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VAERS ID: 513085 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2013-10-22
Onset:0000-00-00
Submitted: 2013-11-07
Entered: 2013-11-14
   Days after submission:7
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS 133401 / UNK UN / IM

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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2013DE126188

Write-up: Case number PHHY2013DE126188 is an initial spontaneous report received from Foreign Health Authority (reference number: DE-PEI-PEI2013065018) ON 05 Nov 2013. This report refers to an elderly male patient. His medical history and concomitant medication were not reported. His vaccination history included administration of Td-RIX (other manufacturer, batch number unknown) in 1998, PNEUMOVAX 23 (other manufacturer, batch number unknown) on 14 Mar 2009 and two doses of INFLUSPLIT SSW (other manufacturer, batch number unknown) on 19 Sep 2011 and 25 Sep 2012. He did not experience any adverse events with these vaccinations. On 22 Oct 2013, he was vaccinated with BEGRIPAL 2013/2014 (batch number: 133401) intramuscularly. On an unspecified date, after vaccination, he died due to an unspecified cause. He was not hospitalized, before his death. It was unknown whether autopsy was performed. No further information was provided.


VAERS ID: 513145 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-14
Entered: 2013-11-14
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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311ISR005786

Write-up: Information was received from a lawyer who reported that since 2006, approximately 21,000 people reported side effects due to the Quadrivalent GARDASIL including 73 fatalities. Additional information is not expected.


VAERS ID: 513609 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2013-10-28
Onset:2013-10-29
   Days after vaccination:1
Submitted: 2013-11-14
   Days after onset:16
Entered: 2013-11-18
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH 12L01A / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Computerised tomogram thorax abnormal, Death, Pneumonia aspiration, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-29
   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: Unknown
Allergies:
Diagnostic Lab Data: Chest CT: (29Oct2013) fluid in the bronchi
CDC Split Type: 2013321482

Write-up: This is a spontaneous report from a contactable pediatrician through a Pfizer sales representative. A 2-month-old female patient received PREVENAR (lot 12L01A) and ACT-HIB (lot unspecified), both administered subcutaneously as single doses on 28Oct2013 at 17:00. Medical history and concomitant medications were unknown. At 17:00 on 28Oct2013, the patient received simultaneous inoculation with PREVENAR and ACT-HIB at the reporter''s hospital. Around 6:00 in the morning of 29Oct2013, the patient was not breathing and an ambulance was called. She was transported to another hospital. Around 7:00, on 29Oct2013, her death was confirmed and chest CT was performed. Since fluid in the bronchi was observed, pneumonia aspiration was diagnosed. The reporting pediatrician classified the event pneumonia aspiration as serious (fatal) and assessed it as unrelated to PREVENAR. The reported cause of death was pneumonia aspiration. No information was provided as to whether an autopsy was performed.


VAERS ID: 513892 (history)  
Form: Version 1.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-13
Entered: 2013-11-19
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Blood pressure increased, Death, Headache, Hydrophobia, Hyperhidrosis, Incomplete course of vaccination, Lip swelling, Muscle spasms, Odynophagia, Oropharyngeal pain, Phobia of flying, Pyrexia, Rabies
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypertension (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Antibiotics
Current Illness: Animal bite, initially a bite in the calf of the right leg and later when he punched the dog hard, the dog fell down and got up with bare teeth and dug its claws into the patient''s face; Lip injury; Lip haemorrhage
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2013PK128404

Write-up: Case number PHHY2013PK128404 is an initial literature report received on 07 Nov 2013. In this article, the author discussed about a case of rabies (killer disease). This report refers to a 45-year-old male patient. His medical history and concomitant medication were not reported. One day, while he was on his way to home from the work, he was bitten by the dog (initially a bite in the calf of the right leg and later in the face). He bled copiously from a cut lip. He dabbed it with the end of his shirt and headed home. His wife applied powdered red chilies into the leg and lip wounds, as a home remedy and took him to the hospital where the face and leg were washed. In the hospital, he was vaccinated with rabies vaccine (manufacturer and batch number unknown, hence conservatively coded as RABIPUR) and tetanus vaccine (manufacturer and batch number unknown, hence conservatively coded as TETANOL PUR) along with prescription for an antibiotic. Next morning he had a swollen lip which was improved over the next few days. Soon after, he ignored to get the remaining injections and continued on his daily work (incomplete course). After six weeks, he started running fever, headache, sweating and his throat was hurting on swallowing. A local doctor recorded his blood pressure as extremely high, and sent him to a hospital. He was given pills (unspecified) to swallow, at which point he said he could not. He also avoided the sight of water. He went to the emergency room and consulted the physician with "suspected rabies". He had unmistakable hydrophobia and aerophobia and he was sweating profusely from every pore of his body into his soaked clothes. In between spasms of his throat, he told to the physician about his misadventure with the vicious dog. The bite wounds were no more visible. The doctor confirmed rabies and thought that the patient was doomed to die and indeed he did die four hours later in an isolation room in the hospital. Author stated that if the patient''s wounds had been washed with soap and water immediately to remove the dog saliva and also if the patient had received rabies immune globulin (RIG) into the bite wounds with a series of 5 vaccine injections into the arm, the patient would have been alive today.


VAERS ID: 514228 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-21
Entered: 2013-11-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (INFANRIX TETRA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Death, Injection site abscess, Injection site oedema
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0943287A

Write-up: This case was reported in a literature article and described the occurrence of injection site abscess in an infant male subject who was vaccinated with DTaP-IPV (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of DTaP-IPV (unknown route, site of injection and batch number). At an unspecified time after vaccination with DTaP-IPV, the subject experienced abscess and edema both at the injection site. The subject died from death (cause unknown). Summary of the article: Few medications are licensed for use in children and off label prescribing is common. Nevertheless, information is scarce about adverse drug reactions (ADRs) from medicine use in children. Spontaneous reporting systems can provide important new information about ADRs and consumer reports provide first-hand information about patients'' experience with medicines and ADRs. However, consumer reports are not medically confirmed, which may impede interpretation of possible ADRs. It is therefore of interest to investigate the characteristics of paediatric consumer reports submitted to the ADR database in order to evaluate whether they contribute with information about new ADRs. The objective of this study was to characterize ADRs in children reported by consumers from 2007 to 2011. The authors analysed ADRs reported to the ADR database, for individuals from birth to 17 years. Data were characterized with respect to age and sex of the child, type of ADR (system organ class and preferred term), seriousness and suspected medicines (anatomical therapeutic chemical classification system level 1 and 5). In total, 240 ADR reports corresponding to 670 ADRs were identified. The relatively largest share of ADRs were reported for infants below 1 year followed by teenagers, and 60% of all ADRs were reported for girls. The majority of ADRs reported were of the general type (20%) and nervous system disorders (15%). The largest share of serious ADRs was of the type nervous system disorders (17% of all serious). Three cases of death were reported. Vaccines and anti-infectives for systemic use contributed to 30% of ADRs, antineoplastic and immunomodulating agents for 23% and sex hormones for 13%. In conclusion, only few paediatric ADR consumer reports were found. Many of these ADRs were serious, and fatal cases were reported, however also nonserious reports were present. The findings indicate that consumer reports may be of value in paediatric ADR signal detection, therefore the authors encourage regulators to provide public access to ADR data reported to national pharmacovigilance databases.


VAERS ID: 514394 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2013-10-08
Onset:2013-10-09
   Days after vaccination:1
Submitted: 2013-11-13
   Days after onset:35
Entered: 2013-11-22
   Days after submission:9
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK NS / IN

Administered by: Other       Purchased by: Other
Symptoms: Cardiac death, Cardiac disorder, Cor pulmonale
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pulmonary hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-09
   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: Concomitant Drug(s) Not Reported
Current Illness: Polio; Gastrointestinal disorder NOS; Electrolyte disturbance
Preexisting Conditions: Coronary artery bypass
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013SE83887

Write-up: A physician report from the Health and Medicines Authority concerns a 78 year old male. His past medical history included polio, gastrointestinal disorder NOS, electrolyte disturbance, and coronary artery surgery. The patient received an unspecified influenza virus vaccination (route and product unspecified) on 08-Oct-2013. According to the police report he was observed after vaccination according to guidelines, so he didn''t die of acute anaphylactic shock. She reported on suspicion alone, and knows not what the patient died of, he might have died of other cause. The patient was not autopsied, but the death certificate stated that the patient died of heart disease. The patient died from the cardiac disorder on 09-Oct-2013. The reporter considered the cardiac disorder to be serious by the criterion of death.


VAERS ID: 514487 (history)  
Form: Version 1.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2013-10-23
Onset:0000-00-00
Submitted: 2013-11-25
Entered: 2013-11-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 24449421A / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
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: ASS (Acetylsalicylic acid); Ramipril
Current Illness:
Preexisting Conditions: Smoker; Alcohol abuse; Arterial hypertension; Severe obstructive sleep apnea syndrome; Head tremor; Nicotine abuse; Contusion of breast; Suspected acute bronchitis; Orthostatic syncope; Orthostatic dysregulation; Severe snoring
Allergies:
Diagnostic Lab Data: Blood pressure, 180/90 mmHg, Apr-2011; MCV, 96.6 fl, 13-Mar-2012
CDC Split Type: 2013039164

Write-up: This health authority report (initial receipt 11-Nov-2013) concerns a 70-year old male patient. The patient''s medical history included smoking, alcohol abuse, head tremor, nicotine abuse and contusion of breast (since 25-Oct-1991). The patient was hospitalised from 19-Nov-2008 until 22-Nov-2008 for orthostatic syncope associated with alcohol use (10 small beers) and nicotine abuse. The patient was hospitalised after loss of consciousness in the evening (after alcohol intake) and in the morning after breakfast, again the patient''s legs had turned weak, sweating and had hit his head upon falling. The patient denied drinking alcohol regularly. This was due to orthostatic dysregulation. However, his long term EKG (electrocardiogram) was normal. Also his physical examination and EKG at rest was normal. His chest x-ray showed left pleural sinus was not sharp, indicating possible pleural fibrosis or effusion, abdominal sonography showed cholecystolithiasis with 3 stones, small haemangioma in right liver lobe. The patient was diagnosed with suspected acute bronchitis, severe obstructive sleep apnoea syndrome, arterial hypertension and was hospitalised from 27-Apr-2011 until 29-Apr-2011. In Apr-2011, the patient''s blood pressure was at 180/90 mmHg and on 13-Mar-2013, the patient underwent lab test for MCV (mean corpuscular volume) which was at 96.6 fl. It was reported that snoring and light sleep had led to his hospitalisation. For the past 3-4 years the patient had difficulty falling asleep for up to 2 hours, several times per week and had an imperative urge to fall asleep after lunch for the past 3-4 years. The patient has an involuntary tremor of head, starting a few years ago. The patient underwent neurological examination which was normal except for a mild tremor of head (in rest). His Epworth Sleepiness scale was 0/24 (normal). The patient underwent polysomnography on 27/28 Apr-2011 which showed severe obstructive breathing disorder in sleep, including severe snoring and decreasing oxygen saturation in all positions. His chest x-ray was normal. He underwent a duplex sonography of cerebral arteries which showed moderate atherosclerosis without evidence of stenosis. ENT (ear, nose and throat) examination was normal. His concomitant medications included acetylsalicylic acid and ramipril. On 23-Oct-2013, the patient was vaccinated with intramuscular AFLURIA (batch number: 24449421A). On 30-Oct-2013, the patient was found dead in his apartment after the door had been opened by the police. He had a plaster on the upper arm and the vaccination card was found on the desk suggesting that he had been vaccinated recently. It was estimated that the death had occurred between 23-Oct-2013 and 25-Oct-2013. The cause of death was reported as unknown. Outcome was reported as death.


VAERS ID: 514504 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2013-11-16
Onset:2013-11-17
   Days after vaccination:1
Submitted: 2013-11-22
   Days after onset:5
Entered: 2013-11-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR J0364 / 2 LA / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Death, Epistaxis, Feeling cold, Gastrointestinal haemorrhage, Muscle rigidity, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-17
   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: Unknown
Current Illness:
Preexisting Conditions: The patient had eczema in the middle of October 2013 and recovered after treatment. The patient was healthy at the time of vaccination. The patient has no adverse event history to the previous vaccines. Family history: there were no inherited diseases in the both their families.
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013SA119133

Write-up: Initial report received from a Health Authority on 17 November 2013. A 3-month-old patient had received an intramuscular second 0.5 ml dose of IPV vaccine (lot number: J0364-1) in the left arm on 16 November 2013 at 16:35 hours. The patient had received an intramuscular 0.5 ml dose 1 of IPV vaccine on 6 October 2013, Dose 2 of Hepatitis B vaccine on 16 September 2013, Dose 1 of Hepatitis B vaccine and BCG vaccine on 14 August 2013. The patient had personal history of full-term uterine-incision delivery, birth weight 3.2kg. The patient had eczema in the middle of October 2013 and recovered after treatment. The patient was healthy at the time of vaccination. The patient has no adverse event history to the previous vaccines. Family history: there were no inherited diseases in the both their families. On 16 November 2013 at 16:35 hours, the patient was crying. The patient was stopped crying after breast feeding. On 17 November 2013 at 10:00 hours, the patient fell asleep and patient got up and found cold and rigidity, not breathing. On 17 November 2013, at 10:46 hours, the patient was hospital and there was diagnosed as gastrorrhagia and rhinorrhagia. By the time they arrived to the hospital, the patient had died for 1-2 hours. Laboratory investigation and corrective treatments were not reported. Lab tests unknown.


VAERS ID: 514506 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-22
Entered: 2013-11-25
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Culture positive, Death, General physical health deterioration, Intensive care, Pneumococcal infection, Pyrexia, Streptococcus test positive
SMQs:, Anaphylactic reaction (broad), 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? 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: Unknown
Allergies:
Diagnostic Lab Data: Pleural fluid test (unknown date): positive for serotype 3 Streptococcus pneumoniae.
CDC Split Type: 2013330235

Write-up: This is a spontaneous report from numerous media reports via medical information team. A 3-year-old male patient of unknown ethnicity had participated in local program and received PCV7 (manufacturer unknown) at single dose on unknown date and PCV10 (manufacturer unknown) on an unknown date as booster dose. Concomitant medications and medical history were not reported. The patient suffered from invasive pneumococcal infection. This kind of infection was caused by Streptococcus pneumoniae. The body, with good past health, presented with fever and cough on 12NovXX (year unknown). He sought medical consultation from two private hospitals on 12NovXX and 14NovXX respectively. He was admitted to another private hospital on 15NovXX. As his condition deteriorated, he was transferred to a local hospital Paediatric Intensive Care Unit on 17NovXX and died on the same day. The boy''s pleural fluid specimens tested positive for serotype 3. He had no recent travel history and his family contacts are currently asymptomatic. No other similar cases have been reported by the kindergarten which he attended. Action taken was unknown. Pfizer is Marketing Authorization Holder of PCV7 in the reporter''s country. This may be a duplicate report in situations where another Marketing Authorization Holder of PCV7 has submitted the same report to the regulatory authorities.


VAERS ID: 514787 (history)  
Form: Version 1.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-25
Entered: 2013-11-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUC3: INFLUENZA (SEASONAL) (OPTAFLU) / NOVARTIS VACCINES AND DIAGNOSTICS 036031A / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Death, Malaise, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (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: No other medications
Current Illness: Cardiac disorder, Advanced cardiopath patient, Severe problems due to his cardiac disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2013ES134162

Write-up: Case number PHHY2013ES134162 is a combined spontaneous report initially received from a CEO of vaccines via Health Authority and follow ups from a physician via Health Authority on 22 Nov 2013. This report refers to a 75 year old male patient. He was an advanced cardiopath patient (had severe problems due to his cardiac disease). He was vaccinated with OPTAFLU (batch number: 036031A) on an unspecified date. After vaccination he went to have breakfast. He did not feel well and went to the toilet where he was found dead, 40 minutes after OPTAFLU administration. Cardiopulmonary resuscitation was performed without success. Cause of the death was reported as cardiac arrest (not acute myocardial infarction, although it could not be ruled out). No information regarding autopsy was reported. HA physician believed that the death was due to the underlying disease and assessed as not suspected to OPTAFLU.


VAERS ID: 514994 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Female  
Location: Foreign  
Vaccinated:2013-11-13
Onset:2013-11-15
   Days after vaccination:2
Submitted: 2013-11-27
   Days after onset:12
Entered: 2013-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC319BA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Muscle rigidity, Pallor, Pulse absent, Respiratory arrest, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Parkinson-like events (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: 2013-11-15
   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: VIGANTOL
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0947837A

Write-up: This case was reported by a physician via a regulatory authority (515-00-04700-2013-2) and described the occurrence of death (cause unknown) in a 6-week old female subject who was vaccinated with ENGERIX B pediatric, (GlaxoSmithKline). The subject had natural diet with addition of VIGANTOL 1 drop daily. The subject''s postnatal measurements were 2920 grams, 48 cm, head circumference of 33 cm, AC 9/10 and natural on-term birth. The subject was discharged from maternity hospital with body weight of 2975 grams and with a diagnosis of neonatus temporary eutrophicus female. On 9 October 2013, subject''s body weight was 3170 grams, 51cm and head circumference of 35 cm. On 8 November 2013, subject''s body weight was 4560 grams, length of 54 cm and head circumference of 38.5 cm. On 13 November 2013, the subject received 2nd dose of ENGERIX B pediatric (intramuscular, unknown injection site). After vaccination, the subject did not experienced local or systemic reaction. On 14 November 2013, at about 8:00 pm, the subject was breasted and left her to sleep.On 15 November 2013, in the morning at about 7:15 am, the father took his baby in the hands, but she did not wake up and was found to be pale. The father called the emergency medical services. On arrival, the subject was found to be dead (cause unknown). The subject was found lying on back with head turned to left in parent''s bed, with no life signs (no pulse and respiration). Examination showed that skin was pale with postmortem stains on the back, posterior thigh side, left ear lobe and on the left side of the scalp with no signs of external injury. No foreign object was found in the oral cavity and nose. Small joints of extremities were rigid. Modest hygienic and residential conditions without tobacco smoke present in the apartment where the subject lived. The physician considered that death was of unknown cause and unknown origin. Forensic examination was required to determine the cause of death.


VAERS ID: 515122 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-11-27
Entered: 2013-11-29
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 3 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: CSF test abnormal, Death, Intensive care, Otitis media, Pneumococcal infection
SMQs:, Guillain-Barre syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-16
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: Liquor serotypisation: confirmed serotype 3
CDC Split Type: 2013331090

Write-up: This is a spontaneous report from a contactable physician via a sales representative. A 3-year-old female patient received 3 doses of PREVENAR 13 in scheme 2+1 on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient developed pneumococcal otitis, which get complicated and lead to patient''s hospitalization. The patient died on 16Nov2013 in a hospital. It was not reported if an autopsy was performed. Further investigation from a serotypization of patient''s liquor confirmed serotype 3. The physician reported that the patient was not examined at the ambulance as she was immediately hospitalized in the paediatric department of a local hospital and subsequently transported to the intensive care unit of another hospital. The reporter also confirmed that did not report this case to the Health Authority.


VAERS ID: 515130 (history)  
Form: Version 1.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-11-15
Onset:2013-11-20
   Days after vaccination:5
Submitted: 2013-11-29
   Days after onset:9
Entered: 2013-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 1901AA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Chest discomfort, Death, Diabetic ketoacidosis
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-20
   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: No other medications
Current Illness: Ill-defined disorder; Diabetes mellitus
Preexisting Conditions: Rheumatic heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311CHN009905

Write-up: Initial information was received from agency (local CDC) on 21-NOV-2013 about the following report: a more than 60 years old female patient who had a history of rheumatic heart disease was inoculated PNEUMOVAX (0.5 mL, batch # T0968, Lot # 1901AA) on 15-NOV-2013. Her current condition included chronic diseases and severe diabetes mellitus. The patient experienced chest distress after the inoculation on 15-NOV-2013. She received treatment in local town hospital on 16-NOV-2013 and then was transferred to local county hospital on 18-NOV-2013. The patient was diagnosed as late stage diabetic acidosis. She died on 20-NOV-2013. No further information is expected. Additional information is not expected.


VAERS ID: 515494 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2013-11-22
Onset:2013-11-23
   Days after vaccination:1
Submitted: 2013-12-02
   Days after onset:9
Entered: 2013-12-03
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR J1472 / 1 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 13C02A / 1 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Apnoea, Cardio-respiratory arrest, Death, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-23
   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: Unknown
Allergies:
Diagnostic Lab Data: 22-NOV-2013, Body temperature, 36.5 Centigrade
CDC Split Type: 2013338211

Write-up: This is a spontaneous report obtained from a contactable pharmacist through a Pfizer sales representative and from the attending contactable physician in the same hospital with the initial reporter received via the Agency under the regulatory report number of V13000910. A 2-month-old female patient received the 1st dose of subcutaneous PREVENAR 13 (Lot # 13C02A) at 0.5 ml and the 1st dose of subcutaneous ACT-HIB (Lot # J1472) at 1 DF, both at around 14:00 on 22Nov2013. The patient''s birth weight was 1778 g and the body temperature before the vaccination was 36.5 degrees C. The patient had no family history, no underlying diseases and no complications. At around 06:00 and 07:00 on 23Nov2013, the patient was given milk and then fell asleep. At around 10:30, the patient''s mother noticed that the patient in a recumbent position on the bed was having apnoea. The patient was immediately transported to a hospital by an ambulance. The patient was in cardiopulmonary arrest. Cardiopulmonary resuscitation failed and the patient died on 23Nov2013. The patient''s death was confirmed at 12:21. It was not reported if an autopsy was performed. The cause of the death was cardiopulmonary arrest. According to the reporting pharmacist, the patient''s attending physician commented that a causal relationship between the event and the vaccines was unknown and causality assessment was impossible because it seemed that the patient had drunk milk normally at 06:00 and 07:00 am on 23Nov2013. The possibility of other factors was also unknown. The reporting pharmacist classified the event as serious (death) and considered that there would be no causal relationship between the event and the vaccines. The reporting physician classified the event as serious (death) and considered that causal relationship between the event and the vaccines was unknown and unassessable, and stated other causal factor was also unknown.


