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Found 593491 cases in entire database

Case Details (Sorted by Vaccination Date)

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VAERS ID:299145 (history)  Vaccinated:2007-11-19
Age:0.2  Onset:2007-11-25, Days after vaccination: 6
Gender:Male  Submitted:2007-12-07, Days after onset: 12
Location:Foreign  Entered:2007-12-10, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: stool analysis positive reaction of enteritis due to rotavirus, specific serotype unknown.
CDC Split Type: WAES0712KOR00003
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Diarrhoea, Enteritis, Rotavirus infection, Rotavirus test positive, Stool analysis abnormal, Urinary tract infection
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a consumer (the patient''s mother) concerning a 2 month old male who on 19-NOV-2007 was vaccinated with Rotateq at a private pediatric hospital. On 25-NOV-2007, 6 days after Rotateq administration, the patient was hospitalized in a general hospital. The doctor in a general hospital performed stool test and the rotavirus was detected in this stool. However the serotype was not checked. This patient was diagnosed with urinary tract infection and enteritis due to rotavirus. The patient was treated in that general hospital (specific treatment is not reported) and discharged on 01-Dec-2007, but symptom of diarrhea (diarrhea due to enteritis) persisted. On 04-Dec-2007, the patient revisited the hospital and received prescription of drugs for the treatment of diarrhea. The patient''s enteritis due to rotavirus persisted and the outcome of urinary tract infection is unknown. And the patient''s mother complained whether urinary tract infection and enteritis due to rotavirus were caused by administration of Rotateq. However the doctor did not report the causality. Additional information is not expected.

VAERS ID:300377 (history)  Vaccinated:2007-11-19
Age:0.5  Onset:2007-12-03, Days after vaccination: 14
Gender:Male  Submitted:2007-12-17, Days after onset: 14
Location:Foreign  Entered:2007-12-19, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712ARG00002
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC. 1PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Intussusception
SMQs:, Gastrointestinal obstruction (narrow)
Write-up: Information has been received from a physician concerning a 5 month old Unknown male who on 19-NOV-2007 was vaccinated with Rotateq (second dose). On 03-DEC-2007 the patient experienced intussusception and was hospitalized. The next day, the patient recovered from intussusception post-manoeuvre. No further information is available.

VAERS ID:300903 (history)  Vaccinated:2007-11-19
Age:18.0  Onset:2007-11-19, Days after vaccination: 0
Gender:Female  Submitted:2007-12-21, Days after onset: 32
Location:Foreign  Entered:2007-12-26, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: body temp 38-38.5 degrees
CDC Split Type: WAES0711USA06170
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Headache, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from the father of an 18 year old female with no medical history who on 19-NOV-2007 was vaccinated with Gardasil (lot# unknown). On 19-NOV-2007 some hours post vaccination the patient developed general malaise. On teh 22-NOV-2007 the patient developed a 38 degree to 38.5 degree fever and intense cephalgia. The patient was admitted to the hospital room through the emergency room. No other information regarding outcome or cessation has been reported. Follow-up information was received on 17-DEC-2007. It was confirmed that the patient was admitted to the hospital (discharge date 04-DEC-2007). Additional information is not expected. Other business partner included are: E2007-08578.

VAERS ID:303182 (history)  Vaccinated:2007-11-19
Age:30.0  Onset:2007-11-19, Days after vaccination: 0
Gender:Female  Submitted:2008-01-18, Days after onset: 60
Location:Foreign  Entered:2008-01-22, 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: WAES0801CAN00121
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1529U UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Eye swelling, Hypersensitivity, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from an agency concerning a 30 year old female (father has environmental allergies) who on 19-NOV-2007 was vaccinated with MMR II (Lot # 655813/1529U). On 19-NOV-2007 the patient experienced allergic reaction described as a small prick rash with white centres developed on the inside of her left arm and her left eye was also swollen. The patient visited the emergency room where therapy with diphenhydramine hydrochloride (BENADRYL) was administered. Subsequently, the patient recovered from allergic reaction and small pink rash with white centres developed on the inside of her left arm and her left eye was also swollen. On 20-NOV-2007 the patient''s rash returned. Therapy with diphenhydramine hydrochloride (Benadryl) was administered and the patient''s symptoms resolved once again. It was reported that the patient had no breathing troubles, swelling of lips or tongue, numbness or tingling. The patient was recommended for allergy testing before further doses of vaccine or its components. This is one of four reports received from the same source. The reporter also discussed the experience of a 1 year old female, refer to (MSD, WAES0801CAN00119), 36 year old female (MSD, WAES0801CAN00122), and a 17 year old male (MSD, WAES0801CAN00123). Additional information is not expected. This case is being submitted to the FDA because it involves lot # 655813/1529U.

VAERS ID:303512 (history)  Vaccinated:2007-11-19
Age:46.0  Onset:2007-11-19, Days after vaccination: 0
Gender:Male  Submitted:2008-01-24, Days after onset: 66
Location:Foreign  Entered:2008-01-24
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Hydrochlorothiazide + irbes; Venlafaxine hydrochloride; Atenolol; Simvastatin
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body mass index, 20-25
CDC Split Type: B0504375A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFUA336AA IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Body mass index, Cold sweat, Dizziness, Somnolence
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority (#GB-MHRA-ADR 20207763) and described the occurrence of abdominal pain in a 46-year-old male subject who was vaccinated with Fluarix for prophylaxis. Concurrent medications included irbesartan hydrochlorothiazide (hydrochlorosthiazide + irbesartan), venlafaxine hydrochloride (venlafaxine), atenolol and simvastatin. On 19 November 2007 the subject received unspecified dose of Fluarix (1 ml, intramuscular). On 19 November 2007, at an unspecified time after vaccination with Fluarix, the subject experienced abdominal pain, feeling faint, cold sweat and drowsiness. The regulatory authority reported that the events were disabling. On 20 November 2007, the events were resolved.

VAERS ID:305212 (history)  Vaccinated:2007-11-19
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-19
Location:Foreign  Entered:2008-02-20, 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: Penicillin allergy; Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA03533
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0354U1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Back pain, Disturbance in attention, Fatigue, Headache, Pain in extremity, Peripheral vascular disorder, Photosensitivity reaction
SMQs:, Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a gynaecologist concerning a 17 year old female patient with penicillin allergy and drug hypersensitivity to acetylcystein who on 19-NOV-2007 was vaccinated IM into the upper arm with a second dose of Gardasil (batch # NF58150) (lot # 0354U). Latency not reported. Subsequently the patient felt tired and experienced asthenia, impaired concentration, photosensitivity, "circulatory disregulation", back pain spreading to the head and pain in the injected arm. The patient recovered from arm pain after one week. All other symptoms were ongoing at the time of reporting. No diagnostics tests had been carried out so far. Because of the long duration of symptoms the reporter considered the events to be serious as an other important medical event (OME). The other business partner''s number included: E2008-01087. No other information available at this time.

VAERS ID:306918 (history)  Vaccinated:2007-11-19
Age:0.08  Onset:2007-11-19, Days after vaccination: 0
Gender:Female  Submitted:2008-03-11, Days after onset: 112
Location:Foreign  Entered:2008-03-12, 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: WAES0803USA00886
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a health care professional concerning a 1 and a half month old female who on 19-NOV-2007 was vaccinated with her first dose of Rotateq (batch# not reported, lot# not reported). On that same day an hour after vaccination, the patient experienced abdominal pain and started vomiting. She did not need to be hospitalized. The patient recovered the day after. Abdominal pain and vomiting were considered to be an other important medical events by the reporter. Other business partner numbers include: E2008-02094. No further information is available.

VAERS ID:311181 (history)  Vaccinated:2007-11-19
Age:41.0  Onset:2007-11-21, Days after vaccination: 2
Gender:Female  Submitted:2008-04-28, Days after onset: 158
Location:Foreign  Entered:2008-04-29, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Asthma; Hypersensitivity; Hay fever
Preexisting Conditions: No reaction on previous exposure to vaccine.
Diagnostic Lab Data: spinal tap 21?Nov07 Comment: not reported; magnetic resonance imaging 21?Nov07 Comment: not reported; diagnostic laboratory test 21?Nov07 Comment: not reported
CDC Split Type: WAES0804USA05190
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Headache, Immobile, Inappropriate schedule of drug administration, Laboratory test, Lumbar puncture, Meningism, Nuclear magnetic resonance imaging
SMQs:, Noninfectious meningitis (narrow), Medication errors (narrow)
Write-up: Information has been received from a physician concerning a 41 year old female patient, who on 04-SEP-2007 was vaccinated with the first dose (well tolerated), and on 19-NOV-2007, was vaccinated with the second dose, IM in the left upper arm, of GARDASIL (lot # 0251U; batch NF56480 - dose 2). On 21-NOV-2007 the patient developed meningism, cephalgia, and became immobile (not further specified). At the time of this report, the patient had not recovered from the events. Follow up information received from a health authority, indicated that the patient, who had an unspecified allergy, asthma and hay fever, was hospitalized due to the events (dates not specified). A cranial magnetic resonance imaging (MRI), lumbar puncture, and diagnostic labs were performed, though results were not reported. At the time of this report, the patient had recovered from meningism and "immobility" within 3 days. Headache was ongoing. Additional information has been requested. Other business partner numbers include: E2008-03438; reference PEI2008004667.

VAERS ID:313045 (history)  Vaccinated:2007-11-19
Age:20.0  Onset:2007-12-21, Days after vaccination: 32
Gender:Female  Submitted:2008-05-22, Days after onset: 152
Location:Foreign  Entered:2008-05-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: cortisone
Current Illness: Unknown
Preexisting Conditions: CHICKEN POX, COLDS, INFLUENZA, SHINGLES
Diagnostic Lab Data: UNK
CDC Split Type: B0515357A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Depression, Dyskinesia, Ear pain, Facial palsy, Musculoskeletal discomfort
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (narrow), Hearing impairment (broad)
Write-up: This case was reported by a consumer and described the occurrence of Bell''s palsy in an 20-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 19 November 2007 the subject received 1st dose of TWINRIX (unknown). On 21 December 2007, 32 days after vaccination with TWINRIX, the subject experienced Bell''s palsy. This case was assessed as medically serious by GSK. At the time of reporting the event was unresolved. On 07 January the subject received the 2nd dose of TWINRIX. In the follow up received on 30 April 2008 it was mentioned that the subject''s medical history included: varicella at the age of 6-7 year-old and shingles at the age of 11-12 year-old. Apart from that the subject did not have had any major problem. In the follow up received on 12-19 May 2008 it was mentioned that 2-3 days prior to the onset of the paralysis the subject complained of having ear ache, "not normal type" but it felt deeper in her ear. The subject did not feel unwell, she did not had fever. Besides it was mentioned that the subject had been taking cortisone before receiving the 2nd dose. The subject was very depressed. There was a little signs of improvement of the paralysis. No adverse event was reporter after the 2nd dose. At this stage we were unaware of any possible link with vaccination. Currently the subject was still suffering from the residual effects. Certain facial movements were uncomfortables as the subject felt muscular tension in cheek when she wanted to smile. Her eye did not blink at the same rate. Unvoluntary facial movements were not working equally on both sides. There were no prognosis available for recovering. The subject was doing muscular exercises to train her muscle.

VAERS ID:318099 (history)  Vaccinated:2007-11-19
Age:21.0  Onset:2007-11-19, Days after vaccination: 0
Gender:Female  Submitted:2008-07-01, Days after onset: 224
Location:Foreign  Entered:2008-07-02, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: amoxicillin
Current Illness: Sleep disorder
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806AUS00129
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Choking sensation, Oedema peripheral, Pruritus, Rash generalised, Rash pruritic, Throat irritation
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information was obtained on request by the Company from the agency via a Case Line Listing and a Public Case Detail form concerning a 21 year old female with sleep disorder who on 19-NOV-2007 was vaccinated with GARDASIL. Other suspect therapy included AMOXIL and STILNOX. On 19-NOV-2007, after vaccination, the patient experienced rash (also reported as a red confluent itchy rash all over her body), oedema peripheral (also reported as swollen hands and feet), choking sensation and throat irritation and was hospitalised. The agency considered that rash, oedema peripheral, choking sensation and throat irritation were possibly related to therapy with GARDASIL, amoxicillin and zolpidem tartrate. The original reporting source was not provided. Subsequently the patient''s experienced was reported in an article, 25-JAN-2008. Additional information is not expected.

VAERS ID:318259 (history)  Vaccinated:2007-11-19
Age:20.0  Onset:2007-11-20, Days after vaccination: 1
Gender:Female  Submitted:2008-07-02, Days after onset: 224
Location:Foreign  Entered:2008-07-07, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEXAPRO; escitalopram oxalate
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0806AUS00123
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Diarrhoea, Drug withdrawal convulsions, Malaise, Vomiting
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Drug withdrawal (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)
Write-up: Information was obtained on request by the Company from the agency via a Case Line Listing and Public Case Detail Form concerning a 20 year old female who on 19-NOV-2007 was vaccinated with GARDASIL. Other suspect therapy included LEXAPRO. Concomitant therapy included DIANE 35 ED. On 20-NOV-2007, 1 day after vaccination, the patient experienced diarrhoea, drug withdrawal convulsions, malaise and vomiting reported as diarrhoea, vomiting and was unwell and had seizures, and was hospitalised. The patient had run out of escitalopram oxalate and had not taken it for 6 days (also reported as stopped 14-OCT-2007). The agency considered that diarrhoea, drug withdrawal convulsions, malaise and vomiting were possibly related to therapy with GARDASIL or withdrawal from therapy with escitalopram oxalate, or a combination of both or an other illness. The original reporting source was not provided. Subsequently the patient''s experience was reported in an article. Additional information is not expected. A copy of the published literature article is attached as further documentation of the patient''s experience.

