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From the 9/17/2021 release of VAERS data:

Found 1,545,504 cases where Symptom is Immune system disorder or Immunodeficiency or Immunoglobulins decreased or Lymphadenopathy



Case Details (Sorted by Age)

This is page 253 out of 1,546

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VAERS ID: 478891 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-23
Onset:2012-10-23
   Days after vaccination:0
Submitted: 2012-12-19
   Days after onset:57
Entered: 2012-12-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20910001C / UNK LA / SC
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER UVA11005 / UNK LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR G9965 / UNK RL / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying
SMQs:, Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201211920

Write-up: Case received from the Health Authorities on 11 December 2012 under the reference number PL-URPL-N1357/2012. A 09-week-old male patient (gender not specified), with no reported medical history, had received his dose of ACT-HIB, batch number G9965-1, route of administration not reported, in the right thigh, concomitantly with his subcutaneous dose of "PIX360326" [interpreted as DTP vaccine] (other manufacturer, batch number 20910001C) in the left arm, and his intramuscular dose of EUVAX B (other manufacturer, batch number UVA11005) in the left thigh, on 23 October 2012. On 23 October 2012, 1 hour post-vaccination, the patient experienced persistent crying. He was hospitalized from 23 to 25 October 2012 for diagnosis. The Health Authorities coded "persistent crying". The patient recovered. Sender''s comment: "Crying-expected reaction". Documents held by sender: none.


VAERS ID: 478892 (history)  
Form: Version 1.0  
Age: 0.48  
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-09-12
Onset:2012-09-12
   Days after vaccination:0
Submitted: 2012-12-19
   Days after onset:98
Entered: 2012-12-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20910001C / UNK RA / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR G9965 / UNK RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR GO120 / UNK LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Hypotonia, Pallor
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Similar symptoms appeared a few times for 2-3 days post-vaccination.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201211924

Write-up: Case received from the Health Authorities on 11 December 2012 under the reference number PL-URPL-N1393/2012. A 06-month-old patient (gender not specified), with no reported medical history, had received an intramuscular dose of ACT-HIB, batch number G9965-1, in the right thigh, concomitantly with a subcutaneous dose of "PIX360326" [interpreted as DTP vaccine] (other manufacturer, batch number 20910001C) in the right arm and an intramuscular dose of IMOVAX POLIO (batch number "GO120") in the left thigh, on 12 September 2012. On 12 September 2012, 2 hour post-vaccination, the patient experienced pallor and flaccidity for a few minutes. "Similar symptoms appeared a few times for 2-3 days post-vaccination". On 14 September 2012, 48 hours post-vaccination, the patient developed uncontrollable crying which lasted for more than 3 hours. The Health Authorities coded "hypotonic-hyporesponsive episode" and "inconsolable crying". The patient recovered. This case was reported as serious, i.e. as a medically important condition. Reporter''s comment: "The child was referred for consultation in the outpatient vaccination clinic for children at high-risk". Sender''s comment: "IVP is produced by Sanofi Pasteur so it is probably IMOVAX POLIO. Hypotonic-hyporesponsive episode is known and expected reaction after DTP vaccine (unexpected for ACT-HIB and IMOVAX POLIO), could appear after many vaccines. Crying is expected reaction after DTP and ACT-HIB, unexpected for IMOVAX POLIO". Documents held by sender: none.


VAERS ID: 478894 (history)  
Form: Version 1.0  
Age: 0.37  
Sex: Male  
Location: Foreign  
Vaccinated:2012-11-23
Onset:2012-11-24
   Days after vaccination:1
Submitted: 2012-12-19
   Days after onset:25
Entered: 2012-12-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: CSF white blood cell count increased, Enterovirus test negative, Febrile convulsion, Laboratory test normal, Lumbar puncture abnormal, Meningitis, Polymerase chain reaction, Viral test negative
SMQs:, Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No relevant medical history reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: E201210508

Write-up: Case received from the Health Authorities in a foreign country via other company on 11-Dec-2012 under the reference number DK-DKMA-ADR-21942045 and DK-DKMA-EFO3785. Case medically confirmed and assessed as serious (hospitalization). A 4-month-old male patient (height and weight not reported), with no relevant medical history reported, had received the first injection of ACTHIB (batch number unknown, route and administration site not reported) and concomitantly the first injection of DITEIPOL (batch number unknown, route and administration site not reported) on 23-Nov-2012. The patient also received the first dose of PREVENAR 13 (batch no. unknown, route and site of administration not reported) on the same day. On the next day the patient was admitted to hospital due to convulsion febrile. Lumbar puncture showed leucocytes 11, predominantly mononuclear. Patient received treatment for meningitis with CEFTRIAXON and AMPICILLIN and ACICLOVIR. Treatment was withdrawn on 24-Nov-2012. No growth, PCR results for herpes and enterovirus were negative. At discharge, nothing was notable neurological. Infection results were normal, the patient was afebrile. No other vaccines or medicines were administered. The patient recovered from febrile convulsion on 24-Nov-2012. A causality assessment was not provided. No further information expected.


VAERS ID: 478897 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:2012-04-03
Onset:2012-04-03
   Days after vaccination:0
Submitted: 2012-12-19
   Days after onset:260
Entered: 2012-12-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase increased, Blood calcium increased, Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood magnesium increased, Blood potassium normal, Blood sodium normal, Blood urea normal, Bowel movement irregularity, Crying, Decreased appetite, Diarrhoea, Eating disorder, Haematocrit decreased, Haemoglobin decreased, Leukopenia, Mean cell haemoglobin concentration normal, Mean cell haemoglobin decreased, Mean cell volume normal, Neutropenia, Neutrophil percentage decreased, Oral candidiasis, Pharyngeal erythema, Platelet count decreased, Pyrexia, Rash, Red blood cell count normal, Red cell distribution width normal, Tympanic membrane hyperaemia, White blood cell count normal
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Agranulocytosis (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: First dose, PREVENAR-13; First dose, INFANRIX HEXA
Allergies:
Diagnostic Lab Data: 09-APR-2012, Alanine aminotransferase, 22 IU/l; 09-APR-2012, Aspartate aminotransferase, 90 IU/l; 09-APR-2012, Blood calcium, 4.30 mEq/l; 09-APR-2012, Blood chloride, 106 mEq/l; 09-APR-2012, Blood creatinine, 0.22 mg/dl; 09-APR-2012, Blood glucose, 80 mg/dl; 09-APR-2012, Blood magnesium, 2.50 mg/dl; 09-APR-2012, Blood potassium, 4.63 mEq/l; 09-APR-2012, Blood sodium, 140 mEq/l; 09-APR-2012, Blood urea, 11 mg/dl; 09-APR-2012, C-reactive protein, <0.1 mg/dl; 09-APR-2012, Haematocrit, 29.0%; 13-APR-2012, Haematocrit, 30.5%; 09-APR-2012, Haemoglobin, 9.9 g/dl; 13-APR-2012, Haemoglobin, 10.3 g/dl; 09-APR-2012, Mean cell haemoglobin, 25.1 pg; 13-APR-2012, Mean cell haemoglobin, 25.1 pg; 09-APR-2012, Mean cell haemoglobin concentration, 34.1%; 13-APR-2012, Mean cell haemoglobin concentration, 33.8%; 09-APR-2012, Red cell distribution width, 14.5%; Hemochrome test (09Apr2012): leukocytes 6620/ul; erythrocytes 3.94 millions/ul; mean corpuscular volume 73.6 fl; Platelet count 171000/ul; screening quantity of neutrophils 4.2%. Hemochrome test (13Apr2012): leukocytes 10.500/ul; erythrocytes 4.10 millions/ul; mean corpuscular volume 74.4 fl; Platelet count 397000/ul; screening quantity of neutrophils: 28.4%. Red cell count (unknown date): 5600 (unknown units)
CDC Split Type: 2012317640

Write-up: This is a spontaneous report from a contactable physician (specialist). This is a report received from the regulatory authority, Regulatory authority report number 185350. A 5-month-old female patient received the second dose of PREVENAR 13 (lot number F59867, expiration date 20Ap2014), intramuscular on 03Apr2012 at 0.5 ml, single in the right thigh and the second dose of INFANRIX HEXA, lot number A21CB217A, expiration date 31Oct2013), intramuscular on 03Apr2012 at 1 dose form (DF), single in the left thigh. No relevant medical history and concomitant medications were reported. The patient experienced diarrhoea, leukopenia, neutropenia, fever and inappetence on 03Apr2012 and diffuse exanthema on 09Apr2012. The reporter described the reaction as follow: in the evening of vaccination day, appearance of fever, inappetence and irregular bowel movements: hospitalization from 07Apr2012 for leukopenia and absolute neutropenia; starting from 09Apr2012 onset of punctiform exanthema diffused. The seriousness criterion for these events was hospitalization in the pediatric department from 07Apr2012 to 09Apr2012. The patient completely recovered on unspecified date. Letter of discharge, written by hospital physicians and provided by the reporter, included the following additional information. Diagnosis at admission was leukopenia during fever (suspected reaction to hexavalent vaccine). Clinical course: the patient was admitted for fever started on 03Apr2012. During the last days reduced feeding (she refused paps but had milk) and irregular bowel movements. No relevant medical history. Observed good general conditions, consolable crying, normal hydration, pharynx and tympanic membranes slightly hyperhemic. No signs of meningoradicular irritation. Blood tests revealed leukopenia with absolute neutropenia and the child was hospitalized. At admission slight fever and thrush in the oral cavity were observed. Oral antibiotic therapy and DAKTARIN oral gel were started. The child remained in good conditions and showed good interaction with the environment. The patient has resumed eating as usual and bowel movements approximately normalized. The last episode of high fever was during the night between 07Apr2012 and 08Apr2012. On 09Apr2012 onset of punctiform diffused exanthema. A subsequent hemochrome test showed a recovery of red cell count/red blood cells value: 5600, normal value 6000) with a persistence of absolute neutropenia. Due to the persistence of good general conditions and resolution of fever the patient was discharged with the adviced to maintain domicililary isolation and to repeat hemochrome tests. During the hospitalization blood laboratory tests were performed. Lab data included hemochrome test (09Apr2012): leukocytes 6620/ul; erythrocytes: 3.94 millions/ul; mean corpuscular volume 73.6 fl; Platelet count 171000/ul; screening quantity of neutrophils 4.2%. Hemochrome test (13Apr2012): leukocytes 10.500/ul; erythrocytes 4.10 millions/ul; mean corpuscular volume 74.4 fl; Platelet count 397000/ul; neutrophils: 28.4%. The diagnosis at discharge was: fever, neutropenia and exanthema in breast-fed patient. Therapy advised at home included to continue amoxicillin-clavulanic acid.


VAERS ID: 478903 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-12-07
Onset:2012-12-11
   Days after vaccination:4
Submitted: 2012-12-18
   Days after onset:7
Entered: 2012-12-20
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Abortion missed, Exposure during pregnancy, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 12/11/2012, Ultrasound scan, Positive, Significant, Revealed "missed abortion" in week 15+4 of pregnancy.
CDC Split Type: PHHY2012CH114686

Write-up: Case number PHHY2012CH114686 is an initial spontaneous report received from a physician on 11 Dec 2012: This case refers to a female patient with unknown age. The patient received AGRIPPAL (batch number: unknown) on 07 Dec 2012. On 10 Dec 2012 no adverse events were noticed but on 11 Dec 2012 sonographic diagnosis revealed "missed abortion" in week "15+4" of pregnancy. The seriousness, event outcome and causality were not reported.


VAERS ID: 478907 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2012-11-09
Submitted: 2012-12-20
   Days after onset:41
Entered: 2012-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Foetal exposure during pregnancy, Hypoxia, Premature baby, Stillbirth, Trisomy 21
SMQs:, Asthma/bronchospasm (broad), Congenital, familial and genetic disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Termination of pregnancy and risk of abortion (narrow), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHFR2012GB006492

Write-up: Case number PHFR2012GB006492, is an initial spontaneous report received from a consumer (patient''s father) via health authority (GB-MHRA-ADR 21929657-003) on 17 Dec 2012. This report refers to a stillbirth neonate. The baby''s mother had 4 prior pregnancies resulted in live births with no history of miscarriage or stillbirths in the family. Her pregnancy was normal all the way through, blood pressure and pulse was normal. The baby''s mother was vaccinated with Influenza vaccine (unknown manufacturer and batch number) parenteral and REPEVAX (batch number: unknown) on 01 Nov 2012. The mother had midwife appointment 3 days before vaccination, when the examinations done revealed normal baby movements and strong heartbeat. The mother''s blood pressure and pulse were also normal. The mother was advised by the mid-wife to receive whooping cough vaccination to protect unborn child and was advised that it was safe. Two days later, the mother received vaccination. After vaccination, things started to slow down and 5 days after the vaccinations baby''s movements stopped and the mother lost slight blood (See case: PHFR2012GB006478). On 06 Nov 2012, mother also noticed a decrease in baby''s movements. Over the next days, the baby''s movements had completely stopped but the mother was able to get a midwife appointment only three days later. At the midwife appointment, it was found that the baby had died. On 09 Nov 2012, the mother delivered a still born baby; he measured 47 cm and weighed 3.1 kg for the age 36.5 weeks. The reporter was in strong belief that the whooping cough vaccination caused the death of the child. The baby''s father had contacted the manufacturers of the vaccine to confirm that no clinical tests were carried out on pregnant women and was of opinion that he would not have allowed the vaccination if he had read the leaflet. He added that this was his wife''s fifth pregnancy, all 4 prior resulted in live births, there was no history of miscarriages or stillbirths in the family, and the only thing that has changed with all 5 pregnancies is the whooping cough vaccination. Post-mortem was not done, but the parents agreed for blood tests, testing on cord, placenta and also tissue. The test results revealed Down syndrome, but the parents believed very slightly as there were no visible signs, and added this as put "out of the blue since there was nothing in their blood that could cause a risk to this and that the placenta was in perfect condition and working order". The cause of death was reported as hypoxia. The parents were of belief that Down syndrome was not the cause of death.


VAERS ID: 479000 (history)  
Form: Version 1.0  
Age: 0.23  
Sex: Male  
Location: Foreign  
Vaccinated:2012-07-17
Onset:2012-07-17
   Days after vaccination:0
Submitted: 2012-12-20
   Days after onset:156
Entered: 2012-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA428CA / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Culture stool positive, Diarrhoea, Enema administration, Escherichia test positive, Haematochezia, Klebsiella test positive, Mood altered, Mucous stools, Ultrasound abdomen normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Stool culture, 14sep2012, Escherichia coli; Ultrasound scan, 14Sep2012, no abnormality
CDC Split Type: B0848915A

Write-up: This case was reported by a physician and described the occurrence of bloody mucus in stool in a 12-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included ACTHIB (non-GSK manufacturer, subcutaneous0 and PREVENAR (non-GSK manufacturer, subcutaneous) given on 20 August 2012. On 17 July 2012, the subject received 1st dose of ROTARIX (1.5 ml, oral). On 17 July 2012, in the evening, less than one day after vaccination with ROTARIX, the subject experienced slight diarrhea. On 25 July 2012, the event was resolved. On 14 September 2012, 59 days after vaccination with ROTARIX, the subject experienced strawberry jam-lie bloody stool with mucus. An ultrasonography performed on the same day showed no abnormality but Escherichia coli and klebsiella pneumonia were detected in stool culture. On 18 September 2012, pink-colored bloody stool with mucus and slight diarrhoea were observed. On 21 September 2012, watery diarrhoea occurred and the second vaccination with ROTARIX was postponed. On 28 September 2012, strawberry jam-like bloody stool with mucus was observed twice and diarrhoea was noted. On 3 October 2012, the subject''s stools returned to normal and the 2nd vaccination with ROTARIX was given. The physician considered the events were clinically significant (or requiring intervention). The physician considered the events were related to vaccination with ROTARIX. Follow-up information received on 14 December 2012: Concurrent vaccination also included PREVENAR (non-GSK manufacturer, subcutaneous) given on 17 July 2012. On 17 July 2012, the subject had experienced diarrhoea tendency from the early evening after the vaccinations until 25 July 2012. On 17 July 2012, at night, the subject experienced diarrhoea once. Thereafter, slight diarrhoea-lie symptom persisted until 25 July 2012. On 25 July 2012, the subject experienced watery diarrhoea twice but the symptom did not develop afterwards. On 14 September 2012, the subject suddenly experienced strawberry-jam-lie diarrhoea in the morning. The subject was taken to the hospital due to a bad mood. The subject received an enema, and presented with mucous and bloody stool. On 18 September 2012, the subject presented with pinkish stool once or twice. The frequency of loose stools decreased to once a day, and the symptoms were considered to be resolving. On 21 September 2012, the subject again experienced watery diarrhoea every hour. The second vaccination with ROTARIX was postponed. On 28 September 2012, the subject experienced episodes of strawberry-jam-like stool (bloody stool) and diarrhoea afterwards. The symptoms subsequently improved. The subject experienced no diarrhoea thereafter. On 3 October 2012, the subject presented with normal stool and received 2nd vaccination with ROTARIX. The third vaccinations with PREVENAR and haemophilus influenzae type B vaccine were simultaneously performed. Although the subject presented with mucous and bloody stool over 2 months after the vaccination, ROTARIX was suspected to be a causative drug as the reporter had successively experienced 2 similar cases. The physician considered that the watery diarrhoea noted 1 week after the vaccination on 17 July 2012 was an adverse drug reaction, but the strawberry-jam-lie diarrhoea was hard to assess as the symptom developed almost 2 months after the vaccination. The abdominal ultrasound confirmed that the symptom was not invagination of intestine.


VAERS ID: 479003 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2012-12-14
Onset:2012-12-14
   Days after vaccination:0
Submitted: 2012-12-20
   Days after onset:6
Entered: 2012-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic shock, Laboratory test normal, Oedema peripheral, Swelling face
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test to confirm whether the anaphylactic shock was induced by infection: Negative
CDC Split Type: B0853738A

Write-up: This case was reported by a physician and described the occurrence of anaphylactic shock in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). ACTHIB (non-GSK) and PREVENAR (non-GSK). On 14 December 2012, the subject received an unspecified dose of ROTARIX (1.5 ml, oral, batch number not provided), an unspecified dose of ACTHIB (0.5 ml, subcutaneous, unknown injection site) and an unspecified dose of PREVENAR (subcutaneous, unknown injection site). On 14 December 2012, approximately 30 minutes after vaccination with ACTHIB, PREVENAR and ROTARIX, the subject experienced anaphylactic shock with swelling of face and arms. The subject was hospitalised for 4 days (from 14 December 2012 to 17 December 2012). A test was performed to confirm whether the shock was induced by infection: the result was negative. Consequently, the shock was considered to be related to the vaccine. The subject was treated with an unspecified treatment. On 14 December 2012, the events were resolved. The physician considered the events were related to vaccination with ROTARIX, ACTHIB and PREVENAR.


VAERS ID: 479004 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2012-12-07
Onset:2012-12-11
   Days after vaccination:4
Submitted: 2012-12-20
   Days after onset:9
Entered: 2012-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA568AA / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Eating disorder, Intussusception
SMQs:, Gastrointestinal obstruction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UN
CDC Split Type: B0853695A

Write-up: This case was reported by a physician and described the occurrence of intussusception in a 3-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 7 December 2012, the subject received 1st dose of ROTARIX (oral). On 11 December 2012, 4 days after vaccination with ROTARIX, the subject was eating poorly. On 13 December 2012, 6 days after vaccination with ROTARIX, intussusception was diagnosed. The physician considered the events were clinically significant (or requiring intervention). The subject was hospitalised for surgery. At the time of reporting, the outcome of the events was unspecified. The physician considered the events were probably related to vaccination with ROTARIX.


VAERS ID: 479048 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-20
Entered: 2012-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS YHIBC593B / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-12-11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0853253A

Write-up: This case was reported by a physician via a Sales Representative and described the occurrence of unknown cause of death in a 4-month-old male subject who was vaccinated with HIBERIX (GlaxoSmithKline). On 9 December 2012, the subject received an unspecified dose of HIBERIX (administration site and route unknown). On 11 December 2101, 2 days after vaccination with HIBERIX, the subject died. The subject died on 11 December 2012, cause of death was not reported. It was unknown whether an autopsy was performed.


VAERS ID: 479053 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-20
Entered: 2012-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA801B / 1 UN / UN
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS ASPNA047BH / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA439AE / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Body temperature increased, Generalised oedema, Injection site erythema, Injection site oedema, Injection site pain, Insomnia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, 24Oct2012, 38deg.C
CDC Split Type: B0853014A

Write-up: This case was reported by a physician via a regulatory authority (SI-JAZMP-NCPHV-2012SI0177_455) and described the occurrence of injection site pain in a 3-month-old female subject who was vaccinated with INFANRIX-POLIO-HIB (GlaxoSmithKline), ROTARIX and SYNFLORIX. On 23 October 2012, the subject received 1st dose of INFANRIX-POLIO-HIB (administration site and route unknown), 1st dose of ROTARIX (oral) and 1st dose of SYNFLORIX (administration site and route unknown). On 23 October 2012, in the evening, 1 day after vaccination with INFANRIX-POLIO-HIB, ROTARIX and SYNFLORIX, the subject experienced generalized edema and generalized urticaria on face, neck and feet. On 24 October 2012, 2 days after vaccination with INFANRIX-POLIO-HIB, ROTARIX and SYNFLORIX, the subject experienced injection site pain, injection site redness, injection site edema and body temperature increased (38 deg.C). At an unspecified time after vaccination with INFANRIX-POLIO-HIB, ROTARIX and SYNFLORIX, the subject experienced insomnia. The subject was hospitalised from 24 to 25 October 2012. The subject was discharged afebrile, without edema and urticaria. The subject was treated with FENISTIL. At the time of reporting, the events were resolved. For the future, diet without cow''s milk and ALLERNOVA were advised.