VAERS ID: 515809 (history)  
Form: Version 1.0  
Age: 0.22  
Sex: Female  
Location: Foreign  
Vaccinated:2013-11-22
Onset:2013-11-23
   Days after vaccination:1
Submitted: 2013-12-04
   Days after onset:11
Entered: 2013-12-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR J1472 / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: Unknown
Current Illness:
Preexisting Conditions: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013SA122835

Write-up: Initial report received from a healthcare professional via marketing partner on 25 November 2013 and follow-up information received on 26 November 2013. A 02-month-old female patient, had received subcutaneous 0.5 ml dose of ACTHIB. The case is not assessable with the presented information. The cause of loss of consciousness is not clear. Extensive description if medical history (family history), clinical and laboratory work up and other diagnostic procedures, data from the autopsy and final diagnosis are needed to assess the case. However two vaccines were administered at same time; so role of other vaccine cannot be denied.


VAERS ID: 515823 (history)  
Form: Version 1.0  
Age: 10.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-12-06
Entered: 2013-12-06
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: Epilepsy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1312CAN001830

Write-up: This spontaneous report as received from a physician refers to a 9-10 year old female patient with epileptic seizures. On an unknown date the patient was vaccinated with GARDASIL. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient passed away three weeks after receiving her vaccine. The relatedness of the death is unknown for with GARDASIL. Additional information has been requested.


VAERS ID: 515943 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-12-02
Onset:2013-12-02
   Days after vaccination:0
Submitted: 2013-12-06
   Days after onset:4
Entered: 2013-12-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Death, Platelet count decreased, Septic shock, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Toxic-septic shock conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (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: Hormones (unspecified)
Current Illness: Chemotherapy; Myelodysplastic syndrome, End stage
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: White blood cell count (WBC) (2013): 2000 or less; Platelet count (2013): 500 or less
CDC Split Type: WAES1312JPN003071

Write-up: Information has been received from a pharmacist concerning on a patient (sex and age were unknown) with myelodysplastic syndrome who was vaccinated with PNEUMOVAX NP 0.5ml once a day subcutaneously on 02-DEC-2013 (indication was not reported). The patient received chemotherapy for myelodysplastic syndrome originally. Concomitant medications include adrenal hormone preparations (manufacturer unknown). On 02-DEC-2013, the patient was vaccinated with pneumococcal vaccine at a hospital nearly. At dusk, the patient could not move after squatting in toilet then was send to reporting hospital by ambulance. The patient developed septic shock. In December 2013, white blood count was less than 2000, platelet was less than 500. Myelodysplastic syndrome was at end stage. In December 2013, the patient died. Death reason was septic shock. About autopsy was not reported. Reporter''s comment: not report. The reporting physician considered that septic shock was serious due to death. The reporting physician did not assess the causal relationship between septic shock and PNEUMOVAX NP. Additional information has been requested.


VAERS ID: 516391 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2013-09-17
Submitted: 2013-12-11
   Days after onset:85
Entered: 2013-12-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS AFLUA782BA / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Sepsis, Streptococcus test negative
SMQs:, Sepsis (narrow), Opportunistic infections (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: Dutasteride; Lamotrigine; Tamsulosin HCl; Phenprocoumon
Current Illness: Chronic renal impairment; Deep vein thrombosis; Depression; Nonsmoker; Prostatic hyperplasia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Streptococcus test negative, 19Sep2013, negative
CDC Split Type: D0082141A

Write-up: This case was reported by a foreign regulatory authority (# DE-PEI-PEI2013074192) and described the occurrence of sepsis in a 79-year-old male subject who was vaccinated with INFLUSPLIT SSW (GlaxoSmithKline). Concurrent medical conditions included chronic renal impairment, deep vein thrombosis, depression, non-smoker and prostatic hyperplasia. Concomitant medications included AVODART, lamotrigine, tamsulosin hydrochloride and phenprocoumon. On an unspecified date in fall 2013 the subject received a dose of INFLUSPLIT SSW (0.5 ml, intramuscular, unknown). At an unspecified time post vaccination with INFLUSPLIT SSW, on 17 September 2013, the subject experienced sepsis. Relevant test results included negative Streptococcus test, performed on 19 September 2013. In the further course, the subject died from sepsis on an unspecified date in 2013. According to the reporter an autopsy had not been performed. The foreign regulatory authority has requested further information. At the moment no further information was available.


VAERS ID: 516461 (history)  
Form: Version 1.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-12-09
Onset:2013-12-10
   Days after vaccination:1
Submitted: 2013-12-12
   Days after onset:2
Entered: 2013-12-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. 0542AE / 2 UN / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-12-10
   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: WAES1312NZL004481

Write-up: This spontaneous report as received from a agency through a phone call refers to a 16 year old female patient. On 09-DEC-2013, the patient was vaccinated with the second dose of GARDASIL (Lot# 0542AE; exp. date: 21-MAR-2015) (dose and route not provided). She also received the script for oral contraceptives (no other details provided). On 10-DEC-2013, in the morning, the girl was found death in her bed. No other details were available. It was noted that a post mortem will be conducted but no date had been set. The cause of death was reported as unknown. It was noted that the country immunization network contacted the Ministry of Health who contacted personnel in another agency. Agency were not planning any media release at this stage, as very few details were available. Additional information is not expected.


VAERS ID: 516694 (history)  
Form: Version 1.0  
Age: 5.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-12-12
Entered: 2013-12-16
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Malaise, Meningitis pneumococcal
SMQs:, Opportunistic infections (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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2013355067

Write-up: This is a spontaneous report from a contactable physician. A 5-year-old female patient was thought to have received PREVNAR as part of the standard vaccination program. Dose, frequency, dates and route of administration were not provided. The patient medical history was not reported. The patient''s concomitant medications were not reported. The physician reported that the five year old became ill very rapidly and died of pneumococcal meningitis on the weekend of 08Dec2013 (Dec2013). She went on to say that the kind of meningitis that it was was not the one that people usually think of, the one that is passed easily from person-to-person; this one was a less common kind of meningitis. She stated that they did not expect any other cases to be associated with this particular incident, and they were not recommending any public health follow-up. Officials did not know whether the type of meningitis that killed the girl was vaccine-preventable, but they did know that it was not meningococcal meningitis. The bacteria that caused the meningitis was a bacteria that was in the environment and it was passed from person to person. Why it was so severe for her, they didn''t know. The physician confirmed that the case was indeed of pneumococcal etiology. It was believed that the child was up-to-date with her vaccinations which would have included PREVNAR. The information on the bacterial serotype was not available at the time of reporting. The action taken in response to the events for PREVNAR was dose not changed. It was not reported if an autopsy was performed.


VAERS ID: 516841 (history)  
Form: Version 1.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2013-11-12
Onset:2013-11-12
   Days after vaccination:0
Submitted: 2013-12-17
   Days after onset:35
Entered: 2013-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Acidosis, Anaphylactic transfusion reaction, Ascites, Asthma, Autopsy, Blood creatinine increased, Blood lactate dehydrogenase increased, Blood pH increased, Blood product transfusion, CSF test, Condition aggravated, Continuous haemodiafiltration, Death, Decreased activity, Decreased appetite, Depressed level of consciousness, Erythema multiforme, Fall, Flushing, Gait disturbance, Meningitis, Muscle rigidity, Neuropsychiatric syndrome, Platelet count decreased, Red blood cell count, Renal failure, Renal failure acute, Respiratory failure, Restlessness, Thrombotic thrombocytopenic purpura, Tremor, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Akathisia (broad), Parkinson-like events (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Renovascular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-12-01
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness:
Preexisting Conditions: Orthostatic hypotension
Allergies:
Diagnostic Lab Data: On 18-NOV-2013: Cerebrospinal fluid examination and special hematology test results indicated a low possibility of Wernicke''s encephalopathy, encephalitis herpes, bacterial meningoencephalitis, tuberculous meningoencephalitis and fungal meningoencephalitis. A blood test on admission revealed significant acidosis (metabolic and respiratory) with pH at 6.9. 11/18/2013, Blood creatinine, 5.63; 11/19/2013, Blood creatinine, 4.46; 11/20/2013, Blood creatinine, 8.88; 11/22/2013, Blood creatinine, 2.84; 11/24/2013, Blood creatinine, 1.81; 11/18/2013, Blood lactate dehydrogenase, 230; 11/19/2013, Blood lactate dehydrogenase, 240; 11/20/2013, Blood lactate dehydrogenase, 224; 11/22/2013, Blood lactate dehydrogenase, 321; 11/24/2013, Blood lactate dehydrogenase, 368; 11/18/2013, Platelet count, 18.8; 11/19/2013, Platelet count, 7.4; 11/20/2013, Platelet count, 8.9; 11/22/2013, Platelet count, 2.5; 11/24/2013, Platelet count, 1.6; 11/18/2013, Red blood cell count, 265; 11/19/2013, Red blood cell count, 231; 11/20/2013, Red blood cell count, 307; 11/22/2013, Red blood cell count, 306; 11/24/2013, Red blood cell count, 305; 11/18/2013, White blood cell count, 9520; 11/19/2013, White blood cell count, 10290; 11/20/2013, White blood cell count, 11170; 11/22/2013, White blood cell count, 22680; 11/24/2013, White blood cell count, 17100
CDC Split Type: WAES1312JPN005965

Write-up: This spontaneous report as received from a pharmacist via PMDA refers to a 62 year old male patient. The patient''s medical history included orthostatic hypotension. On 12-NOV-2013 the patient was vaccinated with a dose of PNEUMOVAX, (dose and indication not reported), parenteral. No information on underlying/concomitant diseases was reported. The patient had no adverse reaction history. Other suspect drug included Influenza HA vaccine injection drug (trade name unknown)(vaccination date: 21-OCT-2013, dose and indication not reported). Information on other concomitant medications was not reported. On 12-NOV-2013, the patient was vaccinated with PNEUMOVAX at a nearby hospital. After the vaccination, flushed face, gradually decreased activity and appetite impaired were observed. The patient developed thrombotic thrombocytopenic purpura. In the morning of 18-NOV-2013, the patient had difficulty in walking and fell due to terror in the four limbs, for which he visited the nearby hospital. At that time, ascites was observed, and the patient went to the reporter''s hospital by ambulance. His consciousness level was decreasing. In addition, and he was in an unrest state and could not follow commands at all. As posterior rigidity was observed, cerebrospinal fluid examination was performed for suspected meningitis, and treatments for Wernicke''s encephalopathy, encephalitis herpes, bacterial meningoencephalitis, tuberculous meningoencephalitis and fungal meningoencephalitis were initiated. Cerebrospinal fluid examination and special hematology test results indicated a low possibility of the meningoencephalitis, so each treatment was completed in sequence. A blood test on admission revealed significant acidosis (metabolic and respiratory) with pH at 6.9. The patient had renal failure and was anuric after admission. He was diagnosed with acute renal failure and continuous haemodiafiltration (CHDF) was initiated. Platelets decreased, renal failure and neuropsychiatric symptoms, thrombotic thrombocytopenic purpura had been suspected since the admission, for which fresh frozen plasma (FFP) 4 units was transfused with a mild improvement in consciousness level thereafter. On 19-NOV-2013, plasma exchange was initiated, after which the patient presented with severe asthma, respiratory failure and erythema multiforme exudativum in 30 minutes of the initiation and was diagnosed with anaphylaxis due to FFP. Plasma exchange was discontinued, and the patient received adrenaline and methylprednisolone. Although DECADRON (83 mg/day on a predonine conversion) had been given for treatment of meningoencephalitis since the admission date, the patient experienced anaphylaxis with plasma exchange. Therefore, administration of FFP was held for a while, and whole body management was performed with CHDF, blood pressure control and respiratory support. However, the patient''s condition gradually aggravated, and his platelets decreased to 15000. His family members still requested another plasma exchange after a full explanation of the current situation. On 28-NOV-2013, as plasma exchange was considered as very high risk, FFP was transfused with steroid pulse therapy (until 30-NOV-2013). On 01-DEC-2013, the patient passed away. In this case, the activity of a disintegrin and metalloproteinase with thrombospondin type-1 motifs 13 (ADAMTS-13), which was considered to be specific to thrombotic thrombocytopenic purpura, decreased to 28%. On the other hand, the patient had no other specific symptoms such as haemolytic anaemia and pyrexia. Therefore, autopsy was performed. The reporting pharmacist considered that thrombotic thrombocytopenic purpura and acute renal failure was serious due to death. The reporting pharmacist did not assess the seriousness of flushed face and anaphylaxis. The reporting pharmacist felt that thrombotic thrombocytopenic purpura was related to PNEUMOVAX and influenza HA vaccine. The reporting pharmacist did not asses the causal relationship of PNEUMOVAX to flushed face and acute renal failure. The reporting pharmacist considered that anaphylaxis was related to FFP and not relate to PNEUMOVAX. Additional information has been requested.


VAERS ID: 517164 (history)  
Form: Version 1.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-11-12
Onset:2013-11-15
   Days after vaccination:3
Submitted: 2013-12-13
   Days after onset:28
Entered: 2013-12-19
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (FOREIGN) / NOVARTIS VACCINES AND DIAGNOSTICS 132402 / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abasia, Acute polyneuropathy, Areflexia, Asthenia, Back pain, Blood bilirubin normal, Blood creatinine increased, Blood folate decreased, Blood glucose, Blood sodium decreased, C-reactive protein normal, Calcinosis, Cardio-respiratory arrest, Cerebellar atrophy, Computerised tomogram abdomen normal, Computerised tomogram abnormal, Cytomegalovirus test, Dysaesthesia, Dysstasia, Echocardiogram abnormal, Electrocardiogram normal, Electromyogram abnormal, Escherichia infection, Facial wasting, Fatigue, Flank pain, Gamma-glutamyltransferase increased, Glomerular filtration rate, Haematocrit decreased, Herpes simplex serology, Hypertension, Immunoglobulins, Lumbar puncture abnormal, Lymphocyte count decreased, Muscle atrophy, Muscular weakness, Neurological examination abnormal, Oedema, Pain, Paraesthesia, Polyneuropathy, Protein total normal, Red blood cell count decreased, Renal pain, Spinal X-ray normal, Spondylitis, Sudden death, Synovial rupture, Urinary tract infection, Vitamin B12, Vomiting, Walking aid user, White blood cell count abnormal
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Peripheral neuropathy (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Lipodystrophy (narrow), Chronic kidney disease (broad), Arthritis (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-12-05
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COTAREG; EUTIROX; Cortisone acetate; Genotropin; DIBASE; BONIVA
Current Illness: Asthenia; Vomiting; Hypertension; Osteoporosis, Under replacement therapy; Hypopituitarism
Preexisting Conditions: 2010, Pathological fracture; Prosthesis implantation; Rehabilitation therapy
Allergies:
Diagnostic Lab Data: 11/23/2013, Blood bilirubin, 0.4; 11/25/2013, Blood bilirubin, 0; 11/26/2013, Blood bilirubin, 0; 11/23/2013, Blood creatinine, 1.6; 11/25/2013, Blood creatinine, 1.7; 11/26/2013, Blood creatinine, 1.5; 11/29/2013, Blood creatinine, 1.3; 12/03/2013, Blood creatinine, 1.6; 11/26/2013, Blood folate decreased, 2.1; 11/23/2013, Blood glucose, 116, Basal glucose; 11/24/2013, Blood glucose, 82, in the cephalorachidian fluid; 11/25/2013, Blood glucose, 107; 11/26/2013, Blood glucose, 300; 11/29/2013, Blood glucose, 109; 11/24/2013, Blood pressure, 130/80; 11/25/2013, Blood sodium, 134; 11/26/2013, Blood sodium, 131; 11/29/2013, Blood sodium, 131; 11/23/2013, C-reactive protein, 0.011; 11/25/2013, C-reactive protein, 0.015; 11/23/2013, EGFR, 30.4; 11/25/2013, EGFR, 28.4; 11/26/2013, EGFR, 32.8; 11/29/2013, EGFR, 38.7; 12/03/2013, EGFR, 30.4; 11/25/2013, Electromyogram, Abnormal, Positive. 11/29/2013, Gamma-glutamyltransferase, 43; 11/29/2013, Haematocrit, 31.8; 12/03/2013, Haematocrit, 30.6; 11/25/2013, Haemoglobin, 1, Significant; 11/26/2013, Haemoglobin, 1, Significant; 11/29/2013, Haemoglobin, 10.5; 12/03/2013, Haemoglobin, 10.4; 11/26/2013, Immunoglobulins, 17.8, Herpes simplex 1 IgG = 27.1, Herpes simplex 2 IgG = 1.64 Ab Anti CMV IgG = 144; 11/24/2013, Oxygen saturation, 95%, in room air; 11/24/2013, Protein total, 80, in cephalorachidian fluid; 11/25/2013, Protein total, 6, Total; 11/25/2013, Red blood cell count, 3.94; 11/26/2013, Red blood cell count, 3.88; 11/29/2013, Red blood cell count, 3.3; 12/03/2013, Red blood cell count, 3.18; 11/26/2013, Vitamin B12, 126; 11/24/2013, Weight, 70; 11/25/2013, White blood cell count, 25; 11/29/2013, White blood cell count, 3.71, Lymphocytes = 0.51
CDC Split Type: PHHY2013IT145251

