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Case Details (Sorted by Age)

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VAERS ID:267941 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2006-11-27
Location:Foreign  Entered:2006-11-29, Days after submission: 2
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: E200606093
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER   UN
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI)AVENTIS PASTEUR   UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Coma, Confusional state, Delirium, Fatigue, Hallucination, Hypotonia, Pyrexia, Rhinorrhoea, Somnolence
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case is linked with the case number E200606223 regarding other adverse reactions following influenza and typhoid vaccinations. Initial report on 11/16/06 it was reported that a female pt born on 8/12/82 received a dose of typhoid vaccine (Typhim VI, batch number not reported). in 1999 or 2000. Under 48 hours post vaccination, possibly during the following night, she developed severe fever, hallucinations, delirium and episodes of coma like state. The symptoms considered as severe quickly resolved in a few hours, ie less than 24 hours. The pt was neither seen by a doctor nor hospitalised. No final diagnosis was made. No other causes but vaccination were found. Additional information on 11/22/06 the reporter described the coma like state, the pt was found to be somnolent and confused, she did not control her thought and was not aware of reality whereas she was usually mentally well balanced. The confusional state lasted 48 hours. Fever and fatigue persisted during 2 to 4 days more. The pt received doses of Typhoid vaccine (Typhim VI and influenza vaccine (Vaxigrip) on 11/17/06. Two hours later she had fever of 38C and felt off colour all day long. On 11/21/06 she also experienced running nose, fatigue and loss of tonus (Case E200606223). According to the reporter the symptoms were due to influenza instead of typhoid vaccination. (OMIC).

VAERS ID:271897 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2007-02-06
Location:Foreign  Entered:2007-02-07, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: platelet count Comment: decreased
CDC Split Type: WAES0701USA04997
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Contusion, Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Accidents and injuries (narrow)
Write-up: Information has been received from a health authority concerning a 17 year old female who was vaccinated IM with a 0.5 ml dose of MMR II vaccine (manufacturer unknown). Subsequently, post vaccination the patient experienced a profound decreased in platelet count (value not provided) and extensive bruising. It was known if the patient has recovered. The patient''s experiences were considered to be an other important medical events by the reporter and health authority. No more is available, this case is closed. Other business partner numbers included E2006-00655 and 20083528.

VAERS ID:272718 (history)  Vaccinated:2006-10-29
Age:17.0  Onset:2006-10-29, Days after vaccination: 0
Gender:Female  Submitted:2007-02-19, Days after onset: 113
Location:Foreign  Entered:2007-02-20, Days after submission: 1
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: UNK
Current Illness: Phobic anxiety
Preexisting Conditions:
Diagnostic Lab Data: blood pressure 29Oct06 110/67 mmHg Comment: sitting BP, physical examination 29Oct06 Comment: Pulse rate 55, Glasgow come scale 29Oct06 Comment: 15/15
CDC Split Type: WAES0612AUS00040
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0444F IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood pressure decreased, Bronchospasm, Dizziness, Dyspnoea, Glasgow coma scale, Heart rate decreased, Oxygen supplementation, Pallor, Palpitations, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a physician concerning a 17 year old female who on 29-OCT-2006 was vaccinated with Gardasil (lot No 654672/0444F, batch no NE01680, Expiry date 23-FEB-2009) on her left deltoid muscle. The patient is needle phobic and had nothing to eat on 29-OCT-2006 until the patient received vaccination on 12:02pm. On 29-OCT-2006 the patient experienced syncope and bronchospasm. Four minutes after injection, the patient had syncope. The symptoms included light headedness, pallor, feeling like fainting and palpitation. The patient had no chest pain but had bronchospasm with dyspnoea. The patient''s sitting blood pressure was 110/67 mmHg and pulse rate was 55. Glasgow Coma Score was 15/15. The patient had oxygen mask. The patient was not hospitalized. The physician considered her diagnosis as phobia, syncope vs drug reaction. Subsequently the patient recovered from syncope and bronchospasm. The physician considered syncope and bronchospasm were related to therapy with Gardasil and asked the patient to reconsider about continuing the next dose of Gardasil. Syncope and bronchospasm were considered to be life threatening by the reporting physician. Additional information is not expected.