VAERS ID: 479057 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2004-12-01
Onset:0000-00-00
Submitted: 2012-12-20
Entered: 2012-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood test abnormal, Immune system disorder, Mucous membrane disorder, Toxicologic test abnormal
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood test, toxic damage
CDC Split Type: B0852994A

Write-up: This case was reported by a consumer via a regulatory authority (DK-DKMA-ADR 21952033) and described the occurrence of immune system disorder in a male subject of unspecified age who was vaccinated with HAVRIX (GlaxoSmithKline), DITE BOOSTER (non-gsk) and GAMMA GLOBULIN. Historic vaccination included hepatitis A vaccine inactivated; GlaxoSmithKline; unknown; unknown given in March 2004. In December 2004, the subject received an unspecified dose of HAVRIX (administration site and route unknown, batch number not provided), in March 2004, the subject received an unspecified dose of DITE Booster (unknown) and in March 1997, the subject received an unspecified dose of GAMMA GLOBULIN (unknown). At an unspecified time after vaccination with DITE BOOSTER, GAMMA GLOBULIN and HAVRIX, the subject experienced immune system disorder and mucus membrane disorder. The regulatory authority reported that the events were clinically significant (or requiring intervention). A screening of his blood in 60000 times magnification showed damage due to toxicity. At the time of reporting, the events were unresolved. The regulatory authority reported that the events were possibly related to vaccination with HAVRIX but unlikely related to DITE BOOSTER and GAMMA GLOBULIN. The reporter suggested a causal relationship between the aluminium content of Td vaccine SSI and the onset of the events.


VAERS ID: 479058 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-12-06
Onset:2012-12-07
   Days after vaccination:1
Submitted: 2012-12-20
   Days after onset:13
Entered: 2012-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abnormal faeces, Diarrhoea, Gastroenteritis, Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0852572A

Write-up: This case was reported by a healthcare professional and described the occurrence of feces bloodstained in a 2-month-old subject of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included Hib (non-gsk); non-GSK manufacturer; subcutaneous; unknown given on 6 December 2012; pneumococcal vaccine (non-gsk); non-GSK manufacturer; subcutaneous; unknown given on 6 December 2012. On 6 December 2012, the subject received 1st dose of ROTARIX (1.5 ml, oral). On 7 December 2012, 1 day after vaccination with ROTARIX, the subject experienced diarrhea (once a day) and stool odor abnormal. No fever, no marked abnormalities in particular. On 11 December 2012, 5 days after vaccination with ROTARIX, the subject experienced feces blood stained. The healthcare professional considered the events were clinically significant (or requiring intervention). An examination revealed no abnormalities such as invagination of intestine. A diagnosis if suspected gastroenteritis was made. At the time of reporting, diarrhea was unresolved. The outcome of the other events was unspecified. The healthcare professional considered diarrhea was related to vaccination with ROTARIX.


VAERS ID: 479061 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2012-12-08
Onset:2012-12-09
   Days after vaccination:1
Submitted: 2012-12-20
   Days after onset:11
Entered: 2012-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS A41CB233A / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Adenovirus test, Diarrhoea, Pyrexia, Rotavirus infection, Rotavirus test positive
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Adenovirus test, 09Dec2012, positive; Rotavirus test, 09Dec2012, positive
CDC Split Type: B0852462A

Write-up: This case was reported by a physician and described the occurrence of rotavirus in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included combined diphtheria, tetanus-acellular pertussis, hepatitis B, inactivated poliomyelitis and Haemophilus influenzae type B vaccine; GlaxoSmithKline; unknown; unknown given on 8 December 2012; SYNFLORIX; GlaxoSmithKline; unknown; unknown given on 8 December 2012. On 8 December 2012, the subject received 1st dose of ROTARIX (oral). On 9 December 2012, 1 day after vaccination with ROTARIX, the subject experienced fever and watery diarrhea. The subject was hospitalised on 10 December 2012 and the physician considered the events were life threatening and clinically significant (or requiring intervention). Stool test showed rotavirus positive and adenovirus negative. At the time of reporting, fever was resolved but she still had diarrhea. The physician considered the events were almost certainly related to vaccination with ROTARIX.


VAERS ID: 479078 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-21
Entered: 2012-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Delirium, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012AU118010

Write-up: Case number PHHY2012AU118010 is an initial spontaneous report received from a Health Authority (reference number: 304307) on 18 Dec 2012: This report refers to a male patient of unspecified age. His medical history and concomitant medication was not reported. He was vaccinated with influenza vaccine (manufacture and batch number: unknown) on an unspecified date. On an unspecified date after vaccination, he experienced delirium, nausea and vomiting. The outcome and seriousness of the events were not reported. The Health authority thinks that, there is a possibility that the vaccine caused the adverse event.


VAERS ID: 479088 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-10-19
Onset:0000-00-00
Submitted: 2012-12-21
Entered: 2012-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Activities of daily living impaired, Arthropathy
SMQs:, Dementia (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: D0078180A

Write-up: This case was reported by a physician and described the occurrence of shoulder problems in a female subject of unspecified age who was vaccinated with TWINRIX adult (GlaxoSmithKline). On 19 October 2012 the subject received a dose of TWINRIX adult. At an unspecified time after vaccination with TWINRIX adult the subject developed shoulder problems. At the time of reporting, on 14 December 2012, the event was still unresolved and the subject had been unable to work since four weeks. This case was assessed as medically serious by GSK.


VAERS ID: 479095 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-11-06
Onset:2012-11-06
   Days after vaccination:0
Submitted: 2012-12-21
   Days after onset:45
Entered: 2012-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Hyporesponsive to stimuli, Hypotonia, Hypotonic-hyporesponsive episode, Somnolence
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: B0854241A

Write-up: This case was reported by a physician via a regulatory authority (PL-URPL-N1430/2012) and described the occurrence of hypotonic-hyporesponsive episode in a 6-week-old subject of unspecified gender who was vaccinated with INFANRIX HEXA (GlaxoSmithKline), ROTARIX. On 6 November 2012 the subject received 1st dose of INFANRIX HEXA (intramuscular, unknown injection site), 1st dose of ROTARIX (oral). On 6 November 2012, less than one day after vaccination with INFANRIX HEXA and ROTARIX, the subject experienced hypotonic-hyporesponsive episode, flaccidity, sleepiness and decreased responsiveness. According to the mother, the episode lasted between 30 sec and 2 min. At 10:15 a.m. the muscle tone was measured and was normal, movements were normal too. The level of consciousness was normal. Because of the symptoms reported by mother of the subject (hypotonic-hyporesponsive episode, sleepiness) the infant was referred to a hospital for observation. The subject was hospitalised for one day. At the time of reporting the events were resolved. The regulatory authority considered the events were possibly related to vaccination with INFANRIX HEXA and ROTARIX. No further information is expected, the foreign Regulatory agency has provided us with all the available information for the time being, if they ever get any further they will send it to us.


VAERS ID: 479096 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-25
Onset:2012-10-27
   Days after vaccination:2
Submitted: 2012-12-21
   Days after onset:55
Entered: 2012-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA759A / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F33615 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Death, Muscle rigidity, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-10-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0854222A

Write-up: This case was reported by another health professional via a regulatory authority (# NO-NOMAADVRE-FHI-2012-15225) and described the occurrence of sudden infant death in a 3-month-old male subject who was vaccinated with INFANRIX-POLIO-HIB (GlaxoSmithKline) and (non-gsk) PREVENAR 13. On 25 October 2012, the subject received 1st dose of INFANRIX-POLIO-HIB (parenteral, administration site unknown) and 1st dose of PREVENAR 13 (parenteral, unknown). On 27 October 2012, 2 days after vaccination with INFANRIX-POLIO-HIB and PREVENAR 13, the subject was found dead in his bed. Rigor mortis was present. The regulatory authority reported that the event was possibly related to vaccination with INFANRIX-POLIO-HIB and PREVENAR 13. The subject died on 27 October 2012 from sudden infant death. An autopsy was performed. Further information has been expected included autopsy report.


VAERS ID: 479097 (history)  
Form: Version 1.0  
Age: 0.27  
Sex: Female  
Location: Foreign  
Vaccinated:2012-10-12
Onset:2012-10-12
   Days after vaccination:0
Submitted: 2012-12-21
   Days after onset:70
Entered: 2012-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA800A / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Allergic colitis, Blood immunoglobulin A decreased, Clostridium test negative, Culture stool negative, Diarrhoea, Diarrhoea haemorrhagic, Frequent bowel movements, Proctoscopy abnormal, Selective IgA immunodeficiency
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific inflammation (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Domperidone
Current Illness: Allergy to lactose; Allergy to starch; Cow milk protein allergy; Gastroesophageal reflux
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Laboratory test, Nov2012, IgA immune defic; Proctoscopy, Nov2012, allergic colitis; Stool culture, 2012, no clostridium
CDC Split Type: B0852474A

Write-up: This case was reported by a consumer and described the occurrence of mucosanguineous diarrhea in an infant female subject who was vaccinated with INFANRIX QUINTA (GlaxoSmithKline) and INFANRIX HEXA. A physician or other health care professional has not verified this report. Concurrent medical conditions included allergy to lactose, allergy to starch, cow milk protein allergy and gastroesophageal reflux. Concurrent medication included MOTILIUM. In 2012, the subject received a 1st dose of INFANRIX HEXA (batch, route and injection site unknown). On the same day, in the evening, the subject experienced diarrhea which lasted 24 hours. On 12 October 2012 at 17:00, the subject received a 2nd dose of INFANRIX QUINTA (batch A20CA800A, route and injection site unknown). On the same day at 21:00, the subject had mucosanguineous diarrhea. Frequency of stools reached up to 17 per day for three days then decreased to 10 times daily for one week. The subject was hospitalized on 17 October 2012. Stool cultures were negative for clostridium and salmonella. The subject was treated with OROKEN and FLAGYL but diarrhea resumed at treatment discontinuation. The subject was discharged from hospital on 24 October 2012. The subject was hospitalized again on 15 November 2012. An IgA immune deficiency was evidenced. A proctoscopy showed an allergic colitis. The subject was discharged from hospital on 16 November 2012. At the time of reporting, diarrhea had resolved two weeks before.


VAERS ID: 479099 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2011-01-17
Onset:2011-07-18
   Days after vaccination:182
Submitted: 2012-12-21
   Days after onset:522
Entered: 2012-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Caesarean section, Cardiac murmur, Congenital anomaly, Foetal exposure during pregnancy, Neonatal respiratory distress syndrome, Premature baby
SMQs:, Congenital, familial and genetic disorders (narrow), Pulmonary hypertension (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0703463B

Write-up: This prospective pregnancy case was reported by a consumer and described the occurrence of respiratory distress in a neonate male subject whose mother was vaccinated with CERVARIX (GlaxoSmithKline) during pregnancy. A physician or other health care professional has not verified this report. On 17 December 2010 and on 17 January 2011, the 33-year-old mother of the subject received 1st and 2nd doses of CERVARIX (unknown route of administration and batch number). On 18 July 2011, 6 months after vaccination with CERVARIX, the subject was prematurely delivered by C-section. The neonate weighted 1.3 kg and had a size of 33 cm. The subject was born with birth defects: he experienced respiratory distress and heart murmur. At the time of reporting the events were resolved. Please see report B0703463A for details regarding the mother case. Additional information has been requested.


VAERS ID: 479101 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-11-11
Onset:2012-11-11
   Days after vaccination:0
Submitted: 2012-12-21
   Days after onset:40
Entered: 2012-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1212USA007583

Write-up: This spontaneous prospective pregnancy report as received from a husband consumer to a his wife a female patient of unknown age with no pertinent medical history and drug reactions not reported. The patient''s history of previous pregnancies and live births was not known. Subsequently, the patient became pregnant with an LMP of 30-OCT-2012 and an EDD of 06-AUG-13. On 11-NOV-2012, the patient was vaccinated with dose 1 GARDASIL. No other co-suspects were reported. No concomitant medications were reported. Initial exposure to GARDASIL was at 2 week(s). The patient was exposed to GARDASIL during trimester 1. The consumer stated that his wife would not be continuing with the other 2 shots in this series until pregnancy is over. No further AE in formation was provided. The outcome of pregnant was unknown. Additional information is not expected.


VAERS ID: 479108 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-11-01
Onset:0000-00-00
Submitted: 2012-12-21
Entered: 2012-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / SYR
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Exposure during pregnancy, Stillbirth, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHFR2012GB006478

Write-up: Case number PHFR2012GB006478, is an initial spontaneous report received from a consumer via health authority (GB-MHRA-ADR 21953832) on 17 Dec 2012. This report refers to a pregnant female patient of unknown age. She was vaccinated with influenza vaccine (unknown manufacturer and batch number) and REPEVAX (batch number: unknown) on 01 Nov 2012. The patient had 4 prior pregnancies resulted in live births with no history of miscarriage or stillbirths in the family. Her pregnancy was normal and blood pressures were good all the way through. Baby movements and heart were strong throughout the pregnancy. The patient had midwife appointment 3 days before vaccination and baby was strong. After vaccination, things started to slow down and 5 days after the vaccination movements stopped and the mother lost slight blood. On 09 Nov 2012, the mother delivered a stillborn baby; he measured 47 cm and weighed 3.1 kg for the age 36.5 weeks. (See case: PHFR2012GB006492). Reporter assessed the event as medically significant. The outcome of the events and causality was not reported.


VAERS ID: 479079 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2012-09-11
Onset:0000-00-00
Submitted: 2012-12-24
Entered: 2012-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal discomfort, Change of bowel habit, Condition aggravated, Constipation, Decreased appetite, Malaise, Mood altered, Sleep disorder, Sleep phase rhythm disturbance, Urinary tract infection
SMQs:, Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: ROTATEQ, Abdominal discomfort; ROTATEQ, Change of bowel habit; ROTATEQ, Diarrhoea; ROTATEQ, Constipation
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1210ESP002994

Write-up: A 2 month-old male patient, with no previous medical history reported, had received the second dose of ROTATEQ (batch not reported) one month after first dose of ROTATEQ administration. The patient presented with the same symptoms he had presented after receiving the first dose of ROTATEQ (2 or 3 extra bowel movements per day. 3 days after vaccine administration, the patient presented with constipation), only worse, he also presented inability to fall asleep and crying. A week later the patient recovered. The patient had received the first dose of ROTATEQ (batch number not reported) on an unspecified date and one day later, the patient presented with 2 or 3 extra bowel movements per day. 3 days after vaccine administration, the patient presented with constipation. However, the patient didn''t present inability to fall asleep and crying after first dose of ROTATEQ administration. A week later the patient recovered. The patient had received the first dose of ROTATEQ (batch number not reported) on an unspecified date and one day after, the patient presented with 2 or 3 extra bowel movements per day. 3 days after vaccine administration, the patient presented with constipation. However, the patient didn''t present inability to fall asleep and crying after first dose of ROTATEQ administration. A week later the patient recovered. No further information reported. Follow-up information received on 17-DEC-2012 from the nurse, the PV form was received. It was reported that the patient was female instead of male as initially reported. The new information provided was: The patient, born on 04-JUN-2012, therefore the patient was 3 months old at the time of events. The patient received the second dose of ROTATEQ (Batch number: 0112AE) via oral on 11-SEP-2012 and one day later, on 12-SEP-2012, the patient presented with malaise, appetite lost, bowel habit disorder and severe intestinal discomfort. The patient recovered on 8-OCT-2012. The patient had no stools for 1 week-10 days, intestinal discomfort highlighted during the feeding (since the beginning of the breastfeeding) leading to appetite lost, sleeping/resting rhythm disturbance and mood disturbance. These AE were considered as moderate (except intestinal discomfort) and serious by the reporter (with other medical important condition as criteria). According to the reporter these reactions were definitive related to vaccination. The patient received corrective treatment (indicated by the paediatrician) with COLIKIND (generic name not reported) via oral from 15-SEP-2012 to 6-OCT-2012 2 pills every 8 hours. The patient improved with the treatment and she fully recovered one month approximately after onset, on 08OCT-2012. On 12-OCT-2012 (reported by the reporter as medical history and not as adverse event) the patient presented with urinary tract infection, the outcome was not reported. The patient had received the first dose of ROTATEQ (batch number: 0112AE) via oral on 10-AUG-2012 and one day later, on 11-AUG-2012, the patient presented with bowel habit disorder and intestinal discomfort during one week. The patient recovered the bowel habit 10-15 days after onset on 23-AUG-2012. These AE were considered as mild and not serious by the reporter. According on the reporter this picture was probably related to vaccination. The patient was exclusively breastfeed. It was decided no administered the third dose of rotavirus vaccine. This case is now considered as serious by the reporter with other medically important condition as criteria. No further information reported.


VAERS ID: 479107 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-13
Onset:2012-12-02
   Days after vaccination:50
Submitted: 2012-12-24
   Days after onset:22
Entered: 2012-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / ID
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea, Enema administration, Haematochezia, Intussusception, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Infection prophylaxis; Antiviral prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1212JPN009530

Write-up: Initial information has been received from a physician concerning a 24 week old male patient (neonate) without any primary disease/ complication or previous illness, who on 13-OCT-2012 was placed on peroral vaccination with live attenuated pentavalent rotavirus vaccine (MSD) sol, 2mlx1 / day. Other concomitant medications included: ACT-HIB, PREVENAR, BIMMUGEN and Freezed-dried BCG vaccine for percutaneous use. On 02-DEC-2012, the patient vomited, and developed bloody stool. Intussusception appeared. It was diagnosed in the hospital and treated with high-pressure enema. On 04-DEC-2012, recovery of diarrhoea was confirmed; the patient was discharged from the hospital, in remission. The patient recovered from the intussusception. The comment of the reporter: It was hard to consider that it was the side reaction of live attenuated pentavalent rotavirus vaccine, for one month and a half had been passed after the vaccination of live attenuated pentavalent rotavirus vaccine. The reporting physician did not identify the relationship of intussusception and live attenuated pentavalent rotavirus vaccine. The reporting physician considered that the intussusception was serious due to hospitalization. The additional information is requested.


VAERS ID: 479270 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Female  
Location: Foreign  
Vaccinated:2012-11-06
Onset:2012-11-07
   Days after vaccination:1
Submitted: 2012-12-21
   Days after onset:44
Entered: 2012-12-26
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Alanine aminotransferase increased, Ammonia, Aspartate aminotransferase increased, Bacterial test negative, Blood electrolytes, Blood lactic acid, Blood urea, C-reactive protein, Computerised tomogram head normal, Crying, Depressed level of consciousness, Dyskinesia, Electrocardiogram normal, Electroencephalogram normal, Encephalitis, Exaggerated startle response, Full blood count normal, Head lag, Hypersomnia, Hypotonia, Irritability, Laboratory test normal, Lumbar puncture normal, Metabolic function test normal, Myoclonus, Rash, Somnolence, Ultrasound skull normal, Unresponsive to stimuli, Urine analysis normal, Viral test negative
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lumbar puncture (unknown): clear; Metabolic studies (unknown): clear; EEG (unknown): clear; CT Brain (unknown): clear; Bacterial and viral cultures (unknown): clear; AST (07Nov2012): 114 (units not specified) - slightly raised; AST (11Nov2012): 48 (units not specified); ALT (07Nov2012): 109 (units not specified) - slightly raised; CRP (07Nov2012): 7.9 (units not specified); FBC (Nov2012): Normal; U/E (unknown date); ALT (unknown date): 98 (units not specified); CRP (unknown date): 3.5 (units not specified); CRP (11Nov2012): 0.6 (units not specified); ECG (Nov2012): normal; Cranial ultrasound (unknown date): normal; Ammonia (unknown date): 49 (units not specified); Urinalysis (unknown date): normal; Serum lactate (Nov2012): 2.5 (units not specified); VEG (11Nov2012): normal
CDC Split Type: 2012321159

Write-up: This is a spontaneous report received from a consultant pediatrician via the contactable agency. Regulatory Authority report number: 2012-015520. A 10 week old, female patient received PREVENAR and INFANRIX HEXA and at an unspecified dose on 06Nov2012. Relevant medical history and concomitant medication were not reported. On 07Nov2012 the patient developed clinical encephalitis, drowsiness, jerking, hypotonia and irritability. The patient was well until 24 hours after she had her first vaccination. She had been given paracetamol post vaccination. The patient presented to the emergency department on 07Nov2012 at 6pm with a history of being irritable on handling, sleeping most of the day, not waking for feeds but feeding reasonably well on the breast when woken, not smiling or fixing/following anymore and having jerky movements. The reporter indicated that these appeared to be startle responses as this was mostly after stimulation but also occurred without this and during sleep. This was not observed by the reporter or nursing staff. The patient''s mother recorded one spell of 7 jerks in succession while asleep and the reporter described these as myoclonic jerks with single exterior jerks of the arms and generalized body jerk. The patient''s mother indicated these also occurred when the patient was awake although she was sleeping most of the time. She had no fever or other systemic symptoms. The patient was breast feeding and has been thriving well. The patient development was reported as normal with smiling, fixing and following before 6 weeks. The patient was seen in a pediatric assessment unit twice before, on 28Sep2012 presenting with crying at night for a week, straining and drawing up the legs which was thought to be mild gastro-oesophageal reflux. She had been treated with INFACOL. A urinanalysis performed was normal and she was described as bright and alert and prescribed 5mg of ranitidine (used only for one day) and sent home. The patient was seen again in the assessment unit on 17Oct2012 with a two week history of diarrhea which was considered to be a normal breastfeeding stool pattern. An examination described the patient as having normal tone and being well, and she was given some lactulose. The patient was born following a first pregnancy and emergency lower segment Caesarean section (LSCS) at 39-2 weeks gestation for failure to progress and meconium grade II (CS2). The patient''s mother was on metoprolol post delivery for 6 weeks. The patient''s birth weight was 4100g, occipitofrontal head circumference was 36.8 cm and 52.5 cm. Cord bloods for maternal rhesus negative showed normal liver function tests (LFT). A neonatal examination was unremarkable. There were no postnatal health or neurological concerns and the patient was discharged home with her mother. There is no family history of epilepsy or developmental disorders or otherwise of note and the parents are not related. The reporting physician examined the patient on 07Nov2012, when her mother reported that after a bolus of intravenous (IV) Sodium chloride (NaCl), she was a bit brighter than she had been all day. The patient was on no medication at the stage apart from CALPOL at home and the fluid bolus in the pediatric assessment unit. Vital signs were all normal and the occipitofrontal and head circumference was 39.6 cm. A systemic examination was normal but the reporter noted the patient was markedly hypotonic even when woken with head lag and hypotonia on vertical suspension. The patient''s power seemed normal. Laboratory tests including urea and electrolytes (U/E), glucose and full blood count (FBC) were normal. Liver function tests were slightly raised including aspartate aminotransferase (AST) 114 and alanine aminotransferase (ALT) 109), C-reactive protein (CRP) 7.5. On examination the reporter felt that the patient was not smiling, fixing but no following, and had significant head lag and axial hypotonia. Peripheral tone and power were normal. The patient''s anterior fontanelle was normal and there was no irritability on handling. She had a faint blanching punctuate rash over her trunk. She had single palmar crease but no other dyamorphic features. The reporter considered the patient experienced an inflammatory reaction to the vaccination and possible sepsis or metabolic disorder and penicillin and gentamycin were commenced. A urine sample was taken for organic acids. The patient was transferred to another hospital and was seen the following day by a consultant pediatrician who also noticed the low tone. No observed jerking was reported by the nursing or medical staff whilst there. The patient''s bloods were repeated the following day which showed normal FBC, U/E, ALT 98, CRP 3.5, normal electrocardiogram (ECG), normal cranial ultrasound, ammonia 49, urinalysis normal, serum lactate 2.5, cerebrospinal fluid (CSF) Nil white blood cell (WBC) or red blood cell (RBC) and clear and colorless, cerebrospinal fluid (CSF) lactate was not performed. CSF was sent for adenovirus and enterovirus studies. Stool sent for investigation. A request for an electroencephalogram (EEG) has been made. The patient was transferred back to the first hospital on 09Nov2012 and IV antibiotics were continued. She was seen on a severe occasional by another doctor, who apart from hypotonia had no acute medical concerns, although the patient''s mother remained very concerned about her continued decreased alertness, excessive sleeping, crying when handled, floppiness and jerking, which she recorded while asleep. The patient continued to breast feed well but needs to be woken. The patient''s vital signs remained normal. The patient appeared to have shown improvements on 11Nov2012 when she smiled for the first time again and woke up for a feed, but early in the morning of 12Nov2012 she was not waking for her feeds and not smiling. Later in the morning she did show fixing, following and smiling. The reporter commented on the patient''s varying but persisting neurological signs and noted that tests so far were reassuring. The reporter sated that further investigations like an EEG, possibly and magnetic resonance imaging (MRI) to rule out any demyelinating findings, or metabolic investigations might be indicated. The patient recovered from the encephalitis, somnolence, jerky movements, hypotonia, feeling jittery and irritability on an unspecified date. No follow up attempts needed. No further information expected.