Write-up: Case number PHHY2013IT145251 is an initial spontaneous report from the health authority received on 10 Dec 2013. This report refers to an 86-year-old female patient. Her medical history included arterial hypertension and pituitary insufficiency. It was reported that her hypopituitarism was diagnosed in 1998 following the onset of asthenia and vomiting, and after a magnetic nuclear resonance (RMN) test of the pituitary gland that had reported a pituitary gland alteration not better specified (the patient excluded the presence of a nodular or expansive pathology). She had concomitant severe osteoporosis with spontaneous fractures of the right femoral bone in 2010, treated with prosthesis. She was ongoing with replacement therapy with EUTIROX and Cortone Acetate 25 mg with the last endocrinological evaluation follow up performed at the Hospital in Sep 2013. Concomitant drugs included COTAREG, EUTIROX 50, Cortone acetate DIBASE, BONVIVA and Genotropin. Her previous vaccinations included FLUARIX vaccine on 23 Nov 2011 and on 29 Nov 2012. She was vaccinated with AGRIPPAL S1 (batch number: 132402, expiry date: 30 Jun 2014) on 12 Nov 2013. On an unknown date, after vaccination she experienced pain at the left flank. The patient got admitted in the emergency department. It was reported that her last visit was performed on 21 Nov 2013 and the patient has been discharged with the diagnosis of lumbar pain and pain at kidney loggia on the left side. A CT scan of the abdomen has been performed that was negative. Treatment with DUROGESIC has been started. Due to the progressive evidence of hyposthenia and dysesthesia at the lower limbs with ingravescent course, characterized by the incapability to walk it has evidenced a diagnostic lumbar tap as far as suspected of Guillain Barre syndrome was concerned. During hospital admission suspected acute polyneuroradiculoneuritis of Guillain Barre type was diagnosed. Her blood pressure was 130/80, heart rate: 84, O2 saturation 95% in room air, body weight: 70 and VAS: 8. Her abdomen was treatable and thoracic examination was within the normal limits. Neurological objective examination at hospital admission showed moderate facial deficit greater on the left side of peripheral type. She had no hyposthenia at the upper limbs, but hyposthenia at the lower limbs, dysesthesia with distal paresthesia up to the umbilical level, osteo-tendon reflexes (ROT) absent at the lower limbs, weak at the upper limbs and cutaneous plantar reflex (RCP) in plantar flexion, GBS disability scale and Erasmus GBS scale filled out as (5/7). On 23 Nov 2013, her basal glucose was 116, creatinine was 1.6, eGFR was 30.4, bilirubine 0.4 and C-reactive protein 0.011. On 24 Nov 2013, the dorsal spine and lumbo sacral spine X-ray showed diffuse reduction of the calcium tone and diffuse spondyloarthritis. No signs of bone fractures and clear somatic collapses can be evidenced. Encephalous CT scab showed notes of cortico-subcortical atrophy, lacunar hypodensity areas due to not recent ischaemic sequels, bilateral, the greater one in the left peri-insular region. Ventricular system regular as far as morphology and content were concerned. On the same date, lab tests showed glucose in the cephalorachidian fluid as 82 and proteins in the cephalorachidian fluid as 80. On 25 Nov 2013, the patient underwent an electromyography examination indicative of symmetrical polyneuropathy at the four limbs, mixed motor-sensitive with predominantly demyelinating characteristics, of marked entity, compatible with the clinical suspect of Guillain-Barre syndrome. Present hospital admission due to suspected acute polyneuroradiculoneuritis of Guillain-Barre. It was reported that the dosage of the RSH has been performed, 0.11 consistent with the primary pituitary deficit sodium 131, potassium 3.5. Integration with dosage of FT3, FT4, prolactine, cortisol, PRA, and aldosterone (to be performed before taking the drugs) would be useful. Cycle of therapy with Ig endovenously at high dosage in slow infusion has then been administered for 5 days from 25 Nov 2013 to 29 Nov 2013. On 25 Nov 2013, the lab tests showed creatinine 1.7, eGfr 28.4, sodium 134, total protein 8, C-reactive protein 0.015, hemoglobin 1, leukocytary esthease 25, RBC 3.94. On the third day the neurological objectivity slightly worsened with reduction of the strength in prension of the hands, peripheral facial deficit bilaterally, but more evident on the left side and the remaining cranial nerves were not compromised. She had persistence of pain symptomatology and para-dysesthesia at the lower limbs of fluctuant intensity and characterized by exacerbations often during the night, despite of the administered analgesic therapies. The dosage of Cortisone acetate has been increased as for endocrinological recommendations. On 26 Nov 2013, creatinine 1.5, eGFR 32.8, sodium 131, immunoglobulins G 17.8, glucose 300, hemoglobin 1, lymphocytes 0.75, Vit B12 126, folic acid 2.1, herpes simplex 1 IgG 27.1, herpes simplex 2 IgG 1.64 and interpretation of previous infection, TSH = 0.118. On 27 Nov 2013, upon endocrinology visit it was reported that the patient had less hyposodiemia, B12 and folates deficit, TSH reduced, compatible with hypopituitarism, fT4 and fT3 not available, IGF1 within the normal limits. The patient was advised to take the steroid therapy switching to Cortisone one tablet half tablet up to hospital discharge or Flebocortid 100 mg that can be repeated every 12 hours and supplementation with B12 folates. The repeated ECG, on 24 Nov 2013 and on 29 Nov 2013 resulted within the normal limits, with sinus rhythm. On 28 Nov 2013 FT3 was 1.31. On 29 Nov 2013, creatinine 1.3, eGfr 38.7, sodium 131, WBC 3.71, gamma-GT 43 and lymphocytes 0.51. On 29 Nov 2013, the patient has started rehabilitation treatment in bed and on 02 Dec 2013 demonstration of the patient capability to control his posture, for this reason the possibility of a subsequent transfer ring to a second level Rehabilitation institution has been taken into account. At the hematobiochemical examination, a mild increase in creatinine has been observed. Since 30 Nov 2013, antibiotic treatment with Amoxicillin/clavulanic acid has been added due to infection of the urinary way due to E. Coli. Thromboembolic prevention therapy with low molecular weight heparin subcutaneously has been performed. Based on physiokinesitherapy evaluation on 29 Nov 2013 and individual rehabilitation plan programmed on 02 Dec 2013, it was reported that the patient was alert, oriented and cooperative. Minimal deficit with difficulty of prension and manipulation at the level of the left upper limb. The patient reported paresthesias at both hands. Recruiting muscle deficit bilaterally at the lower limbs with partial possibility of flexion-extension and abduction-adduction of the hip, extension of the knee was possible (partially even against gravity). Paresthesias, and marked deficit of the sensibility distally. The patient was able to change with a minimal support his own positions while he needed a great support to reach the seated position with his legs outside the bed. The patient was able to control the trunk posture in the seated position. The patient was not able to obtain the standing position even with an intense support. The patient can maintain the standing position with the aid of a deambulator walker but she felt a great fatigue during movements. Neuro-motor rehabilitation treatment was ongoing with mobilization of the lower and upper limbs exercises to improve the offered cooperation and to autonomize the postural changes, propaedeutic exercises to control the trunk with the attempt to recovery the standing position. On 03 Dec 2013, creatinine was 1.6, eGFR 30.4, hemoglobin 10.4, Rbc 3.18 and hematocrit as 30.6. On 04 Dec 2013, the patient underwent Echodoppler examination of the lower limbs, venous and muscle-tendon, with observation of fluid collection in the posterior loggia of the right leg due to probable breaking of a Baker cyst, probable concomitant cause of pain and discrete thickening of the subcutaneous tissue due to edema. On the same date, observation of arterial hypertension, treatment with antihypertensive drug has been withdrawn. Exacerbation of the pain symptomatology at the lower limbs, and some episodes of vomiting have been reported. Feeding orally was possible in autonomy, no dyspnoea, sensorium always not compromised. Treatment received by the patient was reported as Pregabalin, nadroparinum and AUGMENTIN. She also had cardiorespiratory arrest on an unspecified date. She had sudden death in the morning of 05 Dec 2013 at 7.40 a.m with acute, inflammatory polyneuropathy of Guillain-Barre type. The causality of the event Guillain-Barre Syndrome was reported as suspected to be related to vaccination with AGRIPPAL S1. Following an internal review on 13 Dec 2013, a significant correction was done for the information received on 10 Dec 2013: The labeling of the event fatal Guillain Barre syndrome was changed from listed to unlisted.


VAERS ID: 517286 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2013-12-20
Entered: 2013-12-20
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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1310GBR012338

Write-up: This spontaneous report as received from a consumer refers to a hearsay adverse experience. It was reported there was a death case in England a few years ago. It was indicated the reporter heard the news in year 2010 from TV and newspaper (a local newspaper). The reporter barely recalled there was 1 death case reporter and the brand of produce was barely recalled as GARDASIL. The reporter also mentioned her sister, also heard same death reports in 2010. (MARRS# 1311GBR000054). Additional information is not available.


VAERS ID: 517293 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2013-09-26
Onset:2013-09-28
   Days after vaccination:2
Submitted: 2013-12-20
   Days after onset:83
Entered: 2013-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-09-30
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Cyanocobalamin
Current Illness: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1312GBR009370

Write-up: Information has been received from Sanofi Pasteur MSD (SPM) E2013-10851 on 13-Dec-2013. This case was received from a health care professional on 13-Dec-2013. This case is medically confirmed as it was reported by a physician. An 80 year old male patient, with no medical history reported, received on 26-Sep-2013 an injection of ZOSTAVAX, (batch number not reported), dose in series, route and site of administration not reported and the same day, he also received his 3 monthly vitamin B12 injection. On 28-Sep-2013, the patient experienced a myocardial infarction which leaded to the patients death on 30-Sep-2013. The patients outcome was therefore fatal.


VAERS ID: 517429 (history)  
Form: Version 1.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-11-01
Onset:2013-11-01
   Days after vaccination:0
Submitted: 2013-12-19
   Days after onset:48
Entered: 2013-12-20
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute respiratory distress syndrome, Chest X-ray abnormal, Culture negative, Death, Legionella test, Lung infiltration, Mycoplasma test, Pneumonia, Viral test negative
SMQs:, Interstitial lung disease (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: 2013, Influenza vaccine
Allergies:
Diagnostic Lab Data: Chest X-ray (unknown date): bilateral pulmonary infiltrates and confirmed the diagnosis of pneumonia; Cultures for mycoplasma, legionella, klebsiella and viruses NOS (Nov2013): negative
CDC Split Type: 2013350280

Write-up: This is a spontaneous report from a contactable physician, and then from a contactable pneumonologist. An 80-year-old female patient of an unspecified ethnicity received PREVENAR 13 intramuscular in the beginning of Nov2013, at 0.5ml single. The patient medical history and concomitant medications were not reported. The patient received an influenza vaccine in 2013 (unspecified date). About in the middle of Nov2013 the patient was hospitalized due to pneumonia symptoms. Lab data included chest X-ray on an unknown date which revealed bilateral pulmonary infiltrates and confirmed the diagnosis of pneumonia. During hospitalization she underwent cultures for Mycoplasma, Legionella, Klebsiella and viruses NOS, which were negative. While she was hospitalized the patient developed adult acute respiratory distress syndrome, which was treated with cortisone. As per patient''s relatives decision, the patient was not transferred to the ICU in order to be intubated. At the end of Nov2013 the patient died. No autopsy was performed and the exact cause of death was not reported. The treating physician did not consider that the events could be attributed to PREVENAR 13. Follow-up (11Dec2013): New information received from a contactable pneumonologist includes: patient''s age, lab data updated, event "adult acute respiratory distress syndrome" added, event "death" added, past drug history, causality assessment. Follow-up attempts completed. No further information expected.


VAERS ID: 517460 (history)  
Form: Version 1.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-10-31
Onset:2013-10-31
   Days after vaccination:0
Submitted: 2013-12-23
   Days after onset:53
Entered: 2013-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (AFLURIA) / CSL LIMITED 2454941117 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Chest X-ray abnormal, Culture positive, Death, Laboratory test abnormal, Pneumonia, Sepsis
SMQs:, Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
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:
Allergies:
Diagnostic Lab Data: Chest X-ray; Culture; Lab test
CDC Split Type: 2013039656

Write-up: This medically confirmed health authority report (initial receipt 13-Dec-2013) concerns a 77 year old female patient. Influenza vaccination had been used yearly and tolerated in the past. On the 31-Oct-2013, the patient received AFLURIA (batch number ''2454941117'') 1 separate dose. On the 31-Oct-2013, the patient developed pneumonia bilaterally and sepsis which lasted for four days. The patient died on an unknown date. It was unknown whether an autopsy was performed. Diagnosis was confirmed by a chest X-ray, laboratory tests and cultures (blood). No outpatient was needed, however inpatient treatment was needed. The outcome was reported as fatal. Cause of death is unknown.


VAERS ID: 517776 (history)  
Form: Version 1.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2013-12-17
Onset:2013-12-17
   Days after vaccination:0
Submitted: 2013-12-27
   Days after onset:10
Entered: 2013-12-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. 9MP14R / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Dyspnoea, Pneumonia pneumococcal, Sputum culture positive, Urine analysis abnormal
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-12-19
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Gram-positive cocci was detected in the sputum and pneumococcal urinary antigen test resulted positive; 12/17/2013, Body temperature, 36.5 degrees C
CDC Split Type: WAES1312JPN011544

Write-up: Initial information has been received from a physician via Regulatory Authority concerning an 87 year old male patient who on 17-DEC-2013 received the first vaccination with PNEUMOVAX NP (Lot number was reported as 9MP14R) parenteral (dose and indication were not reported). According to the pre-vaccination interview sheet, the patient had no underlying disease, allergy, vaccination or disease within recent one month, current medications, adverse drug reaction history, abnormal status of growth, etc. The patient had no family history. Information on concomitant medications was not reported. On 17-DEC-2013, at 2:00 pm, the patient received the first vaccination with PNEUMOVAX NP (Lot no. 9MP14R). The body temperature prior to vaccination was 36.5 degrees C. The patient presented with dyspnoea from the evening (17-DEC-2013) and was transferred to another hospital. Gram-positive cocci was detected in the sputum and pneumococcal urinary antigen test resulted positive, based on which the patient was diagnosed with pneumococcal pneumonia on 17-DEC-2013. He was treated with antibiotics. On 19-DEC-2013, the symptoms did not improve, and the patient passed away. The cause of death was pneumococcal pneumonia. No information of autobiopsy was provided. Reporter''s comment: It was considered that pneumococcal pneumonia happened to occur around the time of vaccination. The reporting physician considered that the pneumonia was serious due to death. The reporting physician felt that the pneumonia was not related to PNEUMOVAX NP. Upon internal review, it was considered that the causal relationship between the pneumonia and pneumococcal vaccine could not be denied. No further information is available. Information has been received for a direct report from the agency regarding a case provided by the physician. Additional information has been requested.


VAERS ID: 517947 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2013-12-12
Onset:2013-12-13
   Days after vaccination:1
Submitted: 2013-12-24
   Days after onset:11
Entered: 2013-12-30
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR J1493 / 1 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 13C02A / 1 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Computerised tomogram abnormal, Death, Endotracheal intubation, Mechanical ventilation, Peripheral coldness, Respiratory arrest, Resuscitation, Therapeutic aspiration
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (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), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-12-13
   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 baby the first born DD twin; Intrauterine growth retardation born at 37 weeks 0 days
Allergies:
Diagnostic Lab Data: 12-DEC-2013, Body temperature, 35.7 Centigrade; CT (13Dec2013): no cerebral hemorrhage, no fracture; aeration decreased of lung, atelectasis and significant gas accumulation in GIT (without perforation) were observed.
CDC Split Type: 2013363177

Write-up: This is a spontaneous report from a contactable physician via Agency with the regulatory authority report number: V13001032. A 2-month-old male patient received the first PREVENAR 13 (lot #: 13C02A) and the first ACT-HIB (lot number J1493) both subcutaneously at 0.5 ml, single dose at 09:30 on 12Dec2013. The patient medical history included low birth weight baby. The patient was the first born DD twin with intrauterine growth retardation. The gestational age at birth was 37 weeks 0 days. The body weight at birth was 1993g. Concomitant medications were not reported. The body temperature before vaccination was 35.7 degrees C. The patient died on 13Dec2013. It was not reported if an autopsy was performed. The reporter classified the event as serious (death) and assessed it as unassessable (could not be ruled out). Possible causal factors included low birth weight baby and poor weight gain. The clinical course was as follows: On 12Dec2013, the patient suckled as usual at 09PM an slept at 11PM as confirmed by the parents. At 03:24 on 13Dec2013, the patient was found cold on supine position without breathing and moving and transported by ambulance. At the time of arrival, cardiorespiratory arrest was observed. Milk was aspirated out of the pharynx and the respiratory tract. The patient was intubated and ventilated. Chest compression was performed, route was secured, saline was administered via IV drip, and adrenalin was administered IV 15 times. However the patient did not respond to resuscitation an died (death confirmed at 04:51AM). CT showed no cerebral hemorrhage, no fracture; aeration decreased of lung, atelectasis and significant gas accumulation in GIT (without perforation) were observed.


VAERS ID: 517968 (history)  
Form: Version 1.0  
Age: 0.9  
Sex: Female  
Location: Foreign  
Vaccinated:2013-12-10
Onset:2013-12-10
   Days after vaccination:0
Submitted: 2013-12-30
   Days after onset:20
Entered: 2013-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (INFANRIX TETRA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Asphyxia, Autopsy, Brain oedema, Cardiac arrest, Cyanosis, Dyspnoea, Electrocardiogram abnormal, Foreign body, Hyperthermia, Loss of consciousness, Mechanical ventilation, Mydriasis, Pericardial haemorrhage, Pulse absent, Pupillary light reflex tests abnormal, Respiratory arrest, Resuscitation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic 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), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Hyponatraemia/SIADH (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (narrow), Cardiomyopathy (broad), Retinal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-12-11
   Days after onset: 1
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: Paracetamol; Halopyramine HCl
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Body temperature, 10Dec2013, 37.6Deg. C; Body temperature, 11Dec2013, 37.6Deg. C; Electrocardiogram, 11Dec2013, death
CDC Split Type: B0955884A

Write-up: This case was reported by the regulatory authority and described the occurrence of mechanical asphyxia in a 11-month-old female subject who was vaccinated with INFANRIX-IPV (GlaxoSmithKline) and who received PANADOL (GlaxoSmithKline) and SUPRASTIN (other manufacturer). The subject was examined by the paediatrician. Subject''s body temperature was 36.6 Deg. C, there were no complaints. The subject was healthy. On 10 December 2013, the subject received 1st dose of INFANRIX-IPV accordingly to the approved procedure. The vaccine was transported and stored correctly. On 10 December 2013 in the evening, less than one day after vaccination with INFANRIX-IPV, the subject experienced hyperthermia (37.6 Deg. C). The subject was treated with PANADOL and SUPRASTIN. The subject was calm over the night. On 11 December 2013 in the morning, subject''s body temperature was 37.6 Deg. C. PANADOL and SUPRASTIN were given again. The body temperature decreased and hyperthermia resolved. The subject was active. On 11 December 2013, at 10:20 AM, less than one day after receiving PANADOL and SUPRASTIN, 1 day after vaccination with INFANRIX-IPV, when subject''s father was playing with the child, she developed dyspnoea and fainted. The ambulance was called. Parents tried to provide cardiopulmonary resuscitation. Ambulance personnel ascertained absence of consciousness and breathing and asystole. Cardiopulmonary resuscitation was started as well as ventilation with Ambu cardiopulmonary resuscitation mask and external cardiac massage. Adrenaline and dexamethasone IV were given. The subject was admitted to hospital. Examination in the emergency room revealed unconsciousness, mydriasis, absence of photoreaction, absence of pulse on main arteries, breathing absence and cyanotic skin. No signal (baseline) on the electrocardiogram. Biologic death was verified. The regulatory authority reported that hyperthermia was probably related to vaccination with INFANRIX-IPV. Mechanical asphyxia was unrelated to vaccination with INFANRIX-IPV. The subject died on 11 December 2013 from asphyxia caused by foreign body (polyethylene film). An autopsy was performed. According to the results of forensic examination, a foreign body (polyethylene film) was detected in the right main bronchi. Signs of acute asphyxia were detected. A brain oedema and haemorrhages were detected on the dorsal part of the heart and under the epicardium.


VAERS ID: 518190 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2013-12-21
Onset:2013-12-24
   Days after vaccination:3
Submitted: 2013-12-30
   Days after onset:6
Entered: 2013-12-31
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR J1512 / 1 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 13DD1A / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Death, Respiratory syncytial virus test positive
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-12-24
   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: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Unknown; Not reported.
Allergies:
Diagnostic Lab Data: The result of rapid respiratory syncytial virus (RSV) test was positive; Body temperature, UNK, 35.8 Degree C;
CDC Split Type: 2013SA135414

Write-up: Initial case was received from a healthcare professional on 25 December 2013. A 2 month old male infant, who had no medical history reported, received a simultaneous inoculation of 0.5 ml dose of ACTHIB subcutaneously (Batch number: J1512) and PREVENAR13 on 21 December 2013 (route, site, dose not reported and batch number: 13DD1A) as a primary immunization. At the time of birth, his weight was 3225 g and had no familial history. Patient''s body temperature was recorded as 35.8 degrees Centigrade before vaccination. The patient had not reported concomitant medication. It was reported that on 24 December 2013 at around 04:20 am, patient had cardio-respiratory arrest. Patient was then transported to another hospital at 04:38 am. On same day his death was confirmed. The result of rapid respiratory syncytial virus (RSV) test was positive. No corrective treatment was reported. The cause of death and information on whether an autopsy was performed were not provided. According to the reporting Physician, RSV infection was considered to be an alternative explanation for the event and causality assessment was unknown. Outcome of the event was fatal. Documents held by sender: none.


VAERS ID: 518198 (history)  
Form: Version 1.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2013-10-23
Onset:2013-10-24
   Days after vaccination:1
Submitted: 2013-12-31
   Days after onset:68
Entered: 2013-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Aphasia, Apnoea, Blood test, Body temperature increased, Chest X-ray, Coma, Computerised tomogram, Condition aggravated, Death, Dyspnoea, General physical health deterioration, Grand mal convulsion, Incontinence, Mobility decreased, Respiratory disorder, Respiratory failure, Respiratory rate increased, Tachycardia
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), 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), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-11-09
   Days after onset: 16
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: Clonazepam; Lamotrigine; Midazolam; Vitamin B Complex; Thiamine
Current Illness: Unknown
Preexisting Conditions: Lennox-Gastaut syndrome; Seizure; No allergies
Allergies:
Diagnostic Lab Data: Blood test, Unknown; Chest X-ray, Unknown; Computerised tomogram, Unknown; Infection samples taken.
CDC Split Type: B0955305A

Write-up: This case was reported by a regulatory authority (# GB-MHRA-EYC 00107001) and described the occurrence of respiratory rate in a 20-year-old male subject who was vaccinated with Influenza vaccine (manufacturer unspecified). The subject''s medical history included Lennox-Gastaut syndrome and seizure. Concurrent medications included Clonazepam, KEPPRA, Lamotrigine, Midazolam, Vitamin B Complex and Thiamine. On 23 October 2013 the subject received unspecified dose of Influenza vaccine (1 IU Axa). On 24 October 2013, 1 day after vaccination with Influenza vaccine, the subject experienced tachycardia, grand mal seizure, rise in temperature, decreased mobility, loss of speech, and incontinence Approximately 7 days later on 30 October 2013 the patient experienced apnea and then 10 days later on 02 November 2013 the patient experienced Irregular respiration and respiratory rate increased. On an unknown date the patient went into a coma and had general physical health deterioration and condition aggravated. The subject was hospitalised and the regulatory authority reported that the events were disabling and life threatening. The subject died on 09 November 2013 from respiratory failure. It was unknown whether an autopsy was performed. I have contacted the vaccine damage unit but they do not include the seasonal influenza vaccine in their investigation schedule. My son had Lennox Gastaut syndrome and as such had frequent seizures. He was doing well and stable. The day following his influenza vaccine he developed a temperature and difficulty with respiration. He became tachycardic and his seizures increased from his base line target of below 10 to 30, then 50 then in the final days over a hundred grand mal seizures. He was admitted to hospital and no chest infection found, and released. His seizures and temperature kept increasing after discharge and he was readmitted later the same week. His seizures were stabilized and he was also treated with anti-retro viral TAMIFLU, because of possible link to vaccine causing serious deterioration of his health. He slipped into a coma and he died of respiratory failure the following day. My son was also treated at home prior to his admissions by various professionals and the visiting general practitioner just said to give him paracetamol to try to lower temperature. His consultant neurologist said this needs investigation. This was the first time my son had had this vaccine, and his deterioration and subsequently, death appears to be a direct consequence of a reaction from this. My son was admitted to hospital by ambulance twice by ourselves, due to concern over massive seizure increase and temperature and general declining state of health since the flu vaccine.


