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Case Details (Sorted by Age)

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VAERS ID: 509458 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Arizona  
Vaccinated:2011-08-09
Onset:2011-08-14
   Days after vaccination:5
Submitted: 2013-10-24
   Days after onset:802
Entered: 2013-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC002AA / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U3540AA / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 1563Z / 1 LA / SC

Administered by: Other       Purchased by: Public
Symptoms: Asthenia, Hypoaesthesia, Speech disorder, VIIth nerve paralysis
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

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

Write-up: Patient presented to ED with numb and paralyzed right side of the face. Little hard to talk. Focal weakness during neuroreview of systems. Patient has a history of Bell''s Palsy with the previous incident on 09/04/2010.


VAERS ID: 510015 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Indiana  
Vaccinated:2010-10-07
Onset:2011-06-26
   Days after vaccination:262
Submitted: 2013-10-28
   Days after onset:855
Entered: 2013-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0331Z / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Caesarean section, Dyspnoea, Exposure during pregnancy, Feeding disorder neonatal, Foetal heart rate deceleration, Human chorionic gonadotropin positive, Laryngomalacia, Ultrasound antenatal screen normal
SMQs:, Anaphylactic reaction (broad), Congenital and neonatal arrhythmias (broad), Congenital, familial and genetic disorders (narrow), Tumour markers (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOESTRIN 24 FE
Current Illness: Oral contraception; Codeine, Drug hypersensitivity
Preexisting Conditions: Codeine, Drug hypersensitivity
Allergies:
Diagnostic Lab Data: Beta-human chorionic gonadotropin test (unspecified) on 01-NOV-2010 showed positive; 11/16/2010, Ultrasound scan, Viable pregnancy, EDD: 27-JUN-2011
CDC Split Type: WAES1011USA03446

Write-up: Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female patient, with codeine allergy, who on 14-JUN-2010 was vaccinated with the first dose of GARDASIL (Lot # and expire date not reported), 0.5 ml, intramuscularly. On 07-OCT-2010 the patient was vaccinated with the second dose of GARDASIL (Lot # 666929/0331Z and expire date 20-NOV-2012), 0.5 ml, intramuscularly. Concomitant therapy included unspecified birth control pills hormonal. The patient became pregnant "sometime around 01-NOV-2010" and on 01-NOV-2010 a pregnancy test was given to the patient in the office. The patient''s last menstrual period was on 20-SEP-2010 and the estimated delivery date is on 27-JUN-2011. Follow up information has been received from the registered nurse concerning the female patient with no previous pregnancies. The estimated conception date was 04-OCT-2010. It was reported that other medications used during this pregnancy included LOESTRIN 24 FE, daily for oral contraception and was discontinued on 01-NOV-2010. On 16-NOV-2010 an ultrasound was performed and the result showed a viable pregnancy and a EDD (reported as EDC): 27-JUN-2011. Follow up information has been received via telephone call from a registered nurse who reported that the patient delivered a full term infant "with no problems" on 26-JUN-2011. She confirmed that the baby had no congenital anomalies. Also, it was reported that the patient had a C-section because the baby "just did not want to come out" and that it was "nothing related to GARDASIL". At the time of the report, the patient recovered from the C-section. Follow up information has been received from a pediatric medical center. They stated that the mother was not one of their patients. They saw the child but not the mother. Upon internal review, C-section was determined to be an other important medical event. Follow up information has been received. The patient agree to participate in the Pregnancy Registry for GARDASIL. Pediatric medical records were received and reviewed; no adverse experiences related to the prenatal exposure or to other Merck Products. The following experience was identified: on 26-JUN-2011, at a gestational age of 39.6 weeks the baby male was born via C-section for fetal decelerations with a weight of 4.040 kg, length of 52.07 cm, OFC of 34.93 cm, APGAR 1 minute was 7 and 5 minutes was 9. The baby was given aqueous vitamin K 1mg, erythromycin 0.5% in each eye and dose 1 of HepB (manufacturer unknown) vaccine 0.5 ml was given. The baby''s oxygen saturation was 100/98; SBP/DBP/MEAN was 69/41/52. The baby was hospitalized for 3 days following birth because he had initial difficulty breathing and feeding. On 27-JUN-2011, the baby underwent a circumcision procedure. Baby''s initial exam was normal except for irregular heart beat. Subsequently, he had a normal heartbeat and a normal ECHO. On 28-JUN-2011, discharge exam was normal. On 01-AUG-2011, a month exam was performed. The patient experienced laryngomalacia. The patient was referred to speech therapy for possible aspiration. Preventive medicine was discussed with his parents. The patient''s vital signs, review of systems and general examination were normal. On 29-AUG-2011, the patient was vaccinated with dose 2 of HepB (manufacturer unknown) in the left thigh, dose 1 of PENTACEL in the right thigh, dose 1 of PREVNAR 13 in the left thigh and dose 1 of ROTATEQ. On 02-SEP-2011, the patient was admitted to hospital for feeding intolerance. Video-feeding study was performed which showed aspiration with thin and semi-thickened liquids. The patient was hospitalized for training of NG feeds due to failed video feeding. On 03-SEP-2011, the patient was discharged from hospital with a normal discharge physical examination and was prescribed simethicone 20 mg p.o and a diet with SIMILAC. The patient''s discharge weight was 6.04 kg. On 20-OCT-2011, the patient had a doctor visit. The patient''s development was normal. Review of systems was normal excepted for a stuffy nose at night and diarrhea and constipation that they treated with diet. The patient''s weight was 8.3 kg, height was 65.3 cm and OFC was 42.5 cm. The patient was not given any medication. Family history: mom''s sister and brother have ADD. The patient''s mom and dad had seasonal allergies and had allergy shots as children. There was adult onset diabetes and heart disease on grandmother''s side of the mother, hypertension in maternal grandmother and learning disabilities, ADD, ADHD. Maternal grandmother was bipolar and mom''s brother was bipolar. There were thyroid problems with maternal grandmother and pseudoseizures with bipolar in maternal grandmother. On 25-OCT-2011, the patient was vaccinated with dose 2 of PENTACEL in the right thigh, dose 2 of PREVNAR 13 in the left thigh, and dose 2 of ROTATEQ. On 28-NOV-2011, the patient had an appointment for weight check. The patient''s review of systems, vital signs and physical examination were normal. The patient was feeding well now that the NG tube was out. On 27-DEC-2011, the patient was vaccinated with dose 3 of HepB (manufacturer unknown) in the right thigh, a dose of FLUZONE in the left thigh, dose 3 of PENTACEL in the left thigh, dose 3 of PREVNAR 13 in the right thigh and dose 2 of ROTATEQ. On 02-JUL-2012, the patient was vaccinated with dose 1 of HepA (unspecified) in the right thigh, dose 1 of M-M-R II in the left thigh and dose 1 of VARIVAX (Merck) (manufacturer unknown). On 02-OCT-2012, the patient was vaccinated with dose 4 of DTP in the right thigh, dose 4 of Hib in the left thigh, dose 4 of PREVNAR 13 in the left thigh and a dose of FLUZONE in the right thigh. On 07-JAN-2013, the patient was vaccinated with dose 2 of HepA (unspecified) in the left thigh. On 10-JAN-2013, the patient experienced speech delay. The patient''s physical status was healthy. On 06-FEB-2013, the patient''s fine motor score was 12, gross motor score was 15, adaptive score was 6, cognitive score was 17, social communication score was 4 and social score was 4. According to the AEPs, the patient showed -2SD delay in adaptive, social communication and social skills. The patient was placed on strategies. On 01-JUL-2013, the patient went to a 24 month exam. The patient''s review of systems, vital signs and physical examination were normal. All available medical records will be provided upon request. Additional information is not expected.


VAERS ID: 510153 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Iowa  
Vaccinated:2013-10-22
Onset:2013-10-23
   Days after vaccination:1
Submitted: 2013-10-24
   Days after onset:1
Entered: 2013-10-29
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH906AE / 2 LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Erythema, Induration, Oedema, Skin warm, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Got injection on 10/22/13. No problems for 24 hours. Then red, swollen, firm, and hot area 3 inches x 2 inches. Ice applied which seemed to lessen the area redness and edema.


VAERS ID: 510256 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: New York  
Vaccinated:2013-10-10
Onset:2013-10-15
   Days after vaccination:5
Submitted: 2013-10-29
   Days after onset:14
Entered: 2013-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J009243 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Oropharyngeal pain, Pharyngeal erythema, Pharyngeal oedema, Tonsillitis
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Angioedema (narrow), Oropharyngeal infections (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310USA009356

Write-up: This spontaneous report as received from a nurse refers to a 17 year old female patient with no pertinent medical history. On 10-OCT-2013, the patient was vaccinated with GARDASIL (lot #J009243, exp. date: 23-APR-2016) second dose, 0.5 ml, intramuscular. There was no concomitant medication. On 15-OCT-2013, about 5 days after onset of therapy, the patient experienced tonsillitis like symptoms with sore throat, redness and swelling of throat. The patient sought for medical attention (office visit). No lab diagnostics studies performed. Treatment was given for the events (unspecified antibiotic in case symptoms persisted). The outcome of the events was not reported. This is one of several cases received from the same source. Additional information has been requested.


VAERS ID: 510270 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Texas  
Vaccinated:2012-07-09
Onset:0000-00-00
Submitted: 2013-10-29
Entered: 2013-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, Laboratory test normal, No adverse event
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamins (unspecified)
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Routine prenatal lab work (unknown date) no results provided; Standard DB tests (2013), all of which were with normal limits (WNL)
CDC Split Type: WAES1211USA003156

Write-up: Information has been received from a Nurse Practitioner, for varicella virus vaccine live, a Pregnancy Registry product concerning a female patient of unknown age with none of pertinent medical history and none of drug reactions/allergies. The patient''s history of previous pregnancies and live birth was not known. On 09-JUL-2012 the patient was vaccinated with VARIVAX (Merck) (dose and lot # were not provided) while pregnant (the gestation was 20 weeks). Concomitant therapies included vitamins (unspecified) (prenatal vitamins). The LMP was 19-JUN-2012 and EDD was 26-MAR-2013 (also reported as "20-MAR-2013"). The patient was exposed to VARIVAX (Merck) during trimester 2. No adverse effect reported. Routine ultrasound test on 01-NOV-2012 and Route prenatal labs were performed which result not provided. The patient saw the Nurse Practitioner to seek medical attention. Follow up information was received from a Pediatrician. On 16-MAR-13 at 39 weeks gestation, the patient delivered a normal male infant (weight: 15 oz. The pregnancy outcome was live birth-full-term. Standard DB tests were performed which showed all of which were with normal limits (WNL). Additional information is not expected.


VAERS ID: 510284 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: New York  
Vaccinated:2013-10-10
Onset:2013-10-15
   Days after vaccination:5
Submitted: 2013-10-29
   Days after onset:14
Entered: 2013-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J009243 / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Oropharyngeal pain, Pharyngeal erythema, Pharyngeal oedema, Tonsillitis
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Angioedema (narrow), Oropharyngeal infections (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Drug hypersensitivity
Preexisting Conditions: Amoxicillin, Drug hypersensitivity
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310USA008531

Write-up: This spontaneous report as received from a nurse refers to a 17 year old female patient with allergy to Amoxicillin. On 10-OCT-2013, the patient was vaccinated with GARDASIL (lot # J009243, exp. date: 23-APR-2016) second dose, 0.5 ml, intramuscular. There was no concomitant medication. On 15-OCT-2013, about 5 days after onset of therapy, the patient experienced tonsillitis like symptoms with sore throat, redness and swelling of throat. The patient sought for medical attention (office visit). No lab diagnostics studies performed. Treatment was given for the events (unspecified antibiotic in case symptoms persisted). The outcome of the events was not reported. This is one of several cases received from the same source. Additional information has been requested.


VAERS ID: 510415 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Maine  
Vaccinated:2013-10-28
Onset:2013-10-28
   Days after vaccination:0
Submitted: 2013-10-30
   Days after onset:2
Entered: 2013-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BJ2014 / UNK NS / IN

Administered by: Public       Purchased by: Public
Symptoms: Blood glucose increased, Contraindication to vaccination
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Medication errors (broad)

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

Write-up: Pt. visit school nurses office with elevated blood sugars. It was then discovered pt. had type 1 diabetes and received the Flumist. Vaccinator was not informed of diagnosis.


VAERS ID: 510533 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:2013-10-22
Onset:0000-00-00
Submitted: 2013-10-30
Entered: 2013-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. H012250 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310USA011256

Write-up: This spontaneous report as received from a registered nurse refers to a 17 year old patient of unknown gender. Medical history and drug allergies were not reported. On 22-OCT-2013, the patient was vaccinated with RECOMBIVAX HB lot # H012250, expiration date 06-FEB-2015 (concentration, dose and indication were not reported) that was exposed to three low temperature excursions of 28F for 24 hours, 31F for 24 hours and 30F for 96 hours. No adverse effect has been observed or reported. This is one of several reports from the same source. Additional information is not expected.


VAERS ID: 510537 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:2013-10-22
Onset:0000-00-00
Submitted: 2013-10-30
Entered: 2013-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. H012250 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310USA014406

Write-up: This spontaneous report as received from a registered nurse refers to a 17 year old patient of unknown gender. Medical history and drug allergies were not reported. On 22-OCT-2013, the patient was vaccinated with RECOMBIVAX HB lot # H012250, expiration date 06-FEB-2015 (concentration, dose and indication were not reported) that was exposed to three low temperature excursions of 28F for 24 hours, 31F for 24 hours and 30F for 96 hours. No adverse effect has been observed or reported. This is one of severeal reports from the same source. Additional information is not expected.


VAERS ID: 510504 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2013-06-11
Onset:2013-08-01
   Days after vaccination:51
Submitted: 2013-10-30
   Days after onset:90
Entered: 2013-10-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4588AD / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Muscular weakness, Neuromyelitis optica, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Optic nerve disorders (narrow), Demyelination (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 29 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Well visit; Psoriasis
Preexisting Conditions: Psoriasis
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had MENACTRA on 6/11/13. Developed complaints of leg and arm weakness, tingling first week of August 2013. Diagnosed with neuromyelitis optica in mid August, between 8/16 and 8/20/13.


VAERS ID: 510724 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-01-01
Onset:2013-03-01
   Days after vaccination:59
Submitted: 2013-10-31
   Days after onset:243
Entered: 2013-10-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Alopecia, Autoimmune thyroiditis, Blood test, Decreased appetite, Pain in extremity, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Drug hypersensitivity
Preexisting Conditions: Penicillin, drug hypersensitivity
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310USA007735

Write-up: This spontaneous report has been received from a mother who was referring to her daughter. The patient was an approximately 17 years old, not pregnant female with unspecified allergic reaction to penicillin, which started on unspecified date in the past, and with no pertinent medical history. In January 2013, reported as sometime in 2013, the patient was vaccinated with GARDASIL (lot not reported #) first dose, intramuscular (dose, strength not reported). There were no concomitant therapies. It was reported that after the daughter was administered the vaccine she was diagnosed with Hashimoto''s thyroiditis, she experienced soreness of the arm, lost twenty pounds and she was losing her hair and appetite, adverse events onset date was reported as March 2013. It was reported that the patient was being monitored and she had blood drawn every sixty to ninety days (no results provided). The patient sought medical attention by office visit on unspecified dates. The patient did not recover from the adverse events. The relatedness between the adverse event and GARDASIL was not assess by the reporter. Additional information has been requested.


VAERS ID: 510915 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: New Hampshire  
Vaccinated:2013-11-01
Onset:2013-11-01
   Days after vaccination:0
Submitted: 2013-11-01
   Days after onset:0
Entered: 2013-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS J2B32 / 1 LA / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 4735D / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J003727 / 1 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLARITIN D; RITALIN
Current Illness: None
Preexisting Conditions: ADD; Asthma; Allergic rhinitis; Gluten intolerance; Lactose intolerance
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: None stated.


VAERS ID: 511129 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2013-09-23
Onset:2013-09-26
   Days after vaccination:3
Submitted: 2013-10-18
   Days after onset:22
Entered: 2013-11-04
   Days after submission:17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4445AB / 2 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DEPAKOTE
Current Illness: None
Preexisting Conditions: Seizures; Allergic to sulfa drugs
Allergies:
Diagnostic Lab Data:
CDC Split Type: TN13010

Write-up: Vaccine given 9/23/13, pt started having a rash on 9/26/13 and was sent to PCP. Rash and whelps were over large areas of body, esp trunk, arms, and legs. PCP determined it was reaction to vaccine.


VAERS ID: 511227 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2013-11-04
Onset:2013-11-04
   Days after vaccination:0
Submitted: 2013-11-04
   Days after onset:0
Entered: 2013-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH910AC / UNK LA / IM

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

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

Write-up: She fainted while receiving the vaccine.


VAERS ID: 511508 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Virginia  
Vaccinated:2009-12-09
Onset:2010-01-19
   Days after vaccination:41
Submitted: 2013-11-05
   Days after onset:1386
Entered: 2013-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) / MEDIMMUNE VACCINES, INC. 500824P / UNK NS / IN

Administered by: Public       Purchased by: Private
Symptoms: Intensive care, Pericardial drainage, Pericardial effusion, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: Doxycycline
Current Illness: No
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Patient has chronic pericarditis and is still on medicine to treat the illness
CDC Split Type:

Write-up: Large pericardial effusion who had to be admitted to the ICU and a pericardiocentethesis was performed.


VAERS ID: 511512 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Maine  
Vaccinated:2013-10-22
Onset:2013-10-22
   Days after vaccination:0
Submitted: 2013-10-31
   Days after onset:9
Entered: 2013-11-05
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH926AA / 2 LA / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 55RX2 / 2 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J002641 / 3 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Convulsion, Fall, Gaze palsy, Pallor
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

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

Write-up: Pt was given 3 vaccines, pt turned pale, pt set in chair had fell back, eyes rolled back into head and looked like having seizure. Went and got Dr to evaluate and within 2 minutes pt was alert and was made to lay down for 20 minutes and given water. Dr re-evaluated and pt was released.


VAERS ID: 511657 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Indiana  
Vaccinated:2013-10-07
Onset:2013-10-08
   Days after vaccination:1
Submitted: 2013-11-06
   Days after onset:29
Entered: 2013-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH894AB / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood test abnormal, Colitis ulcerative, Colonoscopy abnormal, Diarrhoea, Fatigue, Haematochezia, Muscle spasms, Night sweats, Pyrexia, Stool analysis abnormal, White blood cell count increased, X-ray gastrointestinal tract normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Allergies: sulfa, bees, wasp
Allergies:
Diagnostic Lab Data: Blood work showed inflammation, elevated white blood cell and anemia. Stool sample showed blood (from both Pediatrician and Gastroenterologist). Colonoscopy showed inflammation of entire colon.
CDC Split Type:

Write-up: Patient exhibited fatigue, diarrhea, cramps, fever, blood in stool, night sweats. Patient met with Pediatrician on 10/21/2013. Blood and stool samples taken. Pediatrician recommended patient see a Gastroenterologist. Patient met with Gastroenterologist on 10/25/2013. Blood and stool samples taken. Physician felt patient showed signs of Ulceration Colitis. Patient received colonoscopy and upper GI on 10/30/2013. Colonoscopy showed inflammation of the entire colon. Upper GI was normal. Patient was diagnosed with ulcerative colitis. Patient given Prednisone and Balsalazidr disodium. Symptoms finally started improving on 11/1/2013. As of today, 11/6/2013, patient still has diarrhea. Symptoms continued for almost a month.