VAERS ID: 479274 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2012-12-14
Onset:2012-12-14
   Days after vaccination:0
Submitted: 2012-12-21
   Days after onset:7
Entered: 2012-12-26
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK RA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK LA / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activated partial thromboplastin time shortened, Alanine aminotransferase increased, Anaphylactic reaction, Blood chloride normal, Blood creatinine normal, Blood culture negative, Blood glucose normal, Blood immunoglobulin A, Blood immunoglobulin G normal, Blood immunoglobulin M decreased, Blood lactate dehydrogenase increased, Blood potassium increased, Blood sodium normal, Blood urea normal, Blood urine present, C-reactive protein normal, Cardiothoracic ratio, Chest X-ray normal, Crying, Erythema, Fibrin D dimer, Glucose urine absent, Haemoglobin normal, Injection site erythema, Injection site swelling, Lymphocyte percentage increased, Monocyte percentage decreased, Neutrophil percentage decreased, Platelet count decreased, Procalcitonin, Protein total normal, Protein urine absent, Prothrombin level normal, Purpura, Pyrexia, Respiratory syncytial virus test negative, Skin disorder, Swelling face, Urine ketone body absent, White blood cell count normal, White blood cells urine negative
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Agranulocytosis (broad), Angioedema (narrow), Haematopoietic leukopenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 9 at both 1 minute and at 5 minutes, APGAR score
Allergies:
Diagnostic Lab Data: 14-DEC-2012, Activated partial thromboplastin time, 29.6 seconds; 14-DEC-2012, Alanine aminotransferase, 52 IU/l; 14-DEC-2012, Aspartate aminotransferase, 73 IU/l; 14-DEC-2012, Blood chloride, 105 mEq/l; 14-DEC-2012, Blood creatinine, 0.2 mg/dl; 14-DEC-2012, Blood glucose, 97 mg/dl; 14-DEC-2012, Blood immunoglobulin G, 368 mg/dl; 14-DEC-2012, Blood immunoglobulin M, 13 mg/dl; 14-DEC-2012, Blood lactate dehydrogenase, 432 IU/l; 14-DEC-2012, Blood potassium, 5.5 mEq/l; 14-DEC-2012, Blood sodium, 136 mEq/l; 14-DEC-2012, Blood urea, 7 mg/dl; 14-DEC-2012, Body temperature, 38 Centigrade; 14-DEC-2012, Body temperature, 37.1 Centigrade; 14-DEC-2012, C-reactive protein, 0.0 mg/dl; 14-DEC-2012, Fibrin D dimer, 0.6 ug/ml; 14-DEC-2012, Haemoglobin, 11.4 g/dl; 14-DEC-2012, Lymphocyte percentage, 72.0%; 14-DEC-2012, Monocyte percentage, 1.0%; 14-DEC-2012, Neutrophil percentage, 20.0%; 14-DEC-2012, Oxygen saturation, 100%, at crying; 14-DEC-2012, Platelet count, 45.2 x10 4 /mm3; 14-DEC-2012, Procalcitonin, 0.07 ng/ml; 14-DEC-2012, Protein total, 6.6 g/dl; 14-DEC-2012, Prothrombin level, 12.1 seconds; 14-DEC-2012, White blood cell count, 10100 /mm3; Pulse rate (14Dec2012): 168 bpm; Respiratory rate (RR) (14Dec2012). 56/min; Urine protein (14Dec2012): negative; Urine glucose (14Dec2012): negative; Urine ketone (14Dec2012): negative; Urine occult blood (14Dec2012): 3+; WBC in urine (14Dec2012): negative; Respiratory syncytial virus-Antigen (RSV-Ag) (14Dec2012): negative; Blood culture (14Dec2012): negative for the cultures of pharynx, nasal mucosa and urine; Chest x-ray (14Dec2012): showed no abnormality; Cardio Thoracic Ratio (CTR) (14Dec2012): 44.4%; Immunoglobulin A (IgA) (14Dec2012): less than 5 mg/dL
CDC Split Type: 2012320797

Write-up: This is a spontaneous report from a contactable pediatrician via a Pfizer sales representative. A 2-month-old male patient of PREVENAR 0.5 ml single administered subcutaneously into the left upper arm, ROTARIX single dose orally, and ACT-HIB single dose administered subcutaneously into the right upper arm, all on 14Dec2012. Medical history included 38-week-5 day gestational age, 3130 g birthweight, APGAR score 9 at both 1 minute and 5 minutes, no perinatal period abnormality, and no particular family history noted. Relevant concomitant medications were not reported. The patient experienced anaphylaxis and nonspecific purpura on14Dec2012. The clinical course was as follows: The patient presented to another hospital after 13:00 hours on 14Dec2012 and received pneumococcal 7-valent conjugate vaccine, rotavirus vaccine, and haemophilus b conjugate vaccine. Thirty minutes later, purpura appeared on the forehead. The body temperature (BT) was 38 degrees Centigrade (C). Face and the both upper arm became reddish on the whole. Suspecting anaphylaxis, the patient was referred to the reporter''s department for complete examination and treatment following the administration of DECADRON. The patient was transferred by an ambulance and admitted to the hospital. Findings on admission: BT of 37.1 degrees C, heart rate (HR) of 168 beats per minutes, respiratory rate (RR) of 56/min, SpO2 of 100% and crying. General condition: maintained, Mood: slightly bad, Skin: a few purpura of 1-2 cm in size on the forehead, redness and swelling in the both upper arms, in which the right arm was worse than the left, no induration at the injection site and the face. Head and neck: no redness of pharynx redness, no furry white tongue and no lymph nodes cervical swollen, Respiratory sound: no airway stenosis, good aeration and adventitious sound. Heart sound: no murmur, Abdomen; flat and soft, no mass, and normal bowel sound, Limb: capillary refilling time (CRT) less than 1 second, and no feeling cold. Examination on admission of 14Dec2012: activated partial thromboplastin time (APTT): 29.6 seconds, alanine aminotransferase: 52 IU/l, aspartate aminotransferase: 73 IU/l, blood chloride: 105 meg/l, blood creatinine: 0.2 mg/dl, blood glucose: 97 mg/dl, blood lactate dehydrogenase: 432 IU/l, blood potassium: 5./5 meq/l, blood sodium: 136 meq/l, blood urea: 7 mg/dl, c-reactive protein: 0.0 mg/dl, fibrin d dimer: 0.6 microg/ml, haemoglobin: 11.4 g/dl, lymphocyte percentage: 72.0%, monocyte percentage: 1.0%, neutrophil percentage: 20.0%. Platelet count: 45.2 x 10 4/mm3, procalcitonin: 0.07 ng/ml, protein total: 6.6g/dl, prothrombin level 12.1 seconds, white blood cell (WBC) count: 10100/mm3. Urine protein: negative, Urine glucose: negative, Urine ketone: negative, Urine occult blood: 3+, WBC in urine: negative, Respiratory syncytial virus-Antigen (RSV-Ag): negative, Blood culture: negative for the cultures of pharynx, nasal mucosa and urine, Cardio Throacic Ratio (CTR): 44.4%. No abnormality on chest x-ray, Immunoglobulin G (IgG): 368 mg/dl, Immunoglobulin A (IgA): less than 5 mg/dl, Immunoglobulin M (IgM): 13 mg/dl. A diagnosis of anaphylaxis was made from the clinical course and the physical findings including pyrexia which was measured by the previous doctor and cutaneous symptoms. Redness and swelling were observed in the face and both upper arms. However, there was no airway stenosis, abdominal symptoms and systemic symptoms. Since the patient had received medication with dexamethasone by the previous doctor, only CHLOR TRIMETON infusion at 0.5 mg was administered. Redness and swelling immediately disappeared. However, purpura in the forehead did not improve. Since pyrexia was observed at the previous clinic, and a possibility of infection could not be denied, various culture test was submitted. At the reporter''s hospital, no pyrexia was observed; the condition was stable; the blood test result did not show the symptoms of infection. For that reasons, the patient was under observation without antibacterial drug. No aggravation of the condition during hospitalization was noted. Purpura on the forehead tended to disappear. A causal relationship between the event anaphylaxis and pneumococcal 7-valent conjugate vaccine, ROTARIX, and ACT-HIB was unknown. The patient paid a visit to department of dermatology on 17Dec2012. The symptoms were evaluated as nonspecific purpura and had almost disappeared. The patient was under observation. The patient recovered from anaphylaxis on 17Dec2012. Since the condition was good, the patient was discharged from the hospital on 17Dec2012. The reporter classified anaphylaxis as serious due to hospitalization and assessed it as probably related to pneumococcal 7-valent conjugate vaccine. Reporter comment: Pyrexia was not due to infection. Since the patient was crying, it was unknown whether pyrexia was due to crying or anaphylaxis. It was unknown which vaccines were a cause since the vaccines were administered simultaneously. It could be considered that allergy developed after foreign material got into his mouth. Since the symptoms appeared soon after the vaccines were administered, the vaccines could have been a caused. However, a definite cause could not be identified. Hereafter, a similar symptom would not always appear every time vaccines administered. However, a careful approach was required when the same vaccines were administered as long as a causal relationship with immunisation was suspected. As a general rule, immunisation could not be recommended.


VAERS ID: 479295 (history)  
Form: Version 1.0  
Age: 0.46  
Sex: Male  
Location: Foreign  
Vaccinated:2012-11-06
Onset:2012-11-06
   Days after vaccination:0
Submitted: 2012-12-21
   Days after onset:45
Entered: 2012-12-26
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB437A / 2 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F55131 / 2 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Injection site erythema, Injection site swelling, Rash maculo-papular
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: PREVENAR 13, first dose, No adverse effect; INFANRIX HEXA, first dose, No adverse effect
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012323145

Write-up: This is a spontaneous report received from a foreign Regulatory Authority, regulatory authority reference number SK-SUKLSK-20120880. A contactable physician reported that a 5-month-old male subject was vaccinated on 06Nov2012 with 2nd dose of PREVENAR 13 (lot number F55131) at 0.5 ml single dose intramuscular in his right thigh and INFANRIX HEXA (GlaxoSmithKline, lot number A21CB437A) at 0.5 ml single dose intramuscular in the left thigh. Within 1 minute after vaccination the subject developed extensive swelling with erythema on both lower legs and maculo-papular rash on her trunk. Corrective treatment with hydrocortisone 50 mg intramuscularly and RECTODELT subcutaneously has been administered by medical assistance. The subject was hospitalized for these events for an unspecified period of time. The patient recovered from these events on an unspecified date. Vaccination with first doses of suspect products was without adverse reaction.


VAERS ID: 479297 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2012-12-04
Onset:0000-00-00
Submitted: 2012-12-26
Entered: 2012-12-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Diarrhoea, Intussusception, Ultrasound abdomen abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 12/2012, Ultrasound scan, Intussusception confirmed
CDC Split Type: WAES1212FRA009052

Write-up: Case received from a paediatrician on 12-Dec-2012. Case medically confirmed. A 3-month-old female patient had received the first dose of ROTATEQ (batch number not reported) on 04-Dec-2012 and immediately after vaccination she developed diarrhea which lasted until 09-Dec-2012. She also experienced vomiting from 09 to 11-Dec-2012. One week after vaccination, the patient was diagnosed with intussusception. The diagnosis was confirmed by ultrasound scan. Radiological reduction of intussusception was performed but as the results were not satisfactory, a new reduction either radiological or surgical was scheduled on 12-Dec-2012. According to the reporting paediatrician, as the patient was not in the age range where a peak in intussusception occurrences can be observed, i.e. around 6 months, there could be a relation between the vaccine administration and the event. The reporter also did not rule out intussusception due to virus infection since the patient suffered from diarrhea and vomiting shortly after vaccination. At the time of reporting the patient had not recovered.


VAERS ID: 479323 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-26
Entered: 2012-12-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1212GBR009750

Write-up: This invalid case (multiple unknown patients) a hearsay report was received from a consumer on 12-DEC-2012. This case is not medically confirmed. Up to 200 girls received injections of GARDASIL (batch number not reported), route and site not reported, on an unreported date. The reporter stated that the girls were killed outright and that tens of thousands of others were injured. The outcome of the injured girls was not reported.


VAERS ID: 479332 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-23
Onset:2012-11-04
   Days after vaccination:12
Submitted: 2012-12-26
   Days after onset:52
Entered: 2012-12-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. G019405 / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Ataxia, Body temperature increased, Fatigue, Gait disturbance, Immediate post-injection reaction, Irritability, Mydriasis, Nervous system disorder, Pupillary light reflex tests abnormal, Streptococcus test negative
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Glaucoma (narrow), Retinal disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 10/--/2012, Body temperature, 38.6 grade celsius; 10/30/2012, Body temperature, 41.1 grade celsius; 11/--/2012, Streptococcus test, negative
CDC Split Type: WAES1212SVN008619

Write-up: This spontaneous report as received from a regulatory authority via a physician refers to an 11 months old male infant who received his first dose of M-M-RVAXPRO (batch number G019405) (dose and route not provided) on 23-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. Immediately after vaccination irritability developed. On 30-OCT-2012 increased body temperature up to 41.1 grade celsius and tiredness ensued. On 4th and 6th November the child''s mother and grandmother noticed a couple of hours long periods of ataxia (the child was staggering to one side), which was accompanied by dilated pupils that did not respond to light. Due to this reactions the child was hospitalized from 6-NOV-2012 until 9-NOV-2012. All reported reactions abated, the infant was released home, only outcome for irritability was unknown. During hospitalization no further neurological symptoms developed and the physician stated that neurological reactions remained unexplained. There were no signs for CNS inflammation. With regard to other symptoms diagnose of viral angina tonsillaris was made (Streptotest was negative). Additional information is not expected.


VAERS ID: 479365 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-09-26
Onset:2012-10-01
   Days after vaccination:5
Submitted: 2012-12-26
   Days after onset:86
Entered: 2012-12-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Influenza like illness, Lethargy, Nausea, Pain in extremity, Pelvic pain, Vision blurred
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ibuprofen; acetaminophen; vitamin D (unspecified)
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1212GBR008966

Write-up: This case was received from the health authority on 12-Dec-2012. GB-MHRA-ADR 21942852. This case is not medically confirmed as it was reported by a consumer. A female patient (age not reported, weight 53.06 kg) received an injection of GARDASIL (batch no, dose, route and site of administration not reported) on 26-Sep-2012. Four days later, on 30-Sep-2012, the patient was lethargic and 5 days later, on 01-Oct-2012, she experienced flu-like symptoms. Then, on unreported dates in Oct-2012, she had eyesight a little blurry, was feeling faint and lightheaded, had headache, pelvic joint pain, pain spreading down legs and was extremely tired. Concomitant medications included ibuprofen, paracetamol and vitamin D. The patient received the vaccination at school on the Wednesday and then was in bed with flu symptoms following Monday and Tuesday. She continued to feel tired, nauseous and had headache. She had nausea and tiredness now daily. Pelvic pains started along with periods but did not got away with a dull pain on top of pelvic bone. Sometimes when she was reading her eyesight was a little blurry with headache behind the eyes. She was extremely tired, pelvic pain was now preventing sleep and the pain was spreading down legs occasionally. Corrective treatment included domperidone which was only taken for a week as it did not ease nausea. At the time of reporting the patient had not recovered. The agency considered this case to be serious as an other medically important condition.


VAERS ID: 479337 (history)  
Form: Version 1.0  
Age: 0.51  
Sex: Male  
Location: Foreign  
Vaccinated:2007-06-04
Onset:0000-00-00
Submitted: 2012-12-20
Entered: 2012-12-27
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Ear infection, Infection susceptibility increased, Lactose intolerance, Lung infection, Mental retardation, Otitis media, Pneumococcal infection, Pneumonia, X-ray abnormal
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: x-ray (date unknown): diagnosis confirmed; laboratory examination (date unknown): diagnosis confirmed
CDC Split Type: 2012317719

Write-up: This is a spontaneous report from a non-contactable physician. This is a report received from a foreign Health Authority. Regulatory Authority report number DE-PEI-PEI2012063773. A 6-month-old male patient of an unspecified ethnicity received the first dose of PREVENAR 13, unknown on 04Jun2007 and the second dose on 20Jul2007 at single dose. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously received INFANRIX+HIB for immunization on 07Mar2007 and 04Apr2007 and had been tolerated. The patient also received INFANRIX+HIB on 07May2007 for immunization and experienced infection susceptibility increased and was ongoing. On an unknown date in Jun2007, the patient experienced otitis media and pneumonia recurrent (3 times) and pneumococcal infection recurrent in ears and lungs. The patient''s condition was reported as life-threatening and medically significant for unspecified reason and the causality was reported as "chronologically causal". The diagnosis was confirmed by x-ray and laboratory examination on an unknown date and ambulatory treatment was necessary. The patient recovered with sequelae from the events, otitis media and pneumonia recurrent (3 times) and pneumococcal infection recurrent in ears and lungs, on an unknown date. It was also reported that at 2 years of age, the patient was diagnosed with mental retardation and had developed lactose intolerance at an unknown date. The clinical outcome of the events, mental retardation and lactose intolerance, was unknown. No follow-up attempts needed. No further information expected.


VAERS ID: 479340 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2011-11-23
Onset:2012-07-13
   Days after vaccination:233
Submitted: 2012-12-20
   Days after onset:160
Entered: 2012-12-27
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB119A / 3 UN / UN
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS A69CC893A / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F40144 / 3 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0300AA / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Type 1 diabetes mellitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012319423

Write-up: This is a spontaneous report received from the Health Authority. Regulatory Authority report number DE-PEI-PEI2012062886. A 12-month-old male patient (weight 11.5 kg, height 85.0 cm) was vaccinated with the 3rd dose of INFANRIX HEXA (batch no.: A21CB119A) on 23Nov2011; and third dose of PREVENAR 13 (batch no.: F40144) on 23Nov2011; and third dose of ROTATEQ (batch no.: 0300AA) on 23Nov2011; and first dose of PRIORIX (batch no.: A69CC893A), on 16Jun2012. Past vaccinations included two doses of PREVENAR 13, INFANRIX HEXA and ROTARIX on 07Sep2011 and 11Oct2011 which had been well tolerated. Concomitant medication and relevant medical history were not reported. On 13July2012 after vaccination the patient developed Type I diabetes mellitus, lasting for unknown. The patient showed disabling/incapacitating and was hospitalized and the condition was life threatening. The patient had not recovered (sequel) at the date of reporting. Causality assessment was provided as related to all suspect vaccines. Follow-up information was not available. Follow-up information has been requested/ no further information awaited. No follow-up attempts needed, follow-up automatically provided by agency. This case is being treated according to the Agency IfSG (Protection against Infection Act).


VAERS ID: 479353 (history)  
Form: Version 1.0  
Age: 0.28  
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-11-06
Onset:2012-11-06
   Days after vaccination:0
Submitted: 2012-12-20
   Days after onset:44
Entered: 2012-12-27
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20910001B / UNK RA / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR G9975 / UNK RL / SC
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR G7173 / UNK LA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: not reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201211923

Write-up: Case received from the Health Authorities on 11 December 2012 under the reference number PL-URPL-N1347/2012. A 03-month-old patient (gender not specified), with no reported medical history, had received a subcutaneous dose of IMOVAX POLIO, batch number G7173-1, in the left arm, concomitantly with a subcutaneous dose of ACTHIB, batch number G9975-1, in the right thigh, and a subcutaneous dose of "PIX360326" (interpreted as DTP vaccine) (other manufacturer, batch number 20910001B) in the right arm, on 06 November 2012. On 06 November 2012, 1 hour post-vaccination, the patient experienced persistent crying from 03pm to 08pm with high fever up to 40 degrees C. On 07 November 2012, the patient had slight fever / subfebrile body temperature - without relevant deviations on the physical examination. The Health Authorities coded "persistent crying", "fever" and "slight fever". The patient recovered. This case was assessed as serious, i.e. as a medically important condition. Sender''s comment: "Fever is known and expected reaction, which could appear after administration of all vaccines. Crying - expected reaction after DTP and ACTHIB. Unexpected after IMOVAX POLIO." Documents held by sender: none.


