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Found 5186 cases where Vaccine is RV1

Table

   
AgeCountPercent
< 3 Years448686.5%
3-6 Years170.33%
6-9 Years30.06%
9-12 Years20.04%
12-17 Years20.04%
17-44 Years100.19%
44-65 Years20.04%
Unknown66412.8%
TOTAL5186100%

Case Details

This is page 1 out of 519

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VAERS ID: 311284 (history)  
Form: Version 1.0  
Age: 0.6  
Gender: Female  
Location: Oregon  
Vaccinated:2008-04-12
Onset:2008-04-22
   Days after vaccination:10
Submitted: 2008-04-24
   Days after onset:2
Entered: 2008-04-30
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B137AA / 3 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH B70145E / 3 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS 1620U / 3 MO / PO

Administered by: Public       Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
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: None
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Red, hot, indurated site.


VAERS ID: 311743 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Georgia  
Vaccinated:2008-05-01
Onset:2008-05-01
   Days after vaccination:0
Submitted: 2008-05-06
   Days after onset:5
Entered: 2008-05-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C2950AA / 1 LL / IM
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVB516BA / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF353AA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR A0474 / 1 LL / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C45153 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS 0142X / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Convulsion, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 40 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Klonopin
Current Illness:
Preexisting Conditions: Tremors, cleft palate, poor muscle tone. No specific medical disease diagnosis to explain the tremors or poor muscle tone. PMH: tremors, hypotonia, cleft palate (w/u thus far (-)). NKDA.
Allergies:
Diagnostic Lab Data: Labs and Diagnostics: CBC unremarkable on admission repeat with WBCs 3.84-48 segs, 37% lymphs, 10% monos, RBCs 2.49, Hgb7.2, Hct 20.9. Chem WNL except glucose 206. UA hazy with 1+ protein, large blood, 5 RBCs, urobilinogen 0.2, crystals 3+, sediment 1+. Head CT with concern for mild cerebral edema. EEG abnormal, but not epileptiform. CSF protein 87, otherwise WNL. CRP 1.0. CXR WNL then showing hypoinflation. Brain MRI abnormal-concerning for metabolic d/o , ADEM or anoxic changes. Sleep study (+) for transient hypoxia. Echo (+) for bicuspid aortic valve, mild left peripheral pulmonary stenosis and a PFO.
CDC Split Type:

Write-up: Within 6 hours of getting vaccines, this infant had a seizure, and respiratory failure which resulted in transport to the hospital by helicopter ambulance. 5/27/2008 MR received for DOS 5/01-06/08/2008 with D/C DX: Status epilepticus/Respiratory failure. Infant presented to ER in status epilepticus. During diaper change infant developed generalized seizure with tonic posturing and eye deviation followed by hypotonia. Generalized seizure activity continued in ED. Intubated and sedated 2'' to respiratory distress/failure. Nasoenteric tube for feeds. Nystagmus c/w brainstem involvement. Developed aspiration pneumonia. Extensive w/u. Presumed mitochondrial disorder. D/C on GJ feeds. 6/03/2008 As of today, still in hospital. 9/08/2008 MR received for DOS 6/26-28/2008 with Final DX: Cleft palate, Hypotonia, Aspiration pneumonia, Seizure Disorder, Attention to Gastrostomy tube. Pt presented with intermittant gagging and coughing since D/C. Prior to day of admission suctioning had been clear but today suctioning was formula from the mouth. GJ tube replaced


VAERS ID: 324790 (history)  
Form: Version 1.0  
Age: 0.17  
Gender: Female  
Location: Ohio  
Vaccinated:2008-09-09
Onset:2008-09-09
   Days after vaccination:0
Submitted: 2008-09-10
   Days after onset:1
Entered: 2008-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B156BA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF492AB / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C57543 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA691A / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Dyspnoea, Exaggerated startle response, Injection site streaking, Pallor, Poor sucking reflex
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (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: NONE~ ()~NULL~~In Patient|NONE~ ()~NULL~~In Sibling1|NONE~ ()~NULL~~In Sibling2
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies:
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: EPISODE OF POOR SUCKING,PALNESS AND APPARENT DISTRESS APPORXIMATELY 6 HR AFTER IMMUNIZZTION.ALSO SLEPT AND THEN HAD A 5 MIN EPISODE OF APPRARENT STARTTLE AND GASP. RESOLVED WITH TYLENOL AND OF 2-3 HOURS , EXAM 9/10/08 WNL EXCEPT FOR INJECTION TRACTS IN LATERAL THEIGHS.