VAERS ID: 511893 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Montana  
Vaccinated:2013-11-06
Onset:2013-11-07
   Days after vaccination:1
Submitted: 2013-11-07
   Days after onset:0
Entered: 2013-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH899AC / UNK LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Headache
SMQs:

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

Write-up: Severe sudden onset of HA 4-5 on 1-10 scale.


VAERS ID: 511942 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Missouri  
Vaccinated:2013-10-21
Onset:2013-10-21
   Days after vaccination:0
Submitted: 2013-11-07
   Days after onset:17
Entered: 2013-11-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH921AA / 2 RA / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. J000366 / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J003727 / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4556AA / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4512AA / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J005416 / 2 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Dizziness, Drooling, Gaze palsy, Pallor, Posture abnormal, Snoring, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: PT RECEIVED HPV#1 LAST AND THEN BECAME VERY PALE AND STATED HE FELT LIGHT HEADED. PT THEN FAINTED WHILE SITTING IN THE CHAIR AND HIS HEAD FELL FORWARD. PT WAS STABILIZED BY 2 NURSES AND WHEN HIS HEAD WAS LIFTED UP HIS EYES WERE ROLLED BACK IN HIS HEAD, HE WAS DROOLING AND MAKING "SNORING" SOUNDS AND THEN STARTED SHAKING.


VAERS ID: 512078 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Georgia  
Vaccinated:2013-10-30
Onset:2013-10-31
   Days after vaccination:1
Submitted: 2013-11-04
   Days after onset:4
Entered: 2013-11-08
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BJ2009 / 1 NS / IN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4556AB / 2 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Electroencephalogram, Muscle twitching, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cetirizine; FLONASE; Doxycycline; Tretinoin gel; Benzoyl peroxide
Current Illness: None
Preexisting Conditions: Allergic rhinitis
Allergies:
Diagnostic Lab Data: EEG ordered result pending
CDC Split Type:

Write-up: 10/31/13 4 AM - shaking, twitching arms, legs $g 1 hour, EMS came, advised to see MD.


VAERS ID: 512210 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: West Virginia  
Vaccinated:2013-07-07
Onset:0000-00-00
Submitted: 2013-11-11
Entered: 2013-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / -
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Public       Purchased by: Unknown
Symptoms: Alopecia, Anaemia, Anxiety, Back pain, Depression, Fatigue, Fungal infection, Headache, Hyperhidrosis, Insomnia, Irritable bowel syndrome, Lymphadenopathy, Oropharyngeal pain, Palpitations
SMQs:, Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Anemia, IBD, anxiety attacks, depression, back pain, hair loss, insomnia, racing heart, sore throat, sweats, fatigue, swollen nodes, yeast infection in breasts, headaches.


VAERS ID: 512391 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Michigan  
Vaccinated:2013-10-02
Onset:2013-10-02
   Days after vaccination:0
Submitted: 2013-11-11
   Days after onset:40
Entered: 2013-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J007354 / 2 LA / UN

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

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

Write-up: HPV # 2 - pt had at 8:30/AM - went to school - at 11 AM c/o being lightheaded and nausea. Mother states "had similar reaction" with HPV #1, but did not report. Increased fluids - pt had no further problems.


VAERS ID: 512402 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Arizona  
Vaccinated:2013-11-05
Onset:2013-11-05
   Days after vaccination:0
Submitted: 2013-11-06
   Days after onset:1
Entered: 2013-11-11
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1309701 / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Concussion, Head injury, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Patient passed out/fainted, after shot and walking hit his head. Patient was taken to ER via ambulance and had a concussion. Pt was doing okay the next day.


VAERS ID: 512453 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Nebraska  
Vaccinated:2013-10-25
Onset:2013-10-27
   Days after vaccination:2
Submitted: 2013-11-04
   Days after onset:8
Entered: 2013-11-12
   Days after submission:8
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH898AB / UNK UN / IM

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

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

Write-up: Vaccine received on Friday 10/25/12 over noon hr. Itching began Sunday evening 10/27/13 and by Monday morning rash/hives appeared. Patient was seen by PCP and was told to take benadryl.


VAERS ID: 512482 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Louisiana  
Vaccinated:2013-07-29
Onset:2013-07-29
   Days after vaccination:0
Submitted: 2013-11-11
   Days after onset:105
Entered: 2013-11-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311USA003400

Write-up: This spontaneous report as received from a physician via representative refers to a 17 year old male patient. On 07-AUG-2012 the patient was vaccinated with his first dose of GARDASIL (injection, strength, lot#, dose and route were unspecified). On 29-JUL-2013 the patient was vaccinated with his second dose of GARDASIL (injection, strength, lot#, dose and route were unspecified). Physician reported that patient received his third dose of GARDASIL (injection, strength, lot#, dose and route were unspecified) "too early", on 08-OCT-2013. HCP planned to give the fourth dose of GARDASIL per CDC protocol. This fourth dose has not occurred yet. Patient had not had any side effects from receiving a third dose early. Patient did not seek medical attention as this was paperwork identified event. No lab diagnostics studies were performed and not treatment was given for the event. Therapy was continued and outcome was unknown. Additional information has been requested.


VAERS ID: 512724 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Maryland  
Vaccinated:2013-10-08
Onset:2013-10-15
   Days after vaccination:7
Submitted: 2013-11-12
   Days after onset:28
Entered: 2013-11-13
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH891AA / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006236 / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood thyroid stimulating hormone normal, Borrelia test negative, Diplopia, Full blood count normal, Headache, Intraocular pressure increased, Lumbar puncture normal, Metabolic function test normal, Musculoskeletal stiffness, Nuclear magnetic resonance imaging normal
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Glaucoma (narrow), Ocular motility disorders (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Lyme (-); LP (-); MRI (-); CBC CMP TSH (-)
CDC Split Type:

Write-up: Had GARDASIL and flu shot 10/8/13 came home school headache stiff neck on 10/15/13 -$g ER seen 10/18/13 in office stiff neck - given muscle relaxer 10/21/13 follow up with double vision - sent to neuro ophthal increase pressure ocular -$g MD - LPC-7 lab MRI (-) D/C home now fine.


VAERS ID: 512847 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-13
Entered: 2013-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Winged scapula
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310USA009382

Write-up: This spontaneous report has been received from a patient''s father concerning to a 17 year old female patient. Current conditions, medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL, first dose, (dose, lot# and route not reported). Concomitant medication was not reported. On an unknown date, reported as after first GARDASIL dose, the patient experienced a scapular winging. The reporter stated that the patient was going to physical therapy. The outcome of a scapular winging was unknown. Additional information has been requested.


VAERS ID: 513123 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: California  
Vaccinated:2013-11-10
Onset:2013-11-10
   Days after vaccination:0
Submitted: 2013-11-14
   Days after onset:4
Entered: 2013-11-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH898AB / UNK LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Approximately 2 minutes after administration, the patient fainted in our store twice, but immediately recovered consciousness both times. His parents were with him. We offered paramedics but they refused. We gave him water and let him sit for 15 minutes. Afterward, the patient felt better and they left our store.


VAERS ID: 513233 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Illinois  
Vaccinated:2011-05-19
Onset:0000-00-00
Submitted: 2013-11-15
Entered: 2013-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Maternal exposure before pregnancy, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Pregnancy test: Positive
CDC Split Type: WAES1106USA02501

Write-up: Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 17 year old female pregnant patient with no pertinent medical history and no drug reactions or allergies, who on 31-AUG-2010 was vaccinated with the first 0.5 ml dose of GARDASIL intramuscularly (lot number not reported). Then on 09-NOV-2010 and 19-MAY-2011 she received her second and third 0.5 ml doses (lot numbers not reported), respectively. There was no concomitant medication. It was stated that on 13-JUN-2011, the patient reported that she was pregnant. A monoclonal pregnancy test was performed on an unspecified date. Follow-up information has been received for GARDASIL, a Pregnancy Registry product, in which the estimated due date was reported as approximately March 2012. Last menstrual period (LMP) was approximated to an unknown date in 2011. Additional information has been requested.


VAERS ID: 513369 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: California  
Vaccinated:2013-11-06
Onset:2013-11-09
   Days after vaccination:3
Submitted: 2013-11-15
   Days after onset:6
Entered: 2013-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Public
Symptoms: Abnormal sensation in eye, Cough, Decreased appetite, Eye pain, Headache, Malaise, Myalgia, Nausea, Ocular hyperaemia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: No
Preexisting Conditions: Asthma (mild, never has had an ''attack'' but tends to wheeze with upper respiratory infections, no meds needed in last 3 years); seasonal allergies; Hereditary Multiple Exostoses (HME) (Benign bone tumors)
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Very red sore eyes without discharge x 6 days, pressure in eyes, headache, fever 101F, cough, muscle aches, malaise, loss of appetite, nausea.


VAERS ID: 513482 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-10-15
Onset:2013-10-15
   Days after vaccination:0
Submitted: 2013-11-17
   Days after onset:33
Entered: 2013-11-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J002641 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: On 15-OCT-2013, urine pregnancy test which was negative; On 29-OCT-2013, urine pregnancy test positive
CDC Split Type: WAES1311USA002317

Write-up: This spontaneous prospective pregnancy report as received from a Healthcare Worker refers to a 17 year old female patient. On 15-OCT-2013 the patient received a urine pregnancy test which was negative for pregnancy. After the test, the patient received vaccinated with GARDASIL (lot # J002641, intramuscular, exp 10-DEC-2013) that day. There was none concomitant medication and none medical history. The patient had none drug reactions. On an unspecified date "about 2 weeks later", the patient had another urine pregnancy test which was positive for pregnancy. The EDD was 18-JUN-2014. Initial exposure to GARDASIL was at 5 week(s). The pregnancy outcome was outcome pending. The patient went to see the nurse practitioner. No known adverse effects. Additional information has been requested.


VAERS ID: 513640 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: California  
Vaccinated:2013-11-11
Onset:2013-11-11
   Days after vaccination:0
Submitted: 2013-11-18
   Days after onset:7
Entered: 2013-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH899AB / 1 RA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J003727 / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U446AC / 2 LA / IM

Administered by: Other       Purchased by: Public
Symptoms: Blood pressure decreased, Feeling cold, Hyperhidrosis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: Patient had fainting spell turning cold and sweating with B/P 60/40. Patient had been putting on sitting position and then staff lied him down on the treatment bed. After 15 min., patient felt better without any medication.


VAERS ID: 513735 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Unknown  
Location: New Jersey  
Vaccinated:2012-05-08
Onset:0000-00-00
Submitted: 2013-11-19
Entered: 2013-11-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311USA007736

Write-up: This spontaneous report as received from an office manager refers to an 18 year old patient (gender not specified). No information regarding the patient medical history was provided. On 06-MAR-2012 the patient was vaccinated with GARDASIL injection dose 1. Route not specified. On 08-MAY-2012 the patient received the second dose and on 18-NOV-2013 the patient was in the office to receive the third dose. No concomitant medication was reported. No adverse effect was reported. Additional information has been requested.


VAERS ID: 514070 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Texas  
Vaccinated:2013-01-21
Onset:2013-01-21
   Days after vaccination:0
Submitted: 2013-01-21
   Days after onset:0
Entered: 2013-11-20
   Days after submission:303
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 07449211A / 1 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Dizziness, Gaze palsy, Immediate post-injection reaction, Pallor, Seizure like phenomena
SMQs:, Anticholinergic syndrome (broad), Convulsions (narrow), Vestibular disorders (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

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

Write-up: Immediately after giving the injection the patient said he felt like he was going to pass out. His head went back and his eyes rolled up in his head and it looked like he was having a seizure. It lasted for a few seconds and he looked pale. He put his head between his legs til he felt better. I called 911.


VAERS ID: 514134 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-11-11
Onset:2013-11-11
   Days after vaccination:0
Submitted: 2013-11-20
   Days after onset:9
Entered: 2013-11-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Immediate post-injection reaction, Syncope, Tinnitus, Tonic clonic movements
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Cardiomyopathy (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311USA006122

Write-up: This spontaneous report as received from healthcare student refers to a 17 year old female patient. On 11-NOV-2013, the patient was vaccinated with a first dose of GARDASIL (lot # and expiration date not reported), 0.5 ml, subcutaneous. There was no concomitant medication, pertinent medical history, drug reactions or allergies. On 11-NOV-2013, immediately after administering GARDASIL, the patient began to have ringing in her ears and then experienced tonic clonic jerking and syncope. She was assisted to lie down and her head was lowered. These adverse events were occurred when she was at physician''s office. The patient recovered immediately and was able to walk out of the physician''s office on her own. No treatment was given for adverse event. None lab diagnostics studies were performed. Upon internal review, tonic clonic jerking was considered as medically significant. Additional information has been requested.


VAERS ID: 514412 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Texas  
Vaccinated:2013-11-19
Onset:2013-11-20
   Days after vaccination:1
Submitted: 2013-11-22
   Days after onset:2
Entered: 2013-11-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 37R99 / 1 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4648AA / 1 RA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J004161 / 2 UN / SC

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

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

Write-up: Swelling, redness, itching (L) SQ - day after varicella injection. Patient took BENADRYL OTC 1 cap. Wed night. Today Fri 11-22-2013 pt has a half dollar size reaction with slight itching. PA told patient till take BENADRYL for reaction.


VAERS ID: 514649 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Arizona  
Vaccinated:2013-11-25
Onset:2013-11-25
   Days after vaccination:0
Submitted: 2013-11-25
   Days after onset:0
Entered: 2013-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J008423 / 1 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4556AB / 2 RA / UN

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

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

Write-up: Patient was given GARDASIL on left - arm, subsequently, given MCV4 on right arm. Patient was fine. I stepped out and 10 seconds later Mom yelled patient had fainted. He quickly recovered. Dr immediately evaluated, was given ice pack and watched over a period of 15 mins. Orthostatics were taken and was discharged by Dr.


VAERS ID: 514652 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Puerto Rico  
Vaccinated:2013-11-05
Onset:2013-11-11
   Days after vaccination:6
Submitted: 2013-11-26
   Days after onset:15
Entered: 2013-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 09149221A / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006236 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blindness, Eye inflammation, Eye pain, Intracranial pressure increased, Lumbar puncture, Nausea, Nuclear magnetic resonance imaging abnormal, Optic neuritis, Pain, Visual field tests abnormal
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (narrow), Optic nerve disorders (narrow), Demyelination (narrow), Corneal disorders (broad), Retinal disorders (narrow), Ocular infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Eye pain; Pain; Nausea
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 11/2013, Lumbar puncture, used to reduce intracranial pressure; 11/13/2013, Nuclear magnetic resonance imaging, Showed inflammation; 11/2013, Visual field tests, some loss of vision was noted
CDC Split Type: WAES1311USA009315

Write-up: This spontaneous report as received from a consumer refers to a 17 year old male patient (consumer''s son). On 01-NOV-2013 the patient was vaccinated with GARDASIL (dose, route of administration and lot #batch# were not reported). No medical history and concomitant medication were reported. On 11-NOV-2013, the patient experienced pain, vision loss and nausea after receiving the GARDASIL. It was reported that the patient could open his eyelids but experienced pain when he tried to move his eyes. On an unknown date of November 2013, he was seen by an ophthalmologist, who diagnosed as optic neuritis and inflammation of the optic nerve for both eyes. He was referred to a neurologist. On an unknown date of November 2013, a vision field test was done and some loss of vision was noted. On 13-NOV-2013, the patient was taken to see a neurologist and an MRI was done and it showed inflammation. The patient then underwent a lumbar puncture to decrease the intracranial pressure (dates unspecified, November 2013). The patient sought medical attention (office visit). The patient was also given intravenous steroid therapy at the hospital (name of hospital not provided). It was reported that the patient was not admitted to the hospital but goes almost daily for treatments. The consumer also reported that as a consequence of the lumbar puncture, the patient experienced increased pain and nausea. The patient eye pain has increased since it was first noticed. The outcome of the reported events was reported as not recovered. It was also reported that both physicians have stated optic neuritis and inflammation of the optic nerve for both eyes have developed from receiving the GARDASIL. Upon internal review the event ''vision loss'' was considered to be medically significant. Additional information has been requested.


VAERS ID: 514798 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Iowa  
Vaccinated:2013-08-15
Onset:2013-08-18
   Days after vaccination:3
Submitted: 2013-11-26
   Days after onset:100
Entered: 2013-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Back pain, Henoch-Schonlein purpura, Hypoaesthesia, Musculoskeletal pain, Pain in extremity, Petechiae, Platelet count normal, Prothrombin time normal, Pruritus
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Vasculitis (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zyrtec
Current Illness: Not known
Preexisting Conditions: Not known
Allergies:
Diagnostic Lab Data: Both platelets and prothrombin time were within normal limits
CDC Split Type:

Write-up: On 8/18 pt started getting back pains at T8 that spread down her spine to sacram. Also had pain and numbness spreading to the left leg and part of right leg. Also had pruritis with pain and diffuse petechiae on both upper later/posterior legs and shoulder/upper arms. On 8/20 was admitted to observation. Diagnosed with Menactra induced Henoch-Schonlein Purpura.


VAERS ID: 514827 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Ohio  
Vaccinated:2009-12-01
Onset:2010-01-09
   Days after vaccination:39
Submitted: 2013-11-26
   Days after onset:1417
Entered: 2013-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) / NOVARTIS VACCINES AND DIAGNOSTICS 101326 3P / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Blood test, Chills, Colitis ulcerative, Computerised tomogram, Diarrhoea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal ulceration (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Celiacs Disease
Allergies:
Diagnostic Lab Data: Cat scan, blood draws, IV for fluids. They discovered that I had an autoimmune disorder called Ulcerative Colitis.
CDC Split Type:

Write-up: Chills, fevers (would fluctuate between the two), vomiting, terrible stomach pains (like a knife was being pushed into my stomach over and over again). Was forced to go into the hospital for a 2-night stay. Got a little better after that but then a week later ended up in the hospital again and this time for different symptoms: vomiting, uncontrollable diarrhea, fevers, chills. Was diagnosed with Ulcerative Colitis.


VAERS ID: 514900 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-11-21
Onset:2013-11-21
   Days after vaccination:0
Submitted: 2013-11-27
   Days after onset:6
Entered: 2013-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J009788 / 3 LA / UN

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Headache, Hypoaesthesia oral, Neck pain, Toothache
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Drug hypersensitivity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311USA010831

Write-up: This spontaneous report as received from a health care worker refers to a 17 year old female patient. The patient was allergic to amoxicillin. The patient had no other pertinent medical history. On 01-APR-2013, the patient was vaccinated with GARDASIL dose 1 (Lot # H020002). On 17-JUL-2013, the patient was vaccinated with GARDASIL dose 2 (Lot # H017698). No adverse events were reported with dose 1 and 2. On 21-NOV-2013 the patient was vaccinated with GARDASIL dose 3 (Lot # J009788). The patient was not on any concomitant medications. On 21-NOV-2013, the patient felt dizzy about 5 minutes following the vaccination and the patient was kept at the office for duration of 15 minutes. The patient reproted that on 21-NOV-2013, she developed headache on the left side and neck pain on the left side (same side as GARDASIL vaccination) after the patient left the office. On 22-NOV-2013 when the patient woke up, she experienced numbness of lower lip and teeth pain (teeth hurt). The patient sought medical attention. No treatment was rendered for the event. No lab tests were performed. The outcome of neck pain on the left side (same side as GARDASIL vaccination), teeth pain and numbness of lower lip was reproted as not resolved. The outcome of headache was unknown. The outcome of patient felt dizzy was reported as resolved on 21-NOV-2013. Additional information has been requested.


