National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

Using all 626700 cases in the database

Case Details (Sorted by Vaccination Date)

This is page 3091 out of 6267

Result pages: prev   2992 2993 2994 2995 2996 2997 2998 2999 3000 3001 3002 3003 3004 3005 3006 3007 3008 3009 3010 3011 3012 3013 3014 3015 3016 3017 3018 3019 3020 3021 3022 3023 3024 3025 3026 3027 3028 3029 3030 3031 3032 3033 3034 3035 3036 3037 3038 3039 3040 3041 3042 3043 3044 3045 3046 3047 3048 3049 3050 3051 3052 3053 3054 3055 3056 3057 3058 3059 3060 3061 3062 3063 3064 3065 3066 3067 3068 3069 3070 3071 3072 3073 3074 3075 3076 3077 3078 3079 3080 3081 3082 3083 3084 3085 3086 3087 3088 3089 3090 3091 3092 3093 3094 3095 3096 3097 3098 3099 3100 3101 3102 3103 3104 3105 3106 3107 3108 3109 3110 3111 3112 3113 3114 3115 3116 3117 3118 3119 3120 3121 3122 3123 3124 3125 3126 3127 3128 3129 3130 3131 3132 3133 3134 3135 3136 3137 3138 3139 3140 3141 3142 3143 3144 3145 3146 3147 3148 3149 3150 3151 3152 3153 3154 3155 3156 3157 3158 3159 3160 3161 3162 3163 3164 3165 3166 3167 3168 3169 3170 3171 3172 3173 3174 3175 3176 3177 3178 3179 3180 3181 3182 3183 3184 3185 3186 3187 3188 3189 3190   next


VAERS ID: 289996 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-09-04
Onset:2007-09-05
   Days after vaccination:1
Submitted: 2007-09-06
   Days after onset:1
Entered: 2007-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB186CA / 1 RA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1060U / 1 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2138AA / 1 LA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B021CB / 1 LA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1018U / 2 RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Blister, Contusion, Erythema, Skin warm, Swelling
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: (R) arm red, swollen, hot to touch. Bruised, and blistered


VAERS ID: 290097 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Female  
Location: California  
Vaccinated:2007-09-04
Onset:2007-09-05
   Days after vaccination:1
Submitted: 2007-09-06
   Days after onset:1
Entered: 2007-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Hyperaesthesia, Injection site erythema, Injection site vesicles, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Fever to 101, large erythema at vaccine site with single vesicle and pain to touch. Erythema measuring 10x8 inches.


VAERS ID: 290131 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: Michigan  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2007-09-07
   Days after onset:3
Entered: 2007-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2553AA / 5 RL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB182AA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR 20872 / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0094F / 2 LA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 808666B / 3 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1008U / 2 RA / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None~ ()~NULL~~In Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt broke out with hives the evening after his shots were given. He had small hives over the right upper thigh, that then spread to and thru his groin area. He was brought to the office the next day. He was given Zyrtec syrup and mom was instructed to give him tylenol or motrin for the next 2-3 days. Pt is to return to the office on 9-7-07 for a follow-up appt.


VAERS ID: 290177 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: Florida  
Vaccinated:2007-09-04
Onset:2007-09-05
   Days after vaccination:1
Submitted: 2007-09-07
   Days after onset:2
Entered: 2007-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2650AA / 5 RL / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1025U / 2 RA / UN

Administered by: Private       Purchased by: Public
Symptoms: Cough, Croup infectious, Lethargy, Nasal congestion, Somnolence
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Congestion, Contact derm
Preexisting Conditions: Eczema
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Lethargic, croupy cough, sleeping a lot, congestion.


VAERS ID: 290224 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-09-04
Onset:2007-09-05
   Days after vaccination:1
Submitted: 2007-09-06
   Days after onset:1
Entered: 2007-09-10
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U2291BA / 5 LA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0872 / 4 LA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0425U / 2 RA / SC

Administered by: Private       Purchased by: Private
Symptoms: Body temperature increased, Pneumonia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pulmicort
Current Illness: allergic rhinitis
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 9-4-07 Follow up on pneumonia, lungs clear 9-5-07 Woke up during night vomiting and low grade temp. Started Zofran Vomiting that morning and wouldn''t eat


VAERS ID: 290238 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: California  
Vaccinated:2007-09-04
Onset:2007-09-06
   Days after vaccination:2
Submitted: 2007-09-10
   Days after onset:4
Entered: 2007-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0652U / 2 LL / SC

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

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

Write-up: Mom concerned regarding redden area left thigh thinks might have vaccine reaction. Previous MMR, Varicella shots no problems did use combination ProQuad. Keep checking it if worse make appointment.


VAERS ID: 290246 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: Georgia  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2007-09-10
   Days after onset:6
Entered: 2007-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0240-2 / 4 UN / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0227U / UNK RA / SC

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

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

Write-up: SMALL RED PRICKLY RASH ON FACE;PATIENT WAS GIVEN SOLUMEDROL 20 MG IM


VAERS ID: 290311 (history)  
Form: Version 1.0  
Age: 6.0  
Gender: Female  
Location: Indiana  
Vaccinated:2007-09-04
Onset:0000-00-00
Submitted: 2007-09-11
Entered: 2007-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (FOREIGN) / MERCK & CO. INC. 0489U / 2 RA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR ZO872-2 / 2 LA / SC
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0418U / 2 RA / SC
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2731AA / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1028U / 1 LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Inappropriate schedule of drug administration, Wrong drug administered
SMQs:, Haematopoietic erythropenia (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported on Health History
Preexisting Conditions: ASD, VSD, Mild TR. RV Dilatation. Good LV Contraction. Down''s Syndrome. Mental retardation, severity unspecified. Anemia, HCT: 24%. Anisopokilocytosis, Microcytic hypochromatic
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: No known adverse reaction. Tdap given instead of DTaP. CDC Hot Line was called to get information about how to follow-up. Advised to file VAERS report and discount Tdap and give DTaP as soon as feasible. Dr. was notified and recommended scheduling patient for DTaP in one month.


VAERS ID: 290357 (history)  
Form: Version 1.0  
Age: 31.0  
Gender: Female  
Location: California  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2007-09-12
   Days after onset:8
Entered: 2007-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTOX: DIPHTHERIA TOXOIDS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 LA / -
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LA / -
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 2 LA / -

Administered by: Military       Purchased by: Military
Symptoms: Blood creatine phosphokinase normal, Cellulitis, Chills, Erythema, Nuclear magnetic resonance imaging, Streptococcus identification test, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: MRI - negative for nec fasciitis; CK normal. WBC 21,000, ASO pending
CDC Split Type:

Write-up: Pt developed cellulitis and subsequently admitted to exclude necrotizing fasciitis. Pt vaccinated 4 Sept 07 and had onset of chills and erythema same day. She was admitted 7 sept 07. Unfortunately, all 3 vacines were given in same deltoid - provider counselled.


VAERS ID: 290358 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: Alaska  
Vaccinated:2007-09-04
Onset:0000-00-00
Submitted: 2007-09-05
Entered: 2007-09-12
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C275BAA / 2 LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Overdose, Wrong drug administered
SMQs:, Drug abuse and dependence (broad), Medication errors (narrow)

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

Write-up: 9-4-07 Pt receive 2 Tdap within 2 hrs apart. He should have gotten Hep A. I found out 9-5-07 by school nurse.


VAERS ID: 290488 (history)  
Form: Version 1.0  
Age: 61.0  
Gender: Female  
Location: California  
Vaccinated:2007-09-04
Onset:2007-09-05
   Days after vaccination:1
Submitted: 2007-09-12
   Days after onset:7
Entered: 2007-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0486U 7/18/9 / 1 RA / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: lipitor 40 mg each day Entex PSE 1 tab 2 times per day Azmacort inhaler 2 puffs 3 times per day Albuterol Aspirin 81 each day
Current Illness: not known
Preexisting Conditions: none known
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was informed and given information regarding Pneumovax. By patient report she had never previously had a Pneumovax vaccination. Area was prepared and she was given pneumovax 0.50cc subcutaneous Right are upper outer aspect. patient left with no adverse effects. patient called 9/6/07 to report the discomfort and swelling of her arm at the injection site. Patient was unable to come in to this clinic to be seen, after calling to report swelling and tenderness. Patient report (she is a RN) is as follows: "Pneumovax injection given posterior/laterally of Right upper arm in Chest clinic 9/4/2007 with noted increasing redness, induration and tenderness around the injection site ofver the next 48 hours. Clinic was called. Ms Mowbray was unable to come in and was advised that no Allergy physicians would be on hand the next day (Friday, 9/7/7). Ms Mowbray contacted a physician the following day(72 hours), by which time the redness had spread to and area apporximately 7"x9", with increasing induration and discomfort. Keflex was ordered and redness began to recede with in 18 hours. Five days into 10 day course of Keflex, erythamatous area was significantly reduced."


VAERS ID: 290469 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Arizona  
Vaccinated:2007-09-04
Onset:2007-09-05
   Days after vaccination:1
Submitted: 2007-09-11
   Days after onset:6
Entered: 2007-09-13
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1060U / 2 LA / IM

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

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

Write-up: got vaccine on 9/4/07 (Gardasil #2) started with itching 9/5/07 @ 4 pm and swelling of arm on 9/6/07


VAERS ID: 290492 (history)  
Form: Version 1.0  
Age: 0.17  
Gender: Male  
Location: Indiana  
Vaccinated:2007-09-04
Onset:2007-09-05
   Days after vaccination:1
Submitted: 2007-09-13
   Days after onset:8
Entered: 2007-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2657AA / 1 LL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0039U / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF002AA/UF193AB / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z1009 / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B0869E / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0769U / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Irritability
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prevacid, sucralfate
Current Illness: None
Preexisting Conditions: GERD
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: extreme fussines first two days of vaccination


VAERS ID: 290609 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Male  
Location: Georgia  
Vaccinated:2007-09-04
Onset:2007-09-05
   Days after vaccination:1
Submitted: 2007-09-07
   Days after onset:2
Entered: 2007-09-14
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2402AA / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1028U / 2 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Cold compress therapy, Hyperaemia, Oedema, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

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

Write-up: 3 3/4" X 4 1/2" area of edema and hyperemia, hot to touch. (left arm) Instructed to take Benadryl 50 mg QID, cool compresses, decrease activity left arm


VAERS ID: 290610 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Arizona  
Vaccinated:2007-09-04
Onset:2007-09-05
   Days after vaccination:1
Submitted: 2007-09-11
   Days after onset:6
Entered: 2007-09-14
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2065AA / 1 LL / -
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. 1242F / 2 RL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0111 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B47300F / 1 RL / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0694F / 1 MO / PO

Administered by: Private       Purchased by: Public
Symptoms: Diarrhoea, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Patient on ZANTAC 1ml BID
Current Illness: None
Preexisting Conditions: GERD
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe diarrhea with 101 fever after Rotateq immunization, starting on 9/5/07 for 3-4 days.


VAERS ID: 290631 (history)  
Form: Version 1.0  
Age: 35.0  
Gender: Male  
Location: Hawaii  
Vaccinated:2007-09-04
Onset:2007-09-06
   Days after vaccination:2
Submitted: 2007-09-06
   Days after onset:0
Entered: 2007-09-14
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV110 / 6 RA / -

Administered by: Other       Purchased by: Military
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)

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

Write-up: Patient showed local inflammation at site of Anthrax vaccine associated redness, swelling, induration, tenderness extending concentrically around site from just below shoulder to elbow postercally. Dx: local reaction vs cellulitis.


VAERS ID: 290819 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Female  
Location: Michigan  
Vaccinated:2007-09-04
Onset:2007-09-12
   Days after vaccination:8
Submitted: 2007-09-18
   Days after onset:6
Entered: 2007-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2605AA / 4 LA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0872 / 4 LA / SC
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 1031F / 3 RA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B47300H / 2 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: milk based formula intolerance to age 1
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Parent contacted Health Department on 09/13/07 and stated that child had red blotches on top of both thighs, starting 09/12. These never became bumpy, were more reddened after bath, and never became itchy. No new foods eaten, no new detergents, soaps or fabric softeners being used. No fever. She is quite certain that rash caused by shots given on 09/04. Spoke again on 09/14. Contacted medical provider on 9/13 but did not take her in. They recommended that she use Benedryl cream on the rash, which she did. Rash is now resolved.


VAERS ID: 290852 (history)  
Form: Version 1.0  
Age: 32.0  
Gender: Male  
Location: Oklahoma  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2007-09-04
   Days after onset:0
Entered: 2007-09-18
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TTOX: TETANUS TOXOID (NO BRAND NAME) / SANOFI PASTEUR U1856AA / 1 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Cold compress therapy, Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

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

Write-up: Donor became dizzy and nauseated. Placed donor in supine position, elevated lower extremities bilaterally, applied cold compress. Donor stated he only had bowel of cereal and had smoked a cigarette immediately before vaccination.


VAERS ID: 290862 (history)  
Form: Version 1.0  
Age: 1.5  
Gender: Female  
Location: Ohio  
Vaccinated:2007-09-04
Onset:2007-09-05
   Days after vaccination:1
Submitted: 2007-09-13
   Days after onset:8
Entered: 2007-09-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U2289AA / 4 LL / -

Administered by: Public       Purchased by: Public
Symptoms: Abscess, Arthropod bite, 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Mother states none
Preexisting Conditions: Mother states none
Allergies:
Diagnostic Lab Data: None known, Bactrim 1 tsp. q12 hours for 3 days.
CDC Split Type:

Write-up: Mother reports appearance of "bug bite" at injection site which increased in size and redness over 3 days. On 9-8-07. Mother took child to Urgent Care Clinic. Diagnosis of abscess and mother states it was lanced and drained and packed. Follow-up with family physician was made 9-12-07 packing removed. Infection resolving per Mother.


