MedAlerts Home
  Read the MedAlerts Blog Subscribe to the MedAlerts Blog 

Found 502657 cases in entire database

Case Details (Sorted by Vaccination Date)

This is page 2908 out of 5027

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:302331 (history)  Vaccinated:2008-01-08
Age:61.0  Onset:2008-01-09, Days after vaccination: 1
Gender:Female  Submitted:2008-01-10, Days after onset: 1
Location:Minnesota  Entered:2008-01-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: cellulitis~Vaccine not specified (no brand name)~UN~6~In Patient
Other Medications: Paxil, Lorazepam
Current Illness: Bronchitis-viral
Preexisting Conditions: Sulfa allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2478AA8IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0991U0IMLA
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1413U0SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site cellulitis
SMQs:
Write-up: Cellulitis right arm.

VAERS ID:302332 (history)  Vaccinated:2008-01-08
Age:15.0  Onset:2008-01-10, Days after vaccination: 2
Gender:Male  Submitted:2008-01-10, Days after onset: 0
Location:Minnesota  Entered:2008-01-10
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:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2430AA0SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1580U1SCLA
Administered by: Other     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration, Injection site papule
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 5 cm x 6 cm red, indurated lesion at site of vaccine. 2-3 mm raised, red papule at injection site. 1st noticed 48 hrs after vaccine admin.

VAERS ID:304795 (history)  Vaccinated:2008-01-08
Age:55.0  Onset:2008-01-12, Days after vaccination: 4
Gender:Male  Submitted:2008-01-31, Days after onset: 19
Location:Pennsylvania  Entered:2008-02-12, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lantus; gluiovance; levitra; B12; Zocor; Citalopram; Elavil; Benicon HC72; MVI
Current Illness: None
Preexisting Conditions: HIV; DM; GERD; Bronchitis; Depression
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2889AA IMLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Joint swelling, Malaise, Muscle swelling, Oedema peripheral, 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), Arthritis (broad)
Write-up: Left arm, shoulder, pectoral swelling, redness, warmth, malaise, fever within 48 - 72 hours of vaccination.

VAERS ID:304833 (history)  Vaccinated:2008-01-08
Age:19.0  Onset:2008-01-09, Days after vaccination: 1
Gender:Female  Submitted:2008-02-13, Days after onset: 35
Location:Texas  Entered:2008-02-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: HIV Infection
Preexisting Conditions: HIV infection
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0188U0IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Epistaxis, Headache
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: Headache and nose bleeding around 18-20 hours after vaccination. No treatment requiered. Symtoms stopped 24 hours after started.

VAERS ID:304907 (history)  Vaccinated:2008-01-08
Age:0.7  Onset:2008-02-08, Days after vaccination: 31
Gender:Male  Submitted:2008-02-08, Days after onset: 0
Location:Maine  Entered:2008-02-14, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS80956 UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
SMQs:
Write-up: 0.25 ml Fluviron given Rec $g4 yrs no reaction

VAERS ID:305295 (history)  Vaccinated:2008-01-08
Age:0.5  Onset:2008-01-08, Days after vaccination: 0
Gender:Unknown  Submitted:2008-02-14, Days after onset: 37
Location:Minnesota  Entered:2008-02-19, 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: Unknown
Current Illness: Gastrooesophageal reflux
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA01698
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
SMQs:
Write-up: Information has been received from a licensed practical nurse (LPN) concerning a 6 month-old patient with gastrooesophageal reflux who on 08-JAN-2008 received their first 2.0 ml oral dose of Rotateq. The nurse is planning on giving the patient a second dose in the next 4 to 8 weeks. No adverse experience (AE) reported. A product quality complaint was not involved. Additional information has been requested.

VAERS ID:305615 (history)  Vaccinated:2008-01-08
Age:20.0  Onset:2008-01-08, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 37
Location:Unknown  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA01714
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1287U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Fall, Head injury, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a nurse practitioner concerning a 20 year old female with no medical history or allergies, on 08-JAN-2008 was vaccinated with a first 0.5 ml dose of Gardasil (lot#655327/1287U). There was no concomitant medication. On 08-JAN-2008 the patient experienced fainted, fell off the exam table and bumped her head. Unspecified medical attention was sought. No laboratory diagnostic tests were performed. On 09-JAN-2008, the patient recovered. No product quality complaint was involved. Additional information has been requested.

VAERS ID:305658 (history)  Vaccinated:2008-01-08
Age:  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:Unknown  Entered:2008-02-19, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA02714
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Injection site rash, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information ahs been received from a nurse practitioner concerning a female who on 08-JAN-2008 was vaccinated in the left arm with the third dose of Gardasil. There was no illness reported that the time of vaccination. It was reported on 11-JAN-2008, that on an unspecified date, the patient developed a rash on her left arm after receiving her third dose of Gardasil. The rash extended from the injection site downward to the elbow and upward to the shoulder. The patient was examined in the office and prescribed Benadryl. No laboratory/diagnostic tests were performed. It was reported that on 11-JAN-2008, that the symptoms resolved after the patient started Benadryl but returned when the Benadryl was discontinued. No further information is available.

VAERS ID:326777 (history)  Vaccinated:2008-01-08
Age:17.0  Onset:2008-01-08, Days after vaccination: 0
Gender:Female  Submitted:2008-09-15, Days after onset: 250
Location:Illinois  Entered:2008-09-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS, Allergic reaction to antibiotics
Preexisting Conditions: Abortion, LMP = 12/15/2007
Diagnostic Lab Data: ultrasound - 03/12/08 - 13 weeks - Establish due date WNL, biopsy - 04/30/08 - CINI on Bx, ultrasound - 07/07/08 - EFW 3# measures 28-30 wks, Pap test - 03/04/08 - Abnormal and was positive for HPV type 16
CDC Split Type: WAES0808USA01307
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Biopsy cervix, Cervical dysplasia, Drug exposure during pregnancy, Human papilloma virus test positive, Pregnancy, Smear cervix abnormal, Ultrasound antenatal screen normal
SMQs:, Reproductive premalignant disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Uterine and fallopian tube malignant tumours (broad)
Write-up: Initial and follow-up information have been received from a nurse for the Pregnancy Registry for GARDASIL vaccine (yeast) concerning a 17 year old white female with allergic reaction to CECLOR and a history of one previous pregnancy, one elective termination and no full-term deliveries who on 08-JAN-2008 was vaccinated with GARDASIL vaccine (yeast) (Lot # 659439/1267U) and is pregnant. The patient had a pap test on 04-MAR-2008 that revealed atypical squamous cell of undetermined significance (ASCUS). An ultrasound test was performed on 12-MAR-2008 to established pregnancy due date of 15-SEP-2008. A colposcopy was performed on 18-APR-2008 and a biopsy from 30-APR-2008 provided a diagnosis of cervical intraepithelial neoplasia 1 (CIN 1). An ultrasound test was performed on 07-JUL-2008 and revealed an estimated fetal weight of 3 pounds and a fetal measurement of 28-30 weeks. A repeat pap test was performed on 21-JUL-2008 that revealed ASCUS. Pregnancy was reported as normal to date. Additional information has been requested.

VAERS ID:334998 (history)  Vaccinated:2008-01-08
Age:4.0  Onset:2008-02-05, Days after vaccination: 28
Gender:Female  Submitted:2008-10-23, Days after onset: 260
Location:California  Entered:2008-11-20, Days after submission: 28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions: 04-Dec-2007 PPD; positive. 05-Feb-2008 Gastric aspirates x3 obtained for AFB smear and TB cultures negative. 05-Feb-2008 chest CT scan showed no hilar LAD but 2 areas of infiltrate possibly consistent with resolving pneumonia.
Diagnostic Lab Data: Chest CT scan, No hilar LAD but 2 areas of infiltrate possibly consistent with resolving pneumonia; Gastric aspirates x3 for AFB smear TB cultures-negative x3; Chest X-ray, NI, abnormal
CDC Split Type: MEDI0007261
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 4UNUN
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.506500P IN 
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Chest X-ray abnormal, Computerised tomogram abnormal, Culture negative, Laboratory test normal, Pneumonia
SMQs:, Cardiomyopathy (broad), Eosinophilic pneumonia (broad)
Write-up: A serious report of pneumonia has been received from a study investigator concerning post-marketing study for FLUMIST. This case is submitted in accordance with post-marketing commitment on accelerated reporting for newly indicated population of 2 to 59 months of age for FLUMIST. Medical history included no known allergies, asthma, and a positive purified protein derivate on 04-Dec-2007. Concomitant medication includes amoxicillin and albuterol. On 08-Jan-2008, the subject received FLUMIST. On the same day, the patient also received DTaP and MMR-VAR. Since 04-Dec-2007, the subject had two cases of cough, fever, and abnormal X-ray. She was diagnosed with community accuired pneumonia. Her father had recently been diagnosed with active TB so she was admitted to the hospital on 05-Feb-2008 to rule out active TB. Gastric aspirates x three were obtained for AFB smear and TB cultures. Chest CT scan was obtained to further evaluate the subject''s pulmonary process. It showed no hilar LAD but two areas of infiltrated possibly consistent with resolving pneumonia. The county TB clinic indicated the contact case was pan-sensitive Mycobacterium tuberculosis but very high organism load/infectivity. Given the subject''s risk and possibly abnormal pulmonary imaging, she was discharged on 07-Feb-2008 on quadruple drug therapy to be continued at least until the gastric aspirate cultures were final. On 08-Feb-2008, all three gastric aspirates were negative and the subject was doing well with no respiratory distress and was able to return to preschool. The pneumonia resolved on 11-Feb-2008. The investigator assessed the causality of the event of pneumonia to FLUMIST to be none and provided the alternative etiology of natural, viral. The severity of the event was moderate. Additional information received on 23-Oct_2008 and incorporated into narrative included concomitant therapy, medical history, and event outcome.

VAERS ID:346148 (history)  Vaccinated:2008-01-08
Age:20.0  Onset:2008-05-01, Days after vaccination: 114
Gender:Female  Submitted:2009-05-11, Days after onset: 375
Location:Maryland  Entered:2009-05-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 7 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: YASMIN
Current Illness: Contraception
Preexisting Conditions: 6/10/09 Hospital medical records PMH:allergic rhinitis, BCPs
Diagnostic Lab Data: Unknown 6/10/09 Hospital medical records LABS:EEG abnormal. MRI, CT scan, MRA/MRV all neg. 5/15/09 Medical records received DOS 1/2/09 LABS and DIAGNOSTICS: None
CDC Split Type: WAES0905USA00550
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Angiogram normal, Cerumen impaction, Computerised tomogram normal, Conjunctival hyperaemia, Conjunctivitis infective, Convulsion, Electroencephalogram abnormal, Encephalitis, Epidural blood patch, Eye discharge, Headache, Hyperhidrosis, Loss of consciousness, Lumbar puncture, Nuclear magnetic resonance imaging normal, Oral disorder, Presyncope, Rhinorrhoea, Sinusitis, Speech disorder, Staring, Tongue biting, Tremor, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Severe cutaneous adverse reactions (broad), Acute pancreatitis (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), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conjunctival disorders (narrow), Ocular infections (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad)
Write-up: Information has been received from a 21 year old female concerning herself with no medical history or drug allergy who experienced seizures the next day after receiving the second dose of GARDASIL. There was no concomitant therapy. Patient mentioned that she had seizures attacks for 4 consecutive days and then after that she was hospitalized for 5 days. Patient added that her physician told her that she had sinus infection and she was also prescribed KEPPRA for the seizures and she had been taking KEPPRA now for 20 months. The patient described her seizures, she reported that she would have seizures during her sleep because when she woke up, she would see bite marks on her tongue and her mouth. Patient noted that since she took KEPPRA, she would have occasional pre seizures symptoms but it didn''t result to seizures attacks. At the time of the report the patient was not recovered. She added that her twin sister received the complete GARDASIL series and she did not have the AE. Follow-up information has been received from a registered nurse concerning the patient. The first GARDASIL dose was given in their office on 08-JAN-2008 (lot #659653/1448U). The second dose was given in their office on 29-MAY-2008 (lot #660389/1968U); no other vaccines were given at the same time as the GARDASIL doses. Concomitant medications included YASMIN for birth control and PYRIDIUM for a UTI. Patient had no medical history or drug allergies. Their records showed that the patient was admitted to the hospital on 09-JUN-2008 and was discharged on 13-JUN-2008. The patient was last seen in their office on 02-JAN-2009 for pink eye. The nurse did not know the name of the physician who was following the patient for her seizures, did not know what diagnostic tests were performed. Additional information has been requested. 6/10/09 Received hospital medical records for 6/7-6/13/2008. FINAL DX: seizure disorder w/possible encephalitis possibly due to HSV or related to HPV vaccine; s/p lumbar puncture headache, resolved w/blood patch. Records

VAERS ID:375693 (history)  Vaccinated:2008-01-08
Age:15.0  Onset:2008-03-01, Days after vaccination: 53
Gender:Female  Submitted:2010-01-03, Days after onset: 673
Location:Texas  Entered:2010-01-03
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Muscle Aches
Preexisting Conditions: Allergies-Sulfur Drugs
Diagnostic Lab Data: All kinds of blood labs, x-rays, stomach scans, ct scan, urine/stool analysis
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1062U0IMAR
Administered by: Private     Purchased by: Private
Symptoms: Abdomen scan, Abdominal pain upper, Acne, Anxiety, Blood test, Computerised tomogram, Depression, Dyspepsia, Fatigue, Feeling abnormal, Influenza like illness, Malaise, Myalgia, Stool analysis, Ulcer, Urine analysis, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Dementia (broad), Gastrointestinal ulceration (narrow), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow)
Write-up: Between 1st & 2nd shot of Gardasil patient developed severe stomach pain,cramping, and burning that lasted weeks. Muscle aches and overall feeling of not being well. In August 2009 patient had flu like symptoms, anxiety, depression, fatigue, ulcers, acne, overall feeling of illness or impending death.