VAERS ID: 514981 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Texas  
Vaccinated:2013-11-25
Onset:2013-11-25
   Days after vaccination:0
Submitted: 2013-11-27
   Days after onset:2
Entered: 2013-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006236 / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4561AA / 2 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood pressure increased, Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: BP 5min after syncope 146/94 Pulse 69
CDC Split Type:

Write-up: Pt experienced Z dizziness and syncope in office after vaccination. Occurred at approx 7:45 pm, held pt due to elevated BP until 9:00 pm. No treatment necessary, record BP for 10 days and report to us.


VAERS ID: 515015 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Florida  
Vaccinated:2013-11-26
Onset:0000-00-00
Submitted: 2013-11-27
Entered: 2013-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BK2062 / 1 NS / IN
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS YG4XA / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M12097 / 1 RA / IM
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR U4165BA / 1 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J003705 / 2 LA / SC

Administered by: Military       Purchased by: Military
Symptoms: Migraine, Nausea, Vision blurred
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

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

Write-up: Patient woke up next morning on 11/27/2013 after receiving vaccines complaining of a migraine. Migraine per mother led to blurry vision and nausea.


VAERS ID: 515223 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Connecticut  
Vaccinated:2013-09-13
Onset:2013-09-13
   Days after vaccination:0
Submitted: 2013-09-14
   Days after onset:1
Entered: 2013-12-02
   Days after submission:79
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS TP225 / 1 LA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006879 / 1 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Computerised tomogram head normal, Road traffic accident
SMQs:, Accidents and injuries (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Isoniazid
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: CT Scan of Head in E.D. (-)
CDC Split Type:

Write-up: Patient had MVA after leaving drs office ? of syncopal episode while driving. Timing not perfectly clear from ED report - seems to be 20 -40 minutes post vaccine administration. Pt had been fine - alert active jocular when left office and throughout procedure before leaving.


VAERS ID: 515827 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Michigan  
Vaccinated:2013-10-24
Onset:2013-11-01
   Days after vaccination:8
Submitted: 2013-12-06
   Days after onset:35
Entered: 2013-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4445AB / UNK LA / IM

Administered by: Unknown       Purchased by: Other
Symptoms: Chest X-ray, Feeling abnormal, Lymphadenopathy, Vaccination complication
SMQs:, Dementia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Apri 0.15-30 mg/mcg oral tablet
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Pt was given a chest xray at the ER dept
CDC Split Type:

Write-up: Pt did not feel good and had swollen lymph nodes. Mom took her to been seen and was told it was all caused by MCV4 vaccine which she had previously gotten the week before.


VAERS ID: 516080 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Georgia  
Vaccinated:2012-11-26
Onset:2012-12-23
   Days after vaccination:27
Submitted: 2013-12-09
   Days after onset:351
Entered: 2013-12-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0555AE / 3 UN / UN

Administered by: Unknown       Purchased by: Other
Symptoms: Blood test, Central nervous system inflammation, Computerised tomogram, Convulsion, Electrocardiogram, Electroencephalogram, Nuclear magnetic resonance imaging, Paralysis
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 150 days
   Extended hospital stay? Yes
Previous Vaccinations: ~HPV (Gardasil)~~17.17~Patient
Other Medications: None
Current Illness: No completely healthy. (Took HPV shots)
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: EKG, EEG, MRI, blood work, CAT-scans, etc...
CDC Split Type:

Write-up: Seizures, inflammation on the brain, paralyze all body functions.


VAERS ID: 516136 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2011-11-10
Onset:2012-02-01
   Days after vaccination:83
Submitted: 2013-12-10
   Days after onset:678
Entered: 2013-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. DR OFFICE HAS / 1 UN / SYR

Administered by: Unknown       Purchased by: Private
Symptoms: Asthenia, Blood test abnormal, Muscle atrophy
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Dr has all medical exam, blood work showing before and after vaccines
CDC Split Type:

Write-up: Loss of energy, blood work decline. Prior to shot, Blood work done for NCAA athlete. After 2 shots of Gardasil, child became weak, no energy, loss of muscle, blood work came back horrible where blood work prior to vaccine, showed perfect athlete.


VAERS ID: 516142 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Maryland  
Vaccinated:2013-12-04
Onset:2013-12-05
   Days after vaccination:1
Submitted: 2013-12-10
   Days after onset:5
Entered: 2013-12-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A13012 / 1 LA / IM

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

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

Write-up: Received MENVEO injection and PPD 12/4/13. Pt. started to complain of dizziness about 18 hours after injection. Denied cold symptoms, fever, vomiting, diarrhea. Mother felt dizziness was related to vaccine. Follow-up the next day - pt. had recovered completely.


VAERS ID: 516336 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2012-04-13
Onset:0000-00-00
Submitted: 2013-12-12
Entered: 2013-12-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Pregnancy test, Positive
CDC Split Type: WAES1205USA01138

Write-up: Information has been received from a physician for VARIVAX (Merck), a Pregnancy Registry product, concerning a 17 year old female patient, who on 13-APR-2012 was vaccinated with a "booster" dose of VARIVAX (Merck) (dose route and lot number not reported). Other suspect therapy included third dose of GARDASIL, administered on the same day. It was reported that the patient was due to begin her menstrual cycle on approximately 16-APR-2012. The patient notified the physician on 23-APR-2012 that she took a home pregnancy test which was positive. No adverse effect was reported. The date of the patient''s last menstrual period was approximately 16-MAR-2012 and estimated delivery date is due on 21-DEC-2012. Follow up stated no additional information could be provided since the reporting physician retired the previous year. The pregnancy outcome has been updated to lost to follow up. Additional information is not expected.


VAERS ID: 516356 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2013-12-04
Onset:2013-12-06
   Days after vaccination:2
Submitted: 2013-12-09
   Days after onset:3
Entered: 2013-12-12
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006850 / 2 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood alcohol, Blood magnesium, Computerised tomogram head, Drug screen, Full blood count, Syncope, Tonic clonic movements, Unresponsive to stimuli, Urine analysis
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Working a gas station at register became unresponsive collapsed into cigarette rack, seen in ER. Tonic clonic motor activity as per witnesses.


VAERS ID: 516416 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Virginia  
Vaccinated:2013-10-23
Onset:2013-10-24
   Days after vaccination:1
Submitted: 2013-10-29
   Days after onset:5
Entered: 2013-12-12
   Days after submission:44
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR U4772AA / 4 RA / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J002933 / 5 LA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. J010332 / 1 LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Blood test, Cellulitis, Erythema, Pain in extremity, Swelling
SMQs:, 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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DULERA; PATANASE; Albuterol; PREVACID; PROVENTIL
Current Illness:
Preexisting Conditions: Exercise induced asthma
Allergies:
Diagnostic Lab Data: Blood work at hospital
CDC Split Type:

Write-up: Vaccines given 10/23/13. (L) arm pain 10/24/13, redness and swelling 10/25, to ER 10/26, admitted to hospital 10/27/13. Dx: cellulitis to (L) arm. IV clindamycin and Vancomycin in hospital. Discharged 10/30/13, on oral BACTRIM now. See hospital notes.


VAERS ID: 516432 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Colorado  
Vaccinated:2013-12-03
Onset:2013-12-04
   Days after vaccination:1
Submitted: 2013-12-12
   Days after onset:8
Entered: 2013-12-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH900AE / 6 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4633BA / 1 LA / UN
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. J004387 / 1 LA / UN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR J0520 / 1 RA / UN

Administered by: Private       Purchased by: Private
Symptoms: C-reactive protein increased, Cellulitis, Headache, Injection site pain, Injection site swelling, Local swelling, Myalgia, Pain in extremity, Pyrexia, Ultrasound scan normal, Vomiting, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol
Current Illness: No
Preexisting Conditions: Asthma
Allergies:
Diagnostic Lab Data: Ultrasound arm negative; WBC 13,500; CRP - 156
CDC Split Type:

Write-up: Left deltoid swelling pain, fevers 102.6, myalgias, headache, vomiting for 2 days than (L) arm swelling cellulitis, pain for one week.


VAERS ID: 516443 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Unknown  
Vaccinated:2013-11-19
Onset:2013-11-19
   Days after vaccination:0
Submitted: 2013-12-13
   Days after onset:24
Entered: 2013-12-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1312USA001333

Write-up: This spontaneous report as received from a licensed practical nurse refers to a 16 year old male patient. Medical history and drug reactions/allergies were not reported. On 15-NOV-2012, the patient was vaccinated with GARDASIL lot # J007354 expiry date 20-FEB-2016 first dose, 0.5 ml, intramuscular in the left deltoid. On 19-NOV-2013, the patient was vaccinated with GARDASIL second dose, (lot, dose and route not reported). Concomitant medication was not reported. On 19-NOV-2013, the patient was vaccinated with improperly stored GARDASIL, this was the patient second dose in the series. No adverse effects. Additional information is not expected.


VAERS ID: 516544 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Texas  
Vaccinated:2013-12-05
Onset:2013-12-05
   Days after vaccination:0
Submitted: 2013-12-09
   Days after onset:4
Entered: 2013-12-13
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH718AB / 1 RA / UN

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

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

Write-up: Pruritic rash occurring after vaccine was administered. Pt not allergic to eggs and did not eat any new foods or medications.


VAERS ID: 516665 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-10-02
Onset:2013-10-02
   Days after vaccination:0
Submitted: 2013-12-14
   Days after onset:73
Entered: 2013-12-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J003727 / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Dizziness, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SPRINTEC
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1312USA002366

Write-up: This spontaneous report as received from a certified medical assistant refers to a 17 year old female patient. There was no pertinent medical history and no drug reactions or allergies. On 02-OCT-2013, the patient was vaccinated with GARDASIL lot # J003727 expiry date 07-NOV-2015, first dose, (dose and route not reported) to prevent human papillomavirus (HPV). Concomitant therapies included ethinyl estradiol, SPRINTEC. On 02-OCT-2013, 6 hrs after onset of therapy, the patient experienced dizziness and shortness of breath. The patient did not report these symptoms to anyone prior to her appointment in the office on 03-DEC-2013 when she came in to receive her second dose of GARDASIL. No treatment given for the events. No lab diagnostics performed. The outcome of shortness of breath and dizziness was reported as recovered on 02-OCT-2013. Additional information has been requested.


VAERS ID: 517086 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Montana  
Vaccinated:2013-10-01
Onset:2013-10-20
   Days after vaccination:19
Submitted: 2013-12-19
   Days after onset:60
Entered: 2013-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 RA / UN

Administered by: Public       Purchased by: Private
Symptoms: Alopecia, Thyroid function test normal
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Hair loss~HPV (Gardasil)~2~17.08~Patient
Other Medications: None
Current Illness: No
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: Thyroid test-normal. Has an appointment with an Endocrinologist.
CDC Split Type:

Write-up: My daughter starting losing large amounts of hair a couple weeks after her second Gardasil shot. It is still falling out in large amounts. The doctor checked her thyroid which tested normal. A perfectly healthy girl that does not take any medication. Never sick. Hasn''t changed her lifestyle. Hair loss began shortly after second shot.


VAERS ID: 517112 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: New Hampshire  
Vaccinated:2013-12-17
Onset:2013-12-17
   Days after vaccination:0
Submitted: 2013-12-19
   Days after onset:2
Entered: 2013-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4574BA / 2 RA / UN

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

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

Write-up: Pt. received Meningococcal 12/17 and w/i one hour dev. hive/swelling. Has periodically been taking BENADRYL. F/U 12/19 hive continues - tx. BENADRYL and Loratadine. F/U 12/23 and PRN.


VAERS ID: 517159 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Missouri  
Vaccinated:2013-12-17
Onset:2013-12-18
   Days after vaccination:1
Submitted: 2013-12-19
   Days after onset:1
Entered: 2013-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 RA / UN

Administered by: Unknown       Purchased by: Private
Symptoms: Injection site pruritus, Injection site urticaria, Injection site warmth, Malaise
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow)

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

Write-up: Hives, itching, warmth around injection site. General ill feeling. Given Motrin 600 mg at onset. Applied OTC Cortisone 10 cream in late PM and in AM of 12/19/13. Gave Benadryl 25 mg at bedtime on 12/18/13.


VAERS ID: 517778 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-11-18
Onset:0000-00-00
Submitted: 2013-12-27
Entered: 2013-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Headache
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Drug hypersensitivity
Preexisting Conditions: AUGMENTIN
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1312USA010984

Write-up: This spontaneous report as received from a consumer regarding her granddaughter a 17 year old female patient with AUGMENTIN allergy. In the middle of October 2013, patient receive her first dose of GARDASIL (dose, concentration, and lot number not reported). On 18-NOV-2013, the patient was vaccinated with her second dose of GARDASIL (dose, concentration and lot number not provided). No concomitant therapy was reported. Approximately on November 2013, the patient experienced headache after received the second shot of GARDASIL. The reporter stated that the patient has not yet received a third shot of GARDASIL. The outcome of headache was unknown. Additional information has been requested.


VAERS ID: 517822 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Utah  
Vaccinated:2001-06-30
Onset:2001-06-30
   Days after vaccination:0
Submitted: 2013-12-28
   Days after onset:4564
Entered: 2013-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Private       Purchased by: Unknown
Symptoms: Dizziness, Fatigue, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Fever of 103.5, fatigue, dizziness lasting 3-4 days.


VAERS ID: 518004 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Ohio  
Vaccinated:2013-12-18
Onset:2013-12-18
   Days after vaccination:0
Submitted: 2013-12-30
   Days after onset:12
Entered: 2013-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006850 / 3 RA / UN

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

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

Write-up: Patient developed hive-like rash, abdomen, back, both arms both feet and legs.


VAERS ID: 518121 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Oregon  
Vaccinated:2013-12-23
Onset:2013-12-24
   Days after vaccination:1
Submitted: 2013-12-29
   Days after onset:5
Entered: 2013-12-31
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. H018182 / 2 LA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. H018789 / 2 RA / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluoxetine; Prazosin; Loratadine
Current Illness: None
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type: OR201329

Write-up: Local reaction to (R) upper arm with 3" induration and firmness diameter and 4" diameter of redness and increased temperature. C/O pain and itching at site.


VAERS ID: 518606 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Puerto Rico  
Vaccinated:2014-01-03
Onset:2014-01-03
   Days after vaccination:0
Submitted: 2014-01-03
   Days after onset:0
Entered: 2014-01-07
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4686AA / UNK LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS T25EG / UNK RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J007021 / UNK LA / SC

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

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

Write-up: Patient mentions itchiness on the hands, feet and the posterior part of the thighs. Five minutes after the administration of MCV, Tdap and Varicella.


VAERS ID: 518695 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2014-01-06
Onset:2014-01-07
   Days after vaccination:1
Submitted: 2014-01-08
   Days after onset:1
Entered: 2014-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH899AB / UNK LA / IM

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

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

Write-up: Rash to face/head and neck. Parent denied any other Sx''s parent advised to take her daughter to a urgent care walk-in clinic for further evaluation, or to her PCP. Mother agreed.


VAERS ID: 518730 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Idaho  
Vaccinated:2014-01-07
Onset:0000-00-00
Submitted: 2014-01-08
Entered: 2014-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX) / NOVARTIS VACCINES AND DIAGNOSTICS 010011A / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Drug administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

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

Write-up: Flucelvax flu vaccine approved for 18 and older and was administered to 17 year old.


VAERS ID: 518787 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Iowa  
Vaccinated:2013-10-01
Onset:2013-11-02
   Days after vaccination:32
Submitted: 2014-01-07
   Days after onset:66
Entered: 2014-01-09
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 08449221A / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Nuclear magnetic resonance imaging brain, Nystagmus
SMQs:, Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Ocular motility disorders (narrow)

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

Write-up: Nystagmus.


VAERS ID: 518902 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: North Carolina  
Vaccinated:2013-12-31
Onset:2013-12-31
   Days after vaccination:0
Submitted: 2014-01-09
   Days after onset:9
Entered: 2014-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH894AA / UNK LA / UN

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

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

Write-up: Pt felt light headed pt sat down, we have him H2O.


VAERS ID: 519278 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Washington  
Vaccinated:2014-01-06
Onset:2014-01-06
   Days after vaccination:0
Submitted: 2014-01-14
   Days after onset:8
Entered: 2014-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX) / NOVARTIS VACCINES AND DIAGNOSTICS 01011WA / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

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

Write-up: NONE.


VAERS ID: 519314 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: West Virginia  
Vaccinated:2013-12-05
Onset:2013-12-08
   Days after vaccination:3
Submitted: 2014-01-14
   Days after onset:37
Entered: 2014-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J002641 / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4445AB / 1 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS P572X / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Ear infection, Headache, Upper respiratory tract infection, Urinary tract infection, Vertigo, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Mother states none.
CDC Split Type: WV1401

Write-up: Within 2-4 days of GARDASIL vaccine - blurred vision bilateral, room spinning - continuous. 3 wks after vaccine - went to ER with dx UTI, URI, ear inf. - and room spinning was relieved. Appt. being made with eye doctor today. Date to be determined. Also c/o headache - intermittent relieved by Ibuprofen.


VAERS ID: 519370 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Washington  
Vaccinated:2014-01-07
Onset:2014-01-07
   Days after vaccination:0
Submitted: 2014-01-08
   Days after onset:1
Entered: 2014-01-15
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH907AC / 2 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J008423 / 1 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Blood pressure decreased, Dizziness, Hypoacusis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hearing impairment (narrow), Vestibular disorders (broad), Dehydration (broad)

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

Write-up: Dizziness, decreased hearing, decreased blood pressure while leaving building soon after vaccine administration.


VAERS ID: 519384 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-15
Entered: 2014-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Uveitis
SMQs:, Ocular infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA006185

Write-up: Information has been received from a literature article concerning a 17 year old female patient developed uveitis following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476); time to onset was unknown in this case; the time to onset in this case was 7 days from vaccination. There was one reported rechallenged of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 2 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccine and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.


VAERS ID: 519385 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-15
Entered: 2014-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Corneal deposits, Eye naevus, Macular oedema, Uveitis
SMQs:, Corneal disorders (narrow), Retinal disorders (narrow), Ocular infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA006184

Write-up: Information has been received from a literature article concerning a 17 year old female patient developed uveitis, corneal deposits, choroidal nevus and macula edema following administration of GARDASIL. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17 (range 12-29). The median time from vaccination to onset of ADRs was 30 days (range 0-476); time to onset was unknown in this case; the time to onset in this case was 7 days from vaccination. There was one reported rechallenged of the GARDASIL vaccine. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. Systemic side effects were noted in 9 of the 24 cases and included 3 cases of arthralgia. In 2 case reports multiple vaccines were administered simultaneously. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccine and uveitis was "possible". Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports from the same literature source. Additional information has been requested.


VAERS ID: 519421 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Washington  
Vaccinated:2013-11-22
Onset:0000-00-00
Submitted: 2014-01-15
Entered: 2014-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX) / NOVARTIS VACCINES AND DIAGNOSTICS 006011A / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: Flucelvax was administered to a 17 years old. No adverse reactions noted.


