MedAlerts Home
  Read the MedAlerts Blog Subscribe to the MedAlerts Blog 

Found 551189 cases in entire database

Case Details (Sorted by Vaccination Date)

This is page 2908 out of 5512

Result pages: prev   2809 2810 2811 2812 2813 2814 2815 2816 2817 2818 2819 2820 2821 2822 2823 2824 2825 2826 2827 2828 2829 2830 2831 2832 2833 2834 2835 2836 2837 2838 2839 2840 2841 2842 2843 2844 2845 2846 2847 2848 2849 2850 2851 2852 2853 2854 2855 2856 2857 2858 2859 2860 2861 2862 2863 2864 2865 2866 2867 2868 2869 2870 2871 2872 2873 2874 2875 2876 2877 2878 2879 2880 2881 2882 2883 2884 2885 2886 2887 2888 2889 2890 2891 2892 2893 2894 2895 2896 2897 2898 2899 2900 2901 2902 2903 2904 2905 2906 2907 2908 2909 2910 2911 2912 2913 2914 2915 2916 2917 2918 2919 2920 2921 2922 2923 2924 2925 2926 2927 2928 2929 2930 2931 2932 2933 2934 2935 2936 2937 2938 2939 2940 2941 2942 2943 2944 2945 2946 2947 2948 2949 2950 2951 2952 2953 2954 2955 2956 2957 2958 2959 2960 2961 2962 2963 2964 2965 2966 2967 2968 2969 2970 2971 2972 2973 2974 2975 2976 2977 2978 2979 2980 2981 2982 2983 2984 2985 2986 2987 2988 2989 2990 2991 2992 2993 2994 2995 2996 2997 2998 2999 3000 3001 3002 3003 3004 3005 3006 3007   next


VAERS ID:290133 (history)  Vaccinated:2007-09-06
Age:11.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Female  Submitted:2007-09-07, Days after onset: 1
Location:Illinois  Entered:2007-09-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0927U0IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Blood pressure, Cyanosis, Dizziness, Dyspnoea, Heart rate increased, Syncope, Throat tightness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad)
Write-up: Approximately 10 minutes following administration of Gardisil vaccine, pt became cyanotic, syncopal, and c/o dizziness. Pulse rate was 50 initially then increased to 100. BP 122/90. She then felt like her throat was closing off and was having some shortness of breath. We administered oxygen, gave Benadryl 25mg IM, and patient did recover within 15 minutes.

VAERS ID:290136 (history)  Vaccinated:2007-09-06
Age:9.0  Onset:2007-09-07, Days after vaccination: 1
Gender:Male  Submitted:2007-09-07, Days after onset: 0
Location:Pennsylvania  Entered:2007-09-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1018U1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Local reaction, Rash erythematous, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Local reaction (right posterior upper arm) with circular raised erythematous firm and warm rash, non-tender, approximately 5cm in diameter, developed over first 24 hours after vaccine administration.

VAERS ID:290167 (history)  Vaccinated:2007-09-06
Age:1.5  Onset:2007-09-06, Days after vaccination: 0
Gender:Male  Submitted:2007-09-07, Days after onset: 1
Location:Vermont  Entered:2007-09-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: URI Symptoms - no fever
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: VT0907071
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB129AA1IMLL
Administered by: Private     Purchased by: Private
Symptoms: Rash macular
SMQs:, Hypersensitivity (narrow)
Write-up: Came into office with red splotches behind legs, woke from nap with them. Plan to treat with Atarax and call mom for F/U.

VAERS ID:290233 (history)  Vaccinated:2007-09-06
Age:0.4  Onset:2007-09-07, Days after vaccination: 1
Gender:Female  Submitted:2007-09-07, Days after onset: 0
Location:California  Entered:2007-09-10, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: increased WBC, labs normal otherwise
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B114CA1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF089AA1IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB47442F1IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0667U1PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Crying, Dyskinesia, Irritability, Laboratory test normal, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: Please see attached note

VAERS ID:290251 (history)  Vaccinated:2007-09-06
Age:11.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Male  Submitted:2007-09-10, Days after onset: 4
Location:Texas  Entered:2007-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Focalin XR
Current Illness: none
Preexisting Conditions: ADHD
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSB206B0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1071U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Induration, Local reaction, Pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: local reaction of swelling, erythema, induration, and pain for 72 hours post administration

VAERS ID:290284 (history)  Vaccinated:2007-09-06
Age:14.0  Onset:2007-09-07, Days after vaccination: 1
Gender:Male  Submitted:2007-09-11, Days after onset: 4
Location:New York  Entered:2007-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2392BA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B016BA0IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Approximately 12 hours after given IM injections in R deltoid of Menactra and Boostrix, pt. developed urticarial lesions on R upper back and RUE. The urticaria spread to all extremities within 2 days of injections. + itching

VAERS ID:290289 (history)  Vaccinated:2007-09-06
Age:35.0  Onset:2007-09-07, Days after vaccination: 1
Gender:Male  Submitted:2007-09-11, Days after onset: 4
Location:Unknown  Entered:2007-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: G6PD Deficient
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1101SCRA
Administered by: Military     Purchased by: Military
Symptoms: Arthralgia, Local reaction, Mobility decreased, Musculoskeletal stiffness, Oedema, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Large local reaction to right arm extending below the elbow. Edema, warmth to touch, joint pain to right shoulder, elbow, and wrist present. Stiffness and limited range of motion noted. Rigth axillary edema noted upon elevation of right arm for 30 minutes or more.

VAERS ID:290300 (history)  Vaccinated:2007-09-06
Age:11.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Male  Submitted:2007-09-11, Days after onset: 5
Location:Pennsylvania  Entered:2007-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Seasonal allergies/reactive airway disease
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB186BA UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2327AA UNRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B021CB UNLA
Administered by: Private     Purchased by: Unknown
Symptoms: Asthenia, Erythema, Fatigue, Headache, Hyperhidrosis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad)
Write-up: 2 hours after vaccine - headache, weakness, skin red from head to knees (appearance of sunburn). 9/7 arms and face still red c/o slight headache, tired, increased sweating. 9/8 AM red.

VAERS ID:290301 (history)  Vaccinated:2007-09-06
Age:11.0  Onset:2007-09-09, Days after vaccination: 3
Gender:Male  Submitted:2007-09-17, Days after onset: 8
Location:Georgia  Entered:2007-09-11, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2759AA0IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0839U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Left deltoid red, swollen, warm to touch Raniclor sample-250 mg 1 tid Atarax 10 mg/5 ml 1.5 tsp PRN every 6 hr

VAERS ID:290304 (history)  Vaccinated:2007-09-06
Age:8.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Female  Submitted:2007-09-11, Days after onset: 5
Location:New Mexico  Entered:2007-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0834U1 RA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Erythema of 4-5cm, + itching, induration at site of 3 cm. No abscess.

VAERS ID:290308 (history)  Vaccinated:2007-09-06
Age:22.0  Onset:2007-09-08, Days after vaccination: 2
Gender:Male  Submitted:2007-09-11, Days after onset: 3
Location:Unknown  Entered:2007-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PPD Converter
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1101SCRA
Administered by: Military     Purchased by: Military
Symptoms: Arthralgia, Erythema, Local reaction, Mobility decreased, Oedema, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Parkinson-like events (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Large local reaction to right arm extending below the elbow. Edema, erythema, warmth to touch, joint pain to right elbow, and limited range of motion were noted.

VAERS ID:290312 (history)  Vaccinated:2007-09-06
Age:9.0  Onset:2007-09-10, Days after vaccination: 4
Gender:Female  Submitted:2007-09-11, Days after onset: 1
Location:Iowa  Entered:2007-09-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB186CA IMLL
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2408AA IMRL
TDAP: TDAP (ADACEL)SANOFI PASTEURC2775AA IMLA
Administered by: Public     Purchased by: Private
Symptoms: Cellulitis, Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Left deltoid red swollen on 9-10-07 pt treated for cellutlitis with Keflex 500mg

VAERS ID:290399 (history)  Vaccinated:2007-09-06
Age:64.0  Onset:2007-09-07, Days after vaccination: 1
Gender:Female  Submitted:2007-09-12, Days after onset: 5
Location:Maryland  Entered:2007-09-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no illness.
Preexisting Conditions: none.
Diagnostic Lab Data: The vaccine was Zostavax for shingles prevention. I can''t find it listed in question #13. I only filled in Zoster because I can''t complete this form without picking something.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.    
Administered by: Public     Purchased by: Private
Symptoms: Dizziness, Erythema, Feeling hot, Influenza like illness, Injection site erythema, Injection site pain, Malaise, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: sore arm at injection site the next day and two days following with red welt - felt hot. Got Shingles Vaccine on Thursday evening 9/6. My arm was bad on Friday, Saturday and Sunday. I felt sick and had flu like symptoms including dizziness on Friday evening, Saturday and Sunday. I feel fine now. Injection site still has redness, but has shrunk in size.

VAERS ID:290454 (history)  Vaccinated:2007-09-06
Age:15.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Female  Submitted:2007-09-12, Days after onset: 6
Location:Unknown  Entered:2007-09-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: [therapy unspecified]
Current Illness: Acne
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0709USA01028
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from the mother of a 15 year old female with acne and no history of drug reactions/allergies who on 06-SEP-2007 was vaccinated with the first dose of 0.5 ml Gardasil intramuscularly. Concomitant therapy included unspecified acne medication. On 06-SEP-2007 the patient experienced a seizure while in the physician''s office. Subsequently, the patient recovered from seizure on 07-SEP-2007. No lab testing was performed. Additional information is not expected. Upon internal review, seizure was considered to be an other important medical event.

VAERS ID:290476 (history)  Vaccinated:2007-09-06
Age:18.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Female  Submitted:2007-09-07, Days after onset: 1
Location:Ohio  Entered:2007-09-13, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Polycystic Ovarian Syndrome
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0929U1IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2395BA0IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Flushing, Headache, Myalgia, Rash papular, Skin lesion, Tenderness
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: Headache, myalgia, papular lesion bilateral forearms flushed cheeks. Lesion firm, tender to touch. No fever no SOB, weakness, Sx occurred 24 hours after vaccines.

VAERS ID:290516 (history)  Vaccinated:2007-09-06
Age:25.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Female  Submitted:2007-09-12, Days after onset: 6
Location:Maryland  Entered:2007-09-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin once QD Ambien prn Wellbutrin XL 300 mg QD
Current Illness: None
Preexisting Conditions: HTN, Allergy to Spider bites-Carries Epi pen
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2824AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Dizziness, Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site swelling, Local reaction, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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)
Write-up: Pt. rec''d vaccine in AM. That afternoon, inj. Site became red and sore. She reported dizziness, nausea and achiness. The next morning, pt. reports Temp of 102. Went to ER that night-Dx local reaction. Pt received Decadron 10 mg IM and Benadryl 50 mg po at ER. Followed up at our office on 9/10/07 5x5 sm erythema, ecchymotic, swollen area at (R) deltoid injection site

VAERS ID:290524 (history)  Vaccinated:2007-09-06
Age:4.0  Onset:2007-09-07, Days after vaccination: 1
Gender:Male  Submitted:2007-09-13, Days after onset: 6
Location:Nebraska  Entered:2007-09-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: Drew lab 9-10-07 CRP slightly increased, WBC slightly decreased; Repeat lab 9/13/07
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2655AA4IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01103IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1469F1SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.103861SCLL
Administered by: Private     Purchased by: Private
Symptoms: C-reactive protein increased, Unevaluable event, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad)
Write-up: Notice that he had 2" x 1 3/4" then went up to 4"x4" Rt thigh. 7/8/07 Put on antibiotic BID x 10 days. Topical cream and Epsom salts.

VAERS ID:290525 (history)  Vaccinated:2007-09-06
Age:13.0  Onset:2007-09-07, Days after vaccination: 1
Gender:Female  Submitted:2007-09-10, Days after onset: 3
Location:Montana  Entered:2007-09-13, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0831U1SCRA
Administered by: Private     Purchased by: Private
Symptoms: Injection site induration, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 6"x6" area of swelling and induration - central on site of varicella injection - tx - Aleve, Benadryl, Prednisone 60mg x 2 days.