VAERS ID:381310 (history)  Vaccinated:2008-01-08
Age:4.0  Onset:2010-01-12, Days after vaccination: 735
Gender:Female  Submitted:2010-02-25, Days after onset: 44
Location:Massachusetts  Entered:2010-02-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none noted
Preexisting Conditions: RAD, Atopic dermatitis, food allergies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0185U1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Rash generalised, Varicella
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: pt presented in office with rash on entire body consistent with Varicella starting 1 day prior.

VAERS ID:305113 (history)  Vaccinated:2008-01-08
Age:1.1  Onset:2008-01-10, Days after vaccination: 2
Gender:Female  Submitted:2008-02-18, Days after onset: 39
Location:Foreign  Entered:2008-02-19, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic laboratory test 10Jan08 normal; serum C-reactive protein 10Jan08 normal; serum alkaline phosphatase 10Jan08 normal; stool analysis 10Jan08 No germs; serum electrolytes test 10Jan08 normal; hepatic function tests 10Jan08 normal; c
CDC Split Type: WAES0802USA03100
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALSAC69CA997A IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.NF08830 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood alkaline phosphatase normal, Blood electrolytes normal, C-reactive protein normal, Full blood count normal, Gastroenteritis, Haematemesis, Liver function test normal, Stool analysis normal, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (broad)
Write-up: Information has been received from a health professional concerning a 13 month old female who on 08-JAN-2008 was vaccinated with a first dose intramuscularly of Varivax (batch# "NF08830"). Concomitant vaccination included a first dose intramuscularly of MMR (batch # A69CA997A). On 10-JAN-2008 around noon, the patient developed vomiting. The consulted pediatrician diagnosed gastroenteritis. The same day (10-JAN-2008) in the afternoon, she developed severe haematemesis, 6 to 7 times, and was hospitalized. A blood sample was taken that revealed normal results for: total blood count; C-reactive protein (CRP); clotting factor; liver and kidney parameters; alkaline phosphatase and electrolytes. No germs were found in stool specimens. It was indicated that on the same day the patient had recovered completely, and on 11-JAN-2008, was discharged in good general condition. The case is closed. Other business partner''s manufacturer numbers included E2008-01043.

VAERS ID:309047 (history)  Vaccinated:2008-01-08
Age:45.0  Onset:2008-01-08, Days after vaccination: 0
Gender:Male  Submitted:2008-04-04, Days after onset: 86
Location:Foreign  Entered:2008-04-07, Days after submission: 3
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: TRIGEMINAL NEURALGIA
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 09Jan2008, 130/80mmHg; CAT, Jan2008, normal; Pulse rate, 09Jan2008, 62beats/min
CDC Split Type: B0502645A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB099A0IMRL
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Blood pressure, Cold sweat, Computerised tomogram normal, Condition aggravated, Disturbance in attention, Dry mouth, Fatigue, Heart rate, Influenza like illness, Neuralgia, Photophobia
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad)
Write-up: This case was reported by a physician and described the occurrence of neuralgia in a 45-year-old male subject who was vaccinated with Twinrix (GlaxoSmithKline). The subject''s medical history included trigeminal neuralgia. On 8 January 2008, the subject received unspecified dose of Twinrix (intramuscular, unknown thigh, lot number not provided). After the vaccination, the subject performed fitness activities. Thereafter, on 8 January 2008 in the evening, the subject suffered from tiredness, dryness of the mouth, cold sudor, light sensitivity and attention disturbances which still lasted during 9 January 2008. There was no fever. Pulse rate was regular (62 beats/minute) and blood pressure at 180/80 mmHg. There was no skin rash and no further progression of the symptoms. No drug therapy was initiated. At the time of reporting, the outcome of the events was unspecified. The physician considered the events were possibly related to vaccination with Twinrix. In follow-up information received on 4 March 2008, it was reported that adverse events initially reported occurred 6 hours after vaccination with Twinrix (lot number provided). All the events were moderate and lasted for one month. At time of reporting, the events were resolved. The vaccination course with Twinrix was discontinued. In follow up information received on 27 March 2008 from a regulatory authority (# 2008-00833), it was reported the following; On 8 January 2008, the subject received 1st dose of Twinrix (intramuscular, right thigh). On 8 January 2008, 6 hours after first vaccination with Twinrix (during the night), the subject experienced cold sweat, dry mouth, photosensitivity and deterioration of general health state. Symptoms persisted during the next morning. So patient was not able to work 100%. No local reaction observed at the vaccination site. Flu-like symptoms resolved on 11 January 2008. Nevertheless, on 12 January 2008, 4 days after vaccination, he told about a reactivation of neuralgiform pains in the right face, pains he

VAERS ID:309456 (history)  Vaccinated:2008-01-08
Age:22.0  Onset:2008-01-08, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 96
Location:Foreign  Entered:2008-04-14
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: HOUSE DUST ALLERGY
Diagnostic Lab Data: Blood glucose, unknown; Blood pressure, 112/68; Blood pressure, 114/71; Blood pressure, Normal; ECG, unknown; Pulse rate, 71; Pulse rate, 68
CDC Split Type: B0516210A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB306CA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blood glucose, Blood pressure normal, Dizziness, Electrocardiogram, Feeling cold, Heart rate normal, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: This case was reported by a regulatory authority (# GB-MHRA-ADR 20244727) and described the occurrence of nausea in a 22-year-old female subject who was vaccinated with Engerix B vaccine. The subject''s medical history included house dust allergy. On 8 January 2008 the subject received unspecified dose of Engerix B (1 ml, intramuscular). On 8 January 2008, at an unspecified time after vaccination with Engerix B, the subject experienced nausea, light headedness and cold. The regulatory authority reported that the events were disabling. On 8 January 2008, the events were resolved. MHRA Verbatim text: Patient developed nausea, cold and light headedness. Patient attended A&E where ECG and blood sugar were measured. Blood pressure normal was normal at discharge. Medically Significant: Failed to resolve 2-3 hours after injection.

VAERS ID:309808 (history)  Vaccinated:2008-01-08
Age:  Onset:0000-00-00
Gender:Unknown  Submitted:2008-04-15
Location:Foreign  Entered:2008-04-17, Days after submission: 2
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:
Preexisting Conditions: No reported medical history. 09 January 2008 the patient has been vaccinated on the neonatology unit with BCG vaccine, batch 03806 and first dose of HEPAVAX (batch 0430041) and after vaccination no adverse reactions were reported.
Diagnostic Lab Data:
CDC Split Type: 200800973
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER04300390IMRL
HIBV: HIB (ACTHIB)SANOFI PASTEURA97120IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Apnoea, Crying, Cyanosis, Hypotonic-hyporesponsive episode
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (narrow)
Write-up: Report received from the Health Authorities on 04 April 2008 under the reference number PL-URPL-OCR-20080319007. Other reference: URPL paper id: N128/2008. A patient born on 08 January 2008 (gender not reported), with no reported medical history, experienced hypotonic-hyporesponsive episode after receiving ACT-HIB* and HEPAVAX-GENE* vaccines (dates unspecified). After administration of ACT-HIB* lot A9712-2, intra-muscularly in the front-side part of the left thigh, the patient started crying. After waiting for 5-10 minutes the patient''s health status came back to normal and HEPAVAX-GENE* vaccine, lot 0430039 (recombinant hepatitis B vaccine from another manufacturer) was administered intra-muscularly in the right thigh. After that apnoea and cyanosis on the face occurred. Artificial respiration was performed, but apnoea were coming back in 3-5 minute intervals. Till the emergency ambulance came, approximately 20 minutes, the patient''s condition came back to normal. The patient, in good general condition was taken to the hospital for observation. The diagnosis was "Hypotonic-hyporesponsive episode". According information obtained from the head of paediatric unit the patient was oversensitive on pain. He/she was crying and apnoea occurred during different procedures (operations) for example blood collection, injections. The patient recovered. To be noted that on 09 January 2008 the patient has been vaccinated on the neonatology unit with BCG vaccine, batch 03806 and first dose of HEPAVAX (batch 0430041) and after vaccination no adverse reactions were reported.

VAERS ID:313530 (history)  Vaccinated:2008-01-08
Age:60.0  Onset:2008-01-08, Days after vaccination: 0
Gender:Female  Submitted:2008-05-27, Days after onset: 139
Location:Foreign  Entered:2008-05-27
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: B0522102A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (DITANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Inflammation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: This case was reported by a regulatory authority (foreign Regulatory Authority (clinical) # 520000341) and described the occurrence of inflammation in a 60-year-old female subject who was vaccinated with DITANRIX adult (GlaxoSmithKline). On 8 January 2008, the subject received unspecified dose of DITANRIX adult (intramuscular, unknown injection site). Lot number not provided. On 8 January 2008, less than one day after vaccination with DITRANRIX adult, the subject experienced inflammation and fever. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 8 January 2008, the inflammation was resolved. The fever lasted until 15 January 2008. The regulatory authority reported that the events were possibly related to vaccination with DITANRIX adult. No further information is available, therefore the case has been closed.

VAERS ID:315017 (history)  Vaccinated:2008-01-08
Age:0.3  Onset:2008-03-14, Days after vaccination: 66
Gender:Female  Submitted:2008-06-04, Days after onset: 82
Location:Foreign  Entered:2008-06-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, 19Mar2008, Abnormalunit
CDC Split Type: B0522325A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 1PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Decreased activity, Dehydration, Faecal vomiting, Flatulence, Gastrointestinal hypomotility, Gastrointestinal necrosis, Haematochezia, Intestinal anastomosis, Intestinal resection, Intussusception, Pyrexia, Surgery, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow)
Write-up: This case was reported by a physician in the frame of a study and described the occurrence of intussusception in a 6-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). The subject was under no other medication and had no relevant medical history nor allergy. Previous and/or concurrent vaccination included ROTARIX; GlaxoSmithKline; oral given on 8 November 2007. On 8 January 2008, the subject received 2nd dose of ROTARIX (oral), lot number not provided. On 14 March 2008, 66 days after vaccination with ROTARIX, the subject experienced vomiting and fever. On 16 March 2008, she experienced bloody stools. On 19 March 2008, the subject experienced abdominal distension without peristalsis and 2 vomitings like feces, leading to hospitalisation at emergency ward. At physical examination, the subject was dehydrated, hypoactive with a distended abdomen. Abdominal X-ray showed air fluid levels and lack of air in rectum. The subject was transferred to another hospital where after confirmation of previous examination results, surgery was performed and ileocecocolic intussusception to descendent colon and ileocecal valve with proximal ascendant colon necrosis were found. Taxis was performed in 80 % of intussusceptoin as well as 15 cm of bowel resection end to end anastomosis. The subject was hospitalised for 14 days. The subject was treated with ranitidine, cefotaxime, metamizole, ampicilline, amikacin, metronadizole and dicloxacillin. On 1 April 2008, the events were resolved and the subject was discharged from hospital in good clinical condition. The physician considered the events were unrelated to vaccination with ROTARIX.

VAERS ID:316074 (history)  Vaccinated:2008-01-08
Age:17.0  Onset:2008-01-28, Days after vaccination: 20
Gender:Female  Submitted:2008-06-11, Days after onset: 134
Location:Foreign  Entered:2008-06-12, Days after submission: 1
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: Allergic reaction to antibiotics
Preexisting Conditions: Ankle fractures; Ankle sprain
Diagnostic Lab Data: X-ray; normal, thorax; tuberculin skin test, "tubetest" normal; diagnostic laboratory test, streptococcus normal; serum LDH, normal; serum hepatitis B Ab, normal; serum hepatitis D Ab, normal; serum hepatitis C antibody test, normal
CDC Split Type: WAES0806USA00567
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Blood lactate dehydrogenase normal, Chest X-ray, Erythema nodosum, Hepatitis B antibody negative, Hepatitis C antibody negative, Hepatitis D antibody negative, Streptococcus identification test negative, Tuberculin test negative, X-ray normal
SMQs:, Hypersensitivity (narrow), Arthritis (broad)
Write-up: Information has been received from a Health Authority concerning a 17 year old female with allergy to ALAFATIL and a history of left ankle sprains and ankle fracture (2001) who on 08-JAN-2008 was vaccinated IM with a dose of GARDASIL (site not reported). On 28-JAN-2008, 20 days after vaccination, the patient experienced an erythema nodosum with arthralgia of the lower limbs and subcutaneous nervures. She was hospitalized and treated with diclofenac. Complementary examinations were performed: radiography of thorax, "tubertest." sero D hepatitis C and B, lactate dehydrogenase, streptococcus and were all normal. By the end of February 2008, symptoms disappeared. At the time of the report, the patient had recovered. Other business partners numbers included: E2008-05065 and LL20080204

VAERS ID:320374 (history)  Vaccinated:2008-01-08
Age:41.0  Onset:0000-00-00
Gender:Male  Submitted:2008-07-24
Location:Foreign  Entered:2008-07-24
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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0058154A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Angioedema, Anorexia, Erythema multiforme, Fatigue, Headache, Hypersensitivity, Influenza like illness, Myalgia, Nausea, Orthostatic hypotension, Pruritus, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Oropharyngeal allergic conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority ((vaccines, biologicals) # DE-PEI-PEI2008010652) and described the occurrence of headache in a 41-year-old male subject who was vaccinated with HAVRIX 1440 (GlaxoSmithKline). On 8 January 2008 the subject received 1st dose of HAVRIX 1440 (unknown route and application site). In January 2008, a few days after vaccination with HAVRIX 1440, the subject experienced headache, appetite lost, nausea, vomiting, abdominal pain, exhaustion, tiredness, influenza like symptoms, allergic reaction with Quincke''s edema, itching, erythema multiforme, muscle pain in several muscle groups and orthostatic dysregulation with syncope. The subject was hospitalised. At the time of reporting the events were improved, but still mildly persisting. The final outcome was unknown. No further information will be available.