VAERS ID:420134 (history)  Vaccinated:2007-11-19
Age:43.0  Onset:2008-02-16, Days after vaccination: 89
Gender:Female  Submitted:2011-04-01, Days after onset: 1139
Location:Foreign  Entered:2011-04-01
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: Allergy to vaccine
Diagnostic Lab Data: UNK
CDC Split Type: B0707771A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB37HB42UNRA
Administered by: Other     Purchased by: Other
Symptoms: Haematoma, Impaired work ability, Thrombocytopenia, Thrombotic thrombocytopenic purpura
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, arterial (narrow), Renovascular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by GSK legal department and described the occurrence of thrombopenia in a 44-year-old female subject who was vaccinated with ENGERIX B adult (GlaxoSmithKline). The subject reported medical history of allergy following unspecified vaccination. Previous vaccination included DT + POLIO (non-gsk) on 15 October 2007 (route, injection site and batches unknown). According to the subject, she received on 26 October 2006, 15 October 2007 and 19 November 2007, three doses hepatitis B vaccination with three doses of ENGERIX B adult (route, injection site unknown, third dose batch number : AHBVB37HB4, expiry date in June 2009). According to the vaccination record provided by the subject, she received one dose of ENGERIX B adult on 19 November 2007 and one dose of REVAXIS on 15 October 2007. On 16 February 2008, three months after vaccination with ENGERIX B adult, the subject experienced thrombopenia and hematoma all over body. On 28 March 2008, the subject was prescribed a sick leave for thrombopenia. On 28 April 2008, the subject was prescribed a sick leave for thrombotic thrombocytopenic purpura. It was reported that vaccination with fourth dose of ENGERIX B adult planned for April 2008 was not performed. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified.

VAERS ID:532143 (history)  Vaccinated:2007-11-19
Age:38.0  Onset:2007-12-01, Days after vaccination: 12
Gender:Male  Submitted:2014-05-27, Days after onset: 2368
Location:Foreign  Entered:2014-05-27
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arm pain; Back pain; Blood iron abnormal; Shoulder pain
Preexisting Conditions: Automobile accident; Blackout; Brain concussion; Fall; Hemangioma; Morbus Meulengracht; Neuroborreliosis
Diagnostic Lab Data: Aspartate transferase, 21Aug2007, 20U/l; Autoantibody test, 03Dec2010, negative; Basophil percentage, 21Aug2007, 1%; Bilirubin, 21Aug2007, 1.79mg/dl; Calcium, 14Apr2011, 2.35mmol/l; Computerized tomogram, 14Feb2011, hemangioma; Eosinophil percentage, 21Aug2007, 3%; GPT, 21Aug2007, 14U/l; Gamma globulin, 03Dec2010, 30.0%; Hematocrit, 21Aug2007, 0.49l/l; Hemoglobin, 21Aug2007, 14.9g/dl; Iron, 03Dec2010, 162mcg/dl; Leucocyte count, 21Aug2007, 4.3cells/nl; Leucocyte count, 03Dec2010, 32,000cells/mcl; Lymphocyte percentage, 21Aug2007, 25%; MCH, 21Aug2007, 31pg; MCHC, 21Aug2007, 30g/dl; MCV, 21Aug2007, 101fl; Monocyte percentage, 21Aug2007, 9%; Neutrophil percentage, 21Aug2007, 62%; Red blood cell count, 21Aug2007, 4.9Mio cells/mc; Thrombocyte co
CDC Split Type: D0084080A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB101AE1IMAR
Administered by: Other     Purchased by: Other
Symptoms: Anaemia, Aspartate aminotransferase normal, Asthenia, Autoantibody negative, Back pain, Basophil percentage, Blood bilirubin increased, Blood calcium increased, Cardiovascular disorder, Cervicobrachial syndrome, Computerised tomogram abnormal, Conjunctivitis, Dizziness, Eosinophil percentage, Epicondylitis, Fatigue, Gamma-glutamyltransferase normal, Gene mutation identification test positive, Gilbert's syndrome, Haemangioma, Haemangioma of liver, Haematocrit normal, Haemoglobin normal, Headache, Hereditary haemochromatosis, Hyperbilirubinaemia, Hypergammaglobulinaemia, Immunoglobulins, Impaired work ability, Lymphocyte percentage, Lymphoma, Mean cell haemoglobin concentration decreased, Mean cell haemoglobin normal, Mean cell volume increased, Monocyte percentage, Neuroborreliosis, Neutrophil percentage, Nuclear magnetic resonance imaging spinal abnormal, Osteochondrosis, Performance status decreased, Phlebitis, Plasmacytoma, Platelet count normal, Red blood cell count normal, Spinal disorder, Spinal osteoarthritis, Transferrin normal, Transferrin saturation increased, White blood cell count decreased
SMQs:, Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Liver neoplasms, benign (incl cysts and polyps) (narrow), Congenital, familial, neonatal and genetic disorders of the liver (narrow), Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Congenital, familial and genetic disorders (narrow), Thrombophlebitis (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (broad), Malignant lymphomas (narrow), Arthritis (narrow), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow)
Write-up: This case was reported by a physician via a regulatory authority (# DE-PEI-PEI2014035300) and described the occurrence of plasmacytoma in a 38-year-old male subject who was vaccinated with TWINRIX adult (GlaxoSmithKline). The authority provided structured information, a questionnaire completed by the reporting physician and multiple medical records, including hospital reports, lab data and patient files. According to the authority''s coding of this case the subject''s medical history included suspected hemangioma, morbus Meulengracht and neuroborreliosis. On 19 October 2007, 19 November 2007 and 21 April 2008 the subject received three dose of TWINRIX adult (intramuscular, unknown deltoid). In December 2007 the subject developed plasmacytoma. The subject was hospitalized. The subject had not recovered at the date of reporting. According to the reporting physician he had received the following information on the onset date of plasmacytoma: The subject had experienced early signs of decreased performance in December 2007, according to other sources the onset of the symptoms was in April 2008, and according to patient files of the treating physicians on other later dates (e.g. March, August and September 2011). The following information was contained in the multiple source documents provided: According to medical records (issued in 2011) approximately twenty years prior to the time of reporting the subject was involved in a car accident and suffered from back pain and complaints of shoulder and arm ever since. In 2002 the subject suffered from borreliosis. According to lab data, on 21 August 2007 (prior to the vaccination) the subject''s blood counts were normal except an increase in mean corpuscular volume and a decrease in mean corpuscular hemoglobin concentration. The subject''s bilirubin was above normal levels. On 24 September 2007 (prior to vaccination) the subject fell during skiing because of a short black-out and was diagnosed with rupture of ligament in right knee and suspected with brain concussion. On 19 October 2007, 19 November 2007 and 21 April 2008 the subject received three dose of TWINRIX adult (intramuscular, unknown deltoid). On 27 May 2009 the subject suffered from conjunctivitis. On 15 November 2010 the subject was diagnosed with borreliosis, circulation disorder, headache and anemia. In late 2010 the subject developed persisting tiredness and weakness. On 27 January 2011 the subject suffered from epicondylitis of humerus, cervical spine syndrome and exhaustion. ON 14 February 2011 the subject was examined using computerized tomography because of hepatic foci (as observed by means of X-ray) and known iron circulation disorder. Liver foci were considered hemangioma. On 21 February 2011 the subject suffered from phlebitis. On 30 March 2011 the subject was diagnosed with indirect hyperbilirubinemia, suspect morbus Meulengracht, suspected multiple hepatic hemangioma and hypergammaglobulinemia. The subject was hospitalized between 13 April and 11 May 2011. Diagnoses were back pain, cervicobrachial syndrome and epicondylitis. The subject received physiotherapy and psychotherapy. According to medical records issued on 16 August 2011 the diagnosis of plasmacytoma had been made in March 2011. On 11 September 2011 the subject was examined genetically for suspected hereditary hemochromatosis (iron overload) and was found with a heterozygous mutation of H63, which was considered not pathogenic. On 30 November 2011 the subject suffered from morbus Meulengracht. On 09 February 2012 the subject was examined using nuclear magnetic resonance imaging of lumbar and thoracic spine. Pathologic signs of disseminate bone marrow disorders were observed at almost every spondylus. Diagnoses included osteochondrosis of lumbar segment L4/5, spondyloarthrosis, fatty degeneration of bone marrow as well as diffuse processes of bone marrow of entire spine, which was not typical for plasmacytoma. Differential diagnosis included lymphoma. Betwee

VAERS ID:297381 (history)  Vaccinated:2007-11-20
Age:22.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:2007-11-20, Days after onset: 0
Location:Texas  Entered:2007-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None.
Current Illness: None.
Preexisting Conditions: None.
Diagnostic Lab Data: None.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHAVB409AA2IMLA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB182AA0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: Vaccine error report: On 11/20/2007, this 22-year old client received pediatric formulations of Hepatitis A and Hepatitis B. Per CDC Info, client was notified that she should repeat the correct doses for both Hep A and B at her earliest convenience. Repeat doses of adult formulations scheduled for 11/21/2007. No adverse events.

VAERS ID:297383 (history)  Vaccinated:2007-11-20
Age:32.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:2007-11-20, Days after onset: 0
Location:Wisconsin  Entered:2007-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: patient''s usual medications zyrtec,singular,advair, xopenox
Current Illness: asthma, allergic rhinitis
Preexisting Conditions: asthma, allergic rhinitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2445AA2IMLA
Administered by: Private     Purchased by: Public
Symptoms: Dyspnoea, Pruritus
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: c/o of shortness of breath and itching

VAERS ID:297438 (history)  Vaccinated:2007-11-20
Age:12.0  Onset:0000-00-00
Gender:Female  Submitted:2007-11-20
Location:New York  Entered:2007-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA282DA1IMRA
Administered by: Public     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration, Medication error
SMQs:, Medication errors (narrow)
Write-up: 11-20-07 13 y/o female was given Fluarix 0.5 ml IM in (R) arm lot AFLUA282DA Exp 6/30/08. This vaccine is not approved for children < 19 yrs old. No adverse event reported from parent

VAERS ID:297449 (history)  Vaccinated:2007-11-20
Age:55.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:2007-11-20, Days after onset: 0
Location:Maryland  Entered:2007-11-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None noted
Preexisting Conditions: None noted
Diagnostic Lab Data: 0938 BP = 142/90; 0950 BP = 150/88; 1000 BP = 140/86; 1015 BP = 144/84
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2475JA1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Blood pressure, Dizziness, Hot flush, Nervousness, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypoglycaemia (broad)
Write-up: Pt c/o arm received vaccine in (L) felt "wobbly-like Jello" and (L) side of face felt "tingly". Pt states she had hot flash and it was already hot inside building and she got nervous. States "I know I''m nervous because I can feel it in my stomach." No rash, no breathing probs, no other symptoms.

VAERS ID:297511 (history)  Vaccinated:2007-11-20
Age:0.3  Onset:2007-11-20, Days after vaccination: 0
Gender:Male  Submitted:2007-11-21, Days after onset: 1
Location:South Carolina  Entered:2007-11-21
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: none
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B132BA1IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUF218AA1IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB54013D1IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1129U1PO 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Crying, Cyanosis, Listless
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: parents state patient was "blue around the mouth" after crying out in sleep and very listless. Color improved within 45minutes and no further occurances report throughout the night. Followed up the next morning in office on 11/21/07 with Dr. and was instructed not to recieve Pertussis vaccine in future.

VAERS ID:297673 (history)  Vaccinated:2007-11-20
Age:52.0  Onset:2007-11-21, Days after vaccination: 1
Gender:Male  Submitted:2007-11-21, Days after onset: 0
Location:Pennsylvania  Entered:2007-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: na
Current Illness: none
Preexisting Conditions: pt had a previous seizure but doctor okd flu shot per pt 11-20-07
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2492AA0IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Jaw disorder, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 245 hours after vaccine pt complained of swelling in jaw

VAERS ID:297674 (history)  Vaccinated:2007-11-20
Age:71.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Male  Submitted:2007-11-21, Days after onset: 1
Location:Georgia  Entered:2007-11-21
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
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1382U IMLA
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: REDNESS/SWELLING AROUND INJECTION SITES, INJECTION SITE HARD AND WARM TO THE TOUCH (ALL SYMPTOMS ON LEFT ARM)

VAERS ID:297677 (history)  Vaccinated:2007-11-20
Age:48.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Male  Submitted:2007-11-21, Days after onset: 1
Location:Alaska  Entered:2007-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2513AA IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Chills, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt. complained of fever, chills and body aches lasting approximately 24 hrs.