VAERS ID:274234 (history)  Vaccinated:2007-02-15
Age:17.0  Onset:2007-02-15, Days after vaccination: 0
Gender:Female  Submitted:2007-03-16, Days after onset: 28
Location:Foreign  Entered:2007-03-19, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness:
Preexisting Conditions: UNK
Diagnostic Lab Data: UNK
CDC Split Type: WAES0703CAN00131
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0444F   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Confusional state, Fall, Head injury, Subarachnoid haemorrhage, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic cerebrovascular conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from a physician concerning a 17 year old female who on 15-FEB-2007 was vaccinated with Gardasil (lot # 654672/0444F). There was no concomitant therapy. On 15-FEB-2007, 2-3 minutes after Gardasil injection the patient experienced syncopal episode, fell and hit her head. The patient had a head injury and central lateral subarachnoid bleeding and was hospitalized. The patient''s syncopal episode and head injury and central lateral subarachnoid bleeding persisted. It was reported that the patient had a gradual clearing of confusion. Additional information has been requested.

VAERS ID:274362 (history)  Vaccinated:2007-03-01
Age:17.0  Onset:2007-03-01, Days after vaccination: 0
Gender:Female  Submitted:2007-03-19, Days after onset: 17
Location:Foreign  Entered:2007-03-20, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Amenorrhea; Affect lability
Diagnostic Lab Data: UNK
CDC Split Type: WAES0703USA02432
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0572F0IMLA
Administered by: Unknown     Purchased by: Unknown
Symptoms: Loss of consciousness, Meningism, Muscle spasms, 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), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Information has been received from a gynecologist concerning a 17 year old female with a history of emotional lability and probably "stress-related" amenorrhoea who on 01-MAR-2007 was vaccinated with the first dose of Gardasil, IM into the left arm. Concomitant medication was not reported. On 01-MAR-2007, about 2 minutes post vaccination, the patient experienced a convulsion syncope with meningism, muscular spasm and unconsciousness. Subsequently after about 3 minutes, the patient recovered from convulsion syncope. The patient was admitted to the hospital. Other business partner numbers included E2007-01514. Additional information is not expected.

VAERS ID:275510 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2007-04-02
Location:Foreign  Entered:2007-04-03, Days after submission: 1
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: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0703USA04719
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthenia, Cold sweat, Dyspnoea, Injection site pain, Malaise, Sensation of foreign body
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad)
Write-up: Information has been received from a company representative via a physician''s office concerning a 17 year old female who on an unspecified date was vaccinated with the first dose of Gardasil. Concomitant medication was not reported. Subsequently on an unspecified date, immediately following vaccination, the patient complained about injection site pain. The patient left the practice together with her mother. About 15 minutes post vaccination, the patient and her mother returned. At that time, the patient complained about feeling unwell and an intense global feeling in her pharynx. The patient felt like not being able to breath. The patient was treated with corticosteroids. After about 1 hour, the patient recovered from the global feeling in her pharynx but was asthenic and showed cold sweat. The patient was admitted to the hospital. The patient recovered after two days and was discharged from the hospital. Other business partner numbers included E2007-01818. Additional information is not expected.