VAERS ID: 518512 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2013-10-23
Onset:0000-00-00
Submitted: 2013-12-26
Entered: 2014-01-06
   Days after submission:11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Aphasia, Apnoea, Blood test, Body temperature increased, Chest X-ray, Coma, Computerised tomogram, Condition aggravated, Convulsion, Death, Dyspnoea, General physical health deterioration, Grand mal convulsion, Incontinence, Mobility decreased, Respiratory disorder, Respiratory failure, Respiratory rate, Tachycardia
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), 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), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2013-11-09
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: Clonazepam; KEPPRA; Lamotrigine; Midazolam; Thiamine; Vitamin B complex
Current Illness: Lennox-Gastaut syndrome; Convulsion, Frequently
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood test, unknown; Chest X-ray, unknown; Computerised tomogram, unknown
CDC Split Type: PHFR2013GB007336

Write-up: Case number PHFR2013GB007336, is an initial spontaneous report received from the consumer via health authority (reference number: 22356018) on 23 Dec 2013. This report refers to a 20-year-old male patient. His medical history included Lennox-Gastaut syndrome and frequent seizures. His concomitant medication included clonazepam, KEPPRA, lamotrigine, midazolam, thiamine, vitamin B complex strong. He was vaccinated with seasonal influenza vaccine (unknown manufacturer, batch number: not reported) on 23 Oct 2013. One day after vaccination, his body temperature increased and had difficulty in respiration. He became tachycardiac and his seizures increased from his base line target of below 10 to 30, then 50 and in the final days over a hundred grand mal seizures. He was admitted in the hospital and was released as no chest infection was found. It was reported that he was prescribed paracetamol to lower body temperature. It was reported that his seizures and body temperature increased after his discharge and he was readmitted later in the same week. Lab tests such as blood tests, chest X-ray and computed tomogram was performed. His seizures were stabilized and he was also treated with anti-retroviral TAMIFLU, because of possible link to vaccine causing serious deterioration of his health. It was reported that he also experienced and speech loss on 24 Oct 2013, incontinence on and mobility decreased on 24 Oct 2013, apnea on 30 Oct 2013, respiration irregularity and respiratory rate on 02 Nov 2013. On 09 Nov 2013 he slipped into coma and he died of respiratory failure. The event outcome for apnea was completely recovered. The event outcome for coma, condition aggravated, general physical health deterioration, incontinence, mobility decreased, respiratory irregularity, respiratory rate, seizure grand mal, speech loss, tachycardia, temperature elevation was condition unchanged. The event outcome for respiratory failure was fatal. The causality was assessed as suspected to the vaccination with influenza vaccine.


VAERS ID: 518658 (history)  
Form: Version 1.0  
Age: 0.19  
Sex: Female  
Location: Foreign  
Vaccinated:2013-09-05
Onset:2013-09-05
   Days after vaccination:0
Submitted: 2014-01-03
   Days after onset:120
Entered: 2014-01-07
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB479A / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G77954 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood culture negative, Computerised tomogram normal, Culture negative, Decreased appetite, Haemoglobin normal, Hypophagia, Lymphocyte count increased, Neutrophil count decreased, Platelet count increased, Red blood cells CSF positive, Skeletal survey normal, Sudden infant death syndrome, Viral test negative, White blood cell count decreased
SMQs:, Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Systemic lupus erythematosus (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-09-05
   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: 01-JUL-2013, Lot No. 112030A, (BCG), No adverse event; Death of friend, death of an infant step-brother around the same age
Allergies:
Diagnostic Lab Data: Haemoglobin, 118 g/l; Lymphocyte count, 13 x10 9/l; Neutrophil count, 1.67 x10 9/l; Platelet count, 409 x10 9/l; Red blood cell count, 12.260 x10 9/l; White blood cell count, 0.860 x10 9/l; White blood cell count, 15.2 x10 9/l; Virology screen in nasal secretions (unknown date): negative; Intracardiac blood culture (unknown date): negative; Culture (unknown date): negative; Full skeletal X-ray (unknown date): normal; CT-scan (unknown date): normal
CDC Split Type: 2013373466

Write-up: This is an initial spontaneous report received from the Agency, regulatory authority report number TS20130916. A 10-week-old female patient received the suspected medicinal products (by intramuscular route, on 05Sep2013 at 12 am, at 0.5ml single dose): PREVENAR 13 (Lot# G77954), and INFANRIX HEXA (powder and suspension for injection) (Lot# A21CB479A). No relevant medical history has been provided except past family history included death of an infant step-brother around the same age, not otherwise specified. The patient previously received on 01Jul2013 vaccination with BCG SSI (Lot# 112030A) without any trouble. No concomitant treatment was captured in the agency report or mentioned in its narrative case description. The patient experienced crib death on 05Sep2013. Crib death occurred several hours following primary vaccination with PREVENAR 13 and INFANRIX HEXA, with no risk factor reported except the age and the season of occurrence (Sep2013) within the investigations performed. No autopsy was performed. Normal pregnancy with no tobacco or drug use in the mother. Birth at 40 weeks post-LMP (last menstrual period), vaginal delivery, weight 2,540 kg, height 45.5 cm, cranial circumference 32 cm. Bottle feeding, with thickened milk for simple regurgitation, which had subsequently been stopped (unspecified date). During the days elapsed prior to death, no particular disease or mild fever in the baby or her relatives. On the day of patient''s death, on 05Sep2013, injection of vaccines at 12:00 a.m. following normal physical examination, satisfactory growth with weight 4.7 kg, height 57.5 cm, cranial circumference 38 cm. At 01:00 p.m., the patient presented less appetite than usual, only 30 mL intake of milk instead of classical 150 mL. At 02:30 p.m. the baby was placed to sleep on her back in a body-suit with a nappy on a firm mattress without bedding. The baby was found dead at 04:45 p.m. Virology screen in nasal secretions returned negative, intracardiac blood culture was negative, lumbar puncture: red blood cells 12.260 x 10^9/L, white blood cells 0.860 x 10^9/L, culture negative. Haemoglobin 118 g/L, platelet count 409 x 10^9/L, white blood cells 15.2 x 10^9/L, neutrophils 1.67 x 10^9/L, lymphocytes 13 x 10^9/L. Full skeletal X-ray and CT-scan were normal. Based on the Official Foreign Method of Causality Assessment, all suspected medicinal products PREVENAR 13 and INFANRIX HEXA were rated by the agency as doubtful. No follow-up attempts needed. No further information expected.


VAERS ID: 518781 (history)  
Form: Version 1.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2013-11-05
Onset:2013-11-13
   Days after vaccination:8
Submitted: 2014-01-08
   Days after onset:56
Entered: 2014-01-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Dementia, Epilepsy, Postictal state
SMQs:, Systemic lupus erythematosus (broad), Dementia (narrow), Convulsions (narrow), Noninfectious encephalopathy/delirium (broad), Generalised convulsive seizures following immunisation (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: Diazepam; Levetiracetam; Citalopram; Galantamine hydrobromide
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0956808A

Write-up: This case was reported by the foreign regulatory authority (# GB-MHRA-ADR 22363615) and described the occurrence of epileptic fit in a 61-year-old male subject who was vaccinated with Influenza vaccine unspecified. Concurrent medications included diazepam, levetiracetam, citalopram and GALANTAMINE. On 5 November 2013 the subject received an unspecified dose of Influenza vaccine unspecified (0.5 ml, intramuscular). On 13 November 2013, 8 days after vaccination with Influenza vaccine unspecified, the subject experienced epileptic fit, exacerbation of dementia and postictal state. The subject was hospitalised. At the time of reporting the outcome of the events were was unspecified. On an unknown date the patient died. Verbatim Text: Epileptic seizure. Seizure in known epileptic but postictal worsening of dementia then died. Medically Significant: Associated fit causing worsening of dementia.


VAERS ID: 518936 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2013-12-09
Onset:2013-12-16
   Days after vaccination:7
Submitted: 2014-01-08
   Days after onset:23
Entered: 2014-01-10
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20121241 / 1 UN / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR H0059 / 2 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardio-respiratory arrest, Coma, Cyanosis, Death
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 (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-12-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown; The patient''s birth weight 2.8kg. There was no AE history to the previous vaccines.
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA001302

Write-up: Initial serious report received from a health care professional on 05 January 2014. A 04-months-old male patient with no medical history had received a second dose of IPV (Lot number H0059-1 and site of vaccination was not reported) 0.5 ml intramuscularly and first dose of DTaP 0.5 ml from other manufacturer (Lot number 20121241-1, site of vaccination was not reported) intramuscularly on 09 December 2013. No adverse event was observed within 30 minutes after vaccination. The patient''s birth weight was 2.8kg. There was no AE history to the previous vaccines. The patient had received a dose of BCG (lot number 201107041-1) and first dose of Hepatitis B (Lot number 201104046-2) both intramuscularly on 09 August 2013; a first dose of IPV (Lot number H0059-1 and site of vaccination was not reported) and HIB Lot number H1241-1 and site of vaccination was not reported) both intramuscularly on 25 October 2013, and second dose of Hepatitis B (Lot number 201205018 and site of vaccination was not reported) intramuscularly on 11 September 2013. It was reported that on 16 December 2013, the patient was sent to emergency room at 6 AM. He was in a coma when arriving at the hospital. Physical exam found him a cyanosis of the lips. The patient died after salvage. The patient was diagnosed with respiratory and circulatory arrest. The patient died on 16 December 2013 i.e. 07 days after co-administration with 2nd dose of IMOVAX Polio and 1st dose of DTaP. Autopsy was not performed and cause of death was unknown. Documents held by sender: none.


VAERS ID: 519045 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Female  
Location: Foreign  
Vaccinated:2013-08-20
Onset:2013-08-20
   Days after vaccination:0
Submitted: 2014-01-10
   Days after onset:143
Entered: 2014-01-13
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A31CB463B / 1 UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G34508 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Gene mutation identification test positive, Hypotonia, Increased upper airway secretion, Poor sucking reflex, Sleep disorder, Spinal muscular atrophy, Weight gain poor
SMQs:, Peripheral neuropathy (broad), Congenital, familial and genetic disorders (narrow), Guillain-Barre syndrome (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-01
   Days after onset: 134
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: Spinal muscular atrophy
Allergies:
Diagnostic Lab Data: Gene mutation identification test (unknown date): spinal muscular atrophy
CDC Split Type: 2013347560

Write-up: This is a spontaneous report obtained from a contactable physician through the agency. Regulatory authority number: CZ-CZSUKL-13002105. A 8-week-old female patient received the first dose of PREVENAR 13 (lot G34508) intramuscular at 0.5 ml, single dose and the first dose of INFANRIX HEXA (lot A31CB463B) intramuscular at 1 dose formula (DF), single dose, both on 20Aug2013. On 20Aug2013, after the immunization, sucking disorder, sleep disorder and phlegm appeared. Child also stopped putting on weight and slight hypotonia slowly evolved. The outcome of the events was unknown. The patient died on 01Jan2014. The spinal muscular atrophy diagnosed, which appeared concurrently with vaccination. The cause of death was spinal muscular atrophy. The health authority reported that they are expecting more information from the reporter. Follow-up (06Jan2014 and 07Jan2014): New information received from a contactable physician and from the health authority includes: date and cause of death.


VAERS ID: 519696 (history)  
Form: Version 1.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-17
Entered: 2014-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RUB: RUBELLA (MERUVAX II) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Public       Purchased by: Public
Symptoms: Agitation, Apnoea, Autopsy, Bacterial test negative, CSF culture negative, CSF glucose normal, CSF protein increased, CSF white blood cell count negative, Cardiopulmonary failure, Coma, Confusional state, Cytomegalovirus test negative, Cytomegalovirus test positive, Death, Dysstasia, Electroencephalogram abnormal, Encephalitis, Encephalitis post immunisation, Epstein-Barr virus antibody positive, Epstein-Barr virus test negative, Fungal test negative, General physical health deterioration, HIV antibody negative, Haematocrit normal, Haemoglobin normal, Headache, Herpes simplex serology negative, Histology abnormal, Human herpes virus 6 serology negative, Hypotension, Influenza like illness, Liver function test normal, Lymphocyte percentage decreased, Measles antibody negative, Monocyte percentage, Myalgia, Neutrophil percentage increased, Nuclear magnetic resonance imaging brain normal, Parvovirus B19 test negative, Platelet count normal, Posture abnormal, Pyrexia, Quadriplegia, Red blood cell count, Red blood cell sedimentation rate increased, Renal function test normal, Rubella antibody positive, Varicella virus test negative, Varicella virus test positive, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Haematopoietic leukopenia (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), 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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Haematocrit, 47%; Haemoglobin, 16.2 g/dL; Platelet count, 326,000 /mm3; Red blood cell count, (N 84%L 8%/M 7%), 24,000 /mm3
CDC Split Type: WAES1401BRA002620

Write-up: This literature marketed report as received from a Sanofi Pasteur (aware date: 07-JAN-2014) and refers to a 31 year old male patient who was vaccinated with MERUVAX II on 1992 during a Immunization campaign. The rubella virus (RV) can cause a variety nervous system syndromes, including meningitis, encephalitis, Guillain-Barre syndrome and sub acute sclerosis panencephalitis. This literature reports the occurrence of one fatal case of encephalitis associated with measles-rubella (MR). The patient, previously in good health, presented to the emergency room with confusion and agitation. He was not able to stand and hold his head up. There was no additional alteration in the physical examination. He did not have any skin rashes or oral lesions. The funcion of cranial nerves was normal. There was no history of recent travels, arthropods an animals'' exposure, opportunistic or repeated infections. Ten days prior to admission, he received combined MMR vaccine (Serum Institute). He had received on dose of MMR before, on a vaccination campaign in 1992. There was no epidemiological evidence of rubella transmission where the patient lived. He had ''flu-like'' illness with fever, myalgia and headaches tree days after immunization. Initial laboratory tests revealed Hb 16.2 g/dL; Hct 47%; 24,000 leukocytes/mm3; platelets 326,000 mm3; erythrocyte sedimentation rate 64 mm/h. Liver and renal studies were normal. Brains magnetic resonance imaging (MRI) was normal and his CSF showed: 2 leukocytes/mm3, 0 erythrocyte/mm3; glucose 63 mg/dL, protein 51 mg/dL; direct staining for bacteria, fungi and cultures were negative in the CSF. Electroencephalography showed slow wave activity and no epileptogenic activity. Serum IgM antibodies for measles virus, parvovirus B19 human, Epstein-Barr virus (EBV), cytomegalovirus (CMV), herpes simplex virus 1/2, varicella zoster virus (VZV), herpes virus 6 and Dengue were negative. IgG antibodies were positive for EBV, CMV and VZV. Serum antibodies for HIV and syphillis were negative. IgG against rubella was positive in serum and CSF, but IgM was negative in both samples. Rubella IgG avidity was determined using commercial enzyme immunoassay DIESSE Enzywell (Diagnostica Senese). IgG antibodies were positive with high titers in serum specimens and found to contains high rubella-specific IgG avidity (Al: 60-89%). Initial therapy included acyclovir and immunoglobulin. During hospitalization, his condition deteriorated rapidly with tetraplegia, progression to coma, apnea and hypotension. On the 3rd day, he died after cardiorespiratory failure. An autopsy was made and histological findings of brain samples include neuronal lesion, lymphocytes and histiocytes infiltration cerebral parenchyma formin groups amidst neurons, and mononuclear cells gathering in the Virchow-Robin space around blood vessels. Demyelization was absent. Brain tissue was submitted to indirect immunoperoxidase-staining reaction with monoclonal rubella anti-E1 antibody and it was positive. The cause of death was reported as encephalitis associated with measles-rubella (MR).


VAERS ID: 519958 (history)  
Form: Version 1.0  
Age: 1.08  
Sex: Male  
Location: Foreign  
Vaccinated:2013-11-19
Onset:2013-11-24
   Days after vaccination:5
Submitted: 2014-01-20
   Days after onset:57
Entered: 2014-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. 0000160769 / 1 RL / IM

Administered by: Other       Purchased by: Other
Symptoms: Aspiration tracheal, Biopsy brain abnormal, CSF cell count normal, Convulsion, Encephalitis mumps, Encephalitis post measles, Endotracheal intubation, Injection site infection, Intensive care, Irritability, Laboratory test normal, Lethargy, Localised infection, Mechanical ventilation, Polymerase chain reaction, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: Investigations performed (to be clarified), included cerebrospinal fluid (CSF), tap x 4, which did not indicate the presence of measles, Polymerase Chain Reaction (PCR) was negative and nasopharyngeal aspirate (NPA) indicated shedding. A brain biopsy indicated the presence of mumps in brain tissue and CSF.
CDC Split Type: WAES1401IRL008184

Write-up: This case was reported by a HCP on 15-Jan-2014 and by the agency on 16-Jan-2014, with clarification of the batch number provided on 17-Jan-2014 Agency Ref: 2014-019361. Information has been received from Sanofi Pasteur as part of a business agreement (manufacturer control # IE-1577272925-E2014-00351) on 17-JAN-2014. This case is medically confirmed. A 15 month old male patient who was not taking any concomitant medications and who was previously in good health received dose 1 of MMRVAXPRO, batch J007887, lot number 0000160769, expiry 28-May-2015 on 22-Nov-2013 as reported by the patient''s GP (also reported as 19-Nov-2013 by the HCP). Approximately two days post vaccination, reported as 24-Nov-2013 by the agency, the patient experienced fever and an infection local to the site of injection. The patient''s GP reported the patient had a high temperature and was lethargic and irritable following vaccination and was treated with CALPOL and baby NEUROFEN. The patient also experienced a rash with an unknown onset date. The patient did not improve was subsequently hospitalised on an unreported date having experienced multiple seizures on an unreported date in Dec-2013 and was admitted to ICU. Investigations performed (to be clarified), included cerebrospinal fluid (CSF), tap x 4, which did not indicate the presence of measles, Polymerase Chain Reaction (PCR) was negative and nasopharyngeal aspirate (NPA) indicated shedding. A brain biopsy indicated the presence of mumps in brain tissue and CSF. A possible preliminary diagnosis was reported as Kawasaki syndrome, toxic shock or an autoimmune response (not coded as an event by the agency). The patient was intubated and on a ventilator. The most likely diagnosis was of disseminated measles/mumps encephalitis, suspected to be associated with the vaccine. Corrective treatment included high dose steroids and anti seizure medication. The reporter indicated the event was life threatening and the patient was in a critical condition. The patient''s GP stated the brain biopsy result was received on 14-Jan-2014 and result showed "it was the vaccine". Upon internal review the Company coded additional AE not coded by agency: irritable and lethargic.