VAERS ID: 290964 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Male  
Location: Virginia  
Vaccinated:2007-09-04
Onset:2007-09-14
   Days after vaccination:10
Submitted: 2007-09-14
   Days after onset:0
Entered: 2007-09-20
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UT2456CA / 3 RL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB181AA / 1 RA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0282U / 1 LA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0848U / 1 RA / SC

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

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

Write-up: MMR, Varivax, Hepatitis A, and Fluzone given on 9/4/07. 9/14/07 awoke with rash on torso, neck and face - blotchy, papular. 1 tsp Benadryl given.


VAERS ID: 291142 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2007-09-17
   Days after onset:13
Entered: 2007-09-21
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2606AA / 5 LA / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0413U / 2 RA / -

Administered by: Private       Purchased by: Public
Symptoms: Erythema, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Swelling, redness, warm to touch.


VAERS ID: 291219 (history)  
Form: Version 1.0  
Age: 32.0  
Gender: Female  
Location: South Carolina  
Vaccinated:2007-09-04
Onset:2007-09-06
   Days after vaccination:2
Submitted: 2007-09-11
   Days after onset:5
Entered: 2007-09-24
   Days after submission:13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB412AA / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2824AA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site swelling, Pain, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Whelps, redness, swelling at injection site. HA, body aches, flu-like symptoms.


VAERS ID: 291859 (history)  
Form: Version 1.0  
Age: 72.0  
Gender: Male  
Location: Ohio  
Vaccinated:2007-09-04
Onset:2007-09-14
   Days after vaccination:10
Submitted: 2007-10-02
   Days after onset:18
Entered: 2007-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0883U / 1 RA / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ORAL DIABETES MEDICATION
Current Illness: NONE
Preexisting Conditions: DIABETES
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 10 DAYS POST RECEIVING VACCINE, DEVELOPED RASH, SELF DESCRIBED AS SHINGLES. RASH LOCATED ON LEFT LOWER BACK. ABOUT 17 DAYS POST-VACCINATION, DEVELOPED ADDITIONAL RASH ON LEFT LOWER BACK. CLIENT HAS HAD FRREQUENT BOUTS WITH SHINGLES, "EVERY 3 MONTHS" OR SO. HAD PREVIOUSLY TAKEN VALTRREX DAILY TO PREVENT SHINGLES. HAD BEEN OFF MED FOR "AT LEAST 6 WEEKS TO 2 MONTHS"


VAERS ID: 291868 (history)  
Form: Version 1.0  
Age: 1.33  
Gender: Female  
Location: Illinois  
Vaccinated:2007-09-04
Onset:2007-09-05
   Days after vaccination:1
Submitted: 2007-10-02
   Days after onset:27
Entered: 2007-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER NO ONE TOLD ME / 1 RL / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER OR THE LOT NUMB / 4 LL / IM
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER THE MANUFACTURE / 1 RL / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Eating disorder, Irritability, Lymphadenopathy, Neutrophil count increased, Pyrexia, Screaming, Tuberculin test negative
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: none~ ()~NULL~~In Patient|none~ ()~NULL~~In Sibling1
Other Medications: zantec
Current Illness: none
Preexisting Conditions: gerd,aplaisia
Allergies:
Diagnostic Lab Data: neut was elevated.reactive lymph was 5.tb was neg
CDC Split Type:

Write-up: Ran a persitant fever for 10 days. 9-14-07 given amoxicillin,did blood work up. Everything was normal except for the neut which was elevated. fever ended within 3 days after medication.9-20-07 2 lymph nodes in groin swelled, one nickel size other pea size. took her back to the doctor, they did nothing. 9-25-07 a third lymph node swelled to nickel size next to the other two.Took her back again,they changed her meds and took more blood, and did a tb test. Tb was neg. blood came back normal. Her reactive lymph was a 5.She had not been acting herself through all of this.Was extremly cranky. Screamed for no reason for an hour or 2 at a time. And nothing would sooth her.She would refuse to eat.


VAERS ID: 291914 (history)  
Form: Version 1.0  
Age: 32.0  
Gender: Female  
Location: California  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2007-09-26
   Days after onset:22
Entered: 2007-10-02
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 1 - / -

Administered by: Private       Purchased by: Private
Symptoms: Eye pain, Fatigue, Heart rate increased, Injection site pain, Insomnia
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Glaucoma (broad)

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

Write-up: I felt strange about 30 minutes later. Fatigue set in but I was not able to fall asleep without a sleep aid for 3 weeks. My eyes and upper torso felt like they were on fire and my heart rate increased quite a bit. Site of injection very sore, but that''s normal. Never had trouble sleeping before. Still not sleeping.


VAERS ID: 291991 (history)  
Form: Version 1.0  
Age: 39.0  
Gender: Female  
Location: California  
Vaccinated:2007-09-04
Onset:2007-09-13
   Days after vaccination:9
Submitted: 2007-10-03
   Days after onset:20
Entered: 2007-10-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 9722404 / UNK LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2775AA / UNK LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injected limb mobility decreased
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Effexor
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: On 9/4/07 Tdap and Hep B vaccines given in left deltoid. On 9/13/07 the patient''s husband called and reported that patient was unable to move left arm and had an appointment with a specialist. No further information available.


VAERS ID: 292441 (history)  
Form: Version 1.0  
Age: 38.0  
Gender: Female  
Location: Colorado  
Vaccinated:2007-09-04
Onset:2007-09-07
   Days after vaccination:3
Submitted: 2007-10-08
   Days after onset:31
Entered: 2007-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0182U / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Chills, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Patient reported high fever(did not take temp), shivering and body aches 3 days post vaccination.Immunization injection sight WNL. Symptoms lasted approximately 24 hours.


VAERS ID: 296737 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Florida  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2008-01-07
   Days after onset:125
Entered: 2007-10-12
   Days after submission:87
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0927U / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Blood pressure normal, Body temperature normal, Dizziness, Immediate post-injection reaction, Injection site pain, Oedema peripheral, Pain in extremity, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (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), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADDERALL TABLETS; ORTHO TRI-CYCLEN LO; hydrochloric acid; tetracycline; vitamins (unspecified)
Current Illness: Drug Hypersensitivity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: blood pressure, 09/05?/07, normal; body temp, 09/05?/07, normal
CDC Split Type: WAES0709USA00589

Write-up: Information has been received from a nurse practitioner concerning an 18 year old female with minocycline hypersensitivity who on 04-SEP-2007 at 2:12 pm was vaccinated with 0.5 ml second does of GARDASIL. Concomitant therapy included ADDERALL TABLETS, ORTHO TRI-CYCLEN LO, tetracycline, vitamins (unspecified) and hydrochloride. On 04-SEP-2007 immediately after vaccination she started to feel lightheaded. She reported not having eaten all day. She felt better and went to work. She woke up in the middle of the night with pain in her lower extremities, lower back, stomach, and at the injection site. She went to the local emergency room (ER) and reported her pain level as being an 8 on a scale of 10. The ER reported that there was no fever, blood pressure was normal, and there was no infection redness or swelling. The patient was TRENTAL and sent home. The office reported they would call the patient later to follow-up. Unspecified medical attention was sought. At the time of the report the patient''s outcome was unknown. The patient did not report having a similar experience after her first dose of GARDASIL. Additional information has been requested. Initial and follow-up information has been received from a nurse practitioner concerning an 17 year old white female with a minocycline hypersensitivity who on 22-AUG-2007 at 9:45 am was vaccinated into left antecubital with a first dose of GARDASIL (Lot #658222/0927U). Concomitant therapy included ADDERALL TABLETS, ORTHO TRI-CYCLEN LO, tetracycline, vitamins (unspecified) and hydrochloride. On 25-AUG-2007 the patient was in the office and reported that 2 days after vaccination (24-AUG-2007) she developed knee and leg pain bilaterally and swelling in the feet as bilateral arm pain with a rash on her lower legs. She went to her family doctor and was placed on MEDROL. On an unspecified date the patient recovered. On 04-SEP-2007 at 2:12 pm she was vaccinated with 0.5 ml second dose of GARDASIL. On 04-SEP-2007 immediately after vaccination she started to feel lightheaded. She reported not having eaten all day. She felt better and went to work. She woke up in the middle of the night with pain in her lower extremities, lower back, stomach, and at the injection site. She went to the local emergency room (ER) and reported her pain level as being an 8 on a scale of 10. The ER reported that there was no fever, blood pressure was normal, and there was no infection site redness or swelling. The patient was given TRENTAL and sent home. The office reported they would call the patient later to follow-up. Unspecified medical attention was sought. At the time of the report the patient''s outcome was unknown. Additional information is not expected.


VAERS ID: 298860 (history)  
Form: Version 1.0  
Age: 23.0  
Gender: Female  
Location: California  
Vaccinated:2007-09-04
Onset:2007-09-11
   Days after vaccination:7
Submitted: 2008-01-07
   Days after onset:118
Entered: 2007-10-15
   Days after submission:84
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0530U / 1 UN / IM

Administered by: Private       Purchased by: Other
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Intensive care, Muscular weakness, Nuclear magnetic resonance imaging, Sensory loss
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 18 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MOLTRIN; PROVERA
Current Illness: 12/18/07-records received-Vaginal bleed for 2 weeks after IUD placement. History of diarrhea one week ago which remained for 3 days and resolved spontaneously.
Preexisting Conditions: Pregnancy termination. 12/18/07-records received-HX cervical cancer 6 years ago.
Allergies:
Diagnostic Lab Data: Magnetic resonance 09/07/07 results not reported 12/18/07-records received-Labs: lymphs 51.2, mono 11.6, sed rate 25. Urinalysis WBC 188, RBC 27, e. coli. Pregnancy test positive. CSF protein 56, culture negative.
CDC Split Type: WAES0709USA01558

Write-up: Information has been received from a physician concerning a 23 year old female with a history of being seen in the emergency room with "IUD pregnancy terminated" on 27-AUG 2007. On 04-SEP-2007, the patient was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5ml (# of doses not reported). Concomitant therapy was unspecified. On 04-SEP-2007, the patient was given a prescription to fill for medroxyprogesterone acetate (PROVERA) and ibuprofen (MOTRIN) at the same visit that the HPV rL1 6 11 16 18 VLP vaccine (yeast) was administered. It was unknown if the prescriptions were taken by the patient. On 07-SEP-2007, the patient experienced loss of feelings in her extremities and weakness that progressed until she was examined in the emergency room. On 07-SEP-2007, the patient was hospitalized for possible Guillain-Barre syndrome. The patient had a magnetic resonance imaging performed that was being evaluated. At the time of reporting the patient had not recovered and was in the intensive care unit. The reporting physician felt that the event was serious (Other Important Medical Event), immediately life-threatening, required hospitalization and was disabling. Additional information has been requested. 12/18/07-records received for DOS 9/10-9/28/07- DC DX: Guillain-Barre syndrome, quadriparesis, improving at time of discharge. Decreased mobility in self care. pregnancy has resolved. Urinary tract infection. See in ED wit 2 day history of weakness started in fingers/hands and leg pains. Difficulty walking, can not get up wlk or move legs and arms. Short of breath when she tries to talk. PE: reflexes absent in both lower and upper extremities. This is in follow-up to report(s) previously submitted on 10/12/2007 1/7/2008. Initial and follow-up information has been received from two physicians concerning a 23 year old female with a history of bein seen in the emergency room with "IUD-pregnancy terminated" on 27-AUG-2007. On 04-SEP-2007, the patient was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (Lot #0530U) # of doses not reported. On 14/SEP/2007, the patient was given a prescription to PROVERA and MOTRIN at the same time that GARDASIL was administered. It was unknown if the prescriptions wore taken by the patient. On approximately, 11-SEP-2007, the patient experienced loss of feelings in her extremities and weakness that progressed. She presented to the emergency room, with Guillain Barre syndrome where she was examined. On approximately, 11-SEP-2007, the patient was hospitalized for possible Guillain-Barre syndrome. The patient had a magnetic resonance imaging performed that was being evaluated. At the time of reporting, the patient had not recovered and was in the intensive care unit. The reporting physician felt that the event was serious (Other Important Medical Event) immediately life-threatening, required hospitalization, and was disabling. A review of the release testing data revealed that 0530U conformed to all required testing at the time of product release. Additional information is not expected.


VAERS ID: 293296 (history)  
Form: Version 1.0  
Age: 32.0  
Gender: Female  
Location: Illinois  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2007-10-16
   Days after onset:42
Entered: 2007-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB107AA / 1 LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Asthenia, Insomnia, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Solodyn, q day, 30 days po tab
Current Illness: Stated she was tired from the three day weekend.
Preexisting Conditions: Penicillin allergy
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt. states after the first vaccine she began to feel weak and ill approximately 1 hour after getting the vaccine. Later in the day she developed a 102 degree fever. Took Motrin at 8:00 pm, midnight and 4:30 am. She had difficulty sleeping; expereinced unusual dreams. Decided to go to the local ER for treatment; did not see the MD due to length of wait. Returned home by 6:00 am and began feeling better by 7:00 am. Required no additional treatment.