VAERS ID:275681 (history)  Vaccinated:2007-03-08
Age:17.0  Onset:2007-03-08, Days after vaccination: 0
Gender:Female  Submitted:2007-04-05, Days after onset: 27
Location:Foreign  Entered:2007-04-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cileste (Ethinyloestradiol + Norgestimate)
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Unknown
CDC Split Type: B0464851A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB2541A IM 
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Headache, Loss of consciousness, Pallor, Photophobia, Syncope vasovagal, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow)
Write-up: This case was reported by a regulatory authority and described the occurrence of vasovagal attack in a 17-year-old female subject who was vaccinated with Engerix B for prophylaxis. Previous vaccination included hepatitis B vaccine, intramuscular given on 6 February 2007; polysaccharide typhoid vaccine; intramuscular given on 6 February 2007. Concurrent medications included Cileste. On 8 March 2007 the subject received 2nd dose of Engerix B (intramuscular). On 8 March 2007, just seconds after vaccination with Engerix B, the subject experienced "what appeared to be fit, vasovagal attack. The whole body tremor lasted approximately 10 to 15 seconds with loss of consciousness. Very pale headache and aversion to light." This case was assessed as medically serious by manufacturer. On 8 March 2007, the events were resolved.

VAERS ID:275682 (history)  Vaccinated:2007-03-08
Age:17.0  Onset:2007-03-08, Days after vaccination: 0
Gender:Female  Submitted:2007-04-05, Days after onset: 27
Location:Foreign  Entered:2007-04-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cileste (Ethinyloestradiol + Norgestimate)
Current Illness: UNK
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0465104A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSAHBVB2541A IM 
Administered by: Other     Purchased by: Other
Symptoms: Headache, Loss of consciousness, Pallor, Photophobia, Syncope vasovagal, Tremor
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), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This case was reported and described the occurrence of vasovagal attack in a 17-year-old female subject who was vaccinated with Engerix B for prophylaxis. Previous and/or concurrent vaccination included hepatitis B vaccine, intramuscular given on 6 February 2007; polysaccharide typhoid vaccine intramuscular given on 6 February 2007. Concurrent medications included Cileste. On 8 march 2007 the subject received unspecified dose of Engerix B (intramuscular), batch number AHBVB 2541A. On 8 March 2007, at an unspecified time after vaccination with Engerix B, the subject experienced vasovagal attack, loss of consciousness, photophobia, headache, body shakes and pallor. This case was assessed as medically serious by manufacturer. On 8 March 2007, the events were resolved. Verbatim text received: Just seconds after being given the second dose of hepatitis B, the patient had what appeared to be a fit, vasoattack. The whole body tremor lasted approximately 10-15 secs with loss of consciousness. Very pale, headache and aversion to light.

VAERS ID:275705 (history)  Vaccinated:2007-01-16
Age:17.0  Onset:2007-02-26, Days after vaccination: 41
Gender:Female  Submitted:2007-04-05, Days after onset: 37
Location:Foreign  Entered:2007-04-06, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: cervical smear 02?Mar07- Comment: showed Escherichia coli; HSV type and/or 2 identification PCR 02?Mar07 - Comment: Type I diagnosis made by HCR-PCR; WBC count 02?Mar07 6.4 nl; hematocrit 02?Mar07 39.5%; hemoglobin 02?Mar07 13.6 g/dl; plat
CDC Split Type: WAES0703USA05447
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0902F0IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Burning sensation, Escherichia infection, Haematocrit normal, Haemoglobin normal, Herpes simplex, Platelet count, Platelet count normal, Polymerase chain reaction, Rash pustular, Skin fissures, Smear cervix abnormal, Smear vagina, Superinfection, Vaginal inflammation, Vulvovaginal discomfort
SMQs:, Peripheral neuropathy (broad), Hypersensitivity (narrow)
Write-up: Information has been received from a gynaecologist concerning a 17 year old female who on 16-JAN-2007 was vaccinated with the first dose of Gardasil, (lot #654884/0902P, batch #NE24240), IM into the upper arm. Concomitant medication was not reported. On 26-FEB-2007, the patient experienced rhagades, pustules and burning feeling of vulva. On 28-FEB-2007, the patient developed severe inflammation of introitus vaginae. The patient was admitted to hospital on 02-MAR-2007. Severe herpes simplex genitalis and a superinfection with Escherichia coli were diagnosed. the patient was treated with acyclovir and antiinfectives. On an unspecified date, the following laboratory tests were performed leukocytes 6.4 nl, hemoglobulin 13.6 g/dl, hematocrit 39.5%, thrombocytes 251.000 micro/L, IgM positive, IgG positive, vaginal smear showed Escherichia coli and HSV-PCR diagnosed herpes simplex type I. On 07-MAR-2007, the patient was discharged from the hospital. Subsequently on an unspecified date, the patient recovered completely from herpes simplex type I and superinfection. On 19-MAR-2007, the patient received the second dose of Gardasil which was well tolerated (up to the reporting date). File closed. No further information is available.

