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VAERS ID:479047 (history)  Vaccinated:2012-12-21
Age:1.7  Onset:2012-12-22, Days after vaccination: 1
Gender:Female  Submitted:2012-12-23, Days after onset: 1
Location:New York  Entered:2012-12-23
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: NONE
Preexisting Conditions: NONE
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (NO BRAND NAME)UNKNOWN MANUFACTURER 0 AR
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER 0 AR
Administered by: Private     Purchased by: Other
Symptoms: Heart rate increased, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Vomiting, fever (101.5), and rapid heart rate (180 bpm).

VAERS ID:479048 (history)  Vaccinated:0000-00-00
Age:  Onset:0000-00-00
Gender:Male  Submitted:2012-12-20
Location:Foreign  Entered:2012-12-20
Life Threatening? No
Died? Yes
   Date died: 2012-12-11
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0853253A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (HIBERIX)GLAXOSMITHKLINE BIOLOGICALSYHIBC593B UNUN
Administered by: Other     Purchased by: Other
Symptoms: Death
SMQs:
Write-up: This case was reported by a physician via a Sales Representative and described the occurrence of unknown cause of death in a 4-month-old male subject who was vaccinated with HIBERIX (GlaxoSmithKline). On 9 December 2012, the subject received an unspecified dose of HIBERIX (administration site and route unknown). On 11 December 2101, 2 days after vaccination with HIBERIX, the subject died. The subject died on 11 December 2012, cause of death was not reported. It was unknown whether an autopsy was performed.

VAERS ID:479049 (history)  Vaccinated:2012-12-17
Age:30.0  Onset:2012-12-18, Days after vaccination: 1
Gender:Male  Submitted:2012-12-21, Days after onset: 3
Location:California  Entered:2012-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (ADACEL)SANOFI PASTEURU4421AA0IMLA
Administered by: Private     Purchased by: Other
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Given 12/17 developed chills that evening. 12/18 fever of 103, pain and swelling at site. Same symptoms 12/19. 12/20 102 fever, continued pain, redness and swelling. MD appt 12/21 tx KEFLEX 500mg qid x 10 days as of 12/21 at appt. Pain and fever swelling less.

VAERS ID:479050 (history)  Vaccinated:2012-12-17
Age:65.0  Onset:2012-12-17, Days after vaccination: 0
Gender:Male  Submitted:2012-12-21, Days after onset: 4
Location:Arizona  Entered:2012-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4489AA0IMRA
Administered by: Other     Purchased by: Public
Symptoms: Feeling hot, Malaise, Rash generalised, Rosacea
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt became ill and warm all over. He described a rosacea-like rash on chest, armpit, face, neck & back. Pt still had rash on 12/19/12. On 12/20/12 pt was back to normal. Pt saw his practitioner on 12/18/12 & suggest he should take diphenhydramine.

VAERS ID:479051 (history)  Vaccinated:2012-11-20
Age:60.0  Onset:2012-11-21, Days after vaccination: 1
Gender:Female  Submitted:2012-12-21, Days after onset: 30
Location:Washington  Entered:2012-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKA (UTI, incontinence)
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME)UNKNOWN MANUFACTURER    
Administered by: Private     Purchased by: Unknown
Symptoms: Chills, Myalgia, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Chills, myalgia, fever, vomiting x3 days.

VAERS ID:479052 (history)  Vaccinated:2012-12-20
Age:54.0  Onset:2012-12-20, Days after vaccination: 0
Gender:Female  Submitted:2012-12-21, Days after onset: 1
Location:Indiana  Entered:2012-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Carvedilol; lisinopril; ADVAIR; COMBIVENT; citalopram; gabapentin
Current Illness:
Preexisting Conditions: COPD; HTN; fibromyalgia; cirrhosis of the liver
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURL4481CF IMRA
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H014282 IMLA
Administered by: Public     Purchased by: Private
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: C/O (L) arm pain and swelling from injection site ((L) deltoid) to elbow. Area is red & warm. Pt advised to go to ER & apply cold pack.