VAERS ID:290529 (history)  Vaccinated:2007-09-06
Age:6.0  Onset:2007-09-07, Days after vaccination: 1
Gender:Male  Submitted:2007-09-08, Days after onset: 1
Location:Pennsylvania  Entered:2007-09-13, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Enuresis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0936R0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.3044U1SCRA
Administered by: Private     Purchased by: Other
Symptoms: Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Developed welt (R) triceps 1 day after Varivax administered. Treated w/Benadryl, ice

VAERS ID:290533 (history)  Vaccinated:2007-09-06
Age:18.0  Onset:2007-09-10, Days after vaccination: 4
Gender:Male  Submitted:2007-09-13, Days after onset: 3
Location:Florida  Entered:2007-09-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: no
Current Illness: no
Preexisting Conditions: no
Diagnostic Lab Data: no doctor visit yet.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (FOREIGN)MERCK & CO. INC.0771F1IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1410F1SCRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSC52B013AA1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1028U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pruritus, Pyrexia, Rash generalised
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Patient accompanied by his father @ 2:30pm to HD and complained rashes all over his body and face starting 09-10-07.He had one day fever the following day. The client is alert and oriented to person, time and place.He also c/o itches to his body.

VAERS ID:290603 (history)  Vaccinated:2007-09-06
Age:10.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Male  Submitted:2007-09-10, Days after onset: 4
Location:Washington  Entered:2007-09-14, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: PCN, Sulfa
Diagnostic Lab Data: CBC - normal results
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0651U0SCRA
Administered by: Private     Purchased by: Public
Symptoms: Abdominal pain, Erythema, Full blood count normal, Nausea, Pain, Pruritus, Pyrexia, Swelling, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: Area erythematous with swelling, c/o nausea, wheezing, abdominal pain, fever. Area erythematous by swelling growing larger, painful, itchy. 9/10/07 Pt in for reeval today f/u CBC normal. Swelling has enlarged. CHN provided w/Merck NSC #1 encouraged MD to call and also review package insert - reaction should not preclude f/up dose.

VAERS ID:290607 (history)  Vaccinated:2007-09-06
Age:12.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Female  Submitted:2007-09-07, Days after onset: 1
Location:California  Entered:2007-09-14, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: muscle strain, paresthesia extremity
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2382BA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Dizziness, Gait disturbance, Heart rate increased, Nausea
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: MCV4 given approximately 1417 on 9-6-07. According to mom about 1-2 hours after IZ given patient had dizziness, nausea, difficulty walking and increase HR.

VAERS ID:290619 (history)  Vaccinated:2007-09-06
Age:59.0  Onset:2007-09-07, Days after vaccination: 1
Gender:Male  Submitted:0000-00-00
Location:Florida  Entered:2007-09-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1022F1IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Facial palsy
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: Bells palsy

VAERS ID:290629 (history)  Vaccinated:2007-09-06
Age:1.3  Onset:2007-09-07, Days after vaccination: 1
Gender:Female  Submitted:2007-09-08, Days after onset: 1
Location:Tennessee  Entered:2007-09-14, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Rhinitis
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2156AA3 LL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0075U2 RL
Administered by: Private     Purchased by: Private
Symptoms: Unevaluable event
SMQs:
Write-up: None

VAERS ID:290632 (history)  Vaccinated:2007-09-06
Age:79.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Female  Submitted:2007-09-11, Days after onset: 5
Location:New Mexico  Entered:2007-09-14, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergy - Sulfa, hypertension, CAD, breast cancer
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0803U IM 
Administered by: Public     Purchased by: Other
Symptoms: Body temperature increased, Erythema, Oedema peripheral, Pruritus, Skin warm, Tenderness
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: On 9-6-07 at 12:00 Pneumo vaccine given at about 11:00pm warm to touch, tender. Today right upper arm red, swelling, some itching, T 98.8, PAC notified and examined patient ice packs, Alleve, call nurse on Monday.

VAERS ID:290633 (history)  Vaccinated:2007-09-06
Age:57.0  Onset:2007-09-07, Days after vaccination: 1
Gender:Male  Submitted:2007-09-11, Days after onset: 4
Location:New Mexico  Entered:2007-09-14, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hx - Hep C +
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0803U0IM 
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pyrexia, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: Patient received Pneumovax in left deltoid on 9-6-07 at 2:30 on 9-7-07 AM left arm warm to touch, red, swollen, painful, fever. Doctor notified and examined patient T 98.5, ice pack, move arm, Motrin (fever, pain).

VAERS ID:290649 (history)  Vaccinated:2007-09-06
Age:19.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Female  Submitted:2007-09-14, Days after onset: 8
Location:Wisconsin  Entered:2007-09-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: She received a Depo injection in July. She received a Mantoux on 09-06-2007. Manufacturer-Sanofi Pasteur. Tubersol. Lot # C2512AC given in Left forearm.
Current Illness: She denies illness or exposure to illness
Preexisting Conditions: Denies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2720AA1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Flushing, Hyperhidrosis, Nausea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (broad)
Write-up: Patient received a DTAP and Mantoux on 09-06-2007 at approximately 1:30 p.m. Within 1 hour she states that she became dizzy, her hands began to sweat, her face was flushed. Within 1 1/2 hour she began to vomit, 4 times over next 3 hours. She was nauseated through the night, but was fine by morning.

VAERS ID:290709 (history)  Vaccinated:2007-09-06
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2007-09-10
Location:South Carolina  Entered:2007-09-17, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: N/A
Preexisting Conditions: None
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2408AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Wrong drug administered
SMQs:
Write-up: Gardasil 0.5 ml lot # 0930U, Exp 11/10 given IM inadvertently instead of Tdap.

VAERS ID:290727 (history)  Vaccinated:2007-09-06
Age:13.0  Onset:2007-09-07, Days after vaccination: 1
Gender:Male  Submitted:2007-09-10, Days after onset: 3
Location:Colorado  Entered:2007-09-17, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2404AA0IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2769AA0IMLA
Administered by: Unknown     Purchased by: Public
Symptoms: Body temperature increased, Migraine, Muscle rigidity, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: MOC called stating pt. school nurse told to report vaccine reaction. MOC states child has temp of 101, severe migraine, vomiting, muscle rigidity. MOC called 9/7/07 MOC advised to go to ER-pt not seen at this clinic for symptoms

VAERS ID:290728 (history)  Vaccinated:2007-09-06
Age:22.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Male  Submitted:2007-09-11, Days after onset: 5
Location:Pennsylvania  Entered:2007-09-17, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Wellbutrin, Zyprexa
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.0040U0IMUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1169F SCUN
TDAP: TDAP (ADACEL)SANOFI PASTEURC2644AA0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Pain
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: diarrhea body aches

VAERS ID:290739 (history)  Vaccinated:2007-09-06
Age:0.5  Onset:2007-09-12, Days after vaccination: 6
Gender:Male  Submitted:2007-09-17, Days after onset: 5
Location:Oklahoma  Entered:2007-09-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Unknown
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B124AA3IMRA
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08700H3IMLA
Administered by: Public     Purchased by: Other
Symptoms: Diarrhoea, Viral infection
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Pt was given Rotateq vaccination on 9-6-07 and developed virus on 9-12-07. Mom c/o of diarrhea

VAERS ID:290748 (history)  Vaccinated:2007-09-06
Age:14.0  Onset:0000-00-00
Gender:Male  Submitted:2007-09-07
Location:South Carolina  Entered:2007-09-17, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No illness (well)
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB195AB0  
Administered by: Private     Purchased by: Private
Symptoms: Wrong drug administered
SMQs:
Write-up: Medication error patient received 1 ml of Havrix A vaccine (Adult).

VAERS ID:290787 (history)  Vaccinated:2007-09-06
Age:11.0  Onset:2007-09-15, Days after vaccination: 9
Gender:Male  Submitted:2007-09-18, Days after onset: 3
Location:Ohio  Entered:2007-09-18
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: PMH: ITP 2001 following DTap, IPV, MMR.
Diagnostic Lab Data: Platelet count 9-16-07 3 (Normal 130-400). Labs and Diagnostics: Platelets counts 20K, 4K, up to 34K prior to d/c. IgE high 263. IgG low 713. C4 Complement low 15. Flow cytometry Peripheral T/B Immunophenotype with Lymphocytes low 7, Absolute Lymphocytes low at 896, Absolute CD3 low at 643 and Absolute CD4 low 387, otherwise WNL. Stool Guiac (+).
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2632AA0IMRA
Administered by: Private     Purchased by: Private
Symptoms: Blood immunoglobulin E increased, Blood immunoglobulin G, Blood immunoglobulin G decreased, CD4 lymphocytes decreased, Chills, Complement factor C4 decreased, Epistaxis, Flow cytometry, Idiopathic thrombocytopenic purpura, Lymphocyte count decreased, Nasal congestion, Occult blood positive, Petechiae, Pharyngolaryngeal pain, Platelet count decreased, Pyrexia, Rhinorrhoea, Similar reaction on previous exposure to drug, T-lymphocyte count decreased
SMQs:, Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), Hypersensitivity (narrow)
Write-up: Pt found to have extensive petechial rash 9 days after receiving Tdap. Admitted for ITP to hospital. 11/21/2007 MR received for DOS 9/16-18/2007 with D/C DX: ITP. Child with hx of ITP following vaccines in 2001 (VAERS 179311) presented with platelet count of 3,000 and petechial rash on feet and legs. Pt had a 30 minute nosebleed which was diffficult to control. Admitted to current hospital with platelet count of 20,000. Pt reported high fever with rigors on day of tetanus booster 9/6/07 and currently c/o nasal congestion, rhinorhea, and a sore throat. Pt txd with IVIG with increase in platelets.

VAERS ID:290866 (history)  Vaccinated:2007-09-06
Age:1.1  Onset:2007-09-07, Days after vaccination: 1
Gender:Female  Submitted:2007-09-10, Days after onset: 3
Location:Louisiana  Entered:2007-09-18, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: LA070901
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (TRIHIBIT)SANOFI PASTEURU15365C4IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB148AA1IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0805F1 RA
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB2651084IMRA
Administered by: Public     Purchased by: Public
Symptoms: Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: child started with red rash (head to toe) @ 12:30pm on 9-7-07 mom called hospital, referred to CMC-ER. No fever report.

VAERS ID:290887 (history)  Vaccinated:2007-09-06
Age:50.0  Onset:2007-09-07, Days after vaccination: 1
Gender:Female  Submitted:2007-09-10, Days after onset: 3
Location:Michigan  Entered:2007-09-19, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MVI; Lopressor; Motrin; Fe
Current Illness: None
Preexisting Conditions: PCN, Emycin, Dyslipch
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERC2775AA UNLA
Administered by: Private     Purchased by: Other
Symptoms: Body temperature increased, Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: W/I 24 hours of immunization with Tdap - temp 100.2, local swelling and redness.

VAERS ID:291001 (history)  Vaccinated:2007-09-06
Age:5.0  Onset:2007-09-08, Days after vaccination: 2
Gender:Male  Submitted:2007-05-12, Days after onset: 119
Location:New York  Entered:2007-09-20, Days after submission: 131
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Febrile seizures
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B056DA1UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ08731UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Grand mal convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: generalized seizure (grand mal) duration 2 minutes on 9-8-07

VAERS ID:291076 (history)  Vaccinated:2007-09-06
Age:10.0  Onset:0000-00-00
Gender:Female  Submitted:2007-09-20
Location:Michigan  Entered:2007-09-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Mother not giving med.
Current Illness: None
Preexisting Conditions: NKMA - hx of STV at age 3 yr.
Diagnostic Lab Data: 9-19-07 clinic visit for weak and dizzy - diagnosis dehydration, SVT - holder 24 hour monitor was ordered
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2339AA0IMLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B015AA0IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1012U1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Asthenia, Chest discomfort, Dehydration, Dizziness, Dyspnoea, Erythema, Injection site rash, Injection site swelling, Oedema peripheral, Pruritus, Rash, Skin warm, Supraventricular tachycardia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: 9-6-07 came to clinic for physical - received Tdap, Menactra, and Varicella #2. Symptoms started 9-7-07 - dots around site - changing to rash on second day around site - raised - swollen, turned into 2 long areas - from shoulder to elbow - swollen - warm - red- used hydrocortisone to site - she also c/o SOB, tightness of chest, weak and dizzy. Rash spread to check - chest - legs - size of one-two quarts. Still itches. Pt has hx of STV - in hospital at 3 yrs of age. Returned to clinic 9-19-07 - weak - dizzy - not reported until 9-19-07 visit.