VAERS ID:323705 (history)  Vaccinated:2008-01-08
Age:15.0  Onset:0000-00-00
Gender:Female  Submitted:2008-08-28
Location:Foreign  Entered:2008-08-29, 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: None
Diagnostic Lab Data: magnetic resonance imaging, SI joint negative; steroid therapy, Pulse steroids; steroid therapy, Pulse steroids; serum ANA, ??Mar08, positive 1:80; serum rheumatoid factor, ??Mar08, negative; whole blood HLA antigen test, ??May08, positive
CDC Split Type: WAES0805CAN00017
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
TDAP: TDAP (ADACEL)SANOFI PASTEUR  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Antinuclear antibody positive, HLA marker study positive, Leukocyte antigen B-27 positive, Nuclear magnetic resonance imaging normal, Polyarthritis, Rheumatoid factor negative, Tendonitis
SMQs:, Systemic lupus erythematosus (narrow), Hypersensitivity (broad), Arthritis (narrow)
Write-up: Information has been received from a physician (initial reporter) concerning a 15 year old female who on 08-JAN-2008 was vaccinated with the first dose of GARDASIL, lot # not available. On 24-MAR-2008 the patient was vaccinated with the second dose of GARDASIL, lot # not available. Concomitant therapy included vaccination with ADACEL. In March 2008, the patient was diagnosed with polyarthropathy with positive ANA and negative for rheumatoid factor. In May 2008, the patient was found to be HLA B27 positive. The physician (primary source) reported that the patient was hospitalized twice for pulse steroids and in June 2008 that patient was started on therapy with sulfasalazine 500 mg BID for the treatment of Enthesitis-related arthritis (described also as polyarthropathy with positive ANA and negative rheumatoid and HLA B27 positive). The primary source physician also reported that the patient''s condition is improved, but activity is tricky. A magnetic resonance imaging of sacro-iliac joint was negative. ANA positive 1:80. The initial reporter physician felt that polyarthropathy with positive ANA was possibly related to therapy with GARDASIL. The primary source physician was uncertain whether Enthesitis-related arthritis (also described as polyarthropathy with positive ANA and negative rheumatoid and HLA B27 positive) was related to therapy with GARDASIL. Final outcome of events not provided. No further information is available.

VAERS ID:336237 (history)  Vaccinated:2008-01-08
Age:17.0  Onset:2008-02-02, Days after vaccination: 25
Gender:Female  Submitted:2008-12-29, Days after onset: 331
Location:Foreign  Entered:2008-12-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 11 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 02Feb08)
Preexisting Conditions:
Diagnostic Lab Data: Apgar score, 07-09-10
CDC Split Type: WAES0804USA00199
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.NG300200IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cervical incompetence, Cervix cerclage procedure, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a gynaecologist concerning a 17 year old female patient with no medical history reported, who on 08-JAN-2008 was vaccinated intramuscularly in the left deltoid with the first dose of GARDASIL (Batch # reported as "NG30020"). It was reported that the patient''s last menstrual period was on 02-FEB-2008. Subsequently the patient became pregnant. Her estimated due date is 08-NOV-2008. At the time of reporting the patient was 4+2 gestation week. Upon receipt of new information on 18-DEC-2008, this case was upgraded because of hospitalization. The patient experienced cervical incompetence in 25th week of gestation. She was hospitalized from 10-JUL-2008 to 21-JUL-2008 and a cerclage was performed. Spontaneous birth of a healthy girl (height = 50cm; weight = 2.960 kg) was on 29-OCT-2008. The postnatal examination of mother and child showed no pathologies. Apgar score was 07-09-10. Other business partners numbers: E-2008-01938. No further information is available.

VAERS ID:343514 (history)  Vaccinated:2008-01-08
Age:1.4  Onset:2009-03-26, Days after vaccination: 443
Gender:Female  Submitted:2009-04-03, Days after onset: 8
Location:Foreign  Entered:2009-04-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Exposure to communicable disease
Preexisting Conditions:
Diagnostic Lab Data: Rotavirus test positive, 26Mar2009, positive
CDC Split Type: D0061134A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Pyrexia, Rotavirus infection, Rotavirus test positive, Vaccination failure, Virus stool test positive, 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 severe rotavirus infection in a 19-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent medical conditions included exposure to rotavirus at a day-care centre. On 08 January 2008 and 05 February 2008 the subject received the first and second doses of ROTARIX (0.5 ml, oral). Approximately 14 months and 13 months post vaccination with the first and second dose of ROTARIX, respectively, on 26 March 2009, the subject experienced severe rotavirus infection with stool positive for rotavirus in rotavirus test, fever, vomiting and diarrhea (suspected vaccination failure). This case was assessed as medically serious by GSK criteria. At the time of reporting the outcome of the events was unspecified. Follow-up information has been requested.

VAERS ID:373894 (history)  Vaccinated:2008-01-08
Age:0.3  Onset:2008-01-09, Days after vaccination: 1
Gender:Female  Submitted:2009-12-16, Days after onset: 707
Location:Foreign  Entered:2009-12-17, 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:
Current Illness:
Preexisting Conditions: Relevant medical history was not provided.
Diagnostic Lab Data: None Provided.
CDC Split Type: ITWYEG05111709
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CA345A IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH28168 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Kawasaki's disease, Macrophage activation
SMQs:, Vasculitis (narrow)
Write-up: Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 3-month-old female patient who experienced macrophage activation and disease of Kawasaki. The patient received a dose on 08-Jan-2008. Additional suspect medication included INFANRIX HEXA. The patient experienced macrophage activation and disease of Kawasaki on 09-Jan-2008. The events involved or prolonged inpatient hospitalization. The patient definitely recovered in May 2008. No additional information was available at the time of this report.

VAERS ID:421681 (history)  Vaccinated:2008-01-08
Age:  Onset:0000-00-00
Gender:Male  Submitted:2011-04-25
Location:Foreign  Entered:2011-04-26, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Diagnostic laboratory test, 1.2, hair mercury
CDC Split Type: WAES1104USA02311
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME)SANOFI PASTEURB20601UNUN
MNQ: MENINGOCOCCAL CONJUGATE (NO BRAND NAME)UNKNOWN MANUFACTURERUN51704B UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH279163UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Autism, Disability, Hair metal test abnormal
SMQs:
Write-up: Initial information received on 04-APR-2011 from a lawyer, this case was not medically confirmed. This was a non valid case as adverse event was missing. This case was linked with case E2010-01528 (WAES# 1004USA03843) and was related to a general claim against the Ministry of Health related to all products containing thiomersal. The claim contained 65 cases among which 41 were related to vaccines. Furthermore, this case was also linked with 2 cases related to patients who dropped their complaints. On 04-APR-2011, it was reported that 8 more plaintiffs joint the claim. The claim was not against Sanofi Pasteur MSD, this latter was only a third party. Therefore some of the cases were poorly documented. Current case concerned a male patient. The patient received 3 doses of PENTAVAC (batch numbers and lot numbers not reported, route and site of administration not reported). The first dose was administered at 2 months of age, second dose at 6 months of age and third dose at 18 months of age. Exact dates of vaccination were not reported. The patient also received a dose of VARIVAX (Merck) (batch number and lot number not reported, route and site of administration not reported) at the age of 12 months. Exact date of administration was not reported. It was not reported whether the patient presented any adverse event or not, but as this case was a claim, it had been considered that any adverse event occurred. At the time of reporting, the patient''s outcome was unknown. Case was considered as not serious. Follow-up information received on 13-APR-2011 from the lawyer. According to the patient''s vaccination records, the patient had received the following vaccines: 4 doses of a diphtheria-tetanus-acelullar pertussis-inactivated poliomyelitis-haemophilus influenzae type b vaccine. First dose of INFANRIX-IPV+HIB (batch number A20CA204A, route not reported) on 29-AUG-2006; second dose of INFANRIX-IPV+HIB (batch number A20CA207A, route not reported) on 27-OCT-2006; third dose of PENTAVAC (batch number Z2185-1, route not reported) administered on 28-DEC-2006 and the last dose of PENTAVAC (batch number B2060-1, route not reported) administered on 08-JAN-2008, 3 doses of a Hepatitis B vaccine: first dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown, batch number illegible, route not reported) on 28-JUN-2006, second dose of ENGERIX-B (batch number XHBVB10401) on 29-AUG-2006 and the last one of ENGERIX-B (MSD, thimerosal-free, batch number ND32220, route not reported) on 28-DEC-2006, 4 doses of PREVENAR on 29-AUG-2006 (batch number: 21758, route not reported); on 27-OCT-2006 (batch number: 22315, route not reported); on 28-DEC-2006 (batch number: 23615, route not reported) and 08-JAN-2008 (batch number: 27916, route not reported), one dose of VARIVAX (Merck) (batch number: NE57500, lot number: 654989/0557F, route not reported) on 26-JUN-2007, one dose of MMR (manufacturer unknown, batch number A69FA730A (not batch number), route not reported) on 28-SEP-2007, one dose of MENJUGATE (manufactured by Esteve, batch number: UB3670AR, route not reported) on 29-AUG-2006, 2 doses of meningococcal C polysaccharide vaccine (manufactured by other company, batch numbers UN901996 and UN51704B, route not reported) on 08-JAN-2008 and 28-NOV-2006. According to the report, the patient was diagnosed with autism on an unspecified date and he had disability (grade not reported) which was evaluated on 21-AUG-2009. A test performed in a hair sample (dates not reported) showed that the patient had a mercury level of 1.2 normal range below 0.40 (units not reported). According to the form received from the claimant, only hair test (mineralogram and others) was included. Upon medical review, this case was considered to be serious. Other business partner numbers include E2011-02245. Case is closed. No further information is available.

VAERS ID:302028 (history)  Vaccinated:2008-01-09
Age:4.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Female  Submitted:2008-01-09, Days after onset: 0
Location:Michigan  Entered:2008-01-09
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: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2798AA4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA03423SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0866U1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1584U1SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Fall, Head injury, Lethargy, Pallor
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: About 3-5 mins. after DTaP, IVP, MMR & Varivax given, child became pale & fell & hit head on floor. No LOC but was acting lethargic. Given Epipen Jr & Decadron 4 mg within 1-2 mins after meds given. Child more alert, active, color returned. Monitored about 30 mins in office.

VAERS ID:302321 (history)  Vaccinated:2008-01-09
Age:16.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Female  Submitted:2008-01-10, Days after onset: 1
Location:Maine  Entered:2008-01-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prozac
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0  
MEN: MENINGOCOCCAL (NO BRAND NAME)UNKNOWN MANUFACTURER 0  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cold sweat, Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Daughter became very dizzy and clammy about 10 minutes after taking Gardasil Shot. Felt nauseous and had to lie down.

VAERS ID:302326 (history)  Vaccinated:2008-01-09
Age:0.4  Onset:2008-01-09, Days after vaccination: 0
Gender:Female  Submitted:2008-01-10, Days after onset: 1
Location:North Carolina  Entered:2008-01-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: None~ ()~~0~In Patient|None~ ()~~0~In Sibling|None~ ()~~0~In Sibling
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: sepsis workup including LP negative so far
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B125BB1IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0260U1IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08700K1IMLL
Administered by: Private     Purchased by: Private
Symptoms: Crying, Irritability, Laboratory test, Lumbar puncture normal, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: Shots given 11AM 1/9/08. Began inconsolable crying spell then developed fever to 103. To ER-sepsis workup including LP negative so far. Still fussy but consolable on 1/10/08.

VAERS ID:302339 (history)  Vaccinated:2008-01-09
Age:14.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Female  Submitted:2008-01-10, Days after onset: 1
Location:Massachusetts  Entered:2008-01-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U2IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2904AA IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Immediate post-injection reaction, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Pt. rec. Gardasil 1/9/08. Fainted 2 mins post vaccine. Awoke immediately. Ice applied. No laceration/no sx. head injury.

VAERS ID:302341 (history)  Vaccinated:2008-01-09
Age:7.0  Onset:2008-01-10, Days after vaccination: 1
Gender:Female  Submitted:2008-01-10, Days after onset: 0
Location:Pennsylvania  Entered:2008-01-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: ~Varicella (Varivax)~1~1~In Sibling
Other Medications: Zyrtec
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: N/A
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1495U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt received Varivax 1/10/08. Woke up with swollen red area around injection site 4cm x 4.5 cm.

VAERS ID:302377 (history)  Vaccinated:2008-01-09
Age:62.0  Onset:2008-01-10, Days after vaccination: 1
Gender:Female  Submitted:2008-01-11, Days after onset: 1
Location:Alabama  Entered:2008-01-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: no
Preexisting Conditions: nka
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (NO BRAND NAME)UNKNOWN MANUFACTURER 0SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: I was given a shingles vaccination and had the following symptoms. SWELLING, REDNESS, (2" diameter) TENDER AND WARM AT INJECTION SITE. HEADACHE.

VAERS ID:302494 (history)  Vaccinated:2008-01-09
Age:14.0  Onset:2008-01-10, Days after vaccination: 1
Gender:Male  Submitted:2008-01-11, Days after onset: 1
Location:South Carolina  Entered:2008-01-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Augmentin 875mg BID for 5 days
Current Illness: dog bite
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2904AA IMRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activities of daily living impaired, Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient received Adacel vaccine on 01-09-08 due to dog bite. On 01-10-08 patient developed fever 101 orally with vomiting. Patient complained of redness and pain at injection site right deltoid that interfered with routine activities and had to leave school. Patient returned to office today temperature was 98.1 at 11:30 am stating temperature was 100 this AM. Patient was given Ibuprofen by father this Am. Redness, pain, and swelling still present at injection site.