VAERS ID: 293745 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-09-04
Onset:2007-09-23
   Days after vaccination:19
Submitted: 2007-10-18
   Days after onset:25
Entered: 2007-10-19
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 1482F / 1 UN / SC
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2172AA / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Grand mal convulsion, Inappropriate schedule of drug administration, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: rect T 09/23/07 104.9 degr; body temp 09/22/2007 - developed a fever
CDC Split Type: WAES0710USA03076

Write-up: Information has been received from an investigator concerning a 12-month-old male who entered study. On 04-SEP-2007 the patient was vaccinated subsequently in the left arm with a first dose of 0.5 ml of ProQuad (Oka/Merck upgrade process) (lot3 656445/1482F). Suspect vaccination included a second intramuscular injection in the right thigh of Menactra (lot# U21722AA). On 22-SEP-2007 the patient developed a fever "but was acting fine" and his parents treated with acetaminophen (TYLENOL). On 23-Sep-2007, the patient developed a rectal temperature of 104.9 degrees Fahrenheit, and experienced a grand-mal seizure lasting "a few minutes". He was noted to be post-focal for five minutes following the seizure. The seizure was reported by his mother, who is a pediatrician. His parents treated with fever with acetaminophen (TYLENOL) and a sponge bath, and the fever resolved the following day. No additional seizures were noted. Per the investigator, the patient had no history of febrile seizures. He recovered and continued in the trial. According to the investigator, the event was not related to Menactra. The reporting investigator felt that febrile seizure was related to ProQuad (Oka/Merck upgrade process). Upon internal review, febrile seizure was considered to be an other important medical event. Additional information has been requested.


VAERS ID: 294439 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2007-10-25
   Days after onset:51
Entered: 2007-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1003U / 2 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Erythema, Pain, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol prn pain
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 2-3 cm ertythmetous area with warmth, swelling and pain. Symptomatic care with pain reliever and cool compress.


VAERS ID: 298224 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Washington  
Vaccinated:2007-09-04
Onset:0000-00-00
Submitted: 2007-11-07
Entered: 2007-11-29
   Days after submission:22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2552AA / 1 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: No adverse reaction
SMQs:

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

Write-up: None known (We gave DTaP instead of Tdap).


VAERS ID: 300719 (history)  
Form: Version 1.0  
Age: 19.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2007-09-04
Onset:2007-10-04
   Days after vaccination:30
Submitted: 2007-12-14
   Days after onset:71
Entered: 2007-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1061U / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Colonoscopy, Diarrhoea, Dizziness, Haematemesis, Laboratory test, Motion sickness, Nausea, Nuclear magnetic resonance imaging, Pain in extremity, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOESTRIN. Oral contraceptives, anaprox, vicodin.
Current Illness:
Preexisting Conditions: Environmental allergy 5/15/09 Hospital records received DOS 11/24/07 to 11/25/07. Mild (acid) reflux, childhood asthma, ''food allergy'' to beef, apples, resulting in diarrhea. 8/7/09 Medical records received DOS 9/4/07 to 10/30/07. Alcohol use.
Allergies:
Diagnostic Lab Data: colonoscopy; magnetic resonance; diagnostic laboratory; diagnostic procedure 5/15/09 Hospital records received DOS 11/24/07 to 11/25/07. LABS and DIAGNOSTICS: Urine analysis - Sp Grav 1.036 (H) 1+ protein 1+ ketone. CHEM - Urea Nitrogen 6 MG/DL (L). CBC - HCT 35.3% (L) Abs Neuts 1.9 x10 9th/L (L) LUC 5% (H). 8/7/09 Medical records received DOS 9/4/07 to 10/30/07. LABS and DIAGNOSTICS: PAP WNL.
CDC Split Type: WAES0711USA02589

Write-up: Information has been received from a consumer concerning her daughter, a 19 year old female with a history of environmental allergies to mold and mildew who on 04-SEP-2007 was vaccinated with her first dose of GARDASIL (Lot # 058558/1061U). Concomitant therapy included LOESTRIN. One month after vaccination, the patient developed weight loss(17 pounds since start of GI problems), diarrhea, nausea, vomiting (sometimes bloody), dizziness, abdominal pain, and motion sickness. On 31-OCT-2007 (also reported as 30-Oct-2007) the patient received the second dose of GARDASIL (Lot 3 658563/1063U), the symptoms of weight loss, diarrhea, nausea, vomiting, dizziness, abdominal pain and motion sickness worsened and she developed achy legs. The diarrhea is uncontrollable, the patient is throwing up 5 or more times a day, the abdominal pain has increased. The patient has tried lansoprazole, Phenergan, dicyclomine hydrochloride, unspecified antibiotic, and ondansetron hydrochloride, none of which helped. The patient was seen by a Gastroenterologist and no cause for the gastrointestinal problems can be found. The patient had a colonscopy and follow through procedure, magnetic resonance imaging(MRI), blood tests, and tests for Gallbladder functioning. The patient''s weight loss, diarrhea, nausea, vomiting, dizziness, abdominal pain, motion sickness, and achy legs persisted. Additional information has been requested. 4/27/09-records received-10/9/07-routine office visit-C/O vomiting for 2 days, and vomiting blood and abdominal cramps. Allergies to beef and quarter pounder with cheese which cause diarrhea. PMH: Six month history of epigastric pain, gastric ulcer, esophagitis, nausea, blocked eustachian tube. 10/30/07-C/O dizziness and nausea. Right TMJ tenderness. VNG 11/13/07-normal. 12/13/07-after 2nd Gardasil injection C/O reflux now with 2 cycles dysmenorrhea. 4/1/08-presented of ED with C/O abdominal pain nausea and diarrhea. Subjective fever. this is a new complaint. DX: abdominal pain. Gastroeneritis. 4/27/09-records received-10/9/07-routine office visit-C/O vomiting for 2 days, and vomiting blood and abdominal cramps. Allergies to beef and quarter pounder with cheese which cause diarrhea. PMH: Six month history of epigastric pain, gastric ulcer, esophagitis, nausea, blocked eustachian tube. 10/30/07-C/O dizziness and nausea. Right TMJ tenderness. VNG 11/13/07-normal. 12/13/07-after 2nd Gardasil injection C/O reflux now with 2 cycles dysmenorrhea. 4/1/08-presented of ED with C/O abdominal pain nausea and diarrhea. Subjective fever. this is a new complaint. DX: abdominal pain. Gastroeneritis. krk 5/15/09 Hospital records received DOS 11/24/07 to 11/25/07. FINAL DIAGNOSIS: Recurrent vomiting Post vaccination abdominal pain, nausea, vomiting and diarrhea. Later reports fatigue, fevers, chills, night sweats, myalgias, hematemesis, blood with diarrhea. Watery bowel movements. Symptoms worsen when she eats. 8/7/09 Medical records received DOS 9/4/07 to 10/30/07. Annual physical. Oral contraceptives.


VAERS ID: 300840 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Unknown  
Vaccinated:2007-09-04
Onset:2007-10-01
   Days after vaccination:27
Submitted: 2007-12-14
   Days after onset:74
Entered: 2007-12-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1061U / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Colonoscopy, Laboratory test, Nausea, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOESTRIN
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: colonoscopy - Results unknown
CDC Split Type: WAES0711USA03443

Write-up: Information has been received from a pharmacist concerning a patient who on 04-SEP-2007 was vaccinated with the first dose of Gardasil (lot# 658558/1061U). On 30-OCT-2007 the patient received the second dose of Gardasil (lot# 658563/1063U). Concomitant therapy included LOESTRIN. One month after the first dose the patient experienced lots of nausea and vomiting and a 15 pound weight loss. At the time of 2nd dose of vaccination the patient still had nausea and vomiting. Unknown medical attention was sought. The patient had a lot of unspecified tests that were negative. The patient''s outcome is unknown. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 301717 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2007-09-04
Onset:2007-09-06
   Days after vaccination:2
Submitted: 2007-12-21
   Days after onset:106
Entered: 2007-12-28
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0709USA00770

Write-up: Information has been received from a female who on 04-Sep-2007 was vaccinated with Zostavax. On 06-Sep-2007 the patient experienced injection site elevation with redness. The elevation was swollen and itchy. As of 06-Sep-2007, the patient''s adverse experiences persisted. No further information is available.


VAERS ID: 301724 (history)  
Form: Version 1.0  
Age: 68.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2007-12-21
   Days after onset:108
Entered: 2007-12-28
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0882U / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZETIA; TOPROL XL TABLETS
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0709USA01071

Write-up: Information has been received from a pharmacist and a pharmacy technician concerning a 68 year old Caucasian female with no known allergies and no pertinent medical history who on 04-SEP-2007 was vaccinated with Zostavax to prevent shingles (Lot # 658085/0882U) SQ. Concomitant therapy included TOPROL XL and ezetimibe. On 04-SEP-2007 the patient developed a red spot at the injection site. As of 07-SEP-2007, the patient was recovering. In follow-up the pharmacist reported that on 05-SEP-2007 the patient experience "rash, fever at injection site" until 08-SEP-2007. Additional information was requested.


VAERS ID: 301834 (history)  
Form: Version 1.0  
Age: 70.0  
Gender: Male  
Location: Unknown  
Vaccinated:2007-09-04
Onset:2007-09-09
   Days after vaccination:5
Submitted: 2007-12-21
   Days after onset:103
Entered: 2007-12-28
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COREG; INSPRA; ALTACE
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0709USA01564

Write-up: Information has been received from a 70 year old male consumer with no pertinent medical history who on 04-SEP-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included ALTACE, COREG and INSPRA. On 09-SEP-2007 (five days after vaccination) the patient developed severe dizziness. Unspecified medical attention was sought. No lab studies were performed. No further information was provided. There was no product quality complaint involved. Additional information is not expected.


VAERS ID: 301879 (history)  
Form: Version 1.0  
Age: 63.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2007-12-21
   Days after onset:108
Entered: 2007-12-28
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0356U / UNK UN / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Darvocet-N Maalox Osteo-Bi-Flex Lipitor Allegra Flaxseed Neurontin Daypro Effexor XR Vitamins (unspecified)
Current Illness: Chronic obstructive pulmonary disease; Penicillin allergy
Preexisting Conditions: Lung neoplasm malignant
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES0709USA02489

Write-up: Information has been received from a medical assistant concerning a 63 year old female with chronic obstructive pulmonary disease and amoxicillin allergy and a history of lung cancer who on 04-Sep-2007 was vaccinated SC with a dose of Zostavax (Lot #656858/0356U). Concomitant therapy included atorvastatin calcium (Lipitor), gabapentin (Neurontin), oxaprozin (Daypro), venlafaxine HC1 (Effexor XR), aluminum hydroxide/magnesiumhydroxide (Maalox), flaxseed, vitamins (unspecified), ascorbic acid (+) chondroitin sulfate sodium (+) glucosamine sulfate (+) manganese (unspecified) (Osteo-Bi-Flex), fexofenadine hydrochloride (Allegra) and acetaminophen (+) propoxyphene napsylate (Darvocet-N). On approximately 11-Sep-2007, 7 days after vaccination the patient developed an itchy rash and red spots on her legs, inner thighs and torso. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient had not recovered. No diagnostic laboratory tests were undertaken. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. Further information has been received from a physician concerning this 63 years old female who 7 days after being vaccinated with ZOSTAVAX developed an itchy rash. The patient was seen on 17Sep-2007 with multiple papular lesions to the arms legs and buttocks. The patient recovered on 29-SEP-2007. Additional information is not expected.


VAERS ID: 302240 (history)  
Form: Version 1.0  
Age: 60.0  
Gender: Female  
Location: Idaho  
Vaccinated:2007-09-04
Onset:2007-10-05
   Days after vaccination:31
Submitted: 2007-09-18
   Days after onset:17
Entered: 2008-01-10
   Days after submission:114
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0585U / 1 UN / SC

Administered by: Public       Purchased by: Private
Symptoms: Blister, Pruritus, Urticaria
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None~ ()~~0.00~In Patient|None~ ()~~0.00~In Sibling|None~ ()~~0.00~In Sibling
Other Medications: Prednisone 10 mg BID QD for arthritis
Current Illness: None
Preexisting Conditions: Arthritis
Allergies:
Diagnostic Lab Data: Clinical diagnosis by MD
CDC Split Type: ID07045

Write-up: 3 1/2 weeks after shot, client developed spot on buttocks area. 3 days later it was 2x size with blisters. Client had shingles 6 years ago. 10/25/07-area healed over but still urticaric. No pain. Started Acyclovir 800 mg 5x day x 5 days. Still with healed over blisters, some itching.


VAERS ID: 303426 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-09-04
Onset:0000-00-00
Submitted: 2008-01-07
Entered: 2008-01-16
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0515U / 1 UN / IM

Administered by: Private       Purchased by: Private
Symptoms: Arthralgia, Joint sprain, Joint swelling, Laboratory test, Subcutaneous nodule
SMQs:, Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Diagnostic laboratory results not reported
CDC Split Type: WAES0712USA01164

Write-up: Information has been received from the father of a 16 year old female consumer with no medical history and/or drug reactions/allergies who on 04-Sep-2007 was vaccinated IM with the first 0.5 mL dose of Gardasil (lot not reported). There was no concomitant medication. During the first part of October, 2007, the patient experienced swollen ankle. The patient went to the ER and was diagnosed with ankle sprain. "A couple of days later" her other ankle swelled. At the time of the report the patient was experiencing pain in her ankles, knees, hips, elbows and wrists and she has "subcutaneous nodules" on her arms and legs." Unspecified blood work was performed (results not provided). At the time of the report the patient was recovering. There was no product quality complaint. Additional information has been requested. This is in follow-up to report (s) previously submitted on 1/7/2008. Information has been received from the father of a 16 year old female (119 lbs., 62 inches) with no medical history and/or drug reactions/allergies who on 04-SEP-2007 was vaccinated IM with the first 0.5 mL dose of GARDASIL vaccine (Lot #657872/0515U). There was no concomitant medication. During "the first part of October, 2007, the patient experienced swollen ankle. The patient went to the ER and was diagnosed with ankle sprain. "A couple of days later" her other ankle swelled. At the time of the report the patient was experiencing pain in her ankles, knees, hips, elbows and wrists and she has "subcutaneous nodules" on her arm and legs." Unspecified blood work was performed (results not provided). The patient recovered from her experiences on 17-DEC-2007. No further information is expected.