VAERS ID: 479354 (history)  
Form: Version 1.0  
Age: 0.28  
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-11-22
Onset:2012-11-22
   Days after vaccination:0
Submitted: 2012-12-20
   Days after onset:28
Entered: 2012-12-27
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20911002B / UNK UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR H8097 / UNK UN / UN
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR G7173 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cyanosis, Decreased eye contact, Hypotonia, Hypotonic-hyporesponsive episode, Lividity, Loss of consciousness, Musculoskeletal stiffness, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201211917

Write-up: Case received from the Health Authorities on 11 December 2012 under the reference number PLURPLN139/2012. A 03-month-old patient (gender not reported), with no reported medical history and concomitant therapies, had received a dose of IMOVAX POLIO (batch number G7173-1, route and site of administration not reported), a dose of ACTHIB (batch number H8097-1, route and site of administration not reported) and a dose of "PIX360326" [interpreted as DTP vaccine] (other manufacturer, batch number 20911002B, route and site of administration not reported) on 22 November 2012. On 22 November 2012 post-vaccination, the patient experienced hypotonic-hyporesponsive episode with loss of consciousness, apnea and limbs cyanosis. Near 09:20 pm, the patient had livid whole boy, stiffness then flaccidity, without contact. The patient was hospitalized. At hospital saturation was 99%, pulse rate 146/min, blood pressure 146/7. The patient was in full contact, pale and with lips cyanosis. The patient was admitted in general good health status. The patient was recovering at the time of reporting. Reporter''s comment: the patient was still treated at hospital. Health Authorities comments: Hypotonic-hyporesponsive episode was expected reaction after DTP vaccine (unexpected after ACTHIB and IMOVAX POLIO), could appeared after a lot of vaccine. The HA coded hypotonic-hyporesponsive episode, apnea, loss of consciousness, cyanosis peripheral, cyanosis of lip and pallor.


VAERS ID: 479356 (history)  
Form: Version 1.0  
Age: 0.24  
Sex: Male  
Location: Foreign  
Vaccinated:2012-11-08
Onset:2012-11-08
   Days after vaccination:0
Submitted: 2012-12-20
   Days after onset:42
Entered: 2012-12-27
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20911002B / UNK RA / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR H8093 / UNK LL / UN
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR G7173 / UNK RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Febrile convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Personal and family medical history: not reported.
Allergies:
Diagnostic Lab Data: On 08 November 2012, body temperature was at 38.0-38.4 degree Celsius.
CDC Split Type: 201211836

Write-up: Case received from the Health Authorities through the local affiliate on 11 December 2012 under the reference number PL-URPL-N1346/2012. A 2-month-old male patient, with no reported medical history, had received an intramuscular injection of ACT-HIB (batch number H8093-1) in the left thigh concomitantly with an intramuscular injection of IMOVAX POLIO (batch number G7173-1) in the right thigh and a subcutaneous injection of ''PIX360326" interpreted as "DTP vaccine" (other manufacturer, batch number 20911002B) in the right arm on 08 November 2012. On 08 November 2012, 3.5 hours following the vaccination, the patient experienced fever at 38.0-38.4 degree Celsius and febrile convulsion. At the tim eof reporting, the outcome was unknown. Sender''s comment: "Fever is known and expected reaction, which could appeared after administration of all vaccines. Convulsions are expected reaction for ACT-HIB, IMOVAX POLIO and unexpected for DTP." This case was considered as serious: "other medically important condition". The HA coded "fever" and "fever convulsion".


VAERS ID: 479367 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2012-11-21
Onset:2012-11-24
   Days after vaccination:3
Submitted: 2012-12-27
   Days after onset:33
Entered: 2012-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Haematochezia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1212GRC009446

Write-up: Case received from the Health Authorities in a foreign country on 14-Dec-2012 under the reference number GR-EOF-20121138. Contractual partner reference number SPV12058. The primary reporter was a physician. Case medically confirmed. A 4-month-old male patient had received the second dose of ROTATEQ (batch number unknown) orally on 21-Nov-2012 and on 24-Nov-2012 he developed haematochezia: his stools contained vivid red-coloured blood. The condition improved temporarily and between 28-Nov-2012 and 02-Dec-2012 no blood was seen in stools. On 02-Dec-2012. haematochezia reoccurred. The patient was hospitalised on 06-Dec-2012 for further monitoring. On 08-Dec-2012 the patient recovered completely and was discharged. No information was provided regarding the first dose of ROTATEQ. No other relevant medical history or concomitant medications were reported.


VAERS ID: 479426 (history)  
Form: Version 1.0  
Age: 0.61  
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-10-22
Onset:2012-10-22
   Days after vaccination:0
Submitted: 2012-12-21
   Days after onset:60
Entered: 2012-12-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20911001A / UNK UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR G9974 / UNK RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR G7173 / UNK LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201211926

Write-up: Case received from the Health Authorities on 12 December 2012 under the reference number PLURPLN13992012. A 06-month-old patient (gender not reported0, with no reported medical history and concomitant therapy, had received an intramuscular dose of ACTHIB (batch number G9974-1) in the right thigh, an intramuscular dose of IMOVAX POLIO (batch number G7173-1) in the left thigh and a subcutaneous dose of PIX360326 (DTP vaccine, other manufacturer, batch number 20911001A, site of administration not reported) on 22 October 2012. On 22 October 2012, 5 hours post-vaccination, the patient developed fever at 38.5-38.9 degrees C. The patient was hospitalized for 4 days. The patient recovered within 24 hours. Reporter''s comment: Hospitalization for 4 days. HA''s comment: Fever reaction was known and expected for above vaccines. According to the Health Authorities, the relationship between fever and the vaccines is considered as reasonable possibility. HA coded fever.


VAERS ID: 479430 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2012-12-09
Onset:2012-12-09
   Days after vaccination:0
Submitted: 2012-12-23
   Days after onset:14
Entered: 2012-12-27
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Hypotonic-hyporesponsive episode, Pallor
SMQs:, Hypotonic-hyporesponsive episode (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012319455

Write-up: This is a spontaneous report received from the Health Authority. Regulatory Authority report number DE-PEI-PEI2012064097. A 3-month-old male patient was vaccinated on 09Nov2012 at 2-months with first dose of INFANRIX HEXA (batch n.: Q21CB237B) at 0.5 ml single dose intramuscular (left thigh) and first dose of PREVENAR 13 (batch no.: F64022) at 0.5 ml single dose intramuscular (right thigh). Concomitant medication was not reported. On 09Dec2012 the patient developed Hypotonic-hyporesponsive episode and pallor, lasting for 30 minutes. The patient was not hospitalized but the events were assessed as significant. Unspecified outpatient treatment was necessary. The patient had recovered at the date of reporting. No follow-up attempts needed, no further information expected.


VAERS ID: 479432 (history)  
Form: Version 1.0  
Age: 0.38  
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-11-28
Onset:0000-00-00
Submitted: 2012-12-21
Entered: 2012-12-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20911001D / UNK RA / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR G9975 / UNK LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR G7173 / UNK RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data:
CDC Split Type: 201212072

Write-up: Case received from the Health Authorities on 14 December 2012 under the reference number PLURPLN1464/2012. A 04-month-old patient (gender not reported), with no reported medical history and concomitant therapy, had received an intramuscular dose of IMOVAX POLIO (batch number G7173) in the right thigh, an intramuscular dose of ACTHIB (batch number G9975) in the left thigh and an intramuscular dose of DTP vaccine (other manufacturer, batch number 20911001D) in the right arm on 28 November 2012. On 29 November 2012, i.e. 14.5 hours post-vaccination, the patient developed fever at 39.7 degrees C. The patient was hospitalized (dates not reported). The patient was recovering within 24 hours. HA''s comment: fever was expected reaction after vaccination. The HA coded fever. According to the HA, the relationship between vaccines and fever was considered as reasonable possibility.


VAERS ID: 479436 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-24
Entered: 2012-12-27
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bronchitis, Condition aggravated, Developmental delay, General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: First dose, PREVENAR-13, Bronchitis; First dose, INFANRIX HEXA, Bronchitis; First dose, Rotavirus vaccine, Bronchitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012326084

Write-up: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A patient of unspecified age, and gender received the second dose of PREVENAR 13 0.5 ml, single dose on an unspecified date, and the second dose of INFANRIX HEXA on an unspecified date. The patient medical history included bronchitis after the first vaccination with PREVENAR 13, INFANRIX HEXA and ROTARIX on an unknown date. Relevant concomitant medications were unknown. The patient developed bronchitis after the second vaccination, which became manifest in bronchiolitis on an unknown date. The patient was also in a very bad general condition and the development was not good development status of 3-months-old child). At time of this report, clinical outcome of the events was unknown and no causality was provided.


VAERS ID: 479445 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2010-03-11
Onset:2010-03-11
   Days after vaccination:0
Submitted: 2012-12-21
   Days after onset:1016
Entered: 2012-12-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR DO945 / UNK UN / UN
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UF887AH / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 27090507 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Febrile convulsion, Local reaction, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No personal medical history
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201212309

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 17/03/2010). A 06-month-old male patient, with no medical history and no reported concomitant therapies, had received a dose of H1N1 vaccine (manufacturer Sanofi Pasteur, batch number UF887AH with an expiration date of November 2010, route and anatomical site of administration not reported) concomitantly with a dose of acellular Pentavalent vaccine (manufacturer: Sanofi Pasteur, batch number "DO945" with an expiration date of March 2011, route and anatomical site of administration not reported) and a dose of hepatitis B vaccine (other manufacturer, batch number 27090507 with an expiration date of November 2010, route and anatomical site of administration not reported) on 11 March 2010. The AE start date was reported as 11 March 2010. The patient was initially diagnosed with febrile convulsions and local reaction. The final diagnosis was febrile convulsions. The following additional AEs were reported: convulsion crisis, fever, crying and local reaction. The patient''s outcome was not reported. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. Clinical classification was reported as: "moderate". The causality as concluded by the Ministry of Health was "coincidental". Documents held by sender: None.


VAERS ID: 479455 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2011-07-21
Onset:2012-07-16
   Days after vaccination:361
Submitted: 2012-12-25
   Days after onset:162
Entered: 2012-12-27
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Cardiac failure acute, Congestive cardiomyopathy, Intensive care, Lipids increased, Mitochondrial cytopathy, Mitral valve incompetence, Pneumococcal sepsis, Streptococcus test positive
SMQs:, Cardiac failure (narrow), Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Cardiomyopathy (narrow), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Blood culture (UnkJul2012): returned positive to Streptococcus pneumonia serotype 19A.
CDC Split Type: 2012324170

Write-up: This is a spontaneous report received from the Agency, regulatory authority report number MA20122261. A 13-month-old female patient received intramuscular PREVENAR 13 0.5 ml, single dose on 21Jul2011 and 26Sep2011. Lot number of the first dose was not reported on the health record booklet (a wrong sticker was slicked in place of). Lot number of second dose was F24194 (or F24199 because it was reported that batch number was not easily legible). Relevant medical history and concomitant medications were unknown. The patient developed severe sepsis due to Pneumococcal on 16Jul2012. She was hospitalized on 19Jul2012 for acute heart failure related to dilated cardiomyopathy. Blood culture returned positive to Streptococcus pneumonia serotype 19A. The patient was discharged on 27Sep2012, with left ventricle ejection fraction stabilized at 30%, without any coronary, aortic valve or aortic arch anomaly but with mild mitral incompetence and right ventricular pressure estimated at 30 mmHg. Heart failure resolved, and there was no rhythm disorder or thrombus. Mitochondrial dysfunction on increased lipid concentration in the muscle fibers was considered, according to the investigation results. Outcome was marked by re-hospitalization due to cardiomyography aggravation. The infant was still in the intensive care unit on 20Nov2012. Pneumococcal sepsis resolved without sequelae while acute heart failure had not yet resolved on 20Nov2012. Based on the Official Method of Causality Assessment, the suspected medicinal product was treated by the agency as possible. No follow-up attempts needed. No further information expected.


VAERS ID: 479464 (history)  
Form: Version 1.0  
Age: 0.22  
Sex: Female  
Location: Foreign  
Vaccinated:2012-08-24
Onset:2012-08-29
   Days after vaccination:5
Submitted: 2012-12-25
   Days after onset:118
Entered: 2012-12-27
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB233A / UNK UN / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH F98604 / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA482C / 1 MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Gastroenteritis, Intestinal operation, Intussusception
SMQs:, Gastrointestinal obstruction (narrow), Noninfectious diarrhoea (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012324262

Write-up: This is a spontaneous report received from the foreign Health Authority. Regulatory authority report number DE-PEI-PEI2012064982. A 12-week-old female infant, born on 06Jun2012, was vaccinated with the PREVENAR (batch no.: F98604), intramuscular, first dose of ROTARIX (batch no.: AROLA482C), and INFANRIX HEXA (batch no.: A21CB233A), intramuscular on 24Aug2012. Relevant concomitant medication was not provided. On 29Aug2012, the patient was hospitalised in pediatric clinic due to suspected gastroenteritis. On 01Sep2012, the patient was diagnosed with ileocolic intussusception which was treated with surgical reduction and remedied in the pediatric surgery. The patient had recovered as of 20Dec2012. Causality assessment was not provided. No follow-up attempts needed. No further information expected.


VAERS ID: 479468 (history)  
Form: Version 1.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2012-11-19
Onset:2012-11-19
   Days after vaccination:0
Submitted: 2012-12-25
   Days after onset:36
Entered: 2012-12-27
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB497A / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G34141 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Amenorrhoea, Blood culture negative, Blood glucose decreased, Blood lactate dehydrogenase decreased, Brain scan normal, C-reactive protein increased, Caesarean section, Culture negative, Culture stool positive, Culture urine positive, Echocardiogram normal, Enterobacter test positive, Enterovirus test negative, Exposure during pregnancy, Haemoglobin increased, Herpes simplex serology negative, Hyperammonaemia, Lumbar puncture normal, Mean cell volume normal, Neutrophil count increased, Rotavirus test positive, Ultrasound abdomen normal, Viral test negative, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Fertility disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FUMAFER; UVESTEROL; Vitamine K1
Current Illness:
Preexisting Conditions: Premature birth, at 34 weeks and 5 days of amenorrhea; Hospitalized in neonatal unit from 17Sep2012 to 13Nov2012; Hyaline membrane disease, hospitalized in neonatal unit from 17Sep2012 to 13Nov2012; Pneumothorax; Necrotizing enterocolitis neonatal, stage 1B Day 42, with rectorrhagia. Antibiotic for 5 days. Work up negative
Allergies:
Diagnostic Lab Data: 20-NOV-2012, Blood glucose, 8.46 mmol/l; 20-NOV-2012, Blood lactate dehydrogenase, 3.07 mmol/l; 20-NOV-2012, C-reactive protein, 9.6 mg/l; 20-NOV-2012, Haemoglobin, 105 g/l; 20-NOV-2012, Neutrophil count, 9x10 9/l; 20-NOV-2012, White blood cell count, 16.8x10 9/l; Echocardiography (10Oct2012): was normal except for a light increase in the two distal branches; mean corpuscular volume (20Nov2012): 89 fl; Abdominal ultrasound (20Nov2012): unrevealing; ammonemia (20Nov2012): 60 umol/l; brain CT-scan (20Nov2012): normal, ruled out cerebral gas embolism; lumbar puncture (20Nov2012): sterile; Urine culture test (20Nov2012): positive to Enterobacter cloacae; blood cultures and nasopharyngeal samples tests (20Nov20120: were negative; blood cultures and viral tests results (21Nov2012): negative (herpes simplex virus, enterovirus and parechovirus); stools test (23Nov2012): rotavirus was detected in stools
CDC Split Type: 2012324148

Write-up: This is a spontaneous initial report received from the regulatory authority, regulatory authority report number LYL20121516. A 2 month old male patient received the following suspected vaccines as primary vaccination on 19Nov2010: PREVENAR 13, batch number G34141, by intramuscular route and INFANRIX HEXA, batch number A21CB497A, by intramuscular route. Maternal history: 33 year old, dichorial-diamniotic twin pregnancy following in vitro fertilization. Threat of preterm delivery at 26 weeks of amenorrhea. On 17Sep2012, emergency cesarean delivery at 34 weeks of amenorrhea and 5 days. Premature neonate characteristics: APGAR score 8/9/10/10, weight 2.400 kg, height 44.5 cm, head circumference 33 cm. Neonate medical history included hyaline membrane disease requiring hospitalization in neonatology department from 17Sep2012 to 13Nov2012, pneumothorax, stage 1B neonatal necrotizing enterocolitis (42 days after birth) diagnosed on 29Oct2012 after rectorrhagia; early care consisted in fasting for 5 days then progressive exclusive breastfeeding resumption and antibiotics for 5 days. Infectious work-up (bacteria and virus stool screening) was negative. Normal growth. Exclusive breastfeeding. Concomitant medication included oral supplementation from an unspecified date in Sep2012 (indications not specified) with: FUMAFER (33mg/1 g, oral powder); UVESTEROL VITAMINE A.D.E.C oral solution, 1 ml daily; VITAMINE K1 ROCHE, 2mg/0.2 ml, INFANTS, oral and injectable solution, 2 mg weekly. Clinical course was as followed: On 19Nov2012, at 2 months and 20 days (corrected age), the neonate was vaccinated with first doses of PREVENAR 13 and INFANRIX HEXA. On the same day (19Nov2012)k, the neonate was very agitated and presented inconsolable crying for 6 hours following vaccination. On the next day (20Nov2012), the patient was hospitalized for rectorrhagia without vomiting or fever. It was noted that the patient''s twin had 38C fever. On admission, weight 3.9 kg, pulse: 161/min, oxygen saturation 100 % in ambient air and body temperature 36.4C. Cardio-pulmonary examination was normal. There was no sign of respiratory distress. Abdomen was soft and painless, there was no skin lesions. Laboratory tests: hemoglobin 105 g/l, mean corpuscular volume (MCV) 89 fl, white blood cells (WBCs) 16.8 Giga/L, neutrophils 9 Giga/L, normal platelets count, normal coagulation profile, C-reactive protein (CRP) 9.6 mg/l. Abdominal ultrasound was unrevealing. The neonate management consisted in fasting and drip-feeding. At 04:30 pm, the neonate had persistent crying and experienced serious malaise with cardio-respiratory arrest during peripheral venous catheter rinsing. Cardiac massage and mask ventilation allowed efficient heart rate resuming within 2 minutes. The course was marked by left hemibody convulsive seizure (mouth deviation, looking left and raising the left arm) which resolved within 5 minutes after intravenous administration of midazolam (trade name unspecified) and clonazepam (trade name unspecified). At 05:00 pm, laboratory work-up results showed hyperglycemia 8.46 mmol/l, venous hyperlactatemia 3.07 mmol/l and mild hyperammonemia 60 umol/l. Outcome: progressive recovering and transfer to the intensive care unit. On 21Nov2012, hemoglobin was 85 g/l. Differential diagnosis: By 20Nov2012, cardio-respiratory arrest investigation was still ongoing: normal brain CT-scan, normal and sterile lumbar puncture. Urine culture test was positive to Enterobacter cloacae. On 21Nov2012, blood cultures and viral tests results were negative (herpes simplex virus, enterovirus and parechovirus). At this time, no clinically identified infectious focus was found. On 23Nov2012, rotavirus was detected in stools. Update on 07Dec2012: Echocardiography (10Oct2012) was normal except for a light increase in the two distal branches; to be monitored within 12 months in case of persisting murmur. On 20Nov2012, details regarding the cardio-respiratory arrest circumstances: the neonate was infused for fluid replacement (epicranial route of administration). Clinical evaluation result was suggestive of significant laryngospasm occurring through an unusual scream while the neonate was on his back in his bed. The loud scream and followed by suffocation feeling with severe cyanosis and bradycardia observed on auscultation. Cardio-respiratory arrest was diagnosed. Resuscitation rapidly occurred with ventilation and cardiac massage (no flow <1 min, low flow <2 min). Blood flow immediately resumed. Further investigations: hypothesis of cerebral gas embolism was ruled out based on negative brain CT and healthcare team consultation who reported that the pump was safe and air could not pass through; the purge was carried out against gravity after catheter removal. Renal ultrasound culture was positive to Enterobacter cloacae with CRP 17 mg/l, WBC 15 Giga/L, neutrophils 8 Giga/L, treated with cefotaxime (trade name unspecified), metronidazole (trade name unspecified) and AMIKLIN, all switched to BACTRIM (8 days in total between 20Nov2012 and 27Nov2012) in view of negative test results. Cardio-respiratory records from 24Nov2012 to 26Nov2012 revealed desaturation episodes during feeding bottles, no clear vagal hypertonia, mixed sleep apnoea episodes, which, when compared to the clinical examination where no obstruction and normal cardiorespiratory auscultation was found. Gastroesophageal reflux was suspected. From a neurological point of view, there was a total recovery with a normal electroencephalogram at 48 hours. From a digestive point of view, no rectorrhagia recurrence, probable episode of gastroenteritis (stool culture was positive to rotavirus) requiring hospitalization on 20Nov2012. On 30Nov2012, pH results confirmed the diagnosis of gastroesophageal reflux with acidity episodes lasting more than 20 minutes overnight at rest. Physician''s conclusion: multifactorial cardio-respiratory arrest induced by the association between the stress of the emergency room, the vaccines, the persistent crying, the gastroesophageal reflux and the fasting for more than 12 hours when syncope occurred which could have aggravated the acidity. Convulsive seizure which followed the syncope was probably of hypoxic origin, as there was no evidence that the entire depicted feature fitted a convulsive seizure (no initial tachycardia was observed). The neonate recovered without sequelae. Based on the Official Method of Causality Assessment, both the suspected medicinal products were rated as doubtful. No FU attempts needed or possible. No further information expected.


VAERS ID: 479473 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2010-02-17
Onset:2010-02-17
   Days after vaccination:0
Submitted: 2012-12-21
   Days after onset:1038
Entered: 2012-12-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR US887AS / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Decreased appetite, Malaise, Pyrexia, Rhinorrhoea
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had no personal medical history.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201212354

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 2/25/2010). A six month-old male patient, whose medical history and concomitant therapies were not reported, had received a dose of Monovalent flu H1N1 vaccine, batch number US887AS (not a valid Sanofi Pasteur batch number) with an expiration date of 01 June 2011, (route and anatomical site of administration not reported) on 17 February 2010. The AE start date was reported as 17 February 2010. The patient was initially diagnosed with fever and irritability. The final diagnosis was fever. The following additional AEs were reported: hyporexia, crying, general malaise and rhinorrhea. 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 causal (related to the vaccine). Documents held by sender: None.