VAERS ID:302517 (history)  Vaccinated:2008-01-09
Age:4.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Male  Submitted:2008-01-12, Days after onset: 3
Location:Pennsylvania  Entered:2008-01-11, 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: Albuterol as needed
Current Illness: None
Preexisting Conditions: Asthma, mild; possible Amoxicillin (rash) allergy
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2529AA2IMRA
Administered by: Private     Purchased by: Private
Symptoms: Abnormal behaviour, Cough, Emotional distress, Irritability, Labyrinthitis, Panic reaction, Screaming
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad)
Write-up: Influenza vaccine administered at well checkup 1/9/08 about 3:30pm. Mom reports he became very fussy that night and had barky cough. Neb treatment with Albuterol no help. Next AM, more panic and screaming, seen in office by Dr., did have big inner ear infection but in more distress than expected, saying "it''s an emergency", "I can''t breath" and in tears. Difficult to console in office. Given ear drops (acralfan), Motrin, and then Benadryl, finally about 10 min after Benadryl he fell asleep. Patient seemed to be in a panic, which is out of character for him. Sent home on Zithromax for ear infection and Benadryl every 6 hours. (Exam showed no hives, no swelling, no wheezing, no respiratory distress but very panicked.)

VAERS ID:302523 (history)  Vaccinated:2008-01-09
Age:64.0  Onset:2008-01-10, Days after vaccination: 1
Gender:Male  Submitted:2008-01-11, Days after onset: 1
Location:Michigan  Entered:2008-01-11
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: Allergies: tetanus toxoids, Sulfa. Dx: HTN, BPH, OSA, hyperlipidemia
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1825U IMLA
Administered by: Private     Purchased by: Private
Symptoms: Chills, Fatigue, Pain
SMQs:
Write-up: Chills, body aches,? fever, extreme fatigue. Pt was not seen in clinic for symptoms. Spoke with RN and MD via telephone

VAERS ID:302727 (history)  Vaccinated:2008-01-09
Age:12.0  Onset:2008-01-10, Days after vaccination: 1
Gender:Male  Submitted:2008-01-10, Days after onset: 0
Location:Florida  Entered:2008-01-15, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2383BA0UNRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B011AA0UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1473U1UNLL
Administered by: Private     Purchased by: Private
Symptoms: Headache, Injection site pain, Nausea, Photophobia, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious meningitis (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad)
Write-up: Pt. feels nauseated, headache is ongoing, sensitive to light, fever of 102.0, pain in arm & leg (injection sites).

VAERS ID:302737 (history)  Vaccinated:2008-01-09
Age:28.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Female  Submitted:2008-01-10, Days after onset: 1
Location:Texas  Entered:2008-01-15, 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: None
Current Illness: None
Preexisting Conditions: None diagnosed by physician. History of several allergies (food, seasonal allergies & Type I, latex allergy).
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA319AA0IMRA
HEP: HEP B (FOREIGN)MERCK & CO. INC.1148U0IMRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0418U2SCRA
Administered by: Private     Purchased by: Private
Symptoms: Feeling abnormal, Tongue disorder
SMQs:, Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)
Write-up: Approximately 10 minutes after receiving MMR, hepatitis B & influenza vaccines employee felt "thick tongued" & "loopy". "Loopy" feeling lasted about 30 minutes. "Thick-tongued" for 1 hour. History of several allergies (food, seasonal allergies & Type I, latex allergy).

VAERS ID:302743 (history)  Vaccinated:2008-01-09
Age:5.0  Onset:2008-01-10, Days after vaccination: 1
Gender:Male  Submitted:2008-01-14, Days after onset: 4
Location:Maine  Entered:2008-01-15, 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: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2765AA4IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA017023IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0417U1IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1355U1SCRL
Administered by: Private     Purchased by: Other
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pain, redness, swelling, heat, hardness around inj site. Temp 99.8. Pt. drinking fluids well & active. Tylenol administered.

VAERS ID:302749 (history)  Vaccinated:2008-01-09
Age:0.3  Onset:2008-01-09, Days after vaccination: 0
Gender:Female  Submitted:2008-01-10, Days after onset: 1
Location:West Virginia  Entered:2008-01-15, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: vomiting~Rotavirus (Rotateq)~1~0~In Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B125BB1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF292AB1IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB08702D1IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0904U1PO 
Administered by: Private     Purchased by: Private
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Patient vomited with the first Rotateq but no other problems. She took half of the 2nd dose of Rotateq and then vomited forcefully twice. She had no associated coughing or gagging.

VAERS ID:302774 (history)  Vaccinated:2008-01-09
Age:0.5  Onset:2008-01-10, Days after vaccination: 1
Gender:Male  Submitted:2008-01-11, Days after onset: 1
Location:Arizona  Entered:2008-01-15, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: per history rash in groin area after 4 mth shots but also had given new foods~Vaccine not specified (no brand name)~UN~0~In Pati
Other Medications:
Current Illness: None
Preexisting Conditions: GERD
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B132CA2IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF214AA2IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB70145E2IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1390U2PO 
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Redness & swelling & induration of 1 cm x 1 cm & 0.5 cm x 1 cm noted in R thigh (site of Hib & Prevnar). Fever 102 degrees associated. Seen at clinic 1/10/08 & office 1/11/08.

VAERS ID:302973 (history)  Vaccinated:2008-01-09
Age:11.0  Onset:2008-01-11, Days after vaccination: 2
Gender:Male  Submitted:2008-01-11, Days after onset: 0
Location:Pennsylvania  Entered:2008-01-17, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2508AA2UNLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB214AA0UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2236AA0UNRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B013AA0UNLA
Administered by: Other     Purchased by: Unknown
Symptoms: Mobility decreased, Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Parkinson-like events (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: R hand swelling 2 days after immunizations given, decreased speed of R finger movement. Strength within normal & capillary refill normal. Sent to ER to evaluate. Afebrile.

VAERS ID:302974 (history)  Vaccinated:2008-01-09
Age:1.0  Onset:2008-01-11, Days after vaccination: 2
Gender:Male  Submitted:2008-01-12, Days after onset: 1
Location:Pennsylvania  Entered:2008-01-17, 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: Tylenol
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data: 1. CBC & diff 1/12/08-normal. 2. varicella virus culture from blisters taken 1/12/08.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2505AA1UNLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1501U0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Blister, Full blood count normal, Pyrexia, Varicella, Virus culture
SMQs:, Severe cutaneous adverse reactions (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad)
Write-up: Varicella vaccine given 1/9/08, broke out with varicella on 1/12/08. 102 degree fever on 1/12/08 and 2 blisters of varicella on abdomen on 1/12/08.

VAERS ID:302992 (history)  Vaccinated:2008-01-09
Age:2.0  Onset:2008-01-10, Days after vaccination: 1
Gender:Female  Submitted:2008-01-11, Days after onset: 1
Location:Pennsylvania  Entered:2008-01-17, 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: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNRL
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER 1UNLL
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling, Nightmare, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: swelling of upper thigh where DTaP was injected, along with redness covering the entire thigh; increased sleepiness; nightmares

VAERS ID:303081 (history)  Vaccinated:2008-01-09
Age:37.0  Onset:2008-01-10, Days after vaccination: 1
Gender:Female  Submitted:2008-01-11, Days after onset: 1
Location:Texas  Entered:2008-01-18, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: possibly~Td Adsorbed (no brand name)~UN~25~In Patient|No~ ()~~0~In Sibling|No~ ()~~0~In Sibling
Other Medications: Yaz BC pills; Tylenol for aching now
Current Illness: No
Preexisting Conditions: States last Td in 1995 caused same symptoms, but was much, much less severe.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU1991CA2IMLA
Administered by: Public     Purchased by: Public
Symptoms: Feeling abnormal, Injection site erythema, Injection site induration, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Redness, induration about inj. site. Feeling bad & little fever onset 24hr after inj. Next day induration 2" wide, 101 degree temp & aching in entire upper body. Tylenol & cold compresses helped some. Next day symptoms still there except generally feeling better. Today (5 days after inj) all symptoms gone except for achiness in arm. States last Td in 1995 caused same symptoms, but was much, much less severe.

VAERS ID:303082 (history)  Vaccinated:2008-01-09
Age:38.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Male  Submitted:2008-01-09, Days after onset: 0
Location:Michigan  Entered:2008-01-18, 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:
Current Illness: Healthy
Preexisting Conditions: Asthma, HIV +
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.AHBVB412AA1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Nausea, Pain, Pyrexia, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow)
Write-up: Rec. vaccines (Hep B) at 4:30 pm. 6-6:30 pm - achy, feverish, sweating, chills, wheezing more than normal. Soup eaten. 715 pm nausea and vomiting x3, diarrhea 230 AM 1/10/08 x 4.5. Used inhaler x1 - helped with wheezing. T-97.

VAERS ID:303056 (history)  Vaccinated:2008-01-09
Age:1.0  Onset:2008-01-14, Days after vaccination: 5
Gender:Female  Submitted:2008-01-20, Days after onset: 6
Location:New York  Entered:2008-01-20
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: N/A
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2477FA1IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0748U0IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1363U0IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Pyrexia, Rash maculo-papular
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: FEVER FOR 4 DAYS, 5 DAYS POST VACCINATION ASSOCIATED WITH REDNESS SLIGHT INDURATION ON SITE OF INJECTION, LEFT THIGH. FOLLOWED BY MACULOPAPULAR ERUPTION ON FACE TRUNK WHEN FEVER ABATED.

VAERS ID:303207 (history)  Vaccinated:2008-01-09
Age:7.0  Onset:2008-01-10, Days after vaccination: 1
Gender:Female  Submitted:2008-01-22, Days after onset: 12
Location:Ohio  Entered:2008-01-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NO
Preexisting Conditions: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1494U1SCRA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Local reaction to varicella vaccine; right posterior arm had a silver dollar sized area of redness at injection site; no pain; afebrile; was seen at PCP on 01/12/08 (3 days after vaccination)-- doctor suggested cool compresses and to watch for infection.

VAERS ID:303261 (history)  Vaccinated:2008-01-09
Age:9.0  Onset:2008-01-10, Days after vaccination: 1
Gender:Female  Submitted:2008-01-10, Days after onset: 0
Location:Hawaii  Entered:2008-01-22, 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: PPD
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CBC with diff, Blood cx
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1499U1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Blood culture, Full blood count, Injection site cellulitis
SMQs:
Write-up: (L) arm with cellulitis

VAERS ID:303262 (history)  Vaccinated:2008-01-09
Age:13.0  Onset:2008-01-10, Days after vaccination: 1
Gender:Female  Submitted:2008-01-16, Days after onset: 6
Location:New Jersey  Entered:2008-01-22, 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: None
Preexisting Conditions: Viral meningitis 10/07; + Mono 11/07
Diagnostic Lab Data: Warm soaks, Tylenol, Augmentin 875
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0886F0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Infectious mononucleosis, Injection site erythema, Injection site swelling, Meningitis viral
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Increased temp (103.9), swelling, redness (L) deltoid area - injection site extending down to elbow.

VAERS ID:303353 (history)  Vaccinated:2008-01-09
Age:0.5  Onset:2008-01-11, Days after vaccination: 2
Gender:Male  Submitted:2008-01-11, Days after onset: 0
Location:North Carolina  Entered:2008-01-23, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Candidal intertrigo
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type: NC08013
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B129AA2IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB5400TH2IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1193U2PO 
Administered by: Private     Purchased by: Private
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Fever 104.8.

VAERS ID:303384 (history)  Vaccinated:2008-01-09
Age:17.0  Onset:0000-00-00
Gender:Male  Submitted:2008-01-17
Location:West Virginia  Entered:2008-01-23, 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: No allergies
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2405AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: No adverse reaction
SMQs:
Write-up: No adverse event occurred. Advised by CDC phone contact to report vaccine given 2 yrs ago at another facility. Vaccine given 2 yrs ago at another facility not registered on WV5115, not documented on school health record. Discovered vaccine record brought from home after vaccine given.

VAERS ID:303659 (history)  Vaccinated:2008-01-09
Age:72.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Male  Submitted:0000-00-00
Location:Massachusetts  Entered:2008-01-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Advair, Albuterol, Colchicine, Atarax, Clonopin, Fish oil, Glipizide, Insulin, Digoxin, Lipitor, Lisinopril, Lopressor, Lasix, Zantac
Current Illness: Rash x 1 wk, itch all over
Preexisting Conditions: NKDA; Increased lipids, gout, osteoporosis, GERD, Cancer, CHF, CAD, Anemia, MI, Renal failure, macular degeneration, COPD, small bowel surgery
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)MASS. PUB HLTH BIOL LABTD182 IMLA
Administered by: Private     Purchased by: Public
Symptoms: Hemiparesis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)
Write-up: 1/25/08 Pt reports since getting Tetanus shot in left arm, shoulder has been weak. On exam he has full ROM of the shoulder, but abduction is slightly decreased. No tenderness. Improving.

VAERS ID:303748 (history)  Vaccinated:2008-01-09
Age:12.0  Onset:2008-01-11, Days after vaccination: 2
Gender:Female  Submitted:2008-01-11, Days after onset: 0
Location:California  Entered:2008-01-28, Days after submission: 17
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: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.049541UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR42428AA0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: (L) arm swelling with redness, pain.