VAERS ID: 519492 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-15
Entered: 2014-01-16
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Angiogram abnormal, CSF pressure normal, CSF test normal, Conjunctival hyperaemia, Eye complication associated with device, Inflammation, Keratitis, Nuclear magnetic resonance imaging brain normal, Serology negative, Slit-lamp tests abnormal, Uveitis, Visual acuity tests abnormal
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Glaucoma (narrow), Optic nerve disorders (broad), Corneal disorders (narrow), Retinal disorders (broad), Conjunctival disorders (narrow), Ocular infections (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Best corrected visual acuity at the time was 20/20 in the right eye and 20/25 in the left eye. Magnetic Resonance Imaging of brain and orbits with gadolinium contrast was unremarkable. Cerebrospinal fluid analysis was unremarkable. CSF test, Unremarkable; Nuclear magnetic resonance imaging, Of brain and orbits was Unremarkable; Visual acuity tests, 20/20; Visual acuity tests, 20/25, Left eye
CDC Split Type: WAES1401USA005340

Write-up: Information has been received from a literature article concerning a 17 healthy year old female patient developed conjunctival hyperemia of her right eye and was treated with topical VIGAMOX by her primary care physician. Her optometrist diagnosed contact lens associated keratitis and prescribed loteprednol etabonate, ZYLET. On subsequent examination bilateral anterior uveitis grade as 2+ cell and 1 + flare was noted. Tropicamide 1% TID and PRED FORTE Q1 hour along with dexamethasone, TOBRADEX at bedtime were then prescribed. Reduction of inflammation was noted in one week, however the inflammation recurred as topical corticosteroid therapy was tapered. She was referred for systemic evaluation after six weeks because the inflammation remained active. Physical examination and serologic evaluations were performed by her primary care physician and a rheumatologist; however no underlying cause for her uveitis was discovered. Her maternal grandparents had rheumatoid arthritis. Four months after onset of her symptoms she was referred for uveitis consultation due to persistent inflammation despite PRED FORTE OU BID. History obtained at the time disclosed her initial GARDASIL was administered 2 weeks prior to onset of uveitis and her second vaccination was temporally associated with a flare of uveitis when her topical corticosteroid dose was reduced to twice daily. The patient and her family elected to defer the third vaccination in the series. Best corrected visual acuity at the time was 20/20 in the right eye and 20/25 in the left. The conjunctiva was not injected. The cornea was normal in appearance without evidence of scarring or keratic precipitates. The anterior chamber reaction was graded as 3+ cell in both eyes. Trace vitreous cells were present in both eyes on slit lamp bio microscopy, and fluorescein angiography demonstrated late hyperfluorescence of the optic discs. Additional serologic work-up did not disclose any significant abnormalities. Magnetic resonance imaging of brain and orbits with gadolinium contrast was unremarkable. Lumbar puncture was performed with a normal opening pressure. Cerebrospinal fluid analysis was unremarkable. She was treated with CELEBREX 200mg twice daily and topical steroid therapy was eliminated. A trace amount of cells were observed intermittently in the anterior chamber over the course of the next three years without symptoms or sequelae of uveitis Glaucoma consultation was obtained and co-morbid pigment dispersion syndrome was excluded. CELEBREX was discontinued after 32 months of therapy and uveitis symptoms have not recurred after an additional 20 months. Best corrected visual acuity remained 20/20 in both eyes more than 4 years after onset of her symptoms. A total of 24 cases of uveitis occurred following administration of GARDASIL; the gender in all cases was female. The median age was 17. The median time from vaccination to onset of ADRs was 30 days; time to onset was unknown in 1 case; the time to onset in this case was of 14 days from vaccination. There was one reported rechallenge of the GARDASIL. In 13 of the 24 cases other ocular side effects were noted including 3 case reports of papillitis, 2 case reports of retinitis and 1 case report of papilledema. According to World Health Organization Causality Assessment Guide of Suspected Adverse Reactions, the relationship between human papilloma virus vaccination and uveitis was "possible" Causality assessments are based on the time relationship of drug administration, uveitis development and rechallenge data. This is one of several reports form the same literature source. Additional information has been requested.


VAERS ID: 519872 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Unknown  
Location: Michigan  
Vaccinated:2014-01-13
Onset:2014-01-13
   Days after vaccination:0
Submitted: 2014-01-20
   Days after onset:7
Entered: 2014-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J012212 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA006705

Write-up: This spontaneous report as received from a healthcare worker refers to a 17 yeas old patient. The reporter stated that a shipment of GARDASIL that was shipped from company on 08-JAN-2014 was received at her facility on 13-JAN-2014. One dose of GARDASIL (lot # J012212 exp. date. 18-FEB-2016, dose, route and site of administration not reported) was administered to a patient on 13-JAN-2014 before the status of the shipment was realized. The healthcare worker did not believe that GARDASIL was exposed to temperatures out of the recommended range for longer than 72 hours. No adverse effect had been observed or reported. Additional information has been requested.


VAERS ID: 519890 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: New York  
Vaccinated:2013-12-20
Onset:2013-12-30
   Days after vaccination:10
Submitted: 2014-01-20
   Days after onset:21
Entered: 2014-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Abdominal pain upper, Asthenia, Blindness, Dizziness, Hypoaesthesia, Immediate post-injection reaction, Malaise, Muscle contractions involuntary, Mydriasis, Skin discolouration
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

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

Write-up: Patient immediately began to feel sick she said she felt like she was going to faint. She sat down and began saying that she couldn''t see yet her eyes were wide open. I watched her turn grey and her pupils dilate. She then said that she could not feel her legs. She was very weak. She started getting severe stomach pains. After about 10 mins we managed to move her to an exam room where she could lie down. At this point her hands locked into claws. They remained locked for about 15 mins. The PA gave her a can of ginger ale. After about 20 mins after she drank it her color returned to her face, she began to feel her legs and her hands unlocked. Total time from start to finish was approx 1 hour.


VAERS ID: 520090 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: California  
Vaccinated:2014-01-21
Onset:2014-01-21
   Days after vaccination:0
Submitted: 2014-01-21
   Days after onset:0
Entered: 2014-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH907AC / 2 UN / IM
MEN: MENINGOCOCCAL (MENOMUNE) / SANOFI PASTEUR UH4446AC / 2 UN / IM

Administered by: Other       Purchased by: Public
Symptoms: Dyspnoea, Pallor, Slow response to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: C/O unable to breathe and slow to respond color pale.


VAERS ID: 520195 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Maine  
Vaccinated:2014-01-21
Onset:2014-01-22
   Days after vaccination:1
Submitted: 2014-01-22
   Days after onset:0
Entered: 2014-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006850 / 5 LA / IM

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

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

Write-up: Slight fever.


VAERS ID: 520324 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-22
Entered: 2014-01-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA004739

Write-up: This spontaneous report as received from a medical assistant refers to currently 17 year male patient. The reporter stated that on an unknown date, the patient was administered the GARDASIL that was exposed to a temperature excursion (30 degrees Fahrenheit for 2 hours) (lot number and expiration date unknown), dose, route, anatomical location and dose number were not reported for an unknown indication. No adverse effect was reported. At the time of the report, date administered, vaccine lot number and expiration date, any treatment received, or possible hospital stay were not available. This is one of several reports from the same source. Additional information has been requested.


VAERS ID: 520696 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Oregon  
Vaccinated:2013-12-29
Onset:0000-00-00
Submitted: 2014-01-24
Entered: 2014-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX) / NOVARTIS VACCINES AND DIAGNOSTICS 010011A / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: No adverse event. This vaccine was indicated for 18 years and older. Patient was under that age.


VAERS ID: 520700 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Oregon  
Vaccinated:2014-01-07
Onset:0000-00-00
Submitted: 2014-01-24
Entered: 2014-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX) / NOVARTIS VACCINES AND DIAGNOSTICS 010011A / 1 LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: No adverse event. Patient received a vaccine that was indicated for 18 years and older.


VAERS ID: 520819 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Colorado  
Vaccinated:2014-01-22
Onset:2014-01-24
   Days after vaccination:2
Submitted: 2014-01-24
   Days after onset:0
Entered: 2014-01-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED R56608 / UNK RA / IM

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

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

Write-up: Pt got 2 hives on front chest and 2 hives on his back - said he felt tingling in the area on his back prior to getting the shot.


VAERS ID: 520720 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: New York  
Vaccinated:2013-11-18
Onset:2013-11-24
   Days after vaccination:6
Submitted: 2014-01-25
   Days after onset:62
Entered: 2014-01-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH926AA / 6 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Blood test, Lumbar puncture, Malaise, Nuclear magnetic resonance imaging
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Healthy Dr visit
Preexisting Conditions: Allergic to amoxicillin
Allergies:
Diagnostic Lab Data: Spinal tap, MRI, blood work
CDC Split Type:

Write-up: Stated not feeling well, waited a few days took him to Dr. on Wednesday 11/27/2013 went back to Dr. several different times until December 7, 2013 admitted to medical center.


VAERS ID: 520737 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Oregon  
Vaccinated:2013-12-30
Onset:0000-00-00
Submitted: 2014-01-26
Entered: 2014-01-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX) / NOVARTIS VACCINES AND DIAGNOSTICS 0066011A / 2 RA / IM

Administered by: Other       Purchased by: Private
Symptoms: Unevaluable event
SMQs:

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

Write-up: None.


VAERS ID: 520751 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-11-05
Onset:2013-11-05
   Days after vaccination:0
Submitted: 2014-01-27
   Days after onset:83
Entered: 2014-01-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive, Ultrasound antenatal screen normal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 01/22/2014, Pregnancy test, urine, positive; 01/22/2014, Ultrasound scan, pregnancy of 19 weeks 3 days gestation
CDC Split Type: WAES1401USA010963

Write-up: This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a 17 year old female patient. On 05-NOV-2013 the patient was vaccinated with VARIVAX (Merck) by her unspecified general health care provider. No concomitant medications, pertinent medical history or drug allergies. The patient was subsequently determined to be pregnant. The date of last menstrual period was 08-SEP-2013 and estimated date of delivery was 15-JUN-2014. Initial exposure to VARIVAX (Merck) was at 8 week(s). The pregnancy outcome was pending. The patient had her first obstetrical evaluation with the nurse practitioner on 22-JAN-2014. On 22-JAN-2014, the patient had a positive pregnancy urine test, an ultrasound revealed a pregnancy of 19 weeks 3 days gestation. No problems reported. No treatment was provided. The patient sought medical attention by making an office visit. Additional information has been requested.


VAERS ID: 520816 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Arizona  
Vaccinated:2014-01-17
Onset:2014-01-18
   Days after vaccination:1
Submitted: 2014-01-21
   Days after onset:3
Entered: 2014-01-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J003219 / 2 UN / SC

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

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

Write-up: Patient states varying degrees of edema and redness at site since injection. Currently minimal swelling with very faint redness appx 70mm in diameter.


VAERS ID: 520895 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2014-01-11
Onset:2014-01-11
   Days after vaccination:0
Submitted: 2014-01-12
   Days after onset:1
Entered: 2014-01-27
   Days after submission:15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 13415P / 1 LA / UN

Administered by: Other       Purchased by: Private
Symptoms: Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: After administration of the vaccine (about 5 min) pt experienced an episode of syncope. Pt regained consciousness after a few seconds w/out further complaints.


VAERS ID: 521005 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Colorado  
Vaccinated:2014-01-21
Onset:2014-01-21
   Days after vaccination:0
Submitted: 2014-01-27
   Days after onset:6
Entered: 2014-01-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH900AE / UNK LA / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. J006511 / 3 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4657AA / 2 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea, Fall, Nausea, Salivary hypersecretion
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: UNK
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: 2014SA009039

Write-up: Initial report was received on 22 January 2014 from a health care professional. A 17 year-old male patient with no known allergies and no medical history had received the following vaccines on 21 January 2014: a dose two intramuscular left deltoid injection of MENACTRA, lot number U4657AA, an intramuscular left deltoid injection of FLUZONE, lot number UH900AE (number of previous doses for FLUZONE was reported as several) and dose three right arm injection of Hepatitis B, lot number J006511 (manufacturer not reported) and an unspecified amount of time later after the patient received MENACTRA vaccination "slumped over but caught by nurse and returned to position". The patient was observed for 15 minutes and no other symptoms were noted and the patient left facility for home. The next day patient reported experiencing nausea, increased salivation and shortness of breath. The patient was to be evaluated by a physician assistant. Outcome was not recovered. Documents held by sender: none.


VAERS ID: 521197 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Alaska  
Vaccinated:2013-11-11
Onset:0000-00-00
Submitted: 2014-01-29
Entered: 2014-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: PATIENT RECEIVED FLUCELVAX WHILE UNDER THE AGE OF 18 WITH NO ADVERSE EVENT REPORTED.


VAERS ID: 521199 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2014-01-27
Onset:2014-01-27
   Days after vaccination:0
Submitted: 2014-01-29
   Days after onset:2
Entered: 2014-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4556AC / 2 LA / SYR

Administered by: Private       Purchased by: Private
Symptoms: Dyspnoea, Hyperhidrosis, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: No lightheadedness after vaccination but in the car became sweaty and then took a gasp and passed out.


VAERS ID: 521202 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2014-01-02
Onset:2014-01-02
   Days after vaccination:0
Submitted: 2014-01-29
   Days after onset:27
Entered: 2014-01-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J009098 / 2 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No only vaccines were given on that day
Current Illness: No
Preexisting Conditions: No
Allergies:
Diagnostic Lab Data: Getting biopsy on bump
CDC Split Type:

Write-up: Itchy red bumps all over her body! Given steroid pills, shot, creme for itching. Still on her body and it has been 1 month.


VAERS ID: 521338 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: California  
Vaccinated:2014-01-30
Onset:2014-01-30
   Days after vaccination:0
Submitted: 2014-01-30
   Days after onset:0
Entered: 2014-01-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 51713 / 1 UN / SYR

Administered by: Private       Purchased by: Private
Symptoms: Seizure like phenomena
SMQs:, Convulsions (narrow)

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

Write-up: Seizure-like side effect about 10:15 (5 min) after vaccine was given. Pt was laid down and observed in knee-chest position for 15 - 20 min.


VAERS ID: 521371 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-31
Entered: 2014-01-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA014445

Write-up: This spontaneous report was received from a pharmacist via company representative refers to a 17 year old patient of unknown demography. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose and frequency was not reported). It was reported that the 17 year old patient has been receiving PNEUMOVAX23 every three years since an unspecified date. No adverse effect reported. Additional information has been requested.


VAERS ID: 521434 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Texas  
Vaccinated:2013-09-24
Onset:2013-09-25
   Days after vaccination:1
Submitted: 2014-01-31
   Days after onset:128
Entered: 2014-01-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chills, Dyspnoea, Influenza, Pyrexia, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Thalassemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA010428

Write-up: This spontaneous report as received from a consumer (patient''s mother) refers to a 17 year old female patient with thalassemia and no drug reactions or allergies. Concomitant medications were not specified by the reporter. On 24-SEP-2013 the patient was vaccinated with GARDASIL (lot number, expiration date, dose and strength were not reported) intramuscularly. On 25-SEP-2013 the patient developed flu, trouble breathing, fever, shakes and shivers. The patient went to the emergency room. On 26-SEP-2013 the patient recovered from the events. The patient sought medical attention - went to the emergency room at hospital, the patient was not hospitalized. The relatedness between the events and GARDASIL was not reported. Additional information is expected.


VAERS ID: 521448 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Maine  
Vaccinated:2014-01-21
Onset:2014-01-25
   Days after vaccination:4
Submitted: 2014-01-27
   Days after onset:2
Entered: 2014-01-31
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BK2064 / 3 NS / IN

Administered by: Public       Purchased by: Public
Symptoms: Cellulitis
SMQs:

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

Write-up: Pt received FLUMIST on 1/21/14 and developed nasal cellulitis on 1/26/14 and was treated.


VAERS ID: 521627 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Michigan  
Vaccinated:2014-01-27
Onset:2014-01-27
   Days after vaccination:0
Submitted: 2014-01-27
   Days after onset:0
Entered: 2014-02-03
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BK2063 / 1 NS / IN

Administered by: Private       Purchased by: Private
Symptoms: Expired drug administered
SMQs:, Medication errors (narrow)

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

Write-up: Vaccine expired 1/20/2014; looked at vial but must not have registered the date - until writing down after given.


VAERS ID: 521751 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Ohio  
Vaccinated:2014-01-28
Onset:2014-01-28
   Days after vaccination:0
Submitted: 2014-01-30
   Days after onset:2
Entered: 2014-02-04
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4608A1 / 2 LA / IM

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

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

Write-up: Received Menactra approximately 10 AM on 1/28/14. Noted hives on legs later that evening. Gave Benadryl - hives improved. Hives became progressively worse over next 24-48 hrs.


VAERS ID: 521781 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2012-06-30
Submitted: 2014-02-04
   Days after onset:584
Entered: 2014-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Muscle tightness, Pleuritic pain, Tetanus
SMQs:, Dystonia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Hydrogen peroxide sol.
Current Illness: Pain; Puncture wound
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0964166A

Write-up: This case was reported in a literature article and described the occurrence of tetanus in a 17-year-old male subject who was vaccinated with Diphtheria tetanus acellular pertussis, manufacturer unspecified). The subject''s ethnicity was stated and he was homeschooled at the time of the event. On 26 June 2012 he had stepped on a rusty boat anchor and sustained a puncture wound to his foot while working outdoors for a sailing program. He had cleaned the wound with hydrogen peroxide. He had experienced mild pain but no local erythema, swelling or drainage from the wound. No further information on his medical family history or concurrent medication is available. On an unspecified date, the subject might have received an unspecified dose of Diphtheria tetanus acellular pertussis (administration site and route unknown, batch number not provided) during childhood. However, there was no record of him receiving any vaccination in his school, primary care physician''s office or in the state immunisation registry. On 30 June 2012, at an unspecified time after vaccination with Diphtheria tetanus acellular pertussis, the subject experienced tightness of neck muscles and jaw. The symptoms had worsened during the day and he had developed pleuritic chest pain too. The subject was hospitalised for 5 days. No details of any laboratory tests or diagnostic procedures have been provided. Diagnosis was tetanus infection. Initial treatment consisted of wound cleaning and administration of 250 U of human tetanus immune globulin, tetanus toxoid vaccine, and 500 mg of metronidazole. He was then transferred to a tertiary medical centre where he received 2 mg of lorazepam and was admitted to the general paediatric ward. During his hospitalization there, he received 500 mg of metronidazole every 8 hours for 5 days and an additional 6000 U of human tetanus immune globulin. Outcome was complete recovery with discharge from the hospital without sequelae on 4 July 2012. The author''s conclusion stated that because immunization rates among homeschooled children are largely unknown, this population might be considered at higher risk for contracting more prevalent communicable vaccine preventable diseases.


VAERS ID: 521842 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Arizona  
Vaccinated:2014-01-30
Onset:2014-01-30
   Days after vaccination:0
Submitted: 2014-02-04
   Days after onset:5
Entered: 2014-02-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. J007206 / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1402USA000497

Write-up: This spontaneous report as received from a licensed practical nurse refers to a 17 year old female patient. Pertinent medical history, drug allergies or reactions were not reported. On 30-JAN-2014, the patient was vaccinated with PROQUAD (Merck), 0.5 ml, subcutaneous (lot # reported as "J007206", expiry date: 20-DEC-2014) for prevention of measles, mumps, rubella and varicella. the nurse stated that the patient received PROQUAD (Merck) in place of MMR II and VARIVAX (Merck). No adverse event reported. Additional information is not expected.