VAERS ID: 479479 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-11-15
Onset:2012-11-18
   Days after vaccination:3
Submitted: 2012-12-21
   Days after onset:33
Entered: 2012-12-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20910001A / UNK LL / SC
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER UFA11006 / UNK RL / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR 49975 / UNK RL / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying
SMQs:, Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No medical history reported.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201212176

Write-up: Case received from the health Authorities through the local affiliate on 17 December 2012 under the reference number PL-URPL-N1472/2012. A 06-week-old patient (gender not reported), with no reported medical history, had received a subcutaneous injection of ACT-HIB (batch number "49975-1") in the right thigh, concomitantly with a subcutaneous injection of EUVAX B (batch number UFA 11006) in the right thigh and a subcutaneous injection of DTP (other manufacturer, batch number 20910001A) in the left thigh on 15 November 2012. Three days after vaccination, i.e. on 18 November 2012, the patient experienced uncontrollable crying: the mother could not calm the patient. The patient was hospitalized for 2 days. The patient recovered at an unspecified date. The Health Authorities coded: persistent crying. Sender''s comment: "crying (inconsolable, atypical, persistent, without obvious reason) is expected reaction for above vaccines". Documents held by sender: none.


VAERS ID: 479488 (history)  
Form: Version 1.0  
Age: 0.8  
Sex: Female  
Location: Foreign  
Vaccinated:2010-03-03
Onset:2010-04-06
   Days after vaccination:34
Submitted: 2012-12-21
   Days after onset:990
Entered: 2012-12-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) / SANOFI PASTEUR UF866AA / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Asthmatic crisis, Cough, Crying, Dyspnoea, Local reaction, Malaise, Pneumonia, Pyrexia
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No personal medical history. Family medical history: not reported.
Allergies:
Diagnostic Lab Data: not reported
CDC Split Type: 201212318

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 12/04/2010). A 9-month-old female patient, with no medical history and no reported concomitant therapies, had received a dose of H1N1 (manufacturer Sanofi Pasteur, batch number UF866AA with an expiration date of 01 June 2011, route and anatomical site of administration not reported) on 03 March 2010. The AE start date was reported as 06 April 2010. The patient was initially diagnosed with asthmatic crisis versus pneumonia. The final diagnosis was not reported. The following additional AEs were reported: dyspnoea, fever, general malaise, crying, local reaction and cough. The patient''s outcome was not reported. The case was assessed as serious by the Ministry of Health. The patient was hospitalized. The clinical classification was reported as moderate. The causality as concluded by the Ministry of Health was coincidental. Documents held by sender: None.


VAERS ID: 479491 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Female  
Location: Foreign  
Vaccinated:2009-12-18
Onset:2009-12-21
   Days after vaccination:3
Submitted: 2012-12-21
   Days after onset:1096
Entered: 2012-12-27
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR - / UNK UN / UN
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bronchitis, Bronchospasm, Cough, Decreased appetite, Dyspnoea, Pyrexia, Rhinorrhoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No personal medical history
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201212293

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 05/03/2010). A 07-month-old female patient, with no personal medical history, had received her dose of Seasonal Influenza Vaccine (manufactured by Sanofi Pasteur, batch number, route and anatomical site of administration not reported, with an expiration date not reported), concomitantly with her dose of PENTAXIM (manufactured by Sanofi Pasteur, batch number, route and anatomical site of administration not reported, with an expiration date not reported), on 18 December 2009. The AE start date was reported as 21 December 2009. The patient was initially diagnosed with "bronchilitis". The final diagnosis was "bronchilitis". The following additional AEs were reported: bronchospasm, dyspnea, fever, hyporexia, rhinorrhea and cough. The clinical classification of the case was "moderate". The patient''s outcome was not reported. The case was assessed as serious by the Ministry of Health. The patient was hospitalized on unspecified dates. The causality as concluded by the Ministry of Health was coincidental (not related to the vaccine). Documents held by sender: None.


VAERS ID: 479563 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-27
Entered: 2012-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Depression, Psychotic disorder
SMQs:, Systemic lupus erythematosus (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1212DEU008903

Write-up: Case was received from a healthcare professional on 14-Dec-2012. Case is medically confirmed. An adolescent female patient received a dose of GARDASIL (lot-no., injection route and site not reported) on an unspecified date. Unspecified time later she developed depression and psychosis. The patient was hospitalised. According to the reporter, the reaction was definitely not related to vaccination. She got knowledge of the case in the scope of a physician''s quality circle meeting.


VAERS ID: 479564 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Female  
Location: Foreign  
Vaccinated:2012-11-13
Onset:2012-11-21
   Days after vaccination:8
Submitted: 2012-12-27
   Days after onset:36
Entered: 2012-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. H005256 / UNK UN / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. H012465 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: C-reactive protein, Daydreaming, Electroencephalogram normal, Febrile convulsion, Gaze palsy, General physical health deterioration, Neurological examination normal, Respiration abnormal, Tremor, Tympanic membrane hyperaemia
SMQs:, Neuroleptic malignant syndrome (broad), Convulsions (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 11/2012, Body temperature, 39.6 Celsius; 11/21/2012, C-reactive protein, 6.49; 11/22/2012, Electroencephalogram, Without findings; 11/21/2012, Neurological examination, Without findings
CDC Split Type: WAES1212DEU001609

Write-up: Case was received from a paediatrician on 30-Nov-2012. Case is medically confirmed. An 11-month-old female patient received a dose of MMRVAXPRO (lot-no. H005256) IM and contralaterally a dose of VARIVAX (lot-no. H012465) IM on 13-Nov-2012. Eight days later, on 21-Nov-2012, she developed a febrile seizure leading to hospitalisation the same day. Further course and outcome were not reported. According to the reporter, the reaction was probably related to vaccination. Follow up information received on 18-Dec-2012: The patient was hospitalized from 21-Nov-2012 to 23-Nov-2012. On 21-Nov-2012 at about 6.30 p.m., the patient''s mother noted that the patient was breathing heavily, he was "like absent-minded" with eyes looking upward and trembling of hands. These events lasted for about 5 minutes. He recovered. Body temperature at home was 39.6 degrees C. On admission, the patient was in a reduced general health condition. Both ear drums were reddened. Neurological examination was without findings. Laboratory values on admission included C-reactive protein 6.5 (unit and normal range not reported). EEG on 22-Nov-2012 was normal. The patient was treated with unspecified infusion therapy and paracetamol leading to rapid reduction of fever. The patient was discharged from hospital afebrile and in good condition on 23-Nov-2012.


VAERS ID: 479579 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2012-12-18
Onset:2012-12-18
   Days after vaccination:0
Submitted: 2012-12-27
   Days after onset:9
Entered: 2012-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA431AA / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Aspiration, Cough, Dyspnoea, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0854649A

Write-up: This case was reported by a physician and described the occurrence of dyspnea in a 11-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 18 December 2012, the subject received unspecified dose of ROTARIX (1.5 ml, oral). On 18 December 2012, during vaccination with ROTARIX, the subject experienced cough, aspiration, dyspnea respiratory arrest. The subject was forced to regurgitate the drug and then oxygen inhalation was performed. His respiration immediately recovered and his condition became favorable. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting, the events were resolved but the outcome of the cough was unspecified. The physician considered the events were related to vaccination with ROTARIX.


VAERS ID: 479580 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-10-25
Onset:2012-10-28
   Days after vaccination:3
Submitted: 2012-12-27
   Days after onset:60
Entered: 2012-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS YFLUA734AA / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Ear pain, Headache, Neuritis
SMQs:, Peripheral neuropathy (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0854786A

Write-up: This case was reported by a healthcare professional/physician via a sales representative and described the occurrence of facial neuritis in a female subject aged between 30 and 39 years old who was vaccinated with FLUARIX (GlaxoSmithKline). On 25 October 2012, the subject received unspecified dose of FLUARIX (unknown route and injection site). On 28 October 2012, 3 days after vaccination with FLUARIX, the subject experienced ear pain (pain behind ear) and headache. On 30 October 2012, facial neuritis was diagnosed. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.


VAERS ID: 479581 (history)  
Form: Version 1.0  
Age: 0.26  
Sex: Female  
Location: Foreign  
Vaccinated:2008-07-17
Onset:2010-03-01
   Days after vaccination:592
Submitted: 2012-12-27
   Days after onset:1032
Entered: 2012-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA465D / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Allergy test positive, Hypersensitivity, Pruritus, Skin mass
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Allergy test, positive to alum
CDC Split Type: B0854981A

Write-up: This case was reported by a nurse via a regulatory authority (124616) and described the occurrence of subcutaneous nodule in a 19-month-old female subject who was vaccinated with INFANRIX-POLIO-HIB (GlaxoSmithKline). On 17 July 2008, the subject received 3rd dose of INFANRIX-POLIO-HIB (intramuscular, unknown injection site). In March 2010, 20 months after vaccination with INFANRIX-POLIO-HIB, the subject experienced subcutaneous nodule (on the front side of both thighs, the problems have been most pronounced on the left side), skin nodule, allergic reaction to aluminum and itching. At the time of reporting, when the girl was 4.5 years old the pruritus was less pronounced and comes and goes. The regulatory authority reported that the events were clinically significant (or requiring intervention). Contact allergy has been demonstrated with a patch test. At the time of reporting the events were unresolved. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX-POLIO-HIB. No further information is expected, the Regulatory Authority has provided us with all the available information for the time being, if they ever get any further they will send it to us.


VAERS ID: 479586 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2012-12-13
Onset:2012-12-14
   Days after vaccination:1
Submitted: 2012-12-27
   Days after onset:13
Entered: 2012-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (INFANRIX TETRA) / GLAXOSMITHKLINE BIOLOGICALS AC20B232AB / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cellulitis, Erythema, Extensive swelling of vaccinated limb, Hypersensitivity, Nausea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0854381A

Write-up: This case was reported by a physician and described the occurrence of cellulitis in a male subject of unspecified age who was vaccinated with INFANRIX-IPV (GlaxoSmithKline). On 13 December 2012, the subject received an unspecified dose of INFANRIX-IPV (administration site and route unknown). On 14 December 2012, 1 day after vaccination with INFANRIX-IPV, the subject experienced hypersensitivity. At the time of reporting the outcome of the events was unspecified. This case is one of the 3 cases of hypersensitivity reported by the same reporter regarding the same lot number. Follow-up information received on 19 December 2012: This case was upgraded to serious. On 14 December 2012, 1 day after vaccination with INFANRIX-IPV, the subject experienced cellulitis going down towards his hands, extensive swelling of vaccinated limb (from the shoulder to the elbow), arms redness, fever, hypersensitivity and nausea. This case was assessed as medically serious by GSK. On 18 December 2012, cellulitis, arm swollen and arms redness were improved. At the time of reporting, the outcome of the other events was unspecified. Follow-up information received on 20 December 2012: The physician reported that the subject had not received an extra dose of tetanus/diphtheria at any time. The physician also reported that he would usually see 3 or 4 of these reactions in a while school year so he was a bit concerned about it.


VAERS ID: 479587 (history)  
Form: Version 1.0  
Age: 0.26  
Sex: Male  
Location: Foreign  
Vaccinated:2012-12-17
Onset:2012-12-17
   Days after vaccination:0
Submitted: 2012-12-27
   Days after onset:10
Entered: 2012-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS YHIBC600D / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Oedema peripheral, Rash, Skin discolouration
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0854228A

Write-up: This case was reported by a physician via a Sales Representative and described the occurrence of swollen lower limb in a 3-month-old male subject who was vaccinated with HIBERIX (GlaxoSmithKline). On 17 December 2012, the subject received 1st dose of HIBERIX (administration site and route unknown). On 17 December 2012, less than one day after vaccination with HIBERIX, the subject experienced swollen lower limb and rash on arms and legs with dark color (purple to black). The subject was hospitalised. At the time of reporting, the events were unresolved.


VAERS ID: 479588 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-27
Entered: 2012-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB249AA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Nausea, Presyncope, Product quality issue, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0854079A

Write-up: This case was reported by a physician and described the occurrence of near syncope in an adult subject of unspecified age and gender who was vaccinated with TWINRIX ADULT (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of TWINRIX ADULT (unknown route, unknown injection site). 1.5 hour after vaccination with TWINRIX ADULT, the subject experienced near syncope, nausea and vomiting. At the time of reporting the outcome of the event was unspecified. This was one 3 cases reported by the same physician. Follow up information received on 19 December 2012: The reporter considered the events were clinically significant (or required intervention). This case was associated with a product complaint. A complete review of this batch has been performed and no deviation has been highlighted.


VAERS ID: 479589 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-27
Entered: 2012-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB249AA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Product quality issue, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0854078A

Write-up: This case was reported by a physician and described the occurrence of syncope in an adult subject of unspecified age and gender who was vaccinated with TWINRIX ADULT (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of TWINRIX ADULT (unknown route, unknown injection site). 1.5 hour after vaccination with TWINRIX ADULT, the subject experienced syncope. The subject was hospitalised. At the time of reporting the outcome of the event was unspecified. This was one of 3 cases reported by the same physician. Follow up information received on 19 December 2012: This case was associated to a product complaint. A complete review of this batch has been performed and no deviation has been highlighted.


VAERS ID: 479590 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-27
Entered: 2012-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS AHABB249AA / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Product quality issue, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0854077A

Write-up: This case was reported by a physician and described the occurrence of syncope in an adult subject of unspecified age and gender who was vaccinated with TWINRIX ADULT (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of TWINRIX ADULT (unknown route, unknown injection site). 1.5 hour after vaccination with TWINRIX ADULT, the subject experienced syncope. The subject was hospitalised. At the time of reporting the outcome of the event was unspecified. This was one of 3 cases reported by the same physician. Follow up information received in 19 December 2012: This case was associated to a product complaint. A complete review of this batch has been performed and no deviation has been highlighted.


VAERS ID: 479551 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-28
Entered: 2012-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Nausea, Pallor
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1212AUT010656

Write-up: Case received from a foreign Health Authority/Institute Inspections on 21-Dec-2012 under the reference number INS-640.001-0632-004. Case medically confirmed. This case is the reference case of a cluster consisting of 6 cases after HBVAXPRO vaccination (same reporter, same vaccine, same batch, same events) and is linked with the cases E2012-11120; E2012-11121, E2012-11123, E2012-11126, E2012-11127. A patient (age and gender not reported) with no medical history reported has received one dose of HBVAXPRO (batch number G012582) via not reported route and site of administration on an not reported date. 10 minutes after vaccination the patient experienced nausea, pallor and stomach pain. The outcome was not reported.


VAERS ID: 479552 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-28
Entered: 2012-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Nausea, Pallor
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1212AUT010654

Write-up: Case received from a foreign Health Authority/Institute Inspections on 21-Dec-2012 under the reference number INS-640.001-0632-004. Case medically confirmed. This case is the reference case of a cluster consisting of 6 cases after HBVAXPRO vaccination (same reporter, same vaccine, same batch, same events) with the reference case E2012-11118. A patient (age and gender not reported) with no medical history reported had received one dose of HBVAXPRO (batch number G012582) via not reported route and site of administration on a not reported date. 10 minutes after vaccination the patient developed nausea, pallor and acute stomach pain. The outcome was not reported.


VAERS ID: 479554 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-28
Entered: 2012-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER G012582 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Pallor
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1212AUT010660

Write-up: Case received from a foreign Health Authority/Institute Inspections on 21-Dec-2012 under the reference number INS-640.001-0632-004. Case medically confirmed. This case is part of a cluster consisting of 6 cases after HBVAXPRO vaccination (same reporter, same vaccine, same batch, same events) with the reference case E2012-11118. A patient (age and gender not reported) with no medical history reported had received one dose of HBVAXPRO (batch number G0125820 via not reported route and site of administration on a not reported date. 10 minutes after vaccination the patient developed pallor and stomach pain. The outcome was not reported.


VAERS ID: 479555 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-28
Entered: 2012-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (FOREIGN) / MERCK & CO. INC. G012582 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cardiovascular insufficiency, Nausea, Pallor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1212AUT010658

Write-up: Case received from Health Authority/Institute Inspections on 21-Dec-2012 under the reference number INS-640.001-0632-004. Case medically confirmed. This case is part of a cluster consisting of 6 cases after HBVAXPRO vaccination (same reporter, same vaccine, same batch, same events) with the reference case E2012-11118. A patient (age and gender not reported) with no medical history reported had received one dose of HBVAXPRO, batch number G012582) via not reported route and site of administration on a not reported date. 10 minutes after vaccination the patient developed nausea, pallor and circulatory insufficiency. The outcome was not reported.


VAERS ID: 479691 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2012-11-13
Onset:2012-11-14
   Days after vaccination:1
Submitted: 2012-12-28
   Days after onset:44
Entered: 2012-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (INFANRIX TETRA) / GLAXOSMITHKLINE BIOLOGICALS AC20B209AD / 4 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Blood culture negative, CSF cell count, CSF culture negative, CSF glucose, CSF protein, Enterovirus test negative, Meningitis, Mononuclear cell count, Viral test negative
SMQs:, Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood culture, Nov2012, no growth; CSF culture, Nov2012, see text; CSF mononuclear cell count inc, Nov2012, 4; Cerebrospinal fluid cell count, Nov2012, 38*10E6/l; Cerebrospinal fluid glucose, Nov2012, 3.26mmol/l; Cerebrospinal fluid protein, Nov2012, 0.15g/l; Enterovirus test, Nov2012, negative; Tick-borne encephalitis virus, Nov2012, negative; The cerebrospinal fluid analysis revealed 34 polynuclear cells.
CDC Split Type: B0855410A

Write-up: This case was reported by a physician via a regulatory authority (# 2012-04478) and described the occurrence of meningitis in a 5-year-old male subject who was vaccinated with INFANRIX-POLIO (GlaxoSmithKline). On 13 November 2012, the subject received 4th dose of INFANRIX-POLIO (intramuscular, unknown injection site). On 14 November 2012, 24 hours after vaccination with INFANRIX-POLIO, the subject experienced acute meningitis. Overall, the course was mild and the child was always in relatively good general condition. The subject was hospitalised from 14 November 2012. The blood and cerebrospinal fluid cultures showed no growth. The testing concerning enteroviruses and tick-borne encephalitis virus test (FSME) was negative. The cerebrospinal fluid analysis revealed the following findings: cell count 38* 10E6/l, 4 mononuclear cells, 34 polynuclear cells, protein 0.15 g/l, glucose 3.26 mmol/l. The subject was treated from 15 November 2012 till 17 November 2012 with an antibiotic therapy with ROCEPHIN intravenously. On 17 November 2012 the subject was discharged from hospital in good general condition. At the time of reporting the event was resolved without damage. It was reported that in the present case existed a temporal relation between the fourth vaccination with INFANRIX DTPa-IPV and the occurrence of acute meningitis. A pathogen was not found. Non-medicamentous causes cannot be ruled out in the case described here. The regulatory authority reported that the event was unlikely to be related to vaccination with INFANRIX-POLIO (assessed according to the guidelines of agency). No further information is expected, the Regulatory Authority has provided us with all the available information for the time being, if they ever get any further they will send it to us.


VAERS ID: 479693 (history)  
Form: Version 1.0  
Age: 0.26  
Sex: Male  
Location: Foreign  
Vaccinated:2012-07-05
Onset:2012-07-07
   Days after vaccination:2
Submitted: 2012-12-28
   Days after onset:174
Entered: 2012-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Apnoea, Convulsion, Electroencephalogram abnormal, Musculoskeletal stiffness, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Electroencephalogram, 07Jul2012, various artifact
CDC Split Type: B0855359A

Write-up: This case was reported by a physician via a regulatory authority (# NO-NOMAADVRE-FHI-2012-15231) and described the occurrence of convulsion in a 3-month-old male subject who was vaccinated with Pneumococcal vaccine-unspecified, (manufacturer unspecified) and DTPa-IPV-HIB. On 5 July 2012, the subject received 1st dose of Pneumococcal vaccine-unspecified (parenteral, administration site unknown, batch number not provided) and 1st dose of DTPa-IPV-HIB (parenteral, administration site unknown, batch number not provided). On 7 July 2012, 2 days after vaccination with DTPa-IPV-HIB and Pneumococcal vaccine-unspecified, the subject experienced convulsion, apnea, syncope, pallor and stiffness. The subject was hospitalised and the regulatory authority reported that the events were clinically significant (or requiring intervention). On 7 July 2012, an electroencephalogram was performed. The results showed various artifacts. In the period after the incident, he had an incident with a touch of convulsions. At the time of reporting the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with Pneumococcal vaccine-unspecified and DTPa-IPV-HIB.


VAERS ID: 479817 (history)  
Form: Version 1.0  
Age: 0.47  
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-03-19
Onset:2012-03-21
   Days after vaccination:2
Submitted: 2012-12-26
   Days after onset:280
Entered: 2012-12-31
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Eye haemorrhage, Thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retinal disorders (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012327541

Write-up: This is a spontaneous report from a contactable consumer. A 5-month-old patient of unspecified gender and ethnicity received PREVENAR via an unspecified route of administration, DPT via an unspecified route of administration, Hib via an unspecified route of administration and rotavirus orally, all on 19Feb2012 with the patient was 4 months of age, and also had received PREVENAR on 02Mar2012 and DPT again on 19Mar2012. Relevant medical history and concomitant medications were not reported. The patient developed bleeding point on angle of eye on 21Mar2012, then purple black bleeding point generalised on 25Mar2012. The patient was diagnosed with thrombocytopenic purpura in a local hospital, then was hospitalized on an unspecified date, and discharged from the hospital 3 days later. The patient experienced thrombocytopenic purpura again and was hospitalized on 07Apr2012 and discharged on 09Apr2012. Thrombocytopenic purpura recurred again and the patient was hospitalized on 14Apr2012 and discharged 1 day later. The outcome of the event thrombocytopenic purpura was unknown.