VAERS ID:291089 (history)  Vaccinated:2007-09-06
Age:0.0  Onset:2007-09-13, Days after vaccination: 7
Gender:Male  Submitted:2007-09-21, Days after onset: 8
Location:Texas  Entered:2007-09-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none. PMH: 41 week EGA. Mom GBS (+) treated with abx.
Diagnostic Lab Data: negative WN virus,bacterial cultures of CSF and blood. MRI multifocal cortical lesions. Labs and Diagnostics: EEG abnormal and (+) for seizure activity. MRI brain shows white matter changes. Findings concerning for ADEM. CT Brain x 2 abnormal with bulging fontanelle concerning for elevated ICP. MR Venogram normal. Stool (-) for viral particles. CSF culture (-). CSF WNL. Blood cultures (-). UC (-). HSV PCR (blood and CSF)(-). RSV and Flu (-). Initial CBC WNL. PT 20. PTT 50.2. INR 1.6. Chemistries and LFTs WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB431BA0IMRL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activated partial thromboplastin time prolonged, Bacterial culture, Blood culture negative, CSF culture negative, Computerised tomogram abnormal, Convulsion, Electroencephalogram abnormal, Encephalitis, Encephalitis viral, Encephalopathy, Febrile infection, Feeding disorder neonatal, Fontanelle bulging, Full blood count, Gross motor delay, Herpes simplex serology negative, Hypotonia, Influenza serology negative, International normalised ratio, Intracranial pressure increased, Laboratory test normal, Liver function test normal, Meningitis, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain abnormal, Polymerase chain reaction, Prothrombin time prolonged, Pyrexia, Rash, Scan brain, Sepsis neonatal, Stool analysis normal, Tonic clonic movements, Venogram normal, Virus culture negative, Virus serology test
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Agranulocytosis (broad), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow)
Write-up: Infant readmitted with fever and seizures at around 10 days of life. Sibling with viral illness. Sepsis workup negative; MRI shows multifocal encephalopathy consistent with viral process, likely not related to vaccine (but reported due to old DTP/encephalopathy concerns)Outcome uncertain, viral cultures pending and unclear if permanent disability will be present. 11/01/2007 MR received for hospital DOS beginning 9/13/2007. 12/18/2007 D/C Summary received for DOS 9/13-26/2007 with D/C Dx: Febrile Illness. Suspected neonatal sepsis/meningitis. Seizures. Encephalitis. Poor feeding. One week old infant developed fever and rash and was taken to ER and admitted. In hospital pt developed seizure activity. Pt had some jerking movements c/w tonic-clonic activity. This resolved with meds. Neuro consult with hypotonia noted on PE. Developmental eval with impression: Encephalitis and seizure hx. Clinical picture c/w a viral encephalitis. D/Cd with some diminished tone to be f/u as an outpt Follow up: May be too early to tell if he will have developmental delays. Currently within normal limits for milestones. 1/12/2010 Mild hypotomia and mild gross motor delay.

VAERS ID:291270 (history)  Vaccinated:2007-09-06
Age:1.0  Onset:2007-09-20, Days after vaccination: 14
Gender:Female  Submitted:2007-09-24, Days after onset: 4
Location:Pennsylvania  Entered:2007-09-25, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: NL X-ray right leg, both hips - Normal ultrasound right hip
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB182AA0IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0795F0SCLL
Administered by: Private     Purchased by: Public
Symptoms: Gait disturbance, Ultrasound scan normal, Weight bearing difficulty, X-ray normal
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad)
Write-up: 12 Days after receiving Hepatitis A and Varicella she began limping. The exam was normal except for limping that is not bearing weight on the right leg. She slowly improving.

VAERS ID:291309 (history)  Vaccinated:2007-09-06
Age:14.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Female  Submitted:2007-09-11, Days after onset: 5
Location:Colorado  Entered:2007-09-25, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Same symptoms after all vaccinations; all ages per MOC~ ()~~0~In Patient
Other Medications: None
Current Illness: Denies
Preexisting Conditions: Asthma
Diagnostic Lab Data: Albuterol nebs x 2 - to continue at home
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2771AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Chest pain, Dizziness, Dyspnoea, Erythema, Headache, Nasal congestion, Nausea, Oedema peripheral, Pain in extremity, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad)
Write-up: (L) deltoid edema, erythema, pain, per NOC; dizziness, nausea, headache, chest pain, short of breath, fever congested. Seen on 9/11/07, hx of asthma, + SOB, + chest pain, nauseated, afebrile; 8x3 cm area of mild firm, slight erythema of (L) deltoid.

VAERS ID:291357 (history)  Vaccinated:2007-09-06
Age:39.0  Onset:2007-09-17, Days after vaccination: 11
Gender:Female  Submitted:2007-09-18, Days after onset: 1
Location:Indiana  Entered:2007-09-25, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Penicillin, asthma
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0411U SCLA
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Local reaction, Nodule
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Local reaction left upper arm erythema nodule

VAERS ID:291441 (history)  Vaccinated:2007-09-06
Age:29.0  Onset:2007-09-10, Days after vaccination: 4
Gender:Male  Submitted:2007-09-13, Days after onset: 3
Location:New York  Entered:2007-09-26, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1026F0SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Arthralgia, Pyrexia, Rash vesicular, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Patient called me reporting that on 9/10/07 he developed "boils"-fluid filled on his abdomen, elbow, buttocks (6 total), a fever, and achey joints. (L) knee became swollen on 9/12/07. He plans to be seen in the ER today.

VAERS ID:291604 (history)  Vaccinated:2007-09-06
Age:25.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Female  Submitted:2007-09-19, Days after onset: 13
Location:Massachusetts  Entered:2007-09-28, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lo-estron 1.5/30
Current Illness: None
Preexisting Conditions: Leukemia ALL - age 5
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0929U0 LA
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Dizziness, Malaise, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow)
Write-up: Had not felt well all day, nauseous, dizzy and diarrhea - all sx subsided in 5 days.

VAERS ID:291920 (history)  Vaccinated:2007-09-06
Age:1.1  Onset:2007-09-13, Days after vaccination: 7
Gender:Male  Submitted:2007-09-20, Days after onset: 7
Location:California  Entered:2007-10-02, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Asthma
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0094F SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1035R SCLL
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site papule, Injection site vesicles
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 1 week after 1 year vaccinations patient developed erythematous papules and "water blisters" at site of Varicella vaccine. Over 1 week increase size and with few scattered on abdomen and one patch on left chest.

VAERS ID:292279 (history)  Vaccinated:2007-09-06
Age:14.0  Onset:2007-09-07, Days after vaccination: 1
Gender:Female  Submitted:2007-10-05, Days after onset: 28
Location:New Jersey  Entered:2007-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2222AA0IMRA
Administered by: Public     Purchased by: Public
Symptoms: Chills, Cough, Pain, Pyrexia, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Fever, chills, runny nose, cough, body aches - day after administration of vaccine x 1 week - sx increase - patient was seen at hospital ER.

VAERS ID:292345 (history)  Vaccinated:2007-09-06
Age:42.0  Onset:2007-09-07, Days after vaccination: 1
Gender:Female  Submitted:2007-10-05, Days after onset: 28
Location:California  Entered:2007-10-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: topamax, neurontin, claritin, cymbalta, namenda
Current Illness: none
Preexisting Conditions: failed back syndrome, asthma, allergic to: latex, theophylline, sulfa, oxycontin, ms, seafood
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0200U0IMRA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0357U0SCLA
Administered by: Private     Purchased by: Unknown
Symptoms: Contusion, Erythema, Inappropriate schedule of drug administration, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Hypersensitivity (narrow)
Write-up: pt had large welt- itchy- reddened area for over a week after vaccine given- resembled a large bruise

VAERS ID:296725 (history)  Vaccinated:2007-09-06
Age:22.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Female  Submitted:2007-10-08, Days after onset: 32
Location:Kansas  Entered:2007-10-12, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0709USA01056
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1060U1UNRA
Administered by: Private     Purchased by: Other
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)
Write-up: Information has been received from a physician concerning a 22 year old white female with no relevant medical history or illness at the time of vaccination who on 06-SEP-2007 was vaccinated in the right deltoid with a second dose of GARDASIL. There was no concomitant medication. On 06-SEP-2007 the patient experienced dizziness lasting 1/2 hour. The patient called the office and was instructed to lie down temporarily. The patient was to call if symptoms worsened or persisted The office had no further contact with the patient. On 06-SEP-2007, the patient recovered from dizziness. Additional information is not expected.

VAERS ID:293146 (history)  Vaccinated:2007-09-06
Age:60.0  Onset:2007-09-07, Days after vaccination: 1
Gender:Female  Submitted:2007-10-05, Days after onset: 28
Location:Oregon  Entered:2007-10-15, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Nausea, malaise~Hep A (no brand name)~1~49~In Patient
Other Medications: None
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC Split Type: OR200737
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2734AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Musculoskeletal pain, Neck pain
SMQs:, Rhabdomyolysis/myopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Tdap injection on 9-6-07, afternoon. Friday morning, I had pain in my shoulder above injection site, which radiated into my neck on the left side. Had pain on left side. Symptoms lasted ~ 4 days, improving gradually after 2 days. No treatment.

VAERS ID:298104 (history)  Vaccinated:2007-09-06
Age:  Onset:2007-09-07, Days after vaccination: 1
Gender:Unknown  Submitted:2007-10-12, Days after onset: 35
Location:California  Entered:2007-10-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: stool rotavirus antigen 08/07?/07 - negative for rotavirus
CDC Split Type: WAES0709USA01420
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  UNUN
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Rotavirus test negative
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a physician concerning a child who on 06-SEP-2007 was vaccinated with a dose of Rotateq. Concomitant therapy on the same day may have included "other vaccines." On 07-SEP-2007 the patient developed severe diarrhea and was hospitalized over the weekend. Unspecified medical attention was sought. A rotavirus test was performed and the result was negative for rotavirus. The patient''s treatment was unknown. The patient was noted to be doing better and was released from the hospital. There was no product quality complaint. Additional information has been requested.

VAERS ID:298111 (history)  Vaccinated:2007-09-06
Age:0.2  Onset:2007-09-06, Days after vaccination: 0
Gender:Unknown  Submitted:2007-10-12, Days after onset: 36
Location:Pennsylvania  Entered:2007-10-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0709USA00808
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Other     Purchased by: Other
Symptoms: Regurgitation
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)
Write-up: Information has been received from a physician concerning a 9-week-old patient with no medical history or allergies who on 06-SEP-2007 was vaccinated PO with a dose of ROTATEQ. There was no concomitant therapy. The physician reported that on 06-SEP-2007, about 20 seconds after being vaccinated, the patient regurgitated. The patient was examined in the physician''s office. No laboratory/diagnostic tests were performed. The patient did not require treatment and fully recovered on that same day. No further information is available.

VAERS ID:298755 (history)  Vaccinated:2007-09-06
Age:27.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Female  Submitted:2007-10-12, Days after onset: 36
Location:New Jersey  Entered:2007-10-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions: Depression
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA04567
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U2IMLA
Administered by: Private     Purchased by: Private
Symptoms: Cold sweat, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad)
Write-up: Information has been received from a physician concerning a 27 year old female patient with asthma who on 06-SEP-2007, was vaccinated with a third dose of GARDASIL (Lot# 658560/1062U). Concomitant therapy included SEREVENT, ADVAIR, NUVARING and CELEXA. About one hour after the vaccination, the patient experienced blurred vision and cold sweats. Unspecified medical attention was sought. That same day, the patient recovered. No product quality complaint was involved. Additional information has been requested. 01/07/2008 This is in follow-up to report(s) previously submitted on 10/12/2007. Information has been received from a physician concerning a 27 year old female with asthma and depression who on 06-SEP-2007, was vaccinated IM into the left arm with a third dose of GARDASIL (Lot# 658560/1062U). On 06-MAR-2007 and 08-MAY-2007, the patient was vaccinated IM into the left arm with a first and second dose of GARDASIL (Lot # 654702/0011U), respectively. Concomitant therapy included SEREVENT, ADVAIR, NUVARING and CELEXA. On 06-SEP-2007 about one hour after the vaccination, the patient experienced blurred vision and cold sweats which lasted about 10 minutes. Unspecified medical attention was sought. That same day, the patient recovered. No product quality complaint was involved. Additional information is not expected.

VAERS ID:298841 (history)  Vaccinated:2007-09-06
Age:25.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Female  Submitted:2007-10-12, Days after onset: 36
Location:Unknown  Entered:2007-10-15, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0710USA00004
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1060U IMUN
Administered by: Other     Purchased by: Other
Symptoms: Rash erythematous, Rash macular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a health professional concerning a 25 year old female who on 06-SEP-2007 was vaccinated with Gardasil (yeast, lot # 658556/1060U) in her right deltoid. Concomitant therapy included oral contraceptive (therapy unspecified). When the patient received her first dose of Gardasil, she experienced a rash. The rash was described as a red, blotchy area on her chest that covered an area of approximately 3-5 inches. The rash did not itch or spread. Medical attention was sought, the patient called the office. As of 27-SEP-2007 the outcome was unknown. Additional information has been requested.