VAERS ID:275780 (history)  Vaccinated:2007-01-23
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2007-04-06
Location:Foreign  Entered:2007-04-09, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hormonal contraceptives (unspecified) Unk - Unk
Current Illness:
Preexisting Conditions: Contraception
Diagnostic Lab Data: None
CDC Split Type: WAES0704USA00470
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0902F  UN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Generalised erythema, Injection site discolouration, Pruritus generalised
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)
Write-up: Information has been received from a gynaecologist concerning a 17 year old female with a history of contraception use who on 23-JAN-2007 was vaccinated with Gardasil (lot # 654884/0902F; batch # NE24240) into the left upper arm (number in the series not reported). Concomitant therapy included hormonal contraceptives (unspecified) for systemic use. On 23-JAN-2007, the same day, the patient experienced generalized pruritus and redness, She was treated with antihistamines and recovered on 24-MAR-2007. On an unspecified date in 2007, the patient developed a "white spot" (diameter approximately 4 cm) in the area of the injection site . At the time of reporting, the white spot was ongoing. This was supposed to be a "persisting damage". The events were ongoing to be serious as Other Important Medical Events. File closed. Other business partner numbers included: E2007-01992. No further information is available.

VAERS ID:278276 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Male  Submitted:2007-05-09
Location:Foreign  Entered:2007-05-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0468981A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Allergy to vaccine, Laboratory test, Oedema peripheral, X-ray
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)
Write-up: This case was reported by a consumer and described the occurrence of allergic reaction to vaccine in a 17-year-old male subject who was vaccinated with Hepatyrix, Poliomyelitis vaccine and Tetanus-Diptheria-Polio vaccination for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Hepatyrix (intramuscular), unspecified dose of Poliomyelitis vaccine, unspecified dose of Tetanus-Diptheria-Polio vaccination. At an unspecified time after vaccination with Hepatyrix, Poliomyelitis vaccine and Tetanus-Diptheria-Polio vaccination, the subject experienced allergic reaction to vaccine and swelling in the arm and hand ("doubled in size"). The subject was hospitalised. At the time of reporting the events had improved. Verbatim text: The consumer reported that the patient received Hepatyrix vaccine on an unspecified date. The patient also received co-suspect diphtheria vaccine, tetanus vaccine and polio vaccine. Sites of injections not specified. The patient developed swelling of the right hand and arm - "doubled in size". The patient was admitted to hospital and monitored overnight. An allergic reaction to one of the vaccines was suspected. The consumer commented that the patient received blood tests and an X-ray in hospital.

VAERS ID:278577 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:2007-05-07
Gender:Female  Submitted:2007-05-14, Days after onset: 7
Location:Foreign  Entered:2007-05-15, Days after submission: 1
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: None
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0705AUS00041
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0313U UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Aphasia, Facial paresis, Muscular weakness, Neurological symptom, Neuropathy, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad)
Write-up: Information has been received from the foreign Department of Health, via CSL as part of a business agreement (manufacturer''s number not yet advised). As part of the regular school-based immunisation program funded by the government, a 17 year old female student was vaccinated with Gardasil (Lot No. 655743/0313U, Batch No. J1022, Expiry date August 2009). Subsequently the patient experienced fainting and was taken to hospital. The patient had neurological symptoms and her reaction was serious enough to warrant consideration to intubation (confirmed as not intubated in follow-up information). The provisional diagnosis appears to be "hysterical reaction". The reporter felt that her reactions were related to therapy with Gardasil (Lot No. 655743/0313U, Batch No. J1022, Expiry date August 2009). Further information was received from a physician. It was stated that the patient was previously well. The patient had no significant medical history and no previous reaction to immunisation. There was no concurrent medication. On 07-MAY-2007, after the first dose of Gardasil (Lot No. 655743/0313U, Batch No. J1022, Expiry date August 2009), the patient developed ascending neuropathy with weakness of limb muscles and facial muscles and aphasia and was hospitalised. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the agency and was released by the regulatory agency. Additional information has been requested. This is one of several reports received from the same source.