VAERS ID:297679 (history)  Vaccinated:2007-11-20
Age:65.0  Onset:2007-11-21, Days after vaccination: 1
Gender:Male  Submitted:2007-11-21, Days after onset: 0
Location:Missouri  Entered:2007-11-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Private     Purchased by: Public
Symptoms: Injection site erythema, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Pneumovax in left deltoid. 24 hours later, redness from injection site to 8 cm distal. Warm to touch.

VAERS ID:297633 (history)  Vaccinated:2007-11-20
Age:65.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:2007-11-21, Days after onset: 1
Location:California  Entered:2007-11-23, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes, hypertension
Preexisting Conditions:
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU25099AA UNLA
Administered by: Public     Purchased by: Public
Symptoms: Blood pressure, Dizziness, Heart rate normal, Immediate post-injection reaction, Injection site erythema, Injection site swelling
SMQs:, Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (narrow)
Write-up: Had redness and swelling at injection site (Lt deltoid) immediately after injection was given. Also has slight dizziness. B/P-140/90, pulse 64. Re-checked patient at 9:30AM B/P-144/92, pulse-66. There was less redness and swelling at injection site. Patient feeling good except for slight dizziness. Checked again at 11:00AM B/P-138/88, pulse 72. Feeling good. No pain or redness at injection site. Still very slight dizziness. Instructed to see MD if dizziness continues or has any other symptoms.

VAERS ID:297649 (history)  Vaccinated:2007-11-20
Age:25.0  Onset:2007-11-21, Days after vaccination: 1
Gender:Female  Submitted:2007-11-23, Days after onset: 2
Location:Florida  Entered:2007-11-23
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:
Diagnostic Lab Data: Labs-WNL.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB413AA0IMLA
Administered by: Other     Purchased by: Unknown
Symptoms: Dysgeusia, Laboratory test, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Taste and smell disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: 11/20/08 Hep vaccine administered. 11/21/07 patient reported to work feeling nauseated & advertently threw up multiple times V.S. Labs-WNL. She reported that she is not pregnant. N/V resolved 11/21. c/o "metallic & acidy" taste in her throat & mouth 11/23.

VAERS ID:297833 (history)  Vaccinated:2007-11-20
Age:53.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:2007-11-21, Days after onset: 1
Location:California  Entered:2007-11-26, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS794890IMLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.97334010IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Erythema, Oedema peripheral, Pain in extremity
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Local redness, pain and swelling of right deltoid beginning evening of day received pneumococcal vaccine.

VAERS ID:297857 (history)  Vaccinated:2007-11-20
Age:18.0  Onset:2007-11-27, Days after vaccination: 7
Gender:Female  Submitted:2007-11-27, Days after onset: 0
Location:Arizona  Entered:2007-11-27
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: positive pregnancy test
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB409AA2IMRA
HEPA: HEP A (VAQTA)MERCK & CO. INC.1441U1IMLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0411U1SCLA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2402AA0IMRA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52BO19AA0IMLA
Administered by: Public     Purchased by: Public
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Patient had MMR2 on 11/20/07, found out today that she is pregnant.

VAERS ID:297896 (history)  Vaccinated:2007-11-20
Age:23.0  Onset:2007-11-23, Days after vaccination: 3
Gender:Female  Submitted:2007-11-24, Days after onset: 1
Location:New Jersey  Entered:2007-11-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Spina Bifida, kidney problems
Diagnostic Lab Data: wbc 16,000
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Body temperature increased, Cellulitis, Injected limb mobility decreased, Injection site erythema, Pain in extremity, Pyrexia, Tenderness, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pneumonia vaccine given to pt who is a nurse on 11/20/07. Pt had some tenderness that evening more tenderness the following morning. 11/22/07 in the morning pt developed low grade fever with redness around injection site. By 11/23/07 redness spread to entire arm, temp of 102.6 and arm so tender pt could not lift arm. Pt taken to er, given antibiotics and sent home with diagnosis of cellulitis due to pneumovac

VAERS ID:298067 (history)  Vaccinated:2007-11-20
Age:0.2  Onset:2007-11-25, Days after vaccination: 5
Gender:Female  Submitted:2007-11-26, Days after onset: 1
Location:California  Entered:2007-11-27, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 2007-11-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Unable to breathe through nose
Preexisting Conditions: Cerebropalsy (L) arm; (L) cephalhematoma PMH: jaundice & left brachial plexus birth trauma both of which had resolved by 10/8. SVD w/vacuum assist at 35wks. Perinatal period complicated w/hypoglycemia which resolved before d/c to home.
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B125BB0IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0260U0IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB9728380IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1461U0PO 
Administered by: Private     Purchased by: Private
Symptoms:
SMQs:
Write-up: Death 10/21/08 Autopsy states COD as pneumonia, other undetermined factors, sudden unexpected infant death. Manner of death is undetermined. Autopsy report also states patient found unresponsive in crib in lateral position on a pillow. X-rays revealed healing rib & clavicular fractures. Micro revealed evidence of bronchopneumonia. Investigation revealed patient had cough & nasal congestion x approx 10 days prior to death & had been seen in ER & by PCP for same. Ears had been pierced day before death. 11/30/07 Reviewed pcp medical records which confirm dose & lot as reported. Office note of 11/20 reveals patient had nasal congestion x 1 week. Dx w/formula allergy & formula changed to soy. Had been seen in ER 11/17 for cough with chest/nasal congestion. Exam revealed a sore in left nostril.

VAERS ID:298068 (history)  Vaccinated:2007-11-20
Age:79.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:2007-11-27, Days after onset: 7
Location:Massachusetts  Entered:2007-11-27
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: heart disease w/2 stents
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2526AA UNUN
Administered by: Public     Purchased by: Public
Symptoms: Erythema, Oedema peripheral
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: cellultis on left arm swollen, red down to the wrist 3 IV treatments and oral antibiotics

VAERS ID:298056 (history)  Vaccinated:2007-11-20
Age:37.0  Onset:2007-11-22, Days after vaccination: 2
Gender:Female  Submitted:2007-11-23, Days after onset: 1
Location:Colorado  Entered:2007-11-28, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2454AA0UNLA
Administered by: Unknown     Purchased by: Private
Symptoms: Asthma, Dyspnoea, Rash
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Rash, breathing difficulty, asthma-like attack.

VAERS ID:298197 (history)  Vaccinated:2007-11-20
Age:11.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Male  Submitted:2007-11-21, Days after onset: 1
Location:Arizona  Entered:2007-11-29, Days after submission: 8
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB214AA0UNLA
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B021BA0UNLA
Administered by: Public     Purchased by: Public
Symptoms: Convulsion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (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), Hypoglycaemia (broad)
Write-up: After giving Tdap and Hep A vaccines, patient had syncope, brief seizure activity lasting 3-4 minutes recovered and left clinic with parents. Per call the next morning no further problems

VAERS ID:298231 (history)  Vaccinated:2007-11-20
Age:4.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Male  Submitted:2007-11-20, Days after onset: 0
Location:Florida  Entered:2007-11-29, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2797AA4IM 
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA02733IM 
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0426U1  
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1357U1  
Administered by: Private     Purchased by: Private
Symptoms: Pallor
SMQs:, Hypotonic-hyporesponsive episode (broad)
Write-up: Immediately after giving MMR child turned pale on lips, periorally and on his face. Did not pass out. Lasted for approximately 30-45 seconds. No posturing or loss of consciousness.

VAERS ID:298234 (history)  Vaccinated:2007-11-20
Age:61.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Male  Submitted:2007-11-26, Days after onset: 6
Location:Ohio  Entered:2007-11-29, 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: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0554U0UNRA
Administered by: Public     Purchased by: Public
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: (R) arm swelled from injection site to fingertips. Red. Hot. :for 5 days.

VAERS ID:298493 (history)  Vaccinated:2007-11-20
Age:71.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:2007-12-05, Days after onset: 15
Location:Maryland  Entered:2007-12-03, 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: unknown
Current Illness: none
Preexisting Conditions: unknown
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2456BA IMLA
Administered by: Public     Purchased by: Public
Symptoms: Disorientation, Dizziness, Feeling drunk
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Hypoglycaemia (broad)
Write-up: Woozy, disoriented about 15 minutes after receiving flu vaccine Thermisol free 2mg 0.25 LD. Felt "drunk" for 4 plus hours during ER visit.

VAERS ID:298542 (history)  Vaccinated:2007-11-20
Age:6.0  Onset:2007-11-29, Days after vaccination: 9
Gender:Male  Submitted:0000-00-00
Location:New York  Entered:2007-12-03
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
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1513U1SCLA
Administered by: Private     Purchased by: Private
Symptoms: Pruritus, Rash, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Urticaria rash on legs, lower trunk, very itchy, no fever. Advised by doctor on telephone to use Benadryl 3tsp and Aveeno bath and f/up in office am.

VAERS ID:298725 (history)  Vaccinated:2007-11-20
Age:54.0  Onset:2007-11-21, Days after vaccination: 1
Gender:Female  Submitted:2007-12-03, Days after onset: 12
Location:Ohio  Entered:2007-12-04, 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: Diabetic
Preexisting Conditions:
Diagnostic Lab Data: Seen by doctor at clinic.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0554U0IMLA
Administered by: Public     Purchased by: Unknown
Symptoms: Erythema, Injection site swelling, Skin warm
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Reported 11/30/07. Sore swollen arm (L) site increased in size - hot and red - Pt describes decrease in use - told to see doctor or go to Urgent Care - went to clinic 11/30/07. Given Indocin - Lortab/Zithromax.

VAERS ID:298737 (history)  Vaccinated:2007-11-20
Age:64.0  Onset:2007-11-22, Days after vaccination: 2
Gender:Female  Submitted:2007-12-05, Days after onset: 13
Location:South Carolina  Entered:2007-12-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Lipitor; Vasoretic
Current Illness:
Preexisting Conditions: History of Migraine headaches; history of hypertension; history of gastritis (multiple events)
Diagnostic Lab Data: NONE
CDC Split Type: SC0723
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0646U0IMRA
TD: TD ADSORBED (NO BRAND NAME)SANOFI PASTEUR209601IMRA
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)SANOFI PASTEUR2-0960-20IMLA
YF: YELLOW FEVER (YF-VAX)SANOFI PASTEURUF197AA0SCRA
Administered by: Public     Purchased by: Private
Symptoms: Anorexia, Asthenia, Diarrhoea, Headache, Heart rate increased, Hypotension, Nausea, Oedema peripheral, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow)
Write-up: 2-3 days following vaccination right arm swelling for several days. Resolved, felt weak with headache. Nausea; emesis x2; diarrhea; no appetite 2 days after vaccination. Continues with diarrhea. Was given Phenergan by FNP on visit on 12/3/2007. Blood pressure 78/56; pulse 100; no fever.

VAERS ID:298780 (history)  Vaccinated:2007-11-20
Age:  Onset:2007-11-21, Days after vaccination: 1
Gender:Male  Submitted:2007-12-05, Days after onset: 14
Location:New York  Entered:2007-12-05
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
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0698U IM 
Administered by: Private     Purchased by: Private
Symptoms: Cellulitis, Chills, Oedema peripheral, Pain in extremity, Pyrexia
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: The patient experienced pain, swelling, fevers, chills and cellulitis in the affected arm starting within 24 hours of the IM Pneumovax in the same arm. The patient is a physician began antibiotics because of streaking on the skin(amoxicillin, then levofloxaxin and finally bactrim).

VAERS ID:298923 (history)  Vaccinated:2007-11-20
Age:15.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:2007-11-20, Days after onset: 0
Location:Alabama  Entered:2007-12-06, 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: None
Current Illness: Headache then none
Preexisting Conditions: None
Diagnostic Lab Data: HPV given 1600
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0384U2IMRA
Administered by: Private     Purchased by: Other
Symptoms: Asthenia, Blood glucose increased, Blood pressure increased, Cold sweat, Dizziness, Fall, Headache, Nasopharyngitis, Pain, Pallor
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Hypertension (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Patient was given HPV #3. Right arm today, complained of pain. Stated she felt dizzy, tried to get patient to lie down. Stated she felt better, walked out of room, fell forward, cold, clammy. Blood pressure 120/80 immediately. Pox 1007, pulse 103-124. Stated had headache today. RBS done 127. Mother states patient''s blood pressure has been up with headache. 170/95 per mother. Eye doctor called for visit, stated she got pale and weak on days of appointment.

VAERS ID:298927 (history)  Vaccinated:2007-11-20
Age:23.0  Onset:2007-11-29, Days after vaccination: 9
Gender:Male  Submitted:2007-11-29, Days after onset: 0
Location:California  Entered:2007-12-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (DRYVAX)PFIZER/WYETH40206761OTLA
Administered by: Military     Purchased by: Military
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Erythema about 14x7cm distal to vaccination site noted 11/28/07, resolving by 29Nov07.

VAERS ID:299094 (history)  Vaccinated:2007-11-20
Age:1.0  Onset:2007-11-27, Days after vaccination: 7
Gender:Male  Submitted:2007-12-07, Days after onset: 10
Location:Pennsylvania  Entered:2007-12-07
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: GER, Preterm 35 wk EGA, Kleinfelters Syn.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2469AA1UNLL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB200AA0UNRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0809U0UNLL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.135860UNRL
Administered by: Private     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: 2x3 cm area erythema and induration of right lower thigh at site of Varivax administration. Tx analgesic prn.