VAERS ID:294065 (history)  Vaccinated:2007-09-06
Age:12.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Male  Submitted:2007-10-06, Days after onset: 30
Location:Unknown  Entered:2007-10-22, Days after submission: 16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Mefloquine x 9 weeks
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
JEV: JAPANESE ENCEPHALITIS (JE-VAX)SANOFI PASTEUREJN226A2SCRA
RAB: RABIES (RABIPUR)NOVARTIS VACCINES AND DIAGNOSTICS14122IMLA
Administered by: Other     Purchased by: Public
Symptoms: Pityriasis rosea, Pruritus, Rash erythematous, Rash papular, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: 9/6/07, 6:00 PM - 2 hours after injections parents called doctor reporting that the patient had hives. Benadryl 25 mg. was given to patient with no relief. At 7:00 PM parents brought patient to see doctor who noted ''erythematous papular rash and urticaria.'' Benadryl 50 mg. IM given. 9/7/07 Rash worsens. Pt visits doctor again and was given Benadryl 25 mg. q 4 - 6 hours. 9/18 and 9/20/07 Pt. returned to clinic and saw another doctor who described rash as ''persistent papular erythematous rash and pruritus rash with general itchiness despite Benadryl notable on trunk and thighs.'' 9/27/07 Pt saw doctor again who noted ''pruritis rash probable pityriasis rosea.'' Dermatologist consulted who concurred with pityriasis rosea diagnosis and prescribed Atarax 25 mg instead of Benadryl along with Flutazone (Flutivate E) topical cream. Pt''s mother reported that rash resolved within 2 days of stopping the Benadryl.

VAERS ID:294067 (history)  Vaccinated:2007-09-06
Age:35.0  Onset:2007-10-08, Days after vaccination: 32
Gender:Male  Submitted:2007-10-15, Days after onset: 7
Location:Massachusetts  Entered:2007-10-22, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No
Current Illness: None
Preexisting Conditions: NKDA
Diagnostic Lab Data: WBC 16.8
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0279U SCRA
Administered by: Private     Purchased by: Private
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Headache, Photophobia, White blood cell count increased
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Noninfectious diarrhoea (narrow)
Write-up: Onset of symptoms started after receiving Hep B #2, weak, headache, sensitivity to light sweaty, chills, diarrhea, stomach cramps Treated in the ER 10/10/07 and 10/14/07

VAERS ID:295850 (history)  Vaccinated:2007-09-06
Age:21.0  Onset:2007-10-09, Days after vaccination: 33
Gender:Female  Submitted:2007-11-02, Days after onset: 24
Location:Texas  Entered:2007-11-07, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Negative pregnancy test at screening for study on 23 August 2007, and again on study entry 06 September 2007. The subject has a past medical history of HIV infection, and tubal pregnancy loss.
Diagnostic Lab Data: According to the subject, an ultrasound (date not reported) revealed she experienced a spontaneous abortion about five weeks gestation. 10 October 2007: Ultrasound, results pending at the time of this report.
CDC Split Type: 200703659
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage, Stress, Ultrasound scan abnormal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Initial report received on 26 October 2007. The following is verbatim from that report. "Summary: The subject is a 21 year-old, HIV infected, female, enrolled on September 6, 2007 in a study, who experienced grade 2 miscarriage on October 9, 2007. The subject had negative pregnancy tests at study screening on August 23, 2007 and at study entry on September 6, 2007. She also admitted to using birth control as required in the eligibility criteria. On September 2007, the subject received one single dose of the study agent, Quadrivalent Meningococcal Conjugated vaccine. On study day 33, the subject informed the site that she had spontaneous abortion of a 5 weeks gestation. She reported going through some stress condition before the abortion, because her 2 year-old child was hospitalized for trauma a day before she experienced excessive bleeding. She further stated that, prior to the study entry; she had a past history of tubal pregnancy loss. On October 10, 2007, the subject had an abdominal ultrasound done, the report of which was still pending, as at the time of this report." "Assessment of Relationship: The site Principal Investigator has assessed the event of miscarriage as probably not related to the study agent, Quadrivalent Meningococcal Conjugate vaccine. The DAIDS Medical Officer has assessed the event of miscarriage as probably not related to, but could not rule out the relationship to the study agent, Quadrivalent Meningococcal Conjugate vaccine. After review of the clinical details and investigator comments pertaining to the adverse event, and based upon our experience with this agent, the Division of AIDS does not believe that changes to the conduct of this trial are warranted." "Previous Reports: There has been no similar safety reports previously submitted for this IND." "Patient History and Clinical Evaluation: Clinical Evaluation: The subject is a 21 year-old, HIV infected, female, enrolled on September 6, 2007 in a study, who experienced grade 2 miscarriage on October 9, 2007. The subject had negati

VAERS ID:296572 (history)  Vaccinated:2007-09-06
Age:0.3  Onset:2007-09-06, Days after vaccination: 0
Gender:Female  Submitted:2007-11-12, Days after onset: 67
Location:Illinois  Entered:2007-11-13, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: EEG normal; echo normal; neurological eval
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B115AA1UNLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0067U1UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH826510A1UNRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1375F1PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Echocardiogram normal, Electroencephalogram normal, Neurological examination, Shock
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Shock like syndrome. Tx observation in hospital.

VAERS ID:299945 (history)  Vaccinated:2007-09-06
Age:  Onset:0000-00-00
Gender:Female  Submitted:2007-11-14
Location:Arkansas  Entered:2007-11-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA00939
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Burning sensation, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a female who on approximately 06-SEP-2007 was vaccinated with a 0.5 ml second dose of Gardasil. Subsequently the patient experienced hives and unspecified burning sensation. The patient called the physician. At the time of the report the patient''s outcome was unknown. Additional information has been requested.

VAERS ID:299585 (history)  Vaccinated:2007-09-06
Age:25.0  Onset:2007-09-11, Days after vaccination: 5
Gender:Female  Submitted:2007-11-14, Days after onset: 64
Location:Maryland  Entered:2007-11-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0710USA03886
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Injection site pain
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Information has been received from a physician, concerning a 25 year old female patient with no pertinent medical history and no known allergies, who on 06-SEP-2007 was vaccinated in the left arm ("in the p.m.") with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (lot # not known). There was no concomitant medication; there was no illness at the time of vaccination. On 11-SEP-2007 the patient experienced tenderness around the injection site. On 12-SEP-2007 the patient developed a "red ring" that continued to grow in size until 14-SEP-2007, when the patient visited the office and treatment with an antihistamine (unspecified) and antibiotic (unspecified) was initiated. On 17-SEP-2007, the patient had recovered events. Additional information has been requested.

VAERS ID:300720 (history)  Vaccinated:2007-09-06
Age:14.0  Onset:2007-10-06, Days after vaccination: 30
Gender:Female  Submitted:2007-12-14, Days after onset: 69
Location:Virginia  Entered:2007-12-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Singulair; prednisone
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic procedure
CDC Split Type: WAES0711USA02628
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Movement disorder, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: Information has been received from a physician concerning a female who on 06-SEP-2007 was vaccinated with the first dose of Gardasil. Subsequently the patient called the physician on 29-OCT-2007 and stated that she experienced tremors on the same arm she received the Gardasil. The patient''s tremors on the same arm she received the Gardasil persisted. The sought unspecified medical attention. Follow-up AE information 13-NOV-2007: Per the reporter, one month after receiving the first dose of Gardasil, the patient developed a movement disorder and tremors in the arm in which she was vaccinated. The symptoms have lasted three weeks and are ongoing. Concomitant therapy included montelukast sodium (MSD). The montelukast sodium (MSD) was discontinued and symptoms persisted. The patient has seen a neurologist who states that he has never seen a case like hers before. The neurologist also states that the condition resembles a "rubal tremor". Unspecified diagnostic studies were performed by the neurologist. Patient placed on prednisone treatment and is doing "a little better". Memo 30-NOV-2007: Per the physician, the patient developed tremors and movement disorders in the arm in which she was vaccinated with the first dose of Gardasil. The symptoms persisted for the past 4 weeks. The patient was treated with low dose prednisone and has recovered. Additional information has been requested.

VAERS ID:301877 (history)  Vaccinated:2007-09-06
Age:66.0  Onset:2007-09-13, Days after vaccination: 7
Gender:Male  Submitted:2007-12-21, Days after onset: 99
Location:Oregon  Entered:2007-12-28, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Diabetes, hyperlipidemia
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA02479
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0356U SCUN
Administered by: Private     Purchased by: Private
Symptoms: Herpes zoster
SMQs:
Write-up: Information has been received from a certified medical assistant concerning a white male with diabetes and hyperlipidemia who on 06-SEP-2007 was vaccinated SC on right arm with a dose of Zostavax (Oka/Merck) (Lot #656858/0356U). On 13-SEP-2007 the patient experienced shingles on face. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from the certified medical assistant who stated that patient developed significant herpes zoster on left side of his face. On an unspecified date the patient had recovered. No further information is expected.

VAERS ID:301920 (history)  Vaccinated:2007-09-06
Age:71.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-21
Location:Florida  Entered:2007-12-28, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA03310
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Injection site erythema, Injection site rash, Skin lesion, Smallpox
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a 71 year old male physician who on 06-SEP-2007 was vaccinated with a dose of Zostavax (Oka/Merck). It was reported that after vaccination the patient developed 2 large red lesions. One lesion was on the stomach area and the other was at the injection site. The lesions then developed into smallpox. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.

VAERS ID:302056 (history)  Vaccinated:2007-09-06
Age:63.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Female  Submitted:2007-12-21, Days after onset: 106
Location:Florida  Entered:2007-12-28, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy; Drug hypersensitivity; Allergy to insect sting
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0709USA04589
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0584U0SCUN
Administered by: Private     Purchased by: Private
Symptoms: Incorrect dose administered, Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a registered nurse concerning a 63-year-old female with a penicillin, aspirin and NSAIDS allergy as well as an allergy to insect/bee stings who on 06-SEP-2007 at 10:00 hours was vaccinated subcutaneous in the right arm with a 0.5 ml dose of Zostavax(Lot # 657764/0584U). There were no illnesses at the time of vaccination. Concomitant vaccines included DTaP administered on 06-SEP-2007 in the right arm and influenza virus vaccine (unspecified) administered on 27-SEP-2007. It was reported the patient developed a "welt" at the injection site after vaccination. The patient reported the event during a doctors appointment on 27-SEP-2007. The nurse stated that there was no welt seen on that appointment. She also reported that it was not clear whether the patient has a history of chicken pox. No diagnostic labs were performed. On an unspecified date the patient recovered. A product quality complaint was not involved. Additional information is not expected.

VAERS ID:302290 (history)  Vaccinated:2007-09-06
Age:57.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Female  Submitted:2007-12-21, Days after onset: 106
Location:South Carolina  Entered:2007-12-28, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA06119
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0882U0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Blister, Contusion, Dermatitis contact, Erythema, Inappropriate schedule of drug administration, Rash erythematous, Skin discolouration, 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), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a registered nurse concerning a 57 year old female with no drug reactions/allergies, who on 06-SEP-2007 was vaccinated SC with a 0.65mL dose of ZOSTAVAX (Oka/Merck) (lot number: 658085/0882U). Concomitant therapy included losartan potassium (MSD) and simvastatin (MSD) and doxycycline (manufacturer unknown). Subsequently the patient experienced a three inch area of redness and swelling shortly after receiving the vaccination. When the redness faded the area looked discolored and bruised and then cleared. Approximately one week ago the patient experienced a red rash with blisters that the patient described as looking like a shingles rash. The patient also noted that the rash looked like a burn. The rash had progressively worsened since it started. The patient was not seen by the physician and the rash had not been confirmed to be a shingles rash. No lab diagnostics studies were performed. The outcome was reported as not resolved. Unspecified medical attention was sought through a telephone call to the office. No further information was available. There was no product quality complaint. On 01-NOV-2007 follow-up information was received from a health professional in the physician office who indicated that the physician did not believe the patient had shingles or any adverse experience related to the vaccination. The physician felt the patient had a contact dermatitis and referred her to a dermatologist. Additional information has been requested.

