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Case Details (Sorted by Vaccination Date)

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VAERS ID:313192 (history)  Vaccinated:2008-05-23
Age:22.0  Onset:2008-05-23, Days after vaccination: 0
Gender:Male  Submitted:2008-05-23, Days after onset: 0
Location:Illinois  Entered:2008-05-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC.1837U2IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure, Body temperature, Dizziness, Feeling hot, Heart rate, Injection site warmth, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Approximately 10 minutes after administration of injection, pt felt extremely hot and some lightheadedness and nausea. VS 158/89 pulse 95 temp 98.1 F. Pt sat down and was given some water. Pt recovered from all symptoms in under 15 mins. Area surrounding IM site remains warm to touch, no hardening, no hives.

VAERS ID:313202 (history)  Vaccinated:2008-05-23
Age:17.0  Onset:2008-05-23, Days after vaccination: 0
Gender:Female  Submitted:2008-05-23, Days after onset: 0
Location:Georga  Entered:2008-05-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU25694AA IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure decreased, Malaise, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Pt. was given Menactra vaccine, when she went to leave the room she fainted (which is not uncommon with teenagers, she had not eaten anything and it was about 10:30) We laid her down and gave her some crackers and drink. Her color did not come back and she did not feel well. Dr. checked her blood pressure and it was 80/40. It was 110/70 before the vaccine was given. We monitored the patient for about two hours at the office her BP finally got back to 110/60 at 12:45 and she felt some better, her color had come back. We let her go home. Our concern was not that she fainted but that her BP dropped so low and it took us a while to get her back to an acceptable reading.

VAERS ID:313215 (history)  Vaccinated:2008-05-23
Age:23.0  Onset:2008-05-24, Days after vaccination: 1
Gender:Female  Submitted:2008-05-26, Days after onset: 2
Location:Unknown  Entered:2008-05-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Blisters on hands, fever~Anthrax (no brand name)~UN~23.30~Patient
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (NO BRAND NAME)UNKNOWN MANUFACTURERUNKNOWN1UNUN
Administered by: Military     Purchased by: Unknown
Symptoms: Asthenia, Blister, Influenza like illness, Injection site erythema, Injection site swelling, Malaise, Pyrexia, Vaccine positive rechallenge
SMQs:, Severe cutaneous adverse reactions (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: I received my first Anthrax shot in November 2007 prior to deploying and following the shot I had a fever with flu like symptoms and my hands and elbows broke out with blisters. I received the small pox shot at the same time so they were unsure which shot caused the reaction. I received my second anthrax shot on 23 May 2008 and had a similar reaction. Almost 24 hours after receiving the shot I started feeling sick with flu like symptoms. My body was really weak and I had a fever. Fortunately I had the next day off so I could just lie in bed and rest. The area around the injection is red and swollen and it is 3 inches in diameter. Prior to receiving the second shot I told the medics I had an adverse reaction to the first shot, but they wanted me to get another to see how my body would handle it. I returned to the medics last night and they said they would delay my next shot by one week, but I still needed to continue the cycle.

VAERS ID:313270 (history)  Vaccinated:2008-05-23
Age:4.0  Onset:2008-05-24, Days after vaccination: 1
Gender:Female  Submitted:2008-05-26, Days after onset: 2
Location:California  Entered:2008-05-26
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
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2570AA UNLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB141AA UNRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA03422 UNLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0986F UNRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0832U UNLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site induration, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Developed 10x11 erythematous, indurated painful area around site of injection in deltoid. Rx''d with KEFLEX in case of cellulitis.

VAERS ID:313475 (history)  Vaccinated:2008-05-23
Age:17.0  Onset:2008-05-23, Days after vaccination: 0
Gender:Female  Submitted:2008-05-27, Days after onset: 4
Location:Michigan  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: none
Current Illness: No
Preexisting Conditions: none
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB222AA0IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U0IMLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2428AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B015AA5IMLA
Administered by: Public     Purchased by: Public
Symptoms: Dyskinesia, Inappropriate schedule of drug administration, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Immediately after injecting HPV, which was the fourth injection, client began having jerking movement of upper extremities and was non-responsive for approximately 30 seconds.

VAERS ID:313477 (history)  Vaccinated:2008-05-23
Age:4.0  Onset:2008-05-27, Days after vaccination: 4
Gender:Female  Submitted:2008-05-27, Days after onset: 0
Location:Oklahoma  Entered:2008-05-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None reported
Current Illness: None reported
Preexisting Conditions: None reported
Diagnostic Lab Data: None to date.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B069AB4IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ1069-23SCRA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1744U1SCLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1019U1SCLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Pruritus generalised, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Phone call from pt''s mother reporting "rash, red, itchy all over her body" not present @ bedtime 05/26/08, but present this morning. Temperature @ 99 F, no other symptoms @ this time. Pt spent weekend with father, mother doesn''t know child''s activities over weekend. Taken to ER, diagnosed with chicken pox @ 9:30 AM.

VAERS ID:313823 (history)  Vaccinated:2008-05-23
Age:16.0  Onset:2008-05-27, Days after vaccination: 4
Gender:Female  Submitted:2008-05-27, Days after onset: 0
Location:New Hampshire  Entered:2008-05-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Began Sprintec 5/25
Current Illness: none
Preexisting Conditions: Penicillin, Sulfa, Acetaminophen PMH: parent had syncope w/BCP.
Diagnostic Lab Data: CBC, EKG, CXR in ER, IV fluids LABS: pregnancy test neg. CBC & chemistry WNL. Lyme test neg. CXR neg.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0063X1UNLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2613AA0UNRA
Administered by: Private     Purchased by: Public
Symptoms: Asthenia, Borrelia burgdorferi serology negative, Chest X-ray normal, Contraception, Dizziness, Drug hypersensitivity, Full blood count normal, Laboratory test normal, Pallor, Pregnancy test negative, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Angioedema (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Syncopal episodes 4 days after vaccines administered occurred x3. First time in shower. 6/6/08 Reviewed PCP medical records & vax records. Good health on day of vax, only hx of dysmennorhea. Started bcp 2 days s/p vax & then 2 days later stared syncope. 6/13/08 Reviewed ER medical records of 5/27/08. FINAL DX: syncope, orthostatic Records reveal patient experienced dizziness & weakness while in the shower, felt things going black. Had syncopal episodes x 3. In ER, pale & weak. Had started birth control 2 days prior. Orthostatic in ER. D/C to home to be f/u by PCP next day.

VAERS ID:313861 (history)  Vaccinated:2008-05-23
Age:44.0  Onset:2008-05-23, Days after vaccination: 0
Gender:Female  Submitted:2008-05-28, Days after onset: 5
Location:Oklahoma  Entered:2008-05-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none except motrin
Current Illness: None
Preexisting Conditions: N/A
Diagnostic Lab Data: N/A
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2936BA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Anorexia, Arthralgia, Dizziness, Fatigue, Injection site erythema, Injection site pain, Malaise, Nausea, Pyrexia, Somnolence
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad)
Write-up: Patient states"on 5-23-08 at 10:00 AM received shot. Two hours later began to feel pain,nausea,and light headed.Not feel like eating at all.The same night i ran a fever and was under a lot of pain.Took Motrin as directed.on morning of 5-24-08 woke up with redness underneath the shot site and did not feel good,wanted to sleep all the time with no strenght." continued that night eith pain at injection site and aches in joints that prevented sloeep.On 5-25-08 "redness spread further down my arm,wanted to sleep,continued taking Motrin and using cold packs" On 5-26-08 continued with lack of appetite,pain and fatigue.continued motrin and cold packs to left arm. On 5-27-08 reported to immunization clinic.Had beneath the injection site two areas of erthema measuring 7cm long by4cm wide.Instructed to try an antihistamine, use moist warm packs and continue with the motrin and move arm.

VAERS ID:313881 (history)  Vaccinated:2008-05-23
Age:16.0  Onset:0000-00-00
Gender:Male  Submitted:2008-05-28
Location:Washington  Entered:2008-05-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypothyroid
Preexisting Conditions: Hypothyroid
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2425AA0UNRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B020AA UNRA
Administered by: Private     Purchased by: Unknown
Symptoms: Dizziness, Dyspnoea, Rash, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: SEE ER NOTES; Lightheaded/vomiting this AM. Now raised hives/rash x 1 hour on chest/back/arms. Shortness of breath. Tetanus/Meningococcal shots on Friday.

VAERS ID:314105 (history)  Vaccinated:2008-05-23
Age:70.0  Onset:2008-05-26, Days after vaccination: 3
Gender:Female  Submitted:2008-05-29, Days after onset: 3
Location:Texas  Entered:2008-05-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: On 5/27/2008 patient ran a temperature/rash to left leg appeared.
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0203X SCLA
Administered by: Public     Purchased by: Unknown
Symptoms: Body temperature increased, Herpes zoster
SMQs:, Neuroleptic malignant syndrome (broad)
Write-up: Left leg broke out with shingles.

VAERS ID:314123 (history)  Vaccinated:2008-05-23
Age:4.0  Onset:2008-05-23, Days after vaccination: 0
Gender:Male  Submitted:2008-05-29, Days after onset: 6
Location:California  Entered:2008-05-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B074AB4IMLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04743SCLA
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.1229U1SCRA
Administered by: Private     Purchased by: Unknown
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: HIVE LIKE RASH HAD IMMUNIZATIONS YESTERDAY, NO LOCAL IRRITRATION, RASH ON TORSO

VAERS ID:314133 (history)  Vaccinated:2008-05-23
Age:17.0  Onset:2008-05-24, Days after vaccination: 1
Gender:Female  Submitted:2008-05-24, Days after onset: 0
Location:Arizona  Entered:2008-05-29, 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: Topamax; Antibiotic (?)
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURC2864AA IMLA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEURA0446 IMLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Pruritus, Rash macular
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypersensitivity (narrow)
Write-up: Developed temperature to 102 and blotchy rash, fever resolved. AM developed severe pruritis, not responsive to antihistamine.

VAERS ID:314403 (history)  Vaccinated:2008-05-23
Age:19.0  Onset:2008-05-24, Days after vaccination: 1
Gender:Female  Submitted:2008-06-01, Days after onset: 8
Location:New York  Entered:2008-06-01
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: asthma
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
VARCEL: VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURER 1IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Chills, Fatigue, Headache, Heart rate increased, Injection site pain, Lymphadenopathy, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)
Write-up: Approx 10 hours post-vaccination patient began to have a fever (102.4 F), chills, severe pain at injxn site, headache, joint pain especially in her hands, swollen lymph glands esp. sub-mandibular, nausea, increased heart-rate of 104 beats per minute at rest. This lasted approx 36 hours and after significant resolution patient still was fatigued and had some hand pain.

VAERS ID:314449 (history)  Vaccinated:2008-05-23
Age:63.0  Onset:2008-05-23, Days after vaccination: 0
Gender:Female  Submitted:2008-05-30, Days after onset: 7
Location:Virginia  Entered:2008-06-02, 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:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0161X0SCLA
Administered by: Other     Purchased by: Private
Symptoms: Chills, Headache, Influenza like illness, Injection site erythema, Injection site pruritus, Injection site swelling, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt received ZOSTAVAX injection at approx 2 PM on 5/23/08. Pt reports that 1-2 hrs later, she developed headache. She took TYLENOL but said it resolved the next day. She also experienced flu like symptoms - body ache and chills on 5/24 which lasted for approx 24 hrs. Pt experienced a slightly raised area around injection site which was itchy within 1 hour after injection on 5/30. The area was flat, non itchy but still red.

VAERS ID:314593 (history)  Vaccinated:2008-05-23
Age:8.0  Onset:2008-05-24, Days after vaccination: 1
Gender:Male  Submitted:2008-05-26, Days after onset: 2
Location:North Carolina  Entered:2008-06-02, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC
Current Illness: Cellulitis, Atopic Dermatitis
Preexisting Conditions:
Diagnostic Lab Data: none
CDC 'Split Type': NC08070
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB264BA2IMUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1766U2SCUN
Administered by: Private     Purchased by: Unknown
Symptoms: Cellulitis, 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: Red, swollen, warm at sight. Had noticed the day after. It was hot the afternoon of the injection - Seen 5/26 diagnosed cellulitis; to start KEFLEX

VAERS ID:314798 (history)  Vaccinated:2008-05-23
Age:11.0  Onset:2008-05-23, Days after vaccination: 0
Gender:Female  Submitted:2008-05-24, Days after onset: 1
Location:Wisconsin  Entered:2008-06-03, Days after submission: 10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluoride
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEURC2099A UNUN
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.19769 UNUN
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Local erythema, swelling, pain at site of injection of Varicella and Tdap which were both given together at same area at Public Health- left tricep area

VAERS ID:314966 (history)  Vaccinated:2008-05-23
Age:4.0  Onset:2008-05-23, Days after vaccination: 0
Gender:Male  Submitted:2008-06-04, Days after onset: 12
Location:Louisiana  Entered:2008-06-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2397CA4IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA03013IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0266X1SCRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0091X1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Gait disturbance, Injection site oedema
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 6-04-2008 l LEG EDEMA TO L ANTERIOR NO REDNESSpARENTS STATE COULD NOT WALK ON LEG POST VACCINE AVISED WARM COMPRESSES, MOTRIN PRN WALKING ON LEG NOW WITHOUT APPARENT ISSUE

VAERS ID:314990 (history)  Vaccinated:2008-05-23
Age:9.0  Onset:2008-06-04, Days after vaccination: 12
Gender:Female  Submitted:2008-06-05, Days after onset: 1
Location:Oklahoma  Entered:2008-06-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: sore throat, viral syndrome
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.155X1SCLA
Administered by: Unknown     Purchased by: Private
Symptoms: Pruritus, Rash vesicular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: vesicular scattered rash on trunk with onset 13 days after varicella vaccine, no fever, mild itching. Symptomatic treatment prescribed and observation

VAERS ID:315137 (history)  Vaccinated:2008-05-23
Age:21.0  Onset:2008-05-23, Days after vaccination: 0
Gender:Female  Submitted:2008-06-04, Days after onset: 12
Location:Pennsylvania  Entered:2008-06-06, 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: BENZACLIN
Current Illness: Acne
Preexisting Conditions:
Diagnostic Lab Data: None
CDC 'Split Type': WAES0805USA05094
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Immediate post-injection reaction, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (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), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 21 year old female with acne who on 23-MAY-2008 was vaccinated IM with a first 0.5 ml dose of GARDASIL (lot # 659437/1266U). Concomitant therapy included BENZACLIN. On 23-MAY-2008, immediately after vaccination, the patient seizure, fainted and lost consciousness while in the physician''s office. The patient sought medical attention in the physician''s office. There were no laboratory or diagnostic tests performed. At the time of the report, the patient was recovering. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.