VAERS ID:303838 (history)  Vaccinated:2008-01-09
Age:19.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Female  Submitted:2008-01-28, Days after onset: 19
Location:Pennsylvania  Entered:2008-01-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ORTHO TRI-CYCLEN LO
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA03962
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity, Wound, Wrong technique in drug usage process
SMQs:, Accidents and injuries (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a licensed practical nurse concerning a 19 year old female with no pertinent medical history or drug reactions/allergies who on 12-NOV-2007 was vaccinated intramuscularly with a 0.5 ml first dose of Gardasil. On 09-JAN-2008 the patient was vaccinated intramuscularly in the left upper arm with a 0.5 ml second dose of Gardasil (659055/1522U). Concomitant therapy included ORTHO TRI-CYCLEN LO. On 09-JAN-2008 the patient developed pain to the arm right after receiving the injection. The pain radiates down the left arm and has gotten worse since the injection. The patient called and was seen by her family physician, who told her that the injection was given improperly into the tendon or ligament causing a puncture wound. The patient last saw the reporting physician on 14-JAN-2008. At that time there was no bruising noted at the site. The patient was not able to lift her left arm. The patient has been using TYLENOL, CELECOXIB, and heat as prescribed by her family physician. The patient''s outcome was reported as not recovered. The patient''s mother is requesting an MRI of the left arm, it has not been ordered at this time. There was no product quality complaint involved. Follow up information was received from the licensed practical nurse indicating that she would consider the patient to have temporary incapacity of her arm and therefore felt that the events were disabling. Additional information has been requested.

VAERS ID:303966 (history)  Vaccinated:2008-01-09
Age:61.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Female  Submitted:2008-01-30, Days after onset: 21
Location:Arizona  Entered:2008-01-30
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: none
CDC Split Type: AZ0801
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB448AA3IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB173AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injected limb mobility decreased, Pain in extremity
SMQs:
Write-up: c/o pain upon injection. By the evening, pain from shoulder to elbow. Unable to raise arm. No rednes or swelling at site.

VAERS ID:304049 (history)  Vaccinated:2008-01-09
Age:29.0  Onset:2008-01-10, Days after vaccination: 1
Gender:Male  Submitted:2008-01-13, Days after onset: 3
Location:Georgia  Entered:2008-01-31, Days after submission: 18
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: Prescribed antibiotics
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1105UNLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR  UNRA
Administered by: Military     Purchased by: Military
Symptoms: Arthralgia, Injection site erythema, Injection site warmth, Lethargy, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Arthritis (broad)
Write-up: fever - 101 degF duration 14 hrs; lethargic, joint pain; injection site - red, swollen, hot to touch, muscle aches; *has had this 5 times in the past with no negative side effects*

VAERS ID:304901 (history)  Vaccinated:2008-01-09
Age:1.2  Onset:2008-02-08, Days after vaccination: 30
Gender:Male  Submitted:2008-02-08, Days after onset: 0
Location:Maine  Entered:2008-02-14, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS80956 UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
SMQs:
Write-up: 0.25ml Fluvirin given, $g4yrs rec, no reaction.

VAERS ID:304906 (history)  Vaccinated:2008-01-09
Age:0.8  Onset:2008-02-08, Days after vaccination: 30
Gender:Male  Submitted:2008-02-08, Days after onset: 0
Location:Maine  Entered:2008-02-14, 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:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS80956 UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
SMQs:
Write-up: 0.25ml Fluvirin given, rec $g4 yrs, no reaction.

VAERS ID:305190 (history)  Vaccinated:2008-01-09
Age:9.0  Onset:2008-01-11, Days after vaccination: 2
Gender:Female  Submitted:2008-01-15, Days after onset: 4
Location:New Mexico  Entered:2008-02-19, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Asthma; UTI in past.
Diagnostic Lab Data: None
CDC Split Type: NM020801
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1511U1SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site induration, Skin lesion
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Varicella #2 given 1/9/08. Seen in clinic for indurated erythematous lesion at site of injection. Unsure when lesion started.

VAERS ID:305302 (history)  Vaccinated:2008-01-09
Age:0.3  Onset:2008-01-09, Days after vaccination: 0
Gender:Unknown  Submitted:2008-02-14, Days after onset: 36
Location:Unknown  Entered:2008-02-19, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA02202
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse reaction
SMQs:
Write-up: Information has been received from a nurse concerning a 16 week patient who on 09-JAN-2008 was vaccinated with the first dose of Rotateq. The patient is not experiencing any known symptoms. Additional information has been requested.

VAERS ID:305645 (history)  Vaccinated:2008-01-09
Age:23.0  Onset:2008-01-10, Days after vaccination: 1
Gender:Female  Submitted:2008-02-14, Days after onset: 35
Location:Missouri  Entered:2008-02-19, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Penicillin allergy
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA02522
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1448U1IMLA
Administered by: Private     Purchased by: Private
Symptoms: Rash erythematous, Rash pruritic, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse concerning a 23 year old female who on 09-JAN-2008 was vaccinated with Gardasil. There was no concomitant medication. There was no illness reported at the time of vaccination. On 10-JAN-2008, the patient developed raised, red and itchy rash all over her abdomen, thighs and arms and called the physician. No physician visit was indicated. No laboratory/diagnostic tests were performed. The nurse reported that they advised the patient to take Benadryl. The patient outcome was unknown. Additional information has been requested. Follow-up received 04/16/2008. Initial and follow-up information has been received from a nurse concerning a 23 year old female with penicillin allergy who on 09-JAN-2008 was vaccinated with her second dose of GARDASIL (Lot #659653/1448U) intramuscularly in the left deltoid at approximately 9-9:30 am. There was no concomitant medication and no illness reported at the time of vaccination. On 10-JAN-2008, the patient developed a raised, red, itchy rash all over her abdomen, legs, thighs and arms and called the physician. No physician visit was indicated. The patient was told to take BENADRYL 50 mg orally. The patient phoned the physician''s office 11-JAN-2008 and reported that she never took the BENADRYL and the rash went away on its own. The patient has recovered from the itchy rash as of 11-JAN-2008. No further information is expected.

VAERS ID:305657 (history)  Vaccinated:2008-01-09
Age:20.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 36
Location:Unknown  Entered:2008-02-19, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA02708
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Burning sensation, Dyspnoea, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 20 year old female with no known allergies who on 09-JAN-2008 was vaccinated with Gardasil. There was no concomitant medication. On 09-JAN-2008, 10 minutes after receiving her first dose of the vaccine, the patient experienced anaphylactic reaction. She had a burning feeling in her stomach and head, her tongue started to swell, and she had difficulty breathing. The patient sought unspecified medical attention. The outcome of the patient was not provided. Additional information has been requested.

VAERS ID:306102 (history)  Vaccinated:2008-01-09
Age:25.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:Unknown  Entered:2008-02-19, 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: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Diagnostic laboratory blood work
CDC Split Type: WAES0801USA06057
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Amenorrhoea, Laboratory test, Menstruation irregular
SMQs:, Fertility disorders (broad)
Write-up: Information has been received from a consumer concerning his 25 year old wife with no pertinent medical history, who on 09-JAN-2008 was vaccinated intramuscularly, "in the arm", with the first dose of Gardasil. There was no concomitant medication. The consumer reported that in January 2008, "this past month", after receiving Gardasil, his wife experienced an "irregular menstrual cycle and hasn''t had her period." The patient''s amenorrhea and irregular menstrual cycle persisted. Medical attention was not sought. Unspecified "blood work" was performed. No product quality complaint was involved. No further information is available.

VAERS ID:306163 (history)  Vaccinated:2008-01-09
Age:19.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 36
Location:Unknown  Entered:2008-02-19, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA02036
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1522U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Pain in extremity
SMQs:
Write-up: Information has been received from a registered nurse concerning a 19 year old female with no known allergies and no reported medical history who on 09-JAN-2008 was vaccinated with her first dose of 0.5 ml GARDASIL (Lot #659055/1522U) intramuscularly. On 09-JAN-2008 the patient developed severe pain on both legs. The pain had not been resolved. No other details were reported. Additional information has been requested.

VAERS ID:306606 (history)  Vaccinated:2008-01-09
Age:1.6  Onset:2008-01-11, Days after vaccination: 2
Gender:Male  Submitted:2008-01-28, Days after onset: 17
Location:Illinois  Entered:2008-03-06, Days after submission: 38
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: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B067BA3IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH854015F3IMUN
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Erythema, Induration
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: ? Cellulitis - line drawn (L) shoulder, skin reddened, induration 4" x 3" on 1-11-08. Rechecked on 1-12-08, much improved.

VAERS ID:307285 (history)  Vaccinated:2008-01-09
Age:13.0  Onset:2008-01-10, Days after vaccination: 1
Gender:Female  Submitted:2008-03-18, Days after onset: 67
Location:Louisiana  Entered:2008-03-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: None~ ()~~0~In Patient|None~ ()~~0~In Sibling|None~ ()~~0~In Sibling
Other Medications: Adderall
Current Illness: None
Preexisting Conditions: NKDA, ADHD
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1446U0IMRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2537AA0IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2759AA5IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1367U1SCRA
Administered by: Private     Purchased by: Public
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Mother reported left arm red and swollen for 4 days (incident reported on 3/11/08)

VAERS ID:309598 (history)  Vaccinated:2008-01-09
Age:1.2  Onset:2008-01-10, Days after vaccination: 1
Gender:Female  Submitted:2008-04-07, Days after onset: 87
Location:California  Entered:2008-04-16, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PMH: NSVD at term, no complications. Family Hx: infantile seizures, thallassemia, JODM.
Diagnostic Lab Data: Mitochondrial DNA mutation studies - now back as normal; Encephalitis project - CSF RSV PPR - negative Outlying ER LABS: CBC, chemistry, CSF & UA WNL. CT of head revealed pansinusitis. CXR WNL. LABS: MRI/MRV WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B056DA3IMUN
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB242AA0IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURUF214AA3IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54013B3IMUN
Administered by: Private     Purchased by: Private
Symptoms: CSF test normal, Chest X-ray normal, Computerised tomogram abnormal, Convulsion, Cyanosis, Electroencephalogram normal, Encephalopathy, Foaming at mouth, Full blood count normal, Gaze palsy, Grand mal convulsion, Intensive care, Irritability, Laboratory test normal, Nuclear magnetic resonance imaging normal, Oxygen saturation decreased, Pyrexia, Sinusitis, Tachycardia, Urine analysis normal, Vaccination complication, Viral test negative
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hostility/aggression (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Chronic kidney disease (broad)
Write-up: Seizures requiring one week hospitalization with multiple medications to control. Seizures lasted 2 months despite Dilantin and Keppra. In control at present, weaning anti-seizure medications. MRI/MRV - negative; Video EEG - negative. 4/29/08 Reviewed hospital medical records for 1/10-1/12/2008. FINAL DX: likely pertussis encephalopathy; recurrent seizures. Records reveal patient experienced nasal congestion x 2-3 days, received vaccines, developed fever, irritability, generalized tonic-clonic seizure lasting 3-4 min. Seen in outlying ER & continued to have seizures w/eyes rolling back, frothing at mouth, desaturations & tachycardia despite medications. Total of approx 15-17 seizures. Temp in ER 101.2. Transferred to higher level of care. Peds ICU. Tx w/antiseizure meds & precautionary antivirals initially then d/c''d. Neuro consult done. Continued to have brief seizures w/perioral cyanosis. Progressed w/fewer & shorter seizures. D/C to home on antiseizure med. F/U phone call by MD on 1/13/2008 parent stated continued to seize approx every hour for approx 90 secs w/brief cyanosis. Parents refused readmission, meds were changed & were to f/u w/neuro on 1/14.

VAERS ID:309958 (history)  Vaccinated:2008-01-09
Age:61.0  Onset:2008-01-15, Days after vaccination: 6
Gender:Male  Submitted:2008-03-26, Days after onset: 70
Location:Michigan  Entered:2008-04-16, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Cardiac disorder; Diabetes
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type: WAES0802USA03406
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blister, Herpes zoster, Laboratory test, Pain, Rash vesicular, Skin lesion
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 61 year old male with an unspecified cardiac disorder and diabetes who on 09-JAN-2008 was vaccinated with a "single dose" of Zostavax (Oka/Merck) (Lot # "1131U"), site of administration unspecified. It was reported that on 15 JAN 2008 the patient developed herpes zoster, with dermatome C2-3 involvement. Vesicular lesions were present on the patient''s head and neck. It was also reported that on 15 JAN 2008 the patient developed a shingles like rash on the forehead. On a pain scale of one to ten, the patient''s pain was assessed at three. The patient "was given some topical cream and acyclovir". Unspecified medical attention was sought. There was no product quality complaint. A direct fluorescent antibody was not collected. It was reported that the specimen for the VZV identification program was obtained from a vesicular area (site unspecified). At the time of reporting the patient had recovered (date unspecified). Additional information has been requested.

VAERS ID:310654 (history)  Vaccinated:2008-01-09
Age:12.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Female  Submitted:2008-04-14, Days after onset: 95
Location:Wisconsin  Entered:2008-04-16, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 12/14/2007) Early sexual debut
Preexisting Conditions: Victim of abuse
Diagnostic Lab Data: Ultrasound - pregnant; ultrasound, 03/11/08, normal for dates: first trimester; beta-human chorionic, 02/??/08, pregnant
CDC Split Type: WAES0803USA03300
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Early sexual debut, Hyperemesis gravidarum, Injection site haemorrhage, Pregnancy with young maternal age, Ultrasound uterus
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a certified medical assistant, via the Merck pregnancy registry, concerning a 12 year old female patient with early sexual activity and a history of being abused (details not provided), who experienced her LMP on approximately 14-DEC-2007, and on 09-JAN-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included prenatal vitamins (unspecified) and ZOFRAN. The patient''s pregnancy was confirmed by an ultrasound (date not reported). She developed irregular spotting and bleeding during the pregnancy (dates not provided), as well as vomiting. The estimated date of delivery was 19-SEP-2008. At the time of this report, irregular spotting and bleeding was ongoing; the outcome of vomiting was not specified. The patient was seen at the physician''s office. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2009. Initial and follow up information has been received from a certified medical assistant and a registered nurse, certified. Via the Merck pregnancy registry, concerning a 12 year old female patient with early sexual activity and a history of being abused (details not provided), who experienced her LMP on approximately 14-DEC-2007, and on 09-JAN-2008 was vaccinated with the first dose of GARDASIL. Concomitant therapy included prenatal vitamins (unspecified) and ZOFRAN. There were no previous pregnancies. In February 2008, the pregnancy was confirmed by a pregnancy test, and on 11-MAR-2008, the patient had and ultrasound that was "normal for dates, placenta, amniotic fluid good." She developed irregular spotting and bleeding during the pregnancy (dates not provided), as well as vomiting. The estimated date of delivery was 19-SEP-2008. At the time of this report, the outcome of irregular spotting and bleeding and the outcome of vomiting was not specified. The patient was seen at the physician''s office, and was currently living in a treatment shelter. Additional information has been requested.