VAERS ID: 313985 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2007-09-04
Onset:2007-09-06
   Days after vaccination:2
Submitted: 2008-05-16
   Days after onset:253
Entered: 2008-05-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB186AA / 1 LL / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 658558/1061U / 1 LL / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR 1061U / 1 RL / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B024AA / 6 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 658422/1030U / UNK LA / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Allergic reaction to antibiotics
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA02678

Write-up: Information has been received from a registered nurse concerning a 11 year old female with no pertinent medical history, with an allergy to amoxicillin (+) clavulanate potassium (AUGMENTIN) who on 04-SEP-2007 was vaccinated subcutaneously into the left arm with a second dose varicella virus vaccine live (Oka/Merck) (Lot # 658422/1030U). Concomitant vaccine therapy that same day included a first dose of human papillomavirus vaccine, for the treatment of prophylaxis, administered intramuscularly into the left thigh (Lot # 658558/1061U), a first dose of hepatitis A vaccine (inactive) (HAVRIX) administered intramuscularly into the left thigh (Lot# AHAVB196AA), a fifth dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX) administered intramuscularly into the right arm (Lot# AC52B024AA) and a first dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) administered intramuscularly into the right thigh (Lot # 1061U). On 06-SEP-2007 the patient developed a red, hard, welt "about the size of a silver dollar", which was warm to touch. There was no illness at the time of vaccination. There were no diagnostic tests performed. The patient had no prior history of adverse events following prior vaccinations. The patient recovered on an unspecified date. No further information is expected.


VAERS ID: 314907 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Unknown  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2008-05-16
   Days after onset:255
Entered: 2008-05-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA00856

Write-up: Information has been received from a pharmacist concerning a male who on 04-SEP-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (MSD). Reporter indicated it was due to staff error. No further information was provided. There was no product quality complaint involved. No further information is available.


VAERS ID: 314926 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Female  
Location: Michigan  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2008-05-16
   Days after onset:255
Entered: 2008-05-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1013U / 2 RL / IM

Administered by: Other       Purchased by: Other
Symptoms: Culture negative, Incorrect route of drug administration, Injection site erythema, Injection site vesicles, Injection site warmth, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Ventricular septal defect; Cerebral palsy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: abscess culture 09/06/07 - cultures of bullae fluid, no growth
CDC Split Type: WAES0709USA01074

Write-up: Information has been received from a physician concerning a 5-year-old female with Ventricular septal defect and cerebral palsy who on 04-SEP-2007 (in the AM) was vaccinated intramuscular in the right thigh with a second dose of varicella virus vaccine live (Oka/Merck) (lot # 658178/1013U). Concomitant therapy included a dose of Havrix (manufacturer unspecified). There were no illnesses at the time of vaccination. On 05-SEP-2007, post vaccination, the patient developed on her right leg at the injection site large big bullous 2.5 X 2.5 cm (size of a small donut), with small bullae surrounding (previously described as "with blisters around it") that was fluid filled. There was also a large area of redness and warmth 5 X 5 cm also present at the site of injection and the patient experienced leg pain. The patient was referred to an infectious disease doctor for follow-up. On 06-SEP-2007, anaerobic and aerobic cultures of the bullous fluid were cultured and drained the results showed no growth. The patient was being treated with Clomacin. On the 10-Sep-2007, the patient recovered. No product quality complaint was involved. Additional information is not expected.


VAERS ID: 323442 (history)  
Form: Version 1.0  
Age: 30.0  
Gender: Female  
Location: Michigan  
Vaccinated:2007-09-04
Onset:2007-09-05
   Days after vaccination:1
Submitted: 2008-07-30
   Days after onset:329
Entered: 2008-08-06
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0698U / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Injection site swelling, Oedema peripheral, Pain in extremity, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA08676

Write-up: Information has been received from a licensed practical nurse concerning a 30 year old black female who on 04-SEP-2007 was vaccinated with her first dose of pneumococcal 23v polysaccharide vaccine (Lot #657039/0698U) intramuscularly in the left arm. On 05-SEP-2007, the patient developed a severely swollen and painful left arm, and itching. On 07-SEP-2007, the patient was seen by the physician and there was a 3" X 4" red swollen area at the injection site which extended down her arm and into axilla. The patient was given 40 mg. of KENALOG intramuscularly and MEDROL DOSE PAK. The reaction was resolved within these measures. No additional information is expected.


VAERS ID: 323595 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Maryland  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2008-08-21
   Days after onset:352
Entered: 2008-08-28
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0927U / 1 RA / -
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2233CA / 1 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Blood test, Burning sensation, Computerised tomogram, Confusional state, Decreased appetite, Disturbance in attention, Dizziness, Fatigue, Head injury, Headache, Impaired driving ability, Impaired work ability, Middle ear effusion, Mononucleosis heterophile test, Musculoskeletal stiffness, Myalgia, Neck pain, Nervous system disorder, Neurological examination abnormal, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia, Photosensitivity reaction, Pregnancy test, Single functional kidney, Syncope, Thyroid function test, Vision blurred, Visual acuity tests normal, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None-She was physically active / healthy.
Allergies:
Diagnostic Lab Data: Neurological screening-impairment; CT Scan, MRI, muscle breakdown, mononucleosis, Lyme, thyroid, pregnancy, see pediatrician for others she ordered. Vision exam-20/20 vision 9/3/08-records received-CT normal.All lab values normal.
CDC Split Type:

Write-up: Four minutes post injection, she fainted on her feet and struck the front of her head on the checkout window frame. A receptionist, nurse and attending physician came to her aid. The next 30 days brought severe debilitating headaches, confusion, decreased consciousness, extreme muscle aches, weakness, eye sensitivity, dizziness, decreased appetite, lack of energy, and weight loss. We returned to the pediatrician''s office four days after injections because she suffered from these symptoms. She was diagnosed with fluid behind her ears. Blood was drawn twice, tests were run; all results were negative. A CT scan showed no abnormal development. Still she was suffering from severe persistent headaches. Two months after shots, she visited a neurologist. A 2 1/2 hour screening was done; showed impairment. A copy of the lab report was sent to pediatrician who called our home with sentiments. The neurologist prescribed two different drugs that didn''t touch her headaches, but rendered her unable to drive, work or do school work. Four months after shots, she begins chiropractic care to ease pain. No success. Six months after shots, she has blurred vision. Eye exam performed; no abnormalities detected (20/20 vision). Nine months later; MRI-all normal. Begins physical therapy; persistent pain. Twelve months later; additional problems. Sudden onset of stiff neck & neck pain, joint stiffness, tingling in fingers, burning in lower back muscles, strong aching in arms, and all body muscles. Exhaustion and headaches, headaches! 9/3/08-records received-9/7/07-9/18/07-presented with C/O fatigue and headaches since 9/4/07 date HPV and meningitis vaccines were administered at which time she passed out but recovered. 9/7/07 C/O weakness and fatigue. Head feels heavy and there is pressure. Lethargic, sleeping. Sore throat. Appetite decreased. 10/29/07-evaluation for possibility of concussion after hitting right side of head on 9/4/07. C/O blurry vision and occasional double vision and sensitivity to light. Difficulty concentrating and changes in her memory. Home schooled high achiever and perfectionist. Impression: post concussive syndrome. 11/15/07-continues with complaints-Assessment:status post concussion with severe post concussive syndrome. 4/30/08-continue with complaints. Impression:unresolved ares of somatic dysfunction. 8/22/08-C/O chronic pain and chronic fatigue although worked all summer and her last visit to physician office was May 2008. Malaise with possible anxiety and depression.


VAERS ID: 329271 (history)  
Form: Version 1.0  
Age: 19.0  
Gender: Female  
Location: Louisiana  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2008-10-14
   Days after onset:406
Entered: 2008-10-17
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0522U / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chlamydial infection, Drug exposure during pregnancy, Foetal disorder, Papilloma viral infection, Pregnancy test positive, Ultrasound scan normal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: iron (unspecified); vitamins (unspecified)
Current Illness:
Preexisting Conditions: Cardiac murmur
Allergies:
Diagnostic Lab Data: ultrasound, 09/13/07, normal; beta-human chorionic, positive
CDC Split Type: WAES0710USA02663

Write-up: Initial and follow-up information has been received from a certified medical assistant, for the Pregnancy Registry for GARDASIL concerning a 19 year old female with a history of heart murmur and 1 previous pregnancy and 1 full term delivery who on 04-SEP-2007 was vaccinated intramuscularly with the first dose of GARDASIL during the first trimester of pregnancy. Concomitant therapy included prenatal vitamins and iron tablets. The patient sought unspecified medical attention in the physician''s office. On 13-SEP-2007 routine ultrasound was performed and the result was normal. Follow-up information was received that during pregnancy, the patient developed papilloma viral infection and Chlamydia infection. On 27-January-2008, the patient was placed on ZITHROMAX, 1 gram, 1 dose for the treatment of Chlamydia infection. The outcome was unknown. During labor/delivery, the baby developed umbilical cord around neck. On 05-MAR-2008 the patient delivered a full-term, normal and healthy baby boy with no congenital anomalies. The weight of the baby was 7.4 pounds and the Apgar score was 9/9. Additional information is not expected.


VAERS ID: 347898 (history)  
Form: Version 1.0  
Age: 40.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2009-05-15
   Days after onset:619
Entered: 2009-05-21
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Antibody test negative, Eye infection, Urticaria, Vaccination failure, Varicella zoster serology negative
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Lack of efficacy/effect (narrow), Ocular infections (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Calcium (unspecified); Fatty acids (unspecified); LOVASTATIN; Vitamin d (unspecified)
Current Illness: Hypercholesterolaemia
Preexisting Conditions: Female genital operation;
Allergies:
Diagnostic Lab Data: Serum varicella zoster, 06/05/08, negative
CDC Split Type: WAES0806USA01976

Write-up: Information has been received from a 40 year old female with hypercholesterolaemia and a history of female genital operation concerning on 04-SEP-2007 she was vaccinated with the first dose of VARIVAX (Merck) (lot no. not reported) via intramuscular route. Site of injection was not reported. On 24-OCT-2007, she was vaccinated with the second dose of VARIVAX (Merck) (lot no. not reported) via intramuscular route, site of injection was not reported. Concomitant therapy included LOVASTATIN (manufacturer unknown), vitamin D (unspecified), Omega fatty acids (unspecified) and calcium (unspecified). On 22-NOV-2007 the patient experienced unspecified hives that were treated by numerous unspecified medical personnel with unspecified medications. The patient fully recovered from the hives in several weeks. In December 2007, the patient experienced eye infection. The outcome of eye infection was unknown. On 05-JUN-2008 the varicella titer was negative and the reporter considered this to be vaccine failure. The patient went to physician''s office and sought unspecified medical attention. No other symptoms or treatment reported. No product quality complaint involved. No other information available from the reporter. Additional information has been requested.


VAERS ID: 355483 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: North Dakota  
Vaccinated:2007-09-04
Onset:2007-10-15
   Days after vaccination:41
Submitted: 2009-08-26
   Days after onset:681
Entered: 2009-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0928U / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2379BA / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abdominal pain upper, Appendicectomy, Dizziness, Dysmenorrhoea, Dyspepsia, Eating disorder, Fatigue, Headache, Insomnia, Migraine, Nausea, Pyrexia, Somnolence
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Doxycycline
Current Illness: none. 9/29/09 PCP records received DOS 1/5/07 to 8/7/09. Depression. Allergic rhinitis. Acne.
Preexisting Conditions: allergic to cats. 9/29/09 PCP records received DOS 1/5/07 to 8/7/09. Strep Pharyngitis with fever, nausea and vomiting.
Allergies:
Diagnostic Lab Data: 9/29/09 PCP records received DOS 1/5/07 to 8/7/09. LABS and DIAGNOSTICS: Rapid Strep Test (+). CBC - WBC 13.0 Thous 10*3/ul(H) MPV 7.3 cu mic (L) Grans 81.1% (H) Lymphs 11.2% (L) ABS Gran 10.6 Thous (H). 9/29/09 Hospital records received DOS 10/25/08 and 10/31/08. LABS and DIAGNOSTICS: CT Scan Abdomen - Abnormal. CBC - RBC 4.06 mil/cmm (L) Grans 82.4% (H) Lymphs 9.3% (L) ABS Lymph 0.5 thous (L). Urinalysis - Blood large, Ketones large, Protein (+), casts (+), mucous (+), squamous Epith Cells (+), CA Oxalate crystals (+).
CDC Split Type:

Write-up: Severe headaches/migraines which cause sleeplessness, stomache aches, painful menstrual periods, nausea, always tired and feels like sleeping all the time, dizziness, heartburn. Unable to eat certain foods like fast food burgers. Had appendix taken out October 31, 2008 after one week of fevers above 103 for one week and emergency room visits. Finally after one week surgeon looked at records and determined appendix should have been removed one week earlier. 9/29/09 PCP records received DOS 1/5/07 to 8/7/09. Assessment: Transferred migraine, rebound analgesic headache, anxiety. Patient c/o recent headaches. Repeated strep pharyngitis. Plan B emergency contraception. Oral contraception initiated. Flat affect. Anxiety. Pelvic inflammatory disease. Headaches with photophobia and phonophobia. Pharyngitis/laryngitis with productive cough and wheezing. Bronchitis. Dry eczematous rash skin arms and legs. Abdominal pain, diarrhea, constipation. Gastroenteritis. Depo-Provera initiated. Muscle tension headaches. Insomnia. Painful intercourse. 9/29/09 Hospital records received DOS ER 10/25/08 Inpatient 10/31/08. Assessment: Appendicitis. Patient presented with right lower quandrant abdominal pain. Hematuria. Nauseous, vomited. Discharged from ER. Presents several days later with same complaints. Laparoscopic appendectomy. Pelvic inflammation. ICD-9 Codes: 540.9 Acute Appendicitis NOS, 784.0 Headache, 305.1 Tobacco use disorder/depend.