VAERS ID:315895 (history)  Vaccinated:2008-05-23
Age:4.0  Onset:2008-05-23, Days after vaccination: 0
Gender:Male  Submitted:2008-05-27, Days after onset: 4
Location:North Carolina  Entered:2008-06-10, Days after submission: 14
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:
Diagnostic Lab Data:
CDC 'Split Type': NC08077
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURU2355AA4IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ08733SCRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0428U1SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1766U1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site erythema, Injection site induration, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Varicella site 5/29 immediately after injection site got swollen, hard & red. Gave BENADRYL. Then got white around site (per mom). 5/24 redness spreading. 5/25 redness. 5/26 a red raised & "fired red" had knot. 10x8 cm swollen area. Seen in ER. Given KEFLEX. 5/27 seen in clinic swelling decreased. MMR & VAR site after injection swollen & red. Seen in ER for varicella site reaction.

VAERS ID:316223 (history)  Vaccinated:2008-05-23
Age:1.0  Onset:2008-05-24, Days after vaccination: 1
Gender:Male  Submitted:2008-06-13, Days after onset: 20
Location:Tennessee  Entered:2008-06-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: polyvisol vitamin drops
Current Illness: none
Preexisting Conditions: small reflux issue during first 6-8 months. stopped taking medication 4 months before vaccination
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MEA: MEASLES (NO BRAND NAME)UNKNOWN MANUFACTURER?0UNRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETH?3UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.?0UNLL
Administered by: Private     Purchased by: Private
Symptoms: Anorexia, Erythema, Erythema infectiosum, Immediate post-injection reaction, Irritability, Pyrexia, Rash generalised
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypersensitivity (narrow)
Write-up: He had an immediate fever for 2-3 days with a rash starting at neck and working over entire body on 6th day after shot. He was very irritable and showed signs of lost appitite through out the week. Revisited the doctor 10 days after vaccination showing signs of redness in ears and a more developed rash over entire body. Prescribed w/ Immoxicelin @ 6.25ml 2 twice a day. After 8 days a more prominant rash returned over entire body. Dr diagnosis of B19 (fifths desease) virus on 6/11 without blood test and told to stop medication. Patient had not previously been sick other than a small fever from previous vaccinations. Rash and irritablity still present 6/13/08.

VAERS ID:316368 (history)  Vaccinated:2008-05-23
Age:59.0  Onset:2008-06-01, Days after vaccination: 9
Gender:Male  Submitted:2008-06-16, Days after onset: 15
Location:Massachusetts  Entered:2008-06-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: simvastatin, omeprazole, clonazepam
Current Illness: None
Preexisting Conditions: TKR-osteoarthritis. PMH: Anxiety, HTN. Allergy to codeine
Diagnostic Lab Data: Labs and Diagnsotics: CXR WNL. Blood glucose 130 and 124, 94 by 6/10/08. CBC with WBCs 12.8 peaking at 23.0 with segs increased. ESR 25. Blood cx (-). CSF (+) RBCs. CSF protein 81.8. Parvo B19 IgG 9.1. Hep A Total Ab reactive.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.016240SCLA
Administered by: Private     Purchased by: Private
Symptoms: Arthralgia, Arthritis, Blood culture negative, Blood glucose increased, Bronchospasm, CSF protein increased, Chest X-ray normal, Full blood count, Gastrooesophageal reflux disease, Headache, Hepatitis A antibody positive, Hypercholesterolaemia, Joint swelling, Musculoskeletal discomfort, Neck pain, Neutrophil percentage increased, Oxygen saturation decreased, Parvovirus B19 serology positive, Pyrexia, Rash, Red blood cell sedimentation rate increased, Red blood cells CSF positive, Wheezing, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Liver infections (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (narrow), Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Lipodystrophy (broad), Hypersensitivity (narrow), Arthritis (narrow)
Write-up: Pt well. REceived ZOSTAVAX 5/23 - on 6/1/08 developed multiple joint pain and swelling, arthralgia, high fever (101.3) and headache. O2 sat 88% ran air. 06/20/2008 MR received for DOS 06/7-10/2008 with D/C DX: Polyarthragia, arthritis resolving on steroids. Possible serum sickness reaction to recent varicella zoster vaccine. Fever, headache, neck pain-all resolved. Bronchospasm, resolved. Hypertension. Hypercholerolemia. Anxiety Disorder. GERD exacerbated by steroid use. Pt developed L thumb and hand swelling 1 week after receiving Zostavax. Swelling spead to L knee, wrist, ankle and great toe. Joint swelling and tenderness noted on PE. Pt then developed fever and rash was instructed to be evaluated in ER. IN ER pt''s O2 sat dropped from 98% to 88% and was noted to be wheezing and was admitted. Improvement of all sx noted with IV steroids.

VAERS ID:316490 (history)  Vaccinated:2008-05-23
Age:6.0  Onset:2008-05-27, Days after vaccination: 4
Gender:Female  Submitted:2008-06-09, Days after onset: 13
Location:Massachusetts  Entered:2008-06-17, Days after submission: 8
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; Amoxicillin, Ceftin, Cipro HC.
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Private     Purchased by: Public
Symptoms: Pruritus, Rash papular, Rash pustular, Viral infection
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: 5/27/08 Per mom developed (1) lesion on shoulder area, some itchiness noted. New lesions < 12 developed papular, pustular rash on trunk and extremities; some areas crusted on exam 6/2/08. Diagnosed with varicella infection; comfort measures reviewed.

VAERS ID:316520 (history)  Vaccinated:2008-05-23
Age:16.0  Onset:2008-05-23, Days after vaccination: 0
Gender:Female  Submitted:2008-06-18, Days after onset: 26
Location:Virginia  Entered:2008-06-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a
Current Illness: none
Preexisting Conditions: allergic to nickel
Diagnostic Lab Data: n/a
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER 0IMRA
Administered by: Private     Purchased by: Unknown
Symptoms: Convulsion, Dizziness, Feeling abnormal, Immediate post-injection reaction, Musculoskeletal stiffness, Pain in extremity
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Immediately following the shot, while walking to a chair in the doctors office my daughter said her arm really hurt and she could feel the medicine running through her body. SHe then said she felt dizzy. Before I could get to the nurse, her head dropped and she stiffened up and had a seizure. She was out for about 3-5 minutes. When she awoke, she didn''t remember anything but feeling dizzy.

VAERS ID:316704 (history)  Vaccinated:2008-05-23
Age:11.0  Onset:2008-05-23, Days after vaccination: 0
Gender:Male  Submitted:2008-05-23, Days after onset: 0
Location:Michigan  Entered:2008-06-20, Days after submission: 28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: Parent to take to urgent care for further assessment, will call clinic back.
CDC 'Split Type': MI2008010
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB129AA1IMLA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1564U1SCRA
Administered by: Public     Purchased by: Public
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site urticaria
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Varicella administered right arm S.C. Immediate redness and itchiness and welt 8 mm diameter. In office for 25 minutes, within 2 seconds ice applied to site: decreased redness, decreased size - however continued to be present. T. C. mother, patient is well. Parent reports she did not fly with ambulatory care or family physician. Mother states, redness, itchiness and welt disappeared within 10 minutes of being in the car, with continued application of the ice pack. No further concerns expressed. TC to mother regarding situation of 5/23/08 and she stated no further problems except for itching later in the day. She stated that he had a previous "itchy spell" and redness with 2 previous vaccines given at the clinic and supervisor encouraged her to notify physician for advice regarding future vaccines.

VAERS ID:318341 (history)  Vaccinated:2008-05-23
Age:67.0  Onset:2008-05-23, Days after vaccination: 0
Gender:Male  Submitted:2008-06-30, Days after onset: 38
Location:Utah  Entered:2008-07-07, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methadone; Methylphenidate; Lorazepam
Current Illness: Follow up/meds - (Blood test)
Preexisting Conditions: + Penicillin - Novocain type drugs; MS (osteoporosis steroid induced)
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0233X UNUN
Administered by: Military     Purchased by: Military
Symptoms: Congenital joint malformation, Contusion, Erythema, Eye pain, Headache, Lymphadenopathy, Musculoskeletal stiffness, Nausea, Pain, Pain in extremity, Rash, Skin warm, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Congenital, familial and genetic disorders (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Vaccination given in upper left arm - area below injection (crook of elbow up, on top of arm both very hot and pinkish red). Over several days swelling - bruised look - rash around both thighs - nausea - difficulty sleeping - increased pain and snapping/popping in joints - pain under arm and swelling in lymph glands - stiff neck plus - plus - head - eye pain.

VAERS ID:319769 (history)  Vaccinated:2008-05-23
Age:0.5  Onset:2008-05-27, Days after vaccination: 4
Gender:Male  Submitted:2008-07-15, Days after onset: 49
Location:Florida  Entered:2008-07-17, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: amoxcillin
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0806USA08364
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HIBV: HIB (ACTHIB)SANOFI PASTEUR  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0144X2PO 
Administered by: Other     Purchased by: Other
Symptoms: Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a certified medical assistant concerning a 6 month old male on 01-FEB-2008, 28-MAR-2008 and 23-MAY-2008 was vaccinated po with the first, second and third 2.0 ml doses respectively ROTATEQ (first dose lot #657988/1193U, second dose lot # 660287/1877U and third dose lot # 660379/0144X). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, ACTHIB, PREVNAR and amoxcillin. It was reported that on 27-MAY-2008 the patient experienced vomiting and an unspecified low grade fever. Treatment included dietary changes. There were no other symptoms or treatment reported. On 29-MAy-2008 the mother reported that the symptoms were resolving. The patient sought medical attention at an office visit. It was reported that the patient recovered (date unspecified). This is one of several reports from the same source. Additional information has been requested.

VAERS ID:320059 (history)  Vaccinated:2008-05-23
Age:15.0  Onset:2008-05-23, Days after vaccination: 0
Gender:Female  Submitted:2008-07-15, Days after onset: 53
Location:Unknown  Entered:2008-07-17, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0806USA08649
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Loss of consciousness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a physician assistant concerning a 15 year old female who on 23-MAY-2008 was vaccinated with a first dose of GARDASIL vaccine and included hepatitis A virus vaccine (manufacturer unknown). The physician assistant reported that the patient received the first vaccination with GARDASIL VACCINE on 23-MAY-2008 and passed out. The patient became pale in color and passed out while sitting on the examination table. The patient was treated with cold compresses and recovered after an unspecified time frame. The patient was asked to wait in the office after recovery, but mother needed to leave. There was no product quality complaint. Additional information has been requested.

VAERS ID:320998 (history)  Vaccinated:2008-05-23
Age:60.0  Onset:2008-05-23, Days after vaccination: 0
Gender:Female  Submitted:2008-07-31, Days after onset: 69
Location:South Carolina  Entered:2008-07-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None; Osteoporosis; Penicillin allergy; Hypersensitivity
Preexisting Conditions: Erythromycin/AUGMENTIN=rash
Diagnostic Lab Data: None; biopsy, blisters in mouth
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.3125U0IMLA
Administered by: Other     Purchased by: Private
Symptoms: Biopsy, Blister, Pruritus, Rash, Rash vesicular
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Recurrent blistery spot on anterior chest wall that itches/postvaccination, noninjection site zoster-like rash, anterior chest wall. This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a physician''s office member concerning a 60 year old female consumer with osteoporosis and allergic to penicillin and erythromycin (rash), who on 23-MAY-2008 at 8-9 am was vaccinated with 0.65 mL of the first dose of ZOSTAVAX (Merck) IM in the left arm. Concomitant therapy included alendronate sodium (+) cholecalciferol. The patient did not have any illness at time of vaccination. On 27-MAY-2008, the patient developed blood blister on her chest. The office member reported that the patient had a recurrent blister spot in anterior chest wall that itched. Post vaccination, the patient had a non injection site zoster like rash on her anterior chest wall. The patient has seen the dermatologist, he performed biopsies. The patient now had blisters in the mouth. At the time of the report, patient had not recovered. The patient sought unspecified medical attention. There was no product quality complaint. Additional information is expected.

VAERS ID:324340 (history)  Vaccinated:2008-05-23
Age:  Onset:2008-05-24, Days after vaccination: 1
Gender:Unknown  Submitted:2008-07-30, Days after onset: 67
Location:Unknown  Entered:2008-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0805USA05653
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a registered pharmacist concerning a patient who on 23-MAY-2008 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot# not reported). On 24-MAY-2008, the patient developed a rash and was taken to the emergency room. It was not known if the patient was admitted. The pharmacist reported that the patient may have had an allergic reaction to something that was eaten on leave from the facility. Additional information has been requested.

VAERS ID:324907 (history)  Vaccinated:2008-05-23
Age:12.0  Onset:2008-07-15, Days after vaccination: 53
Gender:Female  Submitted:2008-08-14, Days after onset: 30
Location:Florida  Entered:2008-08-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol; tetanus toxoid
Current Illness: Asthma; Drug hypersensitivity
Preexisting Conditions: Tension headache
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0807USA03269
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U0IMRA
Administered by: Other     Purchased by: Other
Symptoms: Migraine
SMQs:
Write-up: Information has been received from a physician concerning a 12 year old female with asthma and allergy to pertussis and a history of tension headache who on 23-JUN-2008 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL 9lot no. 659437/12660) into the right deltoid. Concomitant therapy included tetanus toxoid and albuterol. The physician''s office got a call "last night", on approximately 15-JUL-2008, stating that the patient experienced severe migraine and went to the emergency room. The patient was treated with IV fluids, REGLAN and released. The patient was not hospitalized. The outcome was unknown. Additional information has been requested.