VAERS ID: 479842 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2012-12-19
Onset:2012-12-19
   Days after vaccination:0
Submitted: 2012-12-28
   Days after onset:9
Entered: 2012-12-31
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 43B / 1 LA / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR H1263 / 2 LA / SC
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR J0058 / 1 RA / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 12D02A / 2 RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaphylactic shock, Crying, Cyanosis, Depressed level of consciousness, Loss of consciousness, Pallor, Respiratory rate decreased, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No relevant personal medical history; No history of adverse event to previous administration of vaccine or drug; Unknown family medical history
Allergies:
Diagnostic Lab Data: not reported
CDC Split Type: 201212393

Write-up: Case reported during the Early Post-marketing Phase Vigilance (6-month enhanced surveillance of adverse events following the launch of IPV). Case received from a Healthcare Professional (pharmacist) on 19 December 2012. Follow-up information received from the Health Authorities through the local affiliate (reference number HIB-468) on 20 December 2012. A 03-month-old male patient, with no relevant personal medical history and no history of adverse event to previous administration of vaccine or drug, had received his 1st primary dose of IMOVAX POLIO (batch number J0058) subcutaneously in the right arm, his 2nd primary dose of ACTHIB (batch number H1263) subcutaneously in the left arm, his 2nd primary dose of PREVENAR (other manufacturer, batch number 12D02A) subcutaneously in the triceps muscle of the right arm and his 1st primary dose of DPT vaccine (other manufacturer, batch number 43B) subcutaneously in the triceps muscle of the left arm on 19 December 2012 in a clinic. The patient had no noteworthy symptoms before vaccination, and no abnormal findings were noted on physical examination. While rotavirus vaccine was being prepared, the patient was crying intensely. At around 14:55, crying diminished and his face turned pale. Suddenly, his breathing became weak, and he developed cyanosis. He had tachycardia (the pediatrician was unable to count the number of pulses). He cried with pain stimulation. The color of the lips improved temporarily when he cried. The color of the entire skin continued to be pale. At around 15:00, he was given BOSMIN 0.3ml intramuscularly at the left buttock and 3L of oxygen. While giving stimulation to the patient, an ambulance was called. With respect to the vaccines, regular quantity had been administered. At 15:08, the ambulance left the clinic for other hospital. Stimulation was continuously given to the right foot, calf, lateral side to the back of the femur, and the back during transportation because breathing was weak without stimulation and the mother was concerned that the patient was not crying. At 15:25, the ambulance arrived at other hospital. His condition including vital signs was stable when he arrived at this hospital. He was admitted to this hospital. The patient experienced tachycardia, decreased level of consciousness or loss consciousness, and cyanosis. The diagnosis was anaphylactic shock. The patient recovered on 19 December 2012. The patient was discharged from hospital on 20 December 2012. Comment of the pediatrician: The reaction started immediately after administration of the vaccines, thus the causal relationship with the suspect vaccines cannot be denied.


VAERS ID: 479844 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Female  
Location: Foreign  
Vaccinated:2012-12-10
Onset:2012-12-11
   Days after vaccination:1
Submitted: 2012-12-27
   Days after onset:16
Entered: 2012-12-31
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Pneumonia viral
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012328615

Write-up: This is a spontaneous report from a contactable consumer from the non-clinical study program. A 4-month-old female patient of an unspecified ethnicity received the second dose of PREVENAR, intramuscular on 10Dec2012 at a single dose. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 11Dec2012, the patient developed cough. There was no effect after receiving drugs for treatment. Then on 11Dec2012, the patient was diagnosed with pneumonia viral in a hospital. Therapeutic measures were taken as a result of pneumonia viral and cough and included treatment with unspecified medications. The clinical outcome of the events, cough and pneumonia viral, was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 479846 (history)  
Form: Version 1.0  
Age: 0.39  
Sex: Female  
Location: Foreign  
Vaccinated:2012-05-11
Onset:2012-11-11
   Days after vaccination:184
Submitted: 2012-12-27
   Days after onset:46
Entered: 2012-12-31
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR G1477 / 3 UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 11H02A / 3 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abnormal behaviour, Asthenia, Meningitis, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 22-FEB-2012, Hib, First dose received; Lot Number G1400; 22-MAR-2012, Hib, Second dose received; Lot Number G1453; 22-FEB-2012, DTP, First dose received: Lot Number F39B; 13-APR-2012, DTP, Second dose received; Lot Number F39C; 22-MAY-2012, DTP, Third dose received; Lot Number F40A; 13-APR-2012, BCG, Lot Number KH158; 12-OCT-2012, Polio Vaccine, First dose; Lot Number H0520; 12-OCT-2012, Influenza vaccine, Lot Number 330A
Allergies:
Diagnostic Lab Data: 09-NOV-2012, Body temperature, 37.5 Centigrade
CDC Split Type: 2012328314

Write-up: This is a spontaneous report from a contactable pediatrician via a Pfizer sales representative. A 10-month-old female patient of unspecified ethnicity received the third dose of PREVENAR (Lot Number 11H02A) and the third dose of ACTHIB (Lot Number G1477) both at 0.5mL, single dose, administered subcutaneously on 11May2012. Relevant medical history and concomitant medications were not reported. Past drug/vaccine history included PREVENAR dose number one on 22Feb2012 with the lot number of 11C03A and dose number two on 22Mar2012 with the lot number 11F01A; Hib dose number one on 22Feb2012 with the lot number of G1400 and dose number two on 22Mar2012 with the lot number of G1453; DPT dose number one on 22Mar2012 with the lot number of F39B, dose number two on 13Apr2012 with the lot number F39C, and dose number three on 22May2012 with the lot number of F40A; BCG vaccine on 13Apr2012 with the lot number of KH158; IPV on 12Oct2012 with the lot number of H0520; and influenza vaccine on 12Oct2012 with the lot number of 330A. The patient experienced meningitis serotype 15B on 11Nov2012. The clinical course was as follows: On 09Nov2012, the patient experienced pyrexia with a body temperature of 37.5 degrees Centigrade and vomiting in the early morning of 11Nov2012 both for which the patient visited the emergency department in another hospital and was hospitalized on 11Nov2012. The patient''s behavior was unusual such as the patient was weak when standing holding on to things. The patient was diagnosed with meningitis serotype 15B on 11Nov2012. "The vaccination according to the age in month had completed"; a fourth dose of PREVENAR had not been received. After receiving treatment at the hospital, the patient recovered from meningitis on 28Nov2012. The patient was discharged from the hospital on 28Nov2012. The reporter classified the event meningitis as serious due to hospitalization and assessed the event meningitis as unrelated to PREVENAR. The treating physician commented as follows: There was no problem in evaluation infant analytical development test with all items were above the equivalent age. Neurologically, there were no abnormalities. A second dose of IPV was received on 14Dec2012 with the lot number of J0035. No follow-up attempts needed. No further information expected.


VAERS ID: 479866 (history)  
Form: Version 1.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:2012-12-17
Onset:2012-12-18
   Days after vaccination:1
Submitted: 2012-12-27
   Days after onset:9
Entered: 2012-12-31
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR H1024 / 3 RA / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Death, Peripheral coldness, Respiratory arrest, Resuscitation, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-12-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Low birth weight (2450g), premature baby (36weeks); Family history not reported; The patient had developed pyrexia over 39 degrees C lasted 1 day on 18 October 2012 after receiving his 1st primary dose of ACTHIB (batch number not reported) on the same day (case 2012-12400). On 26 October 2012, the patient had received his 1st dose of PREVENAR, without abnormalities. On 15 November 2012, the patient had his 2nd dose of ACTHIB (batch number not reported), without abnormalities.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201212386

Write-up: Case received from a Healthcare Professional on 18 December 2012 then follow-up information received from the Health Authorities (reference number HIB-467) on 19 and 20 December 2012 though the local affiliate. This case is linked with case 2012-12400. A 04-month-old male patient, with a medical history of prematurity (36 weeks) and low birth weight at 2450g, had received his 3rd primary dose of ACTHIB (batch number H1024) subcutaneously in the right arm on 17 December 2012 in hospital. The body temperature before the vaccination was 36.6 degrees C. The patient had developed pyrexia over 39 degrees C lasted 1 day on 18 October 2012 after receiving his 1st primary dose of ACTHIB (batch number not reported) on the same day. On 26 October 2012, the patient had received his 1st dose of PREVENAR (other manufacturer), without abnormalities. On 15 November 2012, the patient had received his 2nd dose of ACTHIB (batch number not reported), without abnormalities. On 27 November 2012, the patient had received his 2nd dose of PREVENAR, without abnormalities. The patient had no abnormalities before the vaccination and 30 minutes after the vaccination. After vaccination, the patient went home. There was no abnormalities for the patient until the night of 17 December 2012. On 18 December 2012, at 1:00 the patient drank milk (180cc). At around 6:00 the patient was found not breathing. An ambulance was requested. The patient was taken to the reporting physician''s hospital. At around 06:30, on arrival, the patient was in cardio-respiratory arrest condition. The patient'' body had already been cold. The cardiopulmonary resuscitation was conducted for about one hour but the patient did not respond. At 07:37 the death was confirmed. The reporting physician''s comment: "Causality was unknown." The comment of the physician who vaccinated with ACTHIB to the patient" "Causality was unknown. Although it was considered the possibility of the relationship with ACTHIB was low, I would like to request a specialist''s judgment because the the death was confirmed within 24 hours after the vaccination." The reporting physician asked to perform an autopsy but it was refused.


VAERS ID: 479881 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2011-12-20
Onset:2011-12-21
   Days after vaccination:1
Submitted: 2012-12-26
   Days after onset:371
Entered: 2012-12-31
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR G0446 / 2 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Activated partial thromboplastin time normal, Alanine aminotransferase increased, Albumin globulin ratio, Alpha hydroxybutyrate dehydrogenase, Amylase normal, Aspartate aminotransferase normal, Blood cholinesterase increased, Blood creatinine, Blood fibrinogen normal, Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M, Complement factor C3, Complement factor C4, Cytomegalovirus test negative, Epstein-Barr virus antibody negative, Glomerular filtration rate, HIV antibody negative, Haematocrit decreased, Haemoglobin normal, Hepatitis B core antibody negative, Hepatitis B e antibody negative, Hepatitis B e antigen negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative, Hepatitis C antibody negative, Herpes simplex serology negative, International normalised ratio normal, Lymphocyte count increased, Lymphocyte percentage increased, Neutrophil count decreased, Neutrophil percentage decreased, Petechiae, Platelet count decreased, Platelet distribution width, Prothrombin time prolonged, Rubella antibody negative, Scan bone marrow abnormal, Thrombocytopenic purpura, Toxoplasma serology, Treponema test, White blood cell count increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Liver-related coagulation and bleeding disturbances (narrow), Liver infections (narrow), Agranulocytosis (broad), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Malignant lymphomas (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Personal medical history: the patient experienced upper respiratory tract infection and fever on 11 December 2011.
Allergies:
Diagnostic Lab Data: On 01 January 2012 blood investigations showed: WBC 10.2x10E9/L and 11.3x10E9/L, platelet 46x10E9/L and 23x10E9/L, Neutrophils 1.76x10E9/L, Lymphocytes 8.3x10E9/L, Neutrophils 15.6%, Lymphocytes 73.8%, Hematocrit 33.1%, Platelet Distribution Width 12.7%, PCT 0.03%, hemoglobin 118 g/L, HBsAg (-), HBsAb (+), HBeAg (-), HBeAb (-), HBcAb (-), RIV-Ab (-), HCV-Ab (-), TP (-), EBVCAIgM (-), EBVCAIgG (-), EBVEAIgG (-), EHVNA-IgG (-), TOXO-IgM (-), RV-IgM (-), CMV-IgM (-), HSV-IgM (-), PT 12.2s, PT% 110%, INR 0.95, APTT 38.5s, TT 18.2s, FIB 2.41g/L, ALAT 67U/L, ASAT, 57U/L, GLO 14.8g/L, A/G 3.19, Cr 9umol/L, HBDH 237U/L, a-AMY 28U/L, CHE 12491U/L, IgG 3.91g/L, IgA 0.13g/L, IgM 0.57g/L, C3 0.82g/L, C4 0.2g/L. On 02 January 2012 blood investigations showed: Neutrophils 2.08x10E9/L, Lymphocytes 8.37x10E9/L, Neutrophils% 18.1%, Lymphocytes% 72.5%, Hematocrit 36.3%, Platelet 30x10E9/L, Platelet Distribution Width 13.3%, PCT 0.03%. 03 January 2012, platelet count was at 123x10E9/L, Bone marrow picture showed thrombocytopenia. On 04 January 2012: platelet count was at 194x10E9/L. On 06 January 2012: platelet count was at 187x10E9/L. On 13 January 2012: platelet count was at 268x10E9/L. On 30 January 2012: platelet count was at 169x10E9/L. On 13 February 2012: platelet count was at 137x10E9/L. On 24 February 2012: platelet count was at 287x10E9/L. On 03 May 2012: platelet count was at 461x10E9/L. On 08 August 2012: platelet count was at 327x10E9/L.
CDC Split Type: 201212251

Write-up: Case report received from a Healthcare Professional through the local affiliate on 17 December 2012. A 4-month-old male patient, with history of upper respiratory tract infection with fever on 11 December 2012, had received his second intramuscular dose of IPV (batch number G0446-1) in the left arm on 20 December 2011. The patient had no history of adverse event to previous administration of vaccine or drug and he had not concomitant therapies. On 21 December 2011, i.e 1 day following the second injection, he experienced immunologic thrombocytopenic purpura with petechiae. He was hospitalized on 01 January 2012. On 01 January 2012 blood investigations showed: WBC 10.2x10E9/L and 11.3x10E9/L, platelet 46x10E9/L and 23x10E9/L, Neutrophils 1.76x10E9/L, Lymphocytes 8.3x10E9/L, Neutrophils 15.6%, Lymphocytes 73.8%, Hematocrit 33.1%, Platelet Distribution Width 12.7%, PCT 0.03%, hemoglobin 118 g/L, HBsAg (-), HBsAb (+), HBeAg (-), HBeAb (-), HBcAb (-), RIV-Ab (-), HCV-Ab (-), TP (-), EBVCAIgM (-), EBVCAIgG (-), EBVEAIgG (-), EHVNA-IgG (-), TOXO-IgM (-), RV-IgM (-), CMV-IgM (-), HSV-IgM (-), PT 12.2s, PT% 110%, INR 0.95, APTT 38.5s, TT 18.2s, FIB 2.41g/L, ALAT 67U/L, ASAT, 57U/L, GLO 14.8g/L, A/G 3.19, Cr 9umol/L, HBDH 237U/L, a-AMY 28U/L, CHE 12491U/L, IgG 3.91g/L, IgA 0.13g/L, IgM 0.57g/L, C3 0.82g/L, C4 0.2g/L. On 02 January 2012 blood investigations showed: Neutrophils 2.08x10E9/L, Lymphocytes 8.37x10E9/L, Neutrophils% 18.1%, Lymphocytes% 72.5%, Hematocrit 36.3%, Platelet 30x10E9/L, Platelet Distribution Width 13.3%, PCT 0.03%. 03 January 2012, platelet count was at 123x10E9/L, Bone marrow picture showed thrombocytopenia. On 04 January 2012: platelet count was at 194x10E9/L. On 06 January 2012: platelet count was at 187x10E9/L. On 13 January 2012: platelet count was at 268x10E9/L. On 30 January 2012: platelet count was at 169x10E9/L. On 13 February 2012: platelet count was at 137x10E9/L. On 24 February 2012: platelet count was at 287x10E9/L. On 03 May 2012: platelet count was at 461x10E9/L. On 08 August 2012: platelet count was at 327x10E9/L. Corrective treatments were administered: etamsylate (intravenous) from 01 to 03 January 2012, bromhexine hydrochloride (intravenous) from 02 to 03 January 2012, dexamethasone sodium phosphate (intravenous) from 02 to 03 January 2012 and prednisone (oral) from 03 January to 05 February 2012. The patient was discharged on 03 January 2012. The patient recovered on an unspecified date.


VAERS ID: 479884 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-31
Entered: 2012-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Loss of consciousness, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1212FRA008888

Write-up: Case received from a consumer on 11-Dec-2012. Case not medically confirmed. A female patient of unknown age had received the first dose of GARDASIL (batch number, route and site not reported) about two years before reporting and one to two weeks later, she experienced a first episode of vagal malaise. Since then vagal malaise had recurred. At the time of reporting she had not recovered. Follow-up information received from a health care professional on 18-Dec-2012. The case is not medically confirmed. The patient was around 18 years old. She had received the first dose of GARDASIL (batch number not reported) in 2008 and the second and third doses of GARDASIL (batch numbers not reported) in 2009. Since then (it was unspecified whether after D1, D2 or D3), she experienced several episodes of loss of consciousness diagnosed as vagal reaction. The frequency of the episodes was not known. The patient was hospitalized for investigations but the reporter did not have the hospital report. The episodes usually occurred when she was with family or while other people were around. The patient assessed the events as being related to the vaccine.


VAERS ID: 479908 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2012-12-14
Onset:2012-12-14
   Days after vaccination:0
Submitted: 2012-12-26
   Days after onset:12
Entered: 2012-12-31
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR H1263 / UNK UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaphylactic shock, Laboratory test normal, Oedema peripheral, Swelling face
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: An examination was conducted to determine if the symptoms of shock were caused by infections, and the results were negative
CDC Split Type: 201212384

Write-up: Case received from a Healthcare Professional through the local affiliate on 17 and 19 December 2012. A 02-month-old male patient, with no reported medical history, had received a subcutaneous dose of ACTHIB (batch number H1263, site of administration not reported), an oral dose of ROTARIX (other manufacturer, batch number not reported) and a subcutaneous dose of PREVENAR (other manufacturer, batch number and site of administration not reported) on 14 December 2012. On 14 December 2012 about 30 minutes post-vaccination, the patient developed symptoms of shock and he was transferred to hospital. Swellings were observed on face and upper arms. The patient received corrective treatment for anaphylactic shock (not specified). The patient recovered on 14 December 2012. He was discharged form hospital on 17 December 2012. Physician''s comment: An examination was conducted to determine if the symptoms of shock were caused by infections, and the results were negative. Hence, this event was considered to be related to the vaccines.


VAERS ID: 479977 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-01-01
Entered: 2013-01-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER G012582 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain upper, Cardiovascular insufficiency, Nausea, Pallor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1212AUT010626

Write-up: Case received from Health Authority/Institute Inspections on 21-Dec-2012 under the reference number INS-640.001-0632-004. Case medically confirmed. This case is part of a cluster consisting of 6 cases after HBVAXPRO vaccination (same reporter, same vaccine, same batch, same events) with the reference case E2012-11118. A patient (age and gender not reported) with no medical history reported had received one dose of HBVAXPRO (batch number G012582) via not reported route and site of administration on a not reported date. 10 minutes after vaccination the patient experienced nausea, pallor, stomach pain and circulatory insufficiency. The outcome was not reported.


VAERS ID: 480023 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2012-12-13
Onset:2012-12-13
   Days after vaccination:0
Submitted: 2013-01-02
   Days after onset:20
Entered: 2013-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS M12014 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Agitation, Muscular weakness, Tonic clonic movements, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Vestibular disorders (narrow), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Cetirizine hydrochloride
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood pressure, 130/80 mmHg, Normal
CDC Split Type: PHHY2012IT121471

Write-up: Case number PHHY2012IT121471 is an initial spontaneous report from the foreign Health Authority received on 28 Dec 2012. This report refers to a male patient of an unknown age. Concomitant medication included cetirizine hydrochloride. The patient was vaccinated MENVEO 0.5 ml (batch number: M12014) intramuscularly on 13 Dec 2012. On the same day, 10 minutes after vaccination, the patient experienced vertigo with weakness of the lower limbs. After 40 minutes, the patient experienced tonic-clonic contractions of the facial muscles and also the upper limbs, and experienced general state of agitation. Blood pressure monitoring (130/80 mmHg) was performed. First Aid was called because the symptoms worsen and the patient was admitted to Emergency Room. Outcome of the events was reported as improving and causality as suspected.


VAERS ID: 480034 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-11-21
Onset:2012-11-21
   Days after vaccination:0
Submitted: 2013-01-02
   Days after onset:42
Entered: 2013-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. H015644 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Incorrect storage of drug, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1212USA011256

Write-up: Information has been received from healthcare worker (pharmacy technician) who reported that a dose of PROQUAD lot number reported as H015644 exp. date 23-FEB-2014 (dose and route not reported) that was improperly stored at 36-46 degrees F in the refrigerator for possibly 816 hours on 01-NOV-2012 was administered on 21-NOV-2012. The patient identifiers were not available at the time of the call (age, gender not provided). No adverse effect reported. This is one of several reports from the same source (MAAR # 1212USA011255, 1212USA011257, 1212USA001732). Additional information has been requested.


VAERS ID: 480066 (history)  
Form: Version 1.0  
Age: 0.24  
Sex: Female  
Location: Foreign  
Vaccinated:2012-08-07
Onset:2012-08-29
   Days after vaccination:22
Submitted: 2013-01-02
   Days after onset:126
Entered: 2013-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA414AA / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Haematochezia, Occult blood positive
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0843689A

Write-up: This case was reported by a physician and described the occurrence of bloody stools in a 3-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date, the subject received 1st dose of ROTARIX (1.5 ml, oral). On 29 August 2012, less than one year after vaccination with ROTARIX, the subject experienced bloody stools. On 18 September 2012, the event was resolved. After the next vaccination with ROTARIX the event recurred. On an unspecified date, the subject received 2nd dose of ROTARIX (1.5 ml, oral). On 15 October 2012, less than one year after vaccination with ROTARIX, the subject experienced bloody stools again. The physician considered the events were clinically significant (or requiring intervention). On 29 October 2012, the event was resolved. The physician considered the events were related to vaccination with ROTARIX. Follow-up information received on 28 December 2012: On 7 August 2012, the subject received 1st dose of ROTARIX. On 29 August 2012, 22 days after vaccination with ROTARIX, the subject experienced bloody stool (occult blood: 262 ng/mL). On 18 September 2012, the event was resolved. On 9 October 2012, the subject received 2nd dose of ROTARIX. On 16 October 2012, 7 days after vaccination with ROTARIX, the subject experienced bloody stools (occult blood: more than 800 ng/mL). On 25 October 2012, the event was resolved.


VAERS ID: 480072 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-10-31
Onset:2012-11-08
   Days after vaccination:8
Submitted: 2013-01-02
   Days after onset:55
Entered: 2013-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Fatigue, Mobility decreased, Muscular weakness, Pain, Pruritus, Rash, Vaccination complication
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Chlorthalidone; Thyroxine sodium; Metoprolol succinate; Olmesartan medoxomil; Isosorbide dinitrate; Fentanyl; Nifedipine
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0855668A

Write-up: This case was reported by a healthcare professional via a regulatory authority (# 2012-04228) and described the occurrence of muscle weakness in a 90-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included HYGROTON, EUTHYROX, Metoprolol succinate, Olmesartan medoxomil, SORBIDILAT, Fentanyl and Nifedipine. On 31 October 2012 the subject received unspecified dose of FLUARIX (intramuscular, unknown injection site). Lot number not provided. On 8 November 2012, 8 days (192 hours) after vaccination with FLUARIX, the subject experienced muscle weakness, rash, itching, difficulty moving, diffuse pain, tiredness and vaccination complication. The subject was hospitalised. The subject was treated with prednisolone and Cetirizine. At the time of reporting the events were improved. The regulatory authority reported that the events were possibly related to vaccination with FLUARIX. No further information is expected, since the agency has provided GSK with all the available information for the time being, if they ever get any further they will send it to us. This case is now considered closed.