VAERS ID: 419960 (history)  
Form: Version 1.0  
Age: 1.32  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2007-09-04
Onset:2011-03-28
   Days after vaccination:1301
Submitted: 2011-03-30
   Days after onset:2
Entered: 2011-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 10760 / 1 AR / IM

Administered by: Private       Purchased by: Private
Symptoms: Herpes zoster, Papule, Scab, Skin lesion
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: none
CDC Split Type:

Write-up: The patient presented to my office on 3/30/11 with two days of a rash. The rash was papules, pustuled and crusted lesions in dermatomal distribution consistent with herper zoster.


VAERS ID: 423492 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: New York  
Vaccinated:2007-09-04
Onset:2011-03-05
   Days after vaccination:1278
Submitted: 2011-05-12
   Days after onset:67
Entered: 2011-05-18
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Skin lesion, Varicella post vaccine
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: WAES1103USA01376

Write-up: Information has been received from a licensed practical nurse concerning an 8 year old male with no drug allergies and no medical histories who on 20-NOV-2003 was vaccinated with the first dose of VARIVAX (Merck) (therapy route and lot # not provided). On 04-SEP-2007 he was vaccinated with the second dose of VARIVAX (Merck) (therapy route and lot # not provided). There was no concomitant medication. On 07-MAR-2011 the patient presented to the licensed practical nurse''s practice with multiple lesions characteristic of chicken pox. The patient''s mother stated that the lesions began to appear two days prior to the office visit, on 05-MAR-2011. The patient, who was otherwise "healthy", was started on KEFLEX 500 mg to prevent secondary infection and was being referred to an infectious disease specialist. No lab diagnostics studies were performed. At the time of reporting, the patient''s status was recovering. Additional information has been requested.


VAERS ID: 487782 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Unknown  
Vaccinated:2007-09-04
Onset:2007-10-04
   Days after vaccination:30
Submitted: 2013-03-26
   Days after onset:2000
Entered: 2013-03-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1303USA008822

Write-up: This spontaneous report as received from a consumer refers to her child, a patient of unknown age and gender with no reported medical history. On 04-SEP-2007 the patient was vaccinated with RECOMBIVAX HB (route, dose and lot number unknown) dose 1. On 04-NOV-2007 the patient was vaccinated with RECOMBIVAX HB (route, dose and lot number unknown) dose 2. On 20-FEB-2008 the patient was vaccinated with RECOMBIVAX HB (route, dose and lot number unknown) dose 3. No other suspect therapies or concomitant medications were reported. On an unknown date the patient experienced first dose given on 09-04-2007, second dose on 11/04/2007 and third dose 2/20/2008 (Inappropriate schedule of vaccine administered). Additional information is not expected.


VAERS ID: 290324 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2007-09-12
   Days after onset:8
Entered: 2007-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC
TD: TD ADSORBED (DITANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC12B015JB / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hyperhidrosis, Muscle contracture, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0486392A

Write-up: This case was reported by a regulatory authority and described the occurrence of syncope in a 16-year-old female subject who was vaccinated with Ditanrix, GlaxoSmithKline, MMR vaccine for prophylaxis. On 4 September 2007 the subject received unspecified dose of Ditanrix (intramuscular), unspecified dose of MMR vaccine (subcutaneous). On 4 September 2007, less than one day after vaccination with Ditanrix and MMR vaccine, the subject experienced syncope, contracture of mandibule and sweating. This case was assessed as medically serious by GSK. On 4 September 2007, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with Ditanrix and MMR vaccine.


VAERS ID: 291038 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2007-09-20
   Days after onset:16
Entered: 2007-09-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER 23180 / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER 23180 / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C2501AA / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hypotonia, Pallor
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VITAMIN K (PHYTOMENADIONE), unknown, unknown
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: GBWYE329818SEP07

Write-up: Information regarding Prevenar was received from a healthcare professional via a regulatory authority regarding an 11-week-old male patient who became pale and floppy. The patient received a dose on 04-Sep-2007. The patient became pale, dusky and floppy on 04-Sep-2007. The patient was seen by a general practitioner and was admitted to hospital via ambulance. The patient recovered from the events on an unknown date. No additional information was available at the time of this report.


VAERS ID: 291180 (history)  
Form: Version 1.0  
Age: 24.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2007-09-20
   Days after onset:16
Entered: 2007-09-24
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR C2750A / UNK LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest X-ray normal, Cough, Dyspnoea, Gait disturbance, Injection site swelling, Injection site warmth, Lumbar puncture, Malaise, Meningitis, Nausea, Tuberculosis skin test positive, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient was generally in good health. No known allergies (NKA). The patient is from a foreign country, and had a tuberculin test with a positive results. X ray was normal. The patient was not taking medications. She had a slight cold with runny nose and occasional cough (no fever) at the time of vaccination with Menactra.
Allergies:
Diagnostic Lab Data: Had a tuberculin test with a positive result and chest X ray was normal, prior to vaccination. A lumbar puncture done post vaccination, results not provided.
CDC Split Type: 200703152

Write-up: Initial report received on 13 September 2007 from a physician, who received this report from the patient and a friend of the patient. A 24 year old female patient, received on 04 September 2007, the first dose of Menactra (lot# C2750AB), intramuscular into the deltoid (unknown side of administration). She had a slight cold with runny nose and occasional cough (no fever) at the time of vaccination with Menactra. On 04 September 2007, during the evening of vaccination day, the patient started to feel sicker. Her cough got worse. She had nausea and vomiting. No diarrhea. The next day her arm was swollen and warm at the site of injection. Her symptoms got worse. She began having difficulty to walk and difficulty breathing. She was taken to the hospital by ambulance. She had a lumbar puncture (no results were provided). Apparently, antibiotics were started for meningitis. The patient was feeling better and recovered. The reported had not yet received any medical reports. The patient''s medical history also included the following: the patient was generally in good health. No known allergies (NKA). The patient is from, and had a tuberculin test with a positive result and chest X ray was normal. The patient was not taking medications.


VAERS ID: 291576 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2007-09-27
   Days after onset:23
Entered: 2007-09-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bradycardia, Crying, Depressed level of consciousness, Electrocardiogram normal, Fatigue, Heart rate normal, Injection site pain, Malaise, Syncope vasovagal
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), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: The patient had no relevant medical history.
Allergies:
Diagnostic Lab Data: Heart rate (results: oculocardiac reflex was found normal) and electrocardiogram (results: normal) were done on 04-Sep-2007.
CDC Split Type: FRWYE364024SEP07

Write-up: Information regarding Prevenar was received from a healthcare professional regarding a 2-month-old male patient who experienced crying, vagal malaise, fatigue and pain during injection was suspected. The patient received the first dose on 04-Sep-2007. The patient experienced crying at the time of Prevenar injection on 04-Sep-2007, then vagal malaise manifested by bradycardia and consciousness decrease for a few minutes. The patient was stimulated and did not lose consciousness. After vagal malaise, the patient presented with fatigue and fall asleep in the physician''s arms. He was hospitalized for 24 hours for surveillance. ECG and oculocardiac reflex were found normal. The patient recovered and the events did not recur. The reporter suspected pain during the injection of Prevenar, because the patient started to cry at the time the Prevenar injection, and considered that the pain was the cause of the vagal malaise. Crying and fatigue were non serious events. No additional information was available at the time of this report.


VAERS ID: 291809 (history)  
Form: Version 1.0  
Age: 0.17  
Gender: Male  
Location: Foreign  
Vaccinated:2007-09-04
Onset:2007-09-16
   Days after vaccination:12
Submitted: 2007-10-01
   Days after onset:15
Entered: 2007-10-02
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHEP: DTP + HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Body temperature decreased, Bronchopneumonia, Condition aggravated, Cough, Diarrhoea, Diet refusal, Dyspnoea, Gastroenteritis, Granulocytes abnormal, Haemoglobin decreased, Lymphocyte count increased, Malaria antibody test, Mean cell volume increased, Respiratory distress, Respiratory rate increased, Tachypnoea, White blood cell count
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (broad), Haemorrhage laboratory terms (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Gastroenteritis
Allergies:
Diagnostic Lab Data: body temp 16Sep07 35.6 degrees Celsius, blood Plasmodium species observation 17Sep07 negative, WBC count 18Sep07 10.8 x 10^3 cells/uL 4.5-17.5, hemoglobin 18Sep07 9.4 g/dL 9.0-15.6, lymphocyte count 18Sep07 68.7 percent, blood granulocyte count 18Sep07 20.6 percent, blood granulocyte count 18Sep07 20.6 percent, mean corpuscular volume 18Sep07 89.5 fl
CDC Split Type: WAES0709USC00052

Write-up: Information has been received from an investigator concerning an 8-week-old male with a history of gastroenteritis who entered a study, title as stated above. On 04-SEP-2007, the patient was vaccinated with his first dose of blinded therapy. Concomitant therapy included diphtheria toxoid (+) hepatitis B virus vaccine (unspecified) (+) Hib vaccine (unspecified carrier) (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (unknown manufacturer) and poliovirus vaccine live oral (unknown manufacturer). On 16-SEP-2007, twelve days post dose one of blinded therapy, the patient presented to the hospital with a three-day history of cough, difficulty breathing, and refusal to feed. On examination, he was sick looking, tachypnoeic with a respiration rate of 72 breaths per minute, and in respiratory distress. His temperature was 35.6 degrees Celsius. An impression of bronchopneumonia was made and penicillin was initiated. At the time of this report, the patient was still tachypnoec but stable, and the event of bronchopneumonia was ongoing. The reporting investigator felt that bronchopneumonia was of severe intensity and not related to study therapy. Additional information has been requested. Additional information was received on 19-SEP-2007 from the investigator. On 18-SEP-2007, the patient experienced diarrhea that occurred eight times within 24 hours. He was not tachypnoeic and was afebrile. On 17-SEP-2007, a blood smear for malaria parasites was negative. Laboratory testing performed on 18-SEP-2007 revealed a white blood cell count of 10.8 x 10^3 cells/uL, lymphocyte count of 68.7%, granulocyte count of 20.6%, hemoglobin of 9.4 g/dL, and an MCV of 89.5. A stool sample was taken, but the results were not available. At the time of this report, the patient had not yet recovered. The investigator reported the diagnosis as acute gastroenteritis. Treatment included oral rehydration therapy. The reporting investigator felt that the event of bronchopneumonia was of severe intensity and not related to study therapy and the event of acute gastroenteritis was of moderate intensity and related to study therapy. Additional information has been requested.


VAERS ID: 292391 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2007-10-08
   Days after onset:34
Entered: 2007-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TD: TD ADSORBED (DITANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC12B0115BD / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Urinary incontinence
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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Oral contraceptive
Current Illness: Unknown
Preexisting Conditions: ANXIETY, FAINT
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0489680A

Write-up: This case was reported by a regulatory authority and described the occurrence of convulsion in a 18-year-old female subject who was vaccinated with Ditanrix adult, GlaxoSmithKline for prophylaxis. The subject''s medical history included anxiety and faint. Concurrent medications included Oral contraceptive. The subject had no history of previous adverse reaction to Ditanrix or any other drug. On 4 September 2007, the subject received unspecified dose of Ditanrix adult (intramuscular, unknown injection site). On 4 September 2007, few seconds after vaccination with Ditanrix adult, the subject experienced convulsion with loss of control of the urinary sphincter. This case was assessed as medically serious by GSK. The subject was treated with diazepam and sodium chloride (Saline solution). The subject was not hospitalized due to the adverse reaction. On 4 September 2007, the events were resolved.


VAERS ID: 293769 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Male  
Location: Foreign  
Vaccinated:2007-09-04
Onset:0000-00-00
Submitted: 2007-10-19
Entered: 2007-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA315E / UNK LA / UN
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A20CA315E / UNK LA / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER A20CA315E / UNK LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Apathy, Laboratory test
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Laboratory test 2007 unknown; Physical examination 2007 unknown
CDC Split Type: B0491425A

Write-up: This case was reported by a physician via a sales representative and described the occurrence of apathetic in a few month-old male subject who was vaccinated with Infanrix-IPV/Hib (GlaxoSmithKline) for prophylaxis. On 4 September 2007 and 11 July 2007 the subject received 2nd dose and 1st dose of Infanrix-IPV/Hib (unknown). At an unspecified time after vaccination with Infanrix-IPV/Hib, the subject became apathetic and was therefore hospitalised, where the condition improved. Laboratory tests (unspecified) were performed as well as physical examinations. The subject was treated with motor rehabilitation. The reporter considered that the event was possibly related to vaccination with Infanrix-IPV/Hib.