VAERS ID:327639 (history)  Vaccinated:2008-05-23
Age:60.0  Onset:2008-06-04, Days after vaccination: 12
Gender:Male  Submitted:2008-09-24, Days after onset: 112
Location:Florida  Entered:2008-10-08, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: None
CDC 'Split Type': WAES0806USA01302
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1875U0IMUN
Administered by: Public     Purchased by: Other
Symptoms: Herpes zoster, Incorrect route of drug administration, Paraesthesia, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 60 year old male patient who on 23MAY-2008 was vaccinated with first dose of ZOSTAVAX (LOT # 659763/1875U), intramuscularly at 10:00 hours. There was no concomitant medication. The physician reported that on 04-JUN-2008, the patient developed paresthesian patch like, at the left anterior cervical region with skin eruption. it appeared patient developed zoster 15 days post vaccination. The patient''s symptoms (unspecified symptoms) started 3 days before, in approximately 04-JUN-2008. The patient was given VALTREX. At the time of the report the patient was recovering. The patient sought medical attention. Diagnostic test was clinical exam only. No further information in available.

VAERS ID:339343 (history)  Vaccinated:2008-05-23
Age:67.0  Onset:2008-06-30, Days after vaccination: 38
Gender:Female  Submitted:2009-02-09, Days after onset: 224
Location:Unknown  Entered:2009-02-10, 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: None
Current Illness: Hypertension; osteopenia; rhinitis allergic; asthma; chronic back pain
Preexisting Conditions: Chickenpox
Diagnostic Lab Data: physical examination, classic herpes zoster by visual exam right t 10-11 distribution
CDC 'Split Type': WAES0812USA00471
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0409X SCUN
Administered by: Private     Purchased by: Private
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a nurse practitioner and a female consumer with drug hypersensitivity (No otherwise specified) who on unspecified date in 2008 was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently the patient developed an extreme case of shingles and pain. The patient had an allergic reaction to the medication she was given for the pain and spent most of her time in bed. The patient noted that instead of preventing, the vaccine gave her shingles. As of 18-NOV-2008, the adverse events persisted. The reporter felt that extreme case of shingles and pain were related to therapy with ZOSTAVAX (Merck). Follow up information received from the nurse practitioner reported that a 68 years old female patient (weight 136 pounds, height 66 inches) with hypertension, osteopenia, allergic rhinitis, asthma and chronic low back pain, who on 23-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 659409/0409X) subcutaneously. The patient called the clinic due to painful rash on the right T 10-11 on 30-JUN-2008. The patient was seen on the clinic on 02-JUL-2008, a visual exam was performed, the patient was diagnosed with extensive herpes zoster on the right T 10-11, and this was the first of many visits for extensive herpes zoster on the right T 10-11 distribution. The patient was placed on LYRICA 75 mg twice a day. The herpetic neuralgia persists. It was reported that the patient had a history of chickenpox during childhood. The patient extensive herpes zoster and herpetic neuralgia was considered to be disabling by the nurse practitioner. Additional information is not expected.

VAERS ID:347396 (history)  Vaccinated:2008-05-23
Age:1.6  Onset:2008-11-06, Days after vaccination: 167
Gender:Female  Submitted:2009-05-15, Days after onset: 189
Location:Michigan  Entered:2009-05-21, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0811USA04023
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0167X0UN 
Administered by: Other     Purchased by: Other
Symptoms: Varicella post vaccine
SMQs:
Write-up: Information has been received from a physician concerning a 24 month old female who on 23-MAY-2008 was vaccinated with her first dose of 0.5 mL VARIVAX (Oka/Merck) (Lot 660217/0167X) injection (site not reported). On 06-NOV-2008 the patient experienced minor case of chicken pox. The patient recovered "within the last week or two." Unspecified medical attention was sought. There was no product quality complaint. No further information is expected.

VAERS ID:388118 (history)  Vaccinated:2008-05-23
Age:5.0  Onset:0000-00-00
Gender:Female  Submitted:2010-05-14
Location:Unknown  Entered:2010-05-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0905USA04002
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Varicella
SMQs:
Write-up: Information has been received from a physician concerning two patients who on unspecified dates received both doses of VARIVAX (Merck) and they were both exposed to an outbreak situation and both developed a mild case of varicella. There was no concomitant medication and no pertinent medical history. The patients saw physician for medical attention. Follow up information has been received from the physician''s office, concerning a female patient who received the first dose of VARIVAX (Merck) on 03-FEB-2005, and received the second dose on 23-MAY-2008. The reporter indicated that the lot numbers were unknown because the vaccines were given in another center. This is one of two reports from the same source. Additional information has been requested.

VAERS ID:422586 (history)  Vaccinated:2008-05-23
Age:13.0  Onset:2008-05-23, Days after vaccination: 0
Gender:Female  Submitted:2011-05-10, Days after onset: 1082
Location:Ohio  Entered:2011-05-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No, other than seasonal allergies (spring and fall)
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1968U0 LA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2569AA0 LA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0173X1 LA
Administered by: Unknown     Purchased by: Private
Symptoms: Abdominal discomfort, Activities of daily living impaired, Anaemia, Anxiety, Crying, Depression, Dizziness, Dyspnoea, Fall, Fatigue, Fear, General physical health deterioration, Head injury, Headache, Laboratory test, Local swelling, Loss of consciousness, Lymph node palpable, Menorrhagia, Mononucleosis heterophile test, Palpitations, Panic attack, Panic disorder with agoraphobia, Phonophobia, Sleep disorder, Social avoidant behaviour, Thinking abnormal, Tremor, Weight decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Patient passed out after Gardasil vaccine. A few weeks after first injection, she started showing signs of being unusually afraid of things (being alone, strangers, etc). She also complained of being tired, shortness of breath and stomache issues. She completed the series of shots in December of 2008 and continued to have ''strange'' symptoms more often. She was tested for mono and thyroid issues. Her doctor said she was borderline anemic and suggested vitamins. She continued to deteriorate and we finally realized she was having severe panic attacks. Eventually, she was diagnosed with Panic Disorder with Agoraphobia and Depression. She was terrified to leave our house and we had to pull her out of school and enroll her in a psychiatric partial hospitalization program for 6 weeks. She continues to be treated by a physician to this day.

VAERS ID:471366 (history)  Vaccinated:2008-05-23
Age:1.0  Onset:2008-05-23, Days after vaccination: 0
Gender:Unknown  Submitted:2012-10-18, Days after onset: 1609
Location:Unknown  Entered:2012-10-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1210USA007755
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: This spontaneous report as received from a registered nurse refers to a one year old patient. The patient who was one year of age was vaccinated with dose 1 of GARDASIL (dose, route, lot number not reported) on 23-MAY-2008 and with dose 2 of GARDASIL (dose, route, lot number not reported) on 11-JUL-2008. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. Additional information has been requested.

VAERS ID:483682 (history)  Vaccinated:2008-05-23
Age:70.0  Onset:0000-00-00
Gender:Female  Submitted:2013-02-06
Location:Unknown  Entered:2013-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1302USA001064
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0298X UNLA
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (659406/0298X) ZOSTAVAX on 23-MAY-2008. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.

VAERS ID:315148 (history)  Vaccinated:2008-05-23
Age:0.3  Onset:2008-05-27, Days after vaccination: 4
Gender:Male  Submitted:2008-06-05, Days after onset: 9
Location:Foreign  Entered:2008-06-05
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: ultrasound abdomen, 27May2008, intussusceptunit
CDC 'Split Type': B0523095A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41CA564A0PO 
Administered by: Other     Purchased by: Other
Symptoms: Crying, Depressed mood, Enema administration, Intussusception, Ultrasound abdomen abnormal
SMQs:, Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Depression (excl suicide and self injury) (narrow)
Write-up: This case was reported by a physician and described the occurrence of intussusception in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). No medical history of intussusception was reported. On 23 May 2008, the subject received 1st dose of ROTARIX (oral) as well as the vaccines corresponding for 4 months of age. His twin brother was also vaccinated the same day with ROTARIX. He experienced no adverse event. On 27 May 2008, 4 days after vaccination with ROTARIX, the subject experienced crying crisis and low mood. He didn''t experience diarrhea or bloody stools. The subject was brought to hospital and abdominal ultrasound revealed an intussusception which was resolved by air enema. The subject was hospitalised for 2 days. At the time of reporting the events were resolved. The subject was discharged from hospital in good condition. The physician did not think the intussusception was related to vaccination with ROTARIX but she could not rule out completely. Further information is not expected. This case has therefore been closed.

VAERS ID:317707 (history)  Vaccinated:2008-05-23
Age:21.0  Onset:2008-05-26, Days after vaccination: 3
Gender:Female  Submitted:2008-06-26, Days after onset: 31
Location:Foreign  Entered:2008-06-27, 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: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0806CZE00002
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blister, Hypersensitivity, Rash pruritic
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 21 year old female who on 23-MAY-2008 was vaccinated with GARDASIL. On 26-MAY-2008 the patient experienced skin allergy (itching rash, blisters) and was hospitalized from 28-May-2008 to 2-Jun-2008 on emergency department. Subsequently, the patient recovered from skin allergy. The reporter felt that skin allergy was related to therapy with GARDASIL. Additional information is not expected.

VAERS ID:317869 (history)  Vaccinated:2008-05-23
Age:  Onset:2008-05-30, Days after vaccination: 7
Gender:Female  Submitted:2008-06-27, Days after onset: 28
Location:Foreign  Entered:2008-06-30, Days after submission: 3
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': WAES0806USA08199
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Type 1 diabetes mellitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)
Write-up: Information has been received from a hospital physician concerning an adult female medical student with no reported history who on unspecified dates was vaccinated with a first and second dose of GARDASIL. On 23-MAY-2008, the patient was vaccinated with a third dose of GARDASIL (lot # not reported). On approximately 30-MAY-2008, 1 week post vaccination, the patient was diagnosed with diabetes type I. The reporting physician felt that the type I diabetes mellitus was an other important medical event. Other business partner numbers included: E2008-05651. Additional information is expected.

VAERS ID:318273 (history)  Vaccinated:2008-05-23
Age:  Onset:2008-05-30, Days after vaccination: 7
Gender:Female  Submitted:2008-07-03, Days after onset: 34
Location:Foreign  Entered:2008-07-07, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0806USA09038
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Type 1 diabetes mellitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow)
Write-up: Information has been received from a hospital physician concerning a female medical student who on 23-MAY-2008 was vaccinated with a third dose of GARDASIL. One week post vaccination she was diagnosed with type 1 diabetes mellitus. The patient had not recovered. The reporter contacted to enquire whether an increase of autoimmune diseases is known after administration of GARDASIL. Other business partner numbers included E2008-05651. Additional information is expected.

VAERS ID:318727 (history)  Vaccinated:2008-05-23
Age:19.0  Onset:2008-06-03, Days after vaccination: 11
Gender:Female  Submitted:2008-07-10, Days after onset: 37
Location:Foreign  Entered:2008-07-11, 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: Unknown
Current Illness:
Preexisting Conditions: Appendicectomy; Hypothyroidism; Bone operation
Diagnostic Lab Data: neurological examination, 06Jun08, Comment: loss of sensitivity of lower limbs; neurological examination 06Jun08, Comment: there was tendon reflex; neurological examination, 06Jun08, Comment: muscular tonus was resolving; diagnostic laborat
CDC 'Split Type': WAES0807USA00921
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1146U IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Full blood count normal, Hypoaesthesia, Laboratory test normal, Malaise, Muscular weakness, Neurological examination abnormal, Pelvic pain, Syncope vasovagal, Thyroid function test normal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a health professional concerning a 19 year old female with a history of appendicectomy, hypothyroidism and bone surgery who on 23-MAY-2008, was vaccinated with a dose of GARDASIL (lot # 1146U, batch # NG00400) IM. 11 days later on 03-JUN-2008 she experienced a vagal malaise at school with important pain in pelvis and developed numbness of lower extremities and weakness of lower extremities. Mobile accident unit was called. Electrolytogram and complete blood count was normal. Diagnosis was vagal malaise. She was not hospitalized but came out of hospital in a wheelchair and still had weakness and loss of sensitivity of lower limbs. On 06-JUN-2008 she went to hospital due to persisting symptom to perform complementary work-up. Neurological examination: loss of sensitivity of lower limbs, there was tendon reflex, muscular tonus was resolving. A problem of functional origin was privileged, she was not hospitalized. Medical consultation on 18-JUN-2008: muscular tonus was normal, she was walking normally without any limp, there was tendon reflex, loss of sensitivity of both lower limbs but recovery of bilateral sensitivity with socks. Thyroid work-up was normal. Medullar RMI was scheduled. She had recovered from weakness of lower extremities. She had not recovered from numbness of lower extremities. Other business partner numbers included: E2008-06319. Additional information has been requested.