VAERS ID:299193 (history)  Vaccinated:2007-11-20
Age:12.0  Onset:2007-12-04, Days after vaccination: 14
Gender:Female  Submitted:2007-12-06, Days after onset: 2
Location:Iowa  Entered:2007-12-10, Days after submission: 4
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: Normal platelet count Petechiae resolved.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB176AA1UNRA
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU2331AA0UNLA
Administered by: Private     Purchased by: Private
Symptoms: Body temperature increased, Petechiae, Platelet count normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt received Menactra and Hep A #2 on 11/20/07 - developed temp 100.4 on 12/04/07 along with mild petechial rash scattered sparsely over body.

VAERS ID:299352 (history)  Vaccinated:2007-11-20
Age:23.0  Onset:2007-11-21, Days after vaccination: 1
Gender:Female  Submitted:2007-12-12, Days after onset: 21
Location:Maryland  Entered:2007-12-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: TINGLING L ARM
Preexisting Conditions: NONE
Diagnostic Lab Data: Pt scheduled f/u with PCM
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALSAHABB100AA0IMLA
HPV4: HPV (GARDASIL)MERCK & CO. INC.0503U0IMLA
Administered by: Military     Purchased by: Military
Symptoms: Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: Pt c/o tingling x1day.

VAERS ID:300594 (history)  Vaccinated:2007-11-20
Age:0.4  Onset:2007-11-20, Days after vaccination: 0
Gender:Unknown  Submitted:2007-12-14, Days after onset: 24
Location:South Carolina  Entered:2007-12-18, 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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA04459
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.0553U0PO 
Administered by: Other     Purchased by: Other
Symptoms: Inappropriate schedule of drug administration
SMQs:, Medication errors (narrow)
Write-up: Information has been received from a licensed practical nurse concerning an approximately 23 week old patient who on approximately 20-NOV-2007 was inadvertantly vaccinated PO with the first 2.0 ml dose of RotaTeq (lot# 657511/0553U) at 4 months old. Medical attention was sought at the physician''s office. There was no product quality complaint. Additional information has been requested.

VAERS ID:301327 (history)  Vaccinated:2007-11-20
Age:21.0  Onset:2007-11-24, Days after vaccination: 4
Gender:Female  Submitted:2007-12-14, Days after onset: 20
Location:California  Entered:2007-12-18, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA06623
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1063U0UNRA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Rash, Skin irritation
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a medical assistant concerning a 21 year old female patient with no medical history and no known drug reactions or allergies who on 20-NOV-2007 was vaccinated in the right arm with the first dose of GARDASIL (Lot # 658563/1063U). There was no concomitant medication. The reporter indicated that on 24-NOV-2007, the patient developed an irritation from her bra line to her neck and from shoulder to shoulder after her first dose of the vaccine. She was unable to describe what kind of irritation the patient had. On 27-NOV-2007, the irritation became red and raised. On 28-NOV-2007, the area of irritation spread to her right arm and left breast. No treatment was prescribed. At the time of reporting the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/14/2007. Follow up information was received from the doctor on 29-JAN-2008 indicating the muscle pain was not at the injection site and was unrelated. Additional information has been requested.

VAERS ID:300612 (history)  Vaccinated:2007-11-20
Age:1.0  Onset:2007-12-02, Days after vaccination: 12
Gender:Female  Submitted:2007-12-20, Days after onset: 18
Location:Louisiana  Entered:2007-12-20
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: UNKNOW
Diagnostic Lab Data: NONE
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2460CA0IMRL
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB217AA0IMRL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0748U0SCLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Pyrexia, Rash generalised
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: ON 11/20/07 MMR GIVEN IN LEFT THIGH AND INFULENZA AND HEP. A GIVEN IN RIGHT THIGH. MOTHER STATED BABY DEVELOPED FEVER-101 AND A COMPLETE BODY RASH ON 12/02/07. WENT TO SEE HER PEDIATRIC MD, AND SHE STATED THAT THE BODY RASH WAS POSSIBLY FROM THE MMR. MOTHER CAME IN TODAY FOR THE 2ND FLU INJECTION AND INFORMED ME OF THE ABOVE.

VAERS ID:301020 (history)  Vaccinated:2007-11-20
Age:68.0  Onset:2007-11-25, Days after vaccination: 5
Gender:Female  Submitted:2007-12-11, Days after onset: 16
Location:Michigan  Entered:2007-12-26, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Blood culture negative for bacteria per patient.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA319BA IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood culture negative, Oedema peripheral, Paraesthesia, Tenderness
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Pt began experiencing tingling and tenderness in her extremities similar to a bruise or sunburn. It would come & go & seemed to "travel" around her body. On 12/7/07 her feet began to swell. Symptoms have improved as of 12/11/07. Dr. thought possibly viral infection.

VAERS ID:301473 (history)  Vaccinated:2007-11-20
Age:28.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-21
Location:Unknown  Entered:2008-01-02, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1102SCUN
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered
SMQs:, Medication errors (narrow)
Write-up: Anthrax Lot #FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per Milvax direction.

VAERS ID:301495 (history)  Vaccinated:2007-11-20
Age:21.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-21
Location:Unknown  Entered:2008-01-02, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1102SCUN
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered, No adverse reaction
SMQs:, Medication errors (narrow)
Write-up: Anthrax Lot# FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per Milvax direction.

VAERS ID:301502 (history)  Vaccinated:2007-11-20
Age:20.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-21
Location:Unknown  Entered:2008-01-02, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Allergy: Nickel
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1102SCUN
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered
SMQs:, Medication errors (narrow)
Write-up: Anthrax Lot # FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per milvax direction.

VAERS ID:301503 (history)  Vaccinated:2007-11-20
Age:27.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-21
Location:Unknown  Entered:2008-01-02, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1102SCUN
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered
SMQs:, Medication errors (narrow)
Write-up: Anthrax lot #FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per authority direction.

VAERS ID:301509 (history)  Vaccinated:2007-11-20
Age:41.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-21
Location:Unknown  Entered:2008-01-02, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: PPD converter
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1101SCUN
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered, No adverse reaction
SMQs:, Medication errors (narrow)
Write-up: Anthrax Lot # FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per agency direction.

VAERS ID:301545 (history)  Vaccinated:2007-11-20
Age:18.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-21
Location:Unknown  Entered:2008-01-02, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1101SCUN
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered
SMQs:, Medication errors (narrow)
Write-up: Anthrax lot #FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per milvax direction.

VAERS ID:301574 (history)  Vaccinated:2007-11-20
Age:18.0  Onset:0000-00-00
Gender:Female  Submitted:2007-12-21
Location:Unknown  Entered:2008-01-02, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1101SCUN
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered
SMQs:, Medication errors (narrow)
Write-up: Anthrax lot # FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per authority direction.

VAERS ID:301579 (history)  Vaccinated:2007-11-20
Age:19.0  Onset:0000-00-00
Gender:Male  Submitted:2007-12-21
Location:Unknown  Entered:2008-01-02, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
ANTH: ANTHRAX (BIOTHRAX)EMERGENT BIOSOLUTIONSFAV1101SCUN
Administered by: Military     Purchased by: Military
Symptoms: Expired drug administered
SMQs:, Medication errors (narrow)
Write-up: Anthrax lot #FAV110 administered after expired date due to administrative oversight. No adverse reaction at this time. Report submitted per authority direction.

VAERS ID:301937 (history)  Vaccinated:2007-11-20
Age:0.2  Onset:2007-12-04, Days after vaccination: 14
Gender:Male  Submitted:2008-01-07, Days after onset: 34
Location:Georgia  Entered:2008-01-08, 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:
Preexisting Conditions: None
Diagnostic Lab Data: Hematology. Labs and Diagnostics: CBC with WBCs 24.4, platelets 738. CRP 12.3. LP with CSF WNL. CSF cx (-). Blood cultures (+) for Strep pneumoniae. UA WNL. UC (-). CXR WNL.
CDC Split Type: WAES0712USA09119
Vaccination
Manufacturer
Lot
Dose
Route
Site
DPP: DIPHTHERIA TOXOID + PERTUSSIS + IPV (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
HBHEPB: HIB + HEP B (COMVAX)MERCK & CO. INC.1244F0IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood culture positive, C-reactive protein increased, CSF culture negative, CSF test normal, Chest X-ray normal, Culture urine negative, Full blood count, Haematology test, Hypersomnia, Infection, Leukocytosis, Lumbar puncture normal, Platelet count increased, Pyrexia, Streptococcus identification test positive, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from the mother of a 2 month old male with no past medical history, who on an unspecified date was vaccinated intramuscularly with the first dose of COMVAX. Concomitant vaccination included Rotateq. Other concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine and "PCB". Subsequently, one to two weeks after vaccination, the patient was diagnosed with a "blood infection, an ear infection and throat infection" and was hospitalized. The patient was hospitalized for 2 days and required 7 days of antibiotic therapy. The patient subsequently recovered on an unspecified date from the events. Additional information has been requested. 01/11/2008 Per CDC: Box 10-date of vaccination : 11/20/07 Box 13-lot # for Comvax: 1244F. 01/11/2008 MR received for ER visit 12/4/2207 with c/o fever and increased sleeping. PE WNL (ENT WNL). Txd with Tylenol and ceftriaxone and D/Cd. DX: Fever-Acute. Leukocytosis-Acute.

VAERS ID:302030 (history)  Vaccinated:2007-11-20
Age:52.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:2007-12-28, Days after onset: 38
Location:Michigan  Entered:2008-01-09, Days after submission: 12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2526AA IM 
Administered by: Public     Purchased by: Public
Symptoms: Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)
Write-up: 12-28-07 complained of pain in deltoid since receiving flu vaccine 11-20-07. No edema, erythema, tenderness with palpation. Pain with movement. Referred to private physician.

VAERS ID:302953 (history)  Vaccinated:2007-11-20
Age:33.0  Onset:2007-11-24, Days after vaccination: 4
Gender:Female  Submitted:2008-01-17, Days after onset: 54
Location:Florida  Entered:2008-01-17
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: none
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anxiety, Insomnia, Pain, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)
Write-up: I received a flu shot and The first 3 days I had some soreness. But then the following days I was completely unable to sleep. I had trembling in my body and anxiety. I was not able to sleep even when I took Benadryl. I did not sleep for a week. The dr. had to give me doxepin in order for me to sleep. The flu shot I found out had hydrocortisone. I think this was what produced my reaction.

VAERS ID:303466 (history)  Vaccinated:2007-11-20
Age:0.2  Onset:2007-11-22, Days after vaccination: 2
Gender:Male  Submitted:2008-01-15, Days after onset: 54
Location:Wisconsin  Entered:2008-01-21, 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:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: stool culture, 11/23/07, rotavirus; laboratory test, 11/23/07, unspecified
CDC Split Type: WAES0712USA02913
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.  UNUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.  PO 
Administered by: Other     Purchased by: Other
Symptoms: Culture stool positive, Diarrhoea, Gastroenteritis, Laboratory test, Rotavirus test positive, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)
Write-up: Information has been received from a registered nurse concerning a 9 week old male with no pertinent medical history or drug allergies who on 20-NOV-2007 was vaccinated PO with a single dose of Rotateq (lot# 656659/0942U). Concomitant vaccinations administered on that same day included a dose of PedvaxHIB (OMPC) (MSD), a dose of PEDIARIX and a dose of PREVNAR. On 22-NOV-2007 the patient experienced vomiting and diarrhea. On 23-NOV-2007 the patient was examined in the emergency room the day after symptoms started and was released that same day. Laboratory diagnostic studies included unspecified tests. The patient''s stool also tested positive for rotavirus. The patient also contacted the physician''s office for medical attention. Subsequently, the patient recovered. There was no product quality complaint. It was also noted that on 24-NOV-2007 the patient''s parents experienced gastrointestinal symptoms (unspecified) which lasted 48 hours then resolved (WAES# 0712USA04831).

VAERS ID:304000 (history)  Vaccinated:2007-11-20
Age:21.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:2008-01-15, Days after onset: 56
Location:Arizona  Entered:2008-01-21, 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: Xanax; Nuvaring; Zoloft
Current Illness: Cold; Upper respiratory tract congestion; cough; sputum bloody
Preexisting Conditions: Depression
Diagnostic Lab Data: Blood pressure 11/20/07 (value) 102/6; blood pressure 11/20/07 (value) 102/6; blood pressure 11/20/07 (value) 108/7; chest x-ray 11/20/07 no acute disease; blood pressure 11/20/07 (value) 99/68; body temp 11/20/07 (value) 97.2; total heartb
CDC Split Type: WAES0801USA01331
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1267U1IMUN
Administered by: Private     Purchased by: Private
Symptoms: Blood glucose normal, Blood pressure, Bronchitis, Chest X-ray normal, Culture urine, Dizziness, Fatigue, Full blood count, Heart rate normal, Laboratory test, Oxygen saturation normal, Presyncope, Respiratory rate, Urine human chorionic gonadotropin
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a certified medical assistant concerning a 21 year old white female nonsmoker with a history of depression, no significant social history, no sexual activity, and no drug allergies, who on 20-NOV-2007 at 09:30 was vaccinated intramuscularly in the left deltoid with a second dose of Gardasil (Lot #659439/1267U). Concomitant therapy included sertraline HC1 (ZOLOFT), alprazolam (XANAX), and ethinyl estradiol (+) etonogestrel (NUVARING). On 20-NOV-2007 at 09:45 (also reported as about 10 minutes post vaccination) the patient felt lightheaded and nearly had a syncopal episode while sitting in the chair. The patient never fell out of the chair and there was no injury. The patient was "slow to come to" and felt fatigued. The patient had a head cold followed by a cough and chest congestion that had developed over the past week. The patient had no fever, chest pain, abdominal pain, shortness of breath. The patient was taken to the emergency room where she was treated with normal saline 1000cc, 500cc/hour. Laboratory diagnostics were performed (results located in laboratory section). The patient was diagnosed with being near syncope and bronchitis. It was reported that the patient was feeling better and was discharged to home. The patient''s condition was stable. The patient was advised to follow up with physician. On 20-NOV-2007 the patient recovered from the near syncopal episode, fatigue, and lightheaded/dizziness. The outcome of bronchitis was unknown. Additional information is not expected.