VAERS ID: 293775 (history)  
Form: Version 1.0  
Age: 56.0  
Gender: Male  
Location: Foreign  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2007-10-19
   Days after onset:45
Entered: 2007-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB079CA / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site erythema, Injection site pruritus, Multiple sclerosis, Sensation of heaviness
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Optic nerve disorders (broad), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0688311A

Write-up: This case was reported by a healthcare professional and described the occurrence of multiple sclerosis in a 56-year-old male subject who was vaccinated with Havrix (GlaxoSmithKline) for prophylaxis. On 4 September 2007, the subject received 2nd dose of Havrix, intramuscularly, in the left deltoid. An unspecified amount of time after receiving Havrix, the subject developed erythema and pruritis at the injection site, descending progressively to the elbow in one month. Recently, the subject experienced numbness and heaviness of the left upper limb. Limitation of movement of the left wrist and thumb was reported on the same day, 4 September 2007, of vaccination with Havrix. After medical consultation, a diagnosis of multiple sclerosis secondary to vaccine was made. The healthcare professional considered the events were disabling. The limitation of movement of the left wrist and thumb was considered to be possibly related to treatment with Havrix and not resolved. At the time of reporting the outcomes of all other recorded events were not specifically documented. The subject did not have an MMR vaccine. ON 19 October 2007, it was clarified that the subject received Twinrix and not Havrix. The remainder of the information is as initially reported.


VAERS ID: 294231 (history)  
Form: Version 1.0  
Age: 0.6  
Gender: Male  
Location: Foreign  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2007-10-23
   Days after onset:49
Entered: 2007-10-24
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Body temperature increased, Hypotonia, Pallor, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Concomitant medications were not reported.
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: Body temperature (results: 38.5 deg. Cc) was done on 04-Sep-2007. Body temperature (results: 29.3 deg. C.) was done on 05-Sep-2007.
CDC Split Type: NLWYEG00491007

Write-up: Information regarding Prevenar was received from a healthcare professional regarding a 6-month-old male patient who experienced fever and more pale and hypotonic. The patient received the first dose on 04-Sep-2007. The patient experienced fever of 38.5 deg. c. and more pale and hypotonic on 04-Sep-2007. The G.P. was visited in the evening and the child was treated with a paracetamol suppository (60 mg). The next morning his temperature was 38.7 deg. C and again received a 60 mg paracetamol suppository. In the afternoon his fever had increased to 39.3 deg. C and he was hospitalized for 1 night. The child recovered. No additional information was available at the time of this report.


VAERS ID: 294533 (history)  
Form: Version 1.0  
Age: 1.4  
Gender: Unknown  
Location: Foreign  
Vaccinated:2007-09-04
Onset:2007-09-04
   Days after vaccination:0
Submitted: 2007-10-24
   Days after onset:50
Entered: 2007-10-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / SANOFI PASTEUR C2555AJ / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Febrile convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: not reported medical history
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200703526

Write-up: Report received from the foreign Health Authorities on 16 October 2007, through our company representative under the reference number PL-URPL-OCR-20071002006. A 16-month-old patient (gender not reported), with no reported medical history, experienced febrile convulsion with pyrexia at 39.0-39.4 C on 04 September 2007, the day she/he received subcutaneously a dose of Tripacel*, lot C2555AJ. The febrile convulsion lasted 24 hours. The patient recovered.


VAERS ID: 297549 (history)  
Form: Version 1.0  
Age: 0.9  
Gender: Unknown  
Location: Foreign  
Vaccinated:2007-09-04
Onset:2007-09-05
   Days after vaccination:1
Submitted: 2007-11-21
   Days after onset:77
Entered: 2007-11-23
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SC
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SC
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Altered state of consciousness, Convulsion, Hypotonic-hyporesponsive episode
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0496019A

Write-up: This case was reported by a regulatory authority and described the occurrence of seizures in a 10-month-old subject of unspecified gender who was vaccinated with Infanrix-IPV/Hib (GlaxoSmithKline). On 4 September 2007 the subject received unspecified dose of Infanrix-IPV/Hib (subcutaneous). On 5 September 2007, 1 day after vaccination with Infanrix-IPV/Hib, the subject experienced hypotonic-hyporesponsive episode which lasted for several minutes. The subject had seizures with consciousness disorder. The subject did not have fever. The subject was brought to the emergency room and then to the hospital. The subject was hospitalised. At the time of reporting the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with Infanrix-IPV/Hib.


VAERS ID: 313726 (history)  
Form: Version 1.0  
Age: 50.0  
Gender: Male  
Location: Foreign  
Vaccinated:2007-09-04
Onset:0000-00-00
Submitted: 2008-05-27
Entered: 2008-05-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0724F / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Mastoiditis
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805USA03560

Write-up: Information has been received from a pharmacist (n. 68534) concerning a 50 year old male who on 04-SEP-2007 was vaccinated with his first dose of MMR II (batch# NE29970, lot# 654824/0724F). A few days post vaccination, the patient experienced mastoiditis. It was noted that the patient''s medical history was not provided. The patient had not yet recovered at the time of reporting. Mastoiditis was also considered to be an other important medical event by the reporter. Other business partner numbers include: E2008-04401. Additional information has been requested.


VAERS ID: 314020 (history)  
Form: Version 1.0  
Age: 16.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-09-04
Onset:0000-00-00
Submitted: 2008-05-28
Entered: 2008-05-29
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1518F / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Immunisation
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805USA04808

Write-up: Information has been received from a physician concerning a 16 year old female patient who on 04-SEP-2007 was vaccinated intramuscularly into the upper arm with the second dose of GARDASIL (Lot # 0233U, batch # NF46740). Subsequently, onset not reported, the patient experienced renal insufficiency and was admitted to the hospital. She recovered within an unspecified time. It was also reported that on 11-JUL-2007 the first dose of GARDASIL (Lot # 1518F, batch # NF23330) was administered and was well tolerated. Other business partner numbers include: E200804484. No further information is available.


VAERS ID: 315131 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: Foreign  
Vaccinated:2007-09-04
Onset:2007-09-10
   Days after vaccination:6
Submitted: 2008-06-04
   Days after onset:268
Entered: 2008-06-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK UN / IM
HBHEPB: HIB + HEP B (COMVAX) / MERCK & CO. INC. - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Rectal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805AUS00178

Write-up: Information was obtained on request by the Company from the agency concerning a male infant who on 04-SEP-2007 was vaccinated with ROTATEQ. Other suspect therapy included COMVAX, PREVENAR and QUADRACEL. Subsequently, 6 days after vaccination, the patient developed rectal haemorrhage, also described as "a small amount of blood after opening his bowels, amount only visible on cloth used to wipe his bottom". At the time of reporting on 02-OCT-2007, the outcome of rectal haemorrhage was unknown. The agency considered that rectal haemorrhage was possibly related to therapy with ROTATEQ, COMVAX, PREVENAR and QUADRACEL. The original reporting source was not provided. Upon internal medical review rectal haemorrhage was considered an other important medical event. Additional information is not expected.


VAERS ID: 290138 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-09-05
Onset:2007-09-06
   Days after vaccination:1
Submitted: 2007-09-07
   Days after onset:1
Entered: 2007-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1985AB / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0306-2 / 4 LL / SC
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 0229U / 2 RL / SC

Administered by: Private       Purchased by: Public
Symptoms: Cellulitis, Induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)

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

Write-up: 180cm X 110 cm area of induration and cellulitis on L thigh. Treated with Keflex 250/5 ml 4 ml TID for 10 days. Benadryl 12.5 mg/5 ml 7.5 ml po q6hours prn.


VAERS ID: 290141 (history)  
Form: Version 1.0  
Age: 62.0  
Gender: Male  
Location: Maine  
Vaccinated:2007-09-05
Onset:2007-09-06
   Days after vaccination:1
Submitted: 2007-09-07
   Days after onset:1
Entered: 2007-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / 1 RA / IM

Administered by: Public       Purchased by: Private
Symptoms: Muscular weakness, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: aspirin, clopidogrel, ezetimibe, insulin, lisinopril, metformin, midodrine, pantoprazole, simvastatin
Current Illness: Syncope
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccine was administered and about 12 hours after patient complained of pain/weakness in the arm that injection was given.


VAERS ID: 290144 (history)  
Form: Version 1.0  
Age: 11.0  
Gender: Female  
Location: Michigan  
Vaccinated:2007-09-05
Onset:2007-09-07
   Days after vaccination:2
Submitted: 2007-09-07
   Days after onset:0
Entered: 2007-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2226AA / 1 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0843U / 2 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Arthropod bite, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Skin lesion
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Large area of redness and swelling developed over 48 hours at the site of the immunization - measures approx 3 by 4.5 inches, warm to touch and tender with two small adjacent lesions which look like mosquito bites


VAERS ID: 290237 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Male  
Location: New Jersey  
Vaccinated:2007-09-05
Onset:2007-09-06
   Days after vaccination:1
Submitted: 2007-09-10
   Days after onset:4
Entered: 2007-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U2289AA / 4 RL / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UE95UAA / 4 RL / -
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. 1119F / 1 LL / -

Administered by: Private       Purchased by: Unknown
Symptoms: Erythema, Induration, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Induration, swollen, redness 8cm x 10cm right thigh. Induration 2cm x 2cm left thigh.


VAERS ID: 290302 (history)  
Form: Version 1.0  
Age: 65.0  
Gender: Female  
Location: Massachusetts  
Vaccinated:2007-09-05
Onset:2007-09-05
   Days after vaccination:0
Submitted: 2007-09-07
   Days after onset:2
Entered: 2007-09-11
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1229F / 1 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Injection site erythema, Injection site warmth, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASA 81 mg QD
Current Illness: None
Preexisting Conditions: Inderal, Bacitracin HTN, high cholesterol, protein deficiency
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Began experienced pinkness, warmness at injection site applied cold packs 10 min next morning began experiencing pain "4" 0-$g 10 scale continued cold packs


VAERS ID: 290566 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Female  
Location: California  
Vaccinated:2007-09-05
Onset:2007-09-05
   Days after vaccination:0
Submitted: 2007-09-12
   Days after onset:7
Entered: 2007-09-14
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2650AA / 2 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR A0122 / 2 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0872 / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B97283B / 2 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Autopsy, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2007-09-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Reporter denied the patient had any illnesses, pre-existing medical conditions, use of other medications, or any adverse events following prior vaccinations at the time of the vaccinations on 05 September 2007. It was reported the patient had no known allergies. No vaccines were administered within four weeks prior to the vaccinations on 05 September 2007.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 200703071

Write-up: Initial report received on 10 September 2007 from a health care professional. A four-month-old infant with no concurrent illnesses, no known allergies, and who had no pre-existing medical history, had received a second intramuscular dose of ActHib, lot number UF160AA (Sanofi Pasteur SA lot number A0122-2) in the left thigh; a second intramuscular dose of Daptacel, lot number C2650AA in the right thigh; a second intramuscular dose of IPOL, lot number Z0872-2 (reported as Z0872), in the right thigh; and a second intramuscular dose of Prevnar (manufacturer Wyeth), lot number B97283B, in the left thigh. The patient had not experienced any adverse events following prior vaccinations. Later that evening the patient was "found expired." Reportedly, an autopsy will be completed. 3/19/08 Reviewed autopsy report which states COD as complications of congenital pulmonary malformation. 3/19/08 Autopsy states pathologic diagnoses as: I. Congenital Pulmonary malformation with A. Microscopic characteristics most c/w congenital cystic adenomatoid malformation, Type I B. lymphocytic & macrophage peri-bronchial inflammation, mod to marked C. Intraalveolar hemorrhage, marked D. pulmonary edema, marked III. Abnormal 17 hydroxyprogesterone study w/o microscopic abnormality of adrenal glands.


VAERS ID: 290586 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2007-09-05
Onset:2007-09-06
   Days after vaccination:1
Submitted: 2007-09-06
   Days after onset:0
Entered: 2007-09-14
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1030U / 2 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Hypoxia, Oxygen saturation decreased, Oxygen supplementation, Pneumonia primary atypical, Pneumonia viral, Pyrexia, Rhinorrhoea
SMQs:, Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None Known
Preexisting Conditions: CP, Seizures, Static encephalopathy, profound MR, Uniparental disomy #3, recurrent pneumonia. PMH: Cerebral Palsy encephalopathy, Trisomy 3 abnormality, seizure disorder, metabolic disorder, hypotonia, mental retardation, G-tube, aspiration.
Allergies:
Diagnostic Lab Data: labs and Diagnostics: CXR no acute changes. CBC with WBC 22.2. Chem with K+ of 3.3 CRP 3.03UA with 3 RBCs and 3+ calcium oxalate crystals. UC (-). Blood cultures (-). Impression: Hx and PE and CXR (retrocardiac infiltrate) c/w PNA.
CDC Split Type:

Write-up: 9/6/07 Fever 105.1, thick green mucous suctioned from airway. O2 sat at 78-88, Albuterol neb and O2 given. Sent to ED and pt admitted to hospital. Treated with antibiotic for viral vs atypical pneumonia. Discharged from hospital 9-7-07 in stable condition. 11/13/2007 MR received for DOS 9/6/2007. Pt presented to ER with fever (105''F) and hypoxia. O2 sats at nsg facility dropped to 78-88%. Suctioned for "grren stuff". O2 sats in ER mid 90''s on RA. Txd with abx


VAERS ID: 290599 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: Ohio  
Vaccinated:2007-09-05
Onset:2007-09-09
   Days after vaccination:4
Submitted: 2007-09-13
   Days after onset:4
Entered: 2007-09-14
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2632AA / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Full blood count, Injection site reaction, Local reaction, Rash maculo-papular
SMQs:, Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZOCOR, VERAPAMIL, NS
Current Illness: (R) thigh cellulitis
Preexisting Conditions: Hyperlipidemia, insulin resistance, CAD, HTN
Allergies:
Diagnostic Lab Data: CBC
CDC Split Type:

Write-up: Local reaction at injection site and diffuse macular papular rash develop approximately 48 hours after injection was on 2 antibiotics so with if rash Dpt.