VAERS ID:303663 (history)  Vaccinated:2007-09-06
Age:13.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 131
Location:Indiana  Entered:2008-01-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic laboratory, 9/18/07, mono test, negative; x-ray, 09/06/07, pelvis, negative examination; x-ray, 09/11/07, pelvis, negative examination; x-ray, 09/09/07, right hip, negative examination; x-ray, 09/11/07, right hip, negative examination; full blood chemistry, 09/18/07; whole blood hemoglobin, 09/18/07, 5.4, normal range 4.6-6.2; complete blood cell, 09/18/07
CDC Split Type: WAES0712USA02826
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Back pain, Dizziness, Fatigue, Laboratory test normal, Liver function test normal, Myalgia, Pain in extremity, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician concerning a female "between 13 and 15" who in approximately October 2007, was vaccinated with the second dose of Gardasil. Subsequently, the patient experienced "2 weeks to a month of severe muscle pain and very sleepy mono-like symptoms". The patient recovered from her severe muscle pain and very sleepy mono-like symptoms. The patient sought unspecified medical attention. Lab diagnostic studies included a "mono test and liver test that both results came out fine." Per the reporter, the patient did not have any adverse reaction with the first dose of Gardasil. The lot numbers were unavailable and no further information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/15/2008. Information has been received from a physician concerning a 14 year old female who on 14-JUN-2007, was vaccinated intramuscularly with the first dose of GARDASIL (657736/0389U). On 06-SEP-2007 the patient was vaccinated with the second dose of GARDASIL. Also, the patient complained of right hip pain at the time of the second vaccination. On 11-SEP-2007 the patient reported leg and right hip pain. One week later, on 18-SEP-2007 the patient reported having back and hip pain as well as general muscle aches. The patient was also very tired and falling asleep at school and experiencing dizziness. By 25-SEP-2007 the patient was feeling better. Per the reporter, the patient had recovered by 16-OCT-2007. Lab diagnostic studies included a complete metabolic panel, CBC, mon test, liver A1C test, and 2 series of x-rays of the right hip and pelvis. All labs were unremarkable. Additional information has been requested.

VAERS ID:307168 (history)  Vaccinated:2007-09-06
Age:39.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-14
Location:Unknown  Entered:2008-03-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Gastrooesophageal reflux disease; Drug hypersensitivity; Allergic reaction to antibiotics
Preexisting Conditions: Depression PMH: allergies to erythromycin, biaxin & demerol. LGSIL 7/05. Interstitial cystitis.
Diagnostic Lab Data: Abdominal computed; X-ray; Echocardiography; Bone marrow biopsy; Body temperature $g100 deg LABS: pap smear 9/5 neg. LABS: CBC, CRP, ANA & chemistry WNL. Blood c/s neg. RA (-). Hep B surface AB (+). TSH 6.42 (H). Urine c/s (+) for enterococcus. Burgdorferi (-). Cancer antigen 125 16.9 (H). Echocardiogram WNL. EGD revealed colon polyps, biopsies of stomach, duodenum & esophagus done & revealed only mild reflux esophagitis. Abdomen/pelvis CT scan, CXR & pelvic US WNL.
CDC Split Type: WAES0803USA01222
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0530U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal pain, Abnormal faeces, Activities of daily living impaired, Antinuclear antibody negative, Biopsy, Biopsy bone marrow, Blood culture negative, Blood thyroid stimulating hormone increased, Body temperature increased, Borrelia burgdorferi serology negative, Carbohydrate antigen 125 increased, Chest X-ray normal, Chills, Computerised tomogram normal, Culture urine positive, Echocardiogram normal, Enterococcal infection, Fatigue, Full blood count normal, Hepatitis B antibody, Insomnia, Laboratory test normal, Lethargy, Malaise, Oesophagogastroduodenoscopy, Pain, Polyp colorectal, Pyrexia, Reflux oesophagitis, Rheumatoid factor negative, Ultrasound pelvis, Ultrasound scan normal
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal premalignant disorders (narrow), Tumour markers (narrow), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypothyroidism (broad), Hyperthyroidism (broad), Uterine and fallopian tube malignant tumours (broad), Noninfectious diarrhoea (broad)
Write-up: Information has been received from a physician, concerning herself, a 40 year old female with gastrooesophageal reflux disease, drug hypersensitivity to meperidine (DEMEROL), erythromycin and clarithromycin (BIAXIN), and a history of depression, who on 05-SEP-2007 was vaccinated IM with the first dose of Gardasil (lot # not reported). Concomitant therapy included esomeprazole magnesium (NEXIUM), mirtazapine (REMERON) and alprazolam (XANAX). In approximately September 2007 ("following the vaccination"), the physician felt lethargic and couldn''t sleep. On 06-NOV-2007 she was vaccinated IM with the second dose of Gardasil (lot #655154/1210U). Following the second dose, she developed fevers greater than 100 degrees F, which have continued for 4 months, along with body pain and rigors. She had diagnostic labs and testing performed, including a computed axial tomography (CAT) scan of the chest and abdomen, x-ray, echocardiogram and bone marrow biopsy (dates and results not provided). The physician stated she hadn''t been able to work for 3 months, due to her significant malaise. She reported seeing another physician (details not provided). At the time of this report, the physician had not recovered from the events. The physician indicated that the events were serious as disabling. Additional information has been requested. 4/11/08 Received OB/GYN medical records of 8/23/07 & labs of 9/5/07. 4/15/08 Received primary GYN record of 11/6/07 where received HPV #2, 1210U left deltoid. Reported no side effects from HPV #1. 5/30/08 Reviewed PCP medical records from 7/2007-3/2008 which reveal patient experienced depression & under psych care. Unable to work. In 11/2007, had fever x 5 days, abdominal cramping & increased stools. Tx w/meds & improved until fever returned 12/2007 W/HA & severe fatigue. Meds adjusted & felt better by 1/2008. Fever recurred 2-3/2008 PCP felt could be related to psych meds. Meds adjusted. ID & GYN consult done. No dx stated. Felt better & was able to return to work 4/2008.

VAERS ID:314297 (history)  Vaccinated:2007-09-06
Age:10.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Female  Submitted:2008-05-16, Days after onset: 253
Location:Unknown  Entered:2008-05-23, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA03073
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR  UNUN
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Dehydration, Dizziness, Dyspnoea, Rash, Skin disorder
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a licensed practical nurse (LPN) concerning a 10-year-old female who on 06-Sep-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccination included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) and "PEDAP". Subsequently, on an unspecified date, the patient developed dots that turned into a quarter (25 cents) sized raised rash. The rash started on the shoulders and arms. It spread to her neck, chest and legs. The condition progressed and the patient developed shortness of breath and dizziness which resulted in an Emergency Room visit on 19-Sep-2007. She is still complaining of a sore back and dehydration. No additional information was provided. This is one of several reports from the same source. Additional information has been requested.

VAERS ID:314738 (history)  Vaccinated:2007-09-06
Age:0.4  Onset:0000-00-00
Gender:Male  Submitted:2008-05-29
Location:Wisconsin  Entered:2008-06-03, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Healthy Child
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.05054 PO 
Administered by: Private     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Rotavirus series started late (No problems) because sibling on chemotherapy

VAERS ID:318689 (history)  Vaccinated:2007-09-06
Age:0.2  Onset:2007-09-06, Days after vaccination: 0
Gender:Male  Submitted:2008-07-10, Days after onset: 308
Location:California  Entered:2008-07-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: allergy blood test showed egg white allergy.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B124DB0IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURUF160AA0IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB53981E0IMUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0667U0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Allergy test positive, Bowel movement irregularity, Breath sounds abnormal, Dysphonia, Food allergy, Hypersensitivity, Urticaria, Vaccine positive rechallenge, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (broad), Respiratory failure (narrow)
Write-up: My son had some allergic reaction to his first dose of vaccines. Today I realized it may have been from the Rotavirus. After my son was given the first dose of rotavirus his breathing changed and I could hear mild wheezing. He also seemed to have strong abdominal cramping followed my heavy bowel movements, and some random hives. This happened again with the second dose. The third dose just seemed to make his voice a little raspy. My husband and I also got a case of diarrhea on each dose. I reported the first dose symptoms in September 2007. Since they were mild acording to the advise nurse, she had Dr. call me. He advised to watch for breathing problems, but also assured me that my baby was colicky and his reaction normal. Today I found out that my son is allergic to egg white, and upon surfing the web I found out that rotavirus vaccines are grown in eggs. I did not have this information prior to vaccinating my son. Thus, I hope this report helps alert other parents whose children may have a similar egg allergy. I don''t know if I would have chosen to skip the rotavirus vaccine had I known that my son had an egg allergy, but I would have liked to have had prior knowledge of the link between egg allergies and rotovirus vaccines when I called facility in September.

VAERS ID:319013 (history)  Vaccinated:2007-09-06
Age:10.0  Onset:0000-00-00
Gender:Male  Submitted:0000-00-00
Location:North Carolina  Entered:2008-07-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: NKA
Diagnostic Lab Data: None needed
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0799U0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2632AA0IMRA
Administered by: Private     Purchased by: Public
Symptoms: Inappropriate schedule of drug administration
SMQs:
Write-up: Product given incorrectly. ADACEL - Tdap was given to a 10 year old.

VAERS ID:321938 (history)  Vaccinated:2007-09-06
Age:  Onset:2007-09-07, Days after vaccination: 1
Gender:Male  Submitted:2008-07-30, Days after onset: 327
Location:Texas  Entered:2008-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: body temp, 09/09/07, 108 F
CDC Split Type: WAES0709USA01427
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a health professional concerning a male who on 06-SEP-2007 was vaccinated IM, into the left arm, with a 0.5 ml dose of PNEUMOVAX 23. On 07-SEP-2007 the patient developed welts on his left arm. On 09-SEP-2007 the patient had a fever of 108 F. On 10-SEP-2007, the patient was seen in the physician''s office. At the time of the report, the patient had not recovered. Additional information has been requested.

VAERS ID:321942 (history)  Vaccinated:2007-09-06
Age:76.0  Onset:2007-09-07, Days after vaccination: 1
Gender:Female  Submitted:2008-07-30, Days after onset: 327
Location:Florida  Entered:2008-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Drug hypersensitivity; Allergic reaction to antibiotics; Penicillin allergy
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0709USA01823
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0061U IMLA
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)
Write-up: Information has been received from a health professional concerning a 76 year old female with drug hypersensitivity to clonidine, Codeine, tetracycline, penicillin, MACRODANTIN, MAXZIDE, propranolol hydrochloride, MEVACOR, MOTRIN, ULTRAM, RELAFEN, and CELEBREX who on 06-SEP-2007 was vaccinated intramuscularly in the left deltoid with a dose of PNEUMOVAX (Lot #655765/0061U). There was no concomitant medication. On 07-SEP-2007 the patient experienced injection site redness, swelling, and itchiness. The patient was told to take BENADRYL for the injection site reaction. There were no laboratory or diagnostic tests performed. The patient called the physician over the weekend. On an unspecified date the patient recovered. The office requested a lot check. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the research center and was released. Additional information has been requested.