VAERS ID:310986 (history)  Vaccinated:2008-01-09
Age:22.0  Onset:2008-01-10, Days after vaccination: 1
Gender:Female  Submitted:2008-04-14, Days after onset: 94
Location:Pennsylvania  Entered:2008-04-16, 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:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0803USA04388
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Private     Purchased by: Private
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse practitioner concerning a 22 year old female who on 09-JAN-2008 was vaccinated IM with a 0.5 mL dose of GARDASIL (no lot# provided). On 10-JAN-2008 the patient developed an itchy rash under her arm in the axilla area and rash later spread over her whole body. Subsequently, the patient recovered from itchy rash under her arm in the axilla area and over her whole body. The patient sought medical attention via the family physician. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report previously submitted on 04/14/2008: Followup information has been received from the certified registered nurse practitioner (CRNP). It was reported that the 22 year old female, weighing 175 pounds, height of 65.75 inches, with no pre-existing allergies, birth defects or medical conditions, on 09-JAN-2008 (incorrectly reported as 19-Jan-2008) was vaccinated IM in the left deltoid with the first 0.5 mL dose of GARDASIL (no lot# provided). On 10-JAN-2008 (incorrectly reported as 20-Jan-2008) the patient developed a red, itchy rash under her arm which later became widespread. When the patient returned to the office for the second dose, she notified the physician of the rash she developed after receiving the first dose. It was reported that no treatment was tendered and "self-limited." The patient did not receive the second dose due to the rash she had developed after receiving the first dose. It was reported by the CRNP that she does not think the patient will finish the series due to the rash. No laboratory diagnostics tests were performed. It was also reported that the patient''s 3 year old son had a virus and a rash a week prior to the patient receiving the first dose, so patient does not know if the rash she developed was due to the vaccine or the virus and rash her son had. The patient''s son is not a patient of that office and they have no information on the son''s medical history. It was reported that the patient recovered on an unspecified date (previously reported as 17-Jan-2008). No further information is expected.

VAERS ID:311046 (history)  Vaccinated:2008-01-09
Age:4.0  Onset:2008-01-10, Days after vaccination: 1
Gender:Male  Submitted:2008-01-11, Days after onset: 1
Location:Nebraska  Entered:2008-04-28, Days after submission: 107
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: Healthy child
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2760AA3IMLL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2435AA2IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01253IMLL
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0425U1SCRL
Administered by: Other     Purchased by: Public
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 anterior thigh red, swollen, warm to most of anterior thigh with parts of lateral and medial thigh.

VAERS ID:311931 (history)  Vaccinated:2008-01-09
Age:19.0  Onset:2008-02-01, Days after vaccination: 23
Gender:Female  Submitted:2008-05-08, Days after onset: 96
Location:Unknown  Entered:2008-05-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
    Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: YAZ
Current Illness: Contraception; Allergic reaction to antibiotics
Preexisting Conditions: PMH: Hashimoto''s thyroiditis at age 7, hypothyroidism; pneumonia at age 9; vascular gum irregularity; irregular periods; MVA 4 yrs ago;anxiety. Allergy: zithromax, hives. On Yasmin contraceptive & minocycline for acne. Family hx: heart disease, Hashimotos disease & goiter.
Diagnostic Lab Data: LABS: CT brain WNL. MRI & MRA WNL. Repeat MRI abnormal w/possible focal demyelination. Carotid duplex WNL. Echocardiogram WNL. TEE WNL. Vit B12 194 (L). Influenza A&B neg. ECG w/sinus tachycardia. ANA (H). MRA of neck WNL.
CDC Split Type: WAES0805USA00064
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1063U1IMRA
Administered by: Private     Purchased by: Other
Symptoms: Angiogram, Antinuclear antibody increased, Anxiety, Cerebellar artery occlusion, Cerebrovascular accident, Demyelination, Diplopia, Dizziness, Dysstasia, Echocardiogram, Echocardiogram normal, Electrocardiogram abnormal, Gait disturbance, Influenza serology negative, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Pyrexia, Scan brain, Sinus tachycardia, Ultrasound Doppler, Vitamin B12 abnormal, Vitamin B12 deficiency, Vomiting, Wallenberg syndrome, Weight increased
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic cerebrovascular conditions (narrow), Haemorrhagic cerebrovascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Demyelination (narrow), Vestibular disorders (broad), Ocular motility disorders (broad)
Write-up: Information has been received from a consumer concerning her 20 year old daughter with allergy to azithromycin (ZITHROMAX) who on 09-NOV-2007 was vaccinated with the first dose of GARDASIL, 0.5 mL, (injection form) (Lot # not reported). On 09-JAN-2008, the patient was vaccinated with the second dose of GARDASIL, 0.5 mL, (injection form) (Lot # not reported). Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). On 01-FEB-2008, after getting the second dose of GARDASIL, the patient experienced a stroke and was hospitalized. The patient stayed in the hospital for one week. At the time of this report, the patient was recovering from the event. The causality of the event was not reported. No product quality complaint was involved. Additional information has been requested. 6/3/08 Reviewed hospital medical records for 2/4-2/8/2008. FINAL DX: small right CVA; vitamin B12 deficiency; sinus tachycardia; Wallenberg syndrome. Records reveal patient experienced dizziness, left sided numbness, diplopia, fever & vomiting x 2 days. Developed sinus tachycardia & anxiety controlled w/meds. Cardio & neuro consults done. Improved left face & arm paresthesias but left thigh & lower leg paresthesias persisted at d/c to home. Difficulty getting OOB & walking. To have outpatient PT/OT as well as f/u w/neuro & cardio. 9/5/08 Reviewed heme, neuro & rheum consultant medical records of 3/10-5/30/2008. FINAL DX: CVA, lateral medullary syndrome (Wallenberg''s) related to the occlusion of the posterior inferior cerebellar artery. Records reveal patient experienced recent CVA, 20# weight gain since CVA.

VAERS ID:313851 (history)  Vaccinated:2008-01-09
Age:61.0  Onset:2008-01-12, Days after vaccination: 3
Gender:Male  Submitted:2008-02-14, Days after onset: 33
Location:Tennessee  Entered:2008-05-28, Days after submission: 103
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:
Diagnostic Lab Data:
CDC Split Type: TN08005
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB096AA0IMRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURZ092220IMLA
Administered by: Public     Purchased by: Private
Symptoms: Abdominal distension, Blood test, Muscle spasms, Nausea, X-ray
SMQs:, Acute pancreatitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Clients reports on 2-12-08 he developed nausea, cramps and bloating 3 days after receiving vaccinations on 1/9/08. Patient saw PCP on 2-02-08 and had x-rays, blood work, antibiotics for possible bacterial infection. States was also presented pills for bloating. States is scheduled for endoscopy 2-19-08

VAERS ID:315725 (history)  Vaccinated:2008-01-09
Age:51.0  Onset:0000-00-00
Gender:Male  Submitted:2008-04-01
Location:Georgia  Entered:2008-06-09, Days after submission: 69
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: GA08022
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0090U1IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEURAC52B021AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Wrong drug administered
SMQs:
Write-up: None - given vaccine (TDAP) not licensed for this age.

VAERS ID:317594 (history)  Vaccinated:2008-01-09
Age:28.0  Onset:0000-00-00
Gender:Male  Submitted:2008-04-08
Location:North Carolina  Entered:2008-06-26, Days after submission: 79
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: N/A
Current Illness:
Preexisting Conditions: N/A
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURER  SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Injection site induration, Injection site oedema, Pain, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: SM developed redness, swelling, pain, induration at injection site that went from shoulder to elbow within 24 hours. Edema at injection site $g120 mm not beyond elbow start: 01/09/2008, erythema start: 01/09/2008, swelling start: 01/09/2008, tenderness start 01/09/2008.

VAERS ID:318586 (history)  Vaccinated:2008-01-09
Age:77.0  Onset:2008-01-24, Days after vaccination: 15
Gender:Male  Submitted:2008-07-09, Days after onset: 166
Location:New Hampshire  Entered:2008-07-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 10 mg. lipitor, 6.25 mg. coreg x 2
Current Illness: None
Preexisting Conditions: allergic to bactrim/sulfa drug
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC. 0IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Zostavax/shingles vaccine administered 1/9/08. Rash occured at base of spine by the end of the month. Self treated with Johnson & Johnson Calamine spray 5-7 days.

VAERS ID:320752 (history)  Vaccinated:2008-01-09
Age:49.0  Onset:2008-01-28, Days after vaccination: 19
Gender:Female  Submitted:2008-07-29, Days after onset: 182
Location:Missouri  Entered:2008-07-29
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No medications
Current Illness: No short term illness on that date
Preexisting Conditions: Penicillin, Caffeine allergies, Pre-existing anxiety 2006.
Diagnostic Lab Data: Hematology - Normal; Chemistry normal; Cardiogram normal; Lung X-ray normal; Coagulation - normal 8/14/08-records received- CA 125 normal. Pathology report three simple ovarian cysts. No atypia found in endometrium.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2509 IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHVB173AA0IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.U3240IMLA
Administered by: Public     Purchased by: Private
Symptoms: Carbohydrate antigen 125, Coagulation test normal, Electrocardiogram normal, Haematology test normal, Haemorrhage, Hysteroscopy, Laboratory test normal, Laparoscopy, Menstruation irregular, Oophorectomy, Ovarian cyst, Ultrasound scan abnormal, Uterine dilation and curettage, Uterine enlargement, X-ray normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Ovarian tumours of unspecified malignancy (broad), Fertility disorders (broad)
Write-up: Irregular bleeding, abnormal ultrasound, uterus enlarged, endometrial pelvic, abnormal multiple cysticareas, left ovary solid component, 3.5 cysts with septations: left ovariectomy, endocervic D & C, endometrium D & C, simple hyperplasior laparoscopy ovary evaluation, hyperoscopy evaluation of endometrium operation procedure. Did tests, x-rays, electrocardiogram, hematology. 8/14/08-records received-8/14/08-records received for DOS 3/6/08-Same day surgery for C/O menometrorrhagia and uterine fibers. US sholwed left complex ovarian cyst and abnormal endometrial.Laprascopic adhesiolysis with left oophorectomy. Hysteroscopy with dilatation and curettage.

VAERS ID:333498 (history)  Vaccinated:2008-01-09
Age:12.0  Onset:2008-01-10, Days after vaccination: 1
Gender:Female  Submitted:2008-12-01, Days after onset: 326
Location:Alaska  Entered:2008-12-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: headache,dizziness~HPV (Gardasil)~3~1.80~Patient
Other Medications: Methimazole 5mg one a day; Synthroid .005mcg one per day
Current Illness: None
Preexisting Conditions: Hyperthyroidism
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dizziness, Headache, Nausea, Pain, Photopsia, Vaccine positive rechallenge
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Retinal disorders (narrow), Vestibular disorders (broad)
Write-up: My daughter had all 3 shots in the Gardasil series. 1st shot 12/6/07, also had the Meningococcal that day, no problems noticed until 2nd shot which was on 1/9/08, she started to complain the next day of nausea, headaches and body aches. 3rd shot 6/20/08. symptoms of headache, body aches and dizziness, flashes of color at times have continued on almost a daily basis.

VAERS ID:333854 (history)  Vaccinated:2008-01-09
Age:35.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Female  Submitted:2008-11-14, Days after onset: 310
Location:Unknown  Entered:2008-12-04, Days after submission: 20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamins (unspecified)
Current Illness: Pregnancy NOS (LMP=Unknown)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA02515
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, No adverse event, Wrong drug administered
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Information has been received from a health professional concerning a 35 year old female with no known allergies who on 09-JAN-2008 was vaccinated with GARDASIL. Concomitant therapy included unspecified vitamins. On 09-JAN-2008 the patient received the wrong vaccine. Instead of receiving the flu vaccine (manufacturer unknown), the patient received GARDASIL. No adverse experience was reported. The patient sought unspecified medical attention. The outcome of the patient was not reported. On 14-JAN-2008, additional information was received for the Pregnancy Registry for GARDASIL from the patient''s brother-in-law. He reported that the patient was pregnant when she received her first accidental dose of GARDASIL. No adverse experience was reported. The patient sought unspecified medical attention. Follow-up information has been received which reported that on an unknown date the patient delivered a normal infant with no congenital anomalies.

VAERS ID:335357 (history)  Vaccinated:2008-01-09
Age:0.2  Onset:2008-01-09, Days after vaccination: 0
Gender:Female  Submitted:2008-12-15, Days after onset: 341
Location:New York  Entered:2008-12-15
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:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRL
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMLL
RVX: ROTAVIRUS (NO BRAND NAME)UNKNOWN MANUFACTURER 0PO 
Administered by: Private     Purchased by: Unknown
Symptoms: Crying, Immediate post-injection reaction, Screaming
SMQs:, Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow)
Write-up: Immediately after injection, baby cried, and then had uncontrollable screeming for 4 hours.