VAERS ID: 521917 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Indiana  
Vaccinated:2013-11-25
Onset:0000-00-00
Submitted: 2014-02-05
Entered: 2014-02-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J009788 / 2 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad)

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

Write-up: Continued tenderness left deltoid, no swelling or redness.


VAERS ID: 521975 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Missouri  
Vaccinated:2014-01-03
Onset:0000-00-00
Submitted: 2014-02-06
Entered: 2014-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J003528 / 1 LA / SC

Administered by: Private       Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:

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

Write-up: None stated.


VAERS ID: 521987 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: New York  
Vaccinated:2014-01-22
Onset:2014-01-22
   Days after vaccination:0
Submitted: 2014-01-31
   Days after onset:9
Entered: 2014-02-06
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J010668 / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Blood pressure decreased, Ear discomfort, Feeling abnormal, Pallor, Respiration abnormal, Visual acuity reduced
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Dehydration (broad)

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

Write-up: Not sure exact time vaccine given. Approx 4-5 min after injection my daughter expressed "funny" feeling in head, next felt like she had water in ears - color drained from face - breathing appeared to change - more deliberate. Verbalized not being able to see - RN sought MD to come to room - pt lied down - began to feel better after sev. min - BP dropped but recovered. Everything happened very quickly. Only received GARDASIL vaccine 1st dose.


VAERS ID: 521995 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: New Hampshire  
Vaccinated:2013-11-18
Onset:0000-00-00
Submitted: 2014-02-06
Entered: 2014-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS K4H7M / 3 RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: Patient was given #3 Hep A injections. No side effects or reaction.


VAERS ID: 522087 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Michigan  
Vaccinated:2014-02-05
Onset:0000-00-00
Submitted: 2014-02-06
Entered: 2014-02-07
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. J008091 / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4384AA / 1 LA / IM

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

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

Write-up: Patient was given PEDVAX HIB, should have been MCV4, we have MENVEO in the office.


VAERS ID: 522144 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Ohio  
Vaccinated:2014-01-20
Onset:2014-01-24
   Days after vaccination:4
Submitted: 2014-02-07
   Days after onset:14
Entered: 2014-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / -

Administered by: Other       Purchased by: Other
Symptoms: Anxiety, Panic disorder
SMQs:, Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: anxiety and panic~HPV (no brand name)~3~17.00~Patient|anxiety and panic~HPV (no brand name)~2~19.00~Sibling
Other Medications: None known
Current Illness: None known
Preexisting Conditions: None known
Allergies:
Diagnostic Lab Data: Treated for panic
CDC Split Type:

Write-up: Pateient received HPV vaccines on 7/17/13, 9/18/13, and 1/20/14 through another provider. He started having significant panic and anxiety symptoms requiring psychologist follow up on 8/16/13 and again on 1/24/14. The second episode more significant and patient was placed on medication for anxiety. Sister also had the same type of reaction from one of her HPV vaccines. There is FH of anxiety, so difficult to tell if vaccine related, but mom reports that before this vaccine. Child exhibited no signs of anxiety or panic.


VAERS ID: 522147 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Oregon  
Vaccinated:2013-12-20
Onset:2013-12-20
   Days after vaccination:0
Submitted: 2014-02-07
   Days after onset:49
Entered: 2014-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX) / NOVARTIS VACCINES AND DIAGNOSTICS 010011A / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Drug administered to patient of inappropriate age, Unevaluable event
SMQs:, Medication errors (narrow)

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

Write-up: None.


VAERS ID: 522148 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Oregon  
Vaccinated:2013-12-22
Onset:2013-12-22
   Days after vaccination:0
Submitted: 2014-02-07
   Days after onset:47
Entered: 2014-02-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX) / NOVARTIS VACCINES AND DIAGNOSTICS 010011A / UNK LA / IM

Administered by: Other       Purchased by: Private
Symptoms: Drug administered to patient of inappropriate age, Unevaluable event
SMQs:, Medication errors (narrow)

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

Write-up: None.


VAERS ID: 522251 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: New York  
Vaccinated:2014-02-04
Onset:0000-00-00
Submitted: 2014-02-10
Entered: 2014-02-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH949AA / 2 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4648AA / 1 RA / UN

Administered by: Public       Purchased by: Private
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamins
Current Illness:
Preexisting Conditions: ADHD; Bipolar disorder
Allergies:
Diagnostic Lab Data: Urine pregnancy test positive
CDC Split Type:

Write-up: First dose of MENACTRA administered. Subsequent urine pregnancy test was positive (same day).


VAERS ID: 522327 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: New Mexico  
Vaccinated:2014-01-31
Onset:2014-01-31
   Days after vaccination:0
Submitted: 2014-02-10
   Days after onset:10
Entered: 2014-02-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS K555K / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4412BA / 1 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J005318 / 2 RA / SC

Administered by: Public       Purchased by: Public
Symptoms: Abdominal discomfort, Activities of daily living impaired, Fatigue, Pyrexia, Sluggishness, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Acetaminophen tablets prn
Current Illness: None
Preexisting Conditions: Asthma; hx Varicella/mom
Allergies:
Diagnostic Lab Data: I requested if she is concerned please see PMD.
CDC Split Type:

Write-up: Sluggish while playing basketball - very tired. Slept Sunday evening/night Monday, 2-3-14, began running low grade fever 99-100 degrees/mom. States he has normal appetite when awake, but sleeping so soundly he slept through meal times. Left school Tues early-came home to nap - couldn''t wake him up. "had an upset stomach Wednesday - no N/V. When she got home from work" remained sluggish this weekend as well. Doesn''t think it''s serious enough to see the Dr., but very abnormal for him.


VAERS ID: 522354 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Alaska  
Vaccinated:2014-02-10
Onset:0000-00-00
Submitted: 2014-02-10
Entered: 2014-02-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (FLUCELVAX) / NOVARTIS VACCINES AND DIAGNOSTICS 010011A / 1 LA / IM

Administered by: Other       Purchased by: Unknown
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: Vaccine approved for 18 years old. At the time of report, no adverse reaction yet, within 2 hrs of injection.


VAERS ID: 522498 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Unknown  
Vaccinated:2014-01-29
Onset:2014-01-29
   Days after vaccination:0
Submitted: 2014-02-12
   Days after onset:14
Entered: 2014-02-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. J010159 / UNK RA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J003541 / UNK LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Drug administered to patient of inappropriate age, Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1401USA014727

Write-up: This spontaneous report as received from a Certified Medical Assistant (C.M.A.), refers to a 17 year old male patient. No pertinent medical history or drug reactions/allergies were provided. On 29-JAN-2014, the patient was vaccinated with a dose of PROQUAD (Merck) INJ (Lot number J010159; expiration date 23-FEB-2015), 0.5 ml, subcutaneously, in the right deltoid region. On the same day, during the same office visit, the patient was vaccinated with a dose of VARIVAX (Merck) INJ (Lot number J003541; expiration date 25-MAR-2015), subcutaneously, in the left deltoid region. No concomitant therapies were reported. The C.M.A. had initially reported that the two doses were administered in the deltoid muscle, and when informed that the route of administration for these two products was subcutaneous, she confirmed that the doses were administered subcutaneously. She stated that the patient stated that he "felt fine," and she did not observe any adverse effects. Additional information has been requested.


VAERS ID: 522672 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2014-02-10
Onset:2014-02-12
   Days after vaccination:2
Submitted: 2014-02-14
   Days after onset:2
Entered: 2014-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J013277 / UNK RA / IM

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

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

Write-up: Fine red rash beginning on right arm and radiating to the chest area.


VAERS ID: 522733 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Michigan  
Vaccinated:2014-02-13
Onset:2014-02-13
   Days after vaccination:0
Submitted: 2014-02-14
   Days after onset:1
Entered: 2014-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U460AI / 2 RA / IM

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

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

Write-up: Hives all over, took Benadryl.


VAERS ID: 522962 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2014-02-07
Onset:2014-02-08
   Days after vaccination:1
Submitted: 2014-02-09
   Days after onset:1
Entered: 2014-02-18
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. J01399 / 1 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Asthenia, Back pain, Dizziness, Injection site pain, Injection site swelling
SMQs:, Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Naproxen; Ortho-Tricyclen
Current Illness: None
Preexisting Conditions: NDA: Keflex, Wellbutrin (rash); GERD; Depression; Asthma; Anemia
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt has swelling/pain over the injection site next day developed low back pain/dizziness/weakness sent to the ED due to symptoms.


VAERS ID: 523221 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2014-02-08
Onset:2014-02-09
   Days after vaccination:1
Submitted: 2014-02-20
   Days after onset:11
Entered: 2014-02-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J008423 / 3 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M13012 / 3 LA / UN

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

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

Write-up: (L) deltoid swollen, itchy.


VAERS ID: 523342 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Illinois  
Vaccinated:2014-02-19
Onset:2014-02-20
   Days after vaccination:1
Submitted: 2014-02-20
   Days after onset:0
Entered: 2014-02-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H021608 / 2 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC; QVAR; DEPO PROVERA ISO
Current Illness: None
Preexisting Conditions: Asthma; Seasonal allergies; WPW syndrome; Panic attacks
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 2/20/14 AM - woke up with dizziness and nausea.


VAERS ID: 523391 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: California  
Vaccinated:2014-02-21
Onset:2014-02-21
   Days after vaccination:0
Submitted: 2014-02-21
   Days after onset:0
Entered: 2014-02-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J008423 / 1 LA / UN

Administered by: Public       Purchased by: Unknown
Symptoms: Dyspnoea, Lethargy, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Patient became lethargic with shortness of breath (vasovagal syncope). Patient put in semifowlers position and 2L of O2. Patient placed in dark room while vitals monitored (stable). D/c in stable condition.


VAERS ID: 523589 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-06-27
Entered: 2014-02-24
   Days after submission:242
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN3: INFLUENZA (SEASONAL) (FLUMIST) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness: Spinal muscular atrophy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013SE49762

Write-up: A report has been received from a physician a 17 year old, female subject, who had been receiving FLUMIST (Intranasal). The patient''s concurrent disease(s) included spinal muscular atrophy four. FLUMIST (Intranasal) started on an unknown date. The patient experienced pneumonia. The outcome of the event of pneumonia is unknown. The report was considered to be non-serious by the reporter.


VAERS ID: 523667 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Tennessee  
Vaccinated:2013-10-15
Onset:2013-10-15
   Days after vaccination:0
Submitted: 2013-10-15
   Days after onset:0
Entered: 2014-02-24
   Days after submission:132
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BJ2154 / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Drug administration error, Underdose
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013SE76539

Write-up: A report has been received from a Pharmacist concerning a 17 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST (intranasal) started on 15-Oct-2013. It was reported that during administration product did not go into the first nostril when the clip was removed the FLUMIST streamed into the second nostril and ran down her face onto lips which started on 15-Oct-2013. The outcome of the event of during administration product did not go into the first nostril when the clip was removed the FLUMIST streamed into the second nostril and ran down her face onto lips is unknown. The report was considered to be non-serious.


VAERS ID: 523739 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Ohio  
Vaccinated:2013-12-04
Onset:2013-12-04
   Days after vaccination:0
Submitted: 2013-12-05
   Days after onset:1
Entered: 2014-02-24
   Days after submission:81
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BH2124 / UNK NS / IN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013SE89133

Write-up: A report has been received from a Health Professional concerning a 17 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 04-Dec-2013. It was reported that four patients were inadvertently administered with expired FLUMIST QUADRIVALENT which started on 04-Dec-2013. The outcome of the event of inadvertently administered expired FLUMIST QUADRIVALENT to four patients is unknown. The report was considered to be non-serious.


VAERS ID: 523881 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2013-11-11
Submitted: 2013-11-25
   Days after onset:14
Entered: 2014-02-24
   Days after submission:91
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013SE86915

Write-up: A report has been received from a Pharmacist concerning a 17 year old, female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. Pharmacist reported that the patient received only a half dose of FLUMIST in one nostril which started on 11-Nov-2013 at a mobile clinic. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.


VAERS ID: 523938 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2013-11-11
Onset:2013-11-11
   Days after vaccination:0
Submitted: 2013-11-25
   Days after onset:14
Entered: 2014-02-24
   Days after submission:91
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013SE86874

Write-up: A report has been received from a Pharmacist concerning a patient born on 06-Jan-1996, female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The patient experienced administration of only a half dose of FLUMIST in one nostril. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.


VAERS ID: 523956 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Florida  
Vaccinated:2013-12-05
Onset:2013-12-05
   Days after vaccination:0
Submitted: 2013-12-05
   Days after onset:0
Entered: 2014-02-24
   Days after submission:81
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BJ2012 / UNK NS / IN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013SE89262

Write-up: A report has been received from a Health Professional concerning a 17 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 05-Dec-2013. The reporter stated that the patient was inadvertently administered expired FLUMIST to four patients which started on 05-Dec-2013. The outcome of the event of inadvertently administered expired FLUMIST to four patients is unknown. The report was considered to be non-serious.


VAERS ID: 524018 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: South Dakota  
Vaccinated:2014-02-12
Onset:2014-02-13
   Days after vaccination:1
Submitted: 2014-02-26
   Days after onset:13
Entered: 2014-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH906AA / 4 LA / UN

Administered by: Private       Purchased by: Unknown
Symptoms: Muscular weakness, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: C/O leg/arm muscle pain and weakness ongoing since flu vaccine. Woke up with symptoms the morning following the flu vaccine. Seen 2/26 - Rx ibuprofen tid x 7 days.


VAERS ID: 524124 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Unknown  
Location: Michigan  
Vaccinated:2014-02-10
Onset:2014-02-10
   Days after vaccination:0
Submitted: 2014-02-27
   Days after onset:17
Entered: 2014-02-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1402USA012213

Write-up: This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. On 10-FEB-2014, the patient was administered a dose of GARDASIL (lot#, expiry date, dose, frequency, route and indication not reported) which went through an unsupported temperature excursion. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.


VAERS ID: 524455 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-10-01
Onset:2013-10-01
   Days after vaccination:0
Submitted: 2014-03-04
   Days after onset:154
Entered: 2014-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Computerised tomogram normal, Malaise, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Drug hypersensitivity
Preexisting Conditions: BACTRIM, Drug hypersensitivity
Allergies:
Diagnostic Lab Data: CT scans of the area: Negative (unknown date)
CDC Split Type: WAES1402USA010842

Write-up: This spontaneous report as received from a registered nurse refers to an approximately 17 year old female patient with BACTRIM allergy. The patient received dose one of the GARDASIL injection series about four months ago (in approximately October 2013) (lot #, expiry date, dose and route unknown). Concomitant therapies included amitriptyline (manufacturer unknown) and CARAFATE. The nurse reported that since revealing the GARDASIL, the patient had not felt very well-explained as having a feeling that a hand was around her throat. The nurse reported that because of this sensation, the patient had visited the Ear, Nose and Throat doctor. Patient had CT (computerized tomogram) scans of the area and results were negative. No treatment was given for the event. The patient was not recovered. Additional information has been requested.


VAERS ID: 524478 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Michigan  
Vaccinated:2014-03-03
Onset:2014-03-03
   Days after vaccination:0
Submitted: 2014-03-04
   Days after onset:1
Entered: 2014-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4658BB / 2 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Streaking from the site of the injection~Pneumo (Pneumovax)~3~14.67~Patient
Other Medications: Cetirizine hcl, triprolidine-pseudoephedrine, sertraline and alprazolam.
Current Illness: Depression and EE (eosinophilic esophagitis) and his right ear swelled up the previous night. It became itchy, red and warm to the touch.
Preexisting Conditions: Eggs, Fish, Milk, Nuts, Shellfish, Soy and seasonal allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pt had meningococcal vaccine yesterday at well visit, broke out in hives last night. Had welts covering him from his head/hairline, down his torso, and on his arms. Mom called nurse on call and was told to give Benadryl. Seemed to help a little, this morning still had the hives.


VAERS ID: 524484 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-01-20
Onset:0000-00-00
Submitted: 2014-03-04
Entered: 2014-03-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Adnexa uteri pain, Fungal infection, Increased appetite, Pregnancy test positive, Smear cervix, Therapeutic response unexpected, Vaginal discharge, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Cystitis
Allergies:
Diagnostic Lab Data: 04/23/2012, Pregnancy test, pregnancy
CDC Split Type: WAES1204USA04591

Write-up: Information has been received from a consumer, for GARDASIL, a Pregnancy Registry product, concerning her 16 year old daughter with no known drug reactions/allergies and a history of bladder infection who on 17-AUG-2011 and 20-JAN-2012 was vaccinated with her two doses of GARDASIL (lot # not reported) respectively. There was no concomitant medication. The patient had a yeast infection and pain in her ovaries. Her acne on her face cleared up and her appetite increased. On 23-APR-2012 a pregnancy test was performed. In January 2012, Pap smear was performed. The patient was found pregnant. The patient had called the nurse. The patient''s LMP (last menstrual period) was 14-OCt-2011 and EDD (estimated date of delivery) was 20-JUL-2012. At the time of the report, outcome of the patient was unknown. Follow up information has been received from the nurse practitioner''s receptionist who stated that on 23-APR-2012, the patient was given a pregnancy test. The patient was not seen back in the office until 20-JUN-2013 due to vaginal spotting and vaginal discharge. There was no information available about the outcome of the pregnancy in the patient''s chart. The patient''s vaginal spotting and vaginal discharge outcome was unknown. Additional information has been requested.


VAERS ID: 524558 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Michigan  
Vaccinated:2012-05-15
Onset:2012-05-15
   Days after vaccination:0
Submitted: 2014-03-05
   Days after onset:659
Entered: 2014-03-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, Injection site pain, Pregnancy test positive
SMQs:, Extravasation events (injections, infusions and implants) (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis; Drug hypersensitivity, amoxicillin, continuing; Drug hypersensitivity, LORABID, DIFLUCAN, Continuing
Preexisting Conditions: Amoxicillin, Drug hypersensitivity; DIFLUCAN, fluconazole, drug hypersensitivity; LORABID, loracarbef, drug hypersensitivity
Allergies:
Diagnostic Lab Data: 05/2012, Pregnancy test, Pregnant, 5 tests at home: pregnant, Lab date: Date unknown
CDC Split Type: WAES1205USA04726

Write-up: Information has been received from a 17 year old female patient with drug allergy to DIFLUCAN and LORABID and amoxicillin allergy and with no pertinent medical history, for HPV rL1 6 11 16 18, a Pregnancy Registry product, who on 15-MAY-2012 was vaccinated with a dose of HPV rL1 6 11 16 18 (lot # not reported). Secondary suspect therapy included a dose of hepatitis A virus vaccine inactivated (manufacturer unknown) (lot # not reported) at the same doctor visit. Concomitant therapy included a dose of meningococcal vaccine (unspecified) (lot # not reported) at the same doctor visit. On an unspecified date in May 2012, the patient took 5 pregnancy tests at home which showed that she was pregnant. Last menstrual period (LMP) was on 17-APR-2012 and the estimated delivery date (EDD) was on 22-JAN-2013. On 15-MAY-2012 the patient experienced injection sites hurt for a day or so, but the pain was "now: gone. The patient had sought medical attention by visiting the doctor. Follow-up was received from a registered nurse stating that the patient''s hospital record stated that the baby appeared in good health. The last date that the patient had an appointment was in May 2012. The patient never came in to the office following birth. Additional information is not expected.