VAERS ID: 519964 (history)  
Form: Version 1.0  
Age: 1.94  
Sex: Male  
Location: Foreign  
Vaccinated:2013-10-24
Onset:0000-00-00
Submitted: 2014-01-21
Entered: 2014-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. J007072 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase increased, Asthma, Blood glucose, Blood lactic acid increased, Blood methaemoglobin present, Blood potassium increased, Blood sodium normal, C-reactive protein increased, Calcium ionised decreased, Carboxyhaemoglobin normal, Cardio-respiratory arrest, Coma scale abnormal, Condition aggravated, Cough, Cyanosis, Death, Dyspnoea, Electrocardiogram abnormal, Electroencephalogram abnormal, Erythema, Haemodynamic instability, Haemoglobin normal, Hyperhidrosis, Hypotonia, Increased upper airway secretion, Influenza virus test negative, Mechanical ventilation, Methaemoglobinaemia, Mydriasis, Ophthalmological examination abnormal, PCO2 normal, Procalcitonin increased, Pyrexia, Respiratory distress, Respiratory syncytial virus test negative, Resuscitation, Toxicologic test normal, Unresponsive to stimuli, Viral infection, Wheezing, White blood cell count increased, pH body fluid decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (narrow), Lactic acidosis (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Immunisation
Preexisting Conditions: Asthma; 10/17/2013 - 10/20/2013, Vomiting; 10/17/2013 - 10/20/2013, Diarrhoea; 10/17/2013 - 10/20/2013, Pyrexia; 10/17/2013 - 10/20/2013, Infection
Allergies:
Diagnostic Lab Data: Procalcitonin (26-OCT-2013): 6.67 microgram/liter; 10/26/2013, Alanine aminotransferase, 23 IU/l; 10/26/2013, Aspartate aminotransferase, 110 IU/l; 10/26/2013, Blood glucose, 1.3 g/l; 10/26/2013, Blood lactic acid, 13 not provided; 10/26/2013, Blood potassium, 4.9 mmol/l; 10/26/2013, Blood pressure, 112/74 not provided; 10/26/2013, Blood sodium, 144 mmol/l; 10/26/2013, C-reactive protein, 38 mg/l; 10/26/2013, Calcium ionised, 1.13 mmol/l; 10/26/2013, Carboxyhaemoglobin, 1.1%; 10/26/2013, Coma scale, 3 not provided; 10/26/2013, Electrocardiogram, Flatline, no cardiac electrical activity; 10/26/2013, Electroencephalogram, No electrical activity; 10/26/2013, Haemoglobin, 11.8 g/dL; 10/26/2013, Heart rate, 156 bpm; 10/26/2013, Influenza virus test, Negative; 10/26/2013, Methaemoglobinaemia, 0.7%; 10/26/2013, Ophthalmological examination, Nonreactive bilateral mydriasis; 10/26/2013, Oxygen saturation, with FIO2 of 25% = 99%; 10/26/2013, PCO2, after 1 hour of effective ventilation: 37 not provided; 10/26/2013, Respiratory syncytial virus infection, Negative; 10/26/2013, White blood cell count, 34900 X 10^9/L; 10/26/2013, pH body fluid, 7 not provided
CDC Split Type: WAES1401FRA008865

Write-up: Information received from Sanofi Pasteur MSD (SPM) (E2014-00274) on 13-JAN-2014. Case received from the Health Authorities on 13-Jan-2014 under the reference number AN20140011. A 1-year-old male patient with a medical history of asthmatic bronchitis, had received a dose of M-M-RVAXPRO (batch number J007072) intramuscularly on 24-Oct-2013 and after vaccination, during the night from 24 to 25-Oct, he experienced coughing fits. On 25-Oct-2013 afternoon, he developed fever with facial erythrosis and hypotonia. He was given DOLIPRANE. It is noteworthy that he had had a first infectious episode with fever at 39 degrees C, diarrhoea and vomiting which started on 17-Oct-2013 and lasted for 3 days. During the night from 25 to 26-Oct, he had difficulty breathing with coughing fits and sweats and by the end of the night he experienced wheezing and dyspnea. On 26-Oct-2013 in the morning, the patient developed cyanosis and then had a cardiorespiratory arrest whilst being taken to the emergency department in his parent''s car. He arrived at the emergency department at 11:29 a.m. A resuscitation procedure, i.e. mask ventilation and cardiac massage, was initiated. The patient was given 2 doses of adrenalin (0.01 mg/kg) via an intraosseus catheter and his heart resumed beating. He was quickly transferred to the resuscitation unit for further care. Upon admission, the patient was found to have blood pressure of 112/74, heart rate of 156/min, oxygen saturation of 99% with FiO2 of 25%. He was completely unresponsive and he was found to have unresponsive bilateral mydriasis. His Glasgow Coma Scale score was assessed to be 3. Numerous pearly white sticky secretions on the glottis were noticed whilst intubating the patient. When the patient was in the emergency department, ECG showed no cardiac electrical activity. Laboratory tests showed pH of 7, PCO2 of 37 after 1 hour of effective ventilation, sodium of 144 mmol/L, potassium of 4.9 mmol/L, ionized calcium of 1.13 mmol/L, blood glucose of 1.3 g/L, lactates of 13, hemoglobin of 11.8 g/dL, leukocytes of 34900 G/L, procalcitonin of 6.67 ug/L, C-reactive protein of 38 mg/L, aspartate aminotransferase of 110 IU/L, alanine aminotransferase of 23 IU/L, carboxyhaemoglobin of 1.1% and methemoglobinemia of 0.7%. Toxicity tests showed negative results. Influenza virus and Respiratory syncytial virus tests showed also negative results. A corrective treatment with dobutamine and dopamine was given via the intraosseus catheter. Around 3:30 p.m., the patient was gasping for breath and his hemodynamic status gradually deteriorated making treatment with noradrenaline necessary, but hemodynamic stability could not be achieved. Two EEGs were carried out and both showed no electrical activity. The patient died at 10:15 p.m. after discontinuation of the resuscitation. No autopsy was requested. The Health Authority concluded that a 22-month-old patient died from respiratory distress and cardiorespiratory arrest 48 hours after receiving a dose of M-M-RVAXPRO. The resuscitation team considered cardiorespiratory arrest was caused by severe acute asthma in a context of viral-like infection. The Health Authority assessed the causal relationship between the reported reactions and vaccination as doubtful (VAXIGRIP: C1 S1 B1 I1) according to the updated foreign method of assessment.


VAERS ID: 519971 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2013-11-19
Onset:2013-11-22
   Days after vaccination:3
Submitted: 2014-01-17
   Days after onset:56
Entered: 2014-01-21
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR J0045 / 1 RA / IM

Administered by: Unknown       Purchased by: Unknown
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:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA005729

Write-up: Initial report received from a healthcare professional (CDC via sales representative) on 14 January 2014. A 02-month-old male patient whose medical history and concomitant medications were not reported, had received first intramuscular dose of 0.5 ml IMOVAX POLIO (lot number: J0045-2) in the right arm on 19 November 2013. The patient died on 22 November 2013 i.e. 03 days after receiving first dose of IMOVAX POLIO. On 14 September 2013, the patient had received a dose of BCG vaccine while on 12 September 2013 and 17 October 2013, he received Hep B vaccine (manufacturer: other, lot number, dose number, route and anatomical site of administration were not reported). Physical examination on 17 October 2013 was included: weight 5kg, height 55cm, anterior fontanelle 2cm, head circumference 36.5cm, skin (-), eyes (-), heart (-), lungs (-), liver (-), spleen (-), spinal column (-), limbs (-). An autopsy was not performed. No detailed information was available. Documents held by sender: none.


VAERS ID: 519994 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Female  
Location: Foreign  
Vaccinated:2014-01-09
Onset:2014-01-10
   Days after vaccination:1
Submitted: 2014-01-17
   Days after onset:7
Entered: 2014-01-21
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR J0380 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-10
   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: Con Meds = Unknown; Prev Meds = Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA004937

Write-up: Initial report received from healthcare professional on 13 January 2014. A 02-month-old female patient, medical history and concomitant medications were not reported, had received a 0.5 ml of first dose of IMOVAX POLIO anatomical site of administration was not reported batch number - J0380-1 intramuscular on 09 January 2014. On 10 January 2014, at 7.00 am, the patient was found dead. The autopsy has been performed on 10 January 2014. Corrective treatment and laboratory investigation was not reported. Documents held by sender: None.


VAERS ID: 520007 (history)  
Form: Version 1.0  
Age: 0.76  
Sex: Female  
Location: Foreign  
Vaccinated:2014-01-02
Onset:2014-01-02
   Days after vaccination:0
Submitted: 2014-01-17
   Days after onset:15
Entered: 2014-01-21
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEA: MEASLES (NO BRAND NAME) / UNKNOWN MANUFACTURER J5359 / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G25976 / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Drug ineffective, Dry mouth, Dyspnoea, HIV test negative, Haemoglobin decreased, Muscle twitching, Mycobacterium tuberculosis complex test negative, Pneumonia, Poor sucking reflex, Pyrexia, Rales, Swelling, Thirst, Tongue discolouration, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Lack of efficacy/effect (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dyskinesia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Neonatal disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-03
   Days after onset: 1
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: Breast feeding; 01-JAN-2014, Malaise
Allergies:
Diagnostic Lab Data: 02-JAN-2014, Body temperature, 38.1 Centigrade; 02-JAN-2014, Body temperature, 37.3 Centigrade; 02-JAN-2014, Body temperature, 36.6 Centigrade; 03-JAN-2014, Body temperature, 38.0 Centigrade; 03-JAN-2014, Body temperature, 36.3 Centigrade; Body temperature, 39.7 Centigrade; Physical examination (02Jan2014): Head circumference: 46 cm; HIV status (02Jan2014): negative; TB screening (02Oct2013): no TB Symptoms; TB screening (02Jan2014): no TB Symptoms; Respiration (03Jan2014): 75 breaths per minute; lungs-crepitations
CDC Split Type: 2014011896

Write-up: This is a spontaneous report from a contactable health care professional, a nurse, an axillary nurse and from a consumer (mother). A 9-month-old female patient of unknown ethnicity received PREVENAR 13 (lot number G25976, expiration date Feb2015) intramuscular at a single dose on 02Jan2014. Medical history included breast feeding and malaise since 01Jan2014 (birth weight 3200 g at 36 week of gestation), first baby, healthy baby with good weight gain). No history of allergies. Concomitant medication included measles virus vaccine, (batch number J5359, expiration date Jun2015). The baby had previous vaccinations (unspecified) at 6, 10 and 14 weeks with no problem. On 20May2013 6 weeks evaluation was done with no abnormalities detected. Tuberculosis screening done on 02Oct2013 and again 02Jan2014 showed no TB symptoms. Family history included: father smokes, no asthma, allergy or diseases. Mother status was negative in Jan2011. Post natal visit showed Hb at 8.9 g/dl. Currently healthy, no asthma, no allergy or diseases. The baby experienced fever, non-serious, on 02Jan2014 with outcome of not recovered, pneumonia and drug ineffective on an unspecified date with outcome of unknown, crepitations, non-serious, on an unspecified date with outcome of not recovered, twitching movements, non-serious, on an unspecified date with outcome of unknown, baby is very thirsty, non-serious, on 03Jan2014 with outcome of not recovered, mouth is dry from inside, non-serious, on 03Jan2014 with outcome of not recovered, vomits immediately after swallowing, non-serious, on 03Jan2014 with outcome of not recovered, baby''s tongue was blue in colour, non-serious, on 03Jan2014 with outcome of not recovered, sucking reflection was poor, non-serious, on 03Jan2014 with outcome of not recovered, right side of body became swollen, non-serious, on 03Jan2014 with outcome of not recovered, baby''s eyes were closed and she gasps for air, non-serious, on 03Jan2014 with outcome of not recovered. The patient underwent lab tests and procedures which included body temperature: 38.1 centigrade on 02Jan2014; 37.3 centigrade on 02Jan2014 at 08h35; 36.6 centigrade on 02Jan2014 at 09h50; 38.0 centigrade on 03Jan2014 at 08h20; 36.3 centigrade on 03Jan2014. Therapeutic measures were provided. The patient died on 03Jan2014. An autopsy was not performed. According to clinical records, baby visited to clinic on 02Jan2014 at 08h10 for fever (temperature: 38.1 degrees Celsius, Weight: 9.4 kg; Length: 92 cm, Head Circumference: 46 cm). As treatment PANADO syrup 2.5ml single dose (stat) was given orally. No other cause could be established for the fever. Baby showed no anemia, human immunodeficiency virus (HIV was negative, Tuberculosis unlikely. Health education was given on sponge tapping in case of fever, and to return for follow up in 2 days. Advice was given to the mother on when to return immediately. Temperature repeated at 08h35 was at 37.3 degrees Centigrade and again at 09h50 was at 36.6C. Practical nurse decided to give 9 month vaccines due to temp that was only 36.6C. Mother left facility. Immunizations given were as follows: PREVENAR 13 (batch number: G25976 - Expiration date: Feb2015), vials appeared clear, no flocking and no discoloration; measles virus vaccine (batch number: J5359, Expiration date: Jun2015). On 23Dec2013 another child was vaccinated with same batch number with no adverse event. On 03Jan2014 08h20 at facility, temperature was 38.0 degrees Centigrade, respiratory rate at 75 breaths per minute. According to regulatory authority pneumonia was reported. Treatment provided was AMOXIL (250 mg/5ml) (stat) single dose given orally and then prescribed thereafter 5ml 3x daily (TDS) orally for 5 days. Subject should return within 2 days if not better. Temperature repeated after sponge tapping was 36.3 degrees Celsius. Mother left facility with medication. Cold chain investigation showed no defect. Fridge vaccine cold chain was maintained. No break in monitoring or any power failure. Temperature never in the unsafe range for the whole of Dec2013 and Jan2014 up to date. Fridge is very clean inside. No thick ice builds up. Ice packs clean and neatly stored in freezer compartment. Cooler boxes clean inside. Stock cards available and correct. Vaccine friendly fridge displayed. Do not switch off the fridge is displayed. Fridge temperature on day of investigation: 2 degrees Celsius. On 07Jan2014 interview with nurse was as follows: Baby visited the facility on the 02Jan2014 for fever of 38 degrees Celsius. Baby was sponge tapped. PANADO 2.5ml was given single dose orally. No history of severe illness. Authority record was completed. No cause for the fever could be established. It was very hot outside on the day of the visit. Health education was given on when to return immediately and sponge tapping. Temperature came down to 36 degrees Celsius. Immunizations were given as there were no severe classification according to authority. On the 03Jan2014 the mother visited again and complained of fever. They sponge tapped the child again. Reassessment according to authority was done. Count the breaths, 75 breaths / minute. Lungs showed crepitations. Excluded general danger signs. Gave AMOXIL stat/single dose and prescribed according to guidelines. Gave mother health education with regard to when to return immediately. Follow up in 2 days and sponge tapping. Interview with Axillary Nurse was as follows: Mother returned in the afternoon of the 03Jan2014 to the clinic. A friend of the mother asked nurse if it is normal for a child to have twitching movements after fever. Nurse explained to the friend that it is abnormal. Nurse asked the mother to take the child off her back. There were no jerking movements observed at the time. She asked the mother to wait so that she can call another sister. The mother indicated that the nurse already evaluated the baby and that it is not necessary. Nurse insisted, but the mother decided to leave. Interview with biological mother was as follows: During 01Jan2014 afternoon early evening, the mother recognized that the baby is not well and she gave her some IBUMOL for the fever that the child was having. She has mentioned that the baby slept well during the night and was not restless or any further symptoms of fever during the night. It seems that during the past week no other complaints or problems could be noticed by the mother as the baby presented as a healthy and strong child. On 02Jan2014 the grandmother noticed during the cause of the morning that the baby does not look well and mentioned to the mother that she must take the baby to the clinic as the baby has fever and does not look well. On 02Jan2014 she visited the local clinic where intervention took place in terms of the fever that the baby was presented with. The mother indicated that PANADO was given to the child, in the clinic and she was requested to return within 2 days if there is no improvement. On 03Jan2014 the mother returned to the clinic with the baby as the fever has not improved, despite the medication given to treat the fever. The mother indicated it was past 8 that they were at the clinic. Intervention took place soon after their arrival. Sister evaluated the baby and the fever of the child and sponge the baby with water to manage the fever. This was done more than once and helped only for a short while. The mother indicated also that assessments were done in terms of lungs and she was given information on the reason why the antibiotics will be prescribed for the lungs. Afterwards the family left the facility. The mother went to town and met some friends where she stated that she is not comfortable with the fact that the baby''s fever is not stabilized and that immunizations were also done. She returns to the facility and spoke to sister regarding her problem of the child that is not improving. This was around 14h00; when she gave again some PANADO while at the facility. She asked an employee at the clinic to transport them home, so that she does not have to walk in the sun with the baby on her back. Around 16h30 she notices that the baby is very thirsty and that her mouth is dry from inside. She tried several times to give the baby water and antibiotics, but baby vomits immediately after swallowing. The mother has described that the baby''s tongue was blue of colour. Her sucking reflection was poor as she put her on the breast but this was also not successful. The mother stated she did not use any traditional medication and did not give the child anything else, than the medication received at the clinic. The mother tried to give the baby some porridge but the baby only ate 4 teaspoons, and vomited directly after swallowing it. The mother also noticed that the baby''s right side of the body became swollen. Around 19h00 the mother has decided to call EMS (ambulance) as the baby''s conditions is not well. Emergency services arrived around 21h00 and with observations the fever was 39.7. The mother mentioned that the baby also presented with twitching movements throughout the day, irrespective of any medication that was given. During the trip with the ambulance they put a wet towel over the baby and also gave some oxygen. The baby did not show any reaction like crying, or movement with her hands / arms. The mother indicated that they have waited very long for another patient, at EMS (emergency services offices. An (EMS) emergency services officer was with them all the time and the lady complained about why they should wait for another patient as they have to transport the baby with high fever to hospital. It seems that EMS (emergency services personnel) said that they have to wait for other patients, but they later saw that there was not enough space for another patient and they left for hospital. The mother thought that it was past 23h00 that they arrived at hospital. The baby still had a high fever and was sitting on the mothers lap. The nurse called the medical officer but did not come immediately. The mother mentioned that the fever and vitals were taken. According to the mother the fever was 39 degrees Celsius. She then noticed that the baby''s eyes closed and she gasps for air. The nurse looked for reaction but no response. The medical officer was called again and on arrival it was confirmed that the baby has passed on. Death certificate reported: Unavoidable death natural cause.


VAERS ID: 520310 (history)  
Form: Version 1.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2013-10-19
Onset:0000-00-00
Submitted: 2014-01-23
Entered: 2014-01-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Intensive care, Varicella
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: Acute myeloid leukaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1311GBR002296

Write-up: Information has been received from Sanofi Pasteur MSD (GB-1577272925-E2013-08734) on 21-JAN-2014. This case which is also a misuse case (wrong route of vaccine administered) was received from the health authority on 29-Oct-2013. GB-MHRA-ADR 22289400. This case is medically confirmed as it was reported by a physician. A 79 year old male patient received on 19-Oct-2013 an injection of ZOSTAVAX (batch number not reported) dose, dose in series and site of administration not reported, via intramuscular route instead of subcutaneous route. Two weeks post vaccination, the patient developed chickenpox. The patient was hospitalised. The patient''s medical history included acute myeloid leukaemia which was continuing but the patient was not immune-compromised at the time of reporting. At the time of reporting, the patient had not recovered. The regulatory authority considered that case serious due to patient''s hospitalization. Follow up received from the regulatory authority on 15-Jan-2014: The patient died on an unreported date. He was on the palliative care for most of the morning in the intensive care unit.


VAERS ID: 520381 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-20
Entered: 2014-01-23
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Adverse drug reaction, Death, Idiopathic thrombocytopenic purpura, Ill-defined disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014JP005372

Write-up: An initial literature report received from a health authority on 13 JAN 2014. The article was presented with adverse reactions to influenza vaccine of season 2012 reported from OCT 2012 through the end of MAR 2013. The date of the adverse reactions reported by medical institutions were tabulated and evaluated by the regulatory agency together with those reported by the marketing authorization holders and the necessity of safety measures were discussed in the article. This report refers to a patient whose identifiers, medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date the vaccine was of season 2012). It was reported that on an unknown date the patient died due to idiopathic thrombocytopenic purpura. It was reported that the death might be associated with the vaccination or most likely caused by an adverse reaction to the drug used for the treatment of an underlying disorder.


VAERS ID: 520407 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-03-04
Onset:2013-03-18
   Days after vaccination:14
Submitted: 2014-01-22
   Days after onset:310
Entered: 2014-01-23
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR J4054 / UNK LL / IM
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH F86819 / UNK RL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute respiratory failure, Bacterial test positive, Bronchitis, Cardiac arrest, Cardiac failure acute, Crepitations, Death, Dyspnoea, Electroencephalogram abnormal, Intensive care, Mechanical ventilation, Respiratory arrest, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (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), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-03-18
   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: 16-OCT-2012 to 18-MAR-2013, Congenital anomalies of respiratory system; 16-OCT-2012 to 18-MAR-2013, Epilepsy; 07-DEC-2012 to 18-MAR-2013, Hepatomegaly; 16-OCT-2012 to 18-MAR-2013, Hypoxic encephalopathy; 16-OCT-2012 to 18-MAR-2013, Mental retardation; 16-OCT-2012 to 18-MAR-2013, Paralysis spastic congenital; NOV-2011 to 18-MAR-2013, Pneumonitis aspiration; 17-JAN-2013 to 18-MAR-2013, Gastrostomy tube insertion; 23-NOV-2012 to 18-MAR-2013, Pyelectasia; 16-OCT-2012 to 05-NOV-2012, Mechanical ventilation; 09-NOV-2012 to 09-NOV-2012, BCG vaccine; 16-OCT-2012 to 15-NOV-2012, Phenobarbital, Epileptic seizure
Allergies:
Diagnostic Lab Data: EEG (23Oct2013): coma state; EEG (25Oct2012): diffuse brain damage, seizures; Ultrasound examination (23Nov2012): pyelectasia; Ultrasound examination (07Dec2012): hepatomegaly; Microbiology test (16Mar2013): bacterial infection; MRI Brain (19Oct2012): severe hypoxic ischemic brain injury; MRI Brain (30Oct2012): severe loss of white matter
CDC Split Type: 2014013664

Write-up: This is a spontaneous report from a contactable physician sent an investigated by the National Epidemiology Centre on 15Apr2013; via the regulatory authority. Regulatory authority report number: HU-OGYI-043213. A 5-month-old male patient received PREVENAR (suspension for injection; Batch number: F86819), intramuscularly into the right thigh on 04Mar2013 and PENTAXIM (Batch number J4054-1), intramuscularly into the left thigh on 04Mar2013, single dose. The patient previously received BCG vaccine on 09Nov2012. The patient''s concomitant medications included MOTILIUM 1 mg three times daily, MALTOFER drops, VIGANTOL OIL and TEGRETOL. The patient was born on the 34th gestational week from a pregnancy complicated with gestational diabetes of the mother. The patient''s birth weight was 2730 g, and Apgar score: 4/5. He was born with several congenital respiratory anomalies, congenital spastic paralysis, hepatomegaly, pyelectasia, and had suffered from severe neonatal asphyxia, and as a consequence hypoxic encephalopathy had developed as confirmed by brain magnetic resonance imaging (MRI). Mechanical ventilation was applied for a period of 21 days after birth. The patient had epilepsy (confirmed by electroencephalogram (EEG)) treated with phenobarbital at birth then with carbamazepine 60mg twice a day (B.I.D) from 06Nov2012 until 19Dec2012 with a change of administration frequency on 19Dec2012 to 20mg three times a day (T.I.D). He was both mentally and physically severely retarded. Neurologists characterized his health status as a non-contactable coma-like state. Due to swallowing difficulties the patient had suffered from several episodes of aspiration pneumonia (resulting from the inhalation of food) and sepsis. A gastrostomy tube was inserted on 17/01/2013 for feeding purposes. He was hospitalized several times with bronchitis due to micro-aspirations. On 16Mar2013, the patient was admitted to the intensive care unit (ICU) with dyspnea which developed right after feeding. On physical examination signs of bronchitis and upper respiratory crackles were found of which was treated symptomatically. A bacterial culture of the patient''s sputum performed on 16Mar2013 was positive and AUGMENTIN treatment was applied. On the second day of his hospitalization, on 18Mar2013, acute respiratory and cardiac failure occurred and after transient improvement he died of pulmonary and cardiac arrest. Applied corrective treatment was: mechanical ventilation, oxygen, TONOGEN, DOBUTREX and furosemide. Resuscitation attempt was not successful. Autopsy was not performed by the request of the mother. The outcome of the investigation revealed no causal association of the fatal event with the suspect drugs. The temporal relationship was considered as accidental. It is confirmed by the treating specialists and the investigating authority. Sender Comment: The outcome of the investigation revealed no causal association of the fatal event with the suspect drugs. The temporal relationship was considered as accidental. It is confirmed by the treating specialists and the investigating authority. This fatal case was reported because of the temporal association to the vaccination. No further follow-up is expected, the case is closed. No follow-up attempts possible. No further information expected.