VAERS ID: 480073 (history)  
Form: Version 1.0  
Age: 0.28  
Sex: Male  
Location: Foreign  
Vaccinated:2009-09-10
Onset:0000-00-00
Submitted: 2013-01-02
Entered: 2013-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS AC20CA489A / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 36538 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Motor developmental delay
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0855721A

Write-up: This case was reported by another health professional via a regulatory authority (NO-NOMAADVRE-FHI-2012-15266) and described the occurrence of motor developmental delay in a 3-month-old male subject who was vaccinated with INFANRIX-POLIO-HIB (GlaxoSmithKline) and PREVENAR 13. On 10 September 2009, the subject received an unspecified dose of INFANRIX-POLIO-HIB (parenteral, unknown) and an unspecified dose of PREVENAR 13 (parenteral, unknown). In 2009, less than one year after vaccination with INFANRIX-POLIO-HIB and PREVENAR 13, the subject experienced motor developmental delay. The regulatory authority reported that the event was clinically significant (or requiring intervention0. At the time of reporting, the outcome of the event was unspecified.


VAERS ID: 480127 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2012-12-31
Entered: 2013-01-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Anaemia haemolytic autoimmune, Aspiration, Blood bilirubin increased, Blood lactate dehydrogenase increased, Cardiogenic shock, Coombs direct test positive, Death, Decreased activity, Exchange blood transfusion, Growth retardation, Haematocrit decreased, Haemoglobin decreased, Haemolysis, Haptoglobin normal, Immunoglobulin therapy, Injury, Jaundice, Laboratory test abnormal, Ocular icterus, Osteoporosis, Red blood cell count decreased, Respiratory failure, Resuscitation, Sepsis, Yellow skin
SMQs:, Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Haemolytic disorders (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Haematopoietic erythropenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Conjunctival disorders (narrow), Osteoporosis/osteopenia (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Blood bilirubin, 9.1 mg/dl; Blood lactate dehydrogenase, 430 IU/l; Haematocrit, 12.6%; Haemoglobin, 7.8 g/dl; Haemoglobin, 4.3 g/dl; Haemoglobin, 1.6 g/dl; Haptoglobin, 18 mg/dl; Red blood cell count, 150 x 10 4/ ul; Direct Coombs test: positive (unknown date before admission), C3b3d (+) on admission.
CDC Split Type: 2012328882

Write-up: This is a literature report. A 3-month-old male patient received PREVENAR, subcutaneously on an unspecified date at a single dose, and ACT-HIB, subcutaneously on an unspecified date at a single dose. The patient medical history was not reported. It was reported that the patient had no prior infections. The patient''s concomitant medications were not reported. Approximately one month after the patient received the vaccinations, the patient was diagnosed with autoimmune hemolytic anemia (AIHA) based on examination results including hemoglobin of 7.8 g/dL and direct Coombs test positive and was hospitalized. Due to inactivity and progression of anemia and jaundice, the patient was referred to a different hospital. The patient had conjuntiva bulbi coloring yellow and skin coloring yellow. The liver of 1 cm and the spleen of 2 cm were felt in the hypochondrium. Laboratory tests performed on an unspecified date included: hemoglobin (Hb): 4.3 g/dL, red blood cell count (RBC): 1,500,000/micro liter, hematocrit (Ht): 12.6%, (total bilirubin (T-Bil): 9.1 mg/dL, lactate dehydrogenase (LDH): 430 IU/L, and haptoglobin: <18 mg/dL. Direct Coombs test positive [C3b3d (+)]. At the initial onset of the autoimmune hemolytic anemia, the patient received erythrocyte transfusion and oral administration of prednisolone (PSL). Due to rapid progression of hemolysis, the patient had HbHt of 1.6 g/dL and developed cardiogenic shock on Day 2. After resuscitation, the patient''s condition became less severe following methylprednisolone (mPSL) pulse, exchange transfusion, massive administration of gamma-globulin, and administration of PSL at 6 mg/kg/day and concomitant cyclosporine A (CyA). On Day 98, the transfusion was discontinued and the dose of PSL was decreased. At the time of the first exacerbation: The disease in the patient was exacerbated on Day 130. Due to severe hemolysis, exchange transfusion was performed 14 times in total. The hemolysis became less severe after administration of rituximab (once weekly; 6 doses in total), continuous intravenous infusion of CyA, and dose increase of PSL. On Day 196, the transfusion was discontinued and the dose of PSL could be decreased. At the time of the second exacerbation: The disease in the patient was exacerbated on Day 229. Exchange transfusion was performed 22 times in total. Around Day 289 , when hemolysis seemed to become less intense, respiratory failure started to progress rapidly. And then patient died on Day 291. Sepsis, organ damage associated with iron deposition, and aspiration were suspected. While pediatric AIHA is said to have relatively good prognosis, some cases become fulminant and refractory. Since this patient was highly steroid-dependent and developed impairment in growth and development and osteoporosis related to a long-term use of steroids, drugs such as CyA and rituximab were also concomitantly administered. However, the patient poorly responded to any of the drugs used. In recent years, cases of pediatric AIHA related to vaccines have been reported. As far as we examined, however, there were no reports of pediatric AIHA caused by ACT-HIB or PREVENAR. It is not clear whether these vaccines were related to the fulminant and refractory AIHA in this patient. No information was provided whether an autopsy was performed or not.


VAERS ID: 480422 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-01-03
Entered: 2013-01-04
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (OPTAFLU) / NOVARTIS VACCINES AND DIAGNOSTICS 030011C / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Angina pectoris, Diarrhoea, Musculoskeletal stiffness
SMQs:, Pseudomembranous colitis (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Other ischaemic heart disease (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2012DE098036

Write-up: Case number PHHY2012DE098036 is an initial spontaneous report received from a consumer via agency (reference number: 1-305697361) on 29 Oct 2012, with a follow-up received from a consumer on 02 Jan 2013. This report refers to a female patient (age unknown). She was vaccinated with OPTAFLU (batch number: 030011C) on an undetermined date. On an unspecified date, after vaccination, she presented with strong watery diarrhea (for five days), heart pain, and neck stiffness. She had recovered from diarrhea and heart pain, but not from neck stiffness (ongoing) at the time of this report. The consumer decided not to use OPTAFLU further. No other information was available. Follow-up was received on 02 Jan 2013: The decision that not to use OPTAFLU anymore was updated.


VAERS ID: 480385 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2012-12-23
Onset:2012-12-23
   Days after vaccination:0
Submitted: 2013-01-04
   Days after onset:12
Entered: 2013-01-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 AR / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR H0449 / 2 LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Cyanosis, Death, Pulmonary haemorrhage, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient had no ongoing illness and no personal and family medical history.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201300088

Write-up: Case received from a healthcare professional through the local affiliate in a foreign country on 31 December 2012: A 03-month-old female patient, with no ongoing illness and no personal and family medical history, had received her second intramuscular injection of ACTHIB (lot number H0449-1) in the left thigh concomitantly with her first intramuscular injection of DTaP vaccine (manufacturer: Chengdu Institute of Biologica products Co, Ltd, batch number 20111255-1) in the arm on 23 December 2012. About one hour after vaccination, the parents found the patient with lips cyanosis and no response. The patient did not show any vital signs and was sent to hospital. Autopsy was performed on 27 December 2012: pulmonary hemorrhage was found by naked eye in the autopsy. Final autopsy report was still under investigation at the time of the report. List of documents held by sender: none.


VAERS ID: 480388 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Male  
Location: Foreign  
Vaccinated:2012-12-26
Onset:2012-12-27
   Days after vaccination:1
Submitted: 2013-01-04
   Days after onset:8
Entered: 2013-01-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Peripheral coldness, Resuscitation
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-12-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: No personal medical history. No reported family medical history. No history of adverse event to a previous administration of vaccine/drug. No reported concomitant therapies.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201212587

Write-up: Case received from a healthcare professional through the local affiliate of a foreign country on 28 December 2012. A 07-month-old male patient, with no personal medical history, no reported family medical history and no history of adverse event to a previous administration of vaccine/drug, had received his 3rd primary dose of IMOVAX POLIO (batch number, route and anatomical site of administration not reported) on 26 December 2012. The patient had no reported concomitant therapies. On 26 December 2012, at around 09:30pm, the patient''s family noted that the patient''s body was cold. He was urgently transported to the hospital and hospitalized on 26 December 2012. The patient recovered with resuscitative maneuvers. However, he died on 27 December 2012 at 08:57pm. An autopsy was ongoing at the time of the report. Reporter''s comment: "The cause of death was unknown. Because it make no sense at all that the patient experienced anaphylaxis in terms of the onset time, it was unlikely that IMOVAX POLIO induced the patient''s death". Documents held by sender: none.


VAERS ID: 480389 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-01-04
Entered: 2013-01-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Inflammation, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: The patient''s medical history was unknown.
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201212590

Write-up: Initial report was received from a non-healthcare professional through the local affiliate on 27 December 2012 under local reference number BR-BT2012-0460. A patient (age and gender not reported) received an injection of PANDEMIC INFLUENZA VACCINE (Manufacturer unknown) in 2010 (lot number unknown; route, site, and exact date of administration not reported). The reporter informed that her relative received the vaccine during the massive public campaign and an unspecified amount of time later presented with paralysis and peripheral inflammation of the nervous system. The seriousness was assessed as persistent or significant disability or incapacity due to paralysis. Illness at time of vaccination was unknown. Pre-existing allergies and medical conditions were unknown. No additional information was provided. The patient''s outcome was not reported. Documents held by sender: none.


VAERS ID: 480420 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2011-12-01
Onset:2011-12-01
   Days after vaccination:0
Submitted: 2013-01-07
   Days after onset:403
Entered: 2013-01-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV2: HPV (CERVARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Activities of daily living impaired, Arthralgia, Asthenia, Back pain, Bladder spasm, Chest pain, Constipation, Contracted bladder, Depression, Dizziness, Dysuria, Fatigue, Insomnia, Malaise, Micturition urgency, Muscle spasms, Muscle twitching, Myalgia, Palpitations, Pollakiuria, Somnolence, Tremor, Ultrasound scan abnormal, Vaccine positive rechallenge
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Dyskinesia (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), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: An ultrasound scan showed that even when her bladder is empty it is twitching and having spasms every 15 to 25 minutes.
CDC Split Type: B0855953A

Write-up: This case was reported by a consumer via the regulatory authority and described the occurrence of contracted bladder in a female subject who was vaccinated with CERVARIX (GlaxoSmithKline) for an unknown drug indication. On unspecified date, the subject received the 1st dose of CERVARIX. On an unspecified date in December 2011, after receiving the first dose of CERVARIX at school, the patient experienced feeling sick, and dizzy with abdominal pain that evening. The regulatory authority considered the events as serious for being clinical significant (requiring intervention). The abdominal pain was mild but persisted. The following month, on an unknown date in January 2012, the patient received the second dose of CERVARIX and the abdominal pain became more intense. Doctors tested for water infection but it was clear. She was given two courses of antibiotics which did nothing to help her until finally she was referred to the hospital. She had to wait for five months for her first appointment. Between those four months, she had continuous abdominal and back pain with frequent urgency to urinate every 15 to 25 minutes and was still a current symptom. She had episodes where her heart raced and pains in her chest. She frequently experienced twitching or spasms in her legs and uncontrollable shaking in her hands. Her muscles and joints ached all the time and she had very little energy. She would sleep for hours through the day but struggled to get to sleep at night because of the pain she felt. She felt burning sensations inside when she passed urine and struggled to pass stools without the help of laxatives all the time. She was too unwell to go into classes at school and had to stay in a quiet room away from other children. Her grades had dropped and she had fallen behind on all her work. Four months ago, at the hospital, it was discovered that she had extreme constipation and a shrunken bladder. They advised her to drink a litre and a half of water a day with 6 sachets of MOVICOL and 5ml of SENOKOT. She did this for 3 months. The bowel was "empty" but she had to continue with the MOVICOL and her frequent urgency to urinate was still as strong as it ever was. An ultrasound scan showed that even when her bladder was empty it was "twitching" and having spasms every 15 to 25 minutes. This was giving her terrible pain. She had been given a Tens machine to wear on her back for 40 minutes a day. It was reported that she was exhausted all the time and in pain which caused her to be very depressed. The patient was seen by a physiotherapist, clinical psychologist and doctor and were awaiting a diagnosis. The patient''s parent reported that they were at the clinic and although they strongly agreed she had fatigue, they also felt that she needed a more in depth investigation. At the time of reporting the events of abdomen pain, back pain, urinary urgency, urination frequency, twitch, muscle pain, joint pain, bladder spasm, and exhaustion, were unresolved. The outcome of the remaining events was unknown. Following the first shot of CERVARIX vaccine at school, my daughter complained of feeling sick, dizzy with abdominal pain that evening. We did not suspect the vaccine at this stage. The abdominal pain was mild but persisted. The following month, she received the second shot and the abdominal pain became more intense. Doctors tested for water infection but it was clear. She was given two courses of antibiotics which did nothing to help her until finally she was referred to the hospital but she had to wait of antibiotics which did nothing to help her until finally she was referred to the hospital but she had to wait for 5 months for her first appointment. Between those 4 months, lots of strange things seemed to be happening to her health. She has continuous abdominal and back pain with frequent urgency to urinate every 15 to 25 minutes (this is still current symptom). She has episodes where her heart just races and pains in her chest. She frequently gets twitching or spams in her legs and she gets uncontrollable shaking in her hands. Her muscles and joints ache all the time and she has very little energy. She would sleep for hour through the day but struggled to get to sleep at night because of the pain she felt. She feels burning sensation inside when she passes urine and struggles to pass stools without the help of laxatives all the time. The impact its had on her life and ours is huge. She is too unwell to go into classes at school and has to stay in a quiet room away from other children. Her grades have dropped and she has fallen behind on all her work so the school have got a private tutor in for only 4 hours a week to help her. We have had hospital appointments but each appointment comes with months of waiting so its been hell for her and us. Four months ago, at the hospital, they discovered our daughter had extreme constipation and a shrunken bladder. They advised her to drink a litre and a half of water a day with 6 sachets of MOVICOL and 5ml of SENOKOT. She did this for 3 months and we went back to hospital. The bowel is now empty but she has to continue with the MOVICOL and her frequent urgency to urinate is still as strong as it ever was. An ultrasound scan showed that even when her bladder is empty it is twitching and having spasms every 15 to 25 minutes. This is giving her terrible pain and causing so much heart ache. All she has been given this time is a Tens machine to wear on her back for 40 minutes a day. She is exhausted all the time and in pain which of course has caused her to be very depressed. We had appointment a week ago with a doctor at the Clinic. There she was seen by a physiotherapist, clinical psychologist and doctor. We have to wait until next month for the diagnosis and how they plan to help our daughter. I understand that we were at the clinic when we saw the doctor and although I do strongly agree she has fatigue, we also feel that there is far more wrong with her and she needs a more in depth investigation. The fact that she has had all these different symptoms following after the vaccine is no coincident. And I have other mums in regular contact with me those daughters are going through the same symptoms as our daughter since their vaccine shots. We are all seeing different doctors of course but we all seem to be very frustrated that doctors all believe its just fatigue. Now we are meeting with our MP and praying he can help us in some way or another.


VAERS ID: 480640 (history)  
Form: Version 1.0  
Age: 0.35  
Sex: Male  
Location: Foreign  
Vaccinated:2011-06-29
Onset:2011-08-01
   Days after vaccination:33
Submitted: 2013-01-07
   Days after onset:525
Entered: 2013-01-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute lymphocytic leukaemia, Blood culture positive, Hepatosplenomegaly, Laboratory test, Pneumococcal infection, Streptococcus test positive, Vaccination failure
SMQs:, Liver related investigations, signs and symptoms (narrow), Lack of efficacy/effect (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Blood culture (09Feb2012): serotype 19F with pneumococcal infection
CDC Split Type: 2012048025

Write-up: This is a spontaneous report from a healthcare professional via the contactable Health Protection Agency. A 4-month old male patient received the first dose of PREVENAR 13 of unspecified dose from batch F15375 on 29Jun2011. The patient''s relevant medical history and concomitant medications were not reported. On 09Feb2012, the patient experienced a pneumococcal infection, serotype 19F with pneumococcal infection which was reported as a vaccination failure. The specimen was taken from blood culture on 09Feb2012. The patient was reported to be 11 months old at the time of infection. The outcome of the events were unknown at the time of the report. No follow-up attempts possible. No further information expected. Follow up (12Apr2012): This is a follow report from Pfizer''s Quality Operations Group. An expiry date for batch F15375 was reported as Sep2013. Investigation conclusion was that the plant has reviewed all Aluminum Phosphate investigations associated with this batch from a manufacturing and technical perspective and all investigations were appropriately closed and addressed. There were no events related to this type of complaint. All testing for the Aluminum Phosphate batch was satisfactory and met product specifications. Retained samples meet the product description and the product is in date. No product was returned for examination and the product is not on stability. Investigation conclusion was that the calculated rate of adverse event complaints for product 240-104 in the last six months is 2.2 complaints per million. A review of the executed batch records for formulation batch, filling batch and packaging batch performed by QA indicated that the batch was manufactured according to cGMP procedures. All batch parameter and specifications were met. Customer complaint Investigation concluded that no reported serotype has been supplied for this complaint. It is possible that the serotype of the infection may be one not covered by PREVENAR 13. The batch records were fully reviewed prior to stock being QP released from the Havant site. There were no relevant observations or errors associated with the packaging of the lot in question. The cold chain temperature control data for the bulk stock received at Havant and the data for the packed stock during its journey to the markets Distribution Centre were reviewed and found satisfactory before the batch was QP released thus confirming suitable storage conditions maintained. The Certificate of Analysis shows that all QC testing complied with specification and was QP released. Investigation shows that there were no issues reported during the processes that would have affected the Strength, Identify, Safety, Purity or Quality of this packed lot number. A root cause cannot be determined and the complaint is therefore not confirmed. Reports of this nature will continue to be evaluated and monitored for trends. Monitoring of Adverse Events and Lack of Effect Complaints is also conducted by the Global Safety Group. No follow up attempts possible. No further information expected. Follow-up (02Jan2013): This is a follow up report received via the Health Protection Agency. It was unknown if the patient was born prematurely. The patient had a history of previous unspecified invasive bacterial disease, in Oct2011. The patient had a developmental health risk of immunosuppression. The patient had no homozygous sickle cell disease, no asplenia or splenic dysfunction, no congenital abnormality, no conditions associated with CSF leakage, no chronic respiratory disease, no cardiac, renal or liver disease, no diabetes, no cochlear implants, no coeliac disease, no empyema, no haemolytic uraemia. It was reported that the patient presented with bulky disease, hepatosplenomegaly and testicular screening. The patient was receiving treatment at the time of the report, and was therefore not eligible for vaccination. The outcome of acute lymphoblastic leukaemia was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 480642 (history)  
Form: Version 1.0  
Age: 0.21  
Sex: Male  
Location: Foreign  
Vaccinated:2009-09-04
Onset:0000-00-00
Submitted: 2013-01-07
Entered: 2013-01-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Dehydration, Lower respiratory tract infection, Streptococcus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Infective pneumonia (broad), Dehydration (narrow), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Blood culture (30Nov2012): serotype 19A.
CDC Split Type: 2013001087

Write-up: This is a spontaneous report from a healthcare professional via the Health Protection agency. A 3-years-old male patient received the first dose of PREVENAR 13 single dose from batch D63070 at 2 months on 04Sep2009, the second dose at 10 months on 10May2010 from batch E29196 and the third dose at 13 months on 17Aug2010. The patients relevant medical history and concomitant medications were not reported. On an unspecified date the patient experienced dehydration and a lower respiratory tract infection. On analysis of the patient''s first specimen from a blood culture on 30Nov2012 serotype 19A was noted which was reported as a vaccination failure. The outcome of the events were unknown at the time of this report. No follow up attempts possible. No further information expected.


VAERS ID: 480643 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Female  
Location: Foreign  
Vaccinated:2012-10-11
Onset:0000-00-00
Submitted: 2013-01-07
Entered: 2013-01-08
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH F92555 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Death, Fontanelle bulging, Haemolytic uraemic syndrome, Meningitis, Nausea, Vomiting
SMQs:, Haemolytic disorders (narrow), Acute pancreatitis (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Renovascular disorders (broad), Neonatal disorders (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2012-11-16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Blood culture (15Nov2012) serotype 6C
CDC Split Type: 2013001101

Write-up: This is a spontaneous report from a healthcare professional via the Health protection agency. A 5 month old female patient received the first dose of PREVENAR 13 single dose from batch F92555 at 4 months on 11Oct2012. The patients relevant medical history and concomitant medications were not reported. On an unspecified date the patient experienced meningitis, hemolytic uremic syndrome, nausea, vomiting and bulging fontanelle. On 15Nov2012 serotype 6C was identified in a blood culture specimen. The patient died on 16Nov2012 and the cause of death at the time of this report was unknown. No follow up attempts possible. No further information expected.