VAERS ID:327284 (history)  Vaccinated:2008-05-23
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-10-06
Location:Foreign  Entered:2008-10-07, 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: None
Current Illness:
Preexisting Conditions: Immunisation; Condom; The patient was well tolerated the first dose of GARDASIL given in January 2008.
Diagnostic Lab Data: Beta-human chorionic gonadotropin (unsp), positive
CDC 'Split Type': WAES0806usa01096
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abortion induced, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Menstruation delayed
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Normal pregnancy conditions and outcomes (narrow), Fertility disorders (broad)
Write-up: Information has been received from a general practitioner through the Sanofi Pasteur MSD GARDASIL Pregnancy Registry concerning a 17 year old female who on 23-MAY-2008 was vaccinated with the second dose of GARDASIL. The patient was well tolerated the first dose of GARDASIL given in January 2008. She had no oral contraceptive. At the end of the medical consultation the patient mentioned that she had delayed menstruation of one week. The physician prescribed a pregnancy test. The patient used condom as preservative. In case of pregnancy the patient will ask for requested legal abortion. No adverse effect was reported. Additional information received on 04-JUN-2008 by telephone: pregnancy test was positive. The reporter had not seen the patient again and did not manage to contact her. Follow-up information received from a phone call to the physician on 30-SEP-2008: Case upgraded to serious. The patient decided a voluntary termination of her pregnancy (unspecified date). The case was closed. No further information is available. Other business partner numbers included E2008-04790.

VAERS ID:327286 (history)  Vaccinated:2008-05-23
Age:15.0  Onset:2008-09-19, Days after vaccination: 119
Gender:Female  Submitted:2008-10-06, Days after onset: 17
Location:Foreign  Entered:2008-10-07, 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: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0809USA04993
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Epilepsy, Loss of consciousness, Tongue biting
SMQs:, Torsade de pointes/QT prolongation (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), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: Information has been received from a pediatrician concerning a 15 year old female who on 23-MAY-2008 was vaccinated with the first dose of GARDASIL IM, into the left arm, which was well tolerated. On 19-SEP-2008 the patient developed an epileptic fit with loss of consciousness and tongue biting. She recovered and was hospitalized for diagnostic for 2 days (exact dates not reported). Other business partner number included: E2008-08903. Additional information has been requested.

VAERS ID:337948 (history)  Vaccinated:2008-05-23
Age:47.0  Onset:0000-00-00
Gender:Male  Submitted:2008-12-03
Location:Foreign  Entered:2008-12-19, Days after submission: 16
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': 200813722
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED10059429 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Headache, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow)
Write-up: Report received from a pharmacist on 12-JUN-2008. An 47-year-old male patient received FLUVAX (batch number unknown) for influenza immunisation on 23-MAY-2008. Approximately 2-3 days after immunisation, the patient developed chills, muscle pain, headache, severe fatigue, diarrhoea (20 bowel movements in 12 hours), stomach cramps. The patient received treatment with fluid replacement and food restrictions. The patient had recovered by 06-JUN-2008.

VAERS ID:336347 (history)  Vaccinated:2008-05-23
Age:0.2  Onset:2008-05-24, Days after vaccination: 1
Gender:Male  Submitted:2008-12-31, Days after onset: 221
Location:Foreign  Entered:2009-01-02, 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: Unknown
Current Illness: Hospitalisation
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0812AUS00333
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Apnoea, Oxygen saturation decreased
SMQs:, Acute central respiratory depression (narrow)
Write-up: Information was obtained on request by the Company from the agency, via a Public Case Details form, concerning an 8 week old male who on 23-MAY-2008, as an inpatient in the Neonatal Intensive Care Unit, was vaccinated with ROTATEQ. Other suspect therapy included PREVENAR which was also administered on 23-MAY-2008. On 24-MAY-2008, 24 hours post-vaccination, the patient experienced apnoea and decreased oxygen saturation. He was treated with oxygen and monitoring. On 29-MAY-2008 the patient recovered from apnoea and decreased oxygen saturation. The agency considered that apnoea and decreased oxygen were possibly related to therapy with ROTATEQ and/or PREVENAR. The original reporting source was not provided by the agency. Upon internal medical review, apnoea was considered to be an other important medical event. Additional information is not expected.

VAERS ID:339409 (history)  Vaccinated:2008-05-23
Age:0.9  Onset:2008-12-23, Days after vaccination: 214
Gender:Female  Submitted:2009-02-10, Days after onset: 49
Location:Foreign  Entered:2009-02-11, 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: serum rotavirus IgA antibody, 24Dec08, positive
CDC 'Split Type': WAES0902USA01053
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dehydration, Diarrhoea, Gastroenteritis, Lethargy, Rotavirus test positive, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received on 04-FEB-2009 from a Health Care Professional concerning a 11 month old female patient (also reported as male) who on 23-MAY-2008 was administered the third dose of ROTATEQ (Lot #, batch # not reported). On 23-DEC-2008 the patient presented an acute gastroenteritis. The patient was hospital admitted on the 24-DEC-2008, after presenting with 4 vomits and diarrhoea (maximum 6 bowel movements per day). Upon admittance, the patient was lethargic and presented with 5% to 9% dehydration. The patient was treated with parenteral rehydration. On 24-DEC-2008, the patient was tested for rotavirus and was positive for rotavirus, genotype was yet to be confirmed. On 26-DEC-2008 the patient had recovered and was discharged from hospital. Other business partner numbers include E2009-00981. No further information is available.

VAERS ID:340908 (history)  Vaccinated:2008-05-23
Age:1.3  Onset:2008-06-17, Days after vaccination: 25
Gender:Female  Submitted:2009-02-27, Days after onset: 255
Location:Foreign  Entered:2009-03-02, 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:
Preexisting Conditions: Fever
Diagnostic Lab Data: diagnostic laboratory test, protidogram Ig: within normal ranges; electrocardiogram, within normal limits; RDW, 03Jul08, 17.8%; WBC count, 03Jul08, 6.10 mL; basophil count, 03Jul08, 0.06 mL; eosinophil count, 03Jul08, 0.29 mL; hematocrit, 0
CDC 'Split Type': WAES0902USA04108
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD)MERCK & CO. INC.0866F0SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase abnormal, Aspartate aminotransferase abnormal, Basophil count normal, Blood glucose normal, Complement factor C3, Complement factor C4, Culture stool negative, Cytomegalovirus antibody negative, Electrocardiogram normal, Eosinophil count normal, Epstein-Barr virus antibody negative, Full blood count normal, Haematocrit normal, Haemoglobin normal, Laboratory test abnormal, Laboratory test normal, Lymphocyte count, Lymphocyte count normal, Mean cell haemoglobin decreased, Mean cell haemoglobin normal, Mean cell volume decreased, Monocyte count increased, Neutrophil count, Neutrophil count decreased, Pharyngeal erythema, Platelet count increased, Prothrombin time abnormal, Pyrexia, Rash scarlatiniform, Red blood cell count normal, Red cell distribution width increased, Similar reaction on previous exposure to drug, Tonsillar disorder, Urine analysis normal, White blood cell count decreased
SMQs:, Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Haematopoietic leukopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (broad)
Write-up: Information has been received from a health authority (case n. 95073) (local case n. IT069/09), concerning a 15 month old female who was vaccinated on 23-MAY-2008 with the first dose of PROQUAD (Merck) (Lot number 655202/0866F and Batch number 0866F). It was also reported that following the previous vaccinations (NOS) the child presented with fever. On 17-JUN-2008, she presented with high fever. On 25-JUN-2008, she was admitted to the hospital due to the persistence of the high fever. She was already being treated with AUGMENTIN and since a few days she was also presenting with scarlet fever like exanthema. Upon admission she was in good general condition, slight scarlet fever like exanthema, hyperemic pharynx with tonsillar exudate. Labwork performed: see lab comments screen. During admission the patient was treated with pediatric electrolyte infusion and Augmentin, since the first day of admission the fever receded. She was discharged on 29-JUN-2008, home therapy Augmentin for three days. CBC on 03-JUL-2008 (see lab comment screen). The outcome is recovered on 03-JUL-2008. The case is closed. Other business partner numbers included: E2009-01536.

VAERS ID:456339 (history)  Vaccinated:2008-05-23
Age:0.3  Onset:2008-07-10, Days after vaccination: 48
Gender:Male  Submitted:2012-05-25, Days after onset: 1415
Location:Foreign  Entered:2012-05-29, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Constipation
Diagnostic Lab Data: Physical examination, 10?Jul08, normal abdomen exam, no anal fissure
CDC 'Split Type': WAES1106USA03995
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)
Write-up: Case described in the intermediate clinical study provided by the sponsor of the study, (Health Authorities) on 23-JUN-2010 under the reference number 200900136. Case medically confirmed. A 3 months old male patient with medical history of constipation, had been treated with ROTATEQ for vaccination on 23-May-2008, 26-JUN-2008 and 24-JUL-2008 respectively, pneumococcal saccharide conjugate vaccine, adsorbed from 23-MAY-2008 to 26-JUN-2008, INFANRIX QUINTA (batch number not reported) from 23-MAY-2008 to 26-JUN-2008. On 10-JUL-2008, the patient experienced hematochezia. The patient was hospitalized on 10-JUL-2008. Etiological investigations were performed; normal abdomen exam. No anal fissure. Treatment instaured: macrogol, parafine oil. Outcome: The patient had recovered from hematochezia on 11-JUL-2008. Assessment: Hematochezia is expected. The investigator considered that hematochezia was unlikely related. The sponsor considered that hematochezia was unlikely related. Follow up information received through the final clinical study report provided by the sponsor of the study, on 11-MAY-2012 under the reference number 200900136. According to the sponsor the hematochezia was not related. Other business partner number included: E2011-04097. Additional information is not expected.

VAERS ID:458857 (history)  Vaccinated:2008-05-23
Age:47.0  Onset:2011-10-01, Days after vaccination: 1226
Gender:Female  Submitted:2012-07-06, Days after onset: 279
Location:Foreign  Entered:2012-07-09, Days after submission: 3
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: No information on medical history reported.
Diagnostic Lab Data:
CDC 'Split Type': E201204297
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERC2695AB UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bordetella test, Bordetella test positive, Cough, Pertussis, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Case was received from the Health Authorities on 03-Jul-2012 (reference number PEI2012019523). Case is medically confirmed. A 51-year-old female patient received a dose of COVAXIS (lot-no. C2695AB) on 23-May-2008. Three years later, on 01-Oct-2011, she developed cough and vomiting and was found to have a pertussis breakthrough. On 10-Feb-2012, pertussis serology showed the following results: IgA of 71 of IU/mL and IgG of 134 IU/mL. At the time of reporting to HA (07-May-2012) the patient had not recovered.

VAERS ID:313785 (history)  Vaccinated:2008-05-24
Age:5.0  Onset:2008-05-26, Days after vaccination: 2
Gender:Female  Submitted:2008-05-27, Days after onset: 1
Location:Maryland  Entered:2008-05-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: On antibiotics for strep
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC148084AA1UNLA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04903SCLA
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Oedema peripheral, Pyrexia, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: Swollen red arm; fever to 102.5; vomiting

VAERS ID:314384 (history)  Vaccinated:2008-05-24
Age:42.0  Onset:2008-05-24, Days after vaccination: 0
Gender:Male  Submitted:2008-05-30, Days after onset: 6
Location:Unknown  Entered:2008-05-30
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: none
Preexisting Conditions:
Diagnostic Lab Data: none
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1734IMRA
Administered by: Military     Purchased by: Military
Symptoms: Hemiparesis, Hypoaesthesia, Joint range of motion decreased, Muscle twitching, Swelling face, Vaccine positive rechallenge
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypersensitivity (narrow), Arthritis (broad)
Write-up: Pt Chief complain: 42 yo AD male recieved Anthrax vaccine on 24 May 08, fifth Anthrax vaccination. 10 to 15 minutes after her recieved vaccine his right side face swelled up and the right side of the body became numb right arm and right leg became paralyzed. The pt states he had movement back in his leg on 27 May 2008 and some movement in his right arm but still cont. to have finger twitching and unable to fully exted his right arm but some improvement in strenght.The pt states he had similar reaction to anthrax vaccination after last shot one year ago and the adverse reaction lasted for about 1.5 months.

VAERS ID:314587 (history)  Vaccinated:2008-05-24
Age:35.0  Onset:2008-05-24, Days after vaccination: 0
Gender:Female  Submitted:2008-05-27, Days after onset: 3
Location:Arizona  Entered:2008-06-02, 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: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
TTOX: TETANUS TOXOID (NO BRAND NAME)SANOFI PASTEURU2019AB0UNLA
Administered by: Other     Purchased by: Private
Symptoms: Dizziness, Malaise, Nausea, Pain in extremity, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)
Write-up: Donor complained of vomiting/nausea 1 hour after shot and nausea lasted a few hours, also felt a little dizzy. Arm was sore. Donor states she thinks she felt sick from not eating prior to donation that day - feels fine now.

VAERS ID:316947 (history)  Vaccinated:2008-05-24
Age:15.0  Onset:2008-06-10, Days after vaccination: 17
Gender:Female  Submitted:2008-06-23, Days after onset: 13
Location:New York  Entered:2008-06-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Cellcept, calcium, Cozaar, Enalapril, Lipitor, plaquenil, ferrous sulfate
Current Illness: None known
Preexisting Conditions: systemic lupus erythmatosis and lupus nephritis 7/3/08-records received- Diagnosed with SLE with nephritis 2007.
Diagnostic Lab Data: awaitng results for viral culture obtained 6/20/08
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.L5L4U   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Acne, Blister, Conjunctival hyperaemia, Eye swelling, Eyelid oedema, Local swelling, Pyrexia, Rash macular, Rash pustular, Rhinorrhoea, Varicella, Virus culture
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conjunctival disorders (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow)
Write-up: Afew days after recieving the vaccine the pt developed runny nose and swelling in the rt side of her neck. No fever at that time. On June 10(22 days after dose) pt noted a "pimple on her face" followed on June 11th by 3 vesicles on her left arm, no fever. She was seen by PMD and was treated with ibuprofen and augementin at that time. By 6/15/08 lesions had spead to legs, trunk and face. On 6/17/08 she developed a fever to 102 and was seen at ER. She was started on acyclovir and her Mycophenolate was stopped that that time. ON 6/19/08 she was again seen in the ER for worsening lesions including swelling of right eye. She was admitted for IV acyclovir treatmetn at this time. 7/3/08-records received for DOS 6/19-6/25/08-DC DX: Varicella. SLE with nephritis. C/O generalized vesicles, pustules, fever, rash macular, right eyelid swelling, mild conjunctival injection. Vaccine administered on 5/24/08 and first presented on 6/17/08.

VAERS ID:343745 (history)  Vaccinated:2008-05-24
Age:18.0  Onset:2008-06-25, Days after vaccination: 32
Gender:Female  Submitted:2009-04-08, Days after onset: 287
Location:Texas  Entered:2009-04-08
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: unknown
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEUR  IDLA
Administered by: Military     Purchased by: Military
Symptoms: Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: Vaccinated with ACAM2000 during pregnancy. Pregnancy resulted in full term healthy delivery.

VAERS ID:499312 (history)  Vaccinated:2008-05-24
Age:21.0  Onset:2008-08-01, Days after vaccination: 69
Gender:Female  Submitted:2013-08-14, Days after onset: 1839
Location:Foreign  Entered:2013-08-14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Immunisation; 11/08/2007, GARDASIL, Immunisation
Diagnostic Lab Data: Blood samples had been taken, but results were not provided.
CDC 'Split Type': WAES1308DNK005318
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Blood test, Colitis ulcerative, Functional gastrointestinal disorder, Hemiplegia, Hypoaesthesia, Melaena, Micturition disorder, Paraesthesia, Sensory disturbance
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)
Write-up: Case received from a consumer or other non health care professional via the Health Authorities on 06-Aug-2013 under the references DK-DKMA-ADR 22202249 and DK-DKMA EFO6483. A 21-year old female patient (weight 64 kg, height 170 cm) had received the third injection of GARDASIL (batch number not reported) via not reported route and site of administration on 24-May-2008. Approximately 2 months later, on 01-Aug-2008, the patient developed stomach pain, melena and ulcerative colitis. On an unspecified date, later that year, the patient developed sensory disorders in the left arm, leg and abdomen, paralysis on the right side (both arm and leg), urination problems, bowel problems, numbness in extremity and tingling sensations in extremities. The patient was hospitalised. Blood samples had been taken, but results were not provided. The patient received drug therapy for ulcerative colitis, and medical care and rehabilitation for paralysis. At the time of reporting, the patient had not recovered from stomach pain, melena, ulcerative colitis, sensory disorders in the left arm, leg and abdomen, numbness in extremities and tingling sensations in extremities. The outcome of paralysis on the right side, urination problems and bowel problems was unknown. Previous dose of GARDASIL was given on 08-Nov-2007 (D1). The patient received D2 on an unspecified date. Toleration of the vaccinations was not reported. Noteworthy: The company corrected the patient''s age at onset of events to 21 years, HA reported 26 years (patient was born in 1987)

VAERS ID:313882 (history)  Vaccinated:2008-05-25
Age:19.0  Onset:2008-05-26, Days after vaccination: 1
Gender:Female  Submitted:2008-05-27, Days after onset: 1
Location:Washington  Entered:2008-05-28, 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: none
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.1978U0UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2552AA0UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B015AA0UNLA
Administered by: Private     Purchased by: Public
Symptoms: Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Swelling L upper arm 8 cm wide warm to touch.

VAERS ID:314442 (history)  Vaccinated:2008-05-25
Age:1.0  Onset:2008-05-26, Days after vaccination: 1
Gender:Male  Submitted:2008-05-30, Days after onset: 4
Location:Massachusetts  Entered:2008-06-02, 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: No
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB214AA0IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC451513IMLL
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Induration
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad)
Write-up: (L) thigh 3x5cm induration, surrounding skin is mild red. Observation and warm compress.

VAERS ID:320200 (history)  Vaccinated:2008-05-25
Age:0.4  Onset:2008-05-28, Days after vaccination: 3
Gender:Female  Submitted:2008-07-22, Days after onset: 55
Location:New York  Entered:2008-07-23, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: mild URI; Upper respiratory tract infection
Preexisting Conditions:
Diagnostic Lab Data: Polymerase chain reaction, 00/00/2008, negative for pertussis
CDC 'Split Type': USWYEH04455308
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA03421UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC650420UNRL
Administered by: Private     Purchased by: Other
Symptoms: Cough, Pertussis, Polymerase chain reaction
SMQs:, Anaphylactic reaction (broad)
Write-up: Follow-up information, upgrading this case to serious status, has been received that pertains to event details, patient demographics, medical history and product details. Information regarding PREVNAR was received from a healthcare professional regarding a female patient who experienced pertussis/para pertussis. The patient received the first dose on 25-May-2008. The patient also received the second dose of Poliomyelitis Vaccine inactivated (manufacturer unknown) on 25-May-2008. On 28-May-2008, the patient was hospitalized for 2 days with clinical pertussis/para pertussis. The patient is still coughing but slowly improving. The reporter commented that in his opinion, the event was not related to PREVNAR. No additional information was available at the time of this report.

VAERS ID:348989 (history)  Vaccinated:2008-05-25
Age:0.0  Onset:2009-06-05, Days after vaccination: 376
Gender:Female  Submitted:2009-06-08, Days after onset: 3
Location:Michigan  Entered:2009-06-12, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Fever~Hib (no brand name)~1~0~Patient|Fever~Pneumo (Prevnar)~1~0~Patient|Fever~DTaP + HepB + IPV (Pediarix)~1~0~Patient|Fever~Ro
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0152Y0SCRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHD210523IMLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0359Y0SCLL
Administered by: Private     Purchased by: Private
Symptoms: Pyrexia, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow)
Write-up: Febrile (101) 24 hours after immunizations - red rash on trunk 10 days after immunization

VAERS ID:325327 (history)  Vaccinated:2008-05-25
Age:13.0  Onset:2008-08-09, Days after vaccination: 76
Gender:Female  Submitted:2008-09-16, Days after onset: 38
Location:Foreign  Entered:2008-09-17, 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: Unknown
Diagnostic Lab Data: enterovirus PCR, Negative; serum Borrelia burgdorferi antibody test, Negative
CDC 'Split Type': WAES0809USA01629
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Borrelia burgdorferi serology negative, Enterovirus serology test negative, Facial paresis, Polymerase chain reaction
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad)
Write-up: Information has been received from a hospital neurologist concerning a 13 year old female patient who on 25-MAY-2008 was vaccinated with GARDASIL (lot#, site and route not reported). On 09-AUG-2008 the patient developed right facial paresis. On an unspecified day the patient was hospitalized. Infectious serology (Borrelia, enteroviruses) was negative. After 14 days the patient was completely recovered. Other business partner numbers included: E2008-08440. No further information is available.

VAERS ID:315661 (history)  Vaccinated:2008-05-26
Age:21.0  Onset:2008-06-06, Days after vaccination: 11
Gender:Male  Submitted:2008-06-10, Days after onset: 4
Location:Unknown  Entered:2008-06-09, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: He reported fever, muscle soreness and malaise preceding 48 hours.
Preexisting Conditions: HTN pt was no longer on medication at time of event.
Diagnostic Lab Data: EKG NSR DIFFUSE ST-T ELEVATION CONSIDER INJURY PERICARDITIS OR EARLY REPOLARIZATION. TROPONIN POSITIVE. CK 281; CK MB 20; CKMB% 7 LABS: EKG w/ST-T changes, CK 281 (H), MB 20, troponin (+). CXR. Echocardiogram abnormal.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (ACAM2000)SANOFI PASTEURVV0400340IDLA
Administered by: Military     Purchased by: Military
Symptoms: Acute myocardial infarction, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood pressure, Chest X-ray normal, Chest pain, Dyspnoea, Echocardiogram abnormal, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Hypertension, Influenza like illness, Malaise, Myalgia, Myopericarditis, Night sweats, Pain, Pyrexia, Troponin increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad)
Write-up: 21 YO PATIENT PRESENTED WITH SEVERE MIDSTERNAL CHEST PAIN. SYMPTOMS STARTED THE PRIOR DAY. HE AWOKE AT 5AM WITH 10/10 PAIN AND SOME DYSPNEA. HE REOPORTED “FLU” SYMPTOMS 48 HOURS PRIOR TO HIS PRESENTATION. IN ADDITION HE WAS FEBRILE ON INITIAL PRESENTATION. HE PRESENTED TO MEDICAL AND WITH HTN BP 150/101. EKG REVEALED DIFFUSE ST-T CHANGES AND POSSIBLE OLD IWMI. CARDIAC MARKERS; TROPONIN AND CK-MB WERE POSITIVE. U/S REVEALED PRESERVED LV FXN NO WALL MOTION CHANGES. PT WAS TREATED FOR HTN AND POSSIBLE ISCHEMIC EVENT. NO LMWH WAS GIVEN AS MYOPERICARDITIS WAS HIGH ON DIFFERENTIAL. PT ADMITTED REMAINED STABLE HEMODYNAMICALLY IN ICU. MEDEVACED TO MC WHERE DX OF MYOPERICARDITIS WAS CONFIRMED. PT RECEIVED SMALLPOX VACCINATION 26MAY08. 7/15/08 Reviewed medical records of 6/5-6/6/2008. FINAL DX: NSTEMI; myopericarditis; HTN Records reveal patient experienced awakening w/substernal chest pain x 1 day. Had fever, malaise, muscle aches s/p anthrax vaccination w/night sweats x 2 days. Transferred to higher level of care.

VAERS ID:319747 (history)  Vaccinated:2008-05-26
Age:0.2  Onset:2008-05-29, Days after vaccination: 3
Gender:Female  Submitted:2008-07-15, Days after onset: 47
Location:Arizona  Entered:2008-07-17, 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: None
Current Illness: Protein allergy
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0806USA03413
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1928U0PO 
Administered by: Other     Purchased by: Other
Symptoms: Diarrhoea, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a physician concerning an approximately 10 week old female infant with "severe protein food in tolerance" who "a week after she was 2 months old" on approximately 26-MAY-2008 was vaccinated orally with a first dose of ROTATEQ (Oka/Merck) (lot # 660378/1928U). There was no concomitant medication. Subsequently, on approximately 29-MAY-2008, "3 days after getting the vaccination" the patient experienced diarrhea, vomiting and rash. It was noted that the gastroenterologist said it was ok to give the vaccination to the child. Unspecified medical attention was sought. It was unspecified if lab studies were performed. At the time of the report the patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested.

VAERS ID:330473 (history)  Vaccinated:2008-05-26
Age:14.0  Onset:2008-06-15, Days after vaccination: 20
Gender:Female  Submitted:2008-10-14, Days after onset: 121
Location:Unknown  Entered:2008-10-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0809USA04180
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Dermatitis contact, Leukocytoclastic vasculitis, Petechiae
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Vasculitis (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a registered nurse concerning her 14 year old niece with no pertinent medical history and no allergies or drug reactions, who on 29-MAY-2008 was vaccinated with the second dose of HPV 4L1 6 11 18 VLP vaccine (yeast). There was no concomitant medication. The nurse reported that in "mid June 2008", her niece experienced a generalized, "petechial-type rash". The above was diagnosed by a dermatologist as leukocytoclastic vasculitis. At the time of the report the patient had not recovered. Additional information has been requested. 11/5/08-records received-note of 9/23/08-Left leg superficial perivascular infiltrate of lymphocytes with erythrocyte extravasation consistent with progressive pigmentary purpura. No neutrophilic infiltrate or fibrinoid degeneration of vessels is identified to suggest a true vasculitis. Allergic contact dermatitis. 10/27/08-cancelled follow up appointment.

VAERS ID:468206 (history)  Vaccinated:2008-05-26
Age:67.0  Onset:2012-06-01, Days after vaccination: 1467
Gender:Female  Submitted:2012-08-29, Days after onset: 89
Location:Unknown  Entered:2012-08-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': WAES1208USA008733
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: This spontaneous report was received from a 71 years old female consumer reporting on herself with no pertinent medical history and no drug reactions or allergies, who on 26-MAY-2008, was vaccinated subcutaneously with a dose of ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. Concomitant therapies included unspecified medication for plaque psoriasis. The consumer reported that in June 2012, she had shingles. Unspecified treatment was given for the experience. No lab diagnostics studies were performed. At the time of the report, the patient''s outcome was unknown. The patient sought unspecified medical attention. The relatedness for patient had shingles was unknown for ZOSTAVAX. Additional information has been requested.

VAERS ID:315989 (history)  Vaccinated:2008-05-26
Age:28.0  Onset:2008-05-29, Days after vaccination: 3
Gender:Female  Submitted:2008-06-10, Days after onset: 12
Location:Foreign  Entered:2008-06-11, 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: The patient had ulcerative colitis and Crohns disease for which she was receiving an immune modulator.
Diagnostic Lab Data:
CDC 'Split Type': E200805056
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEUR  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: This case was initially reported to an agency by a health care professional. This case concerns a 28 year old female patient. The patient was receiving an immune modulator as corrective treatment for ulcerative colitis and Crohns disease. The patients YF-VAX was initially delayed by the doctor at the clinic due to the patients treatment with the immune modulator, the patient was advised to check with her gastroenterologist, and was told it was OK to proceed. The doctor at the clinic sought further advice and was advised that the patient should change her itinerary. The patient presented for vaccination when the clinic doctor was unavailable and stated that her doctor had said it was OK for her to proceed with vaccination. On 26-May-2008 the patient received YF-VAX, STAMARIL, batch number not reported, RABIES, manufacturer not reported, and HAVRIX, Hepatyrix manufactured by GSK. Three days later the patient experienced numbness in two fingers. The patient had not recovered at the time of reporting. This case has been upgraded to serious upon internal review by a company physician.

VAERS ID:316363 (history)  Vaccinated:2008-05-26
Age:6.0  Onset:2008-05-26, Days after vaccination: 0
Gender:Male  Submitted:2008-06-16, Days after onset: 21
Location:Foreign  Entered:2008-06-16
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': B0523771A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B058AA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Bronchospasm, Chest pain, Cough, Hyperaemia, Pharyngeal oedema, Throat irritation
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Asthma/bronchospasm (narrow), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of throat irritation in a 6-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included MMR (Sanofi; subcutaneous; unknown) given on an unspecified date. On 26 May 2008 the subject received unspecified dose of INFANRIX (intramuscular, unknown). On 26 May 2008, less than one day after vaccination with INFANRIX, the subject experienced throat irritation, chest pain, pharyngeal hyperemia, pharynx edema, bronchospasm and dry cough. The regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with adrenaline (Adrenalin). At the time of reporting the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX.