VAERS ID:479053 (history)  Vaccinated:0000-00-00
Age:  Onset:0000-00-00
Gender:Female  Submitted:2012-12-20
Location:Foreign  Entered:2012-12-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 24Oct2012, 38deg.C
CDC Split Type: B0853014A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA20CA801B0UNUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA439AE0PO 
UNK: PNEUMO (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSASPNA047BH0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Body temperature increased, Generalised oedema, Injection site erythema, Injection site oedema, Injection site pain, Insomnia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician via a regulatory authority (SI-JAZMP-NCPHV-2012SI0177_455) and described the occurrence of injection site pain in a 3-month-old female subject who was vaccinated with INFANRIX-POLIO-HIB (GlaxoSmithKline), ROTARIX and SYNFLORIX. On 23 October 2012, the subject received 1st dose of INFANRIX-POLIO-HIB (administration site and route unknown), 1st dose of ROTARIX (oral) and 1st dose of SYNFLORIX (administration site and route unknown). On 23 October 2012, in the evening, 1 day after vaccination with INFANRIX-POLIO-HIB, ROTARIX and SYNFLORIX, the subject experienced generalized edema and generalized urticaria on face, neck and feet. On 24 October 2012, 2 days after vaccination with INFANRIX-POLIO-HIB, ROTARIX and SYNFLORIX, the subject experienced injection site pain, injection site redness, injection site edema and body temperature increased (38 deg.C). At an unspecified time after vaccination with INFANRIX-POLIO-HIB, ROTARIX and SYNFLORIX, the subject experienced insomnia. The subject was hospitalised from 24 to 25 October 2012. The subject was discharged afebrile, without edema and urticaria. The subject was treated with FENISTIL. At the time of reporting, the events were resolved. For the future, diet without cow''s milk and ALLERNOVA were advised.

VAERS ID:479054 (history)  Vaccinated:2012-12-20
Age:31.0  Onset:2012-12-20, Days after vaccination: 0
Gender:Male  Submitted:2012-12-21, Days after onset: 1
Location:Idaho  Entered:2012-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12070210UNLA
Administered by: Other     Purchased by: Other
Symptoms: Feeling hot, Hypoaesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)
Write-up: About 5 mins after admin, pt felt hot in face and ears. Feet started to feel numb. Resolved in approx. 10-15 mins.

VAERS ID:479055 (history)  Vaccinated:2012-12-13
Age:3.0  Onset:2012-12-14, Days after vaccination: 1
Gender:Male  Submitted:0000-00-00
Location:Pennsylvania  Entered:2012-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS12059012IMLA
Administered by: Public     Purchased by: Public
Symptoms: Injection site rash
SMQs:, Hypersensitivity (narrow)
Write-up: Rash at site of injection only x 6 days.

VAERS ID:479056 (history)  Vaccinated:2012-12-20
Age:  Onset:2012-12-20, Days after vaccination: 0
Gender:Female  Submitted:2012-12-21, Days after onset: 1
Location:Arkansas  Entered:2012-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEUR  SYRUN
Administered by: Private     Purchased by: Other
Symptoms: Dysgeusia, Headache, Throat irritation, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)
Write-up: About 15-20 minutes after injection, complained of wheezy, scratchy throat with metallic taste. Also complained of headache.