VAERS ID: 520616 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-12-14
Onset:0000-00-00
Submitted: 2014-01-22
Entered: 2014-01-24
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LL / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aorta hypoplasia, Aortic stenosis, Cardiac failure acute, Death, Endocardial fibroelastosis, Heart disease congenital
SMQs:, Cardiac failure (narrow), Congenital, familial and genetic disorders (narrow), Cardiomyopathy (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: Unknown
Current Illness:
Preexisting Conditions: Hypoplastic left heart syndrome; According to information received from a regulatory authority (following): From the provided information it is known that at 20-21 weeks of gestation during the ultrasound the conclusion was issued to the mother that the fetus likely may have presence of congenital heart lesion and that the observed changes may indicate - hypoplastic syndrome of left heart on background of aorta''s hypoplasia, ventricular septal defect, not excluded aortic calcification. Given the recommendation on holding of consilium with geneticists and pediatric cardiac surgery. 2013/08/05 - during the ultrasound at genetic Center the conclusion was issued - Pregnancy 21 week (biometrics), one live fetus, congenital heart disease, possible think of hypoplastic syndrome of left heart, fetus pyeloectasis. On the same day expectant mother given the consultation of geneticists. Concerning on ultrasound data and then, in most cases the hypoplastic syndrome of left heart has a unfavorable prognosis the expectant mother was directed to the commission to decide on the further management of pregnancy. From 2013/08/05 to 2013/08/23 woman didn''t addressed to medical workers. 2013/08/09 her husband wrote the receipt that his pregnant wife at the moment located in another area and that they are categorically refuses to terminate a pregnancy on 21-22 week, because they do not trust doctors. 2013/08/23 - the analogic receipt was written by pregnant woman. During the entire period of pregnancy, a woman consistently refused to conduct any examinations (written refuse forms) and attending obstetrician-gynecologist only after repeated invitations. Also pregnant refuses to tell where she will give birth. About the birth doctor found out 2013/12/16. Mother was asked to conduct ultrasound for newborn child, but she and her husband rudely refused. Over lifetime the child was not sick, epidemiological surroundings - tranquil. 2013/12/22 - at 8.30 am mother has found her baby dead. At 8.40am the ambulance was called who state the biological death.
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA007676

Write-up: Initial report received from healthcare professional via health authority and it was transmitted to LGLS via partner on 10 January 2014. Manufacturer Control Number. : UA-EVX20140110-01. A child that was born in 2013/12/14 was vaccinated 2013/12/14 with vaccine EUVAX B (batch number; UFA13032, vaccination site; left thigh), produced by LG Life Sciences, Ltd. 22 December 2013 - at 8.30 am mother has found her baby dead. At 8.40am the ambulance was called who state the biological death. Forensic diagnosis: Congenital heart lesion, acute cardiovascular failure. In conducting forensic examinations the congenital heart disease, which manifested in hypoplasia of left heart was detected. Anatomically defects consist of hypoplasia of the left ventricle and left atrium in conjunction with aortic stenosis and hypoplasia of the ascending aorta, endocardial fibroelastosis, left ventricular cavity is reduced in size, right ventricle increased significantly, asymmetric hypertrophy of the intraventricular septum. The patient was born 14 December 2013 from the 1st pregnancy, birth weight 3300g. On the same day at the maternity hospital after medical examination and obtaining informed consent from mother the vaccination of EUVAX B (batch number UFA 13032), produced by LG Life Sciences, Ltd. was held. Over 30 minutes - the child was examined by pediatrician at home (primary medical patronage). There were no complaints from mother, the child was breastfed. The recommendations were given regarding newborn care, a balanced diet and the prevention of mother''s hypogalactia. 20 December 2013 - vaccinated for the prevention of tuberculosis. According to information received from a regulatory authority (following): From the provided information it is known that at 20-21 weeks of gestation during the ultrasound the conclusion was issued to the mother that the fetus likely may have presence of congenital heart lesion and that the observed changes may indicate - hypoplastic syndrome of left heart on background of aorta''s hypoplasia, ventricular septal defect, not excluded aortic calcification. Given the recommendation on holding of consilium with geneticists and pediatric cardiac surgery. 05 August 2013- during the ultrasound at genetic Center the conclusion was issued - Pregnancy 21 week (biometrics), one live fetus, congenital heart disease, possible think of hypoplastic syndrome of left heart, fetus pyeloectasis. On the same day expectant mother given the consultation of geneticists. Concerning on ultrasound data and then, in most cases the hypoplastic syndrome of left heart has a unfavorable prognosis the expectant mother was directed to the commission to decide on the further management of pregnancy. From 5 August 2013 to 23 August 2013 woman didn''t addressed to medical workers. 09 August 2013 her husband wrote the receipt that his pregnant wife at the moment located in another area and that they are categorically refuses to terminate a pregnancy on 21-22 week, because they do not trust doctors. 23 August 2013 - the analogic receipt was written by pregnant woman. During the entire period of pregnancy, a woman consistently refused to conduct any examinations (written refuse forms) and attending obstetrician-gynecologist only after repeated invitations. Also pregnant refuses to tell where she will give birth. About the birth doctor found out 2013/12/16. Mother was asked to conduct ultrasound for newborn child, but she and her husband rudely refused. Over lifetime the child was not sick, epidemiological surroundings - tranquil. 2013/12/22 - at 8.30 am mother has found her baby dead. At 8.40am the ambulance was called who state the biological death. Cause (s) of Death: cardiac failure acute.


VAERS ID: 520624 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2013-02-26
Onset:2013-02-28
   Days after vaccination:2
Submitted: 2014-01-21
   Days after onset:327
Entered: 2014-01-24
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR J4054 / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH F86819 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Head injury, Subdural haematoma
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-02-28
   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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014013532

Write-up: This is a spontaneous report from a contactable pediatrician received via the foreign Regulatory Authority. Regulatory Authority Report Number: HU-OGYI-028613. A 2-month-old male patient of unspecified ethnicity received PREVENAR (Batch Number F86819) and PENTAXIM (Batch Number J 4054-1) both on 26Feb2013. Relevant medical history and concomitant medications were not reported. The patient died on 28Feb2013. The reporting pediatrician claimed that the patient was healthy and he was fine after the immunizations. A preliminary autopsy report had been received from the investigating authority in which the cause of death was stated as subdural haematoma due to traumatic head injury of unknown origin. The causal association with the suspect drugs was considered unlikely according to the preliminary report. The final report was expected to be received within the next three months. Follow-up (24Apr2014): New information report from the same contactable pediatrician via the foreign Regulatory Authority includes: cause of death (subdural haematoma), preliminary autopsy report, and causality (unlikely). No follow-up attempts possible. No additional information expected.


VAERS ID: 520780 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-01-26
Entered: 2014-01-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. - / UNK UN / SC

Administered by: Other       Purchased by: Other
Symptoms: Death, Gastrointestinal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (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: No other medications
Current Illness: Decreased immune responsiveness
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1401JPN010852

Write-up: Information has been received from a pharmacist concerning on an old patient (gender was unknown) with immune function decrease who was vaccinated with PNEUMOVAX NP injection 0.5ml once subcutaneously. (Onset date and indication were unknown). The other concomitant medications were not reported. The patient joined clinical research which was about immune function decrease patient at a hospital. On an unspecified date, during the clinical research, in order to provide evidence about that it was well to let immune function decrease patient vaccinated with pneumococcal vaccine, so the patient was vaccinated with pneumococcal vaccine. On an unspecified date, the patient developed haemorrhage of digestive tract and was sent to hospital by ambulance. On an unspecified date, the patient died. The death reason was haemorrhage of digestive tract. The information about autopsy was unknown. Reporter''s comment: about age and gender were not remembered, the physician considered it seems that haemorrhage of digestive tract was not related to pneumococcal vaccine. The reporting pharmacist considered that haemorrhage of digestive tract was serious due to death. The reporting pharmacist considered that haemorrhage of digestive tract was not related to pneumococcal vaccine. Upon internal review, the causal relationship between haemorrhage of digestive tract and pneumococcal vaccine could not be denied. Follow-up attempt was not made because the reporter did not wish to be contacted. Additional information is not expected.


VAERS ID: 521292 (history)  
Form: Version 1.0  
Age: 1.2  
Sex: Female  
Location: Foreign  
Vaccinated:2013-09-16
Onset:2013-09-23
   Days after vaccination:7
Submitted: 2014-01-29
   Days after onset:128
Entered: 2014-01-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENHIB: MENINGOCOCCAL CONJUGATE + HIB (UNKNOWN) / UNKNOWN MANUFACTURER A76CA230A / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS A69DD408A / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. H0069789 / UNK UN / UN
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH F47829 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-09-23
   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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014022489

Write-up: This is a spontaneous report from a contactable consumer, the patient''s parent. This is a report received from a foreign Regulatory Agency. Regulatory authority report number ADR22389233. A 14-month-old female patient of an unspecified ethnicity received PREVENAR (Lot Number: F47829; Expiration Date: Apr2014), MMRVAXPRO (Lot Number: H0069789), MENTORIX (Lot Number: A76CA230A or A76CA176B; Expiration Date May 2015), PRIORIX (Lot Number A69DD408A: Expiration Date: Feb2015); all via the "parenteral" route of administration on 16Sep2013 at single doses. The patient''s medical history and concomitant medications were not reported. On 23Sep2013, the patient died. It was unknown if an autopsy was performed and the cause of death was reported as "death unexplained". The reporter stated that they were unsure which injections their child was given as their general practitioner (GP) provided all the above batch numbers. The reporter was given six completely different batch numbers for three injections and was unsure that their child was given the incorrect vaccine. The reporter further stated that the GP was reluctant to inform the local regulatory authority. No follow up attempts possible. No further information expected.


VAERS ID: 521670 (history)  
Form: Version 1.0  
Age: 0.4  
Sex: Male  
Location: Foreign  
Vaccinated:2014-01-24
Onset:2014-01-27
   Days after vaccination:3
Submitted: 2014-01-31
   Days after onset:4
Entered: 2014-02-03
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-27
   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:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014025995

Write-up: This is a spontaneous report received from a contactable pediatrician through a Pfizer sales representative. A 5-month-old male patient received PREVENAR 13 on 24Jan2014, subcutaneous at 0.5ml single, ACTHIB on 24Jan2014, subcutaneous injection at 1DF single, and TETRABIK on 24Jan2014, subcutaneous injection at 1DF single. Relevant medical history was unknown. No other medications were reported. On 27Jan2014, the patient died. The cause of death was reported as unexplained. It was unknown if an autopsy was performed. The reporting pediatrician classified death as serious (death), and assessed it as unrelated to PREVENAR 13, because the patient died 70 hours after the vaccination.


VAERS ID: 521908 (history)  
Form: Version 1.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2013-12-01
Onset:2013-12-20
   Days after vaccination:19
Submitted: 2014-02-05
   Days after onset:47
Entered: 2014-02-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU3: INFLUENZA (SEASONAL) (FLUARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Ataxia, Cardiac arrest, Death, Gait disturbance, Muscular weakness, Myalgia, Polyneuropathy
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-09
   Days after onset: 20
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: Aspirin; Atorvastatin calcium; Carvedilol
Current Illness: Hypercholesterolemia; Ischemic heart disease
Preexisting Conditions: Aortocoronary bypass
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0966136A

Write-up: This case was reported by a regulatory authority and described the occurrence of a fatal cardiac arrest in a 63-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject''s medical history included aortocoronary bypass. Concurrent medical conditions included hypercholesterolemia and ischemic heart disease. Concurrent medications included Cardio aspirin, TORVAST and DILATREND. On 1 December 2013, the subject received 1st dose of FLUARIX (intramuscular, unknown injection site and batch number). On 20 December 2013, 19 days after vaccination with FLUARIX, the subject experienced polyradiculoneuritis, lower limb weakness, myalgia, walking difficulty and ataxia. The subject was hospitalised and he was treated with SOLUMEDROL. At the time of reporting, the events were not resolved. Follow-up information received on 04 February 2014: The subject died on 9 January 2014 from cardiac arrest. It was unknown whether an autopsy was performed.


VAERS ID: 522097 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2014-01-15
Onset:2014-01-24
   Days after vaccination:9
Submitted: 2014-02-06
   Days after onset:13
Entered: 2014-02-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (INFANRIX QUINTA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Brain oedema, Cyanosis, Death, Peripheral coldness, Pulmonary haemorrhage, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Rhinitis; Wheezing in lungs
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0965419A

Write-up: This case was reported by a consumer (the subject''s mother) via Facebook and described the occurrence of brain edema in a 3-month-old male subject who was vaccinated with Pneumococcal vaccine (manufacturer unspecified) and DTPa-IPV-HIB. A physician or other health care professional has not verified this report. Concurrent medical conditions included symptoms of rhinitis and wheezing lungs according to the mother. On 15 January 2014, the subject received an unspecified dose of Pneumococcal vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of DTPa-IPV-HIB (administration site and route unknown, batch number not provided). On 20 January 2014, his condition worsened. The subject''s mother visited the GP the next day but no symptoms of respiratory infection were diagnosed. The treating physician didn''t hear any wheezing. The subject was treated with nasal drops. On 24 January 2014, 9 days after vaccination with DTPa-IPV-HIB and Pneumococcal vaccine, the subject was found cold with cyanosis. The subject died on 24 January 2014 from brain and lung edema due to pulmonary hemorrhage. An autopsy was performed. A legal and medical expertise is conducted in order to know if there was a relationship between administration of the vaccines and the death.


VAERS ID: 522105 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-04
Entered: 2014-02-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cardiac arrest, Condition aggravated, Death, Influenza like illness, Motor neurone disease
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (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: Unknown
Current Illness:
Preexisting Conditions: Motor neuron disease; The patient had motor neuron disease.
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA013108

Write-up: Case retrieved from the literature on 23 January 2014. This case is linked to 2014SA013070, 2014SA013079, 2014SA013082 and 2014SA013109 (same reporter). The following is verbatim from the article abstract: This report summarizes passive surveillance data for adverse events following immunization (AEFI) reported to the Administration for 2011, and describes reporting trends over the 12-year period 2000 to 2011. There were 2,327 AEFI records for vaccines administered in 2011, a decrease of 40% from 3,894 in 2010. The decrease in 2011 was attributable to a decline in reporting following seasonal influenza (2,354 to 483) and pandemic H1N1 (pH1N1) influenza vaccines (514 to 2). However, reporting rates for some other vaccines were higher in 2011 compared with 2010. The 13-valent pneumococcal conjugate vaccine (13vPCV) replaced the 7-valent pneumococcal conjugate vaccine (7vPCV) and was suspected of involvement in 236 AEFI cases (40 per 100,000 doses). An increase in the number of reports following rotavirus (from 40 to 56 per 100,000 doses), and the hexavalent infant vaccine (from 27 to 40 per 100,000 doses), may have been due at least in part to co-administration with 13vPCV. Reports following DTPa-IPV also increased (from 94 to 139 per 100,00 doses), continuing a trend since 2009. AEFI reports following receipt of the 23-valent pneumococcal vaccine also increased markedly in those aged 65 years, from 155 to 288 records. In response to the increase in reports following 23vPPV, boosters are no longer recommended for those without medical risk factors. The most commonly reported reactions were injection site reactions, fever, allergic reactions and malaise. Only 7% of all the reported adverse events were categorized as serious, as per the database definitions, although some events classified as non-serious may have caused severe illness. Three deaths were temporally associated with vaccination; however, all were attributed to causes other than vaccination. The increase in 2011 was predominantly due to reports of injection site reactions (49% increases in 2011). Increases in some instances may also be partly attributable to an increasing propensity to report AEFI. A male patient (middle-aged) with history of motor neuron disease, had received a dose of Influenza vaccine (manufacturer unknown, batch number, route and site of administration was not reported) on an unspecified date. On an unspecified date, the patient developed flu-like illness after vaccination and had a cardiac arrest. The patient died after 4 days of vaccination. The cause of death was documented as complications of motor neuron disease. Cause(s) of Death: disease complication.


VAERS ID: 522107 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-04
Entered: 2014-02-06
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Acute disseminated encephalomyelitis, Death, Nervous system disorder
SMQs:, Noninfectious encephalitis (narrow), Demyelination (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? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA013109

Write-up: Case retrieved from the literature on 23 January 2014. This case is linked to 2014SA013070, 2014SA013079, 2014SA013082 and 2014SA013108 (same reporter). The following is verbatim from the article abstract: This report summarizes data for adverse events following immunization (AEFI) for 2011, and describes reporting trends over the 12-year period 2000 to 2011. There were 2,327 AEFI records for vaccines administered in 2011, a decrease of 40% from 3,894 in 2010. The decrease in 2011 was attributable to a decline in reporting following seasonal influenza (2,354 to 483) and pandemic H1N1 (pH1N1) influenza vaccines (514 to 2). However, reporting rates for some other vaccines were higher in 2011 compared with 2010. The 13vPCV replaced the 7vPCV and was suspected of involvement in 236 AEFI cases (48 per 100,000 doses). An increase in the number of reports following rotavirus (from 40 to 56 per 100,000 doses), and the hexavalent infant vaccine (from 27 to 40 per 100,000 doses), may have been due at least in part to co-administration with 13vPCV. Reports following DTaP-IPV also increased (from 94 to 139 per 100,000 doses), continuing a trend since 2009. AEFI reports following receipt of the 23-valent pneumococcal vaccine also increased markedly in those aged 65 years, from 155 to 288 records. In response to the increase in reports following 23vPPV, boosters are no longer recommended for those without medical risk factors. The most commonly reported reactions were injection site reactions, fever, allergic reactions and malaise. Only 7% of all the reported adverse events were categorized as serious, as per the database definitions, although some events classified as non-serious may have caused severe illness. Three deaths were temporally associated with vaccination; however, all were attributed to causes other than vaccination. The increase in 2011 was predominantly due to reports of injection site reactions (49% increases in 2011). Increases in some instances may also be partly attributable to an increasing propensity to report AEFI. A patient (elderly), had received a dose of seasonal influenza vaccine (manufacturer unknown, batch number, route and site of administration was not reported) on an unspecified date. On an unspecified date, the patient developed progressive neurological dysfunction. The patient died 29 days after receiving vaccination. The cause of the death was documented as acute disseminated encephalomyelitis (ADEM).


VAERS ID: 522129 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2014-01-24
Onset:2014-01-27
   Days after vaccination:3
Submitted: 2014-02-03
   Days after onset:7
Entered: 2014-02-07
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / UN
HIBV: HIB (ACTHIB) / SANOFI PASTEUR J1570 / 3 UN / SC
PNC: PNEUMO (PREVNAR) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-27
   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: Con Meds =None; Prev Meds =None
Current Illness:
Preexisting Conditions: Patient had no underlying disease, no any concurrent/historical conditions and no any history of adverse drug reactions.
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: 2014SA012776

Write-up: Initial report received from a healthcare professional via marketing partner on 27 January 2014. A 04-month-old male patient, had received 0.5 ml subcutaneous third dose of ACTHIB, batch number: J1570 (anatomical site of vaccination was not reported), PREVENAR from other manufacturer and second dose of TETRABIK from other manufacturer (route, anatomical site of vaccination and batch number was not reported) on 24 January 2014. Patient had no underlying disease, no any concurrent/historical conditions and no any history of adverse drug reactions. Patient spent the day uneventfully after the vaccination. On 27 January 2014, in the morning, the patient was found dead, and a family member of him informed the pediatrician of his death by phone. Corrective treatments were and laboratory investigations were not reported. Reporting physician''s seriousness assessment: Serious (Death) and causality assessment: Not related. Reporting physician''s comment: Some of his family had allergic predispositions including asthma and atopy, but the vaccines were considered as not related to the death since it occurred more than 72 hours after the vaccination. Sudden infant death syndrome was suspected. Documents held by sender: none.