VAERS ID:279094 (history)  Vaccinated:2007-04-25
Age:17.0  Onset:2007-04-28, Days after vaccination: 3
Gender:Female  Submitted:2007-05-18, Days after onset: 20
Location:Foreign  Entered:2007-05-21, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: serum ANA 04May07 Normal; serum C-reactive protein slightly elevated 04May07; serum creatinine 04May07 2.0 mg/dL; serum creatinine 05May07 2.5 mg/dL; serum creatinine 06May07 2.8 mg/dL; serum creatinine 10May07 1.4 mg/dL
CDC Split Type: WAES0705USA02669
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Antinuclear antibody negative, Blood creatinine increased, C-reactive protein increased, Flank pain, Renal failure acute, Ultrasound kidney abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (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), Chronic kidney disease (broad), Tumour lysis syndrome (broad)
Write-up: Information has been received from a physician concerning a 17 year old female patient who on 25-APR-2007 was vaccinated IM in to left upper arm with a first dose of Gardasil. On approximately 28-APR-2007 (3-4 days) post vaccination the patient experienced pain flank. On 04-MAY-2007 she was admitted to the hospital and was diagnosed with Acute renal failure. Her creatinine was 2.0 mg/dL, serum C-reactive protein test (CRP) was slightly increased. Sonographic analysis showed big swollen kidneys. She was treated by Intravenous (IV) fluids therapy. No specified medication was given. The patient improved step by step since 07-MAY-2007. Additional information is not expected.

VAERS ID:280172 (history)  Vaccinated:0000-00-00
Age:17.0  Onset:0000-00-00
Gender:Female  Submitted:2007-06-01
Location:Foreign  Entered:2007-06-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: CONGENITAL TOXOPLASMOSIS. The mother of the subject had been infected by toxoplasmosis virus at the end of the pregnancy.
Diagnostic Lab Data: Unknown
CDC Split Type: B0473210A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Condition aggravated, Eye infection toxoplasmal
SMQs:, Ocular infections (narrow)
Write-up: This case was reported by a physician and described the occurrence of ocular toxoplasmosis in a 17-year-old female subject who was vaccinated with Engerix B, for prophylaxis. The mother of the subject had been infected by toxoplasmosis virus at the end of the pregnancy. Concurrent medical conditions included congenital toxoplasmosis. In 1994, the subject received 3rd dose of Engerix B, unknown batch reference. In 1994, several months after the vaccination with Engerix B, the subject experienced ocular toxoplasmosis and was hospitalised. Physicians thought that the event was related to a reactivation of the virus. This reactivation could be due to the vaccination. The subject was treated with corticosteroid and antibiotics during 6 months. At the time of reporting the event was resolved. The physician considered the event was unlikely to be related to vaccination with Engerix B.