VAERS ID:479057 (history)  Vaccinated:2004-12-01
Age:  Onset:0000-00-00
Gender:Male  Submitted:2012-12-20
Location:Foreign  Entered:2012-12-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood test, toxic damage
CDC Split Type: B0852994A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test abnormal, Immune system disorder, Mucous membrane disorder, Toxicologic test abnormal
SMQs:
Write-up: This case was reported by a consumer via a regulatory authority (DK-DKMA-ADR 21952033) and described the occurrence of immune system disorder in a male subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline), DITE BOOSTER (non-gsk) and GAMMA GLOBULIN. Historic vaccination included hepatitis A vaccine inactivated; GlaxoSmithKline; unknown; unknown given in March 2004. In December 2004, the subject received an unspecified dose of HAVRIX (administration site and route unknown, batch number not provided), in March 2004, the subject received an unspecified dose of DITE Booster (unknown) and in March 1997, the subject received an unspecified dose of GAMMA GLOBULIN (unknown). At an unspecified time after vaccination with DITE BOOSTER, GAMMA GLOBULIN and HAVRIX, the subject experienced immune system disorder and mucus membrane disorder. The regulatory authority reported that the events were clinically significant (or requiring intervention). A screening of his blood in 60000 times magnification showed damage due to toxicity. At the time of reporting, the events were unresolved. The regulatory authority reported that the events were possibly related to vaccination with HAVRIX but unlikely related to DITE BOOSTER and GAMMA GLOBULIN. The reporter suggested a causal relationship between the aluminium content of Td vaccine SSI and the onset of the events.

VAERS ID:479058 (history)  Vaccinated:2012-12-06
Age:0.2  Onset:2012-12-07, Days after vaccination: 1
Gender:Unknown  Submitted:2012-12-20, Days after onset: 13
Location:Foreign  Entered:2012-12-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0852572A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEUR  SCUN
PNC: PNEUMO (PREVNAR)PFIZER/WYETH  SCUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALS 0PO 
Administered by: Other     Purchased by: Other
Symptoms: Abnormal faeces, Diarrhoea, Gastroenteritis, Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)
Write-up: This case was reported by a healthcare professional and described the occurrence of feces bloodstained in a 2-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Hib (non-gsk); non-GSK manufacturer; subcutaneous; unknown given on 6 December 2012; pneumococcal vaccine (non-gsk); non-GSK manufacturer; subcutaneous; unknown given on 6 December 2012. On 6 December 2012, the subject received 1st dose of ROTARIX (1.5 ml, oral). On 7 December 2012, 1 day after vaccination with ROTARIX, the subject experienced diarrhea (once a day) and stool odor abnormal. No fever, no marked abnormalities in particular. On 11 December 2012, 5 days after vaccination with ROTARIX, the subject experienced feces blood stained. The healthcare professional considered the events were clinically significant (or requiring intervention). An examination revealed no abnormalities such as invagination of intestine. A diagnosis if suspected gastroenteritis was made. At the time of reporting, diarrhea was unresolved. The outcome of the other events was unspecified. The healthcare professional considered diarrhea was related to vaccination with ROTARIX.

VAERS ID:479059 (history)  Vaccinated:2012-10-01
Age:  Onset:2012-12-14, Days after vaccination: 74
Gender:Female  Submitted:2012-12-21, Days after onset: 7
Location:Pennsylvania  Entered:2012-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Influenza A virus test positive, 14Dec2012, positive
CDC Split Type: A1005914A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Feeling abnormal, Influenza, Influenza A virus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Dementia (broad)
Write-up: This case was reported by a consumer (GSK employee) and described the occurrence of influenza a in an adult female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. In October 2012 the subject received a dose of FLUARIX (unknown details). On 14 December 2012, within months of vaccination with FLUARIX, the subject experienced influenza a, feeling miserable and vaccination failure ("lack of effect"). The subject stated that she had "just tested positive for A/flu (rapid test)" and that she feels "absolutely miserable." This case was assessed as medically serious by GSK. Relevant test results included influenza a virus test positive on 14 December 2012. At the time of reporting the outcome of the events were unspecified.

VAERS ID:479060 (history)  Vaccinated:2012-12-05
Age:71.0  Onset:2012-12-09, Days after vaccination: 4
Gender:Female  Submitted:2012-12-17, Days after onset: 8
Location:Pennsylvania  Entered:2012-12-21, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Asthma; Barrett''s disease
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE)SANOFI PASTEURU4525AA0IMLA
Administered by: Other     Purchased by: Public
Symptoms: Dizziness, Injection site rash, Lethargy, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)
Write-up: Rash at injection site 1 day after shot. Dizzy, nauseous, achy, lethargic 4 days after injection and remains this way for 1-2 wks.