VAERS ID:303849 (history)  Vaccinated:2007-11-20
Age:0.47  Onset:2007-11-21, Days after vaccination: 1
Gender:Female  Submitted:2008-01-30, Days after onset: 70
Location:South Carolina  Entered:2008-01-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Penicillin (1/2 tsp. twice daily)
Current Illness: Sickle cell trait
Preexisting Conditions: Sickle cell trait
Diagnostic Lab Data:
CDC Split Type: SC0728
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B056BA1IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.0078U1IMLL
IPV: POLIO VIRUS, INACT. (POLIOVAX)SANOFI PASTEUR2087321IMRL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB47300F1IMLL
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: Fine, raised, non-red, bilateral rash on upper thighs lasted 4 days. ER visit.

VAERS ID:304025 (history)  Vaccinated:2007-11-20
Age:24.0  Onset:2007-12-21, Days after vaccination: 31
Gender:Female  Submitted:2008-01-30, Days after onset: 40
Location:Unknown  Entered:2008-01-31, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: creatinine; DEPO-PROVERA; vitamins (unspecified)
Current Illness: Fibromyalgia; migraine
Preexisting Conditions:
Diagnostic Lab Data: serum creatine kinase, 12/21/07, 50,00; serum creatine kinase, 12/21/07, 19,90
CDC Split Type: WAES0801USA04568
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Biopsy muscle, Blood creatine phosphokinase increased, Electromyogram, Enzyme abnormality
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad)
Write-up: Information has been received from a health professional concerning a 24 year old female with fibromyalgia (since age 14) and migraines on 20-NOV-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included creatinine "supplements", multiple various vitamins (unspecified) and DEPO-PROVERA. The patient saw Rheumatologist on 21-DEC-2007 for a routine check-up and when blood was drawn. CK result came back later that day showing 19,900, patient was advised to go to the hospital. Upon admission, CK was 50,000. The patient had been exercising between the blood draws (no baseline CK level available). The patient was hospitalized for three days and received hydration. Discharge diagnosis was "enzyme deficiency". The patient had an EMG and muscle biopsy (dates unspecified) but results are not available. She was due for her second dose of GARDASIL but had canceled her appointment. Additional information has been requested.

VAERS ID:305010 (history)  Vaccinated:2007-11-20
Age:21.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:2008-02-14, Days after onset: 86
Location:Illinois  Entered:2008-02-15, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA01039
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1266U2IMRA
Administered by: Other     Purchased by: Other
Symptoms:
SMQs:
Write-up: Medical assistant mentioned that a patient mentioned to the physician regarding her neighbor''s daughter who was vaccinated with a dose of GARDASIL. Concomitant therapy included MENACTRA. Subsequently the patient became paralyzed. Unknown medical attention was sought. The patient''s outcome is unknown. No product quality complaint was involved. Upon internal review paralysis is considered to be an other important medical event. This is a hearsay report in the absence of an identifiable patient. Attempts are being made to verify the existence of a patient." Additional information has been requested. 7/10/08-records received -11/20/07-collapsed on floor of doctor office, hit head, alert oriented. 11/21/07-follow up phone call sutures in head, returning to school.

VAERS ID:305521 (history)  Vaccinated:2007-11-20
Age:27.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:0000-00-00
Location:Unknown  Entered:2008-02-22
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: Possible reaction to the rabies vaccine.
CDC Split Type: KS2007017
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2514A IMRA
RAB: RABIES (RABAVERT)NOVARTIS VACCINES AND DIAGNOSTICSU12011A IMLA
Administered by: Public     Purchased by: Private
Symptoms: Dizziness, Nausea, Palpitations, Vaccination complication
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: Dizziness, nausea, palpation. Client was seen in emergency room and by family physician. Prescribe Benadryl.

VAERS ID:305771 (history)  Vaccinated:2007-11-20
Age:44.0  Onset:2007-11-21, Days after vaccination: 1
Gender:Female  Submitted:2007-12-12, Days after onset: 21
Location:Colorado  Entered:2008-02-26, Days after submission: 76
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Yasmin; Bupropion; Singulair; Zyrtec
Current Illness: None
Preexisting Conditions: PCN, ASA
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB432AA0IMRA
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB208AA1IMRA
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURA0169 SCLA
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0808U1SCLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1005F1IMLA
TDAP: TDAP (ADACEL)SANOFI PASTEURC2842AA IMLA
Administered by: Other     Purchased by: Private
Symptoms: Unevaluable event
SMQs:
Write-up: None stated

VAERS ID:306364 (history)  Vaccinated:2007-11-20
Age:77.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Male  Submitted:2008-03-03, Days after onset: 104
Location:Oregon  Entered:2008-03-04, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0801USA00955
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1226U0UNRA
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURERC2826AA UNLA
Administered by: Private     Purchased by: Other
Symptoms: Asthenia, Disability, Injection site pain, Pain, Screaming
SMQs:, Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad)
Write-up: Initial and follow up information has been received from a physician and a registered nurse (RN), concerning a 77 year old (previously reported as "over age 65") male patient with no pertinent medical history and no known allergies, who on an 20-NOV-2007, at 12:45 pm, was vaccinated in the right deltoid with the first dose of Pneumovax 23 (lot # 657145/1226U). Concomitant vaccine therapy included a dose in the left deltoid of DTaP (manufacturer not specified; lot # C2826AA). There was no illness at the time of vaccination. The RN indicated at 2:45 pm, "patient returned to our office after receiving the [Pneumovax 23 vaccine) 2 hours prior." The patient was "in excruciating pain/screaming in pain." Treatment included 2 injections of DEMEROL. The patient continued to have pain and weakness at the injection site for 1 month. The event "cleared on its own" (date not specified) and the patient recovered. The nurse considered the events to be serious due to persistent disability/incapacity. Additional information is not expected.

VAERS ID:307832 (history)  Vaccinated:2007-11-20
Age:14.0  Onset:0000-00-00
Gender:Female  Submitted:2008-03-14
Location:New Jersey  Entered:2008-03-17, 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: clonazepam
Current Illness: Sleep disorder
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0802USA06078
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Obsessive-compulsive disorder, Paranoia
SMQs:, Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad)
Write-up: Information has been received from a physician concerning a 14 year old female with no medical history and no drug allergies, who on 13-SEP-2007 was vaccinated with a first dose of GARDASIL. Concomitant therapy included clonazepam for "sleep." Subsequently, post vaccination the patient experienced obsessive compulsive behavior. It was reported that the patient was checking doors and under the bed. The patient began to recover until the second dose. On 20-NOV-2007 the patient was vaccinated with a second dose of GARDASIL. Subsequently, after the second dose of the patient had a more severe reaction. The patient experienced paranoid behavior. It was also reported that the patient had began her menses after the second dose of GARDASIL. The patient was referred to a psychiatrist and was placed on PROZAC. It was reported that the patient''s symptoms had improved. However, the psychiatrist did not believe that the patient had been taking the PROZAC long enough for the improvement to be from the treatment. The patient''s mother believed that the patient had improved because time had passed since she had received the second dose GARDASIL. The patient spoke with physician. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.

VAERS ID:308451 (history)  Vaccinated:2007-11-20
Age:27.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:2008-03-18, Days after onset: 118
Location:Kansas  Entered:2008-03-27, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Please see report A0697555B for details regarding the neonate case. The subject has no history of alcohol use or tobacco use.
Diagnostic Lab Data: UNK
CDC Split Type: A0697555A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER 0UNUN
Administered by: Private     Purchased by: Other
Symptoms: Chest discomfort, Dizziness, Oesophageal stenosis, Panic attack
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Gastrointestinal obstruction (narrow), Vestibular disorders (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of chest heaviness in a 27-year-old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified). The subject''s medical history, concurrent conditions, and concurrent medications were not reported. The subject had no prior vaccination with influenza virus vaccine. On 20 November 2007 the subject received 1st dose of Influenza virus vaccine (unknown). On 21 November 2007, 1 day after vaccination with Influenza virus vaccine, the subject experienced chest heaviness, panic attack and feeling of esophagus closing (described as pressure felt on the esophagus). At the time of receipt of influenza virus vaccine, the subject was breast feeding a child who was born in June 2007. No other details regarding the neonate were provided. The subject was seen at a physician''s office. At the time of reporting the events were worse. Follow-up information on 17 December 2007 indicated that the events actually occurred on the same day of vaccination, 20 November 2007. Light headedness was reported as an additional event also beginning the same day of vaccination, 20 November 2007. The events were all resolved and indicated as possibly related to influenza virus vaccine.

VAERS ID:308453 (history)  Vaccinated:2007-11-20
Age:74.0  Onset:0000-00-00
Gender:Male  Submitted:2008-03-18
Location:Pennsylvania  Entered:2008-03-27, Days after submission: 9
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: No adverse events following previous vaccinations indicated on influenza vaccination consent or screening form.
Diagnostic Lab Data: UNK
CDC Split Type: A0698462A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA305BA0UNLA
Administered by: Public     Purchased by: Public
Symptoms: Pain
SMQs:
Write-up: This case was reported by a pharmacist and described the occurrence of pain all over body in a 74-year-old male subject who was vaccinated with Fluarix (GlaxoSmithKline). No adverse events following previous vaccinations. On 20 November 2007 at 09:45 the subject received 1st dose of Fluarix (.5 ml, left arm). In December 2007, approximately 2 weeks after vaccination with Fluarix, the subject experienced pain all over body. The subject has not required any treatment, but plans to see his physician regarding the all over body pain. At the time of reporting the event was unresolved. The pharmacist considered the event was possibly related to vaccination with Fluarix.

VAERS ID:308719 (history)  Vaccinated:2007-11-20
Age:19.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:2008-04-01, Days after onset: 132
Location:Wisconsin  Entered:2008-04-01
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: Pneumonia - cough - chest x-ray effusion +/- sm. right pleural right lower lobe pneumonia.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Public     Purchased by: Other
Symptoms: Chest X-ray abnormal, Cough, Dysphonia, Dyspnoea, Lobar pneumonia, Musculoskeletal stiffness, Pharyngolaryngeal pain, Pleural effusion, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: HPV given 11/20/07 - In clinic 11/25/07 with 5 days of cough, hoarseness, fever. Non-productive cough - sore throat, stiff neck - hurting to take deep breath.

VAERS ID:309073 (history)  Vaccinated:2007-11-20
Age:15.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:2008-04-07, Days after onset: 138
Location:Iowa  Entered:2008-04-08, 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: Pregnancy NOS (LMP = 11/7/2007)
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA00461
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abortion induced, Drug exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)
Write-up: Initial and follow-up information has been received through the Merck pregnancy registry for Gardasil from a Registered Nurse concerning a 15 year old female who on 20-NOV-2007 was vaccinated with the first dose of Gardasil. Subsequently the patient received the second dose of Gardasil (Lot #658490/0802U) on 24-JAN-2008 and became pregnant. The patient''s estimated LMP is 07-NOV-2007. Follow-up indicated that the patient had an elective termination six to eight weeks after her last menstrual period. It was unknown if the products of conception were examined and it was unknown if the fetus was normal. Upon internal review elective termination was considered to be an other important medical event. Additional information is not expected.

VAERS ID:309703 (history)  Vaccinated:2007-11-20
Age:66.0  Onset:2007-11-21, Days after vaccination: 1
Gender:Female  Submitted:2008-03-26, Days after onset: 125
Location:Virginia  Entered:2008-04-16, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Effexor
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA05069
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.0290U0SC 
Administered by: Private     Purchased by: Other
Symptoms: Erythema, Herpes zoster, Pain, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a 66 year old 120 lb. 64.5 in. white retired female with no allergies and no pertinent medical history who on 20-NOV-2007 at 14:30 hours received a subcutaneous single dose in the right deltoid of ZOSTAVAX (lot# 656395/0290U, or lot# 0657766/0620U). Concomitant therapy included venlafaxine hydrochloride (EFFEXOR). It was reported that one day after the vaccination (21-NOV-2007); she developed itchy, red splotches, and deep aching under her right breast extending around to the right mid back. The patient called the physicians office and was advised to take diphenhydramine (BENADRYL). On 23-OCT-2007, she was examined in the office by the physician who diagnosed her with Herpes Zoster. The Herpes Zoster reportedly affected the T7 to T8 dermatone area. Treatment included administration of kertolac (TORADOL) 60 mg. intramuscular in the office. She was written prescriptions for kertolac (TORADOL), 10 mg tablets, one tablet twice a day, oxycodone (+) actaminophen (PEROCET). She was also prescribed methylprednisolone, hydrocodone, and valacyclovir (VALTREX). The patient was last seen by the physician on 12-DEC-2007, and current patient status was reported as unknown by the physician. A product quality complaint was not reported. Additional information has been requested.

