted. Took child to PMD 6/8/07. PMD said it is a vaccine reaction. Has gotten bigger since 6/8/07. Indentation is about 1.25 inch cir.


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