VAERS ID: 480759 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Male  
Location: Foreign  
Vaccinated:2010-03-16
Onset:0000-00-00
Submitted: 2013-01-08
Entered: 2013-01-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH D84658 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaemia, Haemolytic uraemic syndrome, Infection, Pleural fluid analysis, Renal failure acute, Streptococcus test positive, Thrombocytopenia, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemolytic disorders (narrow), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Lack of efficacy/effect (narrow), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Renovascular disorders (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Pleural fluid (09Nov2012): Serotype 3
CDC Split Type: 2013001093

Write-up: This is a spontaneous report from a contactable Healthcare professional via the Health Protection Agency. A 33 month-old male patient, received at the age of 1.9 months, the first dose of PREVENAR 13 (batch D84658) on 16Mar2010. The patient received the second dose of PREVENAR 13 (from batch E29194) on 25May2010 when he was 4.2 months old and the third of PREVENAR 13 (batch E85022) on 16Mar2011 when he was 13.9 months old. Relevant medical history and concomitant medications were unknown. On an unspecified date the patient experienced acute renal failure, thrombocytopenia, anaemia, and Haemolytic Uraemic Syndrome. A pleural fluid specimen taken on 09Nov2012 identified a vaccination failure confirming Serotype 3. The patient was reported to be 33.8 months old at the time of infection. At time of this report, the clinical outcome of the events were unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 480762 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2009-03-14
Onset:0000-00-00
Submitted: 2013-01-07
Entered: 2013-01-09
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 34253 / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Leukodystrophy, Neonatal disorder
SMQs:, Congenital, familial and genetic disorders (narrow), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Received at the age of 2 months, PENTAVAC; Received at the age of 3 months, PENTAVAC; Received at the age of 4 months, PENTAVAC
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013003750

Write-up: This is a spontaneous report from a contactable paediatrician via a Pfizer sales representative. A 5-month-old male patient received a single dose of PREVENAR approximately 5 years ago (the patient was 7 years of age as of 04Jan2013). No other vaccine was administered at the same time, but the patinet had received PENTAVAC at the age of 2, 3, and 4 months. The patient received only one dose of PREVENAR. Relevant medical history and concomitant medications were not reported. On an unknown date, the patient experienced neonatal leukodystrophy. Therapeutic measures, if any, were not reported. Clinical outcome of the event neonatal leukodystrophy was unknown. The pediatrician will be assigned at the High Court in Feb2013.


VAERS ID: 480763 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-01-08
Entered: 2013-01-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013002327

Write-up: This is a spontaneous report from a non-contactable physician through a Pfizer sales representative. A patient of unspecified age, ethnicity and gender started to receive PREVENAR 13 via an unspecified route of administration on an unspecified date, single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced heart attack on an unspecified date more than one month before this report. Outcome was unknown.


VAERS ID: 480811 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-01-09
Entered: 2013-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / 3 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Arthralgia, Chest pain, Condition aggravated, Fatigue, Irritable bowel syndrome, Memory impairment, Paraesthesia, Rash
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Irritable bowel syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1301GBR003121

Write-up: This case was received from the health authority in a foreign country on 03-Jan-2013. GB-MHRA-ADR 21962497. This case is not medically confirmed as it was reported by a consumer. A female patient received an injection of GARDASIL (batch no, dose and dose in series, route and site of administration not reported) in 2009 and on an unreported date she experienced joint pain, fatigue, skin rashes, forgetfulness and tingling in her hands, chest pain and irritable bowel syndrome. The reporter (patient''s parent) indicated that the patient had had all three GARDASIL vaccines and very soon after this they noticed a difference in her. As time went by they thought it was stress to school but her symptoms have persisted with joint pain, fatigue, skin rashes, forgetfulness and tingling in her hands and chest pains. Although she had been seen by different doctors and consultants, they will not accept that this was linked to the HPV vaccine. The patient also suffered from irritable bowel syndrome. This was having a massive impact on her ability to function properly. The patient''s medical history included irritable bowel syndrome. At the time of reporting the outcome of the patient was unknown. The reporter indicated that she had declined to have his other daughter''s vaccine done. The MHRA considered this case to be serious as an other medically important condition. Upon internal review the company decided to correct the MedDRA LLT for the adverse event "irritable bowel syndrome" to "irritable syndrome aggravated" as the patient had a medical history of irritable bowel syndrome and the MedDRA PT is the same for the two LLT. A clarification request was sent to the MHRA regarding the age of the patient, which was reported as 14 days by the MHRA.


VAERS ID: 480834 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-11-07
Onset:2012-11-09
   Days after vaccination:2
Submitted: 2013-01-09
   Days after onset:61
Entered: 2013-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Abnormal behaviour, Dyskinesia, Fall, Laboratory test abnormal, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Dyskinesia (narrow), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0857301A

Write-up: This case was reported by a physician via a regulatory authority (2012-04248) and described the occurrence of possible epilepsy in a 13-month-old female subject who was vaccinated with INFANRIX-IPV/HIB (GlaxoSmithKline) and PREVENAR 13 (non-GSK). It was not known if there were other vaccinations performed before. On 7 November 2012, the subject received an unspecified dose of INFANRIX-IPV/HIB (intramuscular, unknown injection site) and an unspecified dose of PREVENAR 13 (intramuscular, unknown injection site). On 9 November 2012, 2 days after vaccination with INFANRIX-IPV/HIB and PREVENAR 13, the subject experienced involuntary shaking of the head, abnormal behavior and falling down. Analysis regarding epilepsy were initiated but no results were available at the time of reporting. The regulatory authority reported that the events were clinically significant (or requiring intervention). At the time of reporting, the events were unresolved. The regulatory authority reported that the events were possibly related to vaccination with INFANRIX-IPV/HIB and PREVENAR 13. The narrative mentioned that at the time of reporting, a possible epilepsy was not excluded and that the described symptoms were however not suitable for a hypotonic-hyporesponsive episode.


VAERS ID: 480838 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2012-12-26
Onset:2012-12-26
   Days after vaccination:0
Submitted: 2013-01-09
   Days after onset:14
Entered: 2013-01-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA919A / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Crying, Dyspnoea, Eye swelling, Hypotonic-hyporesponsive episode
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0857066A

Write-up: This case was reported by a physician and described the occurrence of hypotonic-hyporesponsive episode in a 2-month-old male subject who was vaccinated with INFANRIX-IPV/HIB (GlaxoSmithKline). On 26 December 2012, the subject received 1st dose of INFANRIX-IPV/HIB (.5 ml, intramuscular, unknown thigh). On 26 December 2012, 1 hour after vaccination with INFANRIX-IPV/HIB, the subject experienced hypotonic-hyporesponsive episode, subject''s mother noticed that the boy was breathlessness (no breathing) and he had eye swollen (bulging eye) but without spasm. Back to the hospital, at emergency room during the physician''s check up, the infant cried and turn to normal without any treatment. The subject was hospitalised for observation for 1 night. He was discharged in the morning. He stays healthy since leaving from the hospital. At the time of reporting the events were resolved. The physician considered the hypotonic-hyporesponsive episode was almost certainly related to vaccination with INFANRIX-IPV/HIB.


VAERS ID: 480822 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-12-18
Onset:2012-12-20
   Days after vaccination:2
Submitted: 2013-01-07
   Days after onset:18
Entered: 2013-01-10
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Adverse drug reaction, Dysphagia, Hypertension, Palpitations, Pyrexia, Rash generalised, Urinary tract infection
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Paracetamol; Bisacodyl; Ranitidine; Docusate sodium; CENTRUM select; Lactulose; Hypromellose; GOLYTELY; Prev meds = Unknown
Current Illness:
Preexisting Conditions: Asthma; Anxiety; Pneumatosis intestinalis; Folliculitis; Cerebral hemorrhage Sep 2011; Adverse drug reaction DILANTIN; Drain placement; External ventricular drain, Oct 2011
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2012MZ000414

Write-up: This report was received from Merz on 28 Dec 2012. The following is a verbatim report: This spontaneous report received from a physician concerns a 19-year-old female patient (details not reported). She was injected with a total of 100 units of XEOMIN, 25 units into the left flex polisis longus, 50 units into the flexor digitorum superficialis and 25 units into the gastro soleus on 13- Dec-2012. Indication for use of XEOMIN was reported as treatment of spasticity of left upper flex. On 18-Dec- 2012, the patient received a flu shot. Medical history included mild asthma, anxiety, pneumatosis intestinalis, folliculitis, posterior fossa midline hemorrhage and right side of the middle cerebral peduncle and right pons secondary brain hemorrhage, external ventricular drain (EVD) insertion, and severe reaction to DILANTIN. Concomitant medications included bisacodyl, TYLENOL, ranitidine, COLACE, CENTRUM select, lactulose, hydroxypropyl, and GOLYTELY. On 14-Dec-2012, one day after the injection with XEOMIN, the patient experienced skin rashes on the face and left arm. On 20-Dec-2012, two days after administration of a flu vaccine, the patient experienced generalized rash. At the same time, she experienced urinary tract infection, worsening rash, swallowing difficulty, high fever, palpitation and high blood pressure. The patient was treated with BENADRYL and hydrocortisone cream for skin rashes. On 21-Dec-2012, she was treated with ceftriaxone for urinary tract infection. Furthermore, the patient was treated for a drug reaction with prednisone and BENADRYL for three days. The outcome of the event skin rashes was resolved. The outcome of all other events was not reported. Reportedly, the treating physicians were not sure what exactly caused the symptoms. No further information was provided.


VAERS ID: 480825 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Female  
Location: Foreign  
Vaccinated:2011-01-10
Onset:2011-01-22
   Days after vaccination:12
Submitted: 2013-01-09
   Days after onset:718
Entered: 2013-01-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E68146 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Bronchiolitis, Pneumococcal sepsis, Streptococcus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Blood culture (22Jan2011): streptococcus pneumoniae, serotype 3
CDC Split Type: 2012053253

Write-up: This is a spontaneous report from a healthcare professional via the contactable Health Agency. A 1-month-old female patient received the first dose of PREVENAR 13 (lot #E68146) on 10Jan2012. Relevant medical history was as follows: the patient was not born prematurely, that the patient was not considered to be in a risk group, had no homozygous sickle cell disease, no history of previous bacterial disease, no asplenia or splenic dysfunction, no immunosuppressive condition, no malignancy, no congenital abnormality, no CSF leakage associated condition, no chronic respiratory disease, no cardiac, renal or liver disease, no diabetes, no cochlear implants, no coeliac disease and no emphysema, no haemolytic/uraemic syndrome/cerebral access nor other unspecified diseases. Concomitant medications were not reported. On 22Jan2011, at the age of 2 months, the patient experienced streptococcus pneumoniae sepsis, serotype 3 which was reported as a vaccination failure. The patient also presented with bronchiolitis. Lab specimen included a blood culture on 22Jan2011. The patient received no antibiotics. The outcome of the events was unknown at the time of the report. The patient was alive at the time of the report. No follow-up attempts possible. No further information expected. Follow-up (02Jan2013): New information received from the original contactable Health Agency includes: details on patient''s medical history.


VAERS ID: 480826 (history)  
Form: Version 1.0  
Age: 0.15  
Sex: Female  
Location: Foreign  
Vaccinated:2010-05-24
Onset:2011-03-03
   Days after vaccination:283
Submitted: 2013-01-09
   Days after onset:678
Entered: 2013-01-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH E29194 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture positive, Malaise, Pneumococcal bacteraemia, Pyrexia, Streptococcus test positive
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Blood culture (03Mar2011): revealed Streptococcus pneumoniae, serotype 19A.
CDC Split Type: 2011081160

Write-up: This is a spontaneous report from a contactable healthcare professional. This healthcare professional reported similar events for three patients. This is the third of three reports. A 11month-old, female patient received the second dose of PREVENAR 13 (Lot Number: E29197, exp. Date Jul2011) at 0.5 ml single dose on 28Jul2010 at 3-months. The patient did not belong to any following risk groups: premature birth, homozygous sickle cell disease or other haemoglobinopathy, history of previous invasive bacterial disease, asplenia or splenic dysfunction, immunosuppressive condition or drug, malignancy, congenital abnormality, conditions associated with CSF leakage, chronic respiratory disease, (including asthma), cardiac disease, renal disease, liver disease, diabetes mellitus, cochlear implants, coeliac disease, empyema, haemolytic uraemic syndrome, cerebral abscess or any other condition. Concomitant medications were not provided. Relevant past product history included the first dose of PREVENAR 13 (Lot Number: E29194, exp. Date Jul2011) on 24May2010 when the patient was 8-weeks-old. On 03Mar2011 at the age of 11-months-old, the patient experienced invasive pneumococcal disease serotype 19A, detected in a blood culture. It was reported that patient had a vaccine failure. The patient had experienced bacteraemia secondary to Streptococcus pneumonia. The patient was unwell with fever one week prior to presentation. The final outcomes of the events were unknown yet the reporter had stated that the patient was alive at the time of the report. Follow-up (15Apr2011): New information from Product Quality includes: The formulation of PREVENAR 13 was corrected from suspension for injection to solution for injection in pre-filled syringe. The expiration date of both batches was identified as Jul2011. Follow-up attempts completed. No further information is expected. Follow-up (11May2011): New information reported from Product Quality includes: QA results for Lot Number E29197. QA Results were with specifications. Follow-up (17May2011): New information reported from Product Quality includes: AQ results for Lot Number E29194. QA Results were within specifications. Follow-up (13Oct2011): New information reported from a contactable reporter includes: patient demographic, medical history, and clinical details. Follow-up attempts completed. No further information expected. Follow-up (05Oct2011): This is a follow-up report to confirm that the Pfizer Receipt date of the previous follow-up was 05Oct2011 and not 13Oct2011 as previously reported. No follow-up attempts possible. No further information expected. Follow-up (22Feb2012): New information reported from the contactable agency includes: laboratory test results and medical history information. No follow-up attempts possible. No further information expected. Follow-up (02Jan2013): Additional information received from the original contactable agency includes patient and reaction details, updated outcome, new events of malaise and fever. No follow-up attempts possible. No further information expected.


VAERS ID: 480827 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2012-10-17
Onset:2012-12-27
   Days after vaccination:71
Submitted: 2013-01-09
   Days after onset:13
Entered: 2013-01-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Influenza, Influenza like illness, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data: None
CDC Split Type: 201300333

Write-up: Initial report received on 02 January 2012 from a consumer who is the patient. A male patient, date of birth not reported received a dose of flu vaccine, manufacturer, dose and route not reported on 17 October 2012, without event at the time. The patient''s medical history and concomitant medications were not reported. On December 27th, the patient started to feel "flu like symptoms", and on 28 December 2012 he woke with a fever of 102F. The patient was seen on an unspecified date at the walk-in clinic and was prescribed unspecified antibiotics. Relevant laboratory tests were not reported. According to the patient, he "still caught the flu despite the flu vaccine." No further information was available at the time of the report. The patient outcome was not reported. Documents held by sender: None.


VAERS ID: 480830 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-01-09
Entered: 2013-01-10
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: CSF test abnormal, Convulsion, Retrograde amnesia
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Not reported
Allergies:
Diagnostic Lab Data: Not reported
CDC Split Type: 201300122

Write-up: Initial report was retrieved from the scientific literature on 02 January 2013. This case is linked to 2 other cases (2013-00119 and 2013-00121) issued from the same article. A health-care worker patient (demographics unknown), had received an H1N1 influenza vaccine injection (manufacturer and lot number unknown, site and route of administration not reported) on an unspecified date. The patient''s medical history and history of adverse event to previous administration of vaccine/drug was unknown and concomitant medications were not reported. On an unspecified date in 2011, the patient developed seizures and retrograde amnesia with cerebrospinal fluid changes. The patient''s outcome was not reported. List of documents held by the sender: None.


VAERS ID: 480927 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-01-10
Entered: 2013-01-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR - / UNK UN / UN
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Anaphylactic reaction, Lip discolouration, Skin discolouration, Somnolence
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Thyroxine sodium
Current Illness: Unknown
Preexisting Conditions: Congenital Hypothyroidism
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0857341A

Write-up: This case was reported by a consumer via a foreign regulatory authority and described the occurrence of anaphylaxis in a 3-month-old male subject who was vaccinated with ROTARIX. The subject''s medical history included congenital hypothyroidism. Co-suspect vaccinations included an unspecified dose of PEDIACEL, and an unspecified dose of Meningococcal polysaccharide vaccine group C (unknown manufacturer). Concurrent medications included Levothyroxine. On an unspecified date the subject received an unspecified dose of ROTARIX, an unspecified dose of PEDIACEL, and an unspecified dose of Meningococcal polysaccharide vaccine group C. At an unspecified time after vaccination with suspect vaccines, after having the second set of immunisations at 12 weeks of age, the baby would not wake up, was white in color and his lips went white (anaphylaxis). The regulatory authority reported that the event was clinically significant (or requiring intervention). At the time of reporting the outcome of the event was unknown. MHRA Verbatim Text: Baby would not wake up after having 2nd set of immunisation at 12 weeks of age and was white in color and lips went white.


VAERS ID: 480958 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2012-12-27
Onset:0000-00-00
Submitted: 2013-01-11
Entered: 2013-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS 1111083 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Mobility decreased, Petechiae, Phlebitis, Pyrexia, Rash papular
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Haemolytic uraemic syndrome; Diarrhoea
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2013AR000983

Write-up: Case number PHHY2013AR000983 is a combined initial and follow up spontaneous report from a consumer (patient''s mother) on 02 Jan 2013 and a follow up report from the consumer received on 04 Jan 2013. This report refers to a male child who was under 6 years of age. Medical history included hemolytic uremic syndrome and diarrhea at 18 months of age. The patient was vaccinated with MENVEO (batch number: unknown) on 27 Dec 2012. On 28 Dec 2012, after vaccination the patient experienced erythema and swelling that extended from the zone, back of the shoulder to the hand on the same side ( earlier reported as right) of the application. At first, he experienced phlebitis and then derived to cellulitis. The size of the arm was enlarged to 3 times compared to the normal size. The patient was on treatment with cephalexin, OPTAMOX DUO and BACTRIM. Within 48 hours after vaccination, continued local involvement and loss of function was observed in the patient and child pediatrician was consulted who decided to the rotate the antibiotics, amoxicillin-clavulanate and trimethoprim-sufametoxazole. The patient also experienced fever on an unknown date. On an unknown date, the child was afebrile with reduced swelling and improved function. He continued with antibiotics treatment. It was reported that the patient also received BENADRYL from 30 Dec 2012 to 02 Jan 2013 along with the antibiotics. Outcome of the events were reported as condition improving with no sequelae. The child was in good general condition and afebrile. On 04 Jan 2013, although the patient showed decreased swelling and erythema, in the area of the scapular he presented erythematous papular non-pruritic lesions and petechiae in the armpit region. The outcome of the events erythematous papular non-pruritic lesions and petechiae were not reported. The seriousness and causality of the events were not reported. Follow up report from the consumer received on 04 Jan 2013: The events (erythematous papular non-pruritic lesions and petechiae) and treatment (BENADRYL) were added.


VAERS ID: 480989 (history)  
Form: Version 1.0  
Age: 0.51  
Sex: Unknown  
Location: Foreign  
Vaccinated:2012-10-02
Onset:2012-10-02
   Days after vaccination:0
Submitted: 2013-01-11
   Days after onset:101
Entered: 2013-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS A20CA832A / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER UVA11009 / UNK UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA462AD / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, 02Oct2012, 40deg C
CDC Split Type: B0857786A

Write-up: This case was reported by a physician via a regulatory authority (# PL-URPL-N1204/2012) and described the occurrence of convulsion in a 6-month-old subject of unspecified gender who was vaccinated with ROTARIX liquid formulation (GlaxoSmithKline), INFANRIX-POLIO-HIB and hepatitis B vaccine (non-GSK). On 2 October 2012 the subject received unspecified dose of ROTARIX liquid formulation (oral), unspecified dose of INFANRIX-POLIO-HIB (intramuscular, left thigh), unspecified dose of Hepatitis B vaccine (Non-GSK) (intramuscular, right thigh). On 2 October 2012, 2 hours after vaccination with Hepatitis B vaccine (Non-GSK), INFANRIX-POLIO-HIB and ROTARIX liquid formulation, the subject experienced fever (40 deg C). The subject was treated with Antipyretics. On 3 October 2012, in the morning, the subject experienced convulsion. At that time, the subject''s body temperature was normal. The subject was hospitalised for 5 days. The subject''s general condition was good. At the time of reporting the events were resolved. The regulatory authority reported that the events were possibly related to vaccination with ROTARIX liquid formulation, INFANRIX-POLIO-HIB and Hepatitis B vaccine (Non-GSK). No further information is expected, the Regulatory agency has provided us with all the available information for the time being, if they ever get any further they will send it to us.


VAERS ID: 481079 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2012-08-28
Onset:2012-09-01
   Days after vaccination:4
Submitted: 2013-01-11
   Days after onset:132
Entered: 2013-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 0720AA / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Decreased appetite, Fatigue, Intussusception, Pyloric stenosis, Surgery, Ultrasound Doppler abnormal, Vomiting, X-ray abnormal
SMQs:, Acute pancreatitis (broad), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 09/--/2012, Ultrasound Doppler: pylorusstenos; 09/--/2012, X-ray: intestinal intussusception
CDC Split Type: WAES1301FIN004996

Write-up: Initial case was received by health care professional via the Health Authority under the reference FI-FIMEA-20121725. Case was assessed as serious (hospitalization). Case medically confirmed. A 2-month-old male patient (height and weight: not reported) with no medical history reported, had received the first dose of ROTATEQ (batch number 0720AA) via oral route on 28-Aug-2012. 4 days later, on 01-Sep-2012, the patient started to vomit and his appetite decreased. The patient was taken to doctor the same day. The stomach was non sensitive and the baby was tired. The doctor forwarded the patient to hospital because of the vomiting. The stomach was "round". In the ultrasound was nothing as mitral stenosis. The patient had been monitored in the paediatirc department. Vomiting turned as green. In plain X-ray film intestinal intussusception was found, which was operated on 03-Sep-2012. The patient recovered on an unspecified date and was discharged from hospital on 07-Sep-2012. No further information expected.


VAERS ID: 481071 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-01-14
Entered: 2013-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Abortion induced, Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1205USA00827

Write-up: Case received from a welfare officer via a company representative on 20-Apr-2012. Case not medically confirmed. This is a case of pregnancy follow-up, as the woman was 5 weeks pregnant at time of vaccination. A female patient (personal data not reported) had received an injection of GARDASIL (batch number not reported) on an unspecified day and later on she realized she was 5 weeks pregnant at the time of vaccination. At the time of reporting, the outcome was unknown. Follow-up information was received from the welfare officer on 08-Jan-2013: The patient chose to have an abortion (date and gestation week not reported). No further information expected. Upon internal review induced abortion was considered a medically significant event.


VAERS ID: 481073 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:2012-09-08
Onset:2012-10-01
   Days after vaccination:23
Submitted: 2013-01-14
   Days after onset:105
Entered: 2013-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 3 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Abdominal X-ray, Appendicectomy, Blood bicarbonate decreased, Blood chloride increased, Blood potassium decreased, Blood sodium normal, C-reactive protein, Enema administration, Eosinophil percentage, Haematocrit normal, Haemoglobin normal,