VAERS ID:316610 (history)  Vaccinated:2008-05-26
Age:0.7  Onset:2008-05-26, Days after vaccination: 0
Gender:Male  Submitted:2008-06-18, Days after onset: 23
Location:Foreign  Entered:2008-06-19, 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:
Current Illness:
Preexisting Conditions: No other relevant history. No concomitant drug.
Diagnostic Lab Data:
CDC 'Split Type': 200801930
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEUR  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)
Write-up: Initial report received from a health care professional in a foreign country on 11 June 2008 under the local reference number: CN2008040. An 8-month-old male patient with no relevant medical history had immunization with ACT-HIB, I.M., in the deltoid on 26 May 2008. On the same day, following vaccination, he developed generalized rash. He was not taking any concomitant medication. He was admitted to a hospital on 27 May 2008. "Detail was not reported by now." It was reported an unspecified "therapy dates" and "therapy duration" reported as "27 May 2008 to 3 June 2008 and 8 days". The patient recovered within an unspecified time frame.

VAERS ID:316670 (history)  Vaccinated:2008-05-26
Age:38.0  Onset:2008-05-27, Days after vaccination: 1
Gender:Female  Submitted:2008-06-19, Days after onset: 23
Location:Foreign  Entered:2008-06-19
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': D0057592A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B028CA IMLA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Oedema peripheral, Pain, Paraesthesia, Skin reaction, Tension, Vasculitis
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vasculitis (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of skin reactions in a 38-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of BOOSTRIX (unknown route and injection site). At an unspecified time after vaccination with BOOSTRIX, the subject experienced skin reactions, swelling on arm and pins and needles in fingers. Follow-up information was received on 13 June 2008 by the physician. The subject never suffered from vasculitis before. On 26 May 2008 the subject received a dose of BOOSTRIX (intramuscular, left upper arm). On 27 May 2008, 1 day after vaccination with BOOSTRIX, the subject experienced severe swelling and redness of upper arm, which was resolved on 1 June 2008. On 2 June 2008 the subject developed nummular redness of soles and hands, which was resolved on 7 June 2008. Nummular redness of soles and hands was diagnosed as vasculitis by the physician. The subject also suffered from pain and feeling of tension. This case was assessed as medically serious by GSK. In 2008, all events were resolved without any treatment. The physician considered severe swelling and redness of upper arm were almost certainly related to vaccination with BOOSTRIX and vasculitis was probably/almost certainly related to vaccination with BOOSTRIX. The physician stated that there was a clear temporary relation to vaccination with BOOSTRIX.

VAERS ID:317349 (history)  Vaccinated:2008-05-26
Age:1.0  Onset:2008-05-26, Days after vaccination: 0
Gender:Male  Submitted:2008-06-24, Days after onset: 29
Location:Foreign  Entered:2008-06-25, 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: Not reported.
Diagnostic Lab Data:
CDC 'Split Type': E200805614
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEUR  IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypersomnia, Insomnia, Muscle spasms, Pyrexia, Tonic clonic movements
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Initial case was reported as serious on 16-Jun-2008 by the foreign authorities (ref number 20081237). It was reported that a 12-month-old boy was vaccinated against DITEKIPOL, SSI, i.m., batch number and site of administration not reported), and concomitantly with ACT-HIB, intramuscular, batch number and site of administration not reported) and a PREVENAR, Wyeth, batch number not reported on 26-May-2008. The following night the child got fever and did not sleep very well. The next morning, on 27-May-2008, the child was hot, but otherwise he looked okay. Suddenly the child got tonic, clonic cramps. When the ambulance drove the child to the hospital, he received Stesolid, but without any effect. When the child got to the hospital he received corrective treatment (not specified) and fell to deep sleep. The outcome is not reported. Case is closed.

VAERS ID:318704 (history)  Vaccinated:2008-05-26
Age:0.3  Onset:2008-05-26, Days after vaccination: 0
Gender:Male  Submitted:2008-07-10, Days after onset: 45
Location:Foreign  Entered:2008-07-11, 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: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0807USA00922
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1706U PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)
Write-up: Information has been received from a physician concerning a 14 week male patient with no relevant history reported who on 26-MAY-2008 was vaccinated orally with a second dose of ROTATEQ (lot # 657990/1706U). From 26-MAY-2008 to 27-MAY-2008, the patient experienced blood in his stool. At the time of the report, the patient recovered. Other business partner numbers included E2008-06258.

VAERS ID:318740 (history)  Vaccinated:2008-05-26
Age:0.3  Onset:2008-06-02, Days after vaccination: 7
Gender:Male  Submitted:2008-07-10, Days after onset: 38
Location:Foreign  Entered:2008-07-11, 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: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0807CAN00012
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 0PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Intussusception, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad)
Write-up: Information has been received from a physician concerning a 16 week old male patient who on approximately 26-MAY-2008 was vaccinated with ROTATEQ, first dose (lot # not available). On approximately 02-JUN-2008 the patient experienced intussusception. Subsequently, the patient recovered from intussusception. The physician reported that the patient went through significant crying spells and vomiting one week after being vaccinated with ROTATEQ and went to the emergency room. It was reported that the ER personnel suspected an intussusception that spontaneously resolved. Upon internal review, intussusception was considered to be an Other Important Medical Event. No further information is available.

VAERS ID:318811 (history)  Vaccinated:2008-05-26
Age:0.4  Onset:2008-05-26, Days after vaccination: 0
Gender:Male  Submitted:2008-07-11, Days after onset: 46
Location:Foreign  Entered:2008-07-14, 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:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0807USA01451
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1706U1PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)
Write-up: Information has been received from a physician concerning a 19 week old male patient who on 26-MAY-2008 was vaccinated orally with a second dose of ROTATEQ (lot # 657790/1706U). From 26-MAY-2008 to 27-MAY-2008, the patient experienced blood in the stool. At the time of the report, the patient recovered. Upon internal review, the initial received date reported as 02-JUL-2008 was corrected into 28-JUN-2008 and the age of the patient initially reported as 3 months was corrected into 19 weeks. "Blood in stool" was considered an other important medical event. Other business partner numbers included E2008-06258.

VAERS ID:329594 (history)  Vaccinated:2008-05-26
Age:0.2  Onset:2008-06-29, Days after vaccination: 34
Gender:Male  Submitted:2008-10-21, Days after onset: 114
Location:Foreign  Entered:2008-10-22, 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: UNK
Diagnostic Lab Data: None Provided.
CDC 'Split Type': NLWYEG02377608
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH270570IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Cyanosis, Hypotonia, Hypotonic-hyporesponsive episode, Listless, Loss of consciousness, Pallor, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was considered medically important for the hypotonic-hyporesponsive episode. Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 2-month-old male patient who experienced crying, listlessness, cyanosis peripheral, hypotonic-hyporesponsive episode (with pallor, hypotonia and unconsciousness) and vomiting. The patient received the first dose on 26-May-2008. The patient has no relevant medical history. 3 days after the vaccinations the patient experienced listlessness, crying, cyanosis peripheral, hypotonic-hyporesponsive episode (with pallor, hypotonia and unconsciousness) for 10 minutes and vomiting on 29-Jun-2008. The paleness resolved after 30 minutes. The patient recovered. No additional information was available at the time of this report.

VAERS ID:329596 (history)  Vaccinated:2008-05-26
Age:0.7  Onset:2008-05-26, Days after vaccination: 0
Gender:Male  Submitted:2008-10-21, Days after onset: 148
Location:Foreign  Entered:2008-10-22, 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:
Current Illness:
Preexisting Conditions: No relevant medical history.
Diagnostic Lab Data: Blood lab tests performed on 28 May 2008 revealed WBC=11.2 x 10exp9/L, L=33.3%, G=55%, Hgb=94 g/L, platelets= 331x 10exp9/L. No abnormal result was revealed on urine routine test.
CDC 'Split Type': 200803151
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEUR 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood test, Drug eruption, Granulocyte count decreased, Haemoglobin increased, Injection site erythema, Injection site swelling, Lymphocyte percentage, Platelet count normal, Pruritus, Pyrexia, Rash erythematous, Rash generalised, Tonsillitis, Upper respiratory tract congestion, Urine analysis normal, White blood cell count normal
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: Report received from a foreign healthcare professional on 13 October 2008. Local reference number CN2008063. A 08-month-old male patient, with no relevant medical history, was diagnosed with "drug eruption" 1 day after receiving the 1st intra-muscular dose of ACT-HIB, lot number not reported, in the deltoid on 26 May 2008. The patient was not receiving any concomitant drugs. On the same day of the vaccination, i.e. on 26 May 2008, the patient experienced fever and injection site redness and swelling. One day later, i.e. on 27 May 2008, he presented with generalized rash on trunk and limbs. The patient was sent to see a doctor and was admitted to hospital with diagnosis of "drug eruption" on 28 May 2008. Physical examination showed T=37.8 C, red rash with itch on trunk and limbs-the rash was in different sizes-, congestive pharynx, tonsil swelling I, no rough sound of breath. Blood lab tests performed on 28 May 2008 revealed WBC=11.2 x 10exp9/L, L=33.3%, G=55%, Hgb=94 g/L, platelets= 331 x 10exp9/L. No abnormal result was revealed on urine routine test. The patient received corrective treatment with unspecified anti-allergic drugs from 28 May to 02 June 2008. The discharge diagnosis was "drug eruption". He was discharged on 02 June 2008. He had recovered within an unspecified timeframe.

VAERS ID:337944 (history)  Vaccinated:2008-05-26
Age:4.0  Onset:2008-05-26, Days after vaccination: 0
Gender:Female  Submitted:2008-12-03, Days after onset: 191
Location:Foreign  Entered:2008-12-19, Days after submission: 16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': AUBEH200813671
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Decreased appetite, Influenza like illness, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: A 4-year-old female patient (initials: JD) received FLUVAX (batch N20602) for influenza immunization on 26-May-2008. Within one hour of vaccination, the patient experienced flu-like symptoms. The patient was off color for a couple of days with a fever and went off her food. The patient was seen by a doctor on 28-May-2008, and was still a bit off color but improving. Treatment was received with Panadol (paracetmol).

VAERS ID:337945 (history)  Vaccinated:2008-05-26
Age:46.0  Onset:2008-05-26, Days after vaccination: 0
Gender:Male  Submitted:2008-12-03, Days after onset: 191
Location:Foreign  Entered:2008-12-19, Days after submission: 16
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': 200813672
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED10059429 UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Influenza like illness, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad)
Write-up: Report received from a physician on 29-MAY-2008. A male patient received FLUVAX (batch N20602) for influenza immunisation on 26-MAY-2008. Within one hour of vaccination, the patient experienced flu-like symptoms. The patient was off colour for a couple of days and had a fever. It is not known whether the patient received any treatment. It is not known whether the patient recovered. Follow-up information received from physician on 06-JUN-2008: Additional information provided. Patient age: 46 years. Nil relevant medical history. Has not received therapy with influenza vaccine in the past. Patient outcome unknown. Causality assessment by reporter: possible.

VAERS ID:337947 (history)  Vaccinated:2008-05-26
Age:81.0  Onset:0000-00-00
Gender:Male  Submitted:2008-12-03
Location:Foreign  Entered:2008-12-19, Days after submission: 16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Beta blocker
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': AUBEH200813721
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (AFLURIA)CSL LIMITED    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain upper, Azotaemia, Chills, Diarrhoea, Fatigue, Headache, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Noninfectious diarrhoea (narrow)
Write-up: An 81-year-old male patient (initials: WH, DOB: 2/22/1927) received FLUVC (batch number unknown) for influenza immunization on 26-May-2008. The patient was also taking concomitant beta-blocker therapy. Approximately 2-3 days after immunization, the patient developed chills, rigors, irregular biochemistry(?uraemia), myalgia, fatigue, headache, diarrhea, stomach cramps. It is not known whether the patient received any treatment. At the time of reporting, the reaction was ongoing.

VAERS ID:343260 (history)  Vaccinated:2008-05-26
Age:36.0  Onset:2009-01-14, Days after vaccination: 233
Gender:Female  Submitted:2009-04-01, Days after onset: 76
Location:Foreign  Entered:2009-04-01
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': D0057722A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Premature rupture of membranes
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: This case was reported by a physician and was a prospective report of vaccine exposure during pregnancy in a 36-year-old female subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). After vaccination with TWINRIX adult the subject was found to be pregnant in six weeks of gestation. Follow-up information was received on 29 July 2008. The subject received TWINRIX adult on 26 May 2008. Her last menstrual period occurred on 16 April 2008. Pregnancy occurred by normal congestion. The estimated date of delivery was 21January 2009. At the time of follow-up the subject was in 14 weeks of gestation. There were no complications. The last examination was on 02 July 2008. Follow-up information was received on 26 March 2009. On 17 January 2009, after 39+3 weeks of pregnancy the patient gave birth to a male infant weighing 3210 g, with a size of 50 cm, a head circumference of 34 cm and an Apgar score of 8/9/10, by vacuum extraction. Birth had to be forced because of premature rupture of amniotic membranes on 14 January 2009. This case was assessed as medically serious by GSK. The child had congenital anomaly. Please see case D0057722B for details.

VAERS ID:343261 (history)  Vaccinated:2008-05-26
Age:  Onset:0000-00-00
Gender:Male  Submitted:2009-04-01
Location:Foreign  Entered:2009-04-01
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': D0057722B
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Porencephaly, Premature rupture of membranes
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)
Write-up: This case was reported by a physician and described the occurrence of porencephalic cyst in a neonate male subject whose mother was vaccinated with TWINRIX adult (GlaxoSmithKline)during pregnancy. On 26 May 2008, the subject was exposed to unspecified dose of TWINRIX adult transplacentary (maternal vaccine exposure). The neonate was born on 17 January 2009 after 39+3 weeks of pregnancy with a birth weight of 3210 g with a size of 50 cm, a head circumference of 34 cm and an apgar score of 8/9/10, by vacuum extraction after premature rupture of amniotic membranes. The subject was born with porencephalic cyst at the right side. This case was assessed as medically serious by GSK. The reporting physician considered that the causality was not assessable, but his opinion had a tendency to unlikely relation to the mother''s vaccination. Please see the non-serious case D0057722A for details about the mother. No further information will be available.

VAERS ID:381184 (history)  Vaccinated:2008-05-26
Age:14.0  Onset:2008-08-24, Days after vaccination: 90
Gender:Female  Submitted:2010-02-23, Days after onset: 548
Location:Foreign  Entered:2010-02-24, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES1002USA01850
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cerebral haemorrhage, Dizziness, Educational problem, Nervous system disorder, Neurosurgery, Tic
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Haemorrhagic cerebrovascular conditions (narrow), Dyskinesia (broad), Dystonia (broad), Vestibular disorders (broad)
Write-up: Information has been obtained on request by the company from the agency via public case details form concerning a 14 year old patient who on 26-MAY-2008 was vaccinated with her second dose of GARDASIL. Three months after the second dose of GARDASIL, the patient developed dizziness and a cerebral bleed. It was also reported that the patient underwent emergency neurosurgery and was admitted to brain injury unit. There was a neurological deficit, facial tic and poor school performance after neurosurgery. It was also mentioned that 3 month for onset of cerebral bleed post vaccination was difficult to explain plus patient was given the third dose of GARDASIL 10 months after the second dose in approximately 26-MAR-2009 with apparently no adverse event. (Schedule of vaccination was not followed). At the time of the report the patient had not recovered. The reporting source considered the vaccination with GARDASIL to be possibly related to the cerebral haemorrhage and dizziness. This is an amended report. Serious criteria for cerebral hemorrhage was changed from no to yes for hospitalization. Narrative statement was changed from "went to the emergency neurosurgery brain injury unit" to "underwent emergency neurosurgery and was admitted to the brain injury unit". The primary reporting source was not provided. Additional information has been requested.

VAERS ID:403363 (history)  Vaccinated:2008-05-26
Age:1.2  Onset:2008-08-30, Days after vaccination: 96
Gender:Female  Submitted:2010-10-12, Days after onset: 773
Location:Foreign  Entered:2010-10-14, 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: Concomitant medications were not reported.
Current Illness: The patient''s concurrent illness includes congenital osteo-dural defect at the sphenoidal level.
Preexisting Conditions: It is to be noted that the patient underwent three surgical operations to repair the osteo-dural defect which were unsuccessful as clear rhinorrhea persisted.
Diagnostic Lab Data: None Provided.
CDC 'Split Type': FRWYEG06794910
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC: PNEUMO (PREVNAR)PFIZER/WYETH 3UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Deafness, Meningitis pneumococcal
SMQs:, Hearing impairment (narrow)
Write-up: This case was considered medically important. Information regarding PREVENAR was received from a healthcare professional regarding a 17-month-old female patient who experienced pneumococcal meningitis due to serotype 3 and deafness as a sequela. The patient received the fourth dose on 26-May-2008. The patient experienced pneumococcal meningitis due to serotype 3 on 30-Aug-2008 after having received a full vaccination with PREVENAR. The event was considered medically important. The patient recovered with deafness as a sequela. No additional information was available. The patient experienced a second episode of pneumococcal meningitis later (see related case FR-WYE-G06766810). See related case(s) : FR-WYE-G06766810 (adverse event, expedited).

VAERS ID:420256 (history)  Vaccinated:2008-05-26
Age:42.0  Onset:0000-00-00
Gender:Female  Submitted:2011-04-04
Location:Foreign  Entered:2011-04-04
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: Blood erythropoietin, 2010, extremely high Un; Blood test, 2010, unknown Units; Bone marrow biopsy, 2010, normal Units; Computerized tomography, 2010, normal Units; Hemoglobin, 2010, 3.7 Units; Red blood cell count, 2010, slightly elevate; Reticulocyte count, 2010, low Units; Viral test, 2010, negative Units; White blood cells, 2010, normal Units
CDC 'Split Type': B0709639A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 2UNUN
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anaemia, Biopsy bone marrow normal, Blood erythropoietin increased, Blood test, Computerised tomogram abdomen normal, Computerised tomogram normal, Haemoglobin decreased, Platelet count increased, Red blood cell count increased, Reticulocyte count decreased, Transfusion, Viral test negative, White blood cell count normal
SMQs:, Haematopoietic erythropenia (narrow), Haemorrhage laboratory terms (broad)
Write-up: This case was reported by a sales representative and described the occurrence of anemia in a 44-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline) and TWINRIX. A physician or other health care professional has not verified this report. Previous and/or concurrent vaccination included TWINRIX; GlaxoSmithKline; unknown; unknown given on 29 November 2007 and 27 December 2007; CERVARIX; GlaxoSmithKline; unknown; unknown given on 29 November 2007 and 27 December 2007. No concurrent medications. On 26 May 2008, the subject received 3rd dose of CERVARIX (administration site and route unknown, batch number not provided) and 3rd dose of TWINRIX (administration site and route unknown, batch number not provided). In 2010, 2 years after vaccination with CERVARIX and TWINRIX, the subject experienced anemia. The subject was hospitalised. Hemoglobin was 3.7. Blood tests have been taken every week, a biopsy of the bone marrow 4 times which were all normal. 2 computerized tomography of chest and abdomen showed both normal states. For the last 6 months, the blood tests have shown falling hemoglobin, so the patient had to have blood transfusion 5 times. There was no sign of bleeding, haemolysis or nutrient deficiency and all tests for viruses were negative. The reticulocytes were very low and the erythropoietin was extremely high. Leucocytes were at the normal level and the thrombocytes were slightly elevated. At the time of reporting, the event was unresolved.

VAERS ID:314553 (history)  Vaccinated:2008-05-27
Age:17.0  Onset:2008-05-28, Days after vaccination: 1
Gender:Female  Submitted:2008-06-02, Days after onset: 5
Location:Maryland  Entered:2008-06-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2573AA0IMLA
Administered by: Military     Purchased by: Unknown
Symptoms: Dizziness, Dyspnoea, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: 24 hours after receiving vaccination patient complain of nausea, dizziness, shortness of breath, and fainting spells

VAERS ID:314796 (history)  Vaccinated:2008-05-27
Age:4.0  Onset:2008-05-28, Days after vaccination: 1
Gender:Female  Submitted:2008-05-30, Days after onset: 2
Location:Florida  Entered:2008-06-03, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2951BA4IMLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB268AA0IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA04513IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0451X1SCRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1894U1SCLL
Administered by: Private     Purchased by: Private
Symptoms: Erythema, Feeling hot
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: 3 days post immunization, child presented to the office with 7 x 9 cm area of erythema and increased warmth to mid right thigh. She had received her 5th DTaP/1st HEP A intramuscular injections and her second subcutaneous MMR in that leg. The child did not complain of any pain or fever.

VAERS ID:314803 (history)  Vaccinated:2008-05-27
Age:4.0  Onset:2008-05-28, Days after vaccination: 1
Gender:Female  Submitted:2008-05-29, Days after onset: 1
Location:New York  Entered:2008-06-03, 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: None
Current Illness: None
Preexisting Conditions: Amoxicillin
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (TRIPEDIA)SANOFI PASTEURU2354BA4IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA01273IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0285U1IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1475U1IMLL
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad)
Write-up: 16 x 12 cm local swelling and erythema left thigh.

VAERS ID:315999 (history)  Vaccinated:2008-05-27
Age:1.1  Onset:2008-06-03, Days after vaccination: 7
Gender:Male  Submitted:2008-06-05, Days after onset: 2
Location:Pennsylvania  Entered:2008-06-11, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVPOF0UNLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1218F0UNLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHC499233UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.0173X0UNRL
Administered by: Other     Purchased by: Public
Symptoms: Pallor, Pyrexia, Rash macular
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Pt developed rash 8d after MMR vaccine. Accompanied by tactile fever. Rash-blanching, macular; afebrile in office.

VAERS ID:315129 (history)  Vaccinated:2008-05-27
Age:38.0  Onset:2008-05-27, Days after vaccination: 0
Gender:Male  Submitted:2008-06-04, Days after onset: 8
Location:Foreign  Entered:2008-06-06, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Behcet''s syndrome
Preexisting Conditions: Splenectomy
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0806USA00242
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site induration, Pyrexia, Vaccination complication
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from a physician concerning a 38 year old male with Behcet''s syndrome and a history of splenectomy who on 27-MAY-2008 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23. On 27-MAY-2008 the patient developed induration at the injection site measuring approximately 10 cm long and a sustained pyrexia of 39 degrees C and was hospitalized. The reporting physician felt that induration and pyrexia were definitely related to therapy with PNEUMOVAX 23. Additional information has been requested.

VAERS ID:316284 (history)  Vaccinated:2008-05-27
Age:9.0  Onset:2008-05-27, Days after vaccination: 0
Gender:Male  Submitted:2008-06-13, Days after onset: 17
Location:Foreign  Entered:2008-06-16, Days after submission: 3
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': WAES0806USA01397
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR  IMRA
TDAP: TDAP (ADACEL)SANOFI PASTEUR  IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Auricular swelling, Feeling hot, Pharyngolaryngeal pain, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a paediatrician concerning a 9 year old male patient who on 27-MAY-2008 was vaccinated with a first dose of VARIVAX (Oka/Merck) (Lot # not reported), intramuscularly into the left deltoid muscle and concomitantly with a booster dose of REPEVAX (Lot # not reported), intramuscularly into the right deltoid muscle. About 20 minutes post vaccination, the patient experienced a sore throat, hot feeling in face, swollen ears and generalized urticaria. The patient was hospitalized. Treatment with CLEMASTIN, decortin and salbutamol was given. Other business partner numbers included: E2008-05124. Additional information is not expected.

VAERS ID:316700 (history)  Vaccinated:2008-05-27
Age:11.0  Onset:2008-05-27, Days after vaccination: 0
Gender:Male  Submitted:2008-06-19, Days after onset: 23
Location:Foreign  Entered:2008-06-20, 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': WAES0806USA03300
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEUR  IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEUR  IMRA
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC. 0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Auricular swelling, Feeling hot, Flushing, Pharyngolaryngeal pain, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Information has been received from a paediatrician concerning a 11 year old male with no relevant medical history reported who on 27-MAY-2008 was vaccinated concomitantly with a first dose of VARIVAX (Oka/Merck) IM into the left deltoid muscle and a booster dose of REPEVAX IM into the right deltoid muscle. Approximately 20 minutes post vaccination on 27-MAY-2008, the patient experienced a sore throat, hot feeling in face, swollen ears and a generalised urticaria. The patient was hospitalized. Treatment with TEVEGIL, DECORTIN and salbutamol was given. The following day the patient recovered completely. Additional information was received from a hospital report. The patient was admitted to the hospital on 27-MAY-2008. It was reported that the patient received a further treatment with PREDNSOLON, FENISTIL and a single dose of epinephrine. Under this therapy, the patient recovered completely by the next morning and was discharged on 28-MAY-2008. Other business partner numbers included E2008-05124. No further information is available. The case is closed.

VAERS ID:317351 (history)  Vaccinated:2008-05-27
Age:0.3  Onset:2008-05-27, Days after vaccination: 0
Gender:Female  Submitted:2008-06-24, Days after onset: 28
Location:Foreign  Entered:2008-06-25, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: None Provided.
CDC 'Split Type': FRWYEG01729408
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH311140IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cold sweat, Crying, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad)
Write-up: Information regarding PREVENAR was received from a healthcare professional via regulatory authority regarding a 3-month-old female patient who experienced breathing difficulty, unconsolable crying and cold sweats. The patient received a dose on 27-May-2008. The patient had no relevant medical history. Past therapies included BcG Vaccine at birth. Additional suspect medication included INFANRIX HEXA. Concomitant medications were not reported. On 27-May-2008, four hours after vaccination, the patient experienced unconsolable crying, breathing difficulty, and cold sweats, without loss of consciousness. Mobile emergency unit was called. The outcome was favorable. The events lasted for about 20 minutes, then the patient recovered without sequelae. The events were considered medically important and breathing difficulties was considered to be life-threatening. No additional information was available at the time of this report.

VAERS ID:317782 (history)  Vaccinated:2008-05-27
Age:0.3  Onset:2008-05-27, Days after vaccination: 0
Gender:Female  Submitted:2008-06-27, Days after onset: 31
Location:Foreign  Entered:2008-06-27
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Past vaccination included tuberculosis vaccine (BCG), given at birth. The subject had no relevant past medical history.
Diagnostic Lab Data: UNK
CDC 'Split Type': B0526110A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSA20CA403A IMUN
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA20CA403A IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA20CA403A IMUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH31114 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Cold sweat, Crying, Respiratory disorder
SMQs:, Acute central respiratory depression (broad), Depression (excl suicide and self injury) (broad)
Write-up: This case was reported by the regulatory authority (AFSSaPS, PB20080285) and described the occurrence of acute persistence crying in a 2-month-old female subject was vaccinated with INFANRIXQUINTA (GlaxoSmithKline) and PREVENAR (Wyeth). The subject had no relevant past medical history. Past vaccination included tuberculosis vaccine, given at birth. On 27 May 2008, at 15:00, the subject received a dose of INFANRIXQUINTA (intramuscular, batch number A20CA403A) and a dose of PREVENAR (Intramuscular, batch number 31114). Four hours after vaccinations, the subject presented with acute perisitent and inconsolable crying, cold sweat and respiratory difficulty without loss of consciousness. Within 20 minutes, the events resolved. The regulatory authority reported that the events were life threatening and clinically significant, possibly related to vaccination with INFANRIX QUINTA and dubiously related to vaccination with PREVENAR, according to the Method of Imputability. This case has been closed; no more information will be available.