VAERS ID:309719 (history)  Vaccinated:2007-11-20
Age:60.0  Onset:2007-11-21, Days after vaccination: 1
Gender:Female  Submitted:2008-03-26, Days after onset: 125
Location:California  Entered:2008-04-16, Days after submission: 21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Drug hypersensitivity
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA05457
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1820U0UNUN
Administered by: Private     Purchased by: Private
Symptoms: Herpes zoster, Incorrect dose administered, Injection site vesicles, Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a physician concerning a 60 year old female with codeine, ASA and morphine allergy who on 20-NOV-2007 at 10:30 AM was vaccinated with a first 0.6 ml dose of ZOSTAVAX (Lot # 658397/1820U). On 21-NOV-2007 the patient developed blistering around injection site which did spread along dermatome. On 27-NOV-2007 the physician diagnosed it as mild to moderate case of shingles. Additional information has been received from the physician who stated that the patient on 21-NOV-2007 in morning developed zoster like eruption starting at injection site. It was reported that the eruption occurred within 24 hours of vaccination. On an unspecified date the patient recovered. No further information is expected.

VAERS ID:310299 (history)  Vaccinated:2007-11-20
Age:17.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:2008-04-07, Days after onset: 138
Location:Florida  Entered:2008-04-16, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy NOS (LMP = 10/15/2007)
Preexisting Conditions:
Diagnostic Lab Data: Beta-human chorionic, positive; Beta-human chorionic, 11/20/07, negative
CDC Split Type: WAES0801USA01279
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1263U IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Pregnancy test positive, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)
Write-up: Information has been received from a certified medical assistant for the Pregnancy Registry for Gardasil with no pertinent medical history and no history of drug reactions/allergies concerning a 17 year old female who on 20-NOV-2007 was vaccinated with Gardasil (lot # 658282/1263U) 0.5 ml IM. At the time of vaccination, the patient was at 12 weeks gestation as of 08-JAN-2008. Her last menstrual period was on 15-OCT-2007. The patient visited the office. On an unspecified date, she had a positive pregnancy test (beta-human chorionic gonadotropin test (unspecified)). Estimated date of delivery is 21-JUL-2008. Additional information was received from the physician''s assistant. The patient''s last menstrual period was in October 2007. Her period was due on 08-NOV-2007. On 20-NOV-2007, a pregnancy test was negative (same date as the vaccine injection). On 20-NOV-2007, the patient was prescribed PHENERGAN 25 mg q6h for vomiting. The patient (well child) was referred to an OB/GYN physician. Additional information has been requested. 04/07/09 This is in follow-up to report(s) previously submitted on 4/7/2008; 7/8/2008. Follow up information was received from a health care worker in physician''s office by phone call. It was reported that the patient''s delivery was fine and as far as the reporter knew the baby was healthy and normal. The mom had just been in the office on 11-FEB-2009. The reporter did not indicate the reason for the recent visit. No further information was available.

VAERS ID:310317 (history)  Vaccinated:2007-11-20
Age:0.17  Onset:0000-00-00
Gender:Male  Submitted:2008-04-14
Location:Pennsylvania  Entered:2008-04-16, 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:
Current Illness:
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type: WAES0803USA01520
Vaccination
Manufacturer
Lot
Dose
Route
Site
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.1388U0PO 
Administered by: Other     Purchased by: Other
Symptoms: Abnormal faeces, Constipation, Mucous stools
SMQs:, Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (broad)
Write-up: Information has been received from a pharmacist concerning her son with no pertinent medical history or drug allergies who on 20-NOV-2007 and 21-JAN-2008 was vaccinated PO with his first and second doses of ROTATEQ. There was no concomitant medication. In 2007 after the patient''s first dose, the patient''s stools became "mucousy." Subsequently, the patient recovered from stools mucousy. In 2008 after the patient''s second dose the patient became constipated with stool consistency of "peanut butter." It was also reported that the patient had not experienced any bleeding or discomfort with this change. The patient did begin to eat food between the first and second doses of ROTATEQ. The pharmacist contacted the physician for medical attention. No labs or diagnostic studies were performed. The patient was noted to be recovering at the time of this report. There was no product quality complaint. Additional information has been requested.

VAERS ID:313904 (history)  Vaccinated:2007-11-20
Age:  Onset:2007-11-20, Days after vaccination: 0
Gender:Male  Submitted:2008-05-16, Days after onset: 177
Location:Unknown  Entered:2008-05-23, 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:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA02781
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.  SC 
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: Information has been received from a physician who stated that on approximately 20-NOV-2007 he accidentally administered himself with a dose of varicella virus vaccine live (Oka/Merck) (MSD). He indicated that it was no product confusion, he did not read the label. No symptoms were reported. No other details. There was no product quality complaint. Follow-up information indicated no adverse reaction. No new information. Additional information has been requested.

VAERS ID:321248 (history)  Vaccinated:2007-11-20
Age:68.0  Onset:2007-11-21, Days after vaccination: 1
Gender:Female  Submitted:2008-08-04, Days after onset: 256
Location:Pennsylvania  Entered:2008-08-04
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
TDAP: TDAP (ADACEL)SANOFI PASTEUR    
Administered by: Private     Purchased by: Unknown
Symptoms: Local swelling
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: local swelling

VAERS ID:322985 (history)  Vaccinated:2007-11-20
Age:73.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Unknown  Submitted:2008-07-30, Days after onset: 252
Location:Massachusetts  Entered:2008-08-06, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0711USA04675
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1229F UNUN
Administered by: Other     Purchased by: Other
Symptoms: Burning sensation, Erythema, Feeling hot, Pain
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from an office manager concerning a 73 year old patient (gender not reported) who on 20-NOV-2007 was vaccinated (route and site not reported) with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (Lot#655765/1229F). Post vaccination, the patient developed redness on the upper arm, burning, severe pain and hot sensation. It is unknown if the patient received medical attention and if the patient recovered. This is one of 2 reports with the same source. Additional information has been requested.

VAERS ID:324573 (history)  Vaccinated:2007-11-20
Age:63.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Male  Submitted:2007-11-21, Days after onset: 1
Location:Massachusetts  Entered:2008-08-15, Days after submission: 267
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness: Heart disease, unspecified
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: MEDI0006216
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500486P IN 
Administered by: Private     Purchased by: Unknown
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)
Write-up: A non-serious report was received from a physician of FLUMIST INADVERTENTLY ADMINISTERED involving a 63-year-old male. The patient''s medical history includes chronic heart disease. No concomitant medications were reported for this patient. The patient received FluMist on 20 Nov 2007. On 20 Nov 2007, the patient was inadvertently administered FluMist vaccine. FluMist vaccine is approved for patients between 5 and 49 years of age. The reporter indicated that no adverse event occurred as a result of FluMist vaccination. No adverse event was reported. Rechallenge is not applicable. The reporter did not provide a causality assessment. The reporting source of this case is spontaneous, thus the sponsor''s comment is not applicable.

VAERS ID:327344 (history)  Vaccinated:2007-11-20
Age:75.0  Onset:2007-11-22, Days after vaccination: 2
Gender:Female  Submitted:0000-00-00
Location:North Carolina  Entered:2008-10-07
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: Vitiligo-onset at age 26, Bayer Aspirin 1962, 1972-Urticaria
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA296JA UNUN
Administered by: Private     Purchased by: Unknown
Symptoms: Abdominal distension, Allergy to metals, Anxiety, Body temperature increased, Chills, Depression, Diarrhoea, Erythema, Eyelid oedema, Food allergy, Hyperhidrosis, Ocular hyperaemia, Urticaria, Urticaria chronic
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Depression (excl suicide and self injury) (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Red, ringworm looking circles all over body 1-2 days after vaccination /severe chronic urticaria-rash then furious weals, lasting 9 months/shivering temp 100, sweating-bed clothes soaked/red eyes, swollen eyelids, body rejecting sun screen lotion, lotions, watch band (metal), stomach (9 months pregnant- looking swollen), diarrhea, depression, anxiety, food sensitivities-kidney beans, banana, sun flower and pine seeds (never allergic before flu shot).

VAERS ID:331814 (history)  Vaccinated:2007-11-20
Age:64.0  Onset:2007-11-21, Days after vaccination: 1
Gender:Female  Submitted:2008-11-03, Days after onset: 348
Location:Minnesota  Entered:2008-11-10, Days after submission: 7
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: 11/14/08-records received- CBC, glucose chemistry panel and TSH normal. EKG-tachycardia with repolarization changes.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA323BA IMLA
Administered by: Private     Purchased by: Unknown
Symptoms: Anorexia, Blood glucose normal, Blood thyroid stimulating hormone, Colonoscopy, Computerised tomogram, Diarrhoea, Dyspnoea, Echocardiogram, Electrocardiogram, Endoscopy, Erythema, Fatigue, Flushing, Full blood count normal, Heart rate increased, Laboratory test normal, Lethargy, Pain in extremity, Palpitations, Rash macular, Respiratory tract congestion, Tachycardia, Viral infection, Vision blurred, Weight decreased
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Red blotches on (L) arm, severe S.O.B., heart palpitations, increased pulse (up to 165), face flushing, could not eat, weight loss. Hospital in PT 2 times, Endoscopy, Colonoscopy, CT Scans, Echocardiogram, Blurred vision, severe diarrhea, etc, etc. 11/17/08-records received 11/17/08 presented to clinic on 11/29/08- for evaluation of C/O blotchiness distal to injection site for 3 days with soreness. On 11/21/08 felt tired and some lethargy. 1 day of congestion. Bit out of breath on 11/23 and 11/24/08. Assessment-viral syndrome. Next day C/O palpitations and feeling out of breath.Prescribed beta blocker but did not take medication. No hospitalization. 1/28/2010 I still have facial flushing, SOB and heart racing everyday. Also, diarrhea and feeling very tired at times. It has been 2 years now and I do not feel ike I did before the shot.

VAERS ID:335184 (history)  Vaccinated:2007-11-20
Age:34.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:2007-11-28, Days after onset: 8
Location:Arizona  Entered:2008-11-13, Days after submission: 351
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zocor;Lisinopril;Hydpochlorothiazide;Amitriptline, ASA
Current Illness:
Preexisting Conditions: The patient had a history of migraines, hypertension, hperlipidemia, MI thought to be secondary to Triptan use, angioplasty of the LAD with stent placement.
Diagnostic Lab Data:
CDC Split Type: 200704010
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2486A UNLA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.1417U UNRA
Administered by: Private     Purchased by: Private
Symptoms: Neck pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Initial report received on 21 November 2007 from a health care professional. A 34-year-old female patient had received a left deltoid injection of FLUZONE, lot number U2486AA, and a right deltoid injection of PNEUMOVAX, manufacturer Merck, lot number 1417U; on 20 November 2007. Later that evening, the patient experienced left arm pain extending into the left axilla and left neck and a fever of 101.0 degrees Fahrenheit. At the time of this report, the patient had not recovered.

VAERS ID:333852 (history)  Vaccinated:2007-11-20
Age:23.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:2008-11-14, Days after onset: 360
Location:Indiana  Entered:2008-11-17, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: dermatologic (unspecified) DEPO-PROVERA
Current Illness: Pregnancy NOS (LMP = 10/13/2007); Skin disorder; Smoker
Preexisting Conditions: Cervical cancer; Loop electrosurgical excision procedure; papanicolaou smear, abnormal
Diagnostic Lab Data: cervical smear - "current pap test is fine"; ultrasound, 12/07/07 - 7 weeks and 4 days; ultrasound 03/20/07 - normal OB ultrasound; urine beta-human, 12/04/07 - positive
CDC Split Type: WAES0801USA01800
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0515U0IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug exposure during pregnancy, Premature labour, Premature rupture of membranes, Rash papular, Skin hypopigmentation, Smear cervix normal, Tobacco user, Ultrasound scan normal, Urine human chorionic gonadotropin positive
SMQs:, Tumour markers (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Initial and follow-up information has been received from the pregnancy registry for GARDASIL via a registered nurse concerning an 23 year old female smoker with "dermatological problems" and a history of cervical cancer with no documented HPV(2007), abnormal pap and loop electrosurgical excision procedure(14-JUN-2006) who on 20-NOV-2007 was vaccinated IM, with a 0.5 ml first dose of GARDASIL (LOT 657872/0515U). Concomitant therapy included DEPO-PROVERA and dermatologic (unspecified). Subsequently the patient became pregnant. On 04-DEC-2007 she had a positive pregnancy test. On 07-DEC-2007, ultrasound revealed gestational age was 7 weeks and 4 days. Last menstrual period was 12-OCT-2007 and estimated date of delivery was 20-JUL-2008. The patient was seen in the physician''s office on 09-JAN-2008. Follow up information was received which reported that on 09-JUL-2008 the patient had spontaneous rupture of membranes and delivered a female infant at 38 weeks gestational via spontaneous pitocin augmented delivery. The baby''s weight 6lb 12oz. The infant was normal. No congenital anomalies or other complications or abnormalities were noted, head moulding/cone was noted to be resolved. It was also reported that the patient had no complications during the pregnancy and labor. The patient continued to smoke throughout her pregnancy. On 11-JUL-2008 the infant was vaccinated with HEP B virus vaccine (manufacturer unknown), (WAES #0811USA00563). On 11-SEP-2008 it was reported that the patient had a papular rash with mild hypopigmentation to her antecubital crease. Additional information is not expected.