VAERS ID: 522305 (history)  
Form: Version 1.0  
Age: 4.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-01-14
Onset:2014-01-19
   Days after vaccination:5
Submitted: 2014-02-07
   Days after onset:19
Entered: 2014-02-10
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B172AA / UNK AR / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR H7039 / UNK AR / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Circulatory collapse, Splenomegaly, Sudden death, Thymus enlargement, Tonsillar hypertrophy
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (broad), Neonatal disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-19
   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: Autism
Allergies:
Diagnostic Lab Data: It was reported that the histopathological examinations are ongoing. Visible signs of immunological system stimulation (enlarged spleen, thymus and tonsils).
CDC Split Type: 2014SA014312

Write-up: Initial report received from a health authority on 04 February 2014. Health Authority reference number: N79/2014. A 4-year-old male patient had received a dose of IMOVAX Polio (lot: H7039, exp.: 02.2014) intramuscularly in the upper limb and received a dose of INFANRIX DTPa (GlaxoSmithKline Biologicals, lot: AC14B172AA and expiry: 03.2015) intramuscularly in the upper limb on 14 January 2014. The patient was healthy at the time of vaccination. The patient had received a dose of Hepatitis B and BCG on 17 April 2009, a dose of Hepatitis B an INFANRIX IPV+Hib on 07 October 2009 and received a dose of Hepatitis B and INFANRIX IPV+Hib on 09 November 2010. The other vaccinations were not performed because the parents were traveling with children between two countries. Autism was occurring in the child. On 27 December 2013 the mother reported with the child due to an infection of upper airways. Symptomatic treatment without antibiotic therapy was administered. The institution where the vaccination had been performed, found out about the event by accident, in the circumstances when a nurse called the parents to ask them to report with another child. Formally, no report on the sudden death of the child was received. According to the information obtained from the manager of the mortuary, the death resulted from acute circulatory-respiratory failure. Visible signs of immunological system stimulation (enlarged spleen, thymus and tonsils). It was reported that the histopathological examinations are ongoing. Results will be available in about 7 days. The child''s death occurred at home on 19 January 2014. Documents held by sender: None.


VAERS ID: 522465 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Male  
Location: Foreign  
Vaccinated:2014-02-05
Onset:2014-02-06
   Days after vaccination:1
Submitted: 2014-02-11
   Days after onset:5
Entered: 2014-02-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
BCG: BCG (NO BRAND NAME) / UNKNOWN MANUFACTURER KH189 / 1 UN / UN
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER A007A / 3 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER Y7SC / 2 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H021856 / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Cardio-respiratory arrest, Death, Respiratory arrest, Sudden infant death syndrome
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), 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), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-02-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BESOFTEN; KINDAVATE; PROPETO
Current Illness: Asteatosis; Eczema; Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 02/05/2014, Body temperature, 36.6 degrees C
CDC Split Type: WAES1402JPN004065

Write-up: Initial information has been received from a physician via the Agency concerning a 6-month-old male patient with eczema and asteatosis who on 05-FEB-2014 was vaccinated orally with ROTATEQ mixture for internal use (Lot No. H021856, exp. 01-OCT-2014, dose and indication not reported) for the second time. There was a specific note on the Medical Questionnaire for Vaccination indicating that the patient had received application of BESOFTEN cream, KINDAVATE ointment and PROPETO for the treatment of eczema and asteatosis. The patient''s birth weight was 2710 g. Other suspect drugs included DTaP-IPV (manufacturer unknown) injection drug (third time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. A007 A), BCG vaccine (manufacturer unknown) (first time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. KH189) and Hep B vaccine (manufacturer unknown) injection drug (second time) (vaccination date: 05-FEB-2014, amount per dose: unknown, indication: unknown, Lot. No. Y7SC). On 05-FEB-2014, the patient was vaccinated with ROTATEQ (second time), DTaP-IPV (manufacturer unknown) (third time), BCG vaccine (manufacturer unknown) (first time) and Hep B vaccine (manufacturer unknown) (second time). The patient''s body temperature before the vaccination was 36.6 degrees C. On 06-FEB-2014, at 9:00 a.m. the patient was fed milk and baby food. At around 10:00 a.m., his mother got him to sleep in a supine position. At around 11:30 a.m., the patient developed cardio-respiratory arrest. His mother noticed that the patient was in a prone position and was no breathing. The patient''s mother made an emergency call and the patient was transferred to the reporting hospital, where resuscitation was performed but there was no response to treatment. At 13:00, the patient was confirmed dead. It was reported that the cause of death was cardio-respiratory arrest. Postmortem was to be performed. Reporter''s comment: Not provided. The reporting physician considered that cardio-respiratory arrest was serious due to death. The reporting physician felt that the causal relationship of cardio-respiratory arrest to ROTATEQ, BCG vaccine (manufacturer unknown), Hep B vaccine (manufacturer unknown) and cardio-respiratory arrest was unknown. The reporting physician considered that sudden infant death syndrome (SIDS) was the other possible causative factor for cardio-respiratory arrest. Per internal review cardio-respiratory arrest was considered as other important medical event. No further information is available.


VAERS ID: 522503 (history)  
Form: Version 1.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2013-11-04
Onset:2013-11-09
   Days after vaccination:5
Submitted: 2014-02-11
   Days after onset:94
Entered: 2014-02-12
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G60659 / UNK UN / SYR

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aphasia, Blood culture negative, Brain scan normal, CSF culture negative, Culture urine negative, Death, Fumbling, Nuclear magnetic resonance imaging normal, Polymerase chain reaction, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Esomeprazole; COROPRES; ELIGARD; PREVENCOR; SINTROM
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: 12-NOV-2013, Blood culture, Negative results; 12-NOV-2013, CSF culture, Normal; 12-NOV-2013, Culture urine, Normal; 12-NOV-2013, Nuclear magnetic resonance imaging, Normal; 12-NOV-2013, Polymerase chain reaction, Negative; 12-NOV-2013, Scan brain, Normal
CDC Split Type: 2014035010

Write-up: This is a spontaneous report obtained from a contactable physician through the Agency; regulatory authority report number: ES-AGEMED-419249243. A 69-year-old male patient started to receive PREVENAR 13 (Lot number# G60659), via an unspecified route of administration on 04Nov2013. The patient medical history was not reported. Concomitant medications included esomeprazole 20 mg/day, COROPRES (25 mg tablets, 28 tablets) at a total daily dose of 37.5 mg for cardiac failure, ELIGARD TRIMESTRAL (22.5 mg powder and solvent for solution for injection, 1 pre-filled syringe + pre-filled syringe of solvent) at 22.5 mg every 3 months for neoplasm prostate since Jun2013, PREVENCOR (40 mg film-coated tablets, 28 tablets) at 40 mg daily for dyslipidaemia and SINTROM (4 mg tablets, 20 tablets) for stroke since 2009. The patient experienced fever, dysphasia and fumbling from 09Nov2013 to 14Nov2013. The outcome of all events was reported as "death" by the Agency. The patient underwent lab tests and procedures which included; Blood culture which showed negative results, CSF culture was normal, culture urine showed normal result, nuclear magnetic resonance (NMR) imaging was normal, polymerase chain reaction (PCR) was negative and scan brain was normal, all tests were performed on 12Nov2013. The action taken in response to the event for the suspect drug was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. In the narrative reported from Regulatory Authorities, it was stated that patient had fever of non-filiated focus. No follow-up attempts possible. No further information expected.


VAERS ID: 522696 (history)  
Form: Version 1.0  
Age: 0.6  
Sex: Female  
Location: Foreign  
Vaccinated:2013-04-01
Onset:0000-00-00
Submitted: 2014-02-14
Entered: 2014-02-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Abdominal distension, Chemotherapy, Death, Faeces discoloured, Intensive care, Metastases to liver, Muscle spasms, Neuroblastoma, Pulmonary oedema, Respiratory failure, Scan abdomen abnormal
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Dystonia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal disorders (broad), Hypersensitivity (broad), Noninfectious diarrhoea (broad), Respiratory failure (narrow), Non-haematological malignant tumours (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-11-05
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: Abdomen scan, 2013, See text; Abdominal scan showed neuroblastoma behind right kidney with liver metastases
CDC Split Type: B0967532A

Write-up: This case was reported in a newspaper article and described the occurrence of death due to neuroblastoma in a 7-month-old female subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified). The subject''s mother was operated for suspected neuroendocrine tumor and right ovary was removed in 2009. The subject''s mother was also operated due to ileus during the 6th month of pregnancy, though it was a difficult surgery, the subject survived and developed normally. The subject was born by Caesarean section without any complication. In April 2013, the subject received unspecified dose of hepatitis B vaccine (unknown route, injection site and batch number). In 2013, 20 days after vaccination with hepatitis B vaccine, the subject''s stool was yellowish green in colour and her abdomen was more and more bloated. The subject''s mother contacted the nurse via phone, who concluded the subject had cramps and would go away if she monitored her diet. Approximately after 11 days, the subject was taken to the doctor, who found the subject to be vitally endangered. The doctor suspected a tumor and referred to the paediatric emergency room. At the paediatric emergency room, the subject was immediately transferred in the intensive care unit, where abdominal scan showed neuroblastoma behind right kidney with metastases of liver. The subject was diagnosed with neuroblastoma with liver metastases. The subject was treated with cancer chemotherapy. The subject was treated for 3 months at the clinic. The primary tumor and the metastasis reduced significantly, but the subject''s lungs were filled with water after the 4th chemotherapy cycle. On 5 November 2013, the subject died due to lungs filled with fluid and lungs failure. It was unknown whether an autopsy was performed.


VAERS ID: 522788 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Foreign  
Vaccinated:2013-09-18
Onset:2013-10-15
   Days after vaccination:27
Submitted: 2014-02-16
   Days after onset:124
Entered: 2014-02-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H015545 / 1 MO / PO

Administered by: Public       Purchased by: Other
Symptoms: Autopsy, Death, Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-15
   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: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1402FIN006904

Write-up: Information was received from Sanofi Pasteur MSD (MFR Control# E2014-01184) on 12-FEB-2014. Case received from health care professional via other company, Health Authorities and company representative, on 10-Feb-2014 under the reference numbers FI-FIMEA-20140148 and THL 305584. The primary reporter was a nurse. A 3-month-old patient, had received the first primary dose of ROTATEQ (batch number H015545) via oral route on 18-Sep-2013 and later on 15-Oct-2013, he died from Sudden infant death syndrome. It was reported that the child received first dose ROTATEQ at the baby clinic. 10 minutes after administration they went home with satisfaction. After that the mother has not been in contact with the baby clinic. Later on the baby was supposed to have a standard three-months-check at the clinic, but there was no need for it anymore since the baby died before the time of the check. Hence the clinic was informed on 16-Oct-2013 that the check time should be canceled. The cancellation came through centralized appointment center. Further, the coroner''s opinion was reported to vaccine program unit on 15-Jan-2014: "The patient got the Rota first dose on 18-Sep-2013. The baby died on 15-Oct-2013. After the forensic dissection and the additional investigation it''s my opinion that the cause of death is sudden infant death syndrome. It''s my opinion that the death and the vaccine has nothing to do with each other." No medical history reported. At the time of reporting, the outcome was fatal. According to the coroner, the reaction was not related to vaccination.


VAERS ID: 523432 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2013-12-12
Onset:2013-12-13
   Days after vaccination:1
Submitted: 2013-12-27
   Days after onset:14
Entered: 2014-02-24
   Days after submission:59
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR J1493 / 1 UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 13C02A / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aspiration tracheal, Atelectasis, Computerised tomogram abnormal, Death, Endotracheal intubation, Flatulence, Mechanical ventilation, Peripheral coldness, Respiratory arrest, Resuscitation
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: The patient had no family history.
Allergies:
Diagnostic Lab Data: CT scan, UNK, UNK, UNK; body temperature, UNK, 35.7 Degree C
CDC Split Type: 2013SA133558

Write-up: Initial report received from the Health Authority, reported by a physician on 18 December 2013. Authority No: V13001032. A 2-month-year old male patient (birth weight: 1.9 kg) had subcutaneously received first dose of ACTHIB (lot number: J1493, site of administration was not reported) and a dose of PCV13 (lot number: 13C02A, site and route of administration was not reported) simultaneously with ACTHIB on 12 December 2013 at 9:30 am. The patient had no family history and his body temperature before the vaccination was 35.7 degree Celsius. On 12 December 2013, at noon, the patient took 80 mL of milk as usual. The parent saw the patient went to sleep in the evening. On 13-Dec-2013, at 3:24am, the parent found the patient not breathing in the supine position and the patient''s body was motionless and cold. The patient was immediately taken to the reporting hospital by ambulance. Upon arrival, the patient was in a cardio-respiratory arrest and was treated by the reporting physician. Milk was aspirated from the tracheopharynx. He underwent resuscitation including intratracheal intubation, mechanical ventilation, sternal compression, securing an IV route, DIV of normal saline, and IV administration of adrenaline (15 doses in total). However, he did not make any response and was found dead at 4:51am. CT did not show any intracranial hemorrhage or fracture, but showed atelectasis and marked retention of intestinal gas without perforation. The outcome was death. Reporting physician''s causality assessment: Unknown. Reporting physician''s comment: The patient was a first twin born of dichorionic diamniotic twin fetus, had foetal growth retardation, and was born at 37 weeks and 0 days of low birth weight with the weight of 1995 g. Relationship between these facts and the event could not be denied. Possible causative factors for the event were low birth weight baby and poor weight gain.


VAERS ID: 523501 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Male  
Location: Foreign  
Vaccinated:2014-01-28
Onset:0000-00-00
Submitted: 2014-02-24
Entered: 2014-02-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA582AA / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, 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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0971119A

Write-up: This case was reported by a physician and described the occurrence of death in a 6-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 28 January 2014, the subject received unspecified dose of ROTARIX (1.5 ml, oral). The subject''s condition was same as usual, before and after the vaccination and he returned home in the same condition. Less than one month after vaccination with ROTARIX, the subject was found to be dead when the mother tried to wake him up in the morning. An autopsy was performed, but the cause was unspecified. The causal relationship to vaccination was unspecified.


VAERS ID: 523757 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2013-12-22
Onset:2014-01-20
   Days after vaccination:29
Submitted: 2014-02-25
   Days after onset:36
Entered: 2014-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 UN / SYR
TTOX: TETANUS TOXOID (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-20
   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: FAVIRAB; Antitetanus serum
Current Illness: Animal bite
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014PH022816

Write-up: Case number PHHY2014PH022816 is an initial spontaneous report received from a health care professional on 20 Feb 2014. This report refers to a 2-years-old female patient. Her medical history was not reported. She was bitten by a dog on 22 Dec 2013. She was immediately brought to hospital and was vaccinated with first dose of post exposure RABIPUR (batch number: not reported) on 22 Dec 2013. She was concomitantly administered FAVIRAB (batch number: not provided), anti-tetanus serum (ATS) and tetanus toxoid (manufacturer and batch number: not reported) on the same date. She was further administered three doses of post exposure RABIPUR (batch number: not reported) on 24 December 2013, 28 Dec 2013 and 11 Jan 2014. It was reported that she was brought to hospital again on 19 Jan 2014 and she expired due to rabies on 20 Jan 2014. The causality of the event was not reported. No further information was provided.


VAERS ID: 523758 (history)  
Form: Version 1.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-02-25
Entered: 2014-02-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Agitation, Death, Hydrophobia, Oropharyngeal pain, Pain in extremity, Rabies, Salivary hypersecretion
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Tendinopathies and ligament disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Animal bite
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014MW022158

Write-up: Case number PHHY2014MW022158 is an initial literature report received on 22 Feb 2014. The author discussed about the children who died of clinical rabies in a three month period (Sep 2011 to Nov 2011) in a hospital. This report refers to a 14-year-old female patient. She was bitten by a dog on her right arm. It was reported that the dog had been killed at the time of this bite. She had been presented to her local hospital but as there were inadequate ampoules of rabies vaccine, this was shared out between a total of three patients and she only received 3 intramuscular doses of rabies vaccine (manufacturer and batch number: not reported, so conservatively coded as RABIPUR INN). Four months later she presented with painful right arm for two days followed by a one day history of acute agitation and a painful throat. She was mildly agitated but could be settled. She became increasingly confused with signs of hydrophobia and excessive salivation. She was started on a diazepam infusion and intravenous fluids. She died 8 hours following admission due to clinical rabies. The author concluded that the rise of rabies was most likely due to inadequate supply of anti-rabies vaccine and inadequate dog-control measures.


VAERS ID: 523772 (history)  
Form: Version 1.0  
Age: 0.29  
Sex: Female  
Location: Foreign  
Vaccinated:2013-09-20
Onset:2013-10-16
   Days after vaccination:26
Submitted: 2014-02-23
   Days after onset:130
Entered: 2014-02-25
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Congenital absence of bile ducts, Death
SMQs:, Congenital, familial, neonatal and genetic disorders of the liver (narrow), Congenital, familial and genetic disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-10-16
   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: 20-JUL-2013, PREVENAR-13, First dose
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014047148

Write-up: This is a spontaneous report from a non-clinical study program. A contactable nurse reported that a 4 month-old female patient received, on 20Sep2013, at the age of 3 month-old, the second dose of PREVENAR 13 single dose. The patient previously received the first dose of PREVENAR 13 on 20Jul2013. Expiry dates and batch numbers were not given. Relevant medical history and concomitant medications were unknown. The patient experienced biliary atresia on 16Oct2013 and died due to the event on the same day (on 16Oct2013). It was not reported if an autopsy was performed. Follow up-attempts completed. No further information expected.


VAERS ID: 524016 (history)  
Form: Version 1.0  
Age: 0.73  
Sex: Male  
Location: Foreign  
Vaccinated:2014-01-23
Onset:2014-02-02
   Days after vaccination:10
Submitted: 2014-02-25
   Days after onset:23
Entered: 2014-02-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER UFA13016 / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pneumonia, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-02-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Con Meds = Unknown; Prev Meds = Unknown
Current Illness:
Preexisting Conditions: Unknown; Not reported
Allergies:
Diagnostic Lab Data: Body temperature, 02FEB2014, 38.2 degree C
CDC Split Type: 2014SA022546

Write-up: Initial report received from a healthcare professional on 10 February 2014. This initial report received on 10 February 2014. And it was transmitted on 14 February 2014 (number: 14-0000053). A 09-month-old male patient, whose medical history and concomitant medications were not reported, had received EUVAX B (manufactured by LG Life Sciences, batch number: UFA13016, dose, route and site of administration was not reported) on 23 January 2014. The patient was vaccinated against DTP, poliomyelitis and diseases caused by Hib (manufacturer: unknown, dose, route and site of administration was not reported) on 23 January 2014. On 2 February 2014 at 8pm, the patient experience vomiting after eating and 11pm body temperature rise to 38.2 degree Celsius. On 3 February 2014 at 7am, the child was found without signs of life; the ambulance was called which confirmed the death of infant. As a corrective treatment, the patient received NUROFEN on an unspecified date. The preliminary diagnosis: pneumonia. Forensic diagnosis was reported as "unknown". The patient had died and cause of death was unknown. Documents held by sender: none.


VAERS ID: 524144 (history)  
Form: Version 1.0  
Age: 3.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-02-12
Submitted: 2014-02-26
   Days after onset:14
Entered: 2014-02-27
   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: Death, Meningitis
SMQs:, Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-02-12
   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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014052485

Write-up: This is a spontaneous report from a contactable physician received via a Pfizer Sales representative. A 3-year-old male patient received PREVENAR 13 on unspecified date, via an unspecified route of administration, at single dose. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 12Feb2014 the patient experienced meningitis, for which the patient died the same day. It was unknown if an autopsy was performed.


VAERS ID: 524212 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2013-03-01
Onset:0000-00-00
Submitted: 2014-02-28
Entered: 2014-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER K7004 / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Abortion spontaneous, Death, Foetal heart rate abnormal
SMQs:, Foetal disorders (narrow), Termination of pregnancy and risk of abortion (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014040909

Write-up: This health authority report (initial receipt 13-Feb-2014) concerns a patient (foetus). On the 01-Mar-2013, the foetus received influenza (manufacturer and batch number not reported) from the mother in utero (see 2014040810). On an unspecified date after vaccination, the patient had an absence of foetal heartbeat which resulted in a spontaneous abortion. Corrective treatment and laboratory investigations were not reported. The patient''s outcome was fatal. Reporter comments: The regulator reported the case as possible in relation to the influenza vaccine.


VAERS ID: 524580 (history)  
Form: Version 1.0  
Age: 0.16  
Sex: Male  
Location: Foreign  
Vaccinated:2013-04-03
Onset:0000-00-00
Submitted: 2014-02-28
Entered: 2014-03-05
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER J7084 / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Crying, Death, Haemorrhage, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab test unknown
CDC Split Type: 2014SA024261

Write-up: This initial case report is part of a batch of reports associated with several products that was received on 21 February 2014 by the Sanofi Pasteur affiliate who received the report from the Ministry of Health. A male patient age reported as 02 months 02 days, whose medical history and concomitant therapies were not reported, had received first dose of IPV (lot number J7084-1, route and anatomical site of administration not reported), on 02 Apr 2013. On an unspecified date post-vaccination, the patient experienced fever, cry. In the day after was death in patients parents bed and there were vomit and blood secretion around patient. The patient''s outcome was reported as "death". The conduct regarding next vaccinations was reported as: "no conduct". The case was assessed as serious by the Ministry of Health. The patient was hospitalized.