VAERS ID: 524779 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2011-08-31
Onset:0000-00-00
Submitted: 2014-03-06
Entered: 2014-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Adverse event, Exposure during pregnancy, 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)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Human chorionic gonadotropin, positive
CDC Split Type: WAES1109USA00603

Write-up: Information has been received from a consumer for GARDASIL, a Pregnancy Registry product, concerning her granddaughter (who she adopted) 17 year old with no pertinent medical history and no allergies who on 31-AUG-2011 was vaccinated with the second dose of GARDASIL and was pregnant. Also, another vaccine was given on that same date, but consumer did not known which one. After the vaccine administration her granddaughter had exam (results not provided) and urine test which confirmed she was pregnant. Consumer stated her granddaughter was not experiencing any problems, was healthy. The patient sought unspecified medical attention (she was in the office). No treatment was given for the treatment of the adverse event. It was reported that the date of LMP was on 10-JUN-2011. EDD was on 16-MAR-2012. Follow up information has been received. There has been no response to any attempts for outcome. The case is lost to follow up. Pregnancy outcome was reported as lost to follow up. No further information is available.


VAERS ID: 526036 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Georgia  
Vaccinated:2014-03-12
Onset:2014-03-12
   Days after vaccination:0
Submitted: 2014-03-13
   Days after onset:1
Entered: 2014-03-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J011272 / 4 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4585AB / 2 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Incorrect dose administered
SMQs:, Medication errors (narrow)

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

Write-up: Pt was given a 4th dose of GARDASIL in error.


VAERS ID: 526047 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Oregon  
Vaccinated:2014-03-10
Onset:2014-03-10
   Days after vaccination:0
Submitted: 2014-03-12
   Days after onset:2
Entered: 2014-03-18
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4424AA / 1 LA / SYR

Administered by: Other       Purchased by: Public
Symptoms: Blindness, Dyskinesia, Fatigue, Loss of consciousness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Vaccine given with sterile technique. About 1 min post-injection, pt attempted to stand up from chair, pt not coherent. Ran to patient who made a jerking motion, then after a few sec - was able to respond, but not making sense. Very pale. Co-worker came into room. We assisted patient to the bed and placed in supine position. Pt stated "I can''t see, are my eyes open." Within 30 sec, pt was answering appropriately, vision returned. Vitals taken and normal. Complete return to condition prior to incident. Total time of black-out, loss of vision about 1.5 min. Monitored for 45 min post-reaction. Notified mother. Notified FNP. Mother picked up patient. Made f/u care call 1.5 hrs later, patient doing well, just "tired".


VAERS ID: 526171 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Delaware  
Vaccinated:2013-10-28
Onset:2013-10-29
   Days after vaccination:1
Submitted: 2014-03-19
   Days after onset:141
Entered: 2014-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J009243 / 3 LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Decreased appetite, Headache, Syncope, Tremor, Urine analysis normal
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Sulfa drugs
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1403USA004185

Write-up: shakiness; lack of appetite but not necessarily nausea; syncope; headache; low grade temperature of 99F.


VAERS ID: 526367 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Washington  
Vaccinated:2014-03-19
Onset:2014-03-19
   Days after vaccination:0
Submitted: 2014-03-20
   Days after onset:1
Entered: 2014-03-21
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4446AC / 1 RA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Asthma, Chest X-ray, Condition aggravated, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLOVENT; Albuterol; Augmentin; AVIANE
Current Illness: Upper respiratory infection; Asthma
Preexisting Conditions: Peanuts; Tree nuts; Pineapple; Asthma
Allergies:
Diagnostic Lab Data: CXR
CDC Split Type:

Write-up: Worsening SOB; asthma worse w/in 30-60 min. After several hours, shortness of breath, not responding to albuterol inhaler - by 6:00 PM, SOB severe and told Mom.


VAERS ID: 526385 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Michigan  
Vaccinated:2014-03-20
Onset:2014-03-20
   Days after vaccination:0
Submitted: 2014-03-21
   Days after onset:1
Entered: 2014-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. J011385 / 1 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Injection site pain, Rash pruritic, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Parent called approx 1 hour after the Hep A vaccine was administered in the (L) arm. States pt had a rash on both arms, base of neck and upper chest. The vaccine was painful at administration. The rash was itchy. Today mom described the rash as hives.


VAERS ID: 526408 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: California  
Vaccinated:2014-03-17
Onset:2014-03-17
   Days after vaccination:0
Submitted: 2014-03-21
   Days after onset:4
Entered: 2014-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB641AA / 1 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Loss of consciousness, Myalgia, Petit mal epilepsy
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

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

Write-up: Patient recieved an Hep-A vaccine. Did well ok''d to go with father to waiting room to wait another 20 minutes. Observed his father with LOC. Patient himself had LOC with petite type seizure, was brought to floor safely by self and assistants from others in waiting room. LOC x30 seconds. He was also sent back to room. Given cool packs & apple juice. Vital sign checked and was WNL. Patient recovered within 10 minutes. Doing better. Had some sore muscle pain to left ankle. He was advised also to seek medical evaluation. Patient stated that he had no breakfast or lunch prior to visit. Family members arrived with a lunch. Left clinic at 3:45 PM with father and a family driver.


VAERS ID: 526466 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2013-10-22
Onset:2013-11-22
   Days after vaccination:31
Submitted: 2014-03-24
   Days after onset:121
Entered: 2014-03-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H020002 / 2 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1403USA009912

Write-up: This spontaneous report as received from a consumer regarding her daughter refers to a female patient of unknown age. No information about medical history concurrent conditions and concomitant medications was reported. On an unknown date the patient was vaccinated with GARDASIL lot # J007354, 3 doses (specific dates and times of vaccine administration was not reported). On an unknown date the patient experienced trouble breathing (Hospitalization) after receiving a dose of GARDASIL and was admitted into ER (location, duration, demographics unknown). The reporter stated that her daughter had reaction after receiving the recalled lot, lot # J007354. It was unspecified by the reporter after which dose she had the event as she had no specific information about which dose of GARDASIL was the recalled lot. The reporter was also concerned about the letter in the mail which she had received, stating about the recall from Merck. The reporter explained that she wanted Merck to contact the responsible physician in regards to the AE reported. The outcome of trouble breathing was reported as recovering/resolving. The patient had not sought medical attention. No product quality compliant was involved. The causality assessment was not provided. Additional information has been requested.


VAERS ID: 526467 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2014-03-12
Onset:2014-03-12
   Days after vaccination:0
Submitted: 2014-03-18
   Days after onset:6
Entered: 2014-03-24
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UH666AA / UNK LA / SC

Administered by: Private       Purchased by: Private
Symptoms: Dizziness, Malaise, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Fever (low-grade), nausea, dizziness, malaise x 24 hrs.


VAERS ID: 526508 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Georgia  
Vaccinated:2013-10-02
Onset:0000-00-00
Submitted: 2014-03-24
Entered: 2014-03-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J007354 / 2 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Mouth ulceration
SMQs:, Severe cutaneous adverse reactions (broad), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Mom states patient had several ulcers in the mouth after rec. 1st and 2nd dose of the HPV vaccine.


VAERS ID: 526554 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Virginia  
Vaccinated:2014-03-23
Onset:2014-03-24
   Days after vaccination:1
Submitted: 2014-03-24
   Days after onset:0
Entered: 2014-03-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. H018786 / 2 RA / SC

Administered by: Other       Purchased by: Private
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Zoloft 50mg qhs, Vitamin D 10,000iu daily, Melatonin 3mg qhs
Current Illness: No known illness
Preexisting Conditions: NKDA
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Quarter sized lump to injection site with itching. Redness 9cm by 5cm to right arm where injection given. Benadryl 50mg given and hydrocortisone 1% ointment applied to site for itching.


VAERS ID: 526651 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Washington  
Vaccinated:2014-03-20
Onset:2014-03-20
   Days after vaccination:0
Submitted: 2014-03-21
   Days after onset:1
Entered: 2014-03-25
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J012212 / 1 LA / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. J004204 / 1 RA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J006806 / 1 LA / SC

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

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

Write-up: 15 mins post injection; rash, erythema, itching localized approximately 4 cm diameter with approximately 20 mm wheal. No systemic reactions. Benadryl 25 mg P.O. given. 30 mines later local reaction reduced by 75%. Told to repeat Benadryl at home.


VAERS ID: 526675 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Washington  
Vaccinated:2014-01-30
Onset:2014-01-31
   Days after vaccination:1
Submitted: 2014-03-25
   Days after onset:52
Entered: 2014-03-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J007681 / 2 LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Dyspnoea, Injection site erythema, Injection site rash, Rash erythematous
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Red rashes on her neck, ears and injection site, slight dyspnea, given cortisone cream on the neck.


VAERS ID: 526925 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Vermont  
Vaccinated:2014-02-21
Onset:2014-03-16
   Days after vaccination:23
Submitted: 2014-03-27
   Days after onset:11
Entered: 2014-03-28
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J008423 / 1 LA / IM

Administered by: Private       Purchased by: Public
Symptoms: Anti-ganglioside antibody negative, Areflexia, Diplopia, Electromyogram abnormal, Facial paresis, Immunoglobulin therapy, Laboratory test, Lumbar puncture normal, Metabolic function test, Miller Fisher syndrome, Muscular weakness, Paraesthesia, Sensory disturbance, VIIth nerve paralysis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Ocular motility disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: EMG c/w GBS; metabolic panel; Neg LP; neg ganglioside panel; some studies still pending
CDC Split Type:

Write-up: Teen presented 3/18 with facial weakness, diplopia, and tingly progressed with a descending weakness areflexia felt consistent with Miller Fisher syndrome - a Guillain Barre variant. Received IVIG x 5 days with improvement in facial palsies, but persistent weakness, sensory changes.


VAERS ID: 527023 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Kansas  
Vaccinated:2014-03-21
Onset:2014-03-21
   Days after vaccination:0
Submitted: 2014-03-28
   Days after onset:7
Entered: 2014-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J009098 / 3 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Headache, Hiccups, Oropharyngeal pain, Pain in extremity, Vomiting
SMQs:, Acute pancreatitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None indicated at visit
Preexisting Conditions: NKDA; Allergic to eggs and tree nuts; No medicinal conditions
Allergies:
Diagnostic Lab Data: None done
CDC Split Type:

Write-up: Pt presented back to clinic 1 hour after vaccine administration with c/o sore throat, leg pain, headache, and hiccups. Dr assessed pt in clinic at this time and every c/o resolved except hiccups. Pt was sent home in care of his mother. Mother called at 2:00 stating pt also had vomiting once at home.


VAERS ID: 527025 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Puerto Rico  
Vaccinated:2014-03-28
Onset:2014-03-28
   Days after vaccination:0
Submitted: 2014-03-28
   Days after onset:0
Entered: 2014-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J013324 / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M12104 / 1 RA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS N4L777 / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J008650 / 1 LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Body temperature increased, Dyskinesia, Eye movement disorder
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad), Ocular motility disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: Hx of ADD w/o meds
Allergies:
Diagnostic Lab Data: 102; Sat = 99%; BP = 120/82; P = 62
CDC Split Type:

Write-up: I was called by immunization nurse. She told me pt developed involuntary movements after rolled eye with HPV administration.


VAERS ID: 527095 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-29
Entered: 2014-03-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Headache, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1403USA011187

Write-up: This spontaneous report was received from a other health care worker via company representative refers to a 17 year old male patient. On an unknown date, the patient was vaccinated with third dose of GARDASIL (lot number, expiry date was unknown). On an unknown date, the patient experienced headache and nausea after taking the third shot. The outcome of headache and nausea was reported as not recovered/not resolved. Additional information is not expected.


VAERS ID: 527388 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: California  
Vaccinated:2014-03-26
Onset:2014-03-26
   Days after vaccination:0
Submitted: 2014-04-02
   Days after onset:7
Entered: 2014-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J012212 / 1 LA / IM

Administered by: Public       Purchased by: Unknown
Symptoms: Blood glucose, Blood pressure decreased, Dizziness, Fall
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Vestibular disorders (broad), Dehydration (broad)

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

Write-up: Dizziness. Fall. Blood Pressure Drop and stabilize within 15min.


VAERS ID: 527707 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-04-02
Onset:2014-04-02
   Days after vaccination:0
Submitted: 2014-04-07
   Days after onset:5
Entered: 2014-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J011960 / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Fall
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NUVARING
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1404USA003114

Write-up: This spontaneous report as received from a healthcare worker refers to a 17 year old female patient with no drug reactions or allergies and with no medical history. On 02-APR-2014 the patient was vaccinated intramuscularly with the first dose of GARDASIL (lot # J011960, expiration date 06-AUG-2015, dose not reported). Concomitant therapies included NUVARING. On 02-APR-2014 after receiving the first dose of GARDASIL the patient experienced seizure. The reporter stated that the patient fell out of the chair she was sitting in the office. The patient was taken to the hospital by the paramedics and was admitted. The outcome of seizure was unknown. The patient sought medical attention by being at the doctor''s office. The relatedness between the therapy with GARDASIL and seizure was not reported. Upon internal review the event of seizure was determined to be medically significant. Additional information has been requested.


VAERS ID: 527794 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: New York  
Vaccinated:2013-11-04
Onset:2014-01-31
   Days after vaccination:88
Submitted: 2014-04-07
   Days after onset:65
Entered: 2014-04-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS PH43F / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A13017 / 1 RA / IM

Administered by: Private       Purchased by: Private
Symptoms: Blood test normal, Borrelia test negative, Culture urine negative, Cytomegalovirus test negative, Dizziness, Fatigue, Full blood count normal, Headache, Mononucleosis heterophile test negative, Red blood cell sedimentation rate normal, Thyroid function test normal, Vertigo
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Guai Fenesin (Cough, Cold, Allergy) Hives
Allergies:
Diagnostic Lab Data: Bloodwork: Mono, Lyme testing, CBC, CMV, ESR, Thyroid and urine cultures - normal.
CDC Split Type:

Write-up: Dizziness, vertigo, headaches, fatigue. Seen by primary care physician and a neurologist. Bloodwork: Mono, Lyme testing, CBC, CMV, ESR, Thyroid and urine cultures - normal.


VAERS ID: 527806 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2013-05-15
Submitted: 2014-03-13
   Days after onset:302
Entered: 2014-04-08
   Days after submission:26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Erythropsia
SMQs:

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

Write-up: Erythropsia in both eyes - pink/red tinged vision (happens with febrile illnesses) that has been recurrent since May 2013 - one month after Tdap vaccine.


VAERS ID: 527898 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: New York  
Vaccinated:2014-04-07
Onset:2014-04-07
   Days after vaccination:0
Submitted: 2014-04-09
   Days after onset:2
Entered: 2014-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J013324 / 1 RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Asthenia, Dizziness, Heart rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Dehydration (broad)

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

Write-up: Weakness, fast heartbeat, and dizziness.


VAERS ID: 527927 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2014-04-07
Onset:2014-04-07
   Days after vaccination:0
Submitted: 2014-04-09
   Days after onset:2
Entered: 2014-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J004158 / 3 RA / SC

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

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

Write-up: Patient C/O pain, tender to touch at injection site with redness around the area.


VAERS ID: 527963 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Florida  
Vaccinated:2014-03-24
Onset:2014-03-24
   Days after vaccination:0
Submitted: 2014-04-07
   Days after onset:14
Entered: 2014-04-09
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 5B23A / 1 LA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J011272 / 3 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M12090 / 2 LA / UN

Administered by: Private       Purchased by: Public
Symptoms: Asthenia, Eye movement disorder, Tremor, Visual impairment
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Ocular motility disorders (narrow), Hypoglycaemia (broad)

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

Write-up: 2-3 mins after blood drawn 1st vac. was administered (LA) MCV4, pt blinked/winced for pain. Pt claimed that she was feeling weak, nothing to eat that morning, then second vac. given (HepA-LA), pt''s legs were shaking (impatient). 3rd vac. given (HPV-RA) pt claimed that she''s seeing dark spots, leaned head against the wall (resting), noticed pt held hands up (breast level) and eyes were slightly rolled back. Physician was called and ordered 2L of O2, gave pt sweet (lollipop), mom gave pt a sandwich, lie down for observation. After 30 mins pt was discharged in no distress, vital signs were checked and were within normal limits.


VAERS ID: 528202 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: California  
Vaccinated:2014-03-06
Onset:2014-03-06
   Days after vaccination:0
Submitted: 2014-04-08
   Days after onset:32
Entered: 2014-04-11
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) / MEDIMMUNE VACCINES, INC. BL2149 / 2 NS / IN
HEPA: HEP A (VAQTA) / MERCK & CO. INC. J012768 / 2 RA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J012212 / 3 RA / UN
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR J15611 / 3 RA / SC
TD: TD ADSORBED (NO BRAND NAME) / SANOFI PASTEUR C4153AA / 3 LA / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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

Write-up: Temp in the refrigerator was 19 degrees C for approx. 2 hrs. Action recalled client.


VAERS ID: 528266 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: California  
Vaccinated:2014-02-14
Onset:2014-02-14
   Days after vaccination:0
Submitted: 2014-04-10
   Days after onset:54
Entered: 2014-04-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH899AB / 1 LA / SYR
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J005423 / 1 LA / SC

Administered by: Private       Purchased by: Public
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Nausea
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: Pt stayed at office for 30 min after receiving injection. Pt''s mom states, 30 min after injections patient, felt nauseous/swelling at injection site, burning and itching, mom stated she did not call office wanted to wait til patient felt better - Pt''s mom was given info regarding reactions verbally with VIS info hardcopy. Pt is scheduled for 2nd HPV on 4/14/14 which prompted mom to call.


VAERS ID: 528310 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Maine  
Vaccinated:2014-03-28
Onset:2014-03-28
   Days after vaccination:0
Submitted: 2014-04-14
   Days after onset:17
Entered: 2014-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC52B081AA / 1 RA / IM

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

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

Write-up: Vaccine was expired on 02/15/2014.


VAERS ID: 528542 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: New Jersey  
Vaccinated:2013-10-01
Onset:0000-00-00
Submitted: 2014-04-15
Entered: 2014-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 1745AA / 2 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood test, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Cardiac operation; Heart disease congenital
Allergies:
Diagnostic Lab Data: Blood work (date and results unspecified)
CDC Split Type: WAES1403USA013208

Write-up: This spontaneous report as received from the mother of a consumer refers to a 17 year old female patient. The patient''s medical history included heart defect at birth and heart surgery at 1 years old. On 31-JUL-2013 the patient was vaccinated with GARDASIL dose 1, intramuscular in the left arm. The second dose of GARDASIL was received on an unspecified date in October 2013. Five days later on an unspecified date in 2013 the patient experienced frequent headaches for a few weeks, which eventually dissipated. The patient received the third dose of GARDASIL on 17-FEB-2014. The patient did not use any concomitant medication and no known previous drug reactions/allergies. As of approximately 20-FEB-2014 the patient maintained a constant headache sometimes accompanied by nausea. The patient returned to the physician''s office on an unknown date and was prescribed steroids (brand and manufacturer not specified). Unspecified blood work was performed on an unknown date. It was reported that the patient was still experiencing the headaches. The outcome of the nausea was unknown. Additional information has been requested.