VAERS ID:343195 (history)  Vaccinated:2007-11-20
Age:0.0  Onset:2007-12-04, Days after vaccination: 14
Gender:Female  Submitted:2009-03-06, Days after onset: 458
Location:Unknown  Entered:2009-03-18, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Jaundice neonatal
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0809USA03422
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (RECOMBIVAX HB)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Eczema, Erythema, Insomnia, Respiratory tract congestion, Rhinorrhoea, Screaming, Sneezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a pediatrician concerning a 14 day old female baby with a history of exposure to GARDASIL while in uterus (approximately on 14-MAR-2007) (refer to WAES # 0705USA00917) and with neonatal jaundice and no known allergies who on 20-NOV-2007 was vaccinated with a first dose of RECOMBIVAX HB (manufacture unknown). On 27-NOV-2007 the baby had a well baby check-up which revealed the neonatal jaundice was improved and the "levels" were starting to decrease. On 03-DEC-2007 the baby had an office check-up and the mother reported the baby had nasal congestion, sneezing, green nasal drainage and no fever. On 04-DEC-2008 the baby was diagnosed with upper respiratory infection and treated with saline suction. On 03-JAN-2008 the baby was seen for well check up and the mother reported that the baby had bellyache, screaming, "colicky symptoms" and not sleeping well. The baby was diagnosed with colic and treated with ENFAMIL NUTRAMIGEN. On 14-JAN-2008, the baby had a well baby check-up which revealed the colic was improved. The baby also received the following vaccinations that day: RECOMBIVAX HB (manufacturer unknown), ROTATEQ, PEDIARIX and PREVNAR. On 18-Feb-2008 the baby was seen for well check up and the mother reported that the baby had green-yellow nasal drainage, temperature 100.3. The baby was noted to have red cheeks. The baby was diagnosed with upper respiratory infection and eczema and treated with "saline bulb, "propping" and EUCERIN. On 21-FEB-2007 the baby was prescribed nystatin (reason not reported). On 01-APR-2008, the baby was seen for well check up and the mother reported that the baby had sneezing for 1 week and had no fever. The baby was diagnosed with upper respiratory infection and treated with saline. The baby also received the following vaccinations that day: RECOMBIVAX HB (manufacturer unknown), ROTATEQ, PEDIARIX and PREVNAR. On 10-APR-2008, the baby was seen for well check up and the mother reported that the baby had seen spitting up and had constipation. The baby was d

VAERS ID:346462 (history)  Vaccinated:2007-11-20
Age:0.6  Onset:2008-02-05, Days after vaccination: 77
Gender:Male  Submitted:2009-05-07, Days after onset: 456
Location:Florida  Entered:2009-05-18, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: 5/19/09 hospital records received DOS 2/13/08 to 2/18/08. Amoxicillin
Current Illness: PARONYCHIA & CERUMEN IMP
Preexisting Conditions: Developmental D/O-Hearing; ?''s 2 mos-screen passed; No crawl/pincer @ 9 mos 7/7/09 Medical records received DOS 11/20/07 to 3/30/09. Abscess finger. I&D.
Diagnostic Lab Data: MRI Brain/Spine, EEG NL 5/19/09 hospital records received DOS 2/13/08 to 2/18/08. LABS and DIAGNOSTICS: CT head, cervical, thoracic, lumbar spine normal. CSF - WNL. EEG normal.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC2606AA2IMRL
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURUT2474AA1IMRL
HEP: HEP B (FOREIGN)MERCK & CO. INC.00146R2IMLL
PNC: PNEUMO (PREVNAR)PFIZER/WYETHB47300H2IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.087742PO 
Administered by: Private     Purchased by: Public
Symptoms: Areflexia, Blood product transfusion, CSF test normal, Choking, Computerised tomogram normal, Electroencephalogram normal, Erythema, Guillain-Barre syndrome, Loss of control of legs, Mobility decreased, Muscular weakness, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging normal, Otitis media, Posture abnormal, Rash pustular, Sensory loss, Tachypnoea
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalopathy/delirium (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Influenza vaccines rec''d 10/18/07 and 11/20/07. 3 mos later developed Guillain-Barre syndrome/was hospitalizsed for acute lower extr. weakness. 5/19/09 hospital records received DOS 2/13/08 to 2/18/08. FINAL DIAGNOSIS: Acute lower limb weakness, possible Guillain-Barre Syndrome. Post vaccination: Choking episode, weakness and inability to bear weight on lower limbs. Fails to sit up or crawl. Otitis media. Decreased tone and power lower limbs. Biceps/triceps reflexes weak. Absent patellar reflexes. Weak ankle reflexes. Tachypnea, limp 3 doses of intravenous immunoglobulin. 7/7/09 Medical records received DOS 11/20/07 to 3/30/09. Assessment: Acute infective polyneuritis, Guillain-Barre syndrome. Patient presented with absent knee, achilles reflexes and absent superficial reflexes of feet. No rolling, no tactile sensation back. No weight bearing on legs, falls forward when sitting. Keeps legs extended, scissoring. Gradual improvement of neurological findings. Left side of gluteal fold 2 inch erythematous ring surounding pustule.

VAERS ID:350085 (history)  Vaccinated:2007-11-20
Age:  Onset:0000-00-00
Gender:Male  Submitted:2009-05-29
Location:Indiana  Entered:2009-06-17, Days after submission: 19
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: serum measles Ab, 02/24/08, negat; serum measles Ab, 04/30/08, negat
CDC Split Type: WAES0812USA02572
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC. 0SCUN
Administered by: Other     Purchased by: Other
Symptoms: Measles antibody negative
SMQs:
Write-up: Information has been received from a registered nurse concerning a male adult patient who on 20-NOV-2007 was vaccinated subcutaneously with a 0.5ml dose of MMR II and on 26-FEB-2008 received subcutaneously a second 0.5ml dose of MMR II. The physician stated that the patient had titers drawn on 24-Feb-2008 and 04-APR-2008, both titers for measles were negative. The patient sought unspecific medical attention. At the time of the report the patient status was unknown. Additional information has been requested.

VAERS ID:363162 (history)  Vaccinated:2007-11-20
Age:15.0  Onset:2007-12-01, Days after vaccination: 11
Gender:Female  Submitted:2009-10-20, Days after onset: 688
Location:New Hampshire  Entered:2009-10-27, 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: ALBUTEROL PRN
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CBC; LPT''S; CPK; ANA; ENA; Skin biopsy (c/w connect. Tissue disease); ANA Positive; All other labs - Negative/NL
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU2524AA1IMRA
HPV4: HPV (GARDASIL)MERCK & CO. INC.093041IMLA
Administered by: Private     Purchased by: Public
Symptoms: Antinuclear antibody, Antinuclear antibody positive, Biopsy skin abnormal, Blood creatine phosphokinase normal, Connective tissue disorder, Dermatomyositis, Full blood count normal, Liver function test normal, Rash
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Skin tumours of unspecified malignancy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Dermatomyositis - Dx''d 2/2008. 1st Dx''d by rash on knuckles found during DERM visit for acne on 2/7/08. Pt & mother stated rash had been present for few months. Rx''d with PLAQUENIL.

VAERS ID:383887 (history)  Vaccinated:2007-11-20
Age:34.0  Onset:2007-11-21, Days after vaccination: 1
Gender:Male  Submitted:2010-03-31, Days after onset: 860
Location:Unknown  Entered:2010-03-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: denies
Preexisting Conditions: denies
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.500476P   
Administered by: Military     Purchased by: Military
Symptoms: Eye swelling, Rash, Rash papular, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: During the night of vaccination noticed swelling of his eyes and an irritated like rash on his arms. Non itching. Reported that his throat felt tight. With IM vaccination in Oct 08 he reported a heart rash like bumps on both arms. With IM vaccination in Oct 09 he was just recovering from pneumonia and he noticed little red non irritating bumps on injection arm only. Bumps lasted a couple of days.

VAERS ID:390914 (history)  Vaccinated:2007-11-20
Age:21.0  Onset:2008-01-22, Days after vaccination: 63
Gender:Female  Submitted:2010-06-17, Days after onset: 876
Location:Texas  Entered:2010-06-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: arthritis~HPV (Gardasil)~2~21.00~Patient|arthritis~HPV (Gardasil)~3~22.00~Patient
Other Medications:
Current Illness: none
Preexisting Conditions: none
Diagnostic Lab Data: I am positive for the HLA-B27 genetic marker for autoimmune problems. I have autoimmune arthritis which affects joints and organs, and ankylosing spondylitis which will only show up on an xray in about ten years.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1209U0 RA
Administered by: Private     Purchased by: Other
Symptoms: Ankylosing spondylitis, Arthropathy, Autoimmune disorder, Fatigue, HLA marker study positive, Joint swelling, Oedema peripheral, Vaginitis bacterial, X-ray
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad)
Write-up: Bacterium vaginosum 01/22/2008 exhaustion 06/2008. Foot and turning head trouble 06/2008. Left foot and left knee swelling with heat 09/2008. 11/2008 bacteria vaginosum and 3rd shot and spread to rest of joints. Treated with steroids, methotrexate for a year, anti inflammatories for a year. 06/2009 started remicade.

VAERS ID:391186 (history)  Vaccinated:2007-11-20
Age:61.0  Onset:2010-06-04, Days after vaccination: 927
Gender:Female  Submitted:2010-06-16, Days after onset: 12
Location:New York  Entered:2010-06-22, Days after submission: 6
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cough
Preexisting Conditions: Invasive ductal breast CA 12/2005, bilateral, receptor negative; GERD; Hypothyroidism; Rosacea; IBS; Chronic Rhinitis
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
VARZOS: ZOSTER (ZOSTAVAX)MERCK & CO. INC.1412U0SCLA
Administered by: Private     Purchased by: Other
Symptoms: Herpes zoster
SMQs:
Write-up: Pt. received ZOSTAVAX immunization 11/20/07. Pt. diagnosed with shingles 6/4/10.

VAERS ID:299244 (history)  Vaccinated:2007-11-20
Age:67.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:2007-12-10, Days after onset: 20
Location:Foreign  Entered:2007-12-11, 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: Atorvastatin
Current Illness: Penicillin allergy; cholesterol high
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0712USA01536
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.NE26570 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Erythema, Injection site swelling, Joint swelling
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health authority concerning a 67 year old female with penicillin allergy and high cholesterol who on 20-NOV-2007 was vaccinated intramuscularly with a 0.5 ml dose of Pneumovax 23 (Batch #NE26570). Concomitant therapy included atorvastatin. On 20-NOV-2007, on the same day, the patient experienced localized swelling of the deltoid muscle around the injection site, erythema of the upper arm and elbow and a swollen elbow. The patient received treatment with PIRITON. At the time of the report the patient had not recovered. The agency considered injection site swelling, erythema and swelling of elbows to be serious events and an other important medical events. No further information is available. Other business partner numbers included E2007-08881 and 20191010.

VAERS ID:299253 (history)  Vaccinated:2007-11-20
Age:3.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Male  Submitted:2007-12-11, Days after onset: 21
Location:Foreign  Entered:2007-12-11
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: B0498194a
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSA20CA277A IMLA
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSA20CA277A IMLA
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERA20CA277A IMLA
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis, Injection site inflammation, Local reaction
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: This case was reported by a nurse who described a 3-year-old male patient who was vaccinated with Infanrix-IPV+Hib (GlaxoSmithKline) "as part of the catch-up programme as the pre school booster", and experienced a localised reaction at the site of the injection on the left arm. On 20 November 2007 the patient received a "pre school booster" dose of Infanrix (intramuscularly in the left arm). The nurse stated that the injection site was not swabbed before the vaccine was administered "as they do not have a swab policy". Later on the same day, on 20 November 2007, after vaccination with Infanrix, the patient experienced a localized reaction at the site of injection on the left arm. On 22 November 2007, the GP saw the child and reported inflammation, the patient was given chlorphenamine syrup. On 25 November 2007 the patient was taken to accident and emergency and was reported to have post injection cellulitis in the left arm. The patient was given co-amoxiclav antibiotics. On 27 November 2007, the GP reported that "it looked much better, the mother requested more antibiotics". This case was assessed as medically serious by manufacturer. On the 3 December 2007, the infection seemed to have "resolved but not completely." Verbatim Text received: A nurse reported that a patient received Infanrix-IPV+Hib on the 20th of November 07 as recommended by the committee as part of the catch-up programme as the pre school booster. The nurse stated that the injection site was not swabbed before the vaccine was administered as they do not have a swab policy. The same day the patient experienced a localised reaction at the site of the injection on the left arm. On the 22nd of November 07 the GP saw the child and reported inflammation, the patient was given chlorphenamine syrup. On the 25th of November 07 the patient was taken to accident and emergency and was reported to have post injection cellulitis in the left arm. The patient was given co-amoxiclav antibiotics. On the 27th of November 07 the GP reported that it looked much bett

VAERS ID:299395 (history)  Vaccinated:2007-11-20
Age:36.0  Onset:2007-12-01, Days after vaccination: 11
Gender:Male  Submitted:2007-12-03, Days after onset: 2
Location:Foreign  Entered:2007-12-12, Days after submission: 9
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Hyperlipidemia
Diagnostic Lab Data: EKG -$g PR depression; CK-inf(+); Trop-I (+)
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
SMALL: SMALLPOX (DRYVAX)PFIZER/WYETH4020076  UN
Administered by: Military     Purchased by: Military
Symptoms: Blood creatine phosphokinase increased, Electrocardiogram abnormal, Myocarditis, Pericarditis, Troponin I increased
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: 14 days after smallpox vaccination, he developed pericarditis/myocarditis. No clinical heart failure or arrhythmia. Recovered over several days with conservative management.