VAERS ID:282188 (history)  Vaccinated:2007-06-11
Age:17.0  Onset:2007-06-12, Days after vaccination: 1
Gender:Male  Submitted:2007-06-18, Days after onset: 6
Location:Foreign  Entered:2007-06-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: CONGENITAL INSUFFICIENCY OF AORTIC
Diagnostic Lab Data: UNK
CDC Split Type: D0053575A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Dysstasia, Face oedema, Fatigue, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of tiredness in a 17-year-old male subject who was vaccinated with Twinrix adult, GlaxoSmithKline, MMR, Priorix for prophylaxis. Concurrent medical conditions included mild congenital insufficiency of aortic value. On 25 May 2007 the subject received 1st dose of Priorix (unknown route and application site) and on 11 June 2007 at 18:30 the subject received 1st dose of Twinrix adult (unknown route and application site). On 12 June 2007, 1 day after vaccination with Twinrix adult, 18 days after vaccination with Priorix, the subject experienced tiredness, feeling of powerlessness, face edema and weakness of the arm and the legs. The patient could hardly stand. There was no injection site reaction. The subject was hospitalised. At the time of reporting the outcome of the events was unspecified. Follow-up information has been requested.

VAERS ID:282372 (history)  Vaccinated:2007-06-01
Age:17.0  Onset:2007-06-01, Days after vaccination: 0
Gender:Female  Submitted:2007-06-19, Days after onset: 18
Location:Foreign  Entered:2007-06-20, Days after submission: 1
Life Threatening? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Dental operation
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0706USA02451
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Autopsy, Loss of consciousness, Resuscitation, Sudden death
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)
Write-up: Information has been received from a gynecologist who was informed of the case from another gynecologist concerning a 17 year old female who in June 2007 (week 23), was vaccinated with a first dose of Gardasil (lot number, injection site and route not reported). During the evening of the same day, the patient was found unconscious (lifeless) by the mother. Resuscitation was performed by the emergency physician but was unsuccessful. The patient subsequently died. The cause of death was sudden death. It was noted that the patient had a dental surgery the day before she was vaccinated. An autopsy was done. The results were not known. Other business partner numbers include E2007-03769. Additional information has been requested.

VAERS ID:282582 (history)  Vaccinated:2007-03-16
Age:17.0  Onset:2007-04-12, Days after vaccination: 27
Gender:Female  Submitted:0000-00-00
Location:Foreign  Entered:2007-06-21
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: diagnostic laboratory test 12?Apr07 inflammatory alternations, diagnostic laboratory test 05?June07 inflammatory alternations
CDC Split Type: WAES0706USA02684
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Bacterial infection, Inflammation, Laboratory test abnormal, Nausea, Pyrexia, Similar reaction on previous exposure to drug, Staphylococcal sepsis
SMQs:, Acute pancreatitis (broad), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: Information has been received from a general practitioner concerning a 17 week old female who on 16-MAR-2007 received her first dose of Gardasil, intramuscularly into the upper arm. On 12-APR-2007, she experienced staphylococcal sepsis with fever and nausea. She was admitted to the hospital and treated on the intensive care unit. She recovered within an unspecified time. On 01-JUN-2007, the patient received her second dose of the Gardasil, intramuscularly into the upper arm. On 05-JUN-2007, she developed a similar clinical picture (bacterial infection with fever and nausea). She received outpatient treatment with antibiotics. She recovered within an unspecified time. Lab findings in both cases showed inflammatory alternations (not specified). No further information is available. Other business partner numbers included E2007-03785.

VAERS ID:283716 (history)  Vaccinated:2007-04-23
Age:17.0  Onset:2007-04-23, Days after vaccination: 0
Gender:Female  Submitted:2007-07-03, Days after onset: 71
Location:Foreign  Entered:2007-07-03
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Doxycycline, Oral contraceptive
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: CT brain scan 09Jun2007 Normal, Electrocardiogram 14Jun2007 Normal
CDC Split Type: B0469948A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB112AC IMUN
Administered by: Other     Purchased by: Other
Symptoms: Chest pain, Computerised tomogram normal, Dizziness, Dyspnoea, Electrocardiogram normal, Palpitations, Scan brain, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad)
Write-up: This case was reported by a representative via healthcare professional and described the occurrence of tachycardia in a 17-year-old female subject who was vaccinated with Havrix, GlaxoSmithKline for prophylaxis. The subject had no allergy. It was not known if the subject was tobacco or alcohol user. Concurrent medications included Doxycycline and Oral contraceptive (unknown). On 23 April 207, the subject received 2nd dose of Havrix (intramuscular, unknown deltoid). On 23 April 2007, less than one day after vaccination with Havrix, the subject experienced possible tachycardia and shortness of breath which were resolved the same day. On 26 April 2007, she had palpitation, chest pain and dizziness which also resolved on the same day. Additional information has been requested. Follow up information received on 25 and 26 June 2007 from a nurse; The case has been upgraded to serious. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The reporter advised that the subject experienced 1-2 episodes of dizzy spells, shortness of breath and tachycardia a week. The subject was due to an appointment with cardiology on 14 June 2007. CT brain scan performed on 9 June 2007 was normal as well as electrocardiogram on 14 June 2007. The healthcare professional considered the events were possibly related to vaccination with Havrix.