VAERS ID: 528701 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-04-10
Onset:2014-04-12
   Days after vaccination:2
Submitted: 2014-04-17
   Days after onset:5
Entered: 2014-04-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H020901 / 2 LA / IM

Administered by: Private       Purchased by: Other
Symptoms: Hypoaesthesia, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Papilloma viral infection; Drug hypersensitivity
Preexisting Conditions: Penicillin (unspecified); Antimicrobial (unspecified)
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1404USA008942

Write-up: This spontaneous report as received from a health care worker refers to a 17 year old female patient with drug allergy to cephalosporins (manufacturer unknown), penicillins manufacturer unknown) and sulfa drugs (manufacturer). The patient''s pertinent medical history as none. On 04-FEB-2014, the patient was vaccinated with GARDASIL (route: Intramuscularly) for treatment of human papillomavirus (HPV). On 10-APR-2014 the patient was vaccinated with second dose of GARDASIL (Intramuscularly in the left arm) (lot # H020901, Expiry date: 05-JUL-2015). No concomitant therapies were reported. On 12-APR-2014, the patient developed numbness and tingling in the right arm and down to her right leg. No lab diagnostic tests were done. The outcome of developed numbness and tingling after received a second dose of GARDASIL was reported as not recovered/not resolved. The patient sought medical attention by visiting the office of the reporting health care worker. additional information has been requested.


VAERS ID: 528736 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:2014-04-09
Onset:2014-04-09
   Days after vaccination:0
Submitted: 2014-04-17
   Days after onset:8
Entered: 2014-04-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Private       Purchased by: Other
Symptoms: Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1404USA008853

Write-up: This spontaneous report as received from a pharmacist refers to a 17 year old patient. The patient''s pertinent medical history and concurrent conditions were not reported. On 09-APR-2014 the patient was vaccinated with 2 doses of GARDASIL (Dose and route of administration were not reported) in the same office visit at an unspecified physician''s office. No adverse effects were reported. The outcome was not reported. Additional information has been requested.


VAERS ID: 528765 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-04-18
Entered: 2014-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Clumsiness, Headache, Systemic lupus erythematosus
SMQs:, Systemic lupus erythematosus (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1404USA009044

Write-up: This spontaneous report was received from a registered nurse who read a life story of a 17 year old patient on a website. On an unknown date the patient was vaccinated with GARDASIL dose 2 (dose, lot no and route not reported). On an unknown date after the 2nd dose, the patient experienced clumsiness, headache and lupus. The outcome of lupus, headache and clumsiness was unknown. Upon internal review, lupus was determined to be medically significant. This is one of the several reports received from the same source. Additional information is not expected.


VAERS ID: 528821 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Unknown  
Vaccinated:2013-03-01
Onset:2013-03-01
   Days after vaccination:0
Submitted: 2014-04-18
   Days after onset:412
Entered: 2014-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Influenza like illness, Local swelling, Pruritus, Rash generalised, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1404USA004490

Write-up: This spontaneous report as received from the mother of a 17 year old male patient. Pertinent medical history was not reported. On MAR-2013 the patient was vaccinated with his third dose of GARDASIL. He received his first dose in 2012 (month and date unspecified) without symptoms. It was not specified when he received his second dose. Concomitant therapies included amoxicillin (reason taking not identified). Within days of receiving the third dose, the patient experienced full body rash, intermittent swelling in arms from hand to shoulders, "alligator and chicken like scales", itchiness and flu like symptoms. Upon visiting a physician (date unspecified), the patient was referred to a pulmonary allergist. No diagnosis to date had been made. The outcome of the events were reported as not recovered/not resolved. Additional information has been requested.


VAERS ID: 528844 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2014-04-14
Onset:2014-04-14
   Days after vaccination:0
Submitted: 2014-04-15
   Days after onset:1
Entered: 2014-04-18
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4593AB / 2 LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Chest discomfort, Diarrhoea, Dizziness, Dyspnoea, Headache, Oropharyngeal pain, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow)

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

Write-up: 2 hours after office visit and MCV she had chest tightness and difficulty breathing. She was treated for wheezing in the ED with Albuterol x 1. She also reported vomiting and diarrhea x 1 about 4 hours after. Some dizziness; No syncope. Had 2 doses of BENADRYL. Has had headaches on and off too. Sore throat began 4 hours after immun.


VAERS ID: 528881 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-04-18
Entered: 2014-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Alopecia, Antibody test abnormal, Benign breast neoplasm, Breast operation, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Vasculitis (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Surgery
Allergies:
Diagnostic Lab Data: Antibody level test (unknown date): antibodies level normal at times and elevated levels also reported
CDC Split Type: WAES1404USA009121

Write-up: This spontaneous report as received from a physician via company representative refers to a currently 24 year old female patient (age at onset of AE calculated to be approximately 21 years). The patient''s medical history included tonsil removal, no drug allergies. Patient received 3 doses of GARDASIL intramuscular (dose strength was not reported), doses were administered in time frame of 2006 and 2007 when the patient was 17 years old. Lot number was not reported. In 2011, the patient experienced hair loss, weight loss and reported that her thyroid was being attacked by antibodies. Antibodies levels were normal at times while elevated levels were also reported to the physician. The patient had breast surgery to remove a benign fibroid tumour (medically significant). No treatment was provided to the patient at this time for autoimmune symptoms. The patient had sought medical attention. The outcome of event benign fibroid tumor and breast surgery to remove a benign fibroid tumor was unknown. The outcome of the rest of the events was reported as not recovered. Physician informed the company representative that these symptoms have been reported to the VAERS. Upon internal review, the event breast surgery was determined to be medically significant. Additional information has been requested.


VAERS ID: 528969 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2014-03-11
Onset:2014-03-21
   Days after vaccination:10
Submitted: 2014-04-21
   Days after onset:31
Entered: 2014-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. K000146 / 3 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Bronchospasm, Eyelid oedema, Lip swelling, Local swelling, Rash generalised, Serum sickness, Skin discolouration, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Periorbital and eyelid disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Drug hypersensitivity
Preexisting Conditions: Penicillin, Drug Reaction: Drug hypersensitivity; CEFZIL, Drug Reaction: Drug hypersensitivity; ZITHROMAX, Drug Reaction: Drug hypersensitivity; AUGMENTIN, Drug Reaction: Drug hypersensitivity
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1404USA010225

Write-up: This spontaneous report as received from a healthcare worker refers to a 17 year old female patient with no pertinent medical history. The patient was allergic to ZITHROMAX, AUGMENTIN, CEFZIL and penicillin. On 31-OCT-2014 and 03-DEC-2014, the patient was vaccinated with the first and second doses of GARDASIL (lot #, dose and route not reported0, respectively. On 11-MAR-2014 the patient was vaccinated with the third dose of GARDASIL, 120 Y injection, lot # reported as K000146, expiration date 16-AUG-2016, (dose and route not reported). There was no concomitant medication. On 21-MAR-2014, the patient developed a diffuse rash on her entire body after receiving a third dose of GARDASIL. The healthcare worker also mentioned the patient developed swelling of her hands and feet, puffiness under her eyelids and puffy lips, bronchospasm and wheezing, discoloration of her feet and "serum sickness to the unknown". The healthcare worker mentioned the patient was seen in the emergency room. The patient had no previous reactions to GARDASIL before receiving her third dose and the patient was sent to an unspecified allergist. BENADRYL, DECADRON and prednisone were given for adverse event. The outcome of the event was recovered on 03-APR-2014. Additional information has been requested.


VAERS ID: 529093 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-03-31
Onset:2014-04-03
   Days after vaccination:3
Submitted: 2014-04-22
   Days after onset:19
Entered: 2014-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J013324 / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR 44593AB / 1 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Injection site erythema, Injection site pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACZONE; LEXAPRO
Current Illness: Abnormal behaviour; Anxiety; Depression
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1404USA003113

Write-up: Information has been received from a nurse concerning a 17 year old female patient with a history of depression, anxiety and behavioral disorder. Concomitant medication included LEXAPRO and ACZONE. On 31MAR2014 the patient was vaccinated with GARDASIL (lot # J013324, expiration date 12FEB2016), intramuscular, in the left arm for "Going to College". The patient also received a dose of MENACTRA in the left arm that same day. On 03APR2014, 4 days after onset of therapy, the patient experienced leg pain and complained of injection site pain and redness where she received MENACTRA. The outcome of leg pain and injection site pain and redness was unknown. Additional information has been requested.


VAERS ID: 529100 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Kentucky  
Vaccinated:2013-09-24
Onset:2013-09-24
   Days after vaccination:0
Submitted: 2014-04-17
   Days after onset:205
Entered: 2014-04-22
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4445A3 / 1 UN / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4332PA / 6 UN / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. 5003535 / 2 UN / SC

Administered by: Public       Purchased by: Public
Symptoms: Local reaction, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Pt experienced syncope in waiting room and recovered without complication on 9/24/13. Returned on 9/26/13 with local reaction to (R) upper arm. Assessed and advised to see MD; referral given.


VAERS ID: 529264 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-04-15
Onset:2014-04-15
   Days after vaccination:0
Submitted: 2014-04-23
   Days after onset:8
Entered: 2014-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK RA / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1404USA011041

Write-up: This spontaneous report as received from an immunization coordinator via a company representative, refers to a 17 year old female patient. No medical history or concurrent conditions were provided. On 15-APR-2014, the patient was vaccinated with GARDASIL INJ (dose, route and lot number not provided). No co-suspect or concomitant therapies were provided. The reporter stated that on the same visit, on 15-APR-2014, the patient received 2 doses of GARDASIL in different arms. No adverse effects were reported. Additional information has been requested.


VAERS ID: 529362 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Georgia  
Vaccinated:2014-04-23
Onset:2014-04-23
   Days after vaccination:0
Submitted: 2014-04-24
   Days after onset:1
Entered: 2014-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J010668 / 2 LA / IM

Administered by: Public       Purchased by: Private
Symptoms: Hot flush, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Pt reported some shortness of breath about one hour after receiving GARDASIL (2nd in series). Mother reported pt. was having something like hot flashes and sweating spells. Mom took her to ER at 8:30 pm where she was treated with DECADRON and BENADRYL by mouth and mom states within 10 mins she was better. Mom thinks dau. felt panic and got scared. Reports O2 was 100% heart rate normal. Went to school today (4/24/).


VAERS ID: 529388 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Unknown  
Vaccinated:2014-04-16
Onset:2014-04-16
   Days after vaccination:0
Submitted: 2014-04-25
   Days after onset:9
Entered: 2014-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1404USA012006

Write-up: This spontaneous report was received from a medical assistant refers to a 17 year old male patient. No pertinent medical history of the patient was reported. On 16-APR-2014 the patient was vaccinated with GARDASIL, (dose number, dose, lot number and expiration dates were not reported) intramuscular. No concomitant medications were reported. On 16-APR-2014, the patient was inadvertently administered two doses of GARDASIL. There were no adverse effects reported. It was unspecified whether the patient had sought medical attention. There was no product quality complaint involved. Additional information has been requested.


VAERS ID: 529438 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Maryland  
Vaccinated:2014-04-22
Onset:2014-04-22
   Days after vaccination:0
Submitted: 2014-04-22
   Days after onset:0
Entered: 2014-04-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS YZ2F7 / 1 LA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H020901 / 1 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A12132 / 1 RA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 4327T / 1 LA / UN

Administered by: Private       Purchased by: Private
Symptoms: Asthenia, Headache, Nausea, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Fainted after vaccination, after fainting - exhibited headache, weakness, nausea, vomiting. Was monitored at office for 45 minutes, then sent via ambulance to hospital.


VAERS ID: 529959 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-05-01
Entered: 2014-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asthma, Condition aggravated
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis; Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1405USA000280

Write-up: This spontaneous report was received from an office manager who was the wife of the physician, via a sales representative, regarding his 17 year old son with a preexisting asthma and no known drug reactions/allergies. At the same visit, on an unknown date, within the last few months, the patient received a dose of VARIVAX (Merck) (dose, route, lot # and expiry date were not provided). Other suspect therapy included a dose of MENACTRA (dose, route, lot # and expiry date were not provided). Concomitant medications were unknown. It was reported that the patient who was a track runner, began to have exacerbations in his preexisting asthma one week after receiving the dose of VARIVAX (Merck) and MENACTRA. The reporter stated that her son had to start taking unspecified relief medications and a breathing treatment for the asthma after a running episode. No laboratory diagnostic test was performed. At the time of the report, the patient had not recovered from the event. The relatedness between the event and suspect therapies were not provided. Additional information has been requested.


VAERS ID: 529979 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-04-09
Onset:2014-04-22
   Days after vaccination:13
Submitted: 2014-05-01
   Days after onset:9
Entered: 2014-05-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J009166 / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Blood immunoglobulin G decreased, Blood immunoglobulin M increased, Rash generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADDERALL tablets
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 04/23/2014, Blood immunoglobulin G, Decreased, low at less than 135; 04/23/2014, Blood immunoglobulin M, Increased, high at 1.68
CDC Split Type: WAES1404USA015690

Write-up: This spontaneous report as received from a Licensed Practical Nurse refers to a 17 year old female patient with no medical history and no drug reactions/allergies. On 09-APR-2014 the patient was vaccinated with VARIVAX (Merck) (Lot# reported as J009166 and unspecified expiration date), 0.5 ml, subcutaneous. Concomitant therapies included ADDERALL. On 22-APR-2014, the patient was seen in the office with a "generalized rash all over her body". The patient had blood drawn at an unspecified LabCorp on 23-APR-2014. The nurse stated they received the results of the blood work on 24-APR-2014 which showed "varicella zoster IgG was low at less than 135 and varicella zoster IgM was high at 1.68". The nurse stated "our physicians determined that the rash was a reaction to the varicella vaccine and not a reported case of chickenpox". When asked the patient''s present status the nurse stated, "we told her to call if things worsened or if it didn''t go away in a few days. We haven''t heard back from her". No treatment was given for the event. Additional information has been requested.


VAERS ID: 529999 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Unknown  
Location: Unknown  
Vaccinated:2014-02-26
Onset:2014-02-26
   Days after vaccination:0
Submitted: 2014-05-02
   Days after onset:64
Entered: 2014-05-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J013277 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1405USA001162

Write-up: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were vaccinated with GARDASIL (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines'' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Follow up information was received with patient identifiers. This case reported that GARDASIL (dose and route not reported, lot # J013277, expired date: 08-JUN-2015) was administered to a 17 year old patient on 26-FEB-2014. This case was linked to 1405USA001665, 1405USA001164, 1405USA001163, 1405USA001161, 1405UA001166 and 1403USA007265. Additional information has been requested.


VAERS ID: 530057 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: New York  
Vaccinated:2014-04-04
Onset:2014-04-14
   Days after vaccination:10
Submitted: 2014-05-03
   Days after onset:19
Entered: 2014-05-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H021346 / 2 AR / UN

Administered by: Unknown       Purchased by: Other
Symptoms: Asthenia, Blood test normal, Fatigue, Headache, Myalgia, Nausea, Pain in extremity, Pallor, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Felt extremely ill~HPV (Gardasil)~1~17.42~Patient
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: All Blood work normal
CDC Split Type:

Write-up: Persistent fever, weakness, muscle pain, fatigue, headache, nausea, leg pain, paleness.


VAERS ID: 530118 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Georgia  
Vaccinated:2013-12-30
Onset:2014-02-08
   Days after vaccination:40
Submitted: 2014-05-05
   Days after onset:85
Entered: 2014-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J010668 / 2 RA / IM

Administered by: Unknown       Purchased by: Private
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram abnormal, Foaming at mouth, Grand mal convulsion, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

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

Write-up: Grand Mal seizure lasting approximately 5 minutes, foaming at the mouth, convulsions and unresponsive for 10 minutes. Called 911, vitals checked out to be ok, went to emergency room, everything came back as normal, referred to a neurologist. Went to neurologist had normal CT scan, EEG showed some abnormalities.


VAERS ID: 530126 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2014-04-28
Onset:2014-04-28
   Days after vaccination:0
Submitted: 2014-04-30
   Days after onset:2
Entered: 2014-05-05
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4677AA / 1 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J00992 / 2 RA / SC

Administered by: Public       Purchased by: Unknown
Symptoms: Headache, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SINGULAIR; QVAR
Current Illness:
Preexisting Conditions: Foods, in/outdoor allergies,trees, latex, mold; Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient states after receiving immunizations on 3/28/14 in afternoon began having localized pain in right arm that has spread from head to down right leg with pain progressively getting worse. States took Ibuprofen with little relief of pain. Had allergy shots same day as immunizations.


VAERS ID: 530184 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-05-05
Entered: 2014-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Hepatic enzyme increased, Hepatitis B antibody negative, Viral infection
SMQs:, Liver related investigations, signs and symptoms (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Hepatitis B titers (February 2014): less than 3.10, titers not adequate
CDC Split Type: WAES1404USA015448

Write-up: This spontaneous report as received from a registered nurse via a company representative refers to a 17 year old female patient. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (lot, dose and route not reported) for childhood vaccination. Concomitant medication was not reported. On an unspecified date in February 2014, the patient came down with mild virus. On 28-FEB-2014, the patient was seen by the nurse. Blood tests were administered on the patient and it was found that he had elevated liver function enzymes and his Hepatitis B titers were not adequate (less than 3.10). The nurse stated that they will readminister RECOMBIVAX HB series. The nurse also stated that the patient was recovering, his "levels are coming down," and he felt some fatigue. Additional information is not expected.


VAERS ID: 530198 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Texas  
Vaccinated:2014-04-29
Onset:2014-05-02
   Days after vaccination:3
Submitted: 2014-05-06
   Days after onset:4
Entered: 2014-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC190BA / 2 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H02090 / 2 LA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR J1561 / 2 LL / IM
TTOX: TETANUS TOXOID (NO BRAND NAME) / SANOFI PASTEUR C4403BA / 1 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J004159 / 2 RA / SC

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Patient denies any prior meds.
Current Illness: No illness noted at time of vaccine
Preexisting Conditions: None noted at time of vaccine
Allergies:
Diagnostic Lab Data: Doctor ordered the to use Caladryl on rash. Patient instructed to take Benadryl 25 mg q 4 hours as needed for itching. Instructed to return if no improvment or if worsens.
CDC Split Type:

Write-up: Rash on neck going down right arm vesicules noted. Patient c/o itching. No fever noted by parent or patient.


VAERS ID: 530215 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Unknown  
Vaccinated:2014-04-10
Onset:2014-04-10
   Days after vaccination:0
Submitted: 2014-05-06
   Days after onset:26
Entered: 2014-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J012212 / 1 UN / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1404USA011636

Write-up: This spontaneous report as received from a licensed nurse practitioner via a field representative refers to a 17 year old male patient. He had no pertinent medical history. On 10-APR-2014, the patient was vaccinated with the first dose of GARDASIL lot # J012212. No co-suspected or concomitant medications were reported. Two to three seconds after the vaccination, the patient fainted. He woke up 20 seconds later, and it took him another 2-3 minutes to become fully functional again. He received no treatment for the event. He afterwards admitted that he had not been eating or drinking anything for a long time before receiving the vaccination. Routine blood work was performed (results were not reported). This was his first dose of GARDASIL, and he will not be received the next two. A causality assessment was not provided. Additional information has been requested.