VAERS ID: 327589 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Kentucky  
Vaccinated:2008-10-01
Onset:2008-10-02
   Days after vaccination:1
Submitted: 2008-10-08
   Days after onset:6
Entered: 2008-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR 13176AA / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C65931 / 1 LL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA691A / 1 LL / IM

Administered by: Private       Purchased by: Private
Symptoms: Incorrect route of drug administration
SMQs:, Medication errors (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: None
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Received ROTARIX 0.5ml IM- diluted with sterile diluent for manufacturer live virus vaccine (steril water)


VAERS ID: 328065 (history)  
Form: Version 1.0  
Age: 0.17  
Gender: Female  
Location: Virginia  
Vaccinated:2008-10-09
Onset:2008-10-09
   Days after vaccination:0
Submitted: 2008-10-10
   Days after onset:1
Entered: 2008-10-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B192CA / 1 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF498AB / 1 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C86139 / 1 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA691A / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Crying, Injection site erythema, Injection site swelling
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (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: LEG SWELLING, 3 X 2 INCH AREA AND REDNESS, EXCESSIVE CRYING


VAERS ID: 328496 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Texas  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2008-10-09
Entered: 2008-10-13
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Dysgeusia, Grimacing, Regurgitation
SMQs:, Taste and smell disorders (narrow), Dyskinesia (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Unknown
Preexisting Conditions: The reporter mentioned that this event occurred in 5 or 6 babies that received ROTARIX.
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0750119A

Write-up: This case was reported by a physician via a sales representative and described this occurrence of adverse taste in a child subject (baby) of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). In the first week of September 2008 the subject received 1st dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced adverse taste, grimaced and spit out the vaccine. At the time of reporting the outcome of the events was unspecified. The reporter mentioned that this event occurred in 5 or 6 babies that received ROTARIX.


VAERS ID: 328497 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Female  
Location: Kentucky  
Vaccinated:2008-10-01
Onset:2008-10-01
   Days after vaccination:0
Submitted: 2008-10-09
   Days after onset:8
Entered: 2008-10-13
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Private       Purchased by: Private
Symptoms: Diarrhoea, Incorrect route of drug administration, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: A0750857A

Write-up: This case was reported by a physician and described the occurrence of fever in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline), Diphtheria tetanus acellular pertussis). Concurrent vaccination included unspecified vaccine (manufacturer unspecified) given on 1 October 2008. On 1 October 2008 the subject received 1st dose of ROTARIX at 0.5 ml, intramuscularly and 1st dose of Diphtheria tetanus acellular pertussis. ROTARIX was administered via the wrong route. As indicated, ROTATRIX should be administered orally. Also, within 24 hours of vaccination with ROTARIX and diphtheria acellular pertussis, the subject experienced fever and diarrhea and was seen in the emergency room. At the time of reporting the outcome of the events was unresolved. In the physician''s opinion, the events were possibly related to treatment with ROTARIX.


VAERS ID: 331912 (history)  
Form: Version 1.0  
Age: 0.5  
Gender: Female  
Location: Oregon  
Vaccinated:2008-10-30
Onset:2008-11-05
   Days after vaccination:6
Submitted: 2008-11-10
   Days after onset:5
Entered: 2008-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B192CA / 3 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF505AB / 3 LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH UNKNOWN / 3 RL / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA692A / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Enema administration, Intussusception, Surgery, Urinary system X-ray
SMQs:, Gastrointestinal obstruction (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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none. PMH: none
Allergies:
Diagnostic Lab Data: KUB/contrast enemas. Labs and Diagnostics: Air contrast enema (+) for IS. Abd X-ray c/w IS. HCT 31.5. Hgb 10.4. Platelets 15.2K.
CDC Split Type:

Write-up: Intussusception - symptoms started 11/5/08; confirmed by x-ray on 11/6/08; unable to reduce by air contrast and barium contrast; required air transport to tertiary hospital and subsequent surgery. 11/18/2008 D/C Summary recieved for DOS 11/17-19/2008 with Final DX: Intussusception-ileocolic. Pt initially presented with pain, moaning, vomiting and blood streaked stool. Pt presented to hospital from another facility following failed reduction of IS via air contrast barium enema. Again, uanable to reduce so taken to OR for Laparoscopic reduction. Pt tolerated well, diet advance and d/c 11/9/08.


VAERS ID: 332276 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: Missouri  
Vaccinated:2008-10-03
Onset:2008-10-26
   Days after vaccination:23
Submitted: 2008-11-13
   Days after onset:18
Entered: 2008-11-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS AC21B138BA / 1 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UF450AB / 1 UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C86141 / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CA691A / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Intussusception
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
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: No concurrent medication
Current Illness: Unknown
Preexisting Conditions: There was no history of adverse events following previous vaccinations as this was the subjects first set of vaccinations. PMH: none.
Allergies:
Diagnostic Lab Data: Unk. Labs and diagnostics: Air contrast enema (+) for IS in proximal transverse colon. Abd US (+) for ileocolic IS. Abd X-ray c/w bowel obstruction.
CDC Split Type: A0755882A

Write-up: This case was reported by a healthcare professional and described the occurrence of intussusception in a 9-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included ACTHIB (Sanofi), PEDIARIX (GlaxoSmithKline) and PREVENAR (Lederle) all given on 3 October 2008. There were no concurrent medications. On 3 October 2008 at 12:00 the subject received 1st dose of ROTARIX (oral). On 26 October 2008, 23 days after vaccination with ROTARIX, the subject experienced intussusception. The subject was hospitalised and the healthcare professional considered the event was disabling, life threatening and clinically significant (or requiring intervention). The subject was treated with unknown (Unknown treatment). On 6 November 2008, the event was resolved. The healthcare professional considered the event was probably related to vaccination with ROTARIX. 12/01/2008 MR received for DOS 10/26-30/2008 with D/C DX: Intussusception. Pt presented with 4 day hx of fussiness, intermittent emesis, tarry stool and poor po intake. IS noted on Abd US with attempted air enema reduction which was unsuccessful x 3. Taken to OR for an open reduction of IS, appendectomy and repair of serosal tears. initially NPO with PCA pain mgmt. Transitioned to oral diet and pain meds and d/c on POD#3.


VAERS ID: 332507 (history)  
Form: Version 1.0  
Age: 0.2  
Gender: Male  
Location: New York  
Vaccinated:2008-09-29
Onset:2008-10-12
   Days after vaccination:13
Submitted: 2008-11-12
   Days after onset:31
Entered: 2008-11-17
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C3199AA / 1 UN / IM
HEP: HEP B (FOREIGN) / MERCK & CO. INC. 1372V / 2 UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH C80884 / 1 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41FA691A / 1 MO / PO

Administered by: Public       Purchased by: Public
Symptoms: Kawasaki's disease, Platelet count increased
SMQs:, Vasculitis (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? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: Platelet count of 820k LABS: CXR abnormal w/hyperinflated lungs, peribronchial cuffing & increased lung markings. UA WNL. Chemistry. Echo abnormal & revealed coronary artery aneurysm. Blood, csf & urine c/s neg. CRP 10.1 (H), ESR 150(H).
CDC Split Type:

Write-up: Pt developed Kawasaki disease on 10/12/2008. Admitted to hospital. Received ROTARIX on 9/29/2008. 11/21/08 Reviewed hospital medical records of 10/12-10/24/2008. FINAL DX: Kawasaki disease Records reveal patient experienced fever, cough, runny nose, vomiting x 4 days, transient rash & red conjunctiva initially subsided after 2 days. Had been seen in ERon 10/9 & dx w/viral syndrome. ID & cardiac consults done. Tx w/IVIG & high dose ASA. Improved & d/c to home on continued low dose ASA.


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