VAERS ID:317784 (history)  Vaccinated:2008-05-27
Age:2.0  Onset:2008-06-02, Days after vaccination: 6
Gender:Female  Submitted:2008-06-27, Days after onset: 25
Location:Foreign  Entered:2008-06-27
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: C-reactive protein, 02Jun2006, 9.9mg/L
CDC 'Split Type': B0525965A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX)GLAXOSMITHKLINE BIOLOGICALS  SCUN
Administered by: Other     Purchased by: Other
Symptoms: C-reactive protein increased, Cyanosis, Febrile convulsion, Muscle spasms, Pyrexia, Tonic clonic movements
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dystonia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a regulatory authority (# 2008-02213) and described the occurrence of febrile convulsion in a 2-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline), PRIORIX. On 27 May 2008, the subject received unspecified dose of INFANRIX (intramuscular, unknown), unspecified dose of PRIORIX (subcutaneous, unknown). On 2 June 2008, 6 days after vaccination with INFANRIX and PRIORIX, the subject experienced a tonic clonic fever cramp with cyanosis. The cramp lasted about 10 minutes. Fever-lowering measures were accomplished and the child was hospitalized. CRP was 9.9 mg/l. At time of reporting, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX and PRIORIX. A renewed inoculation with the same vaccine should be considered carefully. In any case an antipyretic prophylaxis will make sense.

VAERS ID:320555 (history)  Vaccinated:2008-05-27
Age:0.1  Onset:2008-05-27, Days after vaccination: 0
Gender:Unknown  Submitted:2008-07-25, Days after onset: 59
Location:Foreign  Entered:2008-07-28, Days after submission: 3
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: not reported
Diagnostic Lab Data:
CDC 'Split Type': 200802373
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20907001D SCUN
HEPA: HEP A (NO BRAND NAME)UNKNOWN MANUFACTURER0430047 IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURA9712 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Pyrexia, Restlessness, Screaming
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad)
Write-up: Case received from the Health Authorities on 21 July 2008. A 01-month-old patient (gender not specified), with no reported medical history, experienced restlessness, pyrexia at 38.9C and uncontrollable crying on 27 May 2008, i.e. the same day after receiving an intramuscular dose of ACTHIB, batch number A9712-2, an intramuscular dose of HEPAVAX-GENE (other MFR, batch number 0430047) and a subcutaneous dose of DTP (other MFR, batch number 20907001D). According to the patient''s mother, the patient developed constantly (many hours per day) screaming from the 1st day post-vaccination up to 3 days. Restlessness lasted up to 7 days. Crying resolved after 6 days. The patient received paracetamol and fever resolved within 24 hours. The patient''s health general condition was good and the patient was not seen by a physician. The patient recovered. This case was assessed as a medical important condition.

VAERS ID:323954 (history)  Vaccinated:2008-05-27
Age:0.1  Onset:2008-05-27, Days after vaccination: 0
Gender:Unknown  Submitted:2008-09-02, Days after onset: 98
Location:Foreign  Entered:2008-09-03, 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:
Current Illness:
Preexisting Conditions: No reported medical history.
Diagnostic Lab Data:
CDC 'Split Type': 200802692
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER209060020SCUN
HEP: HEP B (NO BRAND NAME)UNKNOWN MANUFACTURER04300421IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURA62210UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cyanosis, Hypotonia, Hypotonic-hyporesponsive episode, Respiratory disorder, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad)
Write-up: Report received from the Health Authorities on 21 August 2008. A 01-month-old patient (gender not reported), with no reported medical history, experienced hypotonic-hyporesponsive episode with respiratory disorder, cyanosis, flaccidity and unresponsiveness, around 4 hours after receiving the 1st dose of ACT-HIB, route and site not reported, lot A6221-1, associated with vaccines from other manufacturers: 1st dose of DTP vaccine, lot 20906002 subcutaneously and 2nd dose of HEPAVAX GENE, lot 0430042 intra-muscularly on 27 May 2008. The reaction lasted for 15-20 minutes. The patient recovered.

VAERS ID:336465 (history)  Vaccinated:2008-05-27
Age:0.5  Onset:2008-12-07, Days after vaccination: 194
Gender:Male  Submitted:2009-01-05, Days after onset: 29
Location:Foreign  Entered:2009-01-05
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: Abdominal X-ray, 11Dec2008, see text; Blood glucose, 11Dec2008, 123mg/dl; Blood group O, 11Dec2008, Rh+; Leukocyte count NOS, 11Dec2008, 9700/mm3; Neutrophils, 11Dec2008, 68%; Platelet count, 11Dec2008, 537000/mm3
CDC 'Split Type': B0551679A
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 1PO 
Administered by: Other     Purchased by: Other
Symptoms: Abdominal X-ray, Abdominal distension, Abdominal pain, Anorexia, Blood glucose increased, Blood group O, Dehydration, Gastrointestinal sounds abnormal, Haematochezia, Hyperaemia, Intussusception, Mucous stools, Neutrophil percentage, Pallor, Platelet count increased, Pyrexia, Rectal haemorrhage, Vomiting, White blood cell count normal, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: This case was reported by a physician in the frame of a study and described the occurrence of ileocecolic intussusception in a 1-year-old male subject who was vaccinated with ROTARIX. The subject was on no other medication and had no relevant medical history or allergy. Previous vaccination included ROTARIX (oral) given on 27 March 2008. On 27 May the subject received 2nd dose of ROTARIX (oral). Lot number not provided. On 7 December 2008, 6 months after vaccination with ROTARIX, the subject experienced stated with vomiting, abdominal pain, hyporexia, fever and abdominal distention. The patient was admitted at ER on 11 December 2008 and showed at physical exam pallor, dehydration, vomiting, hyperemic pharynx, abdominal distention bowel sounds decreased, blood at rectal tact, and current jelly stool. Abdominal X- ray suggested intestinal obstruction and intussusception was suspected. Ileocecolic intussusception was found, reduced by taxis without complications. The subject was hospitalized and the physician considered the events were clinically significant (or requiring intervention). Laboratory tests were performed on 11 December 2008 and showed the following results: Blood group: o+; Leukocytes: 9700/mm3; Neutrophils: 68%; Platelets: 537 000/mm3; Blood glucose: 123 mg/dl. The subject was treated with CEFTRIXANOE, METRONIDAZOLE; AMIKACINE; CEFOTAXIME; RANITIDINE; BUPRENORPHINE; FUROSEMIDE; BUTILHOSCINE; PIPERACILLIN+ TAZOBACTAM; MEDIZYME and PYRIDOXINE. On 15 December 2008, the events were resolved. The subject was discharged in good clinical conditions. The physician considered the events were unrelated to vaccination with ROTARIX. No additional information requested therefore the case has been closed.

VAERS ID:343171 (history)  Vaccinated:2008-05-27
Age:19.0  Onset:2008-06-17, Days after vaccination: 21
Gender:Female  Submitted:2009-03-31, Days after onset: 287
Location:Foreign  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: hormonal contraceptive (unspecified)
Current Illness:
Preexisting Conditions: Factor V Leiden mutation
Diagnostic Lab Data: Unknown
CDC 'Split Type': WAES0903USA04764
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1068U0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Venous thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow)
Write-up: Case received from a foreign health care professional on 23-MAR-2009. It was reported by gynecologyst that a 19 years old female patient with a medical history of heterozygote Factor V mutation was vaccinated with a first dose of GARDASIL (batch # NH06410, lot number: 1068U) IM into the upper arm on 27-MAY-2008. Concomitant treatment include BELLARA since June-2005. On 17-Jun-2008 the patient developed pelvic vein thrombosis with formation of collaterals and was hospitalized on the same day. Antiphospholipid syndrome was suspected. The patient had been treated with MARCUMAR. The patient fully recovered end of JUL-2008. A causal relation to the vaccine considered to be "likely" on the reporting form. Other business partner include E2009-02494.

VAERS ID:346150 (history)  Vaccinated:2008-05-27
Age:14.0  Onset:2008-06-10, Days after vaccination: 14
Gender:Female  Submitted:2009-05-11, Days after onset: 335
Location:Foreign  Entered:2009-05-12, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic laboratory test, 05Jun08, Electrophysiology showed a partial affection of the right lumbar plexus and a neurogenic and myogeni; cranial puncture, 06Jun08, CSF normal; orthopedic examination, 06Jun08, distortion of semitendinosus tendon; magnetic resonance imaging, 06Jun08, cranial MRI normal; diagnostic laboratory test, 11Jun08, Electrophysiology showed a partial affection of the right lumbar plexus and a neurogenic and myogeni; serum creatine kinase, 06Jun08, 5840 U/l, increased
CDC 'Split Type': WAES0905USA00593
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1114U0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood creatine phosphokinase increased, CSF test normal, Central nervous system inflammation, Electromyogram abnormal, Hypoaesthesia, Joint range of motion decreased, Laboratory test abnormal, Muscular weakness, Myelitis, Neuritis, Nuclear magnetic resonance imaging brain normal, Orthopedic examination abnormal, Tendon disorder, Vaccine positive rechallenge, Viral infection
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad)
Write-up: Information has been received from a healthcare professional on 30-Apr-2009. It was reported by a gynaeocologist that a 14-year physician concerning a 14 year old female who on 27-MAY-2008 was vaccinated with GARDASIL (lot #: 1114U, batch #: NH15190) into the deltoid muscle on 27-MAY-2008. A doctor''s letter was provided. Two weeks p.v. the patient developed weakness on the right lower leg and the mobility of the knee joint was decreased. She experienced hypaesthesia from the knee downwards. The patient was hospitalized from 04-JUN-2008 until 17-JUN-2008. CSF puncture and cranial MRI on 06-JUN-2008 showed normal results. Electrophysiology on 05-JUN-2008 and 11-JUN-2008 showed a partial affection of the right lumbar plexus and a neurogenic and myogenic impairment with suspicion of inflammatory CNS process. Orthopedic examination on 06-JUN-2008 showed a distortion of semitendinosus tendon. CK was increased to 5840 u/l. The cause of the events could not be clarified. Under intensive physiotherapy the motoric and sensory deficits completely resolved, but the patient has not recovered. The physicians considered the symptoms most likely as viral myelitis without detected agent (plexus neuritis was assumed as differential diagnosis). Despite ongoing events the patient was vaccinated with the second dose of GARDASIL (lot #: 1695U, batch #: NH25730) into the deltoid muscle on 28-APR-2009. One day p.v., hypaesthesia of the right lower leg was seen. The patient has not recovered at the time of reporting. Neurological clarification was planned. Additional information has been requested. Other business partner numbers include E2009-03753.

VAERS ID:349457 (history)  Vaccinated:2008-05-27
Age:13.0  Onset:0000-00-00
Gender:Female  Submitted:2009-06-17
Location:Foreign  Entered:2009-06-18, 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: L-Thyroxin
Current Illness:
Preexisting Conditions: Infection
Diagnostic Lab Data: diagnostic laboratory test, ??Apr08, normal; diagnostic laboratory test, ??Jun08, normal; abdominal ultrasound, 18Jun08, a left adrenal gland area with round, low echo and a well limited volume of 1.5 cm; echocardiography, 20Jun08, normal;
CDC 'Split Type': WAES0906USA01992
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0466U2UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Autonomic nervous system imbalance, Borrelia burgdorferi serology negative, Dizziness, Echocardiogram normal, Epstein-Barr virus antibody positive, Exertional headache, Hypothyroidism, Inflammation, Laboratory test normal, Peripheral vascular disorder, Presyncope, Syncope, Thyroxine free increased, Ultrasound abdomen abnormal, Vertebral artery hypoplasia, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Congenital, familial and genetic disorders (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypothyroidism (narrow), Hyperthyroidism (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a health authority under HA reference no. PEI2009012057. It was reported that a 13 year old female patient with a history of vegetative regulation disorder in the context of post inflammatory hypothyroidism and infection NOS who on 15-NOV-2007 and 24-JAN-2008 was vaccinated with the first and second dose of GARDASIL (both lot # 0354U; batch # NF58150). Dose 1 and dose 2 were well tolerated. The patient was vaccinated with the third dose of GARDASIL (lot # 0466U; batch # NG34890) on 27-MAY-2008. Since spring 2008 (exact date not reported) the patient developed dizziness, exertional headache during competitive swimming, peripheral circulatory disorder, pre-syncope and syncope. Routine laboratory findings showed normal results in APR-2008 and JUN-2008. EBV antibody test on 03-JUN-2008 showed a past EBV infection: EBV-VCA-IgG antibody: 283.0 E/ml EBV-EBNAI-IgG antibody: $g600.0 E/ml Thyroid diagnosis on 18-JUN-2008: Suspicion of disseminated autonomy confirmed by a positive elevated TRH test. Sonography of the abdomen showed a left adrenal gland area with round, low echo and a well limited volume of 1.5 cm diameter. The patient was hospitalized from 20-AUG-2008 until 22-AUG-2008 due to clarification for dizziness attacks on exertion with syncope and pre-syncope. After an infection (not otherwise specified) at the beginning of 2008 the patient showed a marked lactate value. Additionally she had developed vertigo (onset not reported). Long-term medication with levothyroxine L-THYROXIN 200 ug. On 14-AUG-2008: Sonography of the abdomen showed normal results. Laboratory findings 22-AUG-2008: Borrelia antibodies (IgG and IgM) were negative. Free T4: 1.88 (slightly increased). On 20-AUG-2008: Echocardiography showed normal results. Stress ECG was discontinued by the patient due to vertigo, feeling of weakness, vegetative symptoms and affective reaction up to a level of exertion of 150 watts, otherwise normal findings. Duplex sonography showed hypoplasia of right vertebral artery compensated

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