VAERS ID:325958 (history)  Vaccinated:2007-09-06
Age:15.0  Onset:2007-09-13, Days after vaccination: 7
Gender:Female  Submitted:2008-09-23, Days after onset: 376
Location:Illinois  Entered:2008-09-24, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Allergy to vaccine
Preexisting Conditions: PMH: mild acne, enlarged tonsils, loud snoring. Vaccine reaction @ 5 mo w/allergy to DPT.
Diagnostic Lab Data: computed axial, seizures activity; sleep study, seizures activity; diagnostic laboratory, blood test LABS: sleep study WNL. EEG abnormal. CT head WNL. CBC & chemistry WNL. GTT abnormal.
CDC Split Type: WAES0809USA02424
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Computerised tomogram normal, Convulsion, Daydreaming, Ear pain, Electroencephalogram abnormal, Epilepsy, Fatigue, Feeling abnormal, Full blood count normal, Glucose tolerance test abnormal, Grand mal convulsion, Headache, Laboratory test normal, Loss of consciousness, Memory impairment, Mental status changes, Paraesthesia, Sleep study normal, Thinking abnormal, Tongue biting
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Lipodystrophy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a consumer concerning her 16 year old daughter with allergy to DPT and pertussis shot, and no pertinent medical history who on 21-JUN-2007 was vaccinated with the first dose of GARDASIL. On 06-SEP-2007, the patient received the second dose of GARDASIL and within a week later, approximately on 13-SEP-2007, she started to feel like she''s not herself and she felt tired all the time. Patient''s mother reported that she feels like she was in a cloud and she has been day dreaming. Patient was brought to her family doctor and had a cat scan, blood test and sleep study and it was determined that she had seizures activity. Patient is currently on seizures medication and the symptoms started to improve. Third dose of GARDASIL was given on 03-JAN-2008. Lot numbers were not available. There was no concomitant medication. Upon internal review, seizures activity was considered to be an other important medical event. Additional information has been requested. 10/1/08 Reviewed PCP medical records of 12/27/07-8/28/08 which include Neuro consult of 1/21/08 FINAL DX: epilepsy Records reveal patient experienced black out spells often after a nap, pain behind left ear, tingling in head & becomes briefly unaware w/different thinking & forgetfulness when resolves. Referred to Neuro for altered mental status & possible seizures. Had generalized tonic-clonic seizure & bit tongue 4/2008. Neuro consult 1/21/08

VAERS ID:331816 (history)  Vaccinated:2007-09-06
Age:50.0  Onset:2007-09-30, Days after vaccination: 24
Gender:Male  Submitted:2007-11-26, Days after onset: 57
Location:Pennsylvania  Entered:2008-11-10, Days after submission: 350
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 11 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None. 9/3/09 Consultant outpatient records received DOS 1/12/09 to 1/16/09. Multiple fractures. Loss of height.
Diagnostic Lab Data: Brain & Spinal MRI; spinal cord fluid test; many infectious disease DNA test. 9/3/09 Consultant outpatient records received DOS 1/12/09 to 1/16/09. LABS and DIAGNOSTICS: MRI BRAIN w/wo Contrast - Abnormal, nonspecific. Bone Density Study/Du
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TYP: TYPHOID LIVE ORAL TY21A (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Public     Purchased by: Private
Symptoms: Acute disseminated encephalomyelitis, Blood product transfusion, Bone densitometry, CSF test, Constipation, Cytomegalovirus antibody positive, Diplopia, Dizziness, Eye pain, Faecaloma, Hypoaesthesia, Laboratory test, Muscle spasms, Muscular weakness, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging brain abnormal, Osteopenia, Pain, Pain in extremity, Photophobia, Sensory loss, Urinary retention, Viral test positive, Vitamin D deficiency
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Demyelination (narrow), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Osteoporosis/osteopenia (narrow), Ocular motility disorders (broad), Tendinopathies and ligament disorders (broad)
Write-up: Acute disseminate encephalomyelitis symptoms. Pain behind eyes, dizziness, shooting pain in lower extremities, urinary retention, bowel impaction, numbness lower extremities, loss of hot/cold sensation in lower legs, muscular weakness in legs, double vision, duration 18 days, treatment: IVIG and ACYCLOVIR. 9/3/09-Clinic progress note of 1/16/09 seen for GI dysfunction, constipation. On-going leg spasms R$gL during sleep. Light sensitivity.

VAERS ID:290325 (history)  Vaccinated:2007-09-06
Age:15.0  Onset:2007-09-06, Days after vaccination: 0
Gender:Female  Submitted:2007-09-12, Days after onset: 6
Location:Foreign  Entered:2007-09-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0486296A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
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)
Write-up: This case was reported by a healthcare professional and described the occurrence of syncope in a 15-year-old female subject who was vaccinated with Boostrix, GlaxoSmithKline for prophylaxis. On 6 September 2007 the subject received unspecified dose of Boostrix (intramuscular). On 6 September 2007, less than one day after vaccination with Boostrix, the subject experienced syncope. The case was considered clinically significant (or requiring intervention) by the GSK physician. At the time of reporting the outcome of the event was not available. The healthcare professional considered the event was possibly related to vaccination with Boostrix.

VAERS ID:290571 (history)  Vaccinated:2007-09-06
Age:2.0  Onset:2007-09-07, Days after vaccination: 1
Gender:Female  Submitted:2007-09-13, Days after onset: 6
Location:Foreign  Entered:2007-09-14, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: Electrocardiogram within normal range
CDC Split Type: ITWYE295212SEP07
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSA21CA314A IMUN
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSA21CA314A IMUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA21CA314A IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA21CA314A IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH266640IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cyanosis, Electrocardiogram normal, Hypotonia, Pallor, Petit mal epilepsy
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information regarding Prevenar was received from a healthcare professional via a regulatory authority regarding a 27-month-old female patient who experienced petit mal epilepsy, pallor of skin, hypotonia and cyanosis. The patient received the first dose on 06-Sep-2007. The patient experienced three episodes of petit mal epilepsy, pallor of skin, hypotonia and cyanosis on 07-Sep-2007 which lasted about 5-6 seconds. The events involved or prolonged inpatient hospitalization. The patient definitely recovered on 08-Sep-2007. Electrocardiogram (results: within normal range) was done on an unspecified date. No additional information was available at the time of this report.

VAERS ID:308199 (history)  Vaccinated:2007-09-06
Age:18.0  Onset:2007-11-08, Days after vaccination: 63
Gender:Female  Submitted:2008-03-25, Days after onset: 137
Location:Foreign  Entered:2008-03-26, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: ibuprofen 08Nov07-Unk
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic laboratory test 21Nov07 Comment: Borrelia, toxoplasmosis, EBC, CMV, influenza parainfluenza, Coxsackie B virus were negative; electromyography 21Dec07 Comment: normal; nerve conduction study 21Dec07 Comment: velocity slightly red
CDC Split Type: WAES0803USA03411
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Blood lactate dehydrogenase increased, Borrelia burgdorferi serology negative, Coxsackie virus serology test negative, Cytomegalovirus test negative, Electromyogram normal, Epstein-Barr virus antibody negative, Gamma-glutamyltransferase increased, Hepatitis, Influenza serology negative, Lymphocyte percentage decreased, Lymphopenia, Monocyte count increased, Monocytosis, Myalgia, Nerve conduction studies abnormal, Neuralgia, Pain in extremity, Polyneuropathy, Rhabdomyolysis, Sports injury, Streptococcus identification test positive, Toxoplasma serology negative
SMQs:, Rhabdomyolysis/myopathy (narrow), Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Haematopoietic leukopenia (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Information has been received from a physician concerning an 18 year old female patient who on 05-JUL-2007 and 06-SEP-2007 was vaccinated intramuscularly with the first and second doses of GARDASIL. The first and second doses were well tolerated. Concomitant therapy included ibuprofen. On 08-NOV-2007 the patient had a sports injury (bruise to his head) and recovered. On 13-NOV-2007 the patient complained of muscle pain in all limbs, improving within the following days, but she had persisting symmetric pain in the lower leg muscles. The patient was hospitalized from 21-NOV-2007 until 28-NOV-2007. Laboratory tests on admission showed normal results except the following values: increase of creatine kinase (CK) (1874 U/L (normal: 10-145), lactate dehydrogenase (LDH) 327 U/L (normal: <248). Serum alanine aminotransferase (SGPT) 615 U/L (normal <34), serum alanine aminotransferase (SGOT) 200 U/L (normal: < 31), gamma-glutamyl transferase (y-GT) 258 U/L (normal <38), lymphopenia (22.6%, normal 25-50), monocytosis (12.7% (normal: 2.0-8.0). A viral infection was suspected. Infectious serology for Borrelia, toxoplasmosis, Epstein Barr Virus (EBV), Cytomegalovirus (CMV), influenza parainfluenza, Coxsackie B virus were negative. The reporter considered the clinical picture to be "rhabdomyolysis with hepatitis." Rheumatological and neurological consultants ruled out rheumatologic disease, collagenosis, vasculitis and myositis. During hospitalization the patient had occasional treatment with VALORON, and TRAMADOL. Lab parameters almost normalized within the following days and the patient recovered. The patient was again hospitalized from 10-DEC-2007 until 13-DEC-2007 because of neuropathic pain in the lower extremities. Suspected diagnosis was polyneuropathy of unknown origin. This time, all lab parameters were within normal range, except slightly elevated gamma-glutamyl transferase (47U/L). Antistreptolysin 0 was moderately elevated (265 IU/mL, normal < 200, no previous value). Treatment with LYRICA 2 x 300 mg/day) was starte

VAERS ID:309524 (history)  Vaccinated:2007-09-06
Age:5.0  Onset:2007-09-07, Days after vaccination: 1
Gender:Male  Submitted:2008-04-15, Days after onset: 221
Location:Foreign  Entered:2008-04-15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 07Sep2007, 38degree C
CDC Split Type: B0516231A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B052CA IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Angioedema, Body temperature increased, Pyrexia
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of angioedema in a 5-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline), MMR II (other manufacturer). On 6 September 2007 the subject received unspecified dose of INFANRIX (intramuscular, unknown), unspecified dose of MMR II vaccine (subcutaneous, unknown). On 7 September 2007, 1 day after vaccination with INFANRIX and MMR II vaccine, the subject experienced angioedema and fever up to 38 degree C. He was hospitalised and treated with antihistamine. On 10 September 2007, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX and MMR II vaccine.

VAERS ID:311911 (history)  Vaccinated:2007-09-06
Age:0.2  Onset:2008-04-16, Days after vaccination: 223
Gender:Female  Submitted:2008-05-08, Days after onset: 22
Location:Foreign  Entered:2008-05-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0057020A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41CA265A PO 
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Pyrexia, Rotavirus infection, Vaccination failure, Vomiting
SMQs:, Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a physician, via a sales representative, and described the occurrence of rotavirus infection in a 9-month-old female subject who was vaccinated with ROTARIX, GlaxoSmithKline. Follow-up was received by the physician on 07 May 2008. There was no concurrent medical condition or concurrent medication or any other risk factors. On 6 September and 1 October 2007 the subject received 2 doses of ROTARIX (oral). Basic immunization course was completed. On 16 April 2008, 7 or 6 months after vaccination with ROTARIX, respectively, the subject experienced rotavirus infection with vomiting, diarrhea and fever (vaccination failure). The child was treated symptomatically. This case was assessed as medically serious by GSK. At the time of reporting the events were resolved.

VAERS ID:312613 (history)  Vaccinated:2007-09-06
Age:0.5  Onset:2007-11-29, Days after vaccination: 84
Gender:Female  Submitted:2008-05-19, Days after onset: 171
Location:Foreign  Entered:2008-05-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray 29Nov2007 intussusc.unit; HCV 03Dec2007 26.7pg; Hematocrit 03Dec2007 33.8%; Hemoglobin 03Dec2007 99.2g/dL; Lymphocytes 03Dec2007 23.7%; MCV 03Dec2007 80.3FL; Neutrophils 03Dec2007 67.7%; White blood cells 03Dec2007 12700mm3
CDC Split Type: B0520384A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 1PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Appendicectomy, Appendicitis, Dehydration, Gastrointestinal sounds abnormal, Haematochezia, Haemoglobin increased, Intussusception, Irritability, Lymphocyte count decreased, Mucous stools, Oral intake reduced, Pharyngeal erythema, Surgery, Vomiting, White blood cell count increased, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad)
Write-up: This case was reported by a physician in the frame of a PASS study and described the occurrence of intussusception in a 8-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was on no other medication and had no relevant medical history nor allergy. Previous vaccination included ROTARIX (GlaxoSmithKline, oral) given on 4 May 2007. On 6 September 2007 the subject received 2nd dose of ROTARIX (9 ml, oral, lot number not provided). On 29 November 2007, 84 days after vaccination with ROTARIX, the subject experienced vomiting, irritability, abdominal pain, oral intolerance and bloody mucus in stool. She was admitted in the emergency room the same day. Physical exam showed dehydration, hyperaemic pharynx and intestinal silent. An abdominal X-ray was performed showing invagination. she was hospitalised for 5 days. A surgery was performed on 29 November 2007, ileocecal position and appendicitis were found and resolved by taxis and appendectomy. No complication occurred. The subject showed a good clinical evolution, she was treated with cefotaxime and amikacin (Amikacine) and was discharged on 03 December 2007, the events were resolved. The physician considered the events were unrelated to vaccination with ROTARIX.

VAERS ID:314322 (history)  Vaccinated:2007-09-06
Age:16.0  Onset:2007-12-12, Days after vaccination: 97
Gender:Female  Submitted:2008-05-29, Days after onset: 168
Location:Foreign  Entered:2008-05-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: No reaction on previous exposure to vaccine.
Diagnostic Lab Data: electroencephalogram, Comment: distinct spike wave complexes
CDC Split Type: WAES0805USA05466
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1475F1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Electroencephalogram abnormal, Epilepsy, Grand mal convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a physician concerning a 16 year old female, who on 13-JUL-2007 was vaccinated with a first dose of GARDASIL (Lot# 654948/0903F; Batch# NE47410). The first dose was well tolerated. On 06-SEP-2007 the patient was vaccinated in the upper arm with a second dose of GARDASIL (Lot# 1475F; Batch# NF37120). The route was not reported. On 12-DEC-07 the patient experienced her first epileptic fit. A second fit occurred on 15-JAN-2008 and was treated with anticonvulsants, LAMOTRIGIN 250mg daily by mouth. It was reported that under this treatment no further epileptic fits appeared. During a former hospitalization (admission date not reported) an electroencephalography (EEG) showed distinct spike wave complexes and the diagnosis of epilepsy grand mal was established. On 19-FEB-2008 the patient was vaccinated with a third dose of GARDASIL (Lot# 0510U; Batch# NG20180). The patient recovered with sequelae. Upon internal review epilepsy grand mal was considered to be an other important medical event. Epileptic fit was considered as a comanifestation of epilepsy grand mal. Other business partner numbers included: E2008-03454. Additional information is not expected. The case is closed.