VAERS ID: 290630 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Male  
Location: Michigan  
Vaccinated:2007-09-05
Onset:2007-09-06
   Days after vaccination:1
Submitted: 2007-09-07
   Days after onset:1
Entered: 2007-09-14
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (TRIPEDIA) / SANOFI PASTEUR U1965CA / 5 - / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1008U / 2 - / SC

Administered by: Private       Purchased by: Public
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Fever 105


VAERS ID: 291136 (history)  
Form: Version 1.0  
Age: 8.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2007-09-05
Onset:2007-09-06
   Days after vaccination:1
Submitted: 2007-09-07
   Days after onset:1
Entered: 2007-09-21
   Days after submission:14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB186BA / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1007U / 2 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Injection site induration, Injection site vesicles, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Sent wound C&S
CDC Split Type:

Write-up: 9 x 9 cm injected and indurated area with vesicles at injection site. Area is warm to touch. Keflex 250mg 2tsp BID x 5 days.


VAERS ID: 291146 (history)  
Form: Version 1.0  
Age: 76.0  
Gender: Female  
Location: Maryland  
Vaccinated:2007-09-05
Onset:2007-09-05
   Days after vaccination:0
Submitted: 2007-09-20
   Days after onset:15
Entered: 2007-09-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0555U / UNK LA / IM

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

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

Write-up: On 9/13/07 patient reported a reaction after receiving the pneumonia shot described that she developed a large hive (note the site of injection on her left arm within 2 hours of receiving the shot reported that she developed one other hive and a slight rash to her left arm. Patient did not seek medical attention.


VAERS ID: 291197 (history)  
Form: Version 1.0  
Age: 1.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-09-05
Onset:2007-09-18
   Days after vaccination:13
Submitted: 2007-09-24
   Days after onset:6
Entered: 2007-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / 4 UN / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. UNKNOWN / 1 UN / SC

Administered by: Public       Purchased by: Public
Symptoms: Irritability, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: Alpha Thal Minor
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: fevers 101-102.3 for 2-3 days. Clingy, fussy behavior (9/18-9/21/2007) followed by a rash several days after the fever resolved. One office visit was made. No tests were done other than a history and physical exam due to the timing of the vaccines and the fevers.


VAERS ID: 298260 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2007-09-05
Onset:2007-09-05
   Days after vaccination:0
Submitted: 2007-10-12
   Days after onset:37
Entered: 2007-10-15
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0243U / 3 UN / UN

Administered by: Other       Purchased by: Other
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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA01937

Write-up: Information has been received from a physician concerning a 17 year old female who on 05-SEP-2007 was vaccinated with a third dose of GARDASIL. On 05-SEP-2007, five minutes after the vaccination, the patient fainted. Medical attention was sought. The patient recovered 5 minutes after fainting and left office 15 minutes after recovery. No product quality complaint was involved. Additional information has been requested.


VAERS ID: 299208 (history)  
Form: Version 1.0  
Age: 46.0  
Gender: Female  
Location: Ohio  
Vaccinated:2007-09-05
Onset:2007-09-05
   Days after vaccination:0
Submitted: 2007-12-05
   Days after onset:91
Entered: 2007-12-10
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB100AA / 3 LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Abdominal pain upper, Hypoaesthesia, Hypoaesthesia facial, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: No - called doctor while symptoms
CDC Split Type:

Write-up: 12pm 9-5-07 received Twinrix - sharp pain in stomach, then L arm & hand tingly, then L side numbness whole body. L arm, leg & face no drooping on face. Symptoms lasted 1 hour, gradual regression.


VAERS ID: 301714 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Male  
Location: New Jersey  
Vaccinated:2007-09-05
Onset:2007-09-05
   Days after vaccination:0
Submitted: 2007-12-21
   Days after onset:107
Entered: 2007-12-28
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0884U / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA00564

Write-up: Information has been received from a registered nurse concerning a 12 year old male who on 05-SEP-2007 was vaccinated SC with a 0.65 ml of Zostavax (Oka/Merck) (Lot # 658211/0884U) instead of a dose of Varivax (Oka/Merck) (MSD). It was reported that the vials looks alike. No adverse event was reported. A product quality complaint was not involved. Additional information has been received from the registered nurse who stated the product confusion occurred because both the vaccine''s vials looked alike and both were stored in the same freezer. There were no adverse symptoms. Additional information has been requested.


VAERS ID: 302554 (history)  
Form: Version 1.0  
Age: 34.0  
Gender: Female  
Location: Wisconsin  
Vaccinated:2007-09-05
Onset:2007-12-30
   Days after vaccination:116
Submitted: 2008-01-13
   Days after onset:14
Entered: 2008-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
ANTH: ANTHRAX (BIOTHRAX) / EMERGENT BIOSOLUTIONS FAV105 / 6 RA / SC
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AVBVB4377CA / 1 RA / IM
SMALL: SMALLPOX (DRYVAX) / PFIZER/WYETH 4020076 / 1 LA / ID

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

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

Write-up: Reports 12 Jan 2008 with symptoms of dull ache in right arm. 2 cm nodule found center of tender area (deltoid) Ache extends down forearm at night. Slightly sore during the day. No signs/symptoms of infection noted. MD reccomended treatment with anti-inflammatories and follow up in one month.


VAERS ID: 303451 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2007-09-05
Onset:0000-00-00
Submitted: 2008-01-07
Entered: 2008-01-16
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA01515

Write-up: Information has been received from a physician concerning a female patient who on approximately 05-Sep-2007 was vaccinated with Gardasil. In September 2007, the patient reported that she had developed hives. At one point the patient reported hives and then the patient was complaining of hives so it is not clear if she still had hives. No other information was reported. Additional information has been requested.


VAERS ID: 308352 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2007-09-05
Onset:2007-09-05
   Days after vaccination:0
Submitted: 2008-03-07
   Days after onset:184
Entered: 2008-03-19
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0570U / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA08033

Write-up: Information has been received from a registered nurse concerning a female patient in her 40''s who was vaccinated with Recombivax HB (Lot # 655871/0570U) 10mcg IM on 05-SEP-2007. There was no concomitant medication or pertinent medical history. Within a few days or a week of the vaccination, the patient developed soreness and aches and pain with range of motion of the injected arm. The patient sought medical attention at the physician''s office and was treated with ibuprofen. The nurse reported that the patient was improving, but the symptoms continued. Additional information has been requested.


VAERS ID: 310969 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Female  
Location: Kansas  
Vaccinated:2007-09-05
Onset:2007-09-05
   Days after vaccination:0
Submitted: 2008-04-14
   Days after onset:222
Entered: 2008-04-16
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0242U / 1 UN / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Nausea, Vaccine positive rechallenge
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA04150

Write-up: Information has been received from a health professional concerning a female who on 05 SEP-2007 was IM vaccinated with her first dose of GARDASIL (654539/0242U). On 21-Nov-2007 the patient was IM vaccinated with her second dose of GARDASIL (lot number 654519/0742U). Subsequently the patient experienced nausea and dizziness after both doses. The patient sought unspecified medical treatment which included the patient''s mother calling the physician. Subsequently, the patient recovered from nausea and dizziness. Additional information has been requested. This is in follow-up to rep(s) previously submitted on 4/14/2008. On 01-Apr-2008 the patient reported receiving her third dose of GARDASIL (lot number 654540/1290U). Concomitant medication included vaccination with meningococcal ACYW conj vaccine (dip toxoid) on 05-Sep-2007. Follow up information clarified the initial discrepancy of the third dose date. It was also reported that when the patient received her third dose, she was placed in a supine position and the patient did not feel as if she were going to pass out.


VAERS ID: 312977 (history)  
Form: Version 1.0  
Age: 14.0  
Gender: Female  
Location: Rhode Island  
Vaccinated:2007-09-05
Onset:0000-00-00
Submitted: 2008-05-15
Entered: 2008-05-22
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0389U / 1 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U2358AA / 2 RA / UN

Administered by: Private       Purchased by: Public
Symptoms: Borrelia burgdorferi serology positive, Fatigue, Hypoaesthesia, Immunology test, Muscular weakness, Pain in extremity, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Patient with prior history of alopecia prior to age 7 plus ANA 1:1280 PMH: allergy to pollens, dust mite, cats & mold.
Allergies:
Diagnostic Lab Data: LABS: ANA (+) (also from age 2). Allergy tests (+). Lyme test (+). MRI head & spine WNL.
CDC Split Type:

Write-up: Lower extremity pain and numbness and pins and needles, fatigue. Also with hand and lower arm weakness, multiple consults. Rheumatology, Psych, Emg - normal, MRI of head and spine - normal. 6/3/08 Reviewed PCP medical records. FINAL DX: (+)ANA syndrome w/arthralgia/alopecia; allergic rhinitis; exercise induced bronchospasm. Records reveal patient experienced alopecia areata (from age 2), arthralgia, lethargy, tiredness, eczema & joint stiffness in 2002. Episode of Lyme disease 9/2007 & developed tingling in hands & feet. Seen in ER 1/2008 w/increased weakness & tingling in hands & legs & difficulty walking. Had been on antibiotics for pyuria. Neuro & rheum consults done.


VAERS ID: 314206 (history)  
Form: Version 1.0  
Age: 13.0  
Gender: Female  
Location: Unknown  
Vaccinated:2007-09-05
Onset:2007-09-07
   Days after vaccination:2
Submitted: 2008-05-16
   Days after onset:252
Entered: 2008-05-23
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 0851U / 2 LA / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA01968

Write-up: Information has been received from a health professional concerning a 13-year-old female who on 05-SEP-2007 was vaccinated subcutaneous in the left arm with her second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657941/0851U). On 07-SEP-2007, the patient developed 1/2 dollar redness and tenderness, as well as warmth to touch and slight pruritic (site unspecified). At the time of the report the patient''s status was unknown. A product quality complaint was not involved. Additional information has been requested.


VAERS ID: 395761 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Maryland  
Vaccinated:2007-09-05
Onset:0000-00-00
Submitted: 2010-08-16
Entered: 2010-08-19
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C2720AA / UNK UN / IJ

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pertussis
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient''s medical history was not reported.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201004336

Write-up: Initial report received from a health care professional via a company representative on 12 August 2010. A 15-year-old girl received at age 12-years an injection (site and route not provided) of ADACEL, lot number C2720AA, and now has confirmed pertussis. The outcome was not reported. Documents held by sender: None.


VAERS ID: 290929 (history)  
Form: Version 1.0  
Age: 0.17  
Gender: Female  
Location: Foreign  
Vaccinated:2007-09-05
Onset:2007-09-05
   Days after vaccination:0
Submitted: 2007-09-19
   Days after onset:14
Entered: 2007-09-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Culture negative, Haematochezia, Occult blood positive, Rotavirus test negative, Viral test negative
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: stool occult blood positive, stool mucus test dense in eryrocyte and leukocyte in mucous membrane, viral culture Rota (-)
CDC Split Type: WAES0709TUR00002

Write-up: Information has been received from a physician concerning a 10 week old female who on 05-SEP-2007 was vaccinated with Rotateq. There was no concomitant medication. On 05-SEP-2007 the patient experienced hematochezia and was hospitalized. The patient''s hematochezia persisted. Additional information has been requested.


VAERS ID: 291036 (history)  
Form: Version 1.0  
Age: 0.42  
Gender: Female  
Location: Foreign  
Vaccinated:2007-09-05
Onset:2007-09-05
   Days after vaccination:0
Submitted: 2007-09-20
   Days after onset:15
Entered: 2007-09-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM
MNC: MENINGOCOCCAL (MENINGITEC) / PFIZER/WYETH - / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Breath holding, Cyanosis, Inappropriate schedule of drug administration
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Allergies:
Diagnostic Lab Data: None Provided.
CDC Split Type: GBWYE338519SEP07

Write-up: This case was considered medically important. Information regarding Meningitec was received from a healthcare professional via a regulatory authority regarding a 5-month-old female patient who experienced cyanosis and breath holding. The patient received a dose on 05-Sep-2007. The patient also received a dose of Prevenar on 05-Sep-2007. The patient experienced cyanosis and breath holding on 05-Sep-2007. The patient recovered from the events on 05-Sep-2007. The reporter considered the events as medically significant. No additional information was available at the time of this report.