VAERS ID:284186 (history)  Vaccinated:2007-06-07
Age:17.0  Onset:2007-06-07, Days after vaccination: 0
Gender:Female  Submitted:2007-07-09, Days after onset: 32
Location:Foreign  Entered:2007-07-10, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: electroencephalography 07Jun07
CDC Split Type: WAES0707AUS00057
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0138U   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Agitation, Anaphylactic reaction, Dyspnoea, Electroencephalogram, Fall, Flushing, Nausea, Tachycardia, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Information has been received from the Department of Health, as part of a business agreement, with follow-up information received on request by the Company via a Line Listing from the Department of Health. As part of the regular school-based immunisation program funded by the government, on 07-JUN-2007 a 17 year old female was vaccinated with Gardasil (Lot No. 655742/0138U, Batch No. J0800, expiry date 07-AUG-2009). Five minutes after being vaccinated with Gardasil, the patient collapsed. Her face was flushed, spreading to her hairline, she was tachycardic and not responding. The patient became agitated, nauseated and experienced mild shortness of breath. Subsequently, 0.5 ml of adrenaline was administered, with little effect, so the dose was repeated. The patient was transferred to the emergency department of hospital and discharged PM, post EEG. The patient recovered from anaphylaxis. The reporter considered that anaphylaxis was probably related to therapy with Gardasil. The original reporting source was not provided. Additional information is not expected.

VAERS ID:284192 (history)  Vaccinated:2007-05-24
Age:17.0  Onset:2007-05-24, Days after vaccination: 0
Gender:Female  Submitted:2007-07-09, Days after onset: 46
Location:Foreign  Entered:2007-07-10, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 0 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES0707AUS00033
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.0138U   
Administered by: Unknown     Purchased by: Unknown
Symptoms: Anaphylactic reaction, Cyanosis, Dyspnoea, Erythema, Livedo reticularis, Nausea, Pharyngeal oedema, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), 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), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)
Write-up: Information has been received from the Department of Health as part of a business agreement with follow-up information on request by the Company received via a Public Case Detail form. As part of the regular school-based immunisation program funded by the government, on 24-MAY-2007 a 17 year old female was vaccinated with Gardasil (Lot No. 655742/0138U, Batch No. J0799, Expiry date 07-AUG-2009). On 24-MAY-2007 the patient experienced anaphylactic reaction, dyspnoea, cyanosis, nausea, pharyngeal oedema and swollen tongue and was hospitalized. It was stated that the patient developed red, mottled face to waist. The patient was nauseated and cyanosed, and experienced difficulty in breathing. The patient''s throat and tongue restricted. However, no stridor cough was developed. The patient was given adrenaline 0.5 ml with no improvement. Further adrenaline 0.5 ml was given 5 minutes later and the patient''s symptoms improved. On 24-MAY-2007 the patient recovered from anaphylactic reaction, dyspnoea, cyanosis, nausea, pharyngeal oedema and swollen tongue. The agency considered that anaphylactic reaction, dyspnoea, cyanosis, nausea, pharyngeal oedema and swollen tongue were probably related to therapy with Gardasil. The original reporting source was not provided. Additional information is not expected.

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