VAERS ID:321287 (history)  Vaccinated:2007-09-06
Age:16.0  Onset:2007-09-12, Days after vaccination: 6
Gender:Female  Submitted:2008-08-04, Days after onset: 327
Location:Foreign  Entered:2008-08-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0807AUS00274
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0138U2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Diplopia, Hypoaesthesia facial, Monoparesis, Myelitis transverse, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (broad)
Write-up: Information was obtained on request by the Company from the agency concerning a 16 year old female who had received a total of 3 doses of GARDASIL (not all vaccination dates were reported). Her first 2 vaccinations included one given on 10-MAY-2007 (Lot No. 655742/0138U, Batch No. J0798, Expiry date 07-AUG-2009). On 06-SEP-2007, she was vaccinated with her third dose of GARDASIL (Lot No. 655742/0138U, Batch No. J0799, Expiry date 07-AUG-2009). On 12-SEP-2007 the patient experienced asthenia (described as left leg weakness), myelitis transverse (described as incomplete transverse myelitis), diplopia, hypoaesthesia facial (described as facial numbness), monoparesis, nausea and vomiting. At the time of reporting to the agency on 10-JUL-2007, the outcome of asthenia, myelitis transverse, diplopia, hypoaesthesia facial, monoparesis, nausea and vomiting was unknown. The agency considered that asthenia, myelitis transverse, diplopia, hypoaesthesia facial, monoparesis, nausea and vomiting were possibly related to therapy with GARDASIL. The original reporting source was not provided. The agency considered the events of asthenia, myelitis transverse, diplopia, hypoaesthesia facial, monoparesis, nausea and vomiting to be serious for the following reason: medically significant. Additional information is not expected.

VAERS ID:290252 (history)  Vaccinated:2007-09-07
Age:5.0  Onset:2007-09-08, Days after vaccination: 1
Gender:Female  Submitted:2007-09-10, Days after onset: 2
Location:Indiana  Entered:2007-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS14B0564IMRL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR100921SCRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.04181SCLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.08551SCLL
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: swelling at injection site, reddness the size of palm of hand

VAERS ID:290253 (history)  Vaccinated:2007-09-07
Age:6.0  Onset:2007-09-09, Days after vaccination: 2
Gender:Male  Submitted:2007-09-10, Days after onset: 1
Location:Kansas  Entered:2007-09-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None reported
Preexisting Conditions: Penicillin
Diagnostic Lab Data: None at the time of this report
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1002U1SCRA
Administered by: Public     Purchased by: Private
Symptoms: Erythema, Pain in extremity, Rash, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Pt came in with mother on 09/07/2007 and received a varicella vaccine subq into RPUA without pain or incident. On Monday 09/10/2007 mom reported to school nurse child went hunting with dady on Saturday (09/08/2007) and Sunday (09/09/2007) am and on Saturday afternoon c/o arm being sore and again on Sunday afternoon but mom did not look at arm till Sunday afternoon then saw about orange size area of reddnes, sl swollen and tender, and red rash to belly. She put ice to area and gave child Tylenol. On Monday morning area was less red, less sore, but rash was on belly and back. School nurse checked rash and reported it to be sl grandular feeling. Child never had fever. No drainage noted from site.

VAERS ID:290797 (history)  Vaccinated:2007-09-07
Age:79.0  Onset:2007-09-11, Days after vaccination: 4
Gender:Male  Submitted:2007-09-13, Days after onset: 2
Location:Texas  Entered:2007-09-18, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hyperlipidemia, Benign HTN, Reflex esophagitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2775AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site pain, Injection site swelling, Skin lesion
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 9/13/07 Pt has skin lesion x 2 days; sore x swollen at site Tdap given 9/7 Appears infected, aggravated by exertion. given Keflex 500 mg #40, 2 tablets every 12 hours with food.

VAERS ID:290809 (history)  Vaccinated:2007-09-07
Age:45.0  Onset:2007-09-08, Days after vaccination: 1
Gender:Female  Submitted:2007-09-12, Days after onset: 4
Location:Alaska  Entered:2007-09-18, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2825AA0IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chest discomfort, Fatigue, Injection site erythema, Injection site induration, Injection site pain, Pruritus, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Vaccine administered (L) deltoid IM 9/7. Pt called 9/10 complaining of low grade fever, extreme tenderness at injection site, facial pruritus, with chest pressure and fatigue and 2" circumscribed area (L) deltoid-red and hard to palpitation. Blotchy hives on face and arm. T:98.9 full range of motion in arm vs stable. as of 9/11-Doing better with ice and Tylenol

VAERS ID:290811 (history)  Vaccinated:2007-09-07
Age:14.0  Onset:2007-09-07, Days after vaccination: 0
Gender:Male  Submitted:2007-09-09, Days after onset: 2
Location:Unknown  Entered:2007-09-18, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR 0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 1UNLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Induration
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: Pt received Varicella vaccine Friday 07Sept07. He developed localized redness, induration later that evening, which worsened and expanded over the next 2 days. Tx''d with Benadryl PO only.

VAERS ID:291768 (history)  Vaccinated:2007-09-07
Age:11.0  Onset:2007-09-11, Days after vaccination: 4
Gender:Male  Submitted:2007-10-01, Days after onset: 20
Location:Illinois  Entered:2007-10-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergies: NKA; Febrile syndrome in Mar/April 2007
Diagnostic Lab Data: Varicella Zoster culture +
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Private
Symptoms: Disturbance in attention, Fatigue, Hallucination, Oedema, Pain, Pyrexia, Rash papular, Varicella zoster virus serology positive
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad)
Write-up: Achy, high fever (103), hallucinating, with scattered edematous papules 5 days after receiving vac. Has been fatigued, unable to concentrate.

VAERS ID:302007 (history)  Vaccinated:2007-09-07
Age:64.0  Onset:2007-09-14, Days after vaccination: 7
Gender:Female  Submitted:2007-12-21, Days after onset: 98
Location:Unknown  Entered:2007-12-28, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPITOR
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0709USA03864
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster, Injection site erythema, Rash macular
SMQs:, Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 64 year old female with no known allergies and no recent exposures to chickenpox or shingles, who on 07-SEP-2007 was vaccinated with zoster vaccine live (Oka/Merck) (lot no. "3073U"). Concomitant therapy included included atorvastatin calcium (LIPITOR). In September 2007, the patient developed erythema at the injection site of th L arm. On 14-SEP-2007 the patient developed a herpes zoster macular rash on the R leg. Additional information has been requested.

VAERS ID:434628 (history)  Vaccinated:2007-09-07
Age:13.0  Onset:2008-09-01, Days after vaccination: 360
Gender:Female  Submitted:2011-09-17, Days after onset: 1111
Location:Hawaii  Entered:2011-09-17
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None!
Preexisting Conditions: None!
Diagnostic Lab Data: Facility has record of all Dr visits.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0171U2UNUN
Administered by: Unknown     Purchased by: Private
Symptoms: Arthralgia, Palindromic rheumatism
SMQs:, Arthritis (narrow)
Write-up: Started with elbow joint pain then progressed to all joint pain. Visited Drs who referred her to Rheumatologist who diagnosed Palindromic Rheumatism. Is on Pain killers daily and Hydrochloroquinnine.

VAERS ID:458693 (history)  Vaccinated:2007-09-07
Age:0.2  Onset:2007-09-08, Days after vaccination: 1
Gender:Female  Submitted:2012-07-05, Days after onset: 1762
Location:Texas  Entered:2012-07-05
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: No illnesses at the time of vaccination
Preexisting Conditions: No pre-existing conditions
Diagnostic Lab Data: Several test have been performed and all have come back within the normal range.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B129AA0IMLL
HIBV: HIB (ACTHIB)CONNAUGHT LABORATORIESUF113AA0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB58845E0IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0407U0PO 
Administered by: Private     Purchased by: Public
Symptoms: Grand mal convulsion, Laboratory test normal, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Fever and grand mal seizure.

VAERS ID:491958 (history)  Vaccinated:2007-09-07
Age:  Onset:0000-00-00
Gender:Female  Submitted:2013-05-16
Location:California  Entered:2013-05-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1305USA004827
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:
Write-up: This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. On 07-SEP-2007 the patient was vaccinated with the first dose of GARDASIL (Lot # not reported) (dose and route not reported). No other co suspects were reported. No concomitant therapy was reported. The healthcare worker stated that the patient received the first dose of GARDASIL when she was 22 years old. The patient was in the office to see if she''s eligible to receive the second dose. No adverse effect reported. Additional information has been requested.

VAERS ID:291031 (history)  Vaccinated:2007-09-07
Age:9.0  Onset:2007-09-07, Days after vaccination: 0
Gender:Female  Submitted:2007-09-20, Days after onset: 13
Location:Foreign  Entered:2007-09-21, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: blood pressure measurement 07Sep07 80/70 mmHg; mean heart rate 07Sep07 80 bts/min
CDC Split Type: WAES0709USA02312
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0737F0SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure, Dizziness, Heart rate, Syncope, Vertigo, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a health authority concerning a 9 year old female who on 07-SEP-2007 was vaccinated subcutaneously (injection site unspecified) with the first dose of Varivax (Lot # 654326/0737F, Batch NE40060). On the same day of vaccination, she presented with lipothymia, vomiting and dizziness. Vertigo persisted for about 1 hour. The child was laid on the stretcher of vaccination ambulatory where BP was evaluated (80/70 mmHg) and HR (80 bt/min). She was being treated with SYMPATOL (oxedrine tartrate) tinset. She was taken to Emergency room by parents and she was admitted to the hospital (duration of admission not reported) where diagnostic labs unspecified were performed. No further information is available. The outcome is not reported.

VAERS ID:291052 (history)  Vaccinated:2007-09-07
Age:13.0  Onset:2007-09-07, Days after vaccination: 0
Gender:Male  Submitted:2007-09-19, Days after onset: 12
Location:Foreign  Entered:2007-09-21, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0486612A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Syncope vasovagal
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a nurse via a sales representative and described the occurrence of vasovagal attack in a 13-year-old male patient who was vaccinated with Havrix, Typherix for prophylaxis. On 7 September 2007 the patient received an unspecified dose of Havrix (720 elisa unit, intramuscular), an unspecified dose of Typherix (25 mcg, intramuscular). On 7 September 2007, on the same day of the administration of Havrix and Typherix, the patient experienced vasovagal attack. This case was assessed as medically serious. On 7 September 2007, the event was resolved. Verbatim text received: A nurse reported via representative that a patient experienced a vasovagal attack but recovered quickly.

VAERS ID:292135 (history)  Vaccinated:2007-09-07
Age:82.0  Onset:2007-09-07, Days after vaccination: 0
Gender:Female  Submitted:2007-10-03, Days after onset: 26
Location:Foreign  Entered:2007-10-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Late effects of cerebral infarction
Preexisting Conditions: Cerebral infarction
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0710USA00251
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Feeling hot
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Information has been received from a physician concerning an 82 year old female patient with late effects of cerebral infarction and a history of cerebral infarction who on 07-SEP-2007 was vaccinated SC with a dose of Pneumovax 23. On 07-SEP-2007 the patient developed redness and feeling hot. As of 09-SEP-2007 the patient was recovering. The physician felt that redness and feeling hot were definitely related to therapy with Pneumovax 23. The physician considered the events to be other important medical events. Additional information has been requested.