VAERS ID:479061 (history)  Vaccinated:2012-12-08
Age:0.2  Onset:2012-12-09, Days after vaccination: 1
Gender:Female  Submitted:2012-12-20, Days after onset: 11
Location:Foreign  Entered:2012-12-20
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Adenovirus test, 09Dec2012, positive; Rotavirus test, 09Dec2012, positive
CDC Split Type: B0852462A
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  UNUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41CB233A0PO 
UNK: PNEUMO (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Adenovirus test, Diarrhoea, Pyrexia, Rotavirus infection, Rotavirus test positive
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of rotavirus in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included combined diphtheria, tetanus-acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type B vaccine; GlaxoSmithKline; unknown; unknown given on 8 December 2012; SYNFLORIX; GlaxoSmithKline; unknown; unknown given on 8 December 2012. On 8 December 2012, the subject received 1st dose of ROTARIX (oral). On 9 December 2012, 1 day after vaccination with ROTARIX, the subject experienced fever and watery diarrhea. The subject was hospitalised on 10 December 2012 and the physician considered the events were life threatening and clinically significant (or requiring intervention). Stool test showed rotavirus positive and adenovirus negative. At the time of reporting, fever was resolved but she still had diarrhea. The physician considered the events were almost certainly related to vaccination with ROTARIX.

VAERS ID:479062 (history)  Vaccinated:0000-00-00
Age:15.0  Onset:0000-00-00
Gender:Male  Submitted:2012-12-20
Location:Foreign  Entered:2012-12-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Enuresis; Migraine
Preexisting Conditions:
Diagnostic Lab Data: Neurological examination, normal; Normal electromyogram, normal; Nuclear magnetic resonance ima, normal; Ultrasound scan, (left arm) normal
CDC Split Type: B0852259A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (NO BRAND NAME)UNKNOWN MANUFACTURER  IMLA
Administered by: Other     Purchased by: Other
Symptoms: Electromyogram normal, Injection site reaction, Local reaction, Lymphadenopathy, Mobility decreased, Neurological examination normal, Nuclear magnetic resonance imaging normal, Pain in extremity, Skin discolouration, Stress, Tenderness, Ultrasound scan normal, X-ray of pelvis and hip normal
SMQs:, Parkinson-like events (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported in a literature article and described the occurrence of sympathetically mediated pain in a 15-year-old male subject who was vaccinated with Tdap (with small D + P, manufacturer unspecified). Concurrent medical conditions included enuresis and migraine. On an unspecified date, the subject received unspecified dose of Tdap (with small D + P) (intramuscular, left deltoid, batch number not provided). He had a small localised reaction at the injection site, but 4 days later developed pain in the left arm and difficulty with movement. He was reviewed in the local emergency department and treated with antibiotics for presumed infection. Eight days post-immunisation he consulted a neurologist, had a normal neurological exam, and was prescribed simple analgesia for symptom management. On review at 3 weeks post-immunisation, he remained symptomatic with a tender, slightly dusky left arm and left-sided lymphadenopathy, but again with a normal neurological examination. He was treated with a 10-day course of oral prednisolone (1 mg/kg) but also steroids, amitriptyline, gabapentin, opioids and physiotherapy. One month post-immunisation he was admitted to hospital for further investigation and management of his persistent symptoms in both his left arm and leg. Result for magnetic resonance imaging of brain was normal, for electromyogram was normal, for ultrasound (left arm) was normal and hip plain radiograph was normal. No sensory disturbance and no sudomotor symptoms were reported. Affected limbs were left arm and left legs. He subsequently has been seen in the pain management unit, and a number of psychosocial stressors identified. A diagnosis of sympathetically mediated pain was made, as he did not fulfill all the CRPS-1 criteria. Two years post-immunisation he continued to experience pain. Summary of literature case: Complex regional pain syndrome type 1 (CRPS-1) is a clinical syndrome that affects one or more extremities and is characterised by persistent pain disproportionate to any inciting event, and at least one sign of autonomic dysfunction in the affected limb(s). The pathogenesis of this syndrome is poorly understood, but its onset is often precipitated by a physical injury, such as minor trauma, fracture, infection or a surgical procedure. In the literature, there are reports of CRPS-1 following immunisation with rubella and Hep B vaccines. The authors present a case series of CRPS-1 following immunisation in adolescents, with either Tdap (B0852259A), or HPV (4 cases). Enhanced awareness of this syndrome and its potential to occur following immunisation in the paediatric population is vital to the prompt and effective management of this condition.