VAERS ID:337567 (history)  Vaccinated:2008-01-09
Age:0.2  Onset:2008-12-15, Days after vaccination: 341
Gender:Male  Submitted:2008-12-01, Days after onset: 14
Location:Unknown  Entered:2008-12-16, Days after submission: 15
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: None
Diagnostic Lab Data: diagnostic laboratory, 11/09/07, see narrative
CDC Split Type: WAES0805USA01089
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2797AA UNUN
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.0016U UNUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0273 UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB52781B UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Private     Purchased by: Other
Symptoms: Dry skin, Laboratory test normal, Rash macular, Seborrhoeic dermatitis, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 42 day old white male who on 09-Jan-2008 was vaccinated with hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (Lot# 656509/0016U). Concomitant therapy included rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot # reported as 1193U). Other concomitant therapy included hepatitis B virus vaccine (unspecified), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine, (PREVNAR) vaccine (CRM197) and Hib conj vaccine (unspecified carrier). On approximately 15-DEC-2007 the patient experienced a rash on his face that had spread over his head. He was not bothered by it, no illness or fevers were reported. The rash was described as a macular rash on his right cheek that went over his right ear and over the top of his head. Both of his cheeks were dry and scaly. The physician''s assessment was seborrheic dermatitis on his face. He was treated with (LOTRIMIN) twice a day and another cream to be used daily. It was also reported, that the infant had newborn screening done 2 days after his birth which resulted as normal. At the time of this report, the infant''s outcome was unknown. Additional information has been requested.

VAERS ID:339632 (history)  Vaccinated:2008-01-09
Age:41.0  Onset:2008-01-13, Days after vaccination: 4
Gender:Male  Submitted:2009-02-06, Days after onset: 390
Location:Washington  Entered:2009-02-13, 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: denies
Current Illness: denies
Preexisting Conditions: Reitens disease
Diagnostic Lab Data: MRI pin pt
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB208AA0UNLA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURU1992EA UNLA
TYP: TYPHOID LIVE ORAL TY21A (NO BRAND NAME)UNKNOWN MANUFACTURER  PO 
Administered by: Public     Purchased by: Private
Symptoms: Nuclear magnetic resonance imaging, Pain, Reiter's syndrome
SMQs:, Arthritis (narrow)
Write-up: Pt states reoccurrence of Reitens Disease after 3rd TYPHOID pill - c/o S-1 pain resolved post backs required steroid use Last episode of Reitens disease was 5 years prior- pain in wrist. Pt reported event today 2/6/09

VAERS ID:341060 (history)  Vaccinated:2008-01-09
Age:81.0  Onset:2008-09-25, Days after vaccination: 260
Gender:Female  Submitted:2009-03-04, Days after onset: 160
Location:Minnesota  Entered:2009-03-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: COPD
Preexisting Conditions: 3/11/09-records received-PMH:breast cancer status post right mastectomy, cervical cancer, glucose intolerance, hypertension, cough with lisinopril, muscle aches with pravachol, colonscopy. Allergy to sulfonamides causes rash.
Diagnostic Lab Data: 3/11/09-records received-ECG normal. Arteriogram with angioplasty to right lower extremity.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Angioplasty, Electrocardiogram normal, Femoral artery occlusion, Intermittent claudication, Reocclusion
SMQs:, Embolic and thrombotic events, arterial (narrow)
Write-up: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 11/06/2008 for left fem artery reocclusion. Vaccination took place on 1/09/2008. According to the physician, the relationship is ''None''. We would be happy to forward the Study''s SAE reporting form upon request. 3/11/09-records received for DSO 9/25-9/26/08-DC DX:Bilateral fem-pop artery in-stent restenosis with disabling claudication. Bilateral lower extremity claudication andovascular intervention.

VAERS ID:341815 (history)  Vaccinated:2008-01-09
Age:65.0  Onset:2008-12-29, Days after vaccination: 355
Gender:Female  Submitted:2009-03-03, Days after onset: 64
Location:Unknown  Entered:2009-03-16, 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:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0967U IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Herpes zoster
SMQs:
Write-up: Pt had severe outbreak of herpes zoster. Patient received vaccine 1/0/08 then on 12/29/08 had a severe outbreak of herpes Zoster.

VAERS ID:342756 (history)  Vaccinated:2008-01-09
Age:23.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Female  Submitted:2009-03-13, Days after onset: 428
Location:Unknown  Entered:2009-03-16, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Pregnancy NOS (LMP = 1/10/2008) Bipolar disorder; Smoker
Preexisting Conditions: Depression; Anxiety; Papanicolaou smear abnormal; Loop electrosurgical excision procedure
Diagnostic Lab Data: ultrasound, 03/05/08 - INP; urine beta-human - positive; serum alpha-fetoprotein, 05/01/08 - within normal limits
CDC Split Type: WAES0804USA01176
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Alpha 1 foetoprotein normal, Drug exposure during pregnancy, Oligohydramnios, Pregnancy test positive, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a certified nurse midwife concerning a 23 year old pregnant female who is bipolar and has a history of depression, anxiety, abnormal pap test and had a loop electrosurgical excision procedure. On 02-NOV-2007 the patient was vaccinated IM with the first dose of GARDASIL vaccine (lot # 658563/1063U). On 09-JAN-2008 the patient was vaccinated IM with the second dose of GARDASIL vaccine (lot #659437/1266U). The last menstrual period was reported to be on 10-JAN-2008. An urine pregnancy test was performed with positive results. On 12-JAN-2008 a maternal serum alpha-fetoprotein test was performed within normal results. On 05-MAR-2008 an ultrasound was performed (NP). It was also reported that this is the patient''s first pregnancy. The estimated delivery date is 16-OCT-2008. The certified nurse midwife reported she wishes to register the patient on the pregnancy registry. Follow-up information has been received from certified nurse midwife concerning the patient, who was also reported to be a smoker with no history of previous pregnancies. On 01-MAY-2008, MSAFP screening test as performed and results were within normal limits. It was reported he mother developed oligohydramnios during the pregnancy. On 21-OCT-2008, 41.1 weeks from the last menstrual period, the patient delivered a normal male baby who weighted 7 pounds and 13.8 ounces. His length was 19 feet. His Apgar score was assessed to be 8/9. No complications occurred during the labor. No further information is available.

VAERS ID:343154 (history)  Vaccinated:2008-01-09
Age:18.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Female  Submitted:2009-03-31, Days after onset: 446
Location:Nebraska  Entered:2009-04-01, 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: Vitamins (unspecified)
Current Illness: Pregnancy NOS (LMP = 2/4/2008); Sulfonamide allergy
Preexisting Conditions: Low grade squamous intraepithelial lesion
Diagnostic Lab Data: Ultrasound, 03/20/08, dating; Beta-human chorionic, positive
CDC Split Type: WAES0803USA01840
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Foetal disorder, Inappropriate schedule of drug administration, Pregnancy test positive, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information and follow up has been received from a physician for the Pregnancy Registry for GARDASIL concerning a 18 year old female with sulfonamide allergy and a history of low grade squamous intraepithelial lesion who on 12-DEC-2007 was vaccinated with her first dose of GARDASIL (lot# not reported). There was no concomitant medication. On 09-JAN-2008 the patient was vaccinated with her second dose of GARDASIL (lot# not reported) and then learned she was pregnant after a positive pregnancy test. The patient''s estimated LMP was 04-FEB-2008 with an EDD of 13-NOV-2008. On 20-MAR-2008 the patient had an ultrasound to check dating. On an unspecified date, the patient began taking prenatal vitamins (unspecified). It was reported that the patient had no previous pregnancies. Subsequently the patient experienced no adverse event and on an unspecified date she sought unspecified medical attention at her physician''s office. Follow-up information has been received from a completed questionnaire. On 08-NOV-2008, 38 weeks from her LMP, the patient delivered a live normal male infant weighing 7 pounds 8 ounces via spontaneous vaginal route. The infant was 20.25 inches in length and 13 inches in head circumference, with an Apgar score of 8/9. No congenital anomalies, complications or abnormalities were reported. Medication during her pregnancy included prenatal vitamin (unspecified) once daily. There were no complications, infections or illnesses during her pregnancy and delivery. Pediatric medical records were received and reviewed and the following experience was identified: On 12-DEC-2008, the 35-day-old infant presented to the clinic with his mother. His mother noticed purulent material in his eyelashes for the past month. He was doing well otherwise and had breast feeding every 3 hours. He has not had any fevers, illness or problems with constipation. There was no passive tobacco smoke exposure. Physical examination regarding his eyes revealed: Positive red reflex bilaterally. No conjunctival infection but he has purulen

VAERS ID:358892 (history)  Vaccinated:2008-01-09
Age:26.0  Onset:2009-09-17, Days after vaccination: 617
Gender:Male  Submitted:2009-09-22, Days after onset: 5
Location:North Carolina  Entered:2009-09-30, 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:
Current Illness: none reported
Preexisting Conditions: none
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Military     Purchased by: Military
Symptoms: Erythema, Oedema, Rash papular, Rash pustular, Scab, Scar
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow)
Write-up: 27 y/o AD WM calls clinic on 17SEP09 concerned about "red, warm, tender area on my right upper arm "under my smallpox vaccination scar." There is no documentation of patients primary SPV date in DEERS or MEDPROS, but historically, the patient states he received his primary SPV just before he deployed over seas in JAN of 2008, the same day he got his AVA #1 (09JAN08) per DEERS. He has a scar on his right upper arm, which is now covered by an extensive, elaborate tattoo, which the patient has placed, in stages, over the past 6 weeks (deltoid of RUE). The patient reports a normal 2-3 week evolution of his primary SPV from papule to pustule to a scab, which dried and fell off without complications in JAN 2008. Thus, it appears that the current area of erythema, edema, and pus on his RUE represents a new infection, secondary to the patients recent tattoo placement on his RUE and is NOT in temporal association with the placement of his primary SPV in JAN of 2008. The patient was seen at the clinic on 17 Sept 09 by NP and Dr., who agreed with assessment. The patient was treated with KEFLEX 250 mg po qid x 10 days and given 800 mg ibuprofen tid po WF #30 prn pain. He was instructed to apply warm compresses 2-3 times a day over the affected area and to F/U with his PCP at clinic the next morning for TD booster, as his last TD was given on 12JUN2001. The patient did as instructed and saw seen by PA-c on SEP 18 09 at clinic and was given a TDAP and instructed to continue the compresses and KEFLEX. The PA-C who saw the patient felt that an I&D of the area was not necessary, as the patient reported that it ruptured spontaneously that evening before after applying the warm compress. NP f/u with patient by phone on 18 SE) 09 and he was doing better, applying the warm compresses and taking the KEFLEX. By second f/u call on 22SEP09, the SM reported that the area was no longer red or warm, but that he could feel a bump, perhaps from scar tissue. SM was in another state at the time. Advised to f/u prn at clinic.

VAERS ID:374324 (history)  Vaccinated:2008-01-09
Age:17.0  Onset:2008-03-26, Days after vaccination: 77
Gender:Female  Submitted:2009-12-18, Days after onset: 632
Location:Unknown  Entered:2009-12-21, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Seasonal allergy; drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Bone scan, no results provided; colonoscopy, no results provided; computed axial, no results provided; magnetic resonance, no results provided; electromyography, 11/18?/09, patient was stable and no neurological symptoms were noted
CDC Split Type: WAES0912USA01364
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0515U UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Activities of daily living impaired, Back pain, Bedridden, Biopsy intestine normal, Bone scan, Bowel movement irregularity, Colonoscopy, Computerised tomogram, Constipation, Diarrhoea, Diplegia, Electromyogram normal, Fall, Haematochezia, Haemorrhoids, Hypoaesthesia, Mass, Nausea, Nuclear magnetic resonance imaging, Ovarian cyst, Pain, Staphylococcal infection, Swelling, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a physician''s administrator, a registered nurse, a medical assistant and a consumer concerning her 17 year old daughter with seasonal allergies and allergy to BENADRYL and BACTRIM who on 14-MAR-2007 was vaccinated with a first 0.5 ml dose of GARDASIL (Lot No. 655618/0186U) administered in her left arm. On 09-JUL-2007 the patient received a second dose of GARDASIL (Lot No. 654272/0319U) administered in her right arm and on 09-JAN-2008 received a third dose of GARDASIL (Lot No. 657872/0515U) administered on her left arm. Concomitant medication included NUVARING. On 26-MAR-2008 the patient developed a "bump" on her thigh. In June 2008 the patient developed a MRSA infection, confirmed on 29-SEP-2008. On 02-JUL-2008 the patient experienced bowel movement issues. The patient''s mother mentioned that the patient is in constant pain which she described as 6 on a scale of 1-10. She also had periodic paralysis of her lower extremities and her "muscles go numb and she falls all the time". She had abdominal pain and nausea and had developed ovarian cysts. The patient saw a pediatric surgeon for her ovarian cysts. The physician''s administrator indicated that the condition had "nothing to do" with GARDASIL. The mother mentioned that the patient was almost completely bedbound. It was reported that the patient''s boyfriend had a breakout of MRSA on 17-FEB-2009. The medical assistant stated that in March 2009 the patient was seen for the last time after a "well check-up". The patient was hospitalized twice in the summer of 2009 for an unknown reason (length of stay unspecified). The patient had been to the neurologist and had tests done on her muscles and her bones and no one could "figure out what''s wrong with her". The medical assistant did not have any information surrounding the patient''s paralysis, ovarian cysts, or hospitalizations. Bone scan, colonoscopy, CT scans and MRI tests were performed with no results provided. On 18-NOV-2009 the patient was seen by a neurologist. An EMG was done along with a physical exam. The patient was stable and no neurological symptoms were noted. At the time of the report, the patient had not recovered. Additional information has been requested.

VAERS ID:382951 (history)  Vaccinated:2008-01-09
Age:26.0  Onset:2008-05-01, Days after vaccination: 113
Gender:Female  Submitted:2010-03-04, Days after onset: 672
Location:Florida  Entered:2010-03-18, Days after submission: 13
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Cataract (congenital); glaucoma
Diagnostic Lab Data: Complete neurological workup
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1757U2IMRA
Administered by: Private     Purchased by: Private
Symptoms: Hypoaesthesia, Pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: May, 2008 complained of acute severe pain, weakness. (R) leg with numbness. Admitted to local hospital. After seeing numerous MD''s, neuromuscular specialist determined due to GARDASIL immunization.

