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VAERS ID: 478847 (history)  
Form: Version 1.0  
Age: 12.0  
Gender: Male  
Location: Kentucky  
Vaccinated:2012-12-13
Onset:2012-12-13
   Days after vaccination:0
Submitted: 2012-12-19
   Days after onset:6
Entered: 2012-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUZONE) / SANOFI PASTEUR UH748AB / 2 RA / UN
HEPA: HEP A (VAQTA) / MERCK & CO. INC. 0419AA / 2 LA / UN
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H012973 / 2 RA / UN

Administered by: Public       Purchased by: Public
Symptoms: Blood glucose decreased, Facial bones fracture, Fall, Laceration
SMQs:, Accidents and injuries (narrow), Hostility/aggression (broad), Hypoglycaemia (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: Blood sugar was 67.
CDC Split Type:

Write-up: Pt received Hepatitis A & Human Papilloma Virus & flu. Remained seated for 10 min after receiving shots. Then went to bathroom fell & fractured chin & sustained a laceration to chin as well.


VAERS ID: 478848 (history)  
Form: Version 1.0  
Age: 60.0  
Gender: Male  
Location: Florida  
Vaccinated:2012-10-31
Onset:0000-00-00
Submitted: 2012-12-19
Entered: 2012-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. 0421AE / 1 LA / SC

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Injection site swelling, Musculoskeletal pain, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: Soreness at injection site. Swelling at injection site. Pain on lifting shoulder, seating or sleeping.


VAERS ID: 478849 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Male  
Location: Foreign  
Vaccinated:2012-12-04
Onset:2012-12-05
   Days after vaccination:1
Submitted: 2012-12-17
   Days after onset:12
Entered: 2012-12-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS 127002 / 1 AR / IM

Administered by: Other       Purchased by: Other
Symptoms: Chills, Eyelid disorder, Fatigue, Nasopharyngitis, Pyrexia, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Periorbital and eyelid disorders (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012DE114529

Write-up: Case number PHHY2012DE114529 is an initial spontaneous report received from a physician via Novartis sales representative on 11 Dec 2012: This report refers to a 02-year-old male patient. Past medical history and concomitant medication were not provided. On 04 Dec 2012 at 3.30 pm the patient was vaccinated for the first time with BEGRIPAL (batch no. 127002) intramuscularly into the upper arm. On 05 Dec 2012 the patient presented with fever, cold, cough, chills, sudden fatigue, open eyes and unresponsiveness. The patient was treated with NUROFEN junior 2%, Diazepam 5 mg, paracetamol 250 mg on 05 Dec 2012. The patient recovered at an undetermined date. The case was assessed serious by the reporter. Causality was not assessed by the reporter.


VAERS ID: 478850 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:2012-10-07
Onset:2012-10-07
   Days after vaccination:0
Submitted: 2012-11-29
   Days after onset:53
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0385AE / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1211USA011098

Write-up: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 07-OCT-2012 19:07, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.


VAERS ID: 478851 (history)  
Form: Version 1.0  
Age: 74.0  
Gender: Female  
Location: Michigan  
Vaccinated:2012-12-09
Onset:2012-12-12
   Days after vaccination:3
Submitted: 2012-12-19
   Days after onset:7
Entered: 2012-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (ZOSTAVAX) / MERCK & CO. INC. H018799 / 1 LA / SC

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

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

Write-up: Patient developed redness and tenderness at site of injection. Area grew up a 6" x 3" hard bump. Was treated with hydrocortisone and BENADRYL creams and the area cleared up over 5 days.


VAERS ID: 478852 (history)  
Form: Version 1.0  
Age: 5.0  
Gender: Male  
Location: Foreign  
Vaccinated:2012-11-22
Onset:2012-11-23
   Days after vaccination:1
Submitted: 2012-12-19
   Days after onset:26
Entered: 2012-12-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK RA / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood culture negative, Haemoglobin normal, Induration, Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth, Lymphadenopathy, Urine cytology normal
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 11/24/2012, Blood creatine phosphokinase, 264; 11/24/2012, Blood creatine phosphokinase MB, 18; 11/24/2012, Haemoglobin, 11.3 g/dl
CDC Split Type: PHHY2012CH114412

Write-up: Case number PHHY2012CH114412 is an initial spontaneous report received from a physician on 11 Dec 2012. This case refers to a 05-year-old male patient. The patient''s medical history and concomitant medications were not reported. He was vaccinated with AGRIPPAL (batch number: not reported) intramuscularly into his right upper arm on 22 Nov 2012. On 23 Nov 2012, he developed massive swelling in the right upper arm down to the middle of the lower arm and it was painful and warm. He also had reddening from the right shoulder to the elbow, induration from the right shoulder to the middle of the lower arm, serous blisters around the injection site and restricted mobility in the elbow joint. His right axial lymph nodes were enlarged. Peripheral blood flow and sensory perception were intact. The patient was hospitalized on an unspecified date due to these events. Laboratory parameters performed of 24 Nov 2012: leucocyte count (Lc) 9300/ul, hemoglobin (Hb) 11.3g/dl, total count (Tc) 192000/ul, C-reactive protein (CrP) 6mg/dl, CK-MB 18U/l and CK 264 U/l. An infectious origin had not been excluded and intravenous antibiotic therapy with AUGMENTIN was started on 24 Nov 2012 (lasting until 26 Nov 2012, dose unknown), with symptomatic treatment with ibuprofen, resulting in a clear regression with a decrease in swelling and warmth. On 24 Nov 2012, a blood culture was started and a bladder smear was examined, the results of which were negative. Antibiotic treatment was then stopped. He had recovered from all the events on an unspecified date. The causality was reported as probably related to AGRIPPAL vaccination. No other information was available at the time of this report.


VAERS ID: 478853 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2012-10-07
Onset:2012-10-07
   Days after vaccination:0
Submitted: 2012-11-29
   Days after onset:53
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0385AE / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1211USA011097

Write-up: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 07-OCT-2012 11:20, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. the outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.


VAERS ID: 478854 (history)  
Form: Version 1.0  
Age: 4.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2012-12-17
Onset:2012-12-18
   Days after vaccination:1
Submitted: 2012-12-19
   Days after onset:1
Entered: 2012-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C4214BA / 5 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR H13541 / 4 LL / SC
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0680AE / 2 RL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. H013640 / 2 LL / SC

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

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

Write-up: Swelling and redness (L) thigh from knee to groin and 10 cm wide.


VAERS ID: 478855 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Male  
Location: Arizona  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-19
Entered: 2012-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B154BAHK / UNK RA / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB605AA / 2 LA / IM

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

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

Write-up: Pt presented with urticarial rash and itching centered primary around site of injection and spreading outward from there. Administered BENADRYL and observed until 1 hour had passed after time of vaccine - urticaria & itching were better.


VAERS ID: 478856 (history)  
Form: Version 1.0  
Age:   
Gender: Male  
Location: Unknown  
Vaccinated:2012-10-08
Onset:2012-10-08
   Days after vaccination:0
Submitted: 2012-11-29
   Days after onset:52
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0385AE / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1211USA011099

Write-up: This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 08-OCT-2012 11:54, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.


VAERS ID: 478857 (history)  
Form: Version 1.0  
Age:   
Gender: Female  
Location: Unknown  
Vaccinated:2012-10-19
Onset:2012-10-19
   Days after vaccination:0
Submitted: 2012-11-29
   Days after onset:41
Entered: 2012-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0385AE / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1211USA011187

Write-up: This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 19-OCT-2012 02:12, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of the event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.


VAERS ID: 478858 (history)  
Form: Version 1.0  
Age: 74.0  
Gender: Female  
Location: North Carolina  
Vaccinated:2012-12-07
Onset:2012-12-07
   Days after vaccination:0
Submitted: 2012-12-12
   Days after onset:5
Entered: 2012-12-19
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUVIRIN) / NOVARTIS VACCINES AND DIAGNOSTICS 1206901 / UNK RA / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. H013399 / 1 LA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine
Current Illness: Hypothyroidism (unk. ideo.)
Preexisting Conditions: NKDA
Allergies:
Diagnostic Lab Data: None as of 12-12-12 date.
CDC Split Type:

Write-up: Approx. 10 hours after vacc. given c/o discomfort, redness, & swelling just below injection site on (L) arm; area continued to increase with edema until "all loose skin was tight"; c/o area hot to touch. Much improved after 3 days. (PNEUMOVAX given in left arm).


VAERS ID: 478859 (history)  
Form: Version 1.0  
Age: 0.17  
Gender: Male  
Location: California  
Vaccinated:2012-12-18
Onset:2012-12-18
   Days after vaccination:0
Submitted: 2012-12-19
   Days after onset:1
Entered: 2012-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR C4371AA / 1 RL / IM
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. H016756 / 2 RL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 918561 / 1 LL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0285AE / 1 MO / PO

Administered by: Private       Purchased by: Unknown
Symptoms: Crying, Depressed level of consciousness, Hyporesponsive to stimuli, Lethargy, Pallor
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Excessive crying at time of event until subsequent lethargy and poor responsiveness. Hard to arouse for about 30 minutes after injection. Pale.


VAERS ID: 478860 (history)  
Form: Version 1.0  
Age: 0.3  
Gender: Unknown  
Location: Foreign  
Vaccinated:2012-10-24
Onset:2012-10-24
   Days after vaccination:0
Submitted: 2012-12-20
   Days after onset:57
Entered: 2012-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1871AA / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Hypotonic-hyporesponsive episode, Loss of consciousness
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), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1212POL006493

Write-up: This spontaneous report as received via a regulatory authority from a physician refers to a 12 weeks old patient. The patient was vaccinated orally with ROTATEQ (lot number 1871AA) on 24-OCT-2012. Other suspect therapies included INFANRIX HEXA (lot number A21CB292A) intramuscularly on 24-OCT-2012. No concomitant medications were reported. On 24-OCT-2012 (6,5 hours after vaccination) the patient experienced hypotonic-hyporesponsive episode (medically significant by the regulatory authority) and loss of consciousness (medically significant by the regulatory authority), approximately 1 minute after feeding. No treatment information was reported. The outcome of hypotonic-hyporesponsive episode and loss of consciousness was reported as recovered/resolved. The events were expected by the regulatory authority. The events were reported as related to ROTATEQ. Additional information is not expected.


VAERS ID: 478861 (history)  
Form: Version 1.0  
Age: 20.0  
Gender: Female  
Location: Arkansas  
Vaccinated:2012-12-17
Onset:2012-12-17
   Days after vaccination:0
Submitted: 2012-12-19
   Days after onset:2
Entered: 2012-12-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA731DA / 1 UN / UN
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. 0384AE / 1 UN / UN

Administered by: Other       Purchased by: Private
Symptoms: Rash macular, Rash pruritic, Skin discolouration
SMQs:, Anaphylactic reaction (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Red, itching blotches entire trunk of body with raised bumps, flesh colored, possible fever, never checked temp.


VAERS ID: 478862 (history)  
Form: Version 1.0  
Age: 26.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-17
Entered: 2012-12-20
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Disturbance in attention, Hypersensitivity, Mobility decreased, Pain in extremity, Sleep disorder
SMQs:, Angioedema (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Food Allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012GB115301

Write-up: Case number PHHY2012GB115301 is an initial anonymised single patient report received from agency on 11 Dec 2012. This report refers to a 26-year-old female patient. The patient received seasonal influenza vaccine (manufacture: unknown, batch number: unknown) on an unknown date. On an unknown date, after vaccination, the patient experienced allergic reactions. The patient reported difficult to move arm as it was so sore where clothing moved over it. The stabbing pains in hands were also so sharp that she couldn''t focus on what she was doing, although they only lasted five minutes at a time intermittently. Treatment with paracetamol did not alleviate the symptoms dramatically but the side effects only lasted 5 days in total so she did not consider it as severe reaction. After the first day she was able to continue her normal activities but had broken sleep and adjusted her activities to accommodate the pain in arm. The patient enquired if it was due to an allergy so that she might potentially be able to have an alternate jab in future. The patient was not allergic to hen eggs but had food allergy. No further information was available.


VAERS ID: 478863 (history)  
Form: Version 1.0  
Age: 26.0  
Gender: Female  
Location: Foreign  
Vaccinated:2012-11-10
Onset:2012-11-10
   Days after vaccination:0
Submitted: 2012-12-18
   Days after onset:38
Entered: 2012-12-20
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth, Nasal congestion, Nasopharyngitis, Oropharyngeal pain, Pain, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Beclazone; DEPO PROVERA; Mebeverine; VENTOLIN
Current Illness: Food allergy
Preexisting Conditions: H1N1 influenza; Antibiotics; Paracetamol
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHFR2012GB006398

Write-up: Case number PHFR2012GB006398 is an initial anonymised single patient report received from agency on 11 Dec 2012. This report refers to a 26-year-old female patient. The patient had previous history of vaccination with influenza virus (unknown) and experienced allergic reactions (See case: PHHY2012GB115301). The patient reported difficult to move arm as it was so sore where clothing moved over it. The stabbing pains in hands were also so sharp that she couldn''t focus on what she was doing, although they only lasted five minutes at a time intermittently. Treatment with paracetamol did not alleviate the symptoms dramatically but the side effects only lasted 5 day in total so she did not consider it as severe reaction. After the first day she was able to continue her normal activities but had broken sleep and adjusted her activities to accommodate the pain in arm. The patient enquired if it was due to an allergy so that she might potentially be able to have an alternate jab in future. The patient was not allergic to hen eggs but had food allergy. The patient contracted swine flu and was prescribed antibiotics for that strain (date not reported). Concomitant medications included Beclazone, DEPO PROVERA, mebeverine and VENTOLIN. The patient received seasonal influenza vaccine (manufacture: unknown, batch number: unknown) on 10 Nov 2012 via parenteral route. On the same day patient experienced ache, cold symptoms, nasal congestional, injection site warmth, pain at injection site, shooting pain and sore throat. On 11 Nov 2012 she experienced injection site wheal and swelling at injection. The patient had also reported sleep disturbance (onset date not reported). The patient was treated with paracetamol. Reporter assessed the events as serious. The events ache, cold symptoms, nasal congestion, shooting pain and sore throat resolved on 12 Nov 2012. The other events were resolved on 15 Nov 2012. The outcome for sleep disturbance was not reported. The causality was not reported.


VAERS ID: 478864 (history)  
Form: Version 1.0  
Age: 33.0  
Gender: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-18
Entered: 2012-12-20
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012AU115038

Write-up: Case number PHHY2012AU115038 is an initial spontaneous report received from health authority (reference number: AU00304130) on 10 Dec 2012. This case refers to a 33-year-old female patient. She was vaccinated with MENVEO (batch number: not reported) on an unspecified date. On the same day, she was also vaccinated with BOOSTRIX (other manufacturer, batch number: not reported). On an unknown date after vaccination she developed hypersensitivity reaction. The seriousness and outcome were not reported. Health authority causality was reported as suspected to be related to both vaccinations. No other information was available.


VAERS ID: 478865 (history)  
Form: Version 1.0  
Age: 2.0  
Gender: Male  
Location: Foreign  
Vaccinated:2012-10-12
Onset:2012-10-13
   Days after vaccination:1
Submitted: 2012-12-19
   Days after onset:67
Entered: 2012-12-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (OPTAFLU) / NOVARTIS VACCINES AND DIAGNOSTICS 031011A / UNK LG / IM

Administered by: Other       Purchased by: Other
Symptoms: Atelectasis, Bacterial test positive, Blood culture negative, C-reactive protein increased, Chest X-ray abnormal, Convulsion, Cyanosis, Faecal fat increased, Fatigue, Fluid retention, Hepatosplenomegaly, Kidney enlargement, Post procedural complication, Pseudomonas test positive, Pyrexia, Staphylococcus test positive, Steatorrhoea, Stool analysis abnormal, Ultrasound abdomen abnormal, Upper respiratory tract infection
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KONAKION; Inzolen; SELEN; Lactobacillus; FLUORETTE; VIGANTOLETTEN; ANTRA MUPS
Current Illness: Mental impairment; Motor developmental delay
Preexisting Conditions: Premature baby; Preternatural anus; Jejunostomy; Necrotising colitis; Small intestinal resection; Large intestine perforation; Bradycardia; Thermal burn; Hyponatraemia; Hyperkalaemia; Dehydration; Hepatomegaly; Kidney enlargement; Upper respiratory tract infection; Adhesiolysis; Meropenem; Vancomycin; LASIX; Theophylline; Influenza vaccine; Neonatal respiratory distress syndrome; Infection; Bronchopulmonary dysplasia; Vena cava thrombosis; Subclavian vein thrombosis; Meconium plug syndrome; Disseminated intravascular coagulation; Sleep apnoea syndrome, Apnea-bradycardia syndrome; Enterococcal sepsis; Endotoxic shock; Sepsis; Laparotomy; Orchidopexy; Hernia repair; Tachypnoea
Allergies:
Diagnostic Lab Data: C-reactive protein, 55 m/L; 10/19/2012, Culture, Abnormal, Significant, Revealed numerous pseudomonas aeruginosa and staphylococcus aureus. 10/17/2012, Stool analysis, Abnormal, Significant, Which revealed traces of fat and starch, MF was negative. 09/14/2012, Ultrasound abdomen, Abnormal, Very slow intestinal peristalsis without evidence of hyperperfusion and fluid filled intestinal loops in the left upper abdomen. 09/16/2012, Ultrasound abdomen, Abnormal, Hepatosplenomegaly and bilateral renomegaly. 09/12/2012, X-ray, Normal, Showed normal sized heart, centrally positioned mediastinum of normal age appropriate width and hili of vascular configuration; 09/13/2012, X-ray, Abnormal, Showed slight signs of postoperative of pulmonary hyperhydration, pulmonary hyperdistension; 09/14/2012, X-ray, Abnormal, Showed complete opacification of the right upper lobe with total atelectasis and postoperative hyperhydration
CDC Split Type: PHHY2012DE099915

Write-up: +Case number PHHY2012DE099915 is a spontaneous report received initially from the health authority (reference number: DE-PEI-DE2012053864) on 30 Oct 2012 with a follow-up received on 09 Nov 2012 with a follow up report received on 06 Dec 2012: This report refers to a 27-month-old male patient. His medical history included treatment with influenza vaccination (manufacturer unknown) with no adverse effect. He was born as a premature baby (26+0 weeks of gestation). The patient''s medical history included retarded mental and motor development, necrotizing enterocolitis, jejunostomy, preternatural anus, respiratory distress syndrome (RDS), newborn infection, broncho-pulmonary dysplasia (BPD), status post (s/p) inferior vena cava thrombosis and thrombosis of the left subclavian vein, s/p meconium plug syndrome, s/p burn of the right lower leg, s/p consumption coagulopathy (treated with fresh frozen plasma and antithrombin III (AT III) substitution). On 21 Aug 2010, he developed apnea-bradycardia syndrome and sepsis with E. germaniae and E. cloaecae (endotoxin shock). On 10 Oct 2010, catheter sepsis due to coagulase negative staphylococcus was observed. He also had sepsis for which immunoglobulin therapy was given from 28 Jan 2012 to 31 Jan 2012 and 04 Feb to 07 Feb 2012). The patient''s past surgical history included laparotomy with AP (anus praeter) creation (21 Aug 2010), perforation and re-laparotomy (on 03 Sep 2010), enterostomy closure and adhesiolysis (on 09 Nov 2010), partial resection of ileum (17 cm due to adhesion ileus on 01 Dec 2010), open gastrostomy creation with transverse colon perforation and suturing (on 27 Jan 2011), resection of 20 cm of small intestine with extensive adhesiolysis and removal of adhesions as well as herniotomy and orchidopexy (on 05 Jan 2012), creation of jejunostomy due to fecal peritonitis with adhesiolysis (on 22 Jan 2012), Hickman catheter placement (on 30 Jan 2012) and adhesiolysis and creation of new AP was performed which included laparotomy and opening of retroperitoneum, relaparotomy and resection of small intestine, segment resection of ileum, open surgery (ileum resection 7 cm, all on 10 Oct 2010). On 06 Jun 2012, he had hyponatremia, hyperkalemia and exsiccosis. He was hospitalized on 05 Sep 2012 for planned surgical intervention which was postponed due to a slight febrile infection of the upper respiratory tract. He was readmitted on 11 Sep 2012 for an elective pediatric surgical intervention. On 12 Sep 2012, the patient underwent laparotomy, extensive adhesiolysis and AP closure. His physical examination was normal. Chest radiography revealed normal sized heart, centrally positioned mediastinum of normal age appropriate width and hill of vascular configuration. On 13 Sep 2012, the patient received red cell concentrate transfusion. Chest and abdominal radiography was normal on 13 Sep 2012 except for slight signs of postoperative of pulmonary hyperhydration, pulmonary hyperdistension. On 13 Sep 2012, his pathological findings were good with focal necroses of ischemic origin and with postoperative chronic fibrotic peritonitis consistent with numerous previous operations. Blood culture on 14 Sep 2012 revealed no growth. Chest and abdominal radiography was normal on 14 Sep 2012 except for complete opacification of the right upper lobe with total atelectasis and postoperative hyperhydration. The patient also developed intermittent tachypnea associated with upper lobe atelectasis post-surgery which improved upon respiratory therapy. Post-surgery, the patient received furosemide and theophylline due to reduced diuresis, levofloxacin for increase reddening of abdomen and also therapy with vancomycin and meropenem. Abdominal ultrasound on 14 Sep 2012 revealed very slow intestinal peristalsis without evidence of hyperperfusion and fluid filled intestinal loops in the left upper abdomen. Abdominal ultrasound on 16 Sep 2012 confirmed hepatosplenomegaly and bilateral renomegaly. Vancomycin, meropenem and levofloxacin therapy were later discontinued and on 24 Sep 2012, the patient was in good general clinical condition. An upper gastro-intestinal passage examination was performed on 25 Sep 2012 due to persisting, green gastric residues which revealed a stenosis in terminal ileum. Blood culture on 27 Sep 2012, revealed no growth. Only on the seventh day after contrast administration through the PEG, contrast medium was detectable and on 04 Oct 2012, there was a spontaneous fecal evacuation. After which, rectal irrigation was suggested to be done twice daily. On 05 Oct 2012, solid diets were re-introduced. He was vaccinated with OPTAFLU (batch number 031011A) intramuscularly in his thigh on 12 Oct 2012. Concomitant medications included KONAKION, inzolen, SELEN, lactobacillus, FLUORETTE, VIGANTOLETTEN and ANTRA MUPS. On 13 Oct 2012, he had generalized convulsion with fever and cyanosis (O2 saturation 30 percent) lasting for five minutes. He was treated with lorazepam. He was prescribed diazepam 5 mg in case of convulsion with fever more than 3 minutes. Lab test revealed C-reactive protein level as 55 m/L. After convulsion, the baby was tired but showed no neurological deficit. On 17 Oct 2012, stool analysis for digestive performance was done which revealed traces of fat and starch, MF was negative. On 19 Oct 2012, gastrotomy swab sample revealed numerous pseudomonas aeruginosa and staphylococcus aureus. This condition was treated locally with antiseptics. On 21 Oct 2012, blood cultures revealed no growth. He was discharged on 26 Oct 2012. Since 28 Oct 2012, he had infection of the upper respiratory tract. The final outcome was reported as completely recovered. The causality was not reported. The outcome, seriousness and causality for the event upper respiratory tract infection were not reported. Follow-up received from the Health Authority on 09 Nov 2012: No new relevant information was provided. Follow up report from health authority received on 06 Dec 2012: Updated patient''s demographics, medical history, lab data, concomitant medications, event (upper respiratory tract infection), hospitalization dates and narrative accordingly.


VAERS ID: 478866 (history)  
Form: Version 1.0  
Age:   
Gender: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-14
Entered: 2012-12-20
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Hypotonia, Inflammation, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012GR113586

Write-up: Case number PHHY2012GR113586 is an initial spontaneous report received from a healthcare professional via marketing program MENVEO focus groups on 08 Dec 2012. This case refers to a patient of an unknown age and gender. The patient had no relevant medical history. The patient was vaccinated with MENVEO (batch number: not reported) on an unspecified date. On an unknown date after vaccination in 2012, the patient experienced fever, localized inflammation reaction and muscle hypotonial upper limb where the injection was given. The patient was hospitalized due these events. Lab data did not reveal anything relating to the events. The outcome of these events was reported as condition improving. The causality was not reported. No other information was available.


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