VAERS ID:292246 (history)  Vaccinated:2007-09-07
Age:0.7  Onset:2007-09-07, Days after vaccination: 0
Gender:Female  Submitted:2007-10-04, Days after onset: 27
Location:Foreign  Entered:2007-10-05, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: Rickets
Preexisting Conditions:
Diagnostic Lab Data: physical examination 15Sep07 see narrative, body temp 08Sep07 38.7 centigrade, WBC count 09Sep07 9.4 10(9)/L 4 - 10, body temp 09Sep07 39 centigrade, lymphocyte count 09Sep07 38.3% 20 - 40, neutrophil count 09Sep07 55.4% 50 - 70, WBC count
CDC Split Type: WAES0709CHN00029
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Alopecia, Body temperature increased, Culture stool negative, Dermatitis diaper, Dysphonia, Erythema, Fontanelle depressed, Lymphocyte count increased, Neutrophil count normal, Pharyngeal erythema, Platelet count decreased, Pyrexia, Rash generalised, Rotavirus test negative, Upper respiratory tract infection, Viral rash, White blood cell count
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Neonatal disorders (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (broad)
Write-up: Information has been received from a physician concerning an 8 month old female with rickets who on 07-SEP-2007 was vaccinated with PedvaxHIB, 0.5ml, IM. There was no concomitant medication. At the same night, the girl developed fever (details unknown). From 08-SEP-2007 till 11-SEP-2007, the girl was continuously sent to clinic every day and her body temperature was measured as 38.7 (08-SEP-2007), 39 (09-SEP-2007) and 38.3 (11-SEP-2007) separately. On 09-SEP-2007, blood examination revealed her white blood cell count was 9.4, ratio of blood neutrophil was 55.4% and ratio of blood lymphocyte was 38.3%. Detailed treatment during this time was unknown. On 11-Sep-2007, the girl was hospitalized under the diagnosis of diaper rash, upper respiratory tract infection and viral exanthema. On her admission, physical examination revealed her anterior fontanel was soft, with size of 4x4cm and pressure alopecia. There was rash all over her body. She had a red throat and hoarse respiratory sound. The crissum skin was red. During hospitalization, the girl was placed on benzylpenicillin sodium and other unspecified anti-infection, stop-coughing and calcium supplementary (regimen unknown). On 15-SEP-2007, physical examination revealed her body temperature was normal. Red throat, as well as hoarse respiratory sound and rash disappeared. Still, the skin of crissum was red. The girl was considered to be recovered from diaper rash, upper respiratory tract infection and viral exanthema and was discharged from the hospital on 15-SEP-2007. The reporting physician felt diaper rash, upper respiratory tract infection and viral exanthema were possibly related to PedvaxHIB. Additional information is not expected.

VAERS ID:293974 (history)  Vaccinated:2007-09-07
Age:48.0  Onset:2007-09-07, Days after vaccination: 0
Gender:Female  Submitted:2007-10-22, Days after onset: 45
Location:Foreign  Entered:2007-10-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0491773A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site inflammation
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a regulatory authority (foreign regulatory authority (clinical) # 215745244) and described the occurrence of injection site inflammation in a 48-year-old female subject who was vaccinated with Ditanrix (GlaxoSmithKline). On 7 September 2007 the subject received unspecified dose of Ditanrix (intramuscular). On 7 September 2007, less than one day after vaccination with Ditanrix, the subject experienced injection site inflammation. 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 Ditanrix. No further information was expected and therefore this case has been closed.

VAERS ID:296063 (history)  Vaccinated:2007-09-07
Age:41.0  Onset:2007-09-07, Days after vaccination: 0
Gender:Female  Submitted:2007-11-07, Days after onset: 61
Location:Foreign  Entered:2007-11-08, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA00800
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Asthenia, Inappropriate schedule of drug administration, Nausea, Vertigo
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow)
Write-up: Information has been received from a gynecologist concerning a 41 year old female patient who on 07-SEP-2007 was vaccinated with the first dose of Gardasil (Lot # not reported). A "few days" post vaccination, she complained of abdominal pain, followed by menstruation. After an unknown duration, the patient fully recovered. On 29-OCT-2007 she experienced vertigo, nausea, and "weakness attacks," and was hospitalized. At the time of this report, the patient had not recovered from vertigo, nausea and weakness. Other business partner numbers include: E2007-07519.

VAERS ID:298175 (history)  Vaccinated:2007-09-07
Age:19.0  Onset:2007-11-19, Days after vaccination: 73
Gender:Female  Submitted:2007-11-28, Days after onset: 9
Location:Foreign  Entered:2007-11-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: folic acid
Current Illness: Pregnancy NOS (LMP = 18Aug07)
Preexisting Conditions:
Diagnostic Lab Data: beta-human chorionic gonadotropin (unsp) Comment: positive
CDC Split Type: WAES0710CAN00002
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a nurse concerning a 19 year old white female with a history of 0 pregnancies and 0 live births who on approximately 07-SEP-2007 was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Concomitant therapy included folic acid. In September 2007, the patient experienced found out she is pregnant. The patient had a positive pregnancy test. The patient last menstrual date was on 18-AUG-2007. On approximately 19-NOV-2007 the patient experienced spontaneous abortion. Upon internal review, spontaneous abortion was considered to be another important medical event. No further information is available.

VAERS ID:331684 (history)  Vaccinated:2007-09-07
Age:34.0  Onset:2008-09-08, Days after vaccination: 367
Gender:Male  Submitted:2008-11-07, Days after onset: 60
Location:Foreign  Entered:2008-11-07
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: allergies
Diagnostic Lab Data: Mercury 24 HR URINE <2 mcg/L 0-20; Lead 24 HR URINE <5 mcg/L 0-80; Arsenic 24 HR URINE <25 mcg/L 0-100; Volume 24 HR URINE 1425 mL; Vitamin B12 (Cobalamins) SERUM 680 pg/mL; Foliate SERUM 15.3 ng/mL; Albumin PLASMA 4.9 g/dL; Alkaline Phosphatase PLASMA 59 U/L; Alanine Aminotransferase PLASMA 20 U/L; Aspartate Aminotransferase PLASMA 24 U/L; Bilirubin PLASMA 0.3 mg/dL; Urea Nitrogen PLASMA 14 mg/dL; Calcium PLASMA 9.2 mg/dL; CO2 PLASMA 31 (H) mmol/L; Chloride PLASMA 102 mmol/L; Creatinine PLASMA 0.9 mg/dL; Glucose PLASMA 102 mg/dL; Potassium PLASMA 4.4 mmol/L; Protein PLASMA 7.7 g/dL; Sodium PLASMA 142 mmol/L; Anion Gap PLASMA 9; Hemoglobin A1c BLOOD 5.6%; Thyrotropin SERUM 0.99 mIU/mL; Albumin PLASMA 5.5 (H) g/dL; Alkaline Phosphatase PLASM
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURERFAV1082SCLA
Administered by: Other     Purchased by: Other
Symptoms: Alanine aminotransferase normal, Amnesia, Anion gap normal, Aspartate aminotransferase normal, Basophil count normal, Basophil percentage, Blood albumin increased, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood folate normal, Blood glucose normal, Blood potassium normal, Blood thyroid stimulating hormone, Blood urea normal, Blood urine absent, C-reactive protein normal, Carbon dioxide normal, Cold sweat, Diarrhoea, Disturbance in attention, Dizziness, Eosinophil count normal, Eosinophil percentage, Erythema, Fatigue, Glucose urine absent, Glycosylated haemoglobin normal, Haematocrit normal, Haemoglobin normal, Headache, Immediate post-injection reaction, Injection site erythema, Injection site oedema, Injection site swelling, Lead urine normal, Lymphocyte count abnormal, Lymphocyte percentage, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Monocyte count normal, Monocyte percentage, Nausea, Neutrophil count normal, Neutrophil percentage, Nitrite urine absent, Nuclear magnetic resonance imaging brain abnormal, Oedema peripheral, Palpitations, Platelet count normal, Protein total increased, Protein urine absent, Red blood cell count normal, Red cell distribution width normal, Specific gravity urine normal, Urine arsenic, Urine bilirubin decreased, Urine ketone body absent, Urine leukocyte esterase, Urine mercury normal, Urobilin urine absent, Vaccine positive rechallenge, Vitamin B12 normal, White blood cell count normal, pH urine normal
SMQs:, Cardiac failure (broad), Liver related investigations, signs and symptoms (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic leukopenia (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Pseudomembranous colitis (broad), Biliary system related investigations, signs and symptoms (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Pt states that he had AVA#1 on 6/18/07 without adverse event. On 9/7/07 the pt was given AVA#2 in his left arm. On 9/8/07 he noted swelling and redness around the injection site (about 1/2 inches in diameter). He had no decrease in ROM or numbness in his left arm or hand. This lasted about 3 weeks. Additionally, he had dizziness which was constant, did not interfere with activities for 5 days. On 9/9/07 he had a severe headache (the top of his head), 8/10, for 48 hours. The headache then became intermittent; MOTRIN decreased the pain but did not completely alleviate the pain; resolved in 2 weeks. 9/9/07 he noted that his heart was beating "hard", not rapid, "I could see the bed move with each heart beat". This symptom was constant for 5 days and has continued to present being intermittent, only occurring at night when he lies down or when he gets up to the BR to void. 9/9/08 he had the sensation that "my blood was hot and I could feel my blood pulsing through my entire body". The pt was not febrile. This sensation was constant for 48 hours and has occurred about 4 times since - occurring during the nite while lying down. On 9/9/07 he noted difficulty concentrating/focusing - it was like "being in a fog" which lasted one month. On 9/9/07 he also experienced fatigue ("I was tired all the time") which also lasted one month. On 9/15/07 the pt started to have loose, watery, frequent (3-4/day) stools which lasted about one month. He had no bloody stool, nausea, vomiting, abdominal pain or decrease in appetite. The pt received AVA#3 on 11/14/07 in the left arm. Immediately he had left arm swelling and redness (less severe than with AVA#2). He again experienced headache, N, cold sweats, diarrhea, pound heart beat, fatigue and difficultly concentrating lasting from 2 days to 2 weeks. Symptoms: Memory Loss, short term, Weakness, Diarrhea, Cognitive deficiency, Fatigue, Malaise < 60 days, Erythema, Edema @ injection site < 30 mm, Clamminess, Nausea w/o vomiting, Palpitations, Diarrhea, Headache, general, Clamminess, Pain, Nausea w/o vomiting, Palpitations, Cognitive deficiency, Fatigue, Malaise <60 days, Edema @ injection site < 30 mm, Erythema, Dizziness

VAERS ID:398285 (history)  Vaccinated:2007-09-07
Age:  Onset:0000-00-00
Gender:Male  Submitted:2010-09-14
Location:Foreign  Entered:2010-09-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1009USA00222
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC208079AA IMUN
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.  IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHH2521 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Apnoea, Condition aggravated, Laboratory test
SMQs:, Acute central respiratory depression (narrow), Respiratory failure (narrow)
Write-up: Information was obtained on request by the company from the agency via public case details form concerning a male who on 07-SEP-2007 was vaccinated with a dose of COMVAX (OMPC). Suspect therapy included INFANRIX (batch # AC208079AA) and PREVENAR (batch # H2521). Following the 2 month vaccines, child experienced return of apnoeas which responded to recommencement of caffeine, nil orally for 24 hours and a septic work-up. Subsequently, the patient was hospitalized. At the time of the report the outcome of the patient was unknown. The agency considered that apnoea and condition aggravated were possible related to therapy with COMVAX, INFANRIX and PREVENAR. The original reporting source was not provided. No further information is available.

Result pages: prev   2809 2810 2811 2812 2813 2814 2815 2816 2817 2818 2819 2820 2821 2822 2823 2824 2825 2826 2827 2828 2829 2830 2831 2832 2833 2834 2835 2836 2837 2838 2839 2840 2841 2842 2843 2844 2845 2846 2847 2848 2849 2850 2851 2852 2853 2854 2855 2856 2857 2858 2859 2860 2861 2862 2863 2864 2865 2866 2867 2868 2869 2870 2871 2872 2873 2874 2875 2876 2877 2878 2879 2880 2881 2882 2883 2884 2885 2886 2887 2888 2889 2890 2891 2892 2893 2894 2895 2896 2897 2898 2899 2900 2901 2902 2903 2904 2905 2906 2907 2908 2909 2910 2911 2912 2913 2914 2915 2916 2917 2918 2919 2920 2921 2922 2923 2924 2925 2926 2927 2928 2929 2930 2931 2932 2933 2934 2935 2936 2937 2938 2939 2940 2941 2942 2943 2944 2945 2946 2947 2948 2949 2950 2951 2952 2953 2954 2955 2956 2957 2958 2959 2960 2961 2962 2963 2964 2965 2966 2967 2968 2969 2970 2971 2972 2973 2974 2975 2976 2977 2978 2979 2980 2981 2982 2983 2984 2985 2986 2987 2988 2989 2990 2991 2992 2993 2994 2995 2996 2997 2998 2999 3000 3001 3002 3003 3004 3005 3006 3007   next

New Search

Link To This Search Result:
http://www.medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=2908&PERPAGE=100&ESORT=VAX-DATE


Copyright © 2016 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166