VAERS ID:531139 (history)  Vaccinated:2008-01-09
Age:1.1  Onset:2014-05-02, Days after vaccination: 2305
Gender:Female  Submitted:0000-00-00
Location:Oregon  Entered:2014-05-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Culture (+) varicella
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 3UNUN
Administered by: Private     Purchased by: Other
Symptoms: Herpes zoster, Varicella virus test positive
SMQs:
Write-up: Shingles

VAERS ID:303074 (history)  Vaccinated:2008-01-09
Age:5.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Male  Submitted:2008-01-21, Days after onset: 12
Location:Foreign  Entered:2008-01-21
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: B0503692A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B050CC IMLA
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Trismus, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported by a regulatory authority (#80698) and described the occurrence of partial loss of consciousness in a 5-year-old male subject who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. On 9 January 2008, the subject received unspecified dose of Infanrix (intramuscular, unknown injection site). On 9 January 2008, less than one day after vaccination with Infanrix, the subject experienced partial loss of consciousness with trismus and vomiting. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with Infanrix.

VAERS ID:303520 (history)  Vaccinated:2008-01-09
Age:42.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Female  Submitted:2008-01-24, Days after onset: 15
Location:Foreign  Entered:2008-01-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0503775A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNRA
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Fatigue, Feeling hot, Hypoaesthesia, Hypoaesthesia oral, Palpitations, Pharyngeal hypoaesthesia, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of anaphylactic reaction in a 42-year-old female subject who was vaccinated with Twinrix (GlaxoSmithKline) for prophylaxis. on 9 January 2008, the subject received 1st dose of Twinrix (unknown route and injection site), lot number not provided. On 9 January 2008, 10 minutes after vaccination with Twinrix, the subject experienced anaphylactic reaction with palpitation, fainting feeling, difficulty breathing, feeling of numbness in throat and tongue, feeling hot, urticaria on whole body and feeling tired. The subject was hospitalised for observation during 1 day. The subject was treated with Clarityn, Betapred, Tavegyl and Adrenalin. On 15 January 2008, the subject reported to the nurse that the events were not completely resolved although she is taking antihistaminic medication. At the time of reporting the events were unresolved.

VAERS ID:303922 (history)  Vaccinated:2008-01-09
Age:45.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Male  Submitted:2008-01-29, Days after onset: 20
Location:Foreign  Entered:2008-01-30, 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: EPILIM, Unk-Unk; lamotrigine, Unk-Unk
Current Illness: Epilepsy; diabetes
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0801USA05153
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0052F IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Local reaction, Oedema peripheral, Pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Information has been received initially from a health professional and the foreign Health Authority concerning a 45 year old patient with epilepsy and diabetes who on 09-JAN-2008 was vaccinated IM into arm with a dose of Pneumovax 23 0.5 mL (lot # 654246/0052F) (batch # ND48950). Concomitant therapy included valproate sodium (EPILIN) and lamotrigine. On 09-JAN-2008, the same day as vaccination, the patient developed a severe local reaction with the upper arm red, swollen and itching. The patient recovered on an unspecified date. Both the reporter and the MHRA considered the events to be an other medically important event. The other business partner numbers included 20209923 and E2008-00551. Additional information is not expected.

VAERS ID:304127 (history)  Vaccinated:2008-01-09
Age:75.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Male  Submitted:2008-01-31, Days after onset: 22
Location:Foreign  Entered:2008-02-01, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: ARTIST
Current Illness: Arrhythmia; chronic obstructive pulmonary disease; glucose tolerance impaired; hyperlipidaemia
Preexisting Conditions:
Diagnostic Lab Data: body temp 09Jan08 38.8 Celsius; body temp 11Jan08 36.9 Celsius
CDC Split Type: WAES0801USA03055
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Erythema, Injection site erythema, Injection site swelling, Oedema peripheral, Pain in extremity, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Initial and follow up information has been received from a physician concerning a 75 year old male patient with arrhythmia chronic obstructive pulmonary disease, borderline diabetes and hyperlipidaemia (allergy and medical history unknown) who on 09-JAN-2008 was vaccinated with a dose of Pneumovax 23. Concomitant therapy included ARTIST. On 09-JAN-2008, Pneumovax 23 was subcutaneously inoculated at the patient''s own request of receiving vaccination because of the presence of chronic obstructive pulmonary disease (COPD). Four hours after vaccination, the patient developed swelling in the vaccinated left upper arm. The physician provided AE terms "swelling from upper arm to forearm" and "redness from upper arm to forearm". On 09-JAN-2008, six hours after vaccination, the patient developed pyrexia of 38.8 degrees Celsius. He called nighttime emergency medical center and was advised hospitalization. He was seen by a nearby physician (not at the reporter''s hospital) and was soon hospitalized there. At the visit, the swelling had spread to the forearm with pain, and he was treated with intravenous (IV) drip, antibiotics and cool compress. On 11-JAN-2008 the patient was discharged. As swelling of the forearm (judgment by photo) and a slight fever (36.9 degrees Celsius) still remained, he visited the reporting physician. The physician prescribed compress and sent him home. On 17-JAN-2008, the patient called the reporting physician stating "Both pain and slight fever disappeared that morning". He used compress for the swelling in the morning but it also resolved in the afternoon except for slight swelling. The reporting physician determined that the patient was almost recovering from "swelling from upper forearm", "redness from upper arm to forearm" and "pyrexia". The reporting physician felt that "swelling from upper arm to forearm", redness from upper arm to forearm" and "pyrexia" are definitely related to Pneumovax 23. The reporting physician considered that the "swelling from upper arm to forearm", "re

VAERS ID:304571 (history)  Vaccinated:2008-01-09
Age:22.0  Onset:2008-01-23, Days after vaccination: 14
Gender:Female  Submitted:2008-02-07, Days after onset: 15
Location:Foreign  Entered:2008-02-08, Days after submission: 1
Life Threatening? Yes
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: WAES0802USA00271
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0483U2IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Intensive care, No reaction on previous exposure to drug, Resuscitation, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow)
Write-up: Information has been received from a gynecologist concerning a 22 year old female who on 09-JAN-2008 was vaccinated intramuscularly into the deltoid muscle with her third dose of Gardasil (lot #0483U). On approximately 23-JAN-2008 the patient experienced ventricular fibrillation. Resuscitation was necessary, she was admitted to the hospital and treated in the ICU. At the time of reporting her condition was stable. No detailed information was available and no cause for the event was found so far. The physician didn''t see a casual relation to the vaccine. On unspecified dates, previous vaccinations with Gardasil were well tolerated. The ventricular fibrillation was considered to be immediately life-threatening and an other important medical event. Other business partner numbers included: E2008-00699. No further information is available.

VAERS ID:306164 (history)  Vaccinated:2008-01-09
Age:86.0  Onset:0000-00-00
Gender:Male  Submitted:2008-02-28
Location:Foreign  Entered:2008-02-29, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BLOPRESS, 2004 - Unk; NORVASC, 2004 - Unk; PANALDINE, 2004 - Unk
Current Illness: Bronchitis chronic; hypertension; infarction
Preexisting Conditions:
Diagnostic Lab Data: body temp 09Jan08 39degrees Celsius; serum C-reactive protein 14Jan08 11 mg/dL; body temp 16Jan08 38 degrees Celsius
CDC Split Type: WAES0801USA05532
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, C-reactive protein increased, Death, Pneumonia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad)
Write-up: Initial and follow-up information has been received from a physician concerning an 86 year old male with chronic bronchitis, hypertension and lacunar infarction (past medical history not reported) who on 09-JAN-2008 was vaccinated with Pneumovax 23 (dose and indication not reported). Concomitant therapy included PANALDINE, BLOPRESS and NORVASC. On 09-JAN-2008 on the night of vaccination, the patient developed pyrexia of 39 degrees Celsius (C). On an unspecified date, the patient developed increased C-reactive protein (CRP). On 14-JAN-2008, intravenous drip infusion of UNASYN 3 gram (g) was given at another hospital. CRP was 11 mg/dL. On 16-JAN-2008, at visit, the patient had persisting pyrexia of 38 degrees C. On 17-JAN-2008, at the time of the report, the patient had not recovered from pyrexia. On an unspecified date, the patient was admitted to another hospital (reason not reported). On an unspecified date, the patient died of pneumonia at another hospital. Autopsy results were not reported. Outcomes of pyrexia and increased CRP were unknown. The reporting physician felt that causal relationship among Pneumovax 23, pyrexia and increased CRP was definitely related. The reporting physician felt that causal relationship between Pneumovax 23 and "die of pneumonia" was definitely not related. The physician considered pyrexia and increased CRP were non-serious. The physician considered that "die of pneumonia" was serious due to death. No further information was available. Follow-up information: The AE terms "increased CRP" and "die of pneumonia" was added. Additional information has been requested.

VAERS ID:306358 (history)  Vaccinated:2008-01-09
Age:25.0  Onset:2008-01-09, Days after vaccination: 0
Gender:Female  Submitted:2008-03-03, Days after onset: 54
Location:Foreign  Entered:2008-03-04, 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: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA06165
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0352U IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crepitations, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a health authority concerning a 25 year old female with no relevant medical history reported who on 09-JAN-2008 was vaccinated intramuscularly with a dose of GARDASIL (batch NG00320, lot 0352U). On 09-JAN-2008, post vaccination, the patient developed injection site pain, crepitations, and scar like retractions for several weeks. The pain was so strong that an abscess was suspected. Subsequently, the patient recovered on an unspecified date. The reporter considered the patient''s experience to be serious as other important medical event. Other business partner numbers include E2008-01690 and 27314. No further information expected. The case was closed.

VAERS ID:306475 (history)  Vaccinated:2008-01-09
Age:5.0  Onset:2008-01-11, Days after vaccination: 2
Gender:Unknown  Submitted:2008-03-03, Days after onset: 52
Location:Foreign  Entered:2008-03-05, Days after submission: 2
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:
Preexisting Conditions: Mild local reaction after the 4th dose of Infanrix-IPV+Hib in 2004.
Diagnostic Lab Data:
CDC Split Type: 200800591
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2733AB IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Pain in extremity, Similar reaction on previous exposure to drug
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Initial report received from health authorities on 26 February 2008. A 5-year-old patient of unspecified gender and medical history developed a very strong injection site reaction more than 10 cm in diameter at 16.00 hours, on 11 January 2008, exceeding the nearest joint which lasted for more than 3 days. The event occurred 2 days following the intramuscular TRIPACEL, lot no: C2733AB on 09 January 2008. Upon visit on 11 January 2008, the patient had injection site oedema and redness about 12 cm in diameter. The patient had pain in the left arm when touched. The patient was hospitalized at an unspecified time and recovered within an unspecified time frame. Of note: the mother did not inform the doctor before this vaccination that, the patient had a mild local reaction after the 4th dose of Infanrix-IPV+Hib in 2004.

VAERS ID:320743 (history)  Vaccinated:2008-01-09
Age:0.2  Onset:2008-01-15, Days after vaccination: 6
Gender:Female  Submitted:2008-07-30, Days after onset: 196
Location:Foreign  Entered:2008-07-29, 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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Abdominal X-ray, Jan2008, IS; Ultrasound abdomen, Jan2008, IS
CDC Split Type: B0530263A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Intestinal obstruction, Intussusception, Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of intussusception in a 2-month-old female subject who was vaccinated with ROTARIX. This case was collected through the Paediatric Surveillance Unit Acute Intussusception study occurring post Rotavirus vaccination. The subject was born at term. The subject''s birth weight is 3.315Kg. The subject had no family history of intussusception. Feeding history: The subject currently fed formula. The subject received no current treatment. The subject received other vaccines as per schedule. On 9 January 2008, the subject received the 1st dose of ROTARIX (unknown, lot number not provided). On 15 January 2008, 6 days after vaccination with the 1st dose of ROTARIX, the subject was admitted at hospital due to intussusception. The subject experienced intestinal obstruction, bile stained vomiting and vomiting. No faeces sample was collected. The diagnosis of intussusception was made based on abdominal ultrasound exam and abdominal X-ray. Intussusception had spontaneously reverted. At the time of reporting the outcome of the events was unspecified.

VAERS ID:432381 (history)  Vaccinated:2008-01-09
Age:18.0  Onset:2010-10-04, Days after vaccination: 999
Gender:Female  Submitted:2011-08-30, Days after onset: 330
Location:Foreign  Entered:2011-08-31, 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:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Diagnostic pathological examination, 04Oct10, PAP IIID; Diagnostic laboratory test, 17Jan11, PCR urine screening test: positive HPV high-risk virus strain
CDC Split Type: WAES1108USA03217
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0276U2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cervical dysplasia, Cytology abnormal, Human papilloma virus test positive, Pathology test, Polymerase chain reaction, Vaccination failure, Viral test positive
SMQs:, Lack of efficacy/effect (narrow), Reproductive premalignant disorders (narrow), Uterine and fallopian tube malignant tumours (broad)
Write-up: Case was received from the Health Authorities on 22-AUG-2011 (reference number PEI2011025855). Case was medically confirmed. A female patient received the complete immunisation series with three doses of intramuscular GARDASIL on 09-JUL-2007 (D1, lot# 1466F, batch # NF15720), on 05-SEP-2007 (D2, lot # 1518F, batch # NF23330) and on 09-JAN-2008 (D3, lot# 0276U, batch # NF58550), all given into the left deltoid muscle. On 04-OCT-2010, at the age of 18 years, a cytology test showed cervical dysplasia PAP IIID with cell maturity grade 3-4. On 17-JAN-2011 a PCR urine screening test showed positive HPV high-risk virus strains. Vaccination failure was concluded. At the time of the report the outcome was not reported. It was stated that the patient''s virginity was intact on completion of the vaccination series. The case was considered as serious by Health Authority (other medically important). File closed. Other business partner numbers included E2011-05039. 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 © 2015 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166