VAERS ID:479063 (history)  Vaccinated:2012-11-27
Age:0.2  Onset:2012-12-05, Days after vaccination: 8
Gender:Male  Submitted:2012-12-21, Days after onset: 16
Location:Unknown  Entered:2012-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Cholecalciferol
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Complete blood cell count (??-DEC-2012): showed elevated white blood cell count; Stool culture (??-DEC-2012): negative; Occult blood test of the stool (??-DEC-2012): positive
CDC Split Type: WAES1212USA005936
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSAC21B370DA0IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.H0129710IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG131830IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.H0156480PO 
Administered by: Other     Purchased by: Other
Symptoms: Culture stool negative, Diarrhoea, Full blood count abnormal, Haematochezia, Occult blood positive, White blood cell count increased
SMQs:, Haematopoietic leukopenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Initial information has been received from a pharmacist concerning his son, a 2 months old male patient, with no pertinent medical history or drug reaction / allergies. On 27-NOV-2012, the patient was vaccinated with ROTATEQ. No other co-suspects were reported. Concomitant medications included: VITAMIN D3. On 05-DEC-2012, the patient developed hematochezia after receiving a first dose of ROTATEQ. The patient had loose stools that contain a varying amount of blood. The reporter stated that the patient had been having bloody stools for one and one half weeks post vaccination with ROTATEQ. The patient had a complete blood cell count that showed an elevated white blood cell count, a stool culture that was negative and an occult blood test that was positive. No treatment information was reported. At the time of report, the patient had not recovered. It was reported that the patient sought medical attention. Additional information has been requested.

VAERS ID:479064 (history)  Vaccinated:2012-12-20
Age:71.0  Onset:2012-12-21, Days after vaccination: 1
Gender:Male  Submitted:2012-12-21, Days after onset: 0
Location:Ohio  Entered:2012-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Allergy-tetanus
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC.H0098260IMUN
Administered by: Other     Purchased by: Private
Symptoms: Erythema, Rash macular
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Next day underarm red, splotch. Took BENADRYL and ice to area.

VAERS ID:479065 (history)  Vaccinated:2012-12-05
Age:11.0  Onset:2012-12-06, Days after vaccination: 1
Gender:Male  Submitted:2012-12-10, Days after onset: 4
Location:California  Entered:2012-12-11, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC52B071BB0UNLA
Administered by: Other     Purchased by: Public
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Father reported today (12-10-12) that his son had fever of 104 degrees on Thursday night (12-6-12). Fever resolved without treatment and temperature was normal on 12-8-12.

VAERS ID:479066 (history)  Vaccinated:2012-12-13
Age:48.0  Onset:2012-12-13, Days after vaccination: 0
Gender:Female  Submitted:2012-12-21, Days after onset: 8
Location:Unknown  Entered:2012-12-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHEH2012US025005
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN)NOVARTIS VACCINES AND DIAGNOSTICS1207201 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Heart rate increased, Insomnia
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad)
Write-up: Case number PHEH2012US025005 is an initial spontaneous report received from a pharmacist on 14 Dec 2012. This case refers to a 48-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1207201) intramuscularly on 13 Dec 2012. Few hours later, she began to experience an accelerated heart rate that resulted in not being able to sleep. The reporter stated that this patient was not familiar to her, so the reporter does not know if the patient had any underlying health condition that might have contributed to this event. The events were ongoing at the time of this report. No other information was reported.

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