VAERS ID: 291048 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Male  
Location: Foreign  
Vaccinated:2007-09-05
Onset:2007-09-10
   Days after vaccination:5
Submitted: 2007-09-19
   Days after onset:9
Entered: 2007-09-21
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC37B024BD / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Guillain-Barre syndrome, Headache, Myalgia, Neck pain, Paraesthesia, Pharyngolaryngeal pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0487330A

Write-up: This case was reported by the patient''s mother and described the occurrence of Guillain Barre Syndrome in a 15-year-old male subject who was vaccinated with Boostrix, GlaxoSmithKline for prophylaxis. On 5 September 2007 the subject received the 1st dose of Boostrix (unknown). On 10 September 2007, 5 days after vaccination with Boostrix, the subject experienced sore throat and muscle pain in neck. On 11 September 2007, he had fever. On 12 September 2007, he experienced cephalea. On 13 September 2007, He experienced abdominal pain. At unspecified date the subject experienced paresthesia in the feet. The fever was treated with dipyrone and Amoxicillin. At the time of reporting the events were unresolved and the outcome of the paresthesia in the feet was unknown. The reporter informed that she believed that the symptoms were due to the Landry-Guillain-Barre Syndrome. Medical evaluation was recommended. The reporter assessed that the events were probably related to the vaccination with Boostrix.


VAERS ID: 291291 (history)  
Form: Version 1.0  
Age: 56.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-09-05
Onset:2007-09-11
   Days after vaccination:6
Submitted: 2007-09-24
   Days after onset:13
Entered: 2007-09-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 0393F / UNK - / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Epistaxis, Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Hypersensitivity
Allergies:
Diagnostic Lab Data: platelet count 13Sep07 4000 ul
CDC Split Type: WAES0709USA02548

Write-up: Information has been received from a 56 year old female physician with a history of allergic diathesis who on 05-SEP-2007 was vaccinated with a second dose of Pneumovax 23 (batch #NE09130) (lot #654979/0393F). On 11-SEP-2007 she developed epistaxis. On 13-SEP-2007 she additionally developed petechiae and was admitted to the hospital. Platelet count at that time was 4000/ul. All other lab findings (not specified) were normal. Diagnosis of idiopathic thrombocytopenic purpura was established. Under therapy with immunoglobulins and corticosteroids (unspecified) symptoms improved. She recovered from epistaxis (duration not reported). Petechiae were ongoing at the time of reporting. Condition was reported to be stable. It was reported that previous dose of Pneumovax 23 was well tolerated. Other Business Prtners numbers included E2007-06095. Additional information is not expected.


VAERS ID: 293958 (history)  
Form: Version 1.0  
Age: 19.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-09-05
Onset:2007-09-05
   Days after vaccination:0
Submitted: 2007-10-19
   Days after onset:44
Entered: 2007-10-22
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hypoaesthesia, Muscle spasms, Musculoskeletal pain, Neck pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710CAN00113

Write-up: Information has been received from a physician concerning a 19 year old female who on 05-SEP-2007 was vaccinated with Gardasil (first dose in the left arm. There was no concomitant medication). On 05-SEP-2007 afternoon, the patient experienced aching in upper arm. The next day, on 06-SEP-2007, the patient experienced numbness on her left hand which then moved all the way up her arm. By the next morning, on 07-SEP-2007, her left neck and shoulder were painful and she experienced muscle spasm. The symptoms got worse on the fifth day after vaccination with Gardasil. Therapy with acetaminophen (+) codeine phosphate (TYLENOL WITH CODEINE # 3) was initiated for 4-5 days. After three weeks, the patient recovered from aching in upper arm, numbness on her left hand which then moved all the way up her arm, left neck and shoulder were painful and muscle spasm. There was "no residual". The patient did not received any other dose of Gardasil "because of the adverse reaction". Numbness on her left hand which then moved all the way up her arm considered to be an important medical event based on foreign agency requirements. Additional information has been requested.


VAERS ID: 293973 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-09-05
Onset:2007-09-05
   Days after vaccination:0
Submitted: 2007-10-22
   Days after onset:47
Entered: 2007-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0491833A

Write-up: This case was reported by a regulatory authority (Regulatory Authority (clinical) # 715696244) and described the occurrence of injection site induration in a 4-year-old female subject who was vaccinated with (Infanrix, GlaxoSmithKline) for prophylaxis. On 5 September 2007, the subject received unspecified dose of Infanrix (intramuscular, unknown injection site), lot number not provided. On 5 September 2007, less than one day after vaccination with Infanrix, the subject experienced injection site induration. The regulatory authority reported that the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unspecified. The regulatory authority reported that the event was possibly related to vaccination with Infanrix. No further information is expected. This case has therefore been closed.


VAERS ID: 295374 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:2007-09-05
Onset:2007-09-05
   Days after vaccination:0
Submitted: 2007-10-31
   Days after onset:56
Entered: 2007-11-02
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20905011B / UNK UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR Z0352 / UNK UN / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0510 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Cyanosis, Hypotonic-hyporesponsive episode, Pallor
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: not reported
Allergies:
Diagnostic Lab Data: not reported
CDC Split Type: 200703643

Write-up: Case received from the Health Authority on 24 October 2007. An infant patient (gender and age not specified, with no reported medical history, had received a dose of Imovax Polio, batch number Z0510-1, a dose of Act-Hib, batch number Z0352-3, and a subcutaneous dose of DTP (other MFR), batch number 20905011B, on 05 September 2007. On 05 September 2007, the patient experienced "crying DPT vaccine related", hypotonic-hyporesponsive episode, pallor of skin and cyanosis of lip. The patient was hospitalized. The patient recovered on an unspecified date.


VAERS ID: 295376 (history)  
Form: Version 1.0  
Age: 0.4  
Gender: Unknown  
Location: Foreign  
Vaccinated:2007-09-05
Onset:2007-09-05
   Days after vaccination:0
Submitted: 2007-10-31
   Days after onset:56
Entered: 2007-11-02
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20905010B / UNK UN / SC
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A72CA232A / UNK UN / SC
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR Z0509 / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying
SMQs:, Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: not reported
Allergies:
Diagnostic Lab Data: not reported
CDC Split Type: 200703646

Write-up: Case received from a Health Authority on 24 October 2007. A 04-month-old patient (gender not specified), with no reported medical history, had received a subcutaneous dose of Imovax Polio, batch number Z0509-1, a subcutaneous dose of Hiberix (other MFR), batch number A?2CA232A and a subcutaneous dose of DTP (other MFR), batch number 20905010B, on 05 September 2007. On 05 September 2007 (2007-06-05 was reported), 5 hours post-vaccination, the patient experienced "crying DTP vaccine related". The patient was hospitalized. The patient recovered on an unspecified date.


VAERS ID: 303711 (history)  
Form: Version 1.0  
Age: 20.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-09-05
Onset:2007-09-26
   Days after vaccination:21
Submitted: 2008-01-25
   Days after onset:121
Entered: 2008-01-28
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Areflexia, Dysaesthesia, Myelitis
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA03716

Write-up: Information has been received from a physician concerning a 20 year old female patient who on 05-Sep-2007, was vaccinated with a second dose of Gardasil. On approximately 26-Sep-2007, 3 weeks after the vaccination, the patient experienced dysaesthesia of both flanks and loss of reflex in both legs. On an unspecified date, she was hospitalized and myelitis was diagnosed. At the time of this report, the patient''s outcome was unknown. It was also reported that the patient had a previous dose of Gardasil and it was well tolerated. Other business partners numbers include: E200800255. No further information is available.


VAERS ID: 306359 (history)  
Form: Version 1.0  
Age: 18.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-09-05
Onset:2007-10-13
   Days after vaccination:38
Submitted: 2008-03-03
   Days after onset:142
Entered: 2008-03-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abortion induced, 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
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Psychiatric disorder NOS
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA08339

Write-up: Information has been received from a general practitioner via Merck pregnancy registry concerning an 18 year old female with an unspecified psychiatric medical history who on 5-Sep-2007 was vaccinated (route and site not reported) with the 1st dose of GARDASIL (lot # not reported). On 13-NOV-2007, the patient was vaccinated (route and site not reported) with the 2nd dose of GARDASIL (batch: NF54050, lot:0275U). On 13-NOV-2007, post vaccination, it was determined that the patient was pregnant (LMP: 13-Oct-2007). The patient received her 2nd dose of GARDASIL 12 days after starting her pregnancy (1-Nov-2007). The reporter stated that the patient intended to have a voluntary termination of pregnancy in spite of the physician''s recommendation as there was no indication for abortion in that particular case. The physician underlined psychiatric context of the patient and her youth. No adverse effected was reported. Other business partners numbers include E2007-09283. Follow-up information reported that the patient underwent voluntary termination of the pregnancy on 22-DEC-2007. The date of conception was 27-OCT-2007, not 01-NOV-2007 as listed previously. No further information was provided. The physician considered this to be an other important medical event.


VAERS ID: 308461 (history)  
Form: Version 1.0  
Age: 15.0  
Gender: Female  
Location: Foreign  
Vaccinated:2007-09-05
Onset:2007-12-22
   Days after vaccination:108
Submitted: 2008-03-27
   Days after onset:95
Entered: 2008-03-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (GENHEVAC B) / SANOFI PASTEUR - / 2 UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Allergy test negative, Antinuclear antibody positive, Rash pruritic, Systemic lupus erythematosus, Telangiectasia
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Antibody test; Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: allergy test: normal; diagnostic laboratory test: Rheumatologist work up revealed positive autoantibodies
CDC Split Type: WAES0803USA03403

Write-up: Information has been received from a physician concerning a 15 year old female patient who on 05-SEP-2007 and 07-NOV-2007 was vaccinated with the first dose and second doses of GARDASIL, respectively. Other suspect concomitant therapy given on 05-SEP-2007 included the second dose of GENHEVAC B. Despite 2 measles, mumps and rubella vaccines (ROR) in her childhood she had antirubella antibodies <10. On 22-DEC-2007 the patient experienced a pruritic cutaneous eruption and telangiectosia. An allergological work up was normal. A rheumatologist work up revealed positive autoantibodies. The diagnosis established was an erythematous lupus. The patient was treated with antihistaminic treatment. At the time of this report the patient had not recovered, the eruption was fluctuant. It was also reported that despite three doses of GENHEVAC B the patient''s sister had no antibodies. Lupus erythematosus and autoantibody positive were considered to be other important medical events. Other business partner numbers include: E200802626. No further information is available.


VAERS ID: 322224 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Foreign  
Vaccinated:2007-09-05
Onset:2008-04-11
   Days after vaccination:219
Submitted: 2008-08-14
   Days after onset:125
Entered: 2008-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Cardio-respiratory arrest, Coma, Cyanosis, Death, Dyspnoea, Haemorrhage, Lower respiratory tract infection, Mechanical ventilation, Metabolic acidosis, Muscle contractions involuntary, Pyrexia, Respiratory distress, Resuscitation, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0532306A

Write-up: This case was reported by a physician and described the occurrence of lower respiratory tract infection in an 18-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 5 September 2007, the subject received the 1st dose of ROTARIX (oral, lot number not provided). On 11 April 2008 (in the emergency room), 7 months after vaccination with the 1st dose of ROTARIX, the subject experienced oral cyanosis and difficulty in breathing. The subject required hospitalization with data of 10 minutes of cardio respiratory arrest. Cardiopulmonary resuscitation was performed, reversing the arrest. The subject was maintained in deep coma with fever and fasciculation. He remained in phase 3 of mechanical ventilation without response to stimuli during all hospitalization with torpid evolution, requiring high parameters of ventilation. The physician considered the events were disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with AMPICILLIN, amikacin, cefotaxime, midazolam, PHENOBARBITAL, dexamethasone and parenteral nutrition. The subjects presented respiratory deterioration, hemorrhage from the upper digestive tube, decompensated metabolic acidosis with control difficulty and finally died due to cardio respiratory arrest. It was unknown whether an autopsy was performed. The physician considered the events were unrelated to vaccination with ROTARIX.


Result pages: prev   2992 2993 2994 2995 2996 2997 2998 2999 3000 3001 3002 3003 3004 3005 3006 3007 3008 3009 3010 3011 3012 3013 3014 3015 3016 3017 3018 3019 3020 3021 3022 3023 3024 3025 3026 3027 3028 3029 3030 3031 3032 3033 3034 3035 3036 3037 3038 3039 3040 3041 3042 3043 3044 3045 3046 3047 3048 3049 3050 3051 3052 3053 3054 3055 3056 3057 3058 3059 3060 3061 3062 3063 3064 3065 3066 3067 3068 3069 3070 3071 3072 3073 3074 3075 3076 3077 3078 3079 3080 3081 3082 3083 3084 3085 3086 3087 3088 3089 3090 3091 3092 3093 3094 3095 3096 3097 3098 3099 3100 3101 3102 3103 3104 3105 3106 3107 3108 3109 3110 3111 3112 3113 3114 3115 3116 3117 3118 3119 3120 3121 3122 3123 3124 3125 3126 3127 3128 3129 3130 3131 3132 3133 3134 3135 3136 3137 3138 3139 3140 3141 3142 3143 3144 3145 3146 3147 3148 3149 3150 3151 3152 3153 3154 3155 3156 3157 3158 3159 3160 3161 3162 3163 3164 3165 3166 3167 3168 3169 3170 3171 3172 3173 3174 3175 3176 3177 3178 3179 3180 3181 3182 3183 3184 3185 3186 3187 3188 3189 3190   next

New Search

Link To This Search Result:

http://www.medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=3091&PERPAGE=100&ESORT=VAX-DATE


Copyright © 2017 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166