VAERS ID: 530259 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2012-12-11
Onset:2013-03-07
   Days after vaccination:86
Submitted: 2014-04-05
   Days after onset:393
Entered: 2014-05-06
   Days after submission:31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H009746 / 3 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Sent to neurologist (they''ve got info r/t these seizures)
CDC Split Type:

Write-up: Seizures (onset for first time) within several months of vaccination (3).


VAERS ID: 530349 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Oklahoma  
Vaccinated:2014-05-07
Onset:2014-05-07
   Days after vaccination:0
Submitted: 2014-05-07
   Days after onset:0
Entered: 2014-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Public       Purchased by: Other
Symptoms: Disorientation, Erythema, Fall, Fatigue, Gaze palsy, Musculoskeletal stiffness, Respiratory arrest
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Ocular motility disorders (narrow), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: Fell out of chair, eyes rolled up, stopped breathing, body stiff, face red and disoriented when she came to. She is extremely tired.


VAERS ID: 530499 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Nebraska  
Vaccinated:2014-05-08
Onset:2014-05-08
   Days after vaccination:0
Submitted: 2014-05-08
   Days after onset:0
Entered: 2014-05-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 7973G / 2 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4610BA / 2 RA / UN

Administered by: Public       Purchased by: Private
Symptoms: Dizziness, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

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

Write-up: 1101AM BP 77/45 1105AM BP 89/58. Patient received immunizations and was sitting in the chair talking with this nurse. She looked at this nurse funny and put her head between her legs. She told me she felt dizzy. I had her sit up in the chair. Became diaphoretic. Was given water, sucker, and fan. Drank a couple glasses of water and ate a sucker. Educated patient and mom to drink plenty of fluids and eat lunch when they get home, follow up with primary doctor if they felt they needed to.


VAERS ID: 530718 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Florida  
Vaccinated:2014-05-07
Onset:2014-05-07
   Days after vaccination:0
Submitted: 2014-05-12
   Days after onset:5
Entered: 2014-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR U4788AA / UNK LA / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. K000943 / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J013324 / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4610BA / 1 LA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U4869AA / 1 LA / IM

Administered by: Private       Purchased by: Private
Symptoms: Immediate post-injection reaction, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

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

Write-up: Patient developed syncope episode immediately following administration of his immunization and while being prepared for blood drawing. Pt has a hx of syncope during blood drawings.


VAERS ID: 530742 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Unknown  
Vaccinated:2014-04-30
Onset:2014-04-30
   Days after vaccination:0
Submitted: 2014-05-13
   Days after onset:13
Entered: 2014-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Crohn''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1405USA001798

Write-up: This spontaneous report as received from a physician via a company representative refers to a 17 year old female patient with Crohn''s disease. On 28-JAN-2014, the patient was vaccinated with the first dose of RECOMBIVAX HB. Dose 2 of RECOMBIVAX HB was administered at the end of February 2014, and the third dose on 30-APR-2014. The patient did not receive any other vaccines at the same time as RECOMBIVAX HB. The physician reported that the third dos of RECOMBIVAX HB was administered too soon (on 30-APR-2014). There were no serious side effects. An outcome was not reported. Additional information has been requested.


VAERS ID: 530952 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Florida  
Vaccinated:2014-04-15
Onset:2014-04-15
   Days after vaccination:0
Submitted: 2014-05-14
   Days after onset:29
Entered: 2014-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J013324 / 4 LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1404USA009363

Write-up: This spontaneous report as received from a consumer refers to her 17 year old daughter. On 15-APR-2014, the patient was vaccinated with a fourth dose of GARDASIL (dose, route and lot # not reported). The consumer stated that the patient received her third dose at a previous doctor''s visit within the same office. The physician stated to the mother that her daughter was in their computer system twice under two names and that was why he administered her the fourth shot of GARDASIL. There were no Lab diagnostics or studies performed. Follow up information was received stated that: On 15-APR-2014 at 4:00 pm, the patient was vaccinated with a fourth dose of GARDASIL (lot # J013324, expiration date 12-FEB-2016), intramuscular in the left arm for prevention of HPV. The patient received a fourth dose of GARDASIL, but they were not aware that the patient received a previous dose at another physician''s office. The patient never had any effects. They had a verbal consent from the parent. Additional information is not expected.


VAERS ID: 530946 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Indiana  
Vaccinated:2014-05-06
Onset:2014-05-13
   Days after vaccination:7
Submitted: 2014-05-15
   Days after onset:2
Entered: 2014-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. J005010 / 1 RA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J012212 / 2 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR A12119 / 2 RA / UN

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

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

Write-up: Patient noted on 5/13/14 arm soreness with movement - (L) upper arm. Then noted red and tender nodule under the skin. Punctuate at (L) deltoid noted. Exam on 5/15/14 revealed sl red, tender, well circumscribed nodule. Recommended warm compresses and treated with AUGMENTIN 875 twice a day for 10 days.


VAERS ID: 531027 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Virginia  
Vaccinated:2014-05-13
Onset:2014-05-13
   Days after vaccination:0
Submitted: 2014-05-16
   Days after onset:3
Entered: 2014-05-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4677AA / 1 LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 33AG5 / UNK RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J002317 / 2 RA / SC

Administered by: Public       Purchased by: Public
Symptoms: Injection site pain, Loss of consciousness, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Fainted. Was on exam table so allowed to lay back onto exam table as became pale. Regained consciousness within 15 seconds. Cool cloth to head. After 15 minutes sat up drank juice. Sat for 15 minutes no other issues. PC to mother 5-16-14 & client doing well only soreness at injection sites.


VAERS ID: 531065 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Illinois  
Vaccinated:2014-05-08
Onset:2014-05-08
   Days after vaccination:0
Submitted: 2014-05-16
   Days after onset:8
Entered: 2014-05-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 9E2GN / UNK LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Haematemesis, Nausea, Urinary tract infection, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Singulair 10mg 1 every evening, Ranitidine 150mg 1 twice a day, Albuterol 108 mcg/act in aers 2 puffs inhalation every 4 hours as needed for wheezing.
Current Illness: None
Preexisting Conditions: Allergies - Sulfa, Z-pak
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Nausea & Vomiting of stomach contents and bright red blood, multiple times prior to seeking treatment in ER. Treated with Zofran 4mg every 8 hours as needed for nausea. Also diagnosed with UTI and treated with an antibiotic.


VAERS ID: 531116 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Virginia  
Vaccinated:2014-03-04
Onset:2014-03-13
   Days after vaccination:9
Submitted: 2014-05-18
   Days after onset:66
Entered: 2014-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: Private
Symptoms: Back pain, Herpes zoster, Neck pain, Pain, Pain in extremity, Rash
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Patient developed a case of shingles after the second varicella shot. Symptoms included rash and pain on one side of body, back, neck & arm areas. Doctor was notified and medicine was given to her to lessen symptoms. Also of note - she had a mild case of chicken pox at the age of 4 months that she caught from her older sister. Her pediatrician at that time (1996) said this was the equivalent of having the vaccine and she would have immunity to the chicken pox. It was discovered at a check-up when she was 17 years old that she did not have the antibodies in her blood & should therefore get the varicella vaccine. She did not have an adverse reaction to the 1st shot which was given on 1/7/2014, but then got shingles after the second shot.


VAERS ID: 531190 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2014-01-24
Onset:0000-00-00
Submitted: 2014-05-12
Entered: 2014-05-19
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH899AE / UNK RA / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB586BA / 1 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 15161AA / 1 RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. H009737 / 2 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Exposure during pregnancy, Ultrasound scan normal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

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

Write-up: Pt was immunized on 1-24-14 and at the time she did not know she was pregnant. We were made aware on 5-9-14. Pt is 5 months pregnant with EDC on 9-24-14. Sonograms normal.


VAERS ID: 531238 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Texas  
Vaccinated:2014-05-19
Onset:2014-05-19
   Days after vaccination:0
Submitted: 2014-05-19
   Days after onset:0
Entered: 2014-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4585AB / UNK LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Convulsion, Dizziness
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Seizure~HPV (no brand name)~2~14.75~Patient
Other Medications:
Current Illness: None Per Parent
Preexisting Conditions: Per mother Hx of seizure with HPV#2 Vaccine on 2/22/2011.
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Seizure after MCV4 administration, when pt came to senses she stated that right before seizure she felt dizzy. First Aid for seizures rendered.


VAERS ID: 531260 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Ohio  
Vaccinated:2014-05-06
Onset:2014-05-18
   Days after vaccination:12
Submitted: 2014-05-20
   Days after onset:2
Entered: 2014-05-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -

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

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

Write-up: Rash on arms and side of neck, big red blotch.


VAERS ID: 531510 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Connecticut  
Vaccinated:2014-05-18
Onset:2014-05-19
   Days after vaccination:1
Submitted: 2014-05-19
   Days after onset:0
Entered: 2014-05-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4657AA / UNK LA / IM

Administered by: Private       Purchased by: Unknown
Symptoms: Dizziness, Fatigue
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad)

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

Write-up: Dizziness, fatigue.


VAERS ID: 531647 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Indiana  
Vaccinated:2014-05-19
Onset:2014-05-19
   Days after vaccination:0
Submitted: 2014-05-21
   Days after onset:2
Entered: 2014-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. K000943 / 1 LA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4610BA / 2 RA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J013729 / 2 RA / UN

Administered by: Private       Purchased by: Private
Symptoms: Injection site cellulitis, Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (broad)

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

Write-up: 4.2 by 6.4cm cellulitis and redness to Rt upper arm after a few hours of getting the vaccine. Pt was given a script for DURICEF caps 500mg 1 cap PO BID x 10 days.


VAERS ID: 531648 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: California  
Vaccinated:2014-02-19
Onset:0000-00-00
Submitted: 2014-04-30
Entered: 2014-05-21
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M12100 / 2 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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

Write-up: Temperature excursions of vaccine(s) listed in item 13.


VAERS ID: 531654 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: California  
Vaccinated:2014-02-11
Onset:0000-00-00
Submitted: 2014-04-30
Entered: 2014-05-21
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR J13821 / 1 LA / SC

Administered by: Public       Purchased by: Public
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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

Write-up: Temperature excursions of vaccine(s) listed in item 13.


VAERS ID: 531690 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: California  
Vaccinated:2014-01-24
Onset:0000-00-00
Submitted: 2014-04-30
Entered: 2014-05-21
   Days after submission:21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M12102 / 1 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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

Write-up: Temperature excursions of vaccine(s) listed in item 13.


VAERS ID: 531758 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Maryland  
Vaccinated:2014-03-12
Onset:0000-00-00
Submitted: 2014-05-22
Entered: 2014-05-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK UN / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Maternal exposure before pregnancy, No adverse event, Pregnancy test urine positive
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Normal pregnancy conditions and outcomes (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Urine home pregnancy test: positive
CDC Split Type: WAES1405USA004707

Write-up: This spontaneous prospective pregnancy report as received from a other health professional refers to a 17 years old female patient of unknown age. On 12-MAR-2014 the patient was vaccinated with VARIVAX (Merck) (lot # was not reported) and M-M-R II (lot # was not reported). The patient became pregnant with LMP of 24-MAR-2014 and EDD of 29-DEC-2014 (also reported estimated date of confinement was 31-DEC-2014). It was 5 weeks Gestation when reported. The patient took a urine home pregnancy test and it was positive. Another urine pregnancy test was performed at the student wellness center and was indeed positive. The patient did not experienced any adverse events. No treatment was given. The pregnancy outcome was pending. Additional information has been requested.


VAERS ID: 531809 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: California  
Vaccinated:2014-01-31
Onset:0000-00-00
Submitted: 2014-04-30
Entered: 2014-05-22
   Days after submission:22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M12100 / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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

Write-up: Temperature excursions of vaccine(s) listed in item 13.


VAERS ID: 531844 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2014-01-24
Onset:0000-00-00
Submitted: 2014-04-30
Entered: 2014-05-22
   Days after submission:22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M12102 / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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

Write-up: Temperature excursions of vaccine(s) listed in item 13.


VAERS ID: 531848 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: California  
Vaccinated:2014-02-26
Onset:0000-00-00
Submitted: 2014-04-28
Entered: 2014-05-22
   Days after submission:24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4556AB / 1 RA / IM

Administered by: Public       Purchased by: Public
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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

Write-up: Temperature excursions of vaccine(s) listed in item 13.


VAERS ID: 532066 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: California  
Vaccinated:2014-01-13
Onset:0000-00-00
Submitted: 2014-04-30
Entered: 2014-05-22
   Days after submission:22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M12100 / 1 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Incorrect storage of drug
SMQs:, Medication errors (narrow)

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

Write-up: Temperature excursions of vaccine(s) listed in item 13.


VAERS ID: 531870 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Massachusetts  
Vaccinated:2014-05-21
Onset:2014-05-22
   Days after vaccination:1
Submitted: 2014-05-23
   Days after onset:1
Entered: 2014-05-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4626AA / 2 LA / IM

Administered by: Public       Purchased by: Other
Symptoms: Cough, Oropharyngeal pain, Petechiae, Rash, Rash erythematous, Rhinorrhoea, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Woke up with mild scratchy sore throat, cough and runny nose. Then in the afternoon noticed a red rash on chest. This rash is in 2 places on chest and is petechiae. Otherwise pt is asymptomatic.


VAERS ID: 531873 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Pennsylvania  
Vaccinated:2014-04-30
Onset:2014-04-30
   Days after vaccination:0
Submitted: 2014-05-23
   Days after onset:23
Entered: 2014-05-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR K1183 / 2 LA / IM
YF: YELLOW FEVER (YF-VAX) / SANOFI PASTEUR UH660AA / 1 LA / SC

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

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

Write-up: Hives throughout body.


VAERS ID: 531916 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Ohio  
Vaccinated:2014-05-09
Onset:2014-05-20
   Days after vaccination:11
Submitted: 2014-05-27
   Days after onset:7
Entered: 2014-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / -

Administered by: Public       Purchased by: Public
Symptoms: Lymphadenopathy, Pyrexia, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: FEVER, SWOLLEN LYMPH NODES, NOT FEELING.


VAERS ID: 531994 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Texas  
Vaccinated:2014-05-27
Onset:2014-05-27
   Days after vaccination:0
Submitted: 2014-05-27
   Days after onset:0
Entered: 2014-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 LA / -

Administered by: Private       Purchased by: Private
Symptoms: Convulsion, Immediate post-injection reaction
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No medications. No previous reaction to any other vaccination. Had a TB test (for college) at same time as HPV vaccination. Had previously had a TB test with no reaction.
Current Illness: No
Preexisting Conditions: No conditions, just allergic to peanut butter, peanuts, and salmon
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Within a few seconds of the Gardasil vaccination, she had a seizure. Nurses turned her on her side and symptoms resolved in about 1 minute.


VAERS ID: 532308 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Oklahoma  
Vaccinated:2007-05-17
Onset:2007-08-15
   Days after vaccination:90
Submitted: 2014-05-29
   Days after onset:2479
Entered: 2014-05-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. UNKNOWN / 2 LA / IM

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

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

Write-up: Severe skin reaction. We were told it was eczema but she never had it before the shots. She has severe outbreaks constantly. She is now 24 and still has reactions to everything.


VAERS ID: 532642 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Ohio  
Vaccinated:2014-05-29
Onset:2014-05-29
   Days after vaccination:0
Submitted: 2014-05-30
   Days after onset:1
Entered: 2014-05-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H020901 / UNK LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A12104 / UNK RA / IM

Administered by: Private       Purchased by: Public
Symptoms: Dizziness, Hypoacusis, Immediate post-injection reaction, Pallor, Presyncope, Speech disorder
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No medication
Current Illness: None
Preexisting Conditions: Poor weight gain; BMI at 5th percentile
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Immediately after vaccine administration patient turned pale said he was lightheaded advised him to lay down. As patient laid down he had near syncope episode. His eyes were open but unable to speak or hear. Patient alert and vocal in 8-10 seconds. Patient had not eaten breakfast and fear of needles. Monitored BP and pulse for 30 min. Patient ate several (2) popsicles and was able to leave office (walking) and went home to eat and he was doing well at discharge without any symptoms.


VAERS ID: 532825 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: New York  
Vaccinated:2014-03-28
Onset:0000-00-00
Submitted: 2014-06-03
Entered: 2014-06-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Unevaluable event
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NYC1400012

Write-up: None stated.


VAERS ID: 533042 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Washington  
Vaccinated:2014-06-03
Onset:2014-06-03
   Days after vaccination:0
Submitted: 2014-06-05
   Days after onset:2
Entered: 2014-06-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS N434L / UNK RA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J006692 / UNK LA / SC

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

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

Write-up: Local redness and swelling to about 5cm of firm induration. No discharge. No evidence of abscess.


VAERS ID: 533137 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Texas  
Vaccinated:2014-06-04
Onset:2014-06-05
   Days after vaccination:1
Submitted: 2014-06-05
   Days after onset:0
Entered: 2014-06-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 7973G / 1 RA / UN
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U4678AA / 1 LA / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J009987 / 2 RA / UN

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

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

Write-up: Rash to R arm in SQ area, rash red and warm


VAERS ID: 533213 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Pennsylvania  
Vaccinated:2012-06-03
Onset:0000-00-00
Submitted: 2014-06-06
Entered: 2014-06-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS H5H4E / 4 RA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Incorrect dose administered, Wrong drug administered
SMQs:, Medication errors (narrow)

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

Write-up: Hepatitis B vaccine was administered. Patient had previously had series of 3. Hepatitis A should have been given.


VAERS ID: 533273 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Male  
Location: Maine  
Vaccinated:2014-06-04
Onset:2014-06-04
   Days after vaccination:0
Submitted: 2014-06-09
   Days after onset:5
Entered: 2014-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J011272 / UNK LA / IM

Administered by: Other       Purchased by: Public
Symptoms: Inappropriate schedule of drug administration, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: NONE - ADMINISTERED BEFORE RECOMMENDED TIME HAD ELAPSED.


VAERS ID: 533347 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Missouri  
Vaccinated:2014-05-09
Onset:2014-05-10
   Days after vaccination:1
Submitted: 2014-05-30
   Days after onset:20
Entered: 2014-06-09
   Days after submission:10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. J006850 / 1 UN / IM

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

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

Write-up: Lump in arm 2/3 size of golf ball at injection site 3 weeks after injection. Pt. states it is non-tender.


VAERS ID: 533408 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2014-06-02
Onset:2014-06-03
   Days after vaccination:1
Submitted: 2014-06-05
   Days after onset:2
Entered: 2014-06-09
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M13058 / 1 LA / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS N59M3 / 6 LA / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diagnosed with mononucleosis in early March 2014
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pts father called to report patient having "rash" on trunk, back and some on hands. Bumps described as tender. Attempted x3 to speak with patient directly but no answer to her phone #.


VAERS ID: 533537 (history)  
Form: Version 1.0  
Age: 17.0  
Gender: Female  
Location: Georgia  
Vaccinated:2014-06-10
Onset:2014-06-10
   Days after vaccination:0
Submitted: 2014-06-10
   Days after onset:0
Entered: 2014-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH921AA / 2 LA / IM
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H020901 / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS A13017 / 1 RA / IM
TDAP: TDAP (ADACEL) / SANOFI PASTEUR E5957 / 3 LA / IM

Administered by: Public       Purchased by: Public
Symptoms: Dizziness, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeuti