MedAlerts Home
  Read the MedAlerts Blog Subscribe to the MedAlerts Blog 

Found 557344 cases in entire database

Case Details (Sorted by Age)

This is page 2684 out of 5574

Result pages: prev   2585 2586 2587 2588 2589 2590 2591 2592 2593 2594 2595 2596 2597 2598 2599 2600 2601 2602 2603 2604 2605 2606 2607 2608 2609 2610 2611 2612 2613 2614 2615 2616 2617 2618 2619 2620 2621 2622 2623 2624 2625 2626 2627 2628 2629 2630 2631 2632 2633 2634 2635 2636 2637 2638 2639 2640 2641 2642 2643 2644 2645 2646 2647 2648 2649 2650 2651 2652 2653 2654 2655 2656 2657 2658 2659 2660 2661 2662 2663 2664 2665 2666 2667 2668 2669 2670 2671 2672 2673 2674 2675 2676 2677 2678 2679 2680 2681 2682 2683 2684 2685 2686 2687 2688 2689 2690 2691 2692 2693 2694 2695 2696 2697 2698 2699 2700 2701 2702 2703 2704 2705 2706 2707 2708 2709 2710 2711 2712 2713 2714 2715 2716 2717 2718 2719 2720 2721 2722 2723 2724 2725 2726 2727 2728 2729 2730 2731 2732 2733 2734 2735 2736 2737 2738 2739 2740 2741 2742 2743 2744 2745 2746 2747 2748 2749 2750 2751 2752 2753 2754 2755 2756 2757 2758 2759 2760 2761 2762 2763 2764 2765 2766 2767 2768 2769 2770 2771 2772 2773 2774 2775 2776 2777 2778 2779 2780 2781 2782 2783   next


VAERS ID:451680 (history)  Vaccinated:2010-03-30
Age:10.0  Onset:2010-04-04, Days after vaccination: 5
Gender:Male  Submitted:2012-03-13, Days after onset: 709
Location:Foreign  Entered:2012-03-13
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:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Leukocyte count NOS, Apr2010, 2.6; Neutrophils, Apr2010, 0.68; Thrombocyte count, Apr2010, increased
CDC Split Type: B0765624A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B108BB UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain upper, Diarrhoea, Incorrect drug dosage form administered, Leukopenia, Lymphadenitis, Neutrophil count decreased, Peritoneal disorder, Platelet count increased, Vomiting, White blood cell count decreased
SMQs:, Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician and described the occurrence of vomiting in a 10-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 30 March 2010, the subject received unspecified dose of INFANRIX (route and injection site unknown). At an unspecified time after vaccination with INFANRIX, the subject experienced vomiting and diarrhea. The subject was hospitalised. At the time of reporting, the outcome of the events was unspecified. Because of these events, there was a discussion whether the subject should be vaccinated with PRIORIX. Follow-up information received on 9 March 2012: This case was also reported by a nurse. On 4 April 2010, 5 days after vaccination with INFANRIX, the subject experienced stomach pain, diarrhea and vomiting. The subject was hospitalised. On 5 April 2010, 6 days after vaccination with INFANRIX, leukopenia was observed with leucocytes count: 2.6 and neutrophils: 0.68. He had discrete peritoneal irritation at the left of the abdomen which could correspond to abdomen lymphadenitis. The subject was fine and eat food. He didn''t have much pain and was released on 5 April 2010. The leucocytes were normalised however, he had a slightly increased thrombocyte count. On 5 April 2010, vomiting and diarrhea were resolved. At the time of reporting, the events were resolved.

VAERS ID:452045 (history)  Vaccinated:2012-02-27
Age:10.0  Onset:2012-02-27, Days after vaccination: 0
Gender:Male  Submitted:2012-03-16, Days after onset: 17
Location:Foreign  Entered:2012-03-19, 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:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0788724A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSAC20B194AB IMUN
Administered by: Other     Purchased by: Other
Symptoms: No adverse event, Wrong drug administered
SMQs:, Medication errors (narrow)
Write-up: This case was reported by a healthcare professional via a regulatory authority (# PT-INFARMED-L201203-209) and described the occurrence of wrong vaccine administered in a 10-year-old male subject who was vaccinated with INFANRIXTETRA (GlaxoSmithKline). The subject had no known clinical antecedents. There were not known previous reactions to either INFANRIXTETRA vaccine or other drugs. On 27 February 2012, the subject received unspecified dose of INFANRIXTETRA by mistake (intramuscular, unknown site of injection), instead of the vaccine against diphtheria and tetanus. The subject did not present any event. The regulatory authority reported that the event was clinically significant (or requiring intervention).

VAERS ID:452298 (history)  Vaccinated:2012-02-22
Age:10.0  Onset:2012-02-22, Days after vaccination: 0
Gender:Male  Submitted:2012-03-22, Days after onset: 28
Location:Foreign  Entered:2012-03-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Body temperature, 22Feb2012, more than 39deg.; Body temperature, 24Feb2012, 38.7deg.C
CDC Split Type: B0784613A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB537AB UNUN
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Chills, Delirium, Fatigue, Feeling cold, Headache, Hyperhidrosis, Hypotonia, Irritability, Malaise, Nausea, Paramnesia, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of cold feeling in a 10-year-old male subject who was vaccinated with HAVRIX JUNIOR (GlaxoSmithKline). On 22 February 2012, the subject received unspecified dose of HAVRIX JUNIOR (unknown route of administration). On 22 February 2012, less than one day after vaccination with HAVRIX JUNIOR, the subject experienced cold feeling, fever, malaise, nausea, headache and huffiness. At the time of reporting the outcome of the events was unspecified. Follow-up information received on 12 March 2012: On 22 February 2012, at midday, the subject received 1st dose of HAVRIX JUNIOR (intramuscular, unknown deltoid). On 22 February 2012, at 07:00 PM, 7 hours after vaccination with HAVRIX JUNIOR, the subject experienced cold feeling, delirium, sweating, fever (more than 39 Deg. C), chills, fever dreams and excessive imagination (fantasy). The same day the subject experienced malaise and huffiness. On 23 February 2012, 1 day after vaccination with HAVRIX JUNIOR, the subject was exhausted but afebrile. On 24 February 2012, 2 days after vaccination with HAVRIX JUNIOR, the subject experienced nausea, headache and floppy. The subject experienced fever again (38.7 Deg. C). On 25 February 2012, 3 days after vaccination with HAVRIX JUNIOR, the subject experienced weakness, no fever. At an unspecified date in February 2012, less than 1 month after vaccination with HAVRIX JUNIOR, the subject experienced nausea again and vomited once. This case was assessed as medically serious by GSK. The subject was treated with MEXALEN and homeopathic medication. On 01 March 2012, all the events were resolved.

VAERS ID:453464 (history)  Vaccinated:2012-03-29
Age:10.0  Onset:2012-03-29, Days after vaccination: 0
Gender:Male  Submitted:2012-04-11, Days after onset: 13
Location:Foreign  Entered:2012-04-12, 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: not reported
Diagnostic Lab Data: not reported
CDC Split Type: 201203537
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEURU38710B UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Fall, Head injury, 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), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: Case received from a healthcare professional through the local affiliate in a foreign country on 29 March 2012 under the local reference number AR-2012-009. A 10-year-old male patient, with no reported medical history, had received his dose of MENACTRA (batch number U38710B, route and anatomical site of administration not reported) on 29 March 2012. The patient had no reported concomitant therapies. In the minutes post-vaccination, the developed an episode of loss of consciousness. Falling led to frontal cranial traumatism. The patient received medical assistance and he was transferred to the hospital. The outcome was not reported. Documents held by sender: none. Corrective version created to clarify the initial received date (IRD) of this case: The initial date received by manufacturer was entered in error as 30 March 2012, but it could not be amended in the database. This case was initially received on 29 March 2012.

VAERS ID:453763 (history)  Vaccinated:2012-02-08
Age:10.0  Onset:2012-03-27, Days after vaccination: 48
Gender:Female  Submitted:2012-04-16, Days after onset: 20
Location:Foreign  Entered:2012-04-16
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Influenza B virus test positive, Mar2012, positive; Polymerase chain reaction, Mar2012, Influenza B
CDC Split Type: D0075192A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSAFLUA635AA0IMAR
Administered by: Other     Purchased by: Other
Symptoms: Headache, Influenza, Influenza B virus test positive, Oropharyngeal pain, Polymerase chain reaction, Pyrexia, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a regulatory authority (# DE-PEI-PEI2012010558) and described the occurrence of influenza B virus infection in 10-year-old female subject who was vaccinated with INFLUSPLIT SSW (GlaxoSmithKline). Past medical history was not provided. On 08 February 2012 the subject received the first dose of INFLUSPLIT SSW (0.5 ml, intramuscular, unknown deltoid). Approximately six to seven weeks (48 days) post vaccination with INFLUSPLIT SSW, on 27 March 2012, the subject experienced influenza B virus infection (vaccination failure) with fever, headache and sore throat. This case was assessed as medically serious by GSK criteria. Influenza B virus infection was confirmed by polymerase chain reaction (PCR). By differential diagnosis other febrile medical conditions have been excluded. The subject was not hospitalised for the events. At the time of reporting, on 03 April 2012, the events were resolved. No further information will be available.

VAERS ID:454127 (history)  Vaccinated:0000-00-00
Age:10.0  Onset:0000-00-00
Gender:Unknown  Submitted:2012-04-20
Location:Foreign  Entered:2012-04-23, 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:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data: Unknown
CDC Split Type: WAES1204USA02539
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Convulsion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Information has been received from a physician (local reference #: LMSD_144_20120) concerning a 10 year old patient who was vaccinated with one dose of GARDASIL. The doctor reported he had vaccinated the patient and had been informed that the child had convulsions and a syncopal attack. The reporter felt that convulsions and syncopal attack were probably related to therapy with GARDASIL. As of reporting time, event outcome was not provided. Upon internal review, Convulsions was determined to be an other important medical event. No further information is available.

VAERS ID:456667 (history)  Vaccinated:2012-05-30
Age:10.0  Onset:2012-05-30, Days after vaccination: 0
Gender:Male  Submitted:2012-06-01, Days after onset: 2
Location:Foreign  Entered:2012-06-01
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions: Dizziness; Vasovagal event; Wrist fracture; Patient''s father has history of fainting but no other record of patient fainting with previous injections.
Diagnostic Lab Data: UNK
CDC Split Type: B0804934A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPATYP: HEP A + TYP (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSATYAB032AB IMUN
TYP: TYPHOID VI POLYSACCHARIDE (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a Nurse and described the occurrence of fainting in a 10-year-old male subject who was vaccinated with HEPATYRIX (GlaxoSmithKline). The subject''s medical history included dizziness, vasovagal event and wrist fracture. Historic vaccination included Hep A vaccine; injection given in 2005. It was reported that the subject had received other non specified travel vaccinations in the past. The subject had no history of fainting after vaccination; however there is a parent history of fainting. On 30 May 2012 the subject received unspecified dose of HEPATYRIX (1 injection, intramuscular) instead of HAVRIX JUNIOR and an unspecified Typhoid vaccine (overdose). Approximately 2 minutes after the vaccination the subject fainted. It was reported that the subject was laid down and the fainting resolved within 5 minutes. This case was assessed as medically serious by GSK.

VAERS ID:462788 (history)  Vaccinated:2012-01-13
Age:10.0  Onset:2012-01-13, Days after vaccination: 0
Gender:Male  Submitted:2012-01-16, Days after onset: 3
Location:Foreign  Entered:2012-08-17, Days after submission: 213
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: MEDI0014613
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.50113B IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered, No adverse event
SMQs:, Medication errors (narrow)
Write-up: A non-serious spontaneous report of administration of expired FLUMIST was received from a pharmacist concerning a 10-year-old male. Neither the patient''s medical history nor the concomitant medications were reported. The product expired on 09-Jan-2012. On 13-Jan-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.

VAERS ID:465313 (history)  Vaccinated:1994-02-09
Age:10.0  Onset:1998-05-01, Days after vaccination: 1542
Gender:Female  Submitted:2012-09-17, Days after onset: 5253
Location:Foreign  Entered:2012-09-17
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: CSF test, 1998, See text; Hepatitis B antibody, Jun1998, See text; Immunology test, 1998, Negative; Neurological examination, 1998, See text; Neurological examination, Apr2001, Nothing in part; Neurological examination, Dec2004, See text; Neurological examination, Sep2010, See text; Nuclear magnetic resonance ima, 1998, See text; Protein urine, Jun1998, 0.26g/24h; Urine analysis, Apr2001, See text; Visual acuity tests, 1998, 3/10; 1998: Neurological examination: sharp deep tendon reflexes in four limbs, hypoesthesia and pallesthesia in left lower limb. The rest of the examination was normal (no Hoffman''s sign, no Babinski''s sign, no motor deficiency, no other cranial nerve anomaly (apart from optic neuritis), no dissymmetry nor adiadococoni
CDC Split Type: B0828195A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALSENG1178B6 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test normal, CSF oligoclonal band present, Cerebellar ataxia, Culture urine positive, Decreased vibratory sense, Demyelination, Gait disturbance, Hepatitis B antibody positive, Hypertonia, Hypoaesthesia, Immunology test normal, Monoparesis, Multiple sclerosis, Neurological examination abnormal, Nuclear magnetic resonance imaging brain abnormal, Optic neuritis, Paraesthesia, Protein urine present, Pyramidal tract syndrome, Sensorimotor disorder, VIIth nerve paralysis, Vision blurred, Visual acuity reduced
SMQs:, Acute renal failure (broad), Liver infections (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Ocular infections (broad), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by GSK Legal Department and described the occurrence of multiple sclerosis in a 14-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject had a family history of polyarthritis in her grandmother. Previous vaccinations included BCG vaccine (non-gsk) given on 26 November 1983, diphtheria, tetanus, pertussis and meningitis B vaccine (non-gsk) given on 10 February 1984, 19 March 1984, 18 April 1984 and 01 March 1985, and DTP vaccine (non-gsk) given on 15 June 1990 and 22 July 1995. On 06 February 1993, 06 March 1993, 03 April 1993 and 09 February 1994, the subject received 1st dose (batch number ENG988D6), 2nd dose (batch number ENG988D6), 3rd dose (batch number ENG913A6) and 4th dose (batch number ENG1178B6) of ENGERIX B (route, site and dosage unknown). In May 1998, i.e. approximately four years after vaccination with ENGERIX B, the subject experienced paresthesia of tingling type in left lower limb after exercise with a fluctuating evolution. In June 1998, she experienced blurred vision in right eye. The ophthalmological examination revealed retrobulbar neuritis with a visual acuity at 3/10. From 20 June 1998 to 23 June 1998, the subject was hospitalised. Neurological examination showed sharp deep tendon reflexes in four limbs, hypoesthesia and pallesthesia in left lower limb. The rest of the examination was normal (no Hoffman''s sign, no Babinski''s sign, no motor deficiency, no other cranial nerve anomaly, no dissymmetry nor adiadococonisita). Brain MRI showed numerous periventricular hypersignals in white matter. CSF analysis showed intrathecal synthesis with an oligoclonal profile. Autoimmune analysis was negative. The subject had a urine protein level of 0.26 g/ 24h (upper limit value at 0.14). Hepatitis serology was consistent with hepatitis B vaccination. The subject was treated with SOLUMEDROL after which neurological and visual symptoms improved. From 11 April 2001 to 15 April 2001, the subject was hospitalised due to flare up of SNC demyelination with right peripheral facial paralysis. The rest of the neurological examination showed nothing in particular. Blood test was normal. Urine analysis found polymicrobial flora to be followed. She received three grams of SOLUMEDROL (one per day). From 21 December 2004 to 27 December 2004, the subject was hospitalised due to motor discomfort in left lower limb associated with distal paresthesia. Neurological examination showed kinetic cerebellar mixed ataxia in left lower limb and pyramidal syndrome in lower limbs predominant on left side with a discreet hypertonia, proximodistal moderate discreet motor deficiency (4/5) on the left and a discreet hypopallesthesia in lower limbs. Biological test was normal and there was no urinary infection. She was treated with intravenous corticoids at one g per day for five days. Walking improved. The subject was discharged from hospital with LISANXIA at four drops in the morning, noon and evening. In May 2010, the subject received a course of methylprednisolone sodium succinate at 1 gram daily to over a period of five days which had improved motor deficiency. On 03 September 2010, the subject was seen in consultation, in emergency, due to worsening of motor and sensory disorders in lower limbs predominant on the right side (which had been lasting for three weeks). Neurological examination showed pyramidal syndrome of lower limbs predominant on the right associated to an increased sensory proprioceptive ataxia. The subject received AVONEX since an unspecified date which was switched to TYSABRI afterwards. Since the beginning of the treatment with natalizumab, the subject presented with worsening of paresis in right lower limb without it suggesting a clear flare up. On 02 May 2011, she was hospitalized for her 6th course of natalizumab. Neurological examination was similar to the previous one. EDSS score was 4. MRI was planned in six months. Multiple sclerosis was state by the physicians. T

VAERS ID:469069 (history)  Vaccinated:2012-09-03
Age:10.0  Onset:2012-09-03, Days after vaccination: 0
Gender:Female  Submitted:2012-10-11, Days after onset: 38
Location:Foreign  Entered:2012-10-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0836820A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA133BO UNUN
Administered by: Other     Purchased by: Other
Symptoms: Hypotension, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician via a regulatory authority authority (# 177990) and described the occurrence of loss of consciousness in a 10-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 3 September 2012, the subject received unspecified dose of CERVARIX (unknown route and injection site). On 3 September 2012, less than one day after vaccination with CERVARIX, the subject experienced loss of consciousness and hypotension. The regulatory authority reported that the events were clinically significant (or requiring intervention). On 3 September 2012, the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with CERVARIX.

VAERS ID:471319 (history)  Vaccinated:2012-10-11
Age:10.0  Onset:2012-10-11, Days after vaccination: 0
Gender:Male  Submitted:2012-10-24, Days after onset: 13
Location:Foreign  Entered:2012-10-24
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: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Heart rate, 11Oct2012, decreased
CDC Split Type: B0839859A
Vaccination
Manufacturer
Lot
Dose
Route
Site
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC37B077AB IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Heart rate increased, Hyperhidrosis, Pulse pressure decreased, Tachyarrhythmia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Tachyarrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician via a regulatory authority (179134) and described the occurrence of tachyarrhythmia in a 10-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 11 October 2012 the subject received unspecified dose of BOOSTRIX (intramuscular, unknown injection site). On 11 October 2012, less than one day after vaccination with BOOSTRIX, the subject experienced tachyarrhythmia, dizziness without loss of consciousness, sweating and weak pulse. The subject was hospitalised. At the time of reporting, the outcome of the events was unspecified. The regulatory authority reported that the events were possibly related to vaccination with BOOSTRIX.

VAERS ID:472013 (history)  Vaccinated:2012-04-14
Age:10.0  Onset:2012-04-15, Days after vaccination: 1
Gender:Male  Submitted:2012-10-29, Days after onset: 197
Location:Foreign  Entered:2012-10-29
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1210AUS010424
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Drug hypersensitivity, Erythema, Oedema peripheral, Rash generalised, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information was obtained on a request by the Company from the agency via a Public Case Detail form (local reference number: AUS/12/2222, Agency # OPR303570) concerning a 10 year old male patient who on 14-APR-2012 who was vaccinated with the second dose of PNEUMOVAX 23, injection, 1 time, 1 milliliter, intramuscular, (batch # 50001). On 15-APR-2012, the patient developed red, hot, swollen arm from elbow to shoulder. The reaction lasted a week, and the patient was commenced on antibiotics and prednisolone. 5 days later, on 20-APR-2012, the patient developed generalized rash. General Practitioner (GP) diagnosed reaction to antibiotic. The patient was commenced on antihistamines. Under allergy specialist, the patient was advised not to have further doses as this was dose 2; given as medical at risk. Subsequently, the patient recovered from hot, swollen arm from elbow to shoulder and generalized rash. The reporter felt that hot, swollen arm from elbow to shoulder and generalized rash were possibly related to PNEUMOVAX 23. The reporter considered that hot, swollen arm from elbow to shoulder and generalized rash were serious due to incapacity/disability. The original reporting source was not provided. Additional information is not expected.

VAERS ID:473895 (history)  Vaccinated:2012-10-22
Age:10.0  Onset:2012-10-22, Days after vaccination: 0
Gender:Female  Submitted:2012-11-12, Days after onset: 21
Location:Foreign  Entered:2012-11-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1211SVN004926
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Daydreaming, Nausea, Vertigo
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow)
Write-up: This is a spontaneous case report received from a physician and concerns a 10 year old female patient who received her first dose of SILGARD vaccine, batch number HO12061 on 22 October 2012 at 12:15. 5 minutes later, at 12:20, vertigo, absent-minded state and nausea developed. The girl was observed for an hour, reaction abated as 13:20. No further data on the patient''s medical history was not provided in the initial report. Additional data in expected.

VAERS ID:473967 (history)  Vaccinated:2012-10-12
Age:10.0  Onset:2012-10-14, Days after vaccination: 2
Gender:Female  Submitted:2012-11-02, Days after onset: 19
Location:Foreign  Entered:2012-11-13, Days after submission: 11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Diagnostic Lab Data: Not reported
CDC Split Type: 201210350
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA)SANOFI PASTEUR 0UNAR
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC. 0UNAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis
SMQs:
Write-up: Case received from a Healthcare Professional on 02 November 2012. A 10-year-old female patient, with no reported medical history and concomitant therapies, had received her 1st primary dose of MENACTRA (batch number U3871AD, route and side of administration not reported) in the arm and his 1st primary dose of PNEUMO 23 (batch number H0394-4, route and side of administration not reported) in the arm on 12 October 2012. On 14 October 2012, the patient developed cellulitis on the left arm. She was hospitalized for 2 days. She was treated with clindamycin. She was recovering at the time of reporting.

VAERS ID:476516 (history)  Vaccinated:2012-10-24
Age:10.0  Onset:2012-10-24, Days after vaccination: 0
Gender:Female  Submitted:2012-11-13, Days after onset: 20
Location:Foreign  Entered:2012-11-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 10/24/2012, Body temperature, 37.1
CDC Split Type: WAES1211SVN005186
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.HO120610IMUN
Administered by: Other     Purchased by: Other
Symptoms: Daydreaming, Muscular weakness, Nausea, Somnolence, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Hypoglycaemia (broad)
Write-up: This is a spontaneous case report received from a physician and concerns a 10 year old female patient who received her first dose of SILGARD vaccine, batch number HO12061 on 24 October 2012 at 11:00. 10 minutes later, at 11:10, vertigo, nausea, mild absent-minded state, muscle weakness of limbs and sleepiness developed. Reaction abated at 13:30, after 140 minutes. She was carefully observed during this time, at least for two hours and a half. She recovered without sequelae. No further data on the patient''s medical history was not provided in the initial report. Additional data is expected.

VAERS ID:474275 (history)  Vaccinated:2007-03-06
Age:10.0  Onset:2012-07-01, Days after vaccination: 1944
Gender:Female  Submitted:2012-11-14, Days after onset: 136
Location:Foreign  Entered:2012-11-14
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: Pertussis identification test, Jul2012, positive
CDC Split Type: D0077289A
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURERAC39B011CB UNUN
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALSAC39B011CB UNUN
Administered by: Other     Purchased by: Other
Symptoms: Bordetella test positive, Cough, Dyspnoea, Pertussis, Polymerase chain reaction, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: This case was reported by a physician, via a sales representative, and described the occurrence of pertussis in a 16-year-old female subject who was vaccinated with BOOSTRIX-POLIO (GlaxoSmithKline), unspecified cell pertussis vaccine (manufacturer unspecified) and INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of BOOSTRIX-POLIO (unknown route and application site). At an unspecified time after vaccination with BOOSTRIX-POLIO, the subject experienced pertussis (vaccination failure). This case was assessed as medically serious by GSK. Follow-up was received from the physician on 13 November 2012, including a questionnaire and a Targeted Follow Up Questionnaire. According to the questionnaire, there was no concurrent medical condition or any other risk factors. On 6 March 2007 the subject received 6th dose of BOOSTRIX-POLIO (intramuscular, unknown arm). According to the Targeted Follow Up Questionnaire, the subject developed Pertussis. On July 2012 the subject experienced cough. Two weeks later, on 17 July 2012, the subject visited the physician. A Pertussis identification test (smear, PCR) was positive. On 20 July 2012 the subject was treated with erythromycin for 2 weeks. On 7 September 2012 cough was unresolved, additionally the subject experienced paroxysmal coughing with dyspnea. The subject was treated with VIANI 50/250. The symptoms improved slowly. At the time of reporting, the subject was "nearly fully recovered". The subject presented with cough and paroxysmal coughing. It was unspecified whether the subject presented fever, vomiting, cyanosis, apnea, enlarged lymph nodes, pseudomembranes, dysphagia, muscular rigidity, trismus or opistotonus. A PCR test for B. Pertussis was performed and was positive. It was unspecified whether the following tests were performed: Anti-pertussis toxin antibodies test, anti-adenyl cyclase hemolysin antibodies, anti-hemaglutinin filamentous antibodies, Culture of B. Pertussis or other serology. Complete blood count was not performed. No other diagnostic tests were performed. The subject was "completely healthy". Relevant Vaccination History: On 16 October 1997 the subject received 4th dose of pertussis vaccine (unknown route and application site). On 7 January 2002 the subject received 5th dose of INFANRIX (intramuscular, unknown application site). The physician reported about another child experiencing pertussis after vaccination with BOOSTRIX-POLIO. Please see also suffix case D0077305A for additional report regarding the same reporter.

VAERS ID:475213 (history)  Vaccinated:2012-10-24
Age:10.0  Onset:2012-10-24, Days after vaccination: 0
Gender:Female  Submitted:2012-11-26, Days after onset: 33
Location:Foreign  Entered:2012-11-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 10/24/2012, Body temperature, 37.1 C
CDC Split Type: WAES1210SVN014651
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0120610IMUN
Administered by: Other     Purchased by: Other
Symptoms: Chills, Daydreaming, Muscular weakness, Nausea, Somnolence, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Hypoglycaemia (broad)
Write-up: This spontaneous report (local reference ID number SLO-2012-194) was received from a physician who refers to a 12 year old female patient. The patient was vaccinated with a first dose of SILGARD (dose and route not reported, lot/batch# reported as HO12061) on 24-OCT-2012. On 24-OCT-2012, after the vaccination, the patient experienced shivering. The reported body temperature was 37.1 C. Adverse events resolved soon in October 2012 after vaccination (date of recovery not provided). Follow up information was received from a physician (local reference # SLO-2012-217) via regulatory authority and concerns a 10 year old female patient who received her first dose of SILGARD (lot number H0120610 on 24-OCT-2012 at 11:00 (route of administration not provided). 10 minutes later, at 11:10, vertigo, nausea, mild absent-minded state, muscle weakness of limbs and sleepiness developed. Reaction abated at 13:30, after 140 minutes. She was carefully observed during this time, at least for two hours and a half. She recovered without sequelae. No further data on the patient''s medical history was not provided in the initial report. Additional information is not expected. It has been determined that case # 1211SVN005186 is a duplicate of case # 1210SVN014651. Therefore, case # 1211SVN005186 is being deleted from our files and the cases consolidated into case # 1210SVN014651.

VAERS ID:475341 (history)  Vaccinated:2006-10-20
Age:10.0  Onset:0000-00-00
Gender:Female  Submitted:2012-11-23
Location:Foreign  Entered:2012-11-26, 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:
Current Illness:
Preexisting Conditions: No information on patient''s medical history reported.
Diagnostic Lab Data:
CDC Split Type: E201208993
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypersensitivity, Local reaction
SMQs:, Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case was received from the Health Authorities on 16-Nov-2012 (reference number PEI2012057693). Case is medically confirmed. Case is liked with serious case E2012-08931 (same patient, different vaccine and similar reaction). A 10-year-old female patient received a dose of unspecified Td-vaccine on 20-Oct-2006 (manufacturer, route and site of administration were not reported). Subsequently, on an unknown date she developed "an allergic local reaction" lasting for six months. No further information available. CASE IS CLOSED.

VAERS ID:475663 (history)  Vaccinated:2012-11-15
Age:10.0  Onset:2012-11-15, Days after vaccination: 0
Gender:Male  Submitted:2012-11-29, Days after onset: 14
Location:Foreign  Entered:2012-11-29
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: Methylphenidate HCl
Current Illness: Attention deficit hyperactivity dis
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: D0077975A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Pain
SMQs:
Write-up: This case was reported by a foreign regulatory authority (# DE-PEI-PEI2012060149) and described the occurrence of general body pain whole left side in 10-year-old male subject who was vaccinated with INFLUSPLIT SSW (GlaxoSmithKline). The case was reported to the foreign regulatory authority (# DE-DCGMA-159445) by a hospital physician. Concurrent medical conditions included attention deficit hyperactivity disorder (ADHS). Concomitant medication included MEDIKINET. On 15 November 2012 the subject received a dose of INFLUSPLIT SSW (0.5 ml, intramuscular, unknown). Immediately post vaccination with INFLUSPLIT SSW, on 15 November 2012, the subject experienced general body pain whole left side which was spontaneously improving. The subject was hospitalised for an unknown period of time. At the time of reporting, on the next day, on 16 November 2012, the event was resolved. No further information will be available.

VAERS ID:476413 (history)  Vaccinated:2012-11-30
Age:10.0  Onset:2012-11-30, Days after vaccination: 0
Gender:Female  Submitted:2012-12-05, Days after onset: 5
Location:Foreign  Entered:2012-12-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1212JPN000641
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Dizziness
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Initial information has been received from a physician concerning a 16 years old female patient(also reported as 10-19) who on an unspecified date, was vaccinated the first dose of GARDASIL and on 30-NOV-2012 was vaccinated the second dose of GARDASIL injection drug via intramuscular injection (Lot number, expiry date and dose were not reported). There was no concomitant medication. On an unspecified date, the patient developed dizziness after the first dose vaccination, which occurred during a test period. Thus, on 30-NOV-2012, the second dose was given under good physical condition. However, about 5 min after the second dose vaccination, the patient developed convulsion. The patient recovered from convulsion on the same day. At the time of this report, the outcome of dizziness after first dose vaccination was unknown. The reporting physician did not assess the seriousness of the dizziness after first dose vaccination and the convulsion. Upon internal review, the convulsion was determined to be serious as another important medical event. The reporting physician felt that the convulsion was definitely related to GARDASIL; The reporting physician did not access the relationship between dizziness and GARDASIL. Additional information has been requested.

VAERS ID:476722 (history)  Vaccinated:2004-08-31
Age:10.0  Onset:0000-00-00
Gender:Female  Submitted:2012-12-06
Location:Foreign  Entered:2012-12-06
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: No other medications
Current Illness: Asthma; Antiviral prophylaxis
Preexisting Conditions:
Diagnostic Lab Data: Imaging in the upper arm did show a radial nerve which was thickened and returned a high STIR signal in the middle/lower third segment of the upper arm. Neurologist considered this would be most consistent with something like a perineuroma although the imaging could not be specific for it. 22-MAY-2012: Examining could not find any abnormality except for the left arm in that the right arm and both lower limbs were normal although the knee jerks were only present with reinforcement. Sensory examination as before showed reduction of pinprick in the left radial and cutaneous nerve of the forearm. 12-JUL-2012: On examination, weakness was confined to the territory of the radial nerve from brachioradialis distally. In particular, the left tricep
CDC Split Type: WAES1012GBR00013
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPVX: HPV (NO BRAND NAME)UNKNOWN MANUFACTURER 2UNUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Appetite disorder, Asthenia, Biopsy peripheral nerve, C-reactive protein normal, Fatigue, Feeling hot, Full blood count normal, Grip strength decreased, Heat rash, Hyperhidrosis, Hypersomnia, Hypoaesthesia, Joint stiffness, Mobility decreased, Monoplegia, Muscle atrophy, Muscle spasms, Muscular weakness, Musculoskeletal pain, Musculoskeletal stiffness, Nerve stimulation test abnormal, Neuroma, Neurosurgery, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging spinal normal, Pain in extremity, Paraesthesia, Peripheral nerve decompression, Peripheral nerve lesion, Peripheral nerve palsy, Radial nerve palsy, Red blood cell sedimentation rate normal, Renal function test normal, Sensory disturbance, Somnolence, Spinal pain, Thyroid function test normal
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: Information has been received from an investigator concerning a 10 year old female with asthma (since 1994) who entered a study. On 12-FEB-2004 the patient was randomised and vaccinated with the first dose of GARDASIL or placebo. On 14-APR-2004 the patient received the second dose of study vaccine. On 31-AUG-2004 the patient received the third dose of study vaccine. In 2009 the patient experienced paralysis of left arm of severe intensity (left arm posterior interosseous nerve palsy) and was hospitalised. The investigator reported "paralysis of muscles innervated by radial nerve - no cause found". The left arm posterior interosseous nerve palsy persisted. The reporting investigator felt that the left arm posterior interosseous nerve palsy was related to study therapy. The left arm posterior interosseous nerve palsy was considered to be disabling and an other important medical event. Follow-up information was received on 21-MAR-2011. The patient was vaccinated in her left arm. The AE was ''just a weakness of muscles innervated by the radial nerve, distal to elbow''. The patient was hospitalised for investigations - multiple magnetic resonance imaging and nerve conduction tests. The report stated: ''case of left arm posterior interosseous nerve palsy. It started as a painless weakness, which seems to be stationary now. She had good triceps function as well as brachioradialis, indicating that the lesion is distal to the elbow. She had weakness for the wrist and finger extension although not completely abolished function. She also claimed decreased sensation for the radial nerve sensory territory. She has had several scans and also electrophysiology indicating that the radial nerve is compressed. The causality of ''yes'' was a ''possible line only - not definite''. The left arm posterior interosseous nerve palsy persisted. Follow-up information was received on 31-MAR-2011. It was reported that the patient "completed the study as per the protocol." Follow-up information was received on 18-APR-2011. Stop dates of the vaccine were confirmed to be 12-FEB-2004, 14-APR-2004 and 31-AUG-2004. Follow-up information was received on 07-JUN-2011. On 27-APR-2011 the patient underwent surgery- exploration of left radial nerve. The duration of general anaesthetic was 90 minutes. Blood loss was minimal. The report stated that the patient had a ''4 - 5 year history of left radial nerve/posterior interosseous nerve (PIN) deficit, with lack of wrist/finger extension and decreased sensation in the radial nerve distribution, but normal triceps and brachioradialis''. For the operation, the patient was in a supine position, with an arm board. A curvilinear incision over the radial nerve/PIN on the anterolateral aspect of the elbow was done. The report stated: ''Pre-operative infiltration with 20 mL of 0.5% bupivacaine with adrenaline. Radial nerve exposed, together with PIN and branches to brachioradialis and wrist extensors. No obvious abnormality or compression. Arcade of Frohse released and neurolysis performed to proximal and distal limits of the wound. Normal conduction with nerve stimulator in branches to brachioradialis and wrist extensors. Closure: 2-0 vicryl, 3-0 monocryl subcut, steristrips, meppre dressing, wool and crepe. Post-operatively: analgesia and observations. Out-patient attendance scheduled for wound check''. On post-operative review, the physician stated: ''it has healed nicely though there were some scratching marks across the wound, which was difficult to know whether it was a reaction to the Steristrips or from the dressing. There was no redness or inflammation, or any signs of infection. Her elbow was very stiff, therefore she will be sent to a physiotherapist to have some stretching exercises. We will wait to see her in clinic in three months time to see if there is any recovery''. The investigator stated that the left arm posterior interosseous nerve palsy, in general, is something that can be resolved. This patient has not yet recovered

VAERS ID:478118 (history)  Vaccinated:0000-00-00
Age:10.0  Onset:0000-00-00
Gender:Male  Submitted:2012-12-13
Location:Foreign  Entered:2012-12-14, 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: No other medications
Current Illness: Animal bite
Preexisting Conditions:
Diagnostic Lab Data: Histology, Abnormal, Significant, Revealed necrotic keratinocytes and degeneration of the basal cell layer, with evidence of early vesicle formation in the epidermis. The papillary dermis showed edema with moderate inflammation in the perivascular area.
CDC Split Type: PHHY2012IN114091
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (RABIPUR)NOVARTIS VACCINES AND DIAGNOSTICS  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Epidermal necrosis, Erythema multiforme, Histology abnormal, Incomplete course of vaccination, Inflammation, Necrosis, Rash erythematous, Rash papular, Skin hyperpigmentation, Skin lesion, Skin oedema, Viral test negative
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case number PHHY2012IN114091 is an initial literature report received on 18 Oct 2012: The authors have presented a case of erythema multiforme possibly triggered by rabies vaccine. This report refers to a 10-year-old male patient. He was bitten by a dog on the leg on an undetermined date. He was vaccinated RABIPUR (batch number: unknown) following the dog bite. The vaccine regimen was started on the day of the dog bite. After vaccination he presented with an erythematous eruption over his face and forearms. Fever and other mucocutaneous and systemic symptoms were denied. There was no history of herpes labialis or drug intake. Examination revealed "target" lesions over the cheeks and dusky-red papules with central necrosis over both forearms. The vaccine and dog bite sites were spared. Histopathology examination revealed necrotic keratinocytes and degeneration of the basal cell layer, with evidence of early vesicle formation in the epidermis. The papillary dermis showed edema with moderate inflammation in the perivascular area. The mother refused consent for rechallenge with the vaccine. Enzyme-linked immunosorbent assay for herpes simplex virus 1 and 2 was negative. Based on the clinicopathologic features and temporal correlation between the administration of vaccine and the onset of rash, a diagnosis of a possible rabies vaccine-induced erythema multiforme (EM) minor was made. The child was prescribed hydroxyzine hydrochloride 10 mg twice a day. The lesions resolved completely over a period of two weeks, leaving behind hyperpigmentation. No recurrence was seen during a follow-up of two months, after which the child was lost to follow-up. Author concluded that vaccine component(s) could have triggered Gell and Coomb''s type III and type IV hypersensitivity, implicated in the immunopathogenesis of EM, in the present case. Vaccine-induced granuloma annulare, an important differential, was excluded with histopathology and added that it is imperative to recognize vaccine induced EM to avoid unnecessary investigations and treatment.

VAERS ID:479503 (history)  Vaccinated:2010-03-02
Age:10.0  Onset:2010-03-03, Days after vaccination: 1
Gender:Male  Submitted:2012-12-21, Days after onset: 1024
Location:Foreign  Entered:2012-12-27, Days after submission: 6
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: The patient had a medical history of "PB" cardiopathy with trimestral monitoring in UMF
Diagnostic Lab Data: not reported
CDC Split Type: 201212289
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Muscle rigidity, Pallor, Post-traumatic epilepsy, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Parkinson-like events (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: This initial case report is part of a batch of several reports associated with several products that was received on 13 December 2012 by the Sanofi Pasteur affiliate who received the report from the Ministry of Health (reference number not reported). A 10-year-old male patient, with a medical history of "PB" cardiopathy with trimestral monitoring in "UMF", had received a dose of H1N1 vaccine (manufacturer unknown, batch number, route and anatomical site of administration not reported) on 02 March 2010. The AE start date was reported as 03 March 2010. The patient was initially diagnosed with moderated cranioencephalic trauma and convulsive crisis. The final diagnosis was post-traumatic crisis. The following additional AEs were reported: pallor, generalized rigidity and syncope. The clinical classification was moderate. The patient''s outcome was not reported. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. The causality as concluded by the Ministry of Health was coincidental. Documents held by sender: None.

VAERS ID:482381 (history)  Vaccinated:2012-09-26
Age:10.0  Onset:2012-09-26, Days after vaccination: 0
Gender:Female  Submitted:2013-01-24, Days after onset: 120
Location:Foreign  Entered:2013-01-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1301SWE010349
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0077410IMLA
Administered by: Other     Purchased by: Other
Symptoms: Muscle spasms, Pain in extremity
SMQs:, Dystonia (broad), Tendinopathies and ligament disorders (broad)
Write-up: Initial case was reported a serious on 16-Jan-2013 by health care professional via the Health Authority in a foreign country under the reference 125044. Case medically confirmed. A 10-year-old female patient (weight and height not reported) with no medical history reported, had received the first dose of GARDASIL (batch number H007741, dosage 0.5 ml) via intramuscular route into the left arm on 26-Sep-2012. On the same day, at night, the patient developed pain and muscle cramps first in the right thigh and thereafter in the left thigh. The pain lasted for approximately 4 hours. No concomitant medication was not reported. At the time of reporting the patient had recovered. According to the Health Authority the events were possibly related to GARDASIL. No further information expected.

VAERS ID:482410 (history)  Vaccinated:0000-00-00
Age:10.0  Onset:0000-00-00
Gender:Female  Submitted:2013-01-17
Location:Foreign  Entered:2013-01-24, Days after submission: 7
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: Failure to thrive; Motor developmental delay; Hyperparathyroidism; Status post, Dermatitis; Status post pancreatitis, Pancreatitis; Status post, Seizures cerebral; Status post, Bronchitis; Status post, Enteritis pseudomembraneous; Status post, Venous thrombosis; IgG decreased; First dose at the age of 24 months, PREVENAR; PREVENAR, the second dose at the age of 65 months; The third dose at the age of 71 months, PREVENAR
Diagnostic Lab Data: Blood culture and liquor (unknown date): S. pneumoniae serotype 35 F
CDC Split Type: 2013014355
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 0UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood culture positive, CSF test abnormal, Meningitis pneumococcal, Streptococcus test positive
SMQs:, Guillain-Barre syndrome (broad)
Write-up: This is a spontaneous report from a contactable physician. A 10-year-old female patient received the first dose of PREVENAR 13, via an unspecified route of administration on an unspecified date at the age of 8-years-old (99 months) at a single dose for vaccination. Medical history included failure to thrive, motor developmental delay and hyperparathyroidism, all from an unknown dates and unknown if ongoing. In addition relevant medical history included status post "recurrent septitides", dermal infections, pancreatitis, cerebral seizures, bronchitis, clostridium-enteritis, multiple venous thromboses and IgG deficiency; all of which from unknown dates and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously received the first dose of PREVENAR at the age of 24 months, the second dose at the age of 65 months, and the third dose at the age of 71 months. On an unknown date in 2012, at the age of 10-years (122 months), the patient experienced meningitis pneumococcal. On anunknown date, S. pneumoniae were detected by blood culture and cerebrospinal fluid analysis. The serotype was 35 F. The clinical outcome of the event, meningitis pneumococcal of serotype 35 F, was unknown. No seriousness criterion was reported for the event, meningitis pneumococcal of serotype 35 F, by the reporter. No follow-up attempmts possible. No further information expected.

VAERS ID:483258 (history)  Vaccinated:2013-01-08
Age:10.0  Onset:2013-01-08, Days after vaccination: 0
Gender:Female  Submitted:2013-02-04, Days after onset: 27
Location:Foreign  Entered:2013-02-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1302SVN000498
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.HO120611UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Erythema, Headache, Nausea, Vertigo
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This is a spontaneous case report received from a physician and concerns a 10 year old female patient who received her second dose of SILGARD vaccine, batch number HO12061 for prophylaxis on 8 January 2013. 10 minutes after application red face, nausea, headache, vertigo and abdominal pain developed. Red face abated after 15 minutes. The patient received Claritine and an infusion. She was appointed to hospital for one day observation. As she recovered from all events on the same day (during her stay in the hospital), she was released home as completely recovered. No further data on the patient''s medical history was provided in the initial report.

VAERS ID:483526 (history)  Vaccinated:2013-01-08
Age:10.0  Onset:2013-01-08, Days after vaccination: 0
Gender:Female  Submitted:2013-02-06, Days after onset: 29
Location:Foreign  Entered:2013-02-06
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1302SVN000085
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0120611UNUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Erythema, Headache, Nausea, Vertigo
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This spontaneous report as received from a physician via the regulatory authority refers to a 10 years old female patient. The patient was vaccinated with lot # (H012061) dose 2 SILGARD on 08-JAN-2013. Route of administration was not reported. No other co-suspects were reported. No concomitant medications were reported. On 08-JAN-2013, 10 minutes after the vaccination, the patient experienced vertigo (hospitalization), abdominal pain (hospitalization), nausea (hospitalization), headache (hospitalization) and red face (hospitalization). Treatment for the events included CLARITINE and an infusion (not further specified). The patient was appointed to a hospital for one day of observation. The outcome of vertigo, abdominal pain, nausea, headache and red face was reported as recovered/resolved on the same day that she was hospitalized. The red face had resolved after 15 minutes. The reported relatedness for vertigo, abdominal pain, nausea, headache and red face is unknown for SILGARD. Additional information has been requested.

VAERS ID:483990 (history)  Vaccinated:2012-01-10
Age:10.0  Onset:0000-00-00
Gender:Male  Submitted:2013-02-11
Location:Foreign  Entered:2013-02-11
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:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: B0866507A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPH: DTAP + HIB (NO BRAND NAME)UNKNOWN MANUFACTURER10AV2F028Z0UNUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSQROLA351BA0PO 
Administered by: Other     Purchased by: Other
Symptoms: Hypotonic-hyporesponsive episode
SMQs:, Hypotonic-hyporesponsive episode (narrow)
Write-up: This case was reported by a healthcare professional (National Immunization Program) and described the occurrence of hypotonic-hyporesponsive episode in a 4-month-old male subject whow as vaccinated with ROTARIX (GlaxoSmithKline) and dtpa-hib (non-gsk). On 10 January 2012, the subject received 1st dose of ROTARIX (oral) and 1st dose of DTPa-Hib (Non-GSK) (unknown). At an unspecified time after vaccination with DTPa-HIB (Non-GSK) and ROTARIX, the subject experienced hypotonic-hyporesponsive episode. The subject was hospitalised and the healthcare professional considered the event was clinically significant (or requiring intervention). At the time of reporting, the event was resolved. This report is one of several cases received as part of a line-listing, each containing minimal information. No further information is expected.

VAERS ID:486095 (history)  Vaccinated:2012-12-04
Age:10.0  Onset:2012-12-04, Days after vaccination: 0
Gender:Female  Submitted:2013-03-05, Days after onset: 91
Location:Foreign  Entered:2013-03-05
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: On 04-DEC-2012, MRI brain: right-sided change with peripheral contrast upload.; 12/04/2012, Nuclear magnetic resonance imaing brain, see relevant test
CDC Split Type: WAES1303SWE001226
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0169231UNUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Blindness, Headache, Nausea, Nuclear magnetic resonance imaging brain abnormal, Visual impairment
SMQs:, Acute pancreatitis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)
Write-up: Initial case was reported as serious by the health care professional via the Health Authority in a foreign country on 26-Feb-2013 under the reference 130299. Case medically confirmed and assessed as serious (other medically important criterion). A 10-year-old female patient (weight and height not reported) with no medical history reported, had received a second dose of GARDASIL (batch no. H016923) via not reported route and site of administration on 04-Dec-2012. On the same day, the patient developed nausea, severe headache that lasted for several hours. She also experienced vision abnormal, reported as centre vision loss and that the patient could not see the person standing in front of her. The symptoms made the patient so disabled that she had to go home from school. She slept for 3 hours and at bedtime that evening, most of the symptoms were gone. The patient used hydrocortisone nasal spray otherwise. At the time of reporting the patient had recovered. According to the Health Authority, the events were possibly related to the vaccination. No further information expected.

VAERS ID:486765 (history)  Vaccinated:2003-09-11
Age:10.0  Onset:2012-12-09, Days after vaccination: 3377
Gender:Male  Submitted:2013-03-13, Days after onset: 93
Location:Foreign  Entered:2013-03-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1303PRT005832
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.H576060 SCUN
Administered by: Other     Purchased by: Other
Symptoms: Mumps, Orchitis, Pyrexia, Salivary gland enlargement, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case of vaccination failure received from the Health Authorities on 27-Feb-2013 under the reference number C201302-125 via the local site Sanofi Pasteur MSD. The primary reporter was a physician. Case medically confirmed. A 19-year-old male patient received a dose of MMR II (batch number H576060) subcutaneously on 11-Sep-2003. He had previously received a dose of MMR (manufacturer unknown, batch number not reported) subcutaneously on 12-Aug-1994. On 09-Dec-2012 he experienced mumps with fever, swelling of the salivary glands and orchitis which lasted 15 days. The reporter stated that this case may be due to a probable vaccination failure. The patient was administered corrective treatment with unspecified anti-inflammatory therapy and he recovered on 24-Dec-2012. The patient had no relevant clinical or pharmacological history and no known previous adverse event to other drugs.

VAERS ID:487162 (history)  Vaccinated:2013-03-05
Age:10.0  Onset:2013-03-05, Days after vaccination: 0
Gender:Female  Submitted:2013-03-18, Days after onset: 12
Location:Foreign  Entered:2013-03-18
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1303ITA006447
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H016269 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Fall, Presyncope, Tooth injury
SMQs:, Anticholinergic syndrome (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Case received from Health Authority (case n. 196040) on 08-MAR-2013 through agency. Case initially reported by a physician (specialist). Case medically confirmed. A 10 year old female patient was vaccinated on 05-MAR-13 with one dose of GARDASIL (batch n. H016269) i.m. On the same day, about 2 minutes post-vaccination, she presented with a lipothymic crisis falling to the ground and breaking one of the upper incisors. Emergencies were called and she was transferred to the ER. The outcome is recovering. Upon medical review the Company judged relevant to code the adverse event "breaking one upper incisor" which was mentioned in the narrative but not coded by HA. The case is closed.

VAERS ID:487178 (history)  Vaccinated:2004-04-29
Age:10.0  Onset:2013-01-02, Days after vaccination: 3170
Gender:Male  Submitted:2013-03-19, Days after onset: 75
Location:Foreign  Entered:2013-03-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1303PRT008518
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  SCUN
Administered by: Other     Purchased by: Other
Symptoms: Mumps, Pyrexia, Salivary gland enlargement, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case of vaccination failure received from the Health Authorities in a foreign country on 05-Mar-2013 under the reference number C201302-145 via the local site Sanofi Pasteur MSD foreign. The primary reporter was a physician. Case medically confirmed. A 19-year-old male patient received a dose of MMR II (batch number HT60340) subcutaneously on 29-Apr-2004. He had previously received a dose of MMR (manufacturer unknown, batch number not reported) subcutaneously on 17-Jun-1999. On 02-Jan-2013 he experienced mumps with fever and swelling of the salivary glands which lasted 4 days. The reporter stated that this case may be due to a probably vaccination failure. The patient was administered corrective treatment with unspecified anti-inflammatory therapy and he recovered on 06-Jan-2013. The patient had no relevant clinical or pharmacological history and no known previous adverse event to the other drugs.

VAERS ID:488265 (history)  Vaccinated:2010-10-29
Age:10.0  Onset:2010-11-17, Days after vaccination: 19
Gender:Male  Submitted:2013-04-02, Days after onset: 866
Location:Foreign  Entered:2013-04-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data: On an unknown date, CT scan; MRI and EEG were normal. On an unknown date, ophthalmological; assessment and orthoptic examination were normal. On an unknown date,lumbar puncture and bloodwork were normal.
CDC Split Type: WAES1303FRA014460
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME)UNKNOWN MANUFACTURER  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Activities of daily living impaired, Asthenia, Blood test normal, Computerised tomogram normal, Electroencephalogram normal, Headache, Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Ophthalmological examination normal, Sleep disorder
SMQs:, Dementia (broad), Guillain-Barre syndrome (broad)
Write-up: Case received from the Health Authorities under reference TO20110555 on 20-Mar-2013. Case medically confirmed. A 10-year-old male patient had received a dose of M-M-RVAXPRO (batch number unknown) via intramuscular route on 29-Oct-2010. Mid-Novembre 2010, on 17-Nov-2010, i.e. 19 days post vaccination, the patient experienced unremarkable cephalgia associated with asthenia leading to sleep disturbances and important chronic school absenteeism. Physical examination was unremarkable: lumbar puncture and blood work were normal. Non-drug related etiologies have been ruled out. CT scan, MRI and EEG were normal. Diagnosis of migraine was ruled out by neurologists. Ophthalmological assessment and orthoptic examination were normal. Slight improvement of cephalgia was noticed. But cephalgia was invading the patient and his parents life, as it was all they both could think about. Psychiatric care was advised. The patient had no relevant medical history and was not taking any long-standing treatment. At the time of reporting, the outcome was unknown. Upon medical review the company judged relevant to code the following adverse events: "asthenia" and "sleep disturbances" which were mentioned by the CA in the narrative but not coded. The Health Authorities assessed the causal relationship between the reported reaction(s) and vaccination as doubtful (C1 S1 I1) according to the method of assessment.

VAERS ID:489509 (history)  Vaccinated:2013-03-15
Age:10.0  Onset:2013-03-15, Days after vaccination: 0
Gender:Female  Submitted:2013-04-17, Days after onset: 33
Location:Foreign  Entered:2013-04-18, 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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2013035451
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED090636402 IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyskinesia
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad)
Write-up: This health authority report (initial receipt: 04-Apr-2013) concerns a 10-year-old female patient. On 15-Mar-2013 the patient received 1 dose of influenza vaccine (batch number: 36402) injection intramuscularly. On 15-Mar-2013, within 5 minutes of receiving influenza vaccine, the patient threw herself back in her mother''s arms. Her both arms outstretched and she appeared to have a involuntary spasm for 5 - 10 seconds. The event outcome was recovered on 15-Mar-2013. Reporter''s comments: On 04-Apr-2013 the reporter considered events to be possible in relation to FLUVAX.

VAERS ID:489613 (history)  Vaccinated:0000-00-00
Age:10.0  Onset:0000-00-00
Gender:Female  Submitted:2013-04-18
Location:Foreign  Entered:2013-04-18
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1304COL008641
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Arthralgia, Haematuria, Juvenile idiopathic arthritis, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Eosinophilic pneumonia (broad), Arthritis (narrow), Tubulointerstitial diseases (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from Vigilance authority via Health Bulletin refers to a 10 years old female patient. On an unknown date the patient was vaccinated with three doses of GARDASIL (lot# unknown) intramuscular at month 0, 2, 6, (strength 0.5 ml). The patient experienced myalgia and arthralgia four days after she was administered the vaccine. She was diagnosed unspecified juvenile arthritis (diagnostic impression) and unspecified hematuria (confirmed diagnosis). Now, she was in rheumatologic follow. These events required hospitalization for evaluation by specialist. The patient was in her 44th week of GARDASIL treatment. The reporter considered myalgia, arthralgia, hematuria and juvenile arthritis as medically significant. The outcome of the events were unknown. The reporter did not provide assessment of the relationship of the adverse events to the suspect therapy. Additional information was requested.

VAERS ID:489583 (history)  Vaccinated:0000-00-00
Age:10.0  Onset:0000-00-00
Gender:Female  Submitted:2013-04-19
Location:Foreign  Entered:2013-04-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1304COL008786
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abscess
SMQs:
Write-up: This spontaneous report as received from a vigilance authority refers to a 10 year old female patient in Patient Support Program. On an unknown date the patient was vaccinated intramuscularly with a dose of GARDASIL (lot number, expiry date unspecified, strength 0.5 ml, frequency at month 0, 2, 6). On an unknown date the patient experienced an abscess three days after she was administered the vaccine. This event required inpatient treatment. The patient was in her 46th week of GARDASIL treatment. The outcome of abscess was unknown. The event of abscess was considered to be medically significant by reporter. Additional information has been requested.

VAERS ID:489584 (history)  Vaccinated:2013-04-01
Age:10.0  Onset:2013-04-01, Days after vaccination: 0
Gender:Female  Submitted:2013-04-19, Days after onset: 18
Location:Foreign  Entered:2013-04-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1304COL008784
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abscess
SMQs:
Write-up: This spontaneous report as received from a vigilance authority refers to a 10 year old female patient who participate in a Patient Support Program. The patient was vaccinated intramuscularly with first 0.5 ml dose of GARDASIL (lot number unspecified) on approximately 04-FEB-2013 (it was reported as the patient was in her 10th week of GARDASIL treatment. Two month later, in April 2013, the patient was vaccinated intramuscularly with second 0.5ml dose of GARDASIL (lot number unspecified). On an unknown date the patient experienced abscess four days after she was administered the vaccine. This event required inpatient treatment. The patient was in her 10th week of GARDASIL treatment. The outcome of abscess was unknown. Abscess was considered to be other important medical event by the reporter. The original reporter was not provided. Additional information has been requested.

VAERS ID:489709 (history)  Vaccinated:0000-00-00
Age:10.0  Onset:0000-00-00
Gender:Female  Submitted:2013-04-19
Location:Foreign  Entered:2013-04-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1304COL009244
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Hypotonia
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This spontaneous report was received from regulatory agency (Agency number not provided) concerning a 10 year old female patient who on an unknown date was vaccinated with a 0.5 ml dose of GARDASIL, intramuscular (frequency reported at month 0, 2 and 6). No other co-suspect or concomitant medications were provided. It was reported that on an unknown date, the patient had experienced non-febrile convulsion and hypotonia 5 minutes after she was administered the vaccine. These events had required inpatient treatment (hospitalization). The patient was on her 10th week of GARDASIL treatment. At the time of the report, the patient outcome was not provided. The agency considered the events of non-febrile convulsion and hypotonia to be medically significant. Additional information has been requested.

VAERS ID:489740 (history)  Vaccinated:0000-00-00
Age:10.0  Onset:0000-00-00
Gender:Unknown  Submitted:2013-04-19
Location:Foreign  Entered:2013-04-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Oxcarbazepine
Current Illness: Status epilepticus
Preexisting Conditions: Convulsion
Diagnostic Lab Data:
CDC Split Type: WAES1304COL009121
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Information has been received via the Vigilance Authority concerning a 10 year old patient. The patient''s medical history included convulsions. On an unknown date, the patient was vaccinated with an unspecified dose of GARDASIL 0.5 ml, intramuscular. Concomitant therapies included oxcarbazepine. On an unknown date, the patient experienced non-febrile convulsion. The outcome of non-febrile convulsion was unknown. Non-febrile convulsion was reported as medically significant by the reporter. Additional information has been requested.

VAERS ID:489745 (history)  Vaccinated:0000-00-00
Age:10.0  Onset:0000-00-00
Gender:Female  Submitted:2013-04-22
Location:Foreign  Entered:2013-04-22
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1304COL009262
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abscess
SMQs:
Write-up: Information has been received via the Vigilance Authority concerning a 10 year old female patient. On an unknown date, the patient was vaccinated with GARDASIL 0.5 ml intramuscular. On an unknown date two days after she was vaccinated, the patient experienced an abscess. This event required inpatient treatment. The patient was in her 37th week of GARDASIL treatment. The outcome of the event was unknown. The reporter considered the event to be an other medical event. Additional information has been requested.

VAERS ID:492561 (history)  Vaccinated:2012-08-07
Age:10.0  Onset:2012-09-15, Days after vaccination: 39
Gender:Female  Submitted:2013-05-27, Days after onset: 254
Location:Foreign  Entered:2013-05-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1305JPN014459
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Blepharospasm, Cough, Dyskinesia, Fatigue, Headache, Hyperventilation, Muscle spasms, Nuclear magnetic resonance imaging brain normal, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Dystonia (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Initial information has been received from the patient''s family via regulatory authority concerning a 10''s year old (reported as 10-19 years) female patient who on 07-AUG-2012 received a dose of GARDASIL injection drug (dose and indication not reported). There was no concomitant medication. ON 11-AUG-2012, the patient developed urticaria. On 17-AUG-2012, cough resembling asthma continued. On 30-AUG-2012, the patient visited the otorhinology. On 06-SEP-2012, the patient visited internal medicine department. On 07-SEP-2012, blepharospasm started. On 10-SEP-2012, the patient visited ophthalmology and pediatrics department. On 15-SEP-2012, after the basketball game, the patient began to cough, developed blepharospasm and foot cramps. Then, involuntary movements of hands and general body appeared. On 18-SEP-2012, the patient visited the first-aid cerebral surgery. On 24-SEP-2012, MRI scans. The patient was introduced to a hospital. It was said no brain waves found to be related to the convulsion. On 29-SEP-2012, hyperpnoea-like cough and convulsion appeared. The drug was discontinued. On 17-OCT-2012, the patient was hospitalized in a public hospital. On 25-OCT-2012, no abnormity appeared, the patient discharged from the hospital. On 14-NOV-2012, the patient visited a different hospital. In December 2012, the symptom was once in remission. In 2013, the symptom appeared again. On 18-MAR-2013, there was no abnormity of the brain. At present, extreme feeling of fatigue, headache, blepharospasm and movements involuntary appeared. At the time of the report, the outcome of urticaria, cough, hyperpnoea was unknown. The patient had not recovered from the blepharospasm, movements involuntary and feeling of fatigue. There was no comment from the reporter. The reporter felt that urticaria, cough, blepharospasm, movements involuntary, fatigue extreme and hyperpnoea were definitely related GARDASIL. The reporter considered that urticaria, cough, blepharospasm, movements involuntary and hyperpnoea were serious due to hospitalization. The reporter did not assess the seriousness of the feeling of fatigue. No further information is available. Additional information is not expected.

VAERS ID:492569 (history)  Vaccinated:2012-08-20
Age:10.0  Onset:2012-12-21, Days after vaccination: 123
Gender:Unknown  Submitted:2013-05-27, Days after onset: 156
Location:Foreign  Entered:2013-05-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: C-reactive protein (CRP) (21-DEC-2012): High price; CT and blood test (27-NOV-2012): no abnormality; MRI (magnetic resonance imaging) and gynecological echo (07-DEC-2012): no abnormality; examination concerning collagen disorder (22-DEC-2012): no abnormality; Blood test (17-JAN-2013): mild positive reaction; MRI (13-FEB-2013): no abnormality
CDC Split Type: WAES1305JPN014465
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abasia, Abdominal pain lower, Arthritis reactive, Blood test abnormal, C-reactive protein increased, Computerised tomogram normal, Gait disturbance, Headache, Juvenile idiopathic arthritis, Laboratory test normal, Muscular weakness, Musculoskeletal stiffness, Nuclear magnetic resonance imaging normal, Pain in extremity, Photosensitivity reaction, Thoracic outlet syndrome
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: Initial information has been received from patient''s family via regulatory authority concerning a 10''s years old patient (reported as 10-19 years) (Sex was not provided) who on 20-JUN-2012 was vaccinated with a first dose of GARDASIL (The dosage and reason for use were not provided). Information on concomitant medication was not provided. On 20-AUG-2012, the patient was vaccinated with a second dose of GARDASIL. On 23-NOV-2012 (the fourth month after vaccinated), the patient developed pain in the right lower quadrant of the abdomen. On 27-NOV-2012, the patient went to A hospital. And there was nothing abnormal in the examination of CT, blood test. On 07-DEC-2012, the patient was carried out MRI and gynecological echo, and there was nothing abnormal. On 15-DEC-2012, the patient developed pain in the lower limb. On 18-DEC-2012, the patient complained of severe and stiffness irregular pain in the hand. On 21-DEC-2012, the patient became difficult in walking and had high level of CRP. On 22-DEC-2012, the patient was hospitalized. And there was nothing abnormal in the examination concerning collagen disorder. The patient was diagnosed with thoracic outlet syndrome. And it didn''t work after using equipment. On 11-JAN-2013, the pain became worse, and the patient went to C hospital. On 17-JAN-2013, the patient was hospitalized because the pain became very strong. There was nothing abnormal except mild positive reaction in the blood test. The patient was considered to have juvenile idiopathic arthritis and arthritis reactive. The patient was place on therapy with ibuprofen and left hospital. On 04-FEB-2013, the patient went to D hospital. On 13-FEB-2013, there was nothing abnormal in the examination of MRI. On 27-FEB-2013, the patient went to psychiatry. On 27-FEB-2013, the patient was slightly able to walk. On 04-APR-2013, the patient became unable to walk again. On 15-APR-2013, the patient went to E clinic. From 15-APR-2013, the patient was trying enzyme bath. As others, the sun sensitivity, muscular weakness and headache were reported, too. At the time of the report, the outcome of difficulty in walking, arthralgia, sun sensitivity, muscular weakness, headache and abdominal pain was unknown. The patient was being placed on therapy with amitriptyline hydrochloride and polycarbophil calcium. The reporter considered that the difficulty in walking, arthralgia, muscular weakness and abdominal pain were serious due to hospitalization. The reporter did not judge the severity of sun sensitivity and headache. The reporter assessed that the difficulty in walking, arthralgia, sun sensitivity, muscular weakness, headache and abdominal pain were related to the GARDASIL. Additional information is not expected.

VAERS ID:492575 (history)  Vaccinated:2011-08-20
Age:10.0  Onset:0000-00-00
Gender:Unknown  Submitted:2013-05-27
Location:Foreign  Entered:2013-05-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 06/08/2012, Body temperature, 39 F
CDC Split Type: WAES1305JPN014451
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Depressed level of consciousness, Herpes zoster, Pain, Pyrexia, Systemic lupus erythematosus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Initial information has been received from a patient''s family via agency concerning a 10''s years old patient (gender: unknown) who on 19-FEB-2011 was vaccinated intramuscularly with the 1st dose of GARDASIL injection drug (The dosage not reported). The patient was healthy and played in the school volleyball team. Information on concomitant medication was not provided. On 18-MAR-2011, the patient was vaccinated intramuscularly with second dose of GARDASIL injection drug. On 20-AUG-2011, the patient was vaccinated intramuscularly with third dose of GARDASIL injection drug. On an unspecified date, the patient developed local pain after received vaccine. From 04-JUN-2012 to 08-JUN-2012, the patient developed pyrexia. On an unspecified date, the patient developed depressed level of consciousness. On 08-JUN-2012, the patient received medical examination due to high fever about 39 degree Centigrade at night, and the patient was admitted to A hospital, then went home. On 09-JUN-2012, the patient received medical examination at night again. The patient visited the emergency outpatient department of the C hospital. The high fever continued intermittently until 21-JUN-2012, and the patient was hospitalized in B hospital. On 22-JUN-2012, the cause was clear and the patient visited to C hospital. The patient hadn''t recovered form pyrexia though the patient visited the hospital from 22-JUN-2012 to 25-JUN-2012. From 26-JUN-202 to 03-JUL-2012, the patient was hospitalized. After that the patient went to hospital regularly. In December 2012, there was no recurrence of high fever, the patient developed herpes zoster (the reporter mentioned systemic lupus erythematosus). At the time of this report, PREDONINE, BLOSTAR M, PRAVASTATIN, ALFAROL, CINAL, PYDOXAL, and FLAVITAN were under internal use. The dose of prednisolone gradually decreased to 6 milligrams (mg) due to it was used effectively at the time of this report. At the time of this report, the outcome of the pyrexia and depressed level of consciousness were not reported. The reporter considered that pyrexia and depressed level of consciousness were serious due to hospitalization. The reporter felt that the pyrexia and depressed level of consciousness were definitely related to GARDASIL. Additional information is not expected.

VAERS ID:492583 (history)  Vaccinated:2012-10-17
Age:10.0  Onset:2012-10-20, Days after vaccination: 3
Gender:Unknown  Submitted:2013-05-27, Days after onset: 219
Location:Foreign  Entered:2013-05-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: CT(Computered tomography) and MRI (Magnetic resonance imaging) (On an unspecified date) showed no abnormality.
CDC Split Type: WAES1305JPN014461
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Back pain, Computerised tomogram normal, Gait disturbance, Headache, Hyperventilation, Nuclear magnetic resonance imaging normal
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypoglycaemia (broad)
Write-up: Initial information has been received from a patient''s family via agency concerning a teenage patient in her 10''s (also reported as teenage patient 10-19 years) (sex was not reported) who on 18-AUG-2012 was vaccinated with the first dose of GARDASIL injection syringe intramuscularly (dose not reported). No information on concomitant medication was provided. On 17-OCT-2012, the patient received the second dose of GARDASIL intramuscularly. On 20-OCT-2012, headache appeared and hyperpnoea appeared at night. Emergency was requested, and after the patient came back home, the patient presented to another hospital. Then the patient was hospitalized for laboratory tests but no abnormality was found. On 22-OCT-2012, the patient was discharged from the hospital. On an unspecified date, CT and MRI and MRI showed no abnormality. On an unspecified date, difficulty in walking appeared. On an unspecified date, low back appeared. On 02-NOV-2012, the patient presented to an orthopedics department but no abnormality was found. And the time for up and down the stairs cost over 10 minutes because the patient went at a slow speed and rested and rested. And then the patient walked slowly with a short steps and the symptom became lighter. The patient could walk without support by anything. At the time of the report, the outcomes of headache, hyperpnoea, difficulty in walking, and low back pain were unknown. The reporter''s comment: After counseling, the physician in a remote location said that it was cerebella ataxia and ADEM. Adverse event report had been reported to agency in April 2013. The reporting consumer considered that headache, hyperpnoea, difficulty in walking, and low back pain were definitely related to GARDASIL. The reporting consumer considered headache and hyperpnoea to be serious due to hospitalization. The reporting consumer did not assess the seriousness of difficulty in walking and low back pain. No further information is available. Additional information is not expected.

VAERS ID:495937 (history)  Vaccinated:2010-04-04
Age:10.0  Onset:2010-07-05, Days after vaccination: 92
Gender:Unknown  Submitted:2013-07-01, Days after onset: 1092
Location:Foreign  Entered:2013-07-05, Days after submission: 4
Life Threatening? No
Died? Yes
   Date died: 2010-07-18
   Days after onset: 13
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: Medical history included asthmatic bronchitis.
Diagnostic Lab Data: Examination for detection of H1N1 was performed with positive results (date not reported).
CDC Split Type: 201307405
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURER  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Arthralgia, Chills, Cough, Death, Influenza A virus test positive, Myalgia, Pyrexia, Rhinitis
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Initial report received from a health care professional via the local affiliate on 25 June 2013. This case is medically confirmed. A 10-year-old patient (date of birth and gender unknown) had received a dose of Influenza Vaccine (manufacturer name and lot number unknown) on 04 April 2010 and on 05 July 2010 presented with fever, cough, coryza, chills, arthralgia and myalgia and was hospitalized that day. Examination for detection of H1N1 was performed with positive results. The patient was medicated with TAMIFLU, but died on 18 July 2010 due to H1N1. The patient had medical history of asthmatic bronchitis. Family history was unknown. No additional information was provided. Documents held by sender: None.

VAERS ID:496286 (history)  Vaccinated:2013-06-10
Age:10.0  Onset:2013-06-11, Days after vaccination: 1
Gender:Female  Submitted:2013-07-09, Days after onset: 28
Location:Foreign  Entered:2013-07-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1307POL001758
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J004473 IMAR
Administered by: Other     Purchased by: Other
Symptoms: Pain, Pruritus, Skin lesion, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: On 10/06/2013 at 13:30 the female child was vaccinated with SILGARD (0,5ml) intramuscular injection in arm. LOT# J004473 EXP 10/20/15). MAH MSD Ltd. On the form to report AE after vaccination other than BCG the following AE were noted: urticaria. In narrative part physician report generalized urticaria (skin lesions on the trunk, painful), hives on the face and upper and lower extremities with pruritus. Urticaria occurred about 14:00, pruritus occurred next day from morning hours. According to AE reporting form AE occurred 10-JUN-2013 at 14:00. Outcome: A full recovery.

VAERS ID:496289 (history)  Vaccinated:2012-11-16
Age:10.0  Onset:2013-02-01, Days after vaccination: 77
Gender:Female  Submitted:2013-07-10, Days after onset: 158
Location:Foreign  Entered:2013-07-10
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation; Prophylaxis
Preexisting Conditions: 09/14/2012, GARDASIL, Immunisation, dose 1, batch number H006967
Diagnostic Lab Data: On 25-Feb-2013 at a doctors appointment after sampling(blood test) hypothyroidism was discovered.
CDC Split Type: WAES1306SWE001859
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H0069671UNUN
Administered by: Other     Purchased by: Other
Symptoms: Blood test abnormal, Genital discomfort, Genital lesion, Genital pain, Hypothyroidism, Pruritus genital, Reproductive tract disorder, Vulvovaginal burning sensation
SMQs:, Hypothyroidism (narrow)
Write-up: Case received from healthcare professional via company representative on 29-May-2013. Case medically confirmed. A female patient (age not reported) had received an injection of GARDASIL (dose 1, batch number unknown, route and administration not reported) on Sept-2012. The patient received an injection of GARDASIL (dose 2, batch number unknown, route and administration not reported) on Nov-2012. The patient developed unclear troubles with vulvovaginal burning sensation after the doses. She developed hyperthyroidism in Feb-2013. Patient medical history was not reported. At the time of reporting, the outcome was not provided. No more information is expected. Follow up information received from healthcare professional vial health authority on 02-JUL-2013. The following information was provided. A 10-year-old female patient was vaccinated with GARDASIL dose 1, 14-SEP-2012 (batch/lot number H006967) and dose 2, 16-Nov-2012 (batch number H912703). In September-October 2012 she develops genital pruritus and pain. She also developed lesion at two occasions. The girl is experience burning sensation and discomfort in the genital area. On 25-Feb-2013 at a doctors appointment after sampling hypothyroidism was discovered and LEVAXIN treatment was started. According to the initial report hyperthyroidism was reported which is a discrepancy with this follow up information. The report was classified as serious due to medical important event. The following events were coded by HA hypothyroidism, burning skin (coded as vulvovaginal burning sensation by company), pruritus (coded as pruritus vaginal female by company) and reproductive tract disorder NOS. Upon medical review it was decided to also code genital wounds and genital pain. The health authority assessed hypothyroidism, burning skin, pruritus and reproductive tract disorder NOS as possible related to the vaccination. At the time of reporting hypothyroidism, burning skin, pruritus and reproductive tract disorder NOS were not recovered and genital pain, genital discomfort and genital lesion not reported.

VAERS ID:496940 (history)  Vaccinated:2013-05-21
Age:10.0  Onset:2013-05-21, Days after vaccination: 0
Gender:Male  Submitted:2013-07-16, Days after onset: 56
Location:Foreign  Entered:2013-07-17, Days after submission: 1
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:
Current Illness:
Preexisting Conditions: Patient in good health. No patient''s and no family''s medical history of convulsion (neither febrile nor afebrile) or neurological disorders.
Diagnostic Lab Data: Clinical examination on arrival at hospital showed a child in good general condition, afebrile, alert, oriented, with strength and sensibility in the four members, and an unremarkable neurological examination.
CDC Split Type: E201305121
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  IMAR
RAB: RABIES (RABIE-VAX)SANOFI PASTEURJ1328 IMAR
Administered by: Unknown     Purchased by: Unknown
Symptoms: Altered state of consciousness, Decreased eye contact, Gaze palsy, Grand mal convulsion, Neurological examination normal, Salivary hypersecretion
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: Case initially reported by a physician and received from the Health Authorities on 04-Jul-2013 under the reference number 2013-02631. Case medically confirmed. A 10-year-old male patient (weight: 27 kg, height: not reported) in usual good health had received one single dose of TOLLWUT IMPFSTOFF MERIEUX (batch number: J1328-10) intramuscularly in the arm on 21-May-2013 due to a trip (no further specified). The child had also received at the same time one dose of TWINRIX (batch number not reported) intramuscularly in the other arm. On 21-May-2013, approximately 12 hours post vaccination, during sleep, the patient had an episode of tonic-clonic convulsion which lasted about 5 minutes, associated with excessive salivation, eye rolling and loss of contact. Neither loss of urine or bite of the tongue were reported. The pediatrician alerted in emergency noticed, a few minutes later, a post-critical phase with altered state of consciousness in an afebrile child. The entire episode lasted about 15 minutes in total, then the child became totally asymptomatic. The child was hospitalised for observation. It was reported that no patient''s and no family''s history of convulsion (neither febrile nor afebrile) or neurological disorders were noted. Clinical examination on arrival at hospital showed a child ie good general condition, afebrile, alert, oriented, with strength and sensibility in the four members, and an unremarkable neurological examination. According to these observations, neurological recovery was rapid. The patient did not receive any medical treatment. The patient recovered on 21-May-2013. According to the doctors in charge of the patient, there was little evidence for an infectious, tumourous or metabolic or traumatic cause. The Health Authorities considered the case was serious (event led to patient''s hospitalisation), and assessed the adverse event convulsion as possibly related to the vaccination with TOLLWUT IMPFSTOFF MERIEUX and possibly related to the vaccination with TWINRIX. Upon medical review, the Company judged relevant to code the event "altered state of consciousness" which was reported in the narrative by the HAs but not coded.

VAERS ID:496941 (history)  Vaccinated:0000-00-00
Age:10.0  Onset:0000-00-00
Gender:Female  Submitted:2013-07-16
Location:Foreign  Entered:2013-07-17, 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:
Current Illness:
Preexisting Conditions: PREVENAR, at the age of 78 months; PNEUMOVAX, at the age of 79 months; Pneumococcal meningitis, five times; Malformation skull, malformation of oto and rhinobasis right; Therapy regimen changed; The patient received one dose of PREVENAR 7 and one dose of PREVENAR 13.
Diagnostic Lab Data: Liquor (unknown date): pneumococcal meningitis serotype 15C
CDC Split Type: 2013205003
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: CSF test abnormal, Meningitis pneumococcal
SMQs:, Guillain-Barre syndrome (broad)
Write-up: This is a spontaneous report from a contactable physician. A 132-months-old female patient of an unspecified ethnicity received the third dose PREVENAR 13, at the age of 97 months (lot. no.: not provided). First dose of PREVENAR 7 was administered at the age of 78 months (lot number not provided) and the second dose PNEUMOVAX was administered at the age of 79 months (lot no.: not provided). Patient was not a former preterm. Chronic diseases included condition after seven meningitis infections, temporo-mesial meningocele and osseous malformation of oto basis and rhino basis. The patient''s concomitant medications were not reported. The patient experienced pneumococcal meningitis (sixth pneumococcal meningitis) on an unspecified date in 2013. Patient did not recover completely but had sequelaes. Pathogen material was liquor. Serotype was provided as 15C. The patient did not die. No follow-up attempts possible. No further information expected.

VAERS ID:497735 (history)  Vaccinated:0000-00-00
Age:10.0  Onset:0000-00-00
Gender:Female  Submitted:2013-07-25
Location:Foreign  Entered:2013-07-26, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2013AU079123
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)NOVARTIS VACCINES AND DIAGNOSTICS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Case number PHHY2013AU079123, is an initial spontaneous report received from a Health Authority (reference number: 315762) on 25 Jul 2013. This case refers to a 10 years old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with influenza vaccine (manufacture and batch number: not reported) on an unspecified date. After vaccination on an unspecified date, she experienced syncope. The health authority reported the causality of the event as suspected. The outcome and seriousness of the event were not reported.

VAERS ID:497904 (history)  Vaccinated:2013-07-12
Age:10.0  Onset:2013-07-12, Days after vaccination: 0
Gender:Female  Submitted:2013-07-29, Days after onset: 17
Location:Foreign  Entered:2013-07-29
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: B0911394A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)
Write-up: This case was reported by a physician and described the occurrence of dyspnea in a 10-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject was not allergic and did not experience any adverse event following the previous vaccination. On 12 July 2013, the subject received unspecified dose of CERVARIX (unknown route, site of injection and batch number). On 12 July 2013, less than one day after vaccination with CERVARIX, the subject experienced dyspnea. The physician considered the event was clinically significant (or requiring intervention). The subject was treated with cortisone. At the time of reporting, the event was unresolved. The physician considered the event was possibly related to vaccination with CERVARIX.

VAERS ID:499228 (history)  Vaccinated:2013-07-31
Age:10.0  Onset:2013-08-01, Days after vaccination: 1
Gender:Male  Submitted:2013-08-13, Days after onset: 12
Location:Foreign  Entered:2013-08-13
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: PHHY2013BR083257
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICS  IMRA
Administered by: Other     Purchased by: Other
Symptoms: Application site erythema, Cellulitis, Erythema, Feeling hot, Induration, Oedema, Pyrexia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case number PHHY2013BR083257, is an initial spontaneous report received from a nurse on 01 Aug 2013, with a combined follow-up received from a quality Assurance department (reference number: 244980) on 06 Aug 2013 and from a nurse and a consumer (mother of the patient) on 07 Aug 2013. This report refers to a 10-year-old male patient. He had no medical history and never experienced previous allergy with medications and vaccines. He was vaccinated with MENVEO, (batch number: not reported) at a one dosage unit, intramuscularly in the right deltoid muscle on 31 Jul 2013 at night. It was reported that he did not receive other vaccines on the same day. On 01 Aug 2013, six hours after vaccination, he experienced warm, edema, and induration, redness at application site which extended to entire arm and also had fever. He went to physician and was diagnosed with extensive cellulitis, eight hours after vaccination. He was treated with cephalexin for seven days. He did not perform any laboratory tests. On 02 Aug 2013, he persisted with high fever and cellulitis. The reporter classified the events as serious (medically significant) and considered a positive causal relationship between the vaccine application and the event. The outcome of the events was reported as recovered as of unspecified date. Combine follow-up was received on 06 Aug 2013 and 07 Aug 2013: Medical condition, vaccination date, event onset date, events (warm, edema, induration, redness at application site which extended to entire arm and fever), treatment drug, outcome, seriousness and causality of the events were updated.

VAERS ID:499536 (history)  Vaccinated:2013-05-17
Age:10.0  Onset:2013-05-24, Days after vaccination: 7
Gender:Female  Submitted:2013-08-14, Days after onset: 82
Location:Foreign  Entered:2013-08-15, 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:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2013036998
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FOREIGN)CSL LIMITED  SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal pain, Blood culture, Culture urine, Dizziness, Headache, Nausea, Oropharyngeal pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This health authority report (initial receipt: 05-Jun-2013) concerns an 10-year-old female patient. On 17-May-2013, the patient received FLUVAX (batch number not specified) one dose unspecified one time. On 24-May-2013, one week after vaccination the patient developed a high fever, headache, abdominal pain, strong nausea, vomiting, dizziness and sore throat. Doctor''s investigations covered appendicitis and other possibilities. Urine and blood samples were taken. Treatment included PANADOL and NUROFEN which kept the temperature away. The patient''s 8-year-old sister and 7-year-old brother experienced the same symptoms after receiving FLUVAX (see cases 2013036712 and 2013036999). The patients other sibling (2-years-old) and parents did not receive FLUVAX and did not experience such symptoms. The outcome for the events was unknown. Reporters comment: The health authority considered the events as possible in relation to FLUVAX and coded preferred term influenza like illness. Case Correction (01-AUG-2013). Upgrade to serious.

VAERS ID:501102 (history)  Vaccinated:2012-08-27
Age:10.0  Onset:0000-00-00
Gender:Female  Submitted:2013-09-02
Location:Foreign  Entered:2013-09-02
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Unspecified examination in a brain surgery department and a prefectural hospital (date unknown): no abnormality was found
CDC Split Type: WAES1308JPN014926
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Gait disturbance, Hypoaesthesia, Laboratory test normal, Muscular weakness, Nasopharyngitis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)
Write-up: Initial information has been received from a physician concerning a female patient in her 10''s. On 27-AUG-2012, she received the third GARDASIL intramuscular (IM) injection drug (injection site and lot number not provided). No concomitant medication was reported. On 29-SEP-2011, the patient received the first GARDASIL IM injection drug (at A hospital). On an unspecified date, the patient received the second GARDASIL IM injection drug (at A hospital). On 27-AUG-2012 as mentioned above, the patient received the third GARDASIL IM injection drug (at A hospital). On an unspecified date, 5 days after the third vaccination, the patient had cold symptoms and then numbness, gait disturbance and weakness of limbs. On an unspecified date, the patient visited a department of brain surgery and a prefectural hospital, where no abnormality was found. The patient then left the symptoms untreated. In NOV-2012, the patient complained of only cold symptoms at A hospital. In APR-2013, the patient presented to B hospital because symptoms such as numbness, gait disturbance and weakness of limbs appeared again. At the time of this report, the outcome of the numbness gait disturbance, cold symptoms and weakness of limbs was unknown. Reporter''s comment: A hospital: I did not know details about the patient''s symptoms because she complained of only cold symptoms when visited our hospital in NOV-2012. Her symptoms (numbness, gait disturbance and weakness of limbs) were reported by the B hospital after her 3 vaccinations. I have never seen her symptoms, so I can do nothing about them. B hospital: The GARDASIL is suspected to be related to the symptoms. The reporting physician assessed that the numbness, gait disturbance and weakness of limbs were related to GARDASIL. The reporting physician did not assess the causal relationship of the cold symptoms with GARDASIL. The reporting physician assessed the numbness, gait disturbance and weakness of limbs as serious (disability). The reporting physician did not assess the seriousness of the cold symptoms. Further information has been requested.

VAERS ID:502300 (history)  Vaccinated:2013-08-28
Age:10.0  Onset:2013-08-28, Days after vaccination: 0
Gender:Male  Submitted:2013-09-12, Days after onset: 15
Location:Foreign  Entered:2013-09-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Univentricular heart; Asplenia
Preexisting Conditions: 09/2006, Cardiac operation
Diagnostic Lab Data:
CDC Split Type: WAES1309JPN002166
Vaccination
Manufacturer
Lot
Dose
Route
Site
PPV: PNEUMO (PNEUMOVAX)MERCK & CO. INC. 1SCUN
Administered by: Other     Purchased by: Other
Symptoms: Flushing, Headache, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Initial information has been received from a physician concerning a 10 years old male patient with asplenia and univentricular heart. 7 years ago, in approximately September 2006, the patient received fontan surgery. From 28-AUG-2013 the patient was vaccinated with PNEUMOVAX NP injection drug via subcutaneous injection, 0.5 ml once a day. (Lot number was not reported). No concomitant medication was reported. On an unspecified date (approximately 6 years ago), in approximately 2007, the patient was firstly vaccinated with PNEUMOVAX NP injection drug (dose and indication not reported). On 28-AUG-2013, the patient was vaccinated with pneumococcal vaccine for the second time. 30 min after the vaccination, the patient developed headache, generalised flushing and pyrexia. Therapy with intravenous drip (unspecified) was performed. Symptoms were improved on the same day; however, as a precaution, the patient was hospitalized and was under observation. On 29-AUG-2013, the patient was recovered from headache, generalised flushing and pyrexia. The reporting physician considered that the generalised flushing was serious due to hospitalization. The reporting physician considered that the headache and pyrexia were non-serious. The reporting physician felt that headache, generalised flushing and pyrexia were definitely related to PNEUMOVAX NP. Additional information is not expected.

VAERS ID:505452 (history)  Vaccinated:0000-00-00
Age:10.0  Onset:0000-00-00
Gender:Female  Submitted:2013-10-02
Location:Foreign  Entered:2013-10-02
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Product used for unknown indication
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1309CAN013925
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
HPV4: HPV (GARDASIL)MERCK & CO. INC.  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Anxiety, Crying, Decreased appetite, Myalgia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: Health Authority Report: This spontaneous report as received from a physician refers to a 10 year old female patient. On an unknown date the patient was vaccinated with GARDASIL, intramuscular. Other suspect therapies included TWINRIX. On an unknown date the patient experienced abdominal pain (medically significant), vaccination site pain (medically significant), myalgia (medically significant), decreased appetite (medically significant), crying (medically significant) and anxiety (medically significant). The outcome of abdominal pain, vaccination site pain, myalgia, decreased appetite, crying and anxiety was reported as recovered/resolved. It is unknown if the events are related to GARDASIL. Additional information is not expected.

VAERS ID:506403 (history)  Vaccinated:2004-04-15
Age:10.0  Onset:2013-01-20, Days after vaccination: 3202
Gender:Female  Submitted:2013-10-04, Days after onset: 256
Location:Foreign  Entered:2013-10-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1310PRT002038
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.HT60340 SCUN
Administered by: Other     Purchased by: Other
Symptoms: Pyrexia, Salivary gland enlargement, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case of vaccination failure received from the Health Authorities in a foreign country on 19-Sep-2013 under the reference number C201309-36 via the local site Sanofi Pasteur MSD. The primary reporter was a physician. A 19-year-old female patient developed fever and bilateral swelling of salivary glands on 20-Jan-2013 18 years after receiving a dose of measles, mumps and rubella vaccine (manufacturer unknown, batch number not reported) subcutaneously on 08-Dec-1994 and 8 years after receiving a dose of MMRVAXPRO (batch number HT60340) subcutaneously on 15-Apr-2004. The patient received unspecified anti-inflammatory therapy as symptomatic treatment. She had no relevant medical history and no previous adverse event to other drugs. The adverse reaction lasted 8 days and resolved on 28-Jan-2013. The reporter stated that the adverse reaction may be due to a probable vaccine failure. The Health Authorities assessed the causal relationship between the reported reactions/vaccination failure and MMR vaccination as certain according to the global introspection.

VAERS ID:509202 (history)  Vaccinated:2013-08-17
Age:10.0  Onset:2013-08-30, Days after vaccination: 13
Gender:Female  Submitted:2013-10-23, Days after onset: 54
Location:Foreign  Entered:2013-10-23
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: Human rabies immunoglobulin Berirab
Current Illness: Dog bite
Preexisting Conditions:
Diagnostic Lab Data: Electromyography: Guillain Barre axonopathic type
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (NO BRAND NAME)UNKNOWN MANUFACTURER345679PU IMRA
Administered by: Public     Purchased by: Public
Symptoms: Electromyogram abnormal, Guillain-Barre syndrome
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow)
Write-up: Guillain Barre syndrome.

VAERS ID:510018 (history)  Vaccinated:2013-09-03
Age:10.0  Onset:2013-09-10, Days after vaccination: 7
Gender:Female  Submitted:2013-10-28, Days after onset: 48
Location:Foreign  Entered:2013-10-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1310SWE011841
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.H006967 SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Dyspnoea, Fatigue, Headache, Muscle twitching, Panic attack, Skin exfoliation
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Dyskinesia (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case received from a consumer via Health Authorities on 21-Oct-2013 under the reference number SE_KRMPAWWW-138139142800. The primary reporter was a relative to the patient. HA considered the report as serious, due to other important medical event: sick-leave. A 10-year-old female patient had received an injection of GARDASIL (batch/lot number H006967) on 03-Sep-2013 and later on 10-Sep-2013 she developed exfoliation of soles of feet, dyspnoea, headache and muscle twitches. Later on unspecified date she experienced panic attack and tiredness. It was reported that girl experienced starting of the symptoms about a week after vaccination with exfoliation of the soles of her feet, dyspnoea, headache and muscle twitches. The girl also had panic attacks a few evenings, and she was "completely exhausted during one day, tired and with headache", about 3-4 weeks post vaccination. The patient had received ALVEDON (other mfr, 500 mg film-coated tablet, dates not rep). It was not specified whether this was for treatment of adverse events or concomitant medication. The patient had no relevant medical history. At the time of reporting, the outcome was reported as recovered with sequelae.

VAERS ID:512759 (history)  Vaccinated:2013-07-06
Age:10.0  Onset:2013-07-06, Days after vaccination: 0
Gender:Female  Submitted:2013-11-12, Days after onset: 129
Location:Foreign  Entered:2013-11-12
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1311COL003727
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abscess, Erythema, Induration, Pain
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This spontaneous report as received from a regulatory authority refers to a 10 year old female patient with no reported medical history. On 03-MAY-2013 (reported as 27 weeks ago) the patient was vaccinated with GARDASIL (intramuscular, lot number unknown) dose 1, 0.5 ml. On 06-JUL-2013 the patient was vaccinated with GARDASIL (intramuscular, lot number unknown) dose 2, 0.5 ml. No other suspect therapy or concomitant medications was reported. On 06-JUL-2013, 46 days after onset of therapy the patient experienced abscess, erythema, local pain and induration. She required hospitalization on 27-Jul-2013. No treatment information was reported. The outcome of abscess, erythema, local pain and induration is unknown. The reporters relatedness of abscess, erythema, local pain and induration to GARDASIL is unknown. Additional information has been requested.

VAERS ID:515823 (history)  Vaccinated:0000-00-00
Age:10.0  Onset:0000-00-00
Gender:Female  Submitted:2013-12-06
Location:Foreign  Entered:2013-12-06
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: No other medications
Current Illness: Epilepsy
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1312CAN001830
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Death
SMQs:
Write-up: This spontaneous report as received from a physician refers to a 9-10 year old female patient with epileptic seizures. On an unknown date the patient was vaccinated with GARDASIL. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient passed away three weeks after receiving her vaccine. The relatedness of the death is unknown for with GARDASIL. Additional information has been requested.

VAERS ID:516572 (history)  Vaccinated:0000-00-00
Age:10.0  Onset:0000-00-00
Gender:Female  Submitted:2013-12-13
Location:Foreign  Entered:2013-12-13
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:
Current Illness: Unknown
Preexisting Conditions: Frequent headaches; Tibia fracture
Diagnostic Lab Data: Activated partial thromboplast, 36.1sec; Alanine aminotransferase, 10U/L; Albumin, 39g/L; Alkaline phosphatase, 328U/L; Anticardiolipin antibodies neg, negative; Antinuclear antibody, negative; Aspartate aminotransferase, 19U/L; Bilirubin total, 14?mol/L; Blood homocysteine, 8.6?mol/L; Blood test, normal; C-reactive protein, less than 5 mg/L; Creatine, 48?mol/L; Erythrocyte sedimentation rate, 26mm/50 min; Erythrocyte sedimentation rate, 20 mm/50 min; FBC, normal; GGT, 6U/L; Glasgow coma scale, 15/15; Hemoglobin, 12.7g/dL; International normalized ratio, 1.04; Liver function test, normal; Nuclear magnetic resonance ang, see text; Ophthalmological examination, see text; Physical examination, see text; Platelet count, 350x10^9/L; Potassium, 4
CDC Split Type: B0951780A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALS  SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Activated partial thromboplastin time normal, Alanine aminotransferase normal, Angiogram cerebral normal, Antinuclear antibody negative, Antiphospholipid antibodies negative, Antithrombin III, Aspartate aminotransferase normal, Ataxia, Balance disorder, Beta-2 glycoprotein antibody negative, Blood albumin decreased, Blood alkaline phosphatase increased, Blood bilirubin normal, Blood creatine, Blood homocysteine normal, Blood immunoglobulin G normal, Blood immunoglobulin M normal, Blood potassium normal, Blood sodium normal, Blood test normal, Blood urea normal, C-reactive protein normal, Cardiolipin antibody negative, Cardiovascular evaluation, Cerebrovascular accident, Coma scale, Coordination abnormal, Diplopia, Dizziness, Double stranded DNA antibody, Eye patch application, Fatigue, Full blood count normal, Fundoscopy normal, Gait disturbance, Gamma-glutamyltransferase normal, Haemoglobin normal, Headache, IVth nerve paralysis, International normalised ratio normal, Liver function test normal, Nuclear magnetic resonance imaging brain abnormal, Ophthalmological examination abnormal, Platelet count normal, Posture abnormal, Protein C, Protein S normal, Protein total normal, Prothrombin time prolonged, Red blood cell sedimentation rate increased, Vertigo, Vision blurred, Visual acuity tests normal, Vomiting, White blood cell count normal
SMQs:, Liver related investigations, signs and symptoms (broad), Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Biliary system related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (narrow), Ocular motility disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported in a literature article and described the occurrence of cerebellar stroke in a 10-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject''s medical history included a traumatic left distal tibial fracture two months prior to presentation and mild infrequent headaches in the past but which had not occurred in the preceding six months. There was no past history of vertigo. There was no family history of migraine headaches, myocardial infarcts or other thrombophilic tendency. Her grandfather had a stroke at an advanced age. There was no prior history of miscarriages in her mother. On an unspecified date, the subject received unspecified dose of FLUARIX (unknown route, injection site and batch number). One day after vaccination with FLUARIX, the subject experienced cerebellar stroke with acute onset of vertiginous giddiness, blurred vision, headache and vomiting (non-bilious). She had new-onset vertiginous giddiness six hours prior to admission, associated with mild frontal headache, which was worse on sitting up. She also complained of a sudden inability to balance herself and had vomited more than 10 times prior to admission. There were no associated symptoms of tinnitus, hearing loss, focal numbness or weakness, and there was no history of head trauma. The subject was hospitalised. On examination, she was tired but cooperative. Her Glasgow Coma Score was 15/15. There was no meningisms though she held her head tilted to the right. She was able to sit and stand up independently but required some effort to steady herself with her arms, and walked with an ataxic gait (she was unable to perform tandem gait). Her coordination was impaired and there was mild post-pointing, which was more prominent on the right, her peripheral tone, reflexes, power and sensations were normal. Her visual acuity was 20/20 and her visual fields were intact. Her extraocular eye movements were grossly intact but she experienced diplopia on upward gaze. Her pupils reacted normally to direct and consensual light and fundoscopy revealed normal optic discs. Her cardiovascular examination was normal and there were no carotid bruits heard. Ophthalmologic evaluation showed mild left fourth nerve palsy. Nuclear magnetic resonance imaging of the brain showed two areas of restricted diffusion in the left cerebellar hemisphere, the first in the superior cerebellar vermis just left of the midline at the roof of the fourth ventricle and the second at the posterosuperior part of the left cerebellar hemisphere. Magnetic resonance angiogram showed no abnormality of the circle of Willis or vessels apart from a fetal origin of the right posterior cerebral artery. Several laboratory tests were performed. The subject was treated with aspirin at a dose of 5 mg/ kg/day from the second day of admission. She had a right eye patch applied for symptomatic control of diplopia. She also underwent physical and occupational therapy. The subject became ambulatory by the sixth day of admission. Her clinical condition continued to improve and she was eventually discharged well from hospital under aspirin treatment. At her six month review at the outpatient clinic she had completely recovered with no residual or new neurological symptoms or signs. Blood tests were normal except the erythrocyte sedimentation rate (20 mm/50 min). The subject was tapered off aspirin after eight months of treatment and remained well at follow-up 10 months after initial presentation. According to the author, the close temporal relationship between the stroke and FLUARIX could be entirely coincidental.

VAERS ID:516894 (history)  Vaccinated:2013-11-02
Age:10.0  Onset:2013-11-15, Days after vaccination: 13
Gender:Female  Submitted:2013-12-02, Days after onset: 17
Location:Foreign  Entered:2013-12-17, Days after submission: 15
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: Beclomethasone; Loratadine; Salbutamol
Current Illness: Asthma; Food allergy
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2013SE88107
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Pancreatitis acute
SMQs:, Acute pancreatitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: A report from a physician via regulatory authority concerns a 10 year old female. No information regarding relevant history was provided. The patient''s concurrent diseases included asthma and possible food allergies. Concomitant medications included beclomethasone dipropionate, loratadine, and salbutamol. She received nasal FLUENZ on 02-Nov-2013, followed by acute pancreatitis on 15-Nov-2013. At the time of reporting, the acute pancreatitis was improving. The reporter considered the event of acute pancreatitis as serious by the criterion of hospitalization.

VAERS ID:517136 (history)  Vaccinated:0000-00-00
Age:10.0  Onset:2013-09-01
Gender:Female  Submitted:2013-12-19, Days after onset: 109
Location:Foreign  Entered:2013-12-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1312SWE007944
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNRA
Administered by: Other     Purchased by: Other
Symptoms: Injection site mass, Lymph node pain, Lymphadenopathy, Vaccination complication
SMQs:, Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control number E2013-10712) on 11 DEC-2013. Case was received from a health care professional via the Health Authorities in a foreign country on 11-Dec-2013 under the reference MPA-2013-000267. Case is medically confirmed. Primary source was a nurse. A 10-year-old female patient with no medical history reported received the first injection of GARDASIL (batch/lot number J000893, 0.5 ml) via intramuscular route into not reported site of administration on 26-Sep-2013. On an unspecified date in Sep-2013, the patient developed vaccination complication including swollen lymph nodes, sore lymph nodes and lump on the vaccination site. It was unknown if other drugs had been administered. The patient had sore swollen lymph nodes in the neck and the left armpit and a lump at the vaccination site. "This persisted for several weeks after vaccination." On 06-Nov-2013, the patient presented for her second vaccination and then the swollen lymph node was gone but "the sore bump" in the left upper arm remained. Therefore the patient received the second dose into the right arm. At the time of reporting, the patient had recovered from swollen lymph nodes and sore lymph nodes, the patient had not recovered from vaccination complication and lump on the vaccination site. According to the HA, the events were possibly related to the vaccination except for the lump on the vaccination site which was assessed as probably related. The adverse reaction were judged as non-serious by the HA, but since the report was assessed as "serious" by the reported, the report is serious.

VAERS ID:517323 (history)  Vaccinated:2013-11-26
Age:10.0  Onset:2013-11-26, Days after vaccination: 0
Gender:Female  Submitted:2013-12-20, Days after onset: 24
Location:Foreign  Entered:2013-12-20
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: GARDASIL, Erythema; GARDASIL, Immunisation, Lip swelling
Diagnostic Lab Data:
CDC Split Type: WAES1312SWE009584
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 1UNUN
Administered by: Other     Purchased by: Other
Symptoms: Anaphylactic reaction, Erythema, Flushing, Headache, Immediate post-injection reaction, Lip swelling, Nausea, Pharyngeal erythema
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Case of adverse event received from health care professional via company representative on 17-Dec-2013. Information has been received from Sanofi Pasteur as part of business agreement (manufacturer control # SE-1577272925-E2013-10880) on 19-DEC-2013. The primary reporter was a physician. A 10 year old female patient, had received the second dose of GARDASIL (batch number not reported) via not reported route of administration in not reported site of administration on 26-Nov-2013 and later on the same day, she developed a suspected anaphylactic reaction, swollen lips, immediate flush, headache and nausea. The patient was treated with antihistamine (unspecified) and BETAPRED (Other MFR) and was better. During the evening, however, she is so ill that she seeks care at Hospital (not hospitalized). The patient was completely recovered after one week. The patient had previously received dose 1 GARDASIL (batch number not reported) via not reported route in not reported site of administration on a non-specified date and later on she developed momentary feeling of swelling of the lips and redness of the face and throat. She recovered after 1 hour. At the time of reporting, the patient had recovered.

VAERS ID:518660 (history)  Vaccinated:2013-12-03
Age:10.0  Onset:2013-12-03, Days after vaccination: 0
Gender:Female  Submitted:2013-12-24, Days after onset: 21
Location:Foreign  Entered:2014-01-07, Days after submission: 14
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness: Coeliac disease
Preexisting Conditions: Drug hypersensitivity
Diagnostic Lab Data:
CDC Split Type: 2013SE93521
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Decreased appetite, Dizziness, Headache, Lethargy, Myalgia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: A report from a consumer via regulatory authority concerns a 10 year old female, Weight: 30.0 Kilograms. The medical history included fainting due to Emla. Her concurrent disease(s) included coeliac disease. Concomitant medications were not reported. She is on a strict gluten-free diet. The patient received Nasal FLUENZ on 03-Dec-2013. She experienced decreased appetite, dizzy spells, fainting, headache, lethargy, and muscle ache on 03-Dec-2013. At the time of reporting, the decreased appetite was improving and the dizzy spells, fainting, headache, lethargy, and muscle ache were ongoing. The reporter assessed the decreased appetite, dizzy spells, fainting, headache, lethargy, and muscle ache to be serious as important medical events.

VAERS ID:520742 (history)  Vaccinated:0000-00-00
Age:10.0  Onset:0000-00-00
Gender:Female  Submitted:2014-01-24
Location:Foreign  Entered:2014-01-24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC Split Type: A1057363A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPAB: HEP A + HEP B (TWINRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Anxiety, Crying, Decreased appetite, Myalgia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a physician via a regulatory authority (000448900) and described the occurrence of anxiety in a 10-year-old female subject who was vaccinated with TWINRIX pediatric (GlaxoSmithKline) and GARDASIL (Non-GSK). Concurrent vaccination included TWINRIX pediatric (GlaxoSmithKline; intramuscular; unknown route, site of injection and batch number) and GARDASIL (Non-GSK; intravenous; unknown route, site of injection and batch number) given on an unspecified date. On an unspecified date, the subject received unspecified dose of TWINRIX pediatric (intramuscular, unknown site of injection and batch number) and unspecified dose of GARDASIL (intravenous, unknown site of injection and batch number). At an unspecified time after vaccination with GARDASIL and TWINRIX pediatric, the subject experienced anxiety, abdominal pain, crying, decreased appetite, myalgia and vaccination site pain. The regulatory authority reported that the events were clinically significant (or requiring intervention). The events resolved after 3 weeks.

VAERS ID:521752 (history)  Vaccinated:2013-12-18
Age:10.0  Onset:2013-12-18, Days after vaccination: 0
Gender:Female  Submitted:2013-12-31, Days after onset: 13
Location:Foreign  Entered:2014-02-04, Days after submission: 35
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LORATADINE; VENTOLIN; SERETIDE
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2014SE00002
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.BH2004 IN 
Administered by: Other     Purchased by: Other
Symptoms: Expired drug administered
SMQs:, Medication errors (narrow)
Write-up: A report from a health professional (nurse practitioner) concerns a female born on 10-Dec-2003. Concomitant medications included fluticasone, salmeterol, and salbutamol for asthma and loratadine for allergies. On 18-Dec-2013, patient received nasal FLUENZ. It was reported that patient received an expired dose of FLUENZ. The outcome of the event of use of an expired FLUENZ product was unknown. The report was considered to be serious as an important medical event. Follow-up information received by AstraZeneca/MedImmune 22-Jan-2014 from a health professional upgraded this case to expeditable: event became serious, vaccine and event start date added, patient''s details provided.

VAERS ID:525097 (history)  Vaccinated:2013-11-27
Age:10.0  Onset:2013-11-27, Days after vaccination: 0
Gender:Female  Submitted:2013-12-05, Days after onset: 8
Location:Foreign  Entered:2014-03-06, Days after submission: 91
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug (s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2013SE87605
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Drug administration error
SMQs:, Medication errors (narrow)
Write-up: A report has been received from a pharmacist concerning a 10 years old female patient. No medical history and concurrent diseases reported. Concomitant medications were not provided. On 27-Nov-2013, the patient has been vaccinated with nasal FLUENZ (intranasal). The dose was accidentally administered up one nostril rather than two by a nurse in the doctor''s office. The action taken with FLUENZ was unknown. The outcome of the event of administered dose in one nostril was unknown. The reporter was considered to be non-serious by the reporter. Summary of follow-up information received by AstraZeneca/MedImmune on 05-Dec-2013 from a pharmacist start date of the event and drug added, reporter details and narrative updated.

VAERS ID:525243 (history)  Vaccinated:2013-11-26
Age:10.0  Onset:2013-11-26, Days after vaccination: 0
Gender:Female  Submitted:2013-12-04, Days after onset: 8
Location:Foreign  Entered:2014-03-06, Days after submission: 92
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2013SE89124
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN3: INFLUENZA (SEASONAL) (FLUMIST)MEDIMMUNE VACCINES, INC.  IN 
Administered by: Other     Purchased by: Other
Symptoms: Epistaxis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)
Write-up: A report has been received from a health professional (nurse) concerning a 10 year old female patient. No medical history, concurrent diseases and concomitant medications were reported. On 26-NOV-2013, the patient experienced nose bleeding almost immediately, a few minutes later, after administration of nasal FLUENZ, one spray each nostril. The child also go FLUENZ last year, however, the nurse did not know if any problems occurred at that time. The patient recovered from the event of nose bleeding on 26-NOV-2013. The event was considered to be non-serious by the company physician.

VAERS ID:526664 (history)  Vaccinated:2014-01-16
Age:10.0  Onset:2014-01-29, Days after vaccination: 13
Gender:Male  Submitted:2014-03-25, Days after onset: 54
Location:Foreign  Entered:2014-03-25
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: Salbutamol sulphate
Current Illness: Foreign travel; Hearing impaired
Preexisting Conditions: Asthma; Headache; Hospitalization; Mononucleosis
Diagnostic Lab Data: UNK
CDC Split Type: B0977581A
Vaccination
Manufacturer
Lot
Dose
Route
Site
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURER  PO 
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Benign rolandic epilepsy, Chest discomfort, Convulsion, Cough, Dyskinesia, Dyspnoea, Eye movement disorder, Headache, Musculoskeletal stiffness, Pallor, Somnolence, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority (Health Authority # 2014M0143) and described the occurrence of afebrile seizure in a 10-year-old male subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline) and POLIO, (GlaxoSmithKline). The subject''s medical history included hospitalizations due to mononucleosis in August 2007. The subject had congenital hearing impairment on the right ear. No medical or family history of febrile fits. The subject had no injury or fall. On 16 January 2014, the subject received unspecified dose of BOOSTRIX (intramuscular, unknown injection site and batch number) and unspecified dose of POLIO (oral, unknown batch number). The subject traveled from 29 January 2014 to 2 February 2014. On 29 January 2014, 13 days after vaccination with BOOSTRIX and POLIO, the subject experienced headache for 6 days. The subject had similar episodes of headache in the past which resolved upon resting. There was no nausea, vomiting, weakness, numbness, slurred speech, double vision, stress or loss of appetite. On 30 January 2014, the subject experienced cough accompanied with shortness of breath and was chesty. The subject was given 2 puffs of VENTOLIN at home and the events resolved after 5 days. The subject also had a tight sensation and did not wake up from sleep. On 3 February 2014 at midnight, the subject experienced afebrile seizure while lying down on bed. The subject was jerking all the 4 limbs with upward rolling eyes, stiffness and was nonresponsive to calling. This lasted for 3-5 minutes and aborted by itself. After the seizure, the subject was drowsy and pale for 10 minutes before becoming alert. There was no cyanosis, tongue biting, incontinence, fever, vomiting or diarrhoea. The subject was hospitalised and the regulatory authority reported that the events were clinically significant (or requiring intervention). The subject was treated with paracetamol, cetirizine and nasal spray of mometasone furoate. Fit charting, blood pressure monitoring and headache charting were performed in every 6 hours. No further fits were seen during hospitalisation and the subject was afebrile. The subject was discharged on 3 February 2014 in a stable condition with a diagnosis of afebrile seizure likely to be benign Rolandic epilepsy.

VAERS ID:528884 (history)  Vaccinated:0000-00-00
Age:10.0  Onset:0000-00-00
Gender:Male  Submitted:2014-04-18
Location:Foreign  Entered:2014-04-18
Life Threatening? No
Died? No
Permanent Disability? Yes
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: B0985154A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALS  UNUN
Administered by: Other     Purchased by: Other
Symptoms: Muscular weakness, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of muscle weakness in a male subject who was 9 years at the time of reporting, who was vaccinated with HAVRIX Junior (GlaxoSmithKline). The patient did not have any significant medical history and was fit and healthy previously. On an unspecified date the subject received an unspecified dose of HAVRIX Junior (720 elisa units). The pharmacist reported that 2 weeks after vaccination with HAVRIX Junior, the subject experienced severe muscle weakness, which came on rapidly. The patient was wheelchair bound and required hoisting for transfer. The pharmacist considered the events were disabling. At the time of reporting the events were unresolved.

VAERS ID:529569 (history)  Vaccinated:0000-00-00
Age:10.0  Onset:2013-10-02
Gender:Female  Submitted:2014-04-28, Days after onset: 208
Location:Foreign  Entered:2014-04-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1404SWE013760
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J000893 UNLA
Administered by: Other     Purchased by: Other
Symptoms: Fatigue, Injection site mass
SMQs:, Extravasation events (injections, infusions and implants) (broad)
Write-up: Information has been received from business partner SPMSD (# SE-1577272925-E2014-03592) on 24-APR-2014. Case received from a health professional via the Health Authority on 23-Apr-2014 under the reference number SE-MPA-2014-002564. Case is medically confirmed. Primary source was an other health professional. A 10-year-old female patient with no medical history reported, had received a dose of GARDASIL (batch number J000893, lot number J000893, expired date 30-JUN-2015) via not reported route into the left deltoid muscle on an unspecified date. On 02-Oct-2013, the patient developed tiredness. On 16-Oct-2013, she also developed a lump on the left deltoid. The HA assessed the case as serious due to other medically important event. No further information was provided. At the time of reporting, the patient had not recovered.

VAERS ID:533138 (history)  Vaccinated:2013-12-16
Age:10.0  Onset:2013-12-16, Days after vaccination: 0
Gender:Male  Submitted:2014-06-06, Days after onset: 171
Location:Foreign  Entered:2014-06-06
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: D0083495A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (HAVRIX)GLAXOSMITHKLINE BIOLOGICALSAHAVB599A20IMLA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Erythema multiforme, Pruritus, Rash pruritic, Rash vesicular, Skin plaque
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a pharmacist and described the occurrence of pox-like vesicular rash / erythema multiforme exudativum in a 10-year-old male subject who was vaccinated with HAVRIX 720 (GlaxoSmithKline). On an unspecified date in December 2013 the subject received an unspecified dose of HAVRIX 720 (0.5 ml, unknown). The subject received a batch of HAVRIX 720 which had been imported by another pharmaceutical company. A short time post vaccination with HAVRIX 720, on an unspecified date in December 2013, the subject experienced pox-like vesicular rash. The subject was treated with KORTISON without success. At the time of reporting, on 04 April 2014, the event was unresolved. On the same date, on 04 April 2014, the same case was reported by another pharmaceutical company. The other pharmaceutical company has received this information from the same reporting pharmacist. According to the reporting pharmacist the subject has received no concomitant medication or vaccination. A short time post vaccination with HAVRIX 720, on an unspecified date in December 2013, the subject experienced pox-like vesicular and severely itchy skin rash at the arms and legs. Furthermore, two pox-like vesicles were found on the head. The rash was also erythematous and oozing. The subject was treated with KORTISON and, as needed, with FENISTIL drops. At the time of reporting the events were still unresolved. Follow-up information was received on 10 April 2014 from the reporting pharmacist. The subject has no underlying or concurrent medical conditions or other risk factors. No concomitant medication was reported. On 16 December 2013 the subject received the first dose of HAVRIX 720 (0.5 ml, intramuscular, unknown). Post vaccination with HAVRIX 720, on an unspecified date, the subject experienced pox-like rash at the legs, at the arms and scattered at the head as well as severe itching. The subject was treated with KORTISON cream topically and FEINISTIL oral drops. At the time of reporting, on 04 April 2014, the events were unresolved. On 22 April 2014 the same case was received from a foreign regulatory authority (# DE-PEI-PEI2014027920). The foreign regulatory authority has received this report by an unknown pharmacist. The case was upgraded to serious. Concomitant medication was not reported. On 16 December 2013 the subject received a dose of HAVRIX 720 (0.5 ml, intramuscular, unknown). Within hours post vaccination with HAVRIX 720, on the same day, on 16 December 2013, the subject experienced red, severely itching skin plaques with an emphasis towards arms and legs and singularly at the head which looked like pox (erythema multiforme exudativum with itchy rash and red skin). This case was assessed as medically serious by GSK criteria. The subject was treated with KORTISON topically and FENISTIL orally. At the time of reporting, on 08 April 2014, the events were unresolved. On 02 May 2014 the other pharmaceutical company informed having received case information (# 185407) by an unknown pharmacist via the foreign regulatory authority. The subject''s weight was between 35 kg and 40 kg; the subject''s height was 152 cm. On 16 December 2013 the subject has received the first dose of HAVRIX 720 in the left deltoid. At the time of last request by the reporting pharmacist, on 24 April 2014, the events were unresolved and stagnating. Follow-up information was received on 02 May 2014 from the foreign regulatory authority. In this follow-up the foreign regulatory authority coded the event simply as rash pruritic. Otherwise all relevant information had already been received via the other pharmaceutical company. No further information will be available.

VAERS ID:533567 (history)  Vaccinated:2013-10-31
Age:10.0  Onset:2013-10-31, Days after vaccination: 0
Gender:Male  Submitted:2014-06-11, Days after onset: 223
Location:Foreign  Entered:2014-06-11
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: Blood pressure, 31Oct2013, 60/100mmHg; Body temperature, 31Oct2013, 35.8Deg. C; heartbeats irregular, 31Oct2013, 84per min
CDC Split Type: B0959780A
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (FLUARIX)GLAXOSMITHKLINE BIOLOGICALSYFLUA777AA IMAR
Administered by: Other     Purchased by: Other
Symptoms: Convulsion, Heart rate irregular, Hyperhidrosis, Malaise, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiac arrhythmia terms, nonspecific (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician via a sales representative and described the occurrence of convulsion in a 10-year-old male subject who was vaccinated with FLUARIX TRIVALENT (GlaxoSmithKline). On 31 October 2013, the subject received unspecified dose of FLUARIX (.5 ml, unknown route and injection site). On 31 October 2013, one and half hour after vaccination with FLUARIX, the subject experienced malaise and convulsion (about 10 episodes) one hour and 40 minutes after vaccination. During the convulsion, the subject had sweating, no loss of consciousness or incontinence occurred. No rash was found. This case was assessed as medically serious by GSK. The subject was treated with dexamethasone and diazepam. Two or three days after, the convulsion reoccurred with two episodes. Thereafter, no more convulsion occurred. On 07 November 2013, the subject had the final medical visit without positive finding. At the time of reporting the events were resolved. Follow-up information received on 3 June 2014 from regulatory authority: On 31 October 2013, the subject received 2nd dose of FLUARIX (intramuscular, unknown upper deltoid). At 1.5 hours after vaccination with FLUARIX, the subject experienced weakness of limbs and about 10 convulsions. No fever or injection site reactions occurred. On 07 November 2013, the subject visited the physician. The reaction classification given was: psychogenic reactions. The subject was treated with symptomatic treatment. At the time of reporting the events were resolved.

VAERS ID:538339 (history)  Vaccinated:2014-07-11
Age:10.0  Onset:2014-07-11, Days after vaccination: 0
Gender:Male  Submitted:2014-07-31, Days after onset: 20
Location:Foreign  Entered:2014-07-31
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic coryza; Allergy to shrimp
Preexisting Conditions:
Diagnostic Lab Data: Tryptase, normal
CDC Split Type: B1018535A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEP: HEP B (ENGERIX-B)GLAXOSMITHKLINE BIOLOGICALS 2IMAR
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  IMAR
Administered by: Other     Purchased by: Other
Symptoms: Bronchospasm, Dyspnoea, Malaise, Tryptase
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)
Write-up: This case was reported by a physician and described the occurrence of bronchial spasm in a 10-year-old male subject who was vaccinated with ENGERIX B pediatric (GlaxoSmithKline) and BOOSTRIX. Concurrent medical conditions included allergic coryza (without asthma) and allergy to shrimp. Previous vaccinations were well tolerated. On 11 July 2014, the subject received 3rd dose of ENGERIX B pediatric (.5 ml, intramuscular, unknown deltoid) and 4th or 5th dose of BOOSTRIX (.5 ml, intramuscular, unknown deltoid). On 11 July 2014, 2 minutes after vaccination with BOOSTRIX and ENGERIX B pediatric, the subject experienced malaise and dyspnea. The subject did not lose consciousness. Malaise lasted for 20 minutes. Ambulance was called by the physician. In the ambulance, approximately 45 minutes after vaccination with BOOSTRIX and ENGERIX B pediatric, bronchial spasm occurred. In the ambulance the bronchial spasm was treated by inhalation of adrenaline and the bronchial spasm improved rapidly. Dyspnoea persisted for 5 hours. The subject was hospitalized for one night but no further problems occurred. Laboratory examination at admission included tryptase which was found to be within normal limits. The subject was discharged approximately after 24 hours. At the time of reporting, bronchospasm was unresolved for which VENTOLIN was prescribed. The physician had reported this case also to the Regulatory Authority.

VAERS ID:539868 (history)  Vaccinated:0000-00-00
Age:10.0  Onset:0000-00-00
Gender:Male  Submitted:2014-08-14
Location:Foreign  Entered:2014-08-14
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: Unknown
Preexisting Conditions: Rash
Diagnostic Lab Data: Diagnostic ultrasound, 17Jun2014, See text; Hemoglobin, 14Jun2014, 11.4; MCH, 14Jun2014, 20.6; MCV, 14Jun2014, 62.5; Nitrite urine, 14Jun2014, Negative; Nitrite urine, 15Jun2014, Negative; Platelet count, 14Jun2014, 402; Protein urine, 14Jun2014, Negative; Protein urine, 15Jun2014, Negative; Red blood cells urine, Jun2014, High red blood c; Red blood cells urine, 14Jun2014, 440; Red blood cells urine, 15Jun2014, 4; Urine analysis, 14Jun2014, Negative leucocy; Urine analysis, 15June2014, Negative leucocy; Urine pH, 14Jun2014, 8; Urine pH, 15Jun2014, 6.0; White blood cells, 14Jun2014, 8.86; On 17 June 2014, ultrasound showed mild wall thickening of right colon, minor dilation of right renal pelvis and urinary bladder with debris
CDC Split Type: B1020645A
Vaccination
Manufacturer
Lot
Dose
Route
Site
OPV: POLIO VIRUS, ORAL (NO BRAND NAME)UNKNOWN MANUFACTURER  PO 
TDAP: TDAP (BOOSTRIX)GLAXOSMITHKLINE BIOLOGICALS  IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Abdominal pain upper, Arthralgia, Diarrhoea, Gait disturbance, Haematuria, Haemoglobin normal, Headache, Henoch-Schonlein purpura, Hypochromic anaemia, Joint swelling, Local swelling, Mean cell haemoglobin decreased, Mean cell volume decreased, Nitrite urine absent, Oedema peripheral, Platelet count increased, Protein urine absent, Pyrexia, Rash, Red blood cells urine positive, Sleep disorder, Ultrasound scan abnormal, Urine analysis abnormal, Urine analysis normal, Vomiting, White blood cell count normal, pH urine normal
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vasculitis (narrow), Chronic kidney disease (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tubulointerstitial diseases (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This case was reported by a regulatory authority (# 2014M0586) and described the occurrence of Henoch Schonlein purpura in a 10-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) and POLIO SABIN (GlaxoSmithKline). The subject had rash 1 year back (not sure what it was and resolved itself). The subject had no travel and contact history. The subject had normal developmental milestone. The subject had no family history of autoimmune disease and but relative had history of thalassemia. No previous admission history. On 20 May 2014, the subject received unspecified dose of BOOSTRIX (intramuscular, unknown injection site and batch number) and unspecified dose of POLIO SABIN (oral, unknown batch number). On 31 May 2014, approximately 11 days after vaccination with BOOSTRIX and POLIO SABIN, the subject experienced rash over bilateral upper limbs and lower limbs (started on lower limbs and then on upper limbs and greater on lower limbs than upper limbs), right ankle pain, mild joint swelling and limping. The subject had no preceding trauma and no other joints were involved. On 9 June 2014 or 10 June 2014, the subject experienced abdominal pain, intermittent epigastric pain and was awake from sleep at 2 am, which lasted for 45 minutes and then resolved with ointment. The subject did not experience fever, vomiting, diarrhea, bubbly urine, haematuria, headache, peripheral edema and lower limb swelling. No recent upper respiratory tract infections or treatment. The subject''s appetite and activity was normal. The subject had good hydration and perfusion, throat not injected, nasal congestion with turbinates enlarged, non-blanchable, non-tender likely palpable pruritic rash on bilateral upper limb and lower limb, rash on upper limb was fading. Initial urine analysis showed high red blood cell count, which was improved in the repeated urine analysis. Hypochromic microcytic anemia was noted in full blood count. The subject was hospitalised and the regulatory authority reported that the events were clinically significant (or requiring intervention). On 17 June 2014, ultrasound showed mild wall thickening of right colon, minor dilation of right renal pelvis and urinary bladder with debris. The subject had 6 hour parameters and blood pressure. The subject was given symptomatic treatment with paracetamol, ibuprofen, magnesium carbonate aromatic mixture. The subject was discharged in well stable condition and was diagnosed with Henoch Schonlein purpura. At the time of reporting, the events were resolved.

VAERS ID:540428 (history)  Vaccinated:2014-03-17
Age:10.0  Onset:2014-03-17, Days after vaccination: 0
Gender:Female  Submitted:2014-08-19, Days after onset: 155
Location:Foreign  Entered:2014-08-19
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1408BRA010752
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J0111800IMAR
Administered by: Public     Purchased by: Public
Symptoms: Apnoea, Dyspnoea, Flushing, Lethargy, Oedema, Oropharyngeal pain, Pallor, Petechiae, Pruritus, Rash, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: This spontaneous report as received from a other health professional (Nurse) via Agency (Ref# PNI-IBFV2014-1036) refers to a 11 year old female patient. On 17-MAR-2014 the patient was vaccinated with GARDASIL lot # J011180 dose 1, 0.5 ml, intramuscular in the arm during National HPV Vaccination Campaign. On 17-MAR-2014 the patient experienced urticaria (hospitalization) lethargy (hospitalization) apnoea (hospitalization), throat pain (hospitalization), breathing difficulty (hospitalization), pruritus (hospitalization), petechiae (hospitalization), pallor (hospitalization), flush (hospitalization), exanthema (hospitalization), oedema (hospitalization) and pain (hospitalization). The outcome of urticaria, lethargy, apnoea, throat pain, breathing difficulty, pruritus, petechiae, pallor, flush, exanthema, oedema and pain was reported as recovered/resolved. The relatedness for all adverse events reported to GARDASIL was not informed. Additional information is not expected.

VAERS ID:542975 (history)  Vaccinated:2014-06-30
Age:10.0  Onset:2014-08-19, Days after vaccination: 50
Gender:Female  Submitted:2014-09-08, Days after onset: 20
Location:Foreign  Entered:2014-09-08
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 glucose, 19Aug2014, 105mg/dl; Blood pressure, 19Aug2014, 115/70; Computerized tomogram, 19Aug2014, Left hemisphere; Nuclear magnetic resonance ima, 19Aug2014, White patches in
CDC Split Type: B1029526A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSAHPVA204AA1SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Blood glucose normal, Brain injury, Computerised tomogram head abnormal, Demyelination, Encephalitis, Hypoaesthesia, Hypoaesthesia oral, Leukoencephalomyelitis, Moyamoya disease, Nuclear magnetic resonance imaging brain abnormal, Pallor, Paraesthesia, Speech disorder
SMQs:, Peripheral neuropathy (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by a physician (subject''s grandmother) via a sales representative and described the occurrence of Moyamoya disease in a 10-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). The subject had no relevant medical history. Concurrent vaccination included 1st dose of CERVARIX (GlaxoSmithKline; unknown route and injection site) given on 14 April 2014. On 30 June 2014, the subject received 2nd dose of CERVARIX (unknown route and injection site). On 19 August 2014, 50 days after vaccination with CERVARIX, while the subject was at school, she experienced paresthesia episode with tongue and arm numbness, speech difficulty and paleness of skin. When the reporter picked up her granddaughter from school, she felt better. She could talk and move her right arm. During that afternoon, a Computerized-assisted Tomography was performed. The reporter said she saw a white shine lesion. The exam showed a brain injury in the left hemisphere. A Nuclear Magnetic Resonance Imaging of brain showed white patches in the white matter. Blood glucose was at 105 mg/dl and blood pressure was 115/70. The subject visited several physicians who agreed together in the diagnosis of Moyamoya disease. Encephalitis and demyelination were also reported. Since the reporter did not accept this diagnosis, the subject was consulted by another physician who diagnosed a leukoencephalomyelitis. The physician considered the events as clinically significant (required intervention). The subject was treated with CEUMID. On 19 August 2014, the paresthesia episode with tongue and arm numbness, speech difficulty and paleness of skin was resolved. At the time of reporting, the outcomes of the other events were unspecified. The subject was still under diagnosis assessment phase.

VAERS ID:543158 (history)  Vaccinated:2014-07-29
Age:10.0  Onset:2014-07-31, Days after vaccination: 2
Gender:Male  Submitted:2014-09-09, Days after onset: 40
Location:Foreign  Entered:2014-09-09
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISEPTINE Dressing
Current Illness: Unknown
Preexisting Conditions: Vaccinal history included 3 doses of unspecified vaccine (s)
Diagnostic Lab Data: Body temperature, 01Aug2014, normal
CDC Split Type: B1031014A
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPV: DTAP + IPV (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSAC20B287BC3IMLA
Administered by: Other     Purchased by: Other
Symptoms: Erythema, Extensive swelling of vaccinated limb, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: This case was reported by the regulatory authority (reference LL20141200) and described the occurrence of extensive swelling of vaccinated limb in a 10-year-old male subject who was vaccinated with INFANRIXTETRA (GlaxoSmithKline). Concurrent medications included BISEPTINE and dressing. Vaccinal history included 3 doses of unspecified vaccine (s) given on unspecified dates. On 29 July 2014, at the age of 10 years (catch-up dose, inappropriate age at vaccine administration according to the recommended immunization schedule),the subject received a 4th dose of INFANRIXTETRA (batch AC20B287BC, intramuscular, left deltoid). Injection site was previously disinfected with BISEPTINE and a dressing was placed after injection. On 31 July 2014, 2 days after vaccination with INFANRIXTETRA, the subject presented with swelling, erythema and hotness on third part of lateral external side of left arm, outside of injection site (local erythema and heat). On 01 August 2014, the swelling extended on 16 x 8 cm without fever. There was no induration, suppuration or joint injury. The event resolved within an unspecified time. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting, the events were resolved. According to the ANSM, based on the method of assessment, the reported events were possibly related to vaccination with INFANRIXTETRA.

VAERS ID:543378 (history)  Vaccinated:2014-05-09
Age:10.0  Onset:2014-06-09, Days after vaccination: 31
Gender:Female  Submitted:2014-09-11, Days after onset: 94
Location:Foreign  Entered:2014-09-11
Life Threatening? No
Died? No
Permanent Disability? Yes
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: Laboratory test, Aug2014, Reactive juvenile
CDC Split Type: B1030269A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALS 1SYRUN
Administered by: Other     Purchased by: Other
Symptoms: Cerebellar syndrome, Encephalitis viral, Gait disturbance, Juvenile idiopathic arthritis, Laboratory test abnormal
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Arthritis (narrow), Hypoglycaemia (broad)
Write-up: This case was reported by a physician and described the occurrence of juvenile arthritis in a 10-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Historic vaccination included 1st dose of CERVARIX (GlaxoSmithKline, unknown route, site of injection and batch number) given on 9 October 2013. On 9 May 2014, the subject received 2nd dose of CERVARIX (unknown route, site of injection and batch number). On 8 June 2014, 30 days after vaccination with CERVARIX, the subject started with cerebellar syndrome signs and was admitted to a hospital (different institution from reporter) and for this reason, the reporting physician did not have information about this admission. On 8 August 2014, the subject was admitted to third level hospital of the reporter institution presenting gait difficulties and was initially diagnosed with viral encephalitis not specified, to discard encephalopathy post-vaccination. The case was reported to the Medical Direction area as a possible adverse event case associated with the vaccination with CERVARIX. Different studies and tests were performed (date and type of studies not specified). On 18 August 2014, the subject was diagnosed with reaction juvenile arthritis. The physician considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting, the outcome of the events was unspecified. According to the medical evaluation performed at that time, the event was considered as not related to the vaccination and for that reason no more information was received as a CERVARIX associated event. No additional information was provided.

VAERS ID:543451 (history)  Vaccinated:0000-00-00
Age:10.0  Onset:0000-00-00
Gender:Female  Submitted:2014-09-12
Location:Foreign  Entered:2014-09-12
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 61 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1409COL005333
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC. 2IMUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Asthenia, Headache, Muscular weakness, Viral infection, Walking aid user, Wheelchair user
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This spontaneous report as received from a consumer reporting on 10 year old daughter. On an unknown date the patient was vaccinated with a third dose of GARDASIL 0.5 ml, intramuscular (lot # not reported). On an unknown date the patient experienced headache, legs weakness, strength loss and abdominal pain initially diagnosed as a virus infection. However the patient presented a new relapse and was hospitalized for two months (dates unspecified). The patient was discharged on a wheelchair, without medical opinion. By the time of the report the patient must have used crutches in the daily routines. The patient did not recover from headache, legs weakness, strength loss and. The outcome of abdominal pain and viral infection was unknown. Relatedness between all events and GARDASIL was not specified. Upon internal review all events were assessed as disabling. Additional information is not expected as no follow up was available.

VAERS ID:548428 (history)  Vaccinated:2014-09-04
Age:10.0  Onset:2014-09-05, Days after vaccination: 1
Gender:Female  Submitted:2014-10-17, Days after onset: 42
Location:Foreign  Entered:2014-10-17
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: WAES1410SWE006441
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV4: HPV (GARDASIL)MERCK & CO. INC.J003047 IMUN
Administered by: Other     Purchased by: Other
Symptoms: Dizziness, Petit mal epilepsy, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)
Write-up: Information has been received from SPMSD (manufacture control number SE-1577272925-E2014-09320) on 13-OCT-2014. Case received from health care professional via Health Authorities on 07-OCT-2014 under the reference number SE-MPA-2014-005360. The primary reporter was a nurse. A 10-year-old female patient with no medical history had received one dose of GARDASIL (batch/Lot number J003047, expiration date 30-JUN-2015) via i.m. route of administration in unspecified site of administration on 04-SEP-2014 and later on 05-SEP-2014 she fainted in the bathtub and a relative called for ambulance. The patient quickly awakes however, but it takes some time before she is back on track. On the same day she also experienced dizziness which she recovers from without sequelae. The reporter has also reported absence attack as an adverse event. The patient was not at the time of reporting treated with any concomitant drug or vaccine. At the time of reporting, the patient had recovered. According to the Health Authorities, the reactions were possibly related to vaccination.

VAERS ID:553653 (history)  Vaccinated:2014-10-06
Age:10.0  Onset:2014-10-06, Days after vaccination: 0
Gender:Female  Submitted:2014-10-16, Days after onset: 10
Location:Foreign  Entered:2014-10-30, Days after submission: 14
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Concomitant Drug(s) Not Reported
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: 2014SE78939
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLUN4: INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT)MEDIMMUNE VACCINES, INC.CF2250C IN 
Administered by: Other     Purchased by: Other
Symptoms: Headache, Lip swelling, Nausea, Swelling face
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: A report from a health professional via regulatory authority concerns a 10 year old female. Relevant medical history, concurrent diseases, and concomitant medications were not provided. On 06-Oct-2014 the patient received FLUENZ TETRA (intranasal). Two hours post vaccination facial swelling including lips started. Headache and nausea also occurred. The patient had no breathing or swallowing problems. It was unknown if the reactions were treated. The patient recovered from the facial swelling, headache, lip swelling, and nausea on an unspecified date. The reporter assessed the facial swelling, headache, lip swelling and nausea to be serious as a life-threatening condition.

VAERS ID:555045 (history)  Vaccinated:2014-08-19
Age:10.0  Onset:2014-09-02, Days after vaccination: 14
Gender:Female  Submitted:2014-11-04, Days after onset: 63
Location:Foreign  Entered:2014-11-04
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Constipation; Heart disease congenital, characterised by mitral valve leakage; Carbon monoxide poisoning, in utero (mother''s 1st month pregnancy)
Diagnostic Lab Data: Serology test (03-SEP-2014): negative for CMV and parvovirus, former EBV infection; 09/03/2014, Activated partial thromboplastin time, 1.17; 09/03/2014, Autoantibody test, antinuclear and soluble anti-antigene negatives; 09/03/2014, Blood electrolytes, unremarkable; 08/24/2014, Body temperature, 40 degrees C; 09/03/2014, Fundoscopy, normal no haemorrhage; 09/03/2014, Liver function test, unremarkable; 09/03/2014, Platelet count, <5000/micro-l; 09/06/2014, Platelet count, 75000/micro-l; 09/15/2014, Platelet count, 364000/micro-l; 09/03/2014, Prothrombin time, 100%; 09/03/2014, Renal function test, unremarkable; 09/03/2014, Scan brain, unremarkable-no hematoma nor meningeal hemorrhage
CDC Split Type: WAES1411FRA000206
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.I0091120IDUN
Administered by: Other     Purchased by: Other
Symptoms: Abdominal pain, Activated partial thromboplastin time, Autoantibody negative, Blood electrolytes normal, Brain scan normal, Contusion, Cytomegalovirus test negative, Ear haemorrhage, Epistaxis, Epstein-Barr virus test negative, Fundoscopy normal, Haematemesis, Headache, Immunoglobulin therapy, Liver function test normal, Mouth haemorrhage, Parvovirus B19 test negative, Platelet count decreased, Prothrombin time normal, Purpura, Rash maculo-papular, Renal function test normal, Thrombocytopenic purpura
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Retroperitoneal fibrosis (broad), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Information has been received from Sanofi Pasteur MSD (E2014-10087), as part of a business agreement, on 31-OCT-2014. Case received from the Health Authorities on 27-Oct-2014 under the reference number TO20141537. A 10-year-old female patient with a medical history of carbon monoxide poisoning occurring in utero (mother''s 1st month pregnancy), heart malformation characterized by mitral valve leakage, and chronic constipation had received the first dose of MMRVAXPRO (batch number I009112) via intradermal route on 19-Aug-2014. On 24-Aug-2014, she developed fever at 40 degrees C associated with cephalgia and abdominal pain. On 29-Aug-2014, she presented with maculopapular rash. On 02-Sep-2014, she presented with purpura on the legs and then secondarily on the trunk. She experienced epistaxis and ear bleeding with simple scrubbing. She experienced vomiting associated with blood streaks, and adding to that cephalgia and abdominal pain in the night from 2 to 3 Sept-2014. Hemorrhage score (Buchanan) was at grade 3. The child was hospitalized from 3 to 4 Sept-2014. From a cutaneous standpoint, she presented with purpuric stains on the feet, the legs and the trunk, petechiaes in the mouth and bruises on the legs. Hemorrhage score (Buchanan) was at grade 3. Abdominal pain regressed and cephalgia resolved. On 03-Sep-2014 biological work-up was performed. Platelet count was < 5000/microliter (ul). Hemostasis work-up was normal: Prothrombin time at 100%. Ratio of Activated partial thromboplastin time was 1.17. Blood electrolytes, liver function tests and renal function test were unremarkable. Serology tests were negative for CMV, parvovirus, and showed a former infection for EBV. Autoantibodies test were negative for antinuclear and soluble anti-antigene. Fundoscopy was normal with no haemorrhage. Brain scan was unremarkable, with no hematoma nor meningeal hemorrhage. Search for non-drug etiologies: No disseminated intravascular coagulation as prothrombin time was at 100% and ratio of Activated partial thromboplastin time at 1.17. There was no infection. Biological work-up was normal. The patient was treated with immunoglobulins 35 g via intravenous route on 03-Sep-2014. Physical evolution was favourable as petechiae and hematomas resolved. On 06-Sep-2014 Platelet count was at 75000/ul. The child did not experience any further hemorrhagic symptom. The last repeat work-up on 15-Sep-2014 showed platelet count at 364000/ul. If the child was to present physical symptoms again, a blood work-up would be performed. At the time of reporting, the child had recovered from thrombocytopenic purpura. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as C1 S2 I1 according to the method of assessment. Upon medical review the company judged relevant to code the adverse events fever, maculopapular rash, headache, and abdominal pain which were mentioned by the competent authorities in the narrative but not coded.

VAERS ID:575199 (history)  Vaccinated:2014-10-29
Age:10.0  Onset:2015-02-08, Days after vaccination: 102
Gender:Female  Submitted:2015-02-23, Days after onset: 15
Location:Foreign  Entered:2015-02-23
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: 02/2015, Polymerase chain reaction, Positive for Influenza A
CDC Split Type: DE2015GSK022686
Vaccination
Manufacturer
Lot
Dose
Route
Site
FLU3: INFLUENZA (SEASONAL) (NO BRAND NAME)UNKNOWN MANUFACTURERAFLBA028AA0UNUN
Administered by: Other     Purchased by: Other
Symptoms: Influenza, Influenza A virus test positive, Polymerase chain reaction positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)
Write-up: This case was reported by a other health professional via regulatory authority and described the occurrence of vaccination failure in a 10-year-old female patient who received INFLUSPLIT TETRA (batch number AFLBA028AA, expiry date unknown). On 29th October 2014, the patient received the 1st dose of INFLUSPLIT TETRA. On 8th February 2015, 102 days after receiving INFLUSPLIT TETRA, the patient experienced vaccination failure (serious criteria GSK medically significant) and Influenza A virus infection (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the Influenza A virus infection was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure and Influenza A virus infection to be related to INFLUSPLIT TETRA. Additional details provided as follows: Previous unspecified vaccinations were well tolerated. The diagnosis was confirmed by polymerase chain reaction, which was positive for Influenza A. No further information was available.

VAERS ID:603044 (history)  Vaccinated:2014-05-29
Age:10.0  Onset:2014-06-13, Days after vaccination: 15
Gender:Female  Submitted:2015-10-16, Days after onset: 490
Location:Foreign  Entered:2015-10-16
Life Threatening? Yes
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
    Extended hospital stay? Yes
Previous Vaccinations: Guillain Barre~HPV (Cervarix)~2~10.83~Patient
Other Medications: Prednisone adverse reaction. Acute disseminated encephalomyelitis
Current Illness: When the vaccine did not have disease
Preexisting Conditions: Asthmatic bronchitis
Diagnostic Lab Data: Paralysis of lower limbs and upper limbs ascending treated with prednisone high medical hospital. Psychological disorder.
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
HPV2: HPV (CERVARIX)GLAXOSMITHKLINE BIOLOGICALSUNPUBLISHED IN1IMLA
Administered by: Public     Purchased by: Public
Symptoms: Asthenia, Back pain, Diplegia, Guillain-Barre syndrome, Immediate post-injection reaction, Immunoglobulin therapy, Mental disorder
SMQs:, Peripheral neuropathy (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (narrow)
Write-up: May 29, 2104 second HPV vaccine doses, adverse reaction immediate loss of strength in both piernasl pain in the lower back, applies Cervarix HPV June 2 lumbar MRI is requested. June 12 enters Hospital a CD. June 13 ascending paralysis symmetrical, medicated with prednisone 5 days after regaining strength sequel sagging hip and left leg. Psychological disorder discharged from the hospital on June 19. It is particularly applied immunoglobulin reacts positively. The doctor suspected Guillain-Barre syndrome.

VAERS ID:628799 (history)  Vaccinated:2016-01-26
Age:10.0  Onset:0000-00-00
Gender:Female  Submitted:2016-02-08
Location:Foreign  Entered:2016-02-08
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type: GB2016GSK015938
Vaccination
Manufacturer
Lot
Dose
Route
Site
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO)NOVARTIS VACCINES AND DIAGNOSTICSX15093 UNUN
Administered by: Other     Purchased by: Other
Symptoms: Cellulitis
SMQs:
Write-up: This case was reported by a nurse via local affiliate and described the occurrence of cellulitis in a adolescent female patient who received MENVEO (batch number X15093, expiry date January 2018). On 26th January 2016, the patient received MENVEO. In January 2016, less than a week after receiving MENVEO, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. It was unknown if the reporter considered the cellulitis to be related to MENVEO. Additional details were provided as follows: The case was reported by a community school nurse. The patient was approximately 14-15 year old (year 10). The patient''s medical history or concomitant medication was not available. The patient received MENVEO (MenCWY batch number X15093, expiry date January 2018 and MenA batch number A15093, expiry date January 2016). On the following Sunday, on 17th January 2016, the symptoms appeared. The reporting nurse had not seen the reaction herself but was aware that the patient went to the doctor. The reporter confirmed that the case was reported via the yellow card scheme; however the reference number was not available. No further information was provided. This case was one of the 4 cases reported by the same reporter.

VAERS ID:635427 (history)  Vaccinated:2012-05-25
Age:10.0  Onset:0000-00-00
Gender:Unknown  Submitted:2016-05-13
Location:Foreign  Entered:2016-05-13
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: Test Date: 2014; Test Name: Poliovirus test; Result Unstructured Data: 16; Comments: POLIOVIRUS TYPE 2; Test Date: 2014; Test Name: Poliovirus test; Result Unstructured Data: 6; Comments: POLIOVIRUS TYPE 1; Test Date: 2014; Test Name: Poliovirus test; Result Unstructured Data: LESS THAN 4; Comments: POLIOVIRUS TYPE 3
CDC Split Type: ROSA2016SA088422
Vaccination
Manufacturer
Lot
Dose
Route
Site
IPV: POLIO VIRUS, INACT. (NO BRAND NAME)UNKNOWN MANUFACTURER 4UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Paralysis, Poliovirus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)
Write-up: Upon internal review, significant correction done on 11 May 2016, to correct the seriousness of the case to IME instead of disability. Initial unsolicited report received from literature on 27-Apr-2016. This case is linked to case 2016SA087736 and 2016SA087716 (same literature). Abstract: Poliovirus (PV), a member of the Enterovirus genus, is the etiological agent of poliomyelitis. A study carried out between 2013-2014 on 30 serum samples from acute flaccid paralysis (AFP) cases, showed a protective antibody level of 90% against poliovirus Sabin strains type 1 and type 2 and of 88% against type 3. No PV strains were isolated from 2009 to 2015 in Romania. Maintaining a high vaccine coverage level against polio is mandatory until global polio eradication, especially as the risk of polio importation remains elevated in Romania. This case involves a 24-month-old patient (gender was not reported) who was vaccinated with a dose of IPV (VERO) (Inactivated Polio Vaccine) (batch number, expiration date, route and site of administration was not reported) on 25 May 2012. Patient''s medical history and concomitant medications were not reported. On an unspecified date, after vaccination the patient experienced acute flaccid paralysis. It was a case of vaccination failure. Laboratory investigations included Acute phase (AP) serum specimens were tested for neutralizing antibodies against each of the three poliovirus serotypes. Antibodies against poliovirus types 1, 2, and 3 were determined using a microembolization assay with 100 TCID50 (100 into 50% tissue culture infective doses) of Sabin strains. Serum sample was considered positive (indicating immunity to poliomyelitis). Corrective treatment was not reported. Upon internal review the case was considered as serious due to Important Medical Event: flaccid paralysis. The outcome of the event was not reported. Documents held by sender: none. Addendum: 11 May 2016. Upon second medical examination of case at time of internal review the seriousness of the case was corrected from disability to important medical event. Sender''s Comments: This is a poorly documented case referring to a 2 years old child who experienced acute flaccid paralysis. Patient was vaccinated with INACTIVATED POLIOMYELITIS VACCINE (IMOVAX POLIO) approximately one year back from the occurrence of the event. Although the information available is very limited, considering the nature of the event, vaccination failure of INACTIVATED POLIOMYELITIS VACCINE (IMOVAX POLIO) cannot be ruled out.

VAERS ID:25968 (history)  Vaccinated:1990-08-17
Age:11.0  Onset:1990-08-18, Days after vaccination: 1
Gender:Male  Submitted:1990-09-13, Days after onset: 26
Location:Illinois  Entered:1990-09-17, 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: Mild cold symptom
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.14735   
Administered by: Private     Purchased by: Private
Symptoms: Diarrhoea, Hepatitis, Nausea, Pharyngitis, Vomiting
SMQs:, Hepatitis, non-infectious (narrow), Acute pancreatitis (broad), Agranulocytosis (broad), Pseudomembranous colitis (broad), Oropharyngeal infections (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Following MMR had URI symptom including N/V/D. Evaluation on 24AUG90 showed abd soft with mild generalized tenderness. GI liver enlargement noted. 1cm below ribs.

VAERS ID:26717 (history)  Vaccinated:1990-10-29
Age:11.3  Onset:1990-10-29, Days after vaccination: 0
Gender:Female  Submitted:1990-11-19, Days after onset: 21
Location:Colorado  Entered:1990-11-26, Days after submission: 7
Life Threatening? Yes
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1486S1SC 
Administered by: Military     Purchased by: Military
Symptoms: Anaphylactoid reaction, Cough, Dizziness, Dyspnoea, Face oedema, Rash
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt vaccinated with MMR experienced light headedness within 15 min facial swelling, coughy, difficulty breathing & rash. Given O2 Epi, Benedryl, solumedrol. Admitted overnight.

VAERS ID:26855 (history)  Vaccinated:1990-10-31
Age:11.9  Onset:1990-11-03, Days after vaccination: 3
Gender:Male  Submitted:1990-11-05, Days after onset: 2
Location:Connecticut  Entered:1990-11-30, Days after submission: 25
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: Myopia, Osgood-Schlater disease
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1696S1SCLA
Administered by: Private     Purchased by: Public
Symptoms: Arthralgia, Headache, Injection site pain, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad)
Write-up: Pt vaccinated with MMR c/o pain in the joints of his lt hand & wrist & pain at the site of injection. c/o occipital headache, pain in his lt knee (transient), paresthesias of the skin of his lt forearm. Physical exam-normal.

VAERS ID:26965 (history)  Vaccinated:1990-08-16
Age:11.0  Onset:1990-08-30, Days after vaccination: 14
Gender:Male  Submitted:0000-00-00
Location:Michigan  Entered:1990-12-11
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: Culture DEC80 - negative - Strep; Renal biopsy 21MAY81focal glomerulosclerosis.
CDC Split Type: WAES90110966
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0218S0  
Administered by: Unknown     Purchased by: Unknown
Symptoms: Albuminuria, Condition aggravated, Glomerulonephritis, Hypertension, Hypoproteinaemia, Nephrotic syndrome, Renal impairment, Urine analysis abnormal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Hypertension (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt vaccinated with MMR developed "flu/cold" symptoms, edema. Admitted to hosp w/nephrotic synd. A renal biopsy performed dx focal glomerulosclerosis made. Treated w/cyclophosphamide, Prednisone, Furosemide & spironolactone.

VAERS ID:27098 (history)  Vaccinated:1990-12-13
Age:11.0  Onset:1990-12-13, Days after vaccination: 0
Gender:Male  Submitted:1990-12-14, Days after onset: 1
Location:New York  Entered:1990-12-18, 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: Proventil
Current Illness:
Preexisting Conditions: Hx mild asthma, no egg allergies.
Diagnostic Lab Data:
CDC Split Type:
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1881S1IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Asthma, Dyspnoea, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt vaccinated with MMR 15 min after administration developed urticaria, respiratory distress, wheezing treated w/Epi x2 & Proventil.

VAERS ID:27312 (history)  Vaccinated:1990-12-10
Age:11.7  Onset:1990-12-10, Days after vaccination: 0
Gender:Female  Submitted:1990-12-10, Days after onset: 0
Location:Alabama  Entered:1991-01-07, Days after submission: 28
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:
Diagnostic Lab Data:
CDC Split Type: AL90008
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.1700S1SCLA
Administered by: Other     Purchased by: Public
Symptoms: Dizziness, Injection site hypersensitivity, Nausea, Rash, Vasodilatation
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Became hot & dizzy w/ solid red rash over upper lt arm, nausea. Ice pack applied. BP 138/80; P 100; 10 min later BP 140/60; P 96 ; R 24. No SOB, Wheezing, rash becoming worse, extending to shoulder, cheeks, bilat temporal area, chest, etc.

VAERS ID:27423 (history)  Vaccinated:0000-00-00
Age:11.0  Onset:1989-12-01
Gender:Female  Submitted:0000-00-00
Location:Rhode Island  Entered:1991-01-14
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
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.  IM 
Administered by: Unknown     Purchased by: Unknown
Symptoms: Lung disorder, Oedema, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Pt vaccinated with MMR 1 wk later developed lung inflamation, put on Ibuprofen, developed fifth disease (total body redness & swelling) put on Prednisone.

VAERS ID:27464 (history)  Vaccinated:1990-11-03
Age:11.8  Onset:1990-11-05, Days after vaccination: 2
Gender:Female  Submitted:1990-11-20, Days after onset: 15
Location:Pennsylvania  Entered:1991-01-18, Days after submission: 59
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
    Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Pt received TD after lacerating her heel. Past medical hx & family hx are both negative for seizures.
Diagnostic Lab Data: EEG: - normal; CBC: Normal; CT - Brain: Normal
CDC Split Type: 890332011B
Vaccination
Manufacturer
Lot
Dose
Route
Site
TD: TD ADSORBED (NO BRAND NAME)PFIZER/WYETH4908049 IMA
Administered by: Private     Purchased by: Private
Symptoms: Convulsion, Gaze palsy, Hyperventilation, Paraesthesia, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)
Write-up: Developed seizure 36 hrs post-vaccination. Experienced four episodes over a four hr period of eyes rolling back, moaning, gurgling, tonic-clonic movement, and brief 15 min post-ictal periods. Temp 100.8F.

VAERS ID:27476 (history)  Vaccinated:1990-08-26
Age:11.0  Onset:1990-09-11, Days after vaccination: 16
Gender:Female  Submitted:0000-00-00
Location:Michigan  Entered:1991-01-18
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: CO3645
Vaccination
Manufacturer
Lot
Dose
Route
Site
RAB: RABIES (IMOVAX ID)CONNAUGHT LABORATORIES    
Administered by: Unknown     Purchased by: Unknown
Symptoms: Hypotonia, Paraesthesia, Urinary incontinence
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Numbness & tingling of feet, finger tips & lips. Urinary Incontinence. Bitten by bat 25AUG90; 1st dose 26AUG, 2nd 30AUG; 3rd 04SEP. 4th due today. Upon exam had weaken finger grip, other wise appeared normal.

VAERS ID:27712 (history)  Vaccinated:1991-01-15
Age:11.4  Onset:1991-01-18, Days after vaccination: 3
Gender:Female  Submitted:1991-01-28, Days after onset: 10
Location:West Virginia  Entered:1991-02-01, Days after submission: 4
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: None
Diagnostic Lab Data:
CDC Split Type: WV911
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.2168S1SCLA
Administered by: Other     Purchased by: Public
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Mom states child had ''welts on entire body for 3 days beginning 18JAN91. Phone call to MD 18JAN91 ordered Benedryl, sx persisted & child was started on Atarax 19JAN91. MD stated child had experienced previous episodes of hives.

VAERS ID:28101 (history)  Vaccinated:1991-01-15
Age:11.9  Onset:1991-01-28, Days after vaccination: 13
Gender:Male  Submitted:1991-01-30, Days after onset: 2
Location:West Virginia  Entered:1991-02-14, Days after submission: 15
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: no
Current Illness: no
Preexisting Conditions: "allergies"
Diagnostic Lab Data: 29JAN91 CBC - ATYP High 4.0%, MCV Low 76.3; All else within normal range
CDC Split Type: WV912
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.2168S1SCRA
Administered by: Other     Purchased by: Public
Symptoms: Cough, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)
Write-up: Mom states child coughed a lot on 28JAN91 & had temp to 102 oral that PM. Took to MD 29JAN91 & started Amoxicillin & Naldelate. Highest temp was 103 oral 29JAN91. Sx improved 30JAN91 temp 99 oral 1FEB91 father states child has recovered.

Result pages: prev   2585 2586 2587 2588 2589 2590 2591 2592 2593 2594 2595 2596 2597 2598 2599 2600 2601 2602 2603 2604 2605 2606 2607 2608 2609 2610 2611 2612 2613 2614 2615 2616 2617 2618 2619 2620 2621 2622 2623 2624 2625 2626 2627 2628 2629 2630 2631 2632 2633 2634 2635 2636 2637 2638 2639 2640 2641 2642 2643 2644 2645 2646 2647 2648 2649 2650 2651 2652 2653 2654 2655 2656 2657 2658 2659 2660 2661 2662 2663 2664 2665 2666 2667 2668 2669 2670 2671 2672 2673 2674 2675 2676 2677 2678 2679 2680 2681 2682 2683 2684 2685 2686 2687 2688 2689 2690 2691 2692 2693 2694 2695 2696 2697 2698 2699 2700 2701 2702 2703 2704 2705 2706 2707 2708 2709 2710 2711 2712 2713 2714 2715 2716 2717 2718 2719 2720 2721 2722 2723 2724 2725 2726 2727 2728 2729 2730 2731 2732 2733 2734 2735 2736 2737 2738 2739 2740 2741 2742 2743 2744 2745 2746 2747 2748 2749 2750 2751 2752 2753 2754 2755 2756 2757 2758 2759 2760 2761 2762 2763 2764 2765 2766 2767 2768 2769 2770 2771 2772 2773 2774 2775 2776 2777 2778 2779 2780 2781 2782 2783   next

New Search

Link To This Search Result:
http://www.medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=2684&PERPAGE=100&ESORT=AGE


Copyright © 2016 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166