VAERS ID:303920 (history)  Vaccinated:2007-11-20
Age:44.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Female  Submitted:2008-01-29, Days after onset: 70
Location:Foreign  Entered:2008-01-30, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: blood pressure measurement 20Nov07 90/60; total heartbeat count 20Nov07
CDC Split Type: WAES0801USA05060
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure, Cold sweat, Dizziness, Erythema, Heart rate, Malaise, Sensation of foreign body
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a health professional and health authority concerning a 44 year old female patient who on 20-NOV-2007 was vaccinated with a dose of Pneumovax 23. The Health Authority reported that on 20-NOV-2007 the patient experienced lump feeling in throat, cold sweat, red face, unwell and dizziness. Dizziness and unwell was reported to appear 15 minutes after the vaccination. Pulse rate was regular and blood pressure was 90/60 as tested on 20-NOV-2007. According to the Health Authority the adverse event involved or prolonged inpatient hospitalization. The outcome was recovered. No further information was available. The other business partner numbers included NOMAADVRE-2008-5066 and E2008-00475. The case is closed. Additional information is not expected.

VAERS ID:303931 (history)  Vaccinated:2007-11-20
Age:0.4  Onset:2007-11-20, Days after vaccination: 0
Gender:Male  Submitted:2008-01-28, Days after onset: 69
Location:Foreign  Entered:2008-01-30, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 200800169
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTP: DTP (NO BRAND NAME)UNKNOWN MANUFACTURER20906002A SCUN
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURZ04861 SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Apathy, Crying, Ecchymosis, Gaze palsy, Hypotonia, Hypotonic-hyporesponsive episode, Oedema peripheral, Pallor
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad)
Write-up: Initial report received from health authority in foreign on 16 January 2008 under the authority reference number: PL-URPL-OCR-20071214003. A 4-month-old male patient with no reported medical history had foot edema, edema hands, ecchymoses, hypotonic-hyporesponsive episode, apathy, pallor, hypotonia and upward raise of eyeballs on 20 November 2007 at 13.00 hours, the day he received his subcutaneous IMOVAX POLIO, lot no: Z0486-1, 0.5 ml, and subcutaneous DTP vaccine, 0.5 ml, other MFR, lot no: 20906002A. According to the mother and grandmother of the patient, after DTP injection (arm) the child was crying very much, after some minutes calmed down and then the nurse administered two injections in the thigh. The patient was apathetic, did not cry, later on turned pale, was flaccid, the eyeballs turned up. The distal parts of the limbs got red-livid and oedematous. The child was referred to a hospital. Outcome was not reported.

VAERS ID:304981 (history)  Vaccinated:2007-11-20
Age:49.0  Onset:0000-00-00
Gender:Female  Submitted:2008-02-14
Location:Foreign  Entered:2008-02-14
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: A0709441A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA020A1 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Chills, Delirium, Myalgia, Pyrexia, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a nurse, via a regulatory authority and described the occurrence of delirium in a 49-year-old female subject who was vaccinated with Fluviral, GlaxoSmithKline for prophylaxis. On 20 November 2007, the subject received an unspecified dose of Fluviral (unknown). Six hours after vaccination with Fluviral, the subject experienced rigors, fever, myalgia and tachycardia. At an unspecified time after vaccination with Fluviral, the subject experienced delirium. This case was assessed as medically serious by GSK. At the time of reporting, the events were resolved with sequelae.

VAERS ID:307641 (history)  Vaccinated:2007-11-20
Age:1.0  Onset:2007-11-21, Days after vaccination: 1
Gender:Male  Submitted:2008-03-19, Days after onset: 118
Location:Foreign  Entered:2008-03-21, 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:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0803USA01981
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.NF551500SCUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Insomnia, Irritability, Malaise, Pyrexia, Rhinorrhoea, Upper respiratory tract inflammation
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Information has been received from a health authority concerning a 12 month old male who on 20-NOV-2007 was vaccinated SC with a first dose of MMR II (lot number: / ; batch number: NF55150). Concomitant therapy that day included INFANRIX (batch number: A21CA346A) administered IM. On 21-NOV-2007 the patient presented with a high fever that lasted 6 days, general malaise, irritability, insomnia and rhinorrhea (duration 8-10 days). On 21-NOV-2007 the patient was taken to the ER where he was diagnosed with upper respiratory tract inflammation. After 5 days with high fever, he was evaluated by the general practitioner. The case reported as serious by both HA and the reporter. The reporter considered the causal relation between the event and vaccination as possible. At the time of report the patient''s condition had improved. The final outcome was not reported. The case was closed. The events were considered to be an important medical event. Other business partner numbers included: E2008-02215.

VAERS ID:314535 (history)  Vaccinated:2007-11-20
Age:72.0  Onset:2007-12-01, Days after vaccination: 11
Gender:Male  Submitted:2008-05-30, Days after onset: 180
Location:Foreign  Entered:2008-06-02, Days after submission: 3
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Metabolic disorder; Gastrooesophageal reflux disease; Varicose vein; Arteriovenous malformation
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0805USA04806
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER078501 UNUN
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.0467F UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Laryngeal oedema, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from a health authority concerning a 72 year old male patient with metabolic disorder, reflux disease, arteriovenous malformation of the brain and varicose, who on 20-NOV-2007 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 655055/0467F; batch # NE33150). Concomitant suspect therapy included FLUAD (Lot # 07851). On 01-DEC-2007 the patient experienced life threatening urticaria and edema of glottis. The patient recovered within 3 days. Other business partner numbers include: E200804551 and PEI2008005938. Additional information is not expected. This case is closed.

VAERS ID:350516 (history)  Vaccinated:2007-11-20
Age:60.0  Onset:2007-11-20, Days after vaccination: 0
Gender:Male  Submitted:2009-06-30, Days after onset: 587
Location:Foreign  Entered:2009-06-30
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: A0792865A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLULAVAL)GLAXOSMITHKLINE BIOLOGICALSAFLLA014AA0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Adverse event
SMQs:
Write-up: This case was reported by a nurse via a regulatory authority (V0900711) and described the occurrence of an adverse event in a 60-year-old male subject who was vaccinated with FLUVIRAL (GlaxoSmithKline). On 20 November 2007 the subject received 1st dose of FLUVIRAL (unknown). In November 2007, nine hours after vaccination with FLUVIRAL, the subject experienced adverse event not other wise specified that lasted for five days. The subject was hospitalised for three days. At the time of reporting the event was resolved.

VAERS ID:532762 (history)  Vaccinated:2007-11-20
Age:14.0  Onset:2007-12-23, Days after vaccination: 33
Gender:Female  Submitted:2014-06-03, Days after onset: 2353
Location:Foreign  Entered:2014-06-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Infection; 09/25/2007, GARDASIL, Dose 1, lot-no. reported as NF46470, No adverse event
Diagnostic Lab Data: Albumin globulin ratio, pathologically increased; Blood glucose, 51.3 /uL; Blood lactic acid, 1.38 mmol/l; Blood test, expected reduction of lymphocytes; Borrelia test, negative; Electroencephalogram, normal; Electromyogram, slow down of nerve conduction velocity of left arm; Electromyogram, SEP unremarkable; 03/25/2008, Laboratory test, normal; Neurological examination, discreet left sided pupillary defect; Nuclear magnetic resonance imaging, no changes of head to preliminary findings; Nuclear magnetic resonance imaging, new hyperintense lesions in cervical spine (C2/C3); Nuclear magnetic resonance imaging, multiple cerebral hyperintensities; 01/20/2014, Nuclear magnetic resonance imaging, new lesions compared to May-2013; Protein total, 5
CDC Split Type: WAES1405DEU015295
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.1536F1IMLA
Administered by: Other     Purchased by: Other
Symptoms: Albumin globulin ratio increased, Blood glucose decreased, Blood lactic acid normal, Borrelia test negative, Bronchitis, CSF protein increased, CSF white blood cell count increased, Diplopia, Electroencephalogram normal, Electromyogram abnormal, Gait disturbance, Guillain-Barre syndrome, Headache, Hypoaesthesia, Laboratory test normal, Local reaction, Lymphocyte count decreased, Multiple sclerosis, Neurological examination abnormal, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal, Optic neuritis, Paraesthesia, Pupillary disorder, Somatosensory evoked potentials, Tandem gait test abnormal, Visual evoked potentials abnormal, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Ocular infections (broad), Ocular motility disorders (broad), Proteinuria (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow)
Write-up: Information has been received from Sanofi Pasteur MSD (manufacturer control # E2014-04705) on 28-MAY-2014. Case was received from the Health Authorities on 27-May-2014 (reference no. PEI2014036678). Case is medically confirmed. A 14-year-old female patient with a medical history of recurrent infections received the second dose of GARDASIL (lot-no. NG01520) IM into the left upper arm on 20-Nov-2007. On 21-Nov-2007 the patient developed headache and mild local reaction which resolved on 22-Nov-2007. On 23-Dec-2007 she developed numbness and tingling paraesthesia of the feet and was hospitalised (exact dates not reported, hospital report not available). Diagnostics at that time were inconspicuous, the symptoms resolved spontaneously. Diagnosis of Guillain-Barre syndrome was established. On 21-Mar-2008, the patient developed paraesthesia of the left part of the body and double vision. She was hospitalised from 25-Mar-2008 to 01-Apr-2008. On admission, double vision was still evident and tandem-gait test was unstable. Laboratory blood tests were normal. Borrelia test was negative. Lumbar puncture revealed leukocytes 24 /ul, erythrocytes 0 /ul, glucose 51.3 mg/dl, lactate 1.38 mmol/l and proteins 57.33 mg/dl. Albumin ration was pathologically increased. A mild disturbance of barrier function was detected. Intrathecal immunoglobulin G production was suspected. Intrathecal immunoglobulin M production was proven. Borrelia was negative. EEG was normal. MEP revealed mild deceleration of central motor nerve conduction velocity of the left arm. SEP was unremarkable. VEP showed left sided delay consistent with neuritis of N. optici. Cerebral MRI revealed multiple hyperintensities. Further hyperintensity was found in the pons shank. Spine myelon was unaffected. Diagnosis of multiple sclerosis was established. The patient received URBASON impulse therapy leading to complete regression of symptoms. The patient again was hospitalised from 05-May-2008 till 11-May-2008. The patient was diagnosed with a second episode of multiple sclerosis. Since 02-May-2008, the patient had suffered from bronchitis. Since 03-May-2008, the patient had developed paraesthesia of feet and legs extending to lower trunk as well as tingling of fingertips. On admission, sensitivity of legs and feet was decreased. Tandem-gait test was slightly unstable. A "sensitive paraplegia" as diagnosed. Laboratory blood tests were normal. Cerebral MRI revealed no changes compared to prior findings. MRI of spine showed new hyperintense lesions in the region of C2/C3. The patient received IV URBASON impulse therapy for 5 days. Symptoms significantly improved. Bronchitis was resolving. The patient was discharged in a good condition. The patient presented to the outpatient clinic on 05-Jun-2013. At that time she was free of complaints. Meanwhile the patient had been treated with BETAFERON from Apr-2008 to Oct-2010. Treatment had been stopped due to further MS flare (retrobulbar neuritis in Oct-2010). The patient also had been treated with TYSABRI. Last infusion was given on 24-Apr-2013. Anti-JC-virus antibody seroconversion was detected in Apr-2013. Neurological examination only revealed discrete left sided pupillary defect. Cranial and spinal MRI results were unchanged. MRI of the head on 20-Jan-2014, compared with imaging of May-2013, showed new lesions. Treatment with TYSABRI was initiated. In Dec-2013, the patient''s treatment had been switched to GILENYA. Blood examination showed expected reduction of lymphocytes, other tests were unremarkable. Previous dose of GARDASIL (D1, lot-no. reported as NF46470) was given IM into the left arm on 25-Sep-2007, well tolerated.

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