VAERS ID: 525153 (history)  
Form: Version 1.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-06
Entered: 2014-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Abdominal pain, Abnormal sensation in eye, Adrenal disorder, Adverse drug reaction, Autopsy, Balance disorder, Blood pressure fluctuation, Blood test abnormal, Cardiopulmonary failure, Chest X-ray abnormal, Chest pain, Computerised tomogram head abnormal, Dizziness, Fatigue, Haematuria, Ileus, Leukocytosis, Microscopy, Orthostatic hypotension, Palpitations, Peripheral coldness, Phaeochromocytoma, Pneumonia, Pulmonary oedema, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (broad), Cardiomyopathy (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological tumours of unspecified malignancy (narrow), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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; Mesothelioma malignant
Preexisting Conditions: Chemotherapy; Radiotherapy; Lung lobectomy; Splenectomy; Thrombocytopenia; Cystitis haemorrhagic; Haematuria; Pleurectomy; Prostatectomy; Prostate cancer
Allergies:
Diagnostic Lab Data: Blood pressure, 75/60 mmHg; Blood pressure, 65/40 mmHg; Blood pressure, 100/75 mmHg; Blood pressure, 120/80 mmHg; Blood test, leucocytosis; Computerised tomogram, slightly enlarged left adrenal gland; Microscopy, pheochromocytoma; Physical examination, tachycardia; X-ray, pneumonia
CDC Split Type: WAES1403SWE001023

Write-up: Information has been received from business partner Sanofi Pasteur (Mfr # SE-1577272925-E2014-01666) on 28-FEB-2014. Case of adverse reaction retrieved from the literature on 25-FEB-2014. The primary report was a physician. A 67-year-old male patient (unknown initials, date of birth not reported) with a medical history including prostate cancer, malignant mesothelioma and splenectomy, had received an injection of pneumococcal vaccine (manufacturer (MFR) # unknown) (batch number not reported) via not reported route of administration in not reported site of administration on an unspecified date and later on (unspecified date), he developed fainting episodes, dizziness, balance problems, heart palpitations, tachycardia, tiredness, cold peripherally, brightness of eyes, orthostatic, ileus, leucocytosis, pneumonia, abdominal pain, lung/heart failure with pulmonary edema and organ stasis, pheochromocytoma and enlarged left adrenal gland. The patient had medical care at home due to his need for assistance with pain treatment (he suffered from severe thorax pain on the right side). A few months after the home care began, the patient had complained about heart palpitations. Examination showed tachycardia hence he received Metoprolol (Mfr other, per orally) 25 mg 1 x 1, which then increased to 50 mg 1 x 1 with good effect. Due to tiredness, he was ordered a 4 days treatment of Betamethasone (other Mfr, per orally) with the traditional reduction, no significant effect on the patient''s symptoms. During the time with home care, he had visited emergency doctors several times due to syncope. During examination the blood pressure was between 75/60 and 65/40 mm Hg. He was cold peripherally and tired however was able to speak. The patient described that during at least 2 different fainting episodes he felt "brightness of eyes and then it disappears". According to the reporter, the fainting was not confirmed by any health care professional but there are no reason to doubt information from the relatives. Blood pressure between the fainting episodes varies between 100/75 and 120/80 mmHg. Patient was investigated several times at the emergency hospital, where they at first assessed that the fainting was due to beta blocker (which was discontinued) or hypotension orthostatic, but even ileus and radiographic pneumonia was identified as the cause of symptoms which then also included abdominal pain. Unremarkable laboratory results except for leucocytosis which was only in connection with pneumonia. The patient''s fainting episodes continues even after the beta blocker was discontinued. The situation at home was even more unsustainable, hence he was referred to Palliative care department. The patient was rapidly worsen and deceased three weeks after admission at Palliative care (dates not reported). In consultation with patient''s relatives a clinical autopsy was performed, as apart from status post right-sided pulmectomy, status post splenectomy and pleural plaques of asbestos, also showed lung/heart failure with pulmonary edema and organ stasis and enlarged left adrenal gland (5X3X2 cm) with tumor without necrosis, which on microscopic examination confirmed to be a pheochromocytoma. After review of the CT scan (performed 2 months before patient died) did not reveal anything incidental, however, was noted slightly enlarged left adrenal gland. The patient''s medical history includes prostate cancer and malignant mesothelioma. The patient had previously undergone a pulm- and pleurectomy and received adjuvant radiotherapy with a total 106 Gy and chemotherapy. As a complication encountered macroscopic hematuria, which was judged to be due to hemorrhagic radiation cystitis. The patient had also had immune thrombocytopenia, which by hematology clinic was assessed due to bone marrow effects of radiotherapy and which was treated with high-dose steroids and gamma globulin without effect so splenectomy was performed. The outcome for the reactions: cold peripherally, tiredness, leucocytosis, balance problems, brightness of eyes, palpitation, tachycardia, abdominal pain, thorax pain, pneumonia, ileus, orthostatic was not reported. The outcome for the reactions: dizziness, fainting episodes, enlarged left adrenal gland, pulmonary edema, heart failure and lung failure was not recovered. Outcome for pheochromocytoma was fatal. At the time of reporting, the patient had died. According to the reporter, the cause of patient''s death was pheochromocytoma.


VAERS ID: 525185 (history)  
Form: Version 1.0  
Age: 0.27  
Sex: Male  
Location: Foreign  
Vaccinated:2014-02-06
Onset:2014-02-21
   Days after vaccination:15
Submitted: 2014-03-06
   Days after onset:13
Entered: 2014-03-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPHEPBIP: DTAP + HEPB + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Autopsy, Crying, Death, Inappropriate schedule of drug administration
SMQs:, Depression (excl suicide and self injury) (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-02-21
   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: Immunisation
Preexisting Conditions: 01/11/2014, Inguinal hernia
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1403DEU002036

Write-up: Information has been received from Sanofi Pasteur (mfr # DE-15772792925-E2014-01833) on 05-MAR-2014. Case of fatal outcome and medication error (first dose of ROTATEQ given too late) was received from a paediatrician on 28-Feb-2014. Case is medically confirmed. This case is linked to not serious case E2014-01836 (same reporter, same vaccine, different reaction). A 14-week-old male patient with a medical history of inguinal hernia operation on 11-Jan-2014, received a first dose of HEZYON (lot-no., injection route and site not reported), a first dose of PREVENAR 13 (Pfizer, lot-no, not reported) and a first dose of ROTATEQ (lot-no. not reported) orally, on 06-Feb-2014. Immediately p.v. he started to cry for about 20 - 30 minutes. 15 days later, on 21-Feb-2014, he was fed at about 5 am. Two hours later he was found lifeless in his bed. Emergency doctor was called but no reanimation was performed. An autopsy was performed on an unknown date. Results were pending. According to the paediatrician the only risk for SIDS was that the boy slept in his own bedroom. According to the reporter, SIDS was not related to vaccinations.


VAERS ID: 525335 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-10
Entered: 2014-03-10
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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1403NZL002674

Write-up: This spontaneous report as received from a immunisation nurse via a company representative, refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with GARDASIL (also reported as HPV vaccine). Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse stated the female patient died "last month" (approximately in February 2014), and no other patient identifiers are available. The nurse mentioned the region where this reportedly occurred was "the same place where a girl''s death after GARDASIL vaccination was previously reported in December (MARRS # 1312NZL004481). No patient identifiers or additional information was available. The reporting nurse also advised that received information from another nurse, who had heard from someone else that one of the mothers in the area had recently not consented to her daughter being vaccinated with GARDASIL because "her cousin died from HPV vaccine about a month ago". The reporting nurse is trying to contact a total of 15 patients who had not consented to their daughters'' vaccination during that time, to identify the reporter of the above information. The nurse stated that the area is not the most highly populated area and she is trying to contact physicians in the area to confirm the report. The nurse stated that if there had been a death, she and her team would know about it. The reporting nurse "suspects very strongly that this is a duplicate case" (of MARRS # 1312NZL004481) with which she had been previously involved. The causality was not reported. Additional information has been requested.


VAERS ID: 525421 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Foreign  
Vaccinated:2014-02-26
Onset:2014-02-28
   Days after vaccination:2
Submitted: 2014-03-10
   Days after onset:9
Entered: 2014-03-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR J1601 / UNK UN / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / SC
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA823AA / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-02-28
   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: Respiratory disorder neonatal
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0974944A

Write-up: This case was reported by a pharmacist and described the occurrence of death through unknown cause in a 2-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), ACTHIB (non-GSK), HEPTAVAX (non-GSK) and PREVENAR 13 (non-GSK). The subject''s medical history included neonatal respiratory disorder. On 26 February 2014, the subject received unspecified dose of ROTARIX (1.5 ml, oral), unspecified dose of ACTHIB (1 IU Axa, subcutaneous, unknown injection site and batch number), unspecified dose of HEPTAVAX (Non-GSK) (.25 ml, subcutaneous, unknown injection site and batch number) and unspecified dose of PREVENAR 13 (.5 ml, subcutaneous, unknown injection site and batch number). On 28 February 2014, 2 days after vaccination with ACTHIB, HEPTAVAX (Non-GSK), PREVENAR 13 and ROTARIX, the subject died due to an unknown cause. It was unknown whether an autopsy was performed. Further information was requested.


VAERS ID: 525526 (history)  
Form: Version 1.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2013-11-11
Onset:2013-11-15
   Days after vaccination:4
Submitted: 2014-03-10
   Days after onset:114
Entered: 2014-03-11
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Antineutrophil cytoplasmic antibody negative, Antinuclear antibody positive, Atrial flutter, Atrial tachycardia, Bacterial test negative, Blood lactate dehydrogenase normal, C-reactive protein normal, Chest X-ray abnormal, Death, Dyspnoea, Endotracheal intubation, Intensive care, Interstitial lung disease, Mechanical ventilation, Oedema peripheral, Pleural effusion, Pulmonary fibrosis, Red blood cell sedimentation rate normal, Respiratory failure, Rheumatoid factor negative, Right ventricular failure, Viral test negative, White blood cell count normal
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Interstitial lung disease (narrow), Systemic lupus erythematosus (narrow), Supraventricular tachyarrhythmias (narrow), 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), Acute central respiratory depression (narrow), Pulmonary hypertension (narrow), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-12-27
   Days after onset: 42
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: Bladder tumor resection, Transurethral resection of the bladder; Bleomycin sulfate, Drug intolerance; Chronic obstructive pulmonary disease, In oxygen therapy
Allergies:
Diagnostic Lab Data: NOV-2013, Blood lactate dehydrogenase, within limits; NOV-2013, C-reactive protein, normal; NOV-2013, Red blood cell sedimentation rate, normal; NOV-2013, White blood cell count, normal; Chest X-ray (Nov2013): interstitial involvement, in absence of indexes of phlogosis; Chest X-ray (29Nov2013): usual interstitial pneumonia (UIP), with involvement of medium basal areas; Screening of autoimmunity (Unknown date): positivity to antibodies ENA anti Jo 1, high title without muscular involvement; while rheumatoid factor and ANCA were normal; Unspecified test (Unknown date): There was no evidence of bacterial or viral infection. The excretion showed few mycetes.
CDC Split Type: 2014064275

Write-up: This is a spontaneous report from a contactable hospital physician received from the Regulatory Authority. Regulatory Authority report number 240550. A 78-year-old male patient received PREVENAR 13, intramuscular, 0.5 ml single dose, on 11Nov2013. Medical history included bladder neoplasm surgery (transurethral resection of the bladder, TURB). The patient''s concomitant medications were not reported. The patient previously took bleomycin sulfate and experienced drug intolerance. The patient experienced dyspnea and interstitial lung disease on 15Nov2013. The events were fatal and were described as follows: dyspnea; interstitial lung disease type Usual Interstitial Pneumonia (UIP) with rapid onset and unfavorable evolution, with respiratory insufficiencies. The patient died on 27Dec2013. No autopsy was performed. Details information on clinical course was provided as follows: The patient suffered from chronic obstructive pulmonary disease on nocturnal oxygen therapy and on exertion, previous resection of bladder neoplasia by TURB surgery and therapy with bleomycin suspended due to drug intolerance. He underwent pneumococcal vaccination on 11Nov2013. The patient did not show any local reactions or systemic symptoms until 15Nov2013, when he started to note dyspnea. In the next days the conditions quickly worsened with increase of dyspnea and onset of lower limbs edema, probable diagnosis was right cardiac failure. Chest x-ray showed interstitial involvement, without phlogosis indexes (WBC, ESR, CRP), LDH within limits. The patient was admitted on an unspecified date in Nov2013 and treated with antibiotics diuretics. Peripheral edema resolved and the symptoms seemed to improve. On 29Nov2013 chest x-ray showed evidence of usual interstitial pneumonia (UIP) with involvement of basal medium areas. Screening for autoimmunity showed positivity to antibodies ENA anti Jo 1, high title without muscular involvement; while rheumatoid factor and ANCA were normal. There was no evidence of bacterial or viral infection. The excretion showed few mycetes. The patient was treated with high-dose steroids without improvement, indeed progressive worsening of conditions with respiratory insufficiency type I with PaO2/FiO2 ratio markedly reduced. The clinical condition did not allow invasive investigations such as bronchoscopy (BAL neither VATS). The appearance of atrial tachycardia, flutter type, resistant to every therapy, led again to condition of heart failure, with edema and pleural effusion. Therefore the patient was transferred to intensive care on 16Dec2014, first ventilated with non-invasive ventilation and then intubated, with progressive respiratory failure that led to exitus, without possibility of further diagnosis. The following comments were reported: there was a temporal relationship between vaccine administration (11Nov2013) and onset of respiratory symptoms, vaccine administration was not the cause of UIP (usual interstitial pneumonia), the appearance of the above clinical conditions were not considered a possible adverse event of vaccine, in the PREVENAR 13 data sheet there was not evidence of such complications, the complete lack of response to steroid did not support the hypothesis of an immune-mediated mechanism in the genesis of the disease, the clinical outcome in absence of phlogosis indexes, the lack of response to steroid, suggested an UIP with quick evolution (pulmonary fibrosis syndrome, once referred to as Hamman-Riche syndrome).


VAERS ID: 526055 (history)  
Form: Version 1.0  
Age: 7.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-13
Entered: 2014-03-18
   Days after submission:5
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Blood immunoglobulin G increased, Brain herniation, Confusional state, Death, Fatigue, Headache, Immunoglobulins normal, Meningitis, Purpura, Pyrexia, Respiratory failure, Sepsis, Streptococcus test positive, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Dementia (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (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: CEFPROZIL
Current Illness:
Preexisting Conditions: Deficiency of the interleukin-1 receptor antagonist; Trimethoprim, Drug indication: Lymphadenitis bacterial; Phenoxymethylpenicillin, Drug indication: Lymphadenitis bacterial; Neutropenia
Allergies:
Diagnostic Lab Data: Immunoglobulins, normal g/l; Immunoglobulins, 3.4 g/l; Blood and CSF grew Streptococcus pneumoniae type 6C (date unknown): resistant to second-generation cephalosporins; Immunoglobulins (date unknown): were normal except IgG was increased (3.4 g/L)
CDC Split Type: 2014068800

Write-up: This is a literature report from a journal. Full publication has been requested. IRAK-4 deficiency causes IL-1R and TLR signaling failure, resulting in minimal clinical features despite invasive bacterial infection. We report the course of a 7-year-old IRAK-4-deficient girl presenting in the first year with multiple occult Staphylococcus aureus lymphadenitis. She was managed with antibiotic prophylaxis (sulfa/trimethoprim/PenV, then due to neutropenia - CEFPROZIL), pneumococcal vaccination (PCV-7 PNEUMOVAX23, PCV-13) and vigilance. Pneumococcal-specific IgG levels were monitored. No bacterial infections occurred on prophylaxis for 6 years after initial presentation. IgG response to PPV was satisfactory but short-lived, requiring frequent boosting. At age 7, patient developed a morning headache and vomited once. CEFPROZIL was administered and re-dosed. Over 12 h, she was fatigued without other symptoms. Low fever accompanied another emesis. A few hours later she was confused, and purpuric rash appeared. Emergency physicians diagnosed sepsis/meningitis and started vancomycin-ceftriaxone. Respiratory failure and cerebellar herniation occurred <24 h after first symptoms. Blood and CSF grew Streptococcus pneumoniae type 6C resistant to second-generation cephalosporins. The patient''s latest PCV-13 vaccination was 6 weeks before death, which included serotype 6A. Immunoglobulins were normal except IgG4 was increased (3.4 g/L). IgG response to vaccine antigens was satisfactory. IgG to 6A is reported to cross-react with 6C, but this was not the case here. Conclusion: Despite antibiotic prophylaxis and repeated vaccination, even older IRAK-4-deficient patients are at high risk of rapidly fatal infection due to emergence of antibiotic resistance. These patients need early assessment at any age, bacterial culturing, alternative empiric antibiotic therapy and close observation when even vaguely unwell. Based on increasingly recognized immunological and/or clinical impairments in B cell function, and possibly other defects, long-term IgG prophylaxis in addition to antibiotics is recommended.


VAERS ID: 526067 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:2014-03-01
Onset:2014-03-01
   Days after vaccination:0
Submitted: 2014-03-12
   Days after onset:10
Entered: 2014-03-18
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR J0380 / UNK - / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Cough, Crying, Death, Pyrexia
SMQs:, Anaphylactic reaction (broad), 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? Yes
   Date died: 2014-03-06
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Cesarean section, 16AUG2013
Allergies:
Diagnostic Lab Data: Body temperature, 06MAR2014, 38.6-39 Degree C
CDC Split Type: 2014SA030099

Write-up: Initial report received from healthcare professional (district CDC via sales representative) on 07 March 2014. A 06-month-old female patient, whose medical history and concomitant medications were not reported, had received 0.5 ml intramuscular dose of IMOVAX POLIO, batch number: J0380-1 (dose number and anatomical site of administration were not reported) on 01 March 2014 at 04:00 PM. The patient personal medical history includes P2, delivered by uterine-incision delivery and birth weight 2.6 Kg. It was reported that on 01 March 2014, same day after receiving IMOVAX POLIO, the patient experienced mild cough in the evening and on 02 March 2014, the cough was aggravated and at that time, the patient was not given any treatment. On 04 or 05 March 2014, the patient was sent to hospital and was given symptomatic treatment. The symptom was not relieved. The patient was crying in the evening on 5 March 2014. On 06 March 2014, the patient experienced fever (38.6-39 Degrees Celsius) and died at 05:00 AM. The patient''s laboratory investigations were not reported. At the time of this report, the outcome was fatal. Autopsy details were not reported. Documents held by sender: none. Cause(s) of Death: unknown cause of death.


VAERS ID: 526101 (history)  
Form: Version 1.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2014-03-07
Onset:2014-03-07
   Days after vaccination:0
Submitted: 2014-03-12
   Days after onset:4
Entered: 2014-03-18
   Days after submission:6
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4342AE / UNK AR / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Anaphylactic shock, Death
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Con Meds =HYPERTET; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: 2014SA030450

Write-up: Initial and follow-up information was received from a healthcare professional on 08 Mar 2014. A 30-year-old male patient (weight 80 kg and height 175 cm) whose medical history and concomitant medication were not reported received, a 0.5 ml dose of ADACEL intramuscularly in arm on 07 Mar 2014 (Batch number C4342AE). It was reported that patient had scratched his left finger. So he received wound care (he didn''t get stitched on his finger) and was treated with HYPERTET inj. (250 IU) on his hip. After treatment, he was applied with ADACEL for prevention of tetanus. After vaccination, he was observed for about 10 minutes and discharged. On the same day, after 2 hours of vaccination, the patient experienced shock and was rushed to the ER. He died in ER on the same day. Reporter supposed anaphylactic shock could have caused death. Laboratory investigations and corrective treatment were not reported. It was not known whether an autopsy was performed. The outcome was fatal. Reporter''s (surgeon) Causality Assessment: possible. List of documents held by sender: None.


VAERS ID: 526267 (history)  
Form: Version 1.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:1995-09-19
Onset:1997-09-01
   Days after vaccination:713
Submitted: 2014-03-20
   Days after onset:6044
Entered: 2014-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death, Immunoglobulins normal, Immunology test normal, Lumbar puncture normal, Nuclear magnetic resonance imaging brain abnormal, Optic neuritis, Visual acuity reduced, Visual acuity tests abnormal, White matter lesion
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (narrow), Demyelination (narrow), Lens disorders (broad), Retinal disorders (broad), Ocular infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2013-12-25
   Days after onset: 5959
Permanent Disability? No
Recovered? No
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: Gamma globulin, Normal; Immunology test, Negative; Lumbar puncture, Normal; Nuclear magnetic resonance ima, See text; Visual acuity tests, Dec1997, 3/10 (right eye); DEC1997: Brain MRI showed multiple hypersignals in supratentorial white matter, not enhanced with Gadolinium.
CDC Split Type: B0239909A

Write-up: Report number 2000026048-1 describes the occurrence of optic neuritis in a 56-year-old male patient receiving ENGERIX-B. This case was reported by the agency (PA0000528). Medical and drug histories are unknown in this patient. On 05 October 1990 and 19 September 1995, the patient was vaccinated with ENGERIX-B. In September 1997, two years after the last injection of ENGERIX-B the patient experienced right eye visual acuity decrease (3/10), and was hospitalized. Cerebral MRI showed normal white matter; lumbar puncture was normal; gammaglobulinemia was normal; immunological check-up was negative. The diagnosis was optic neuritis. The patient was treated with three tablets of methylprednisolone. Vision disorder didn''t resolve. The most recent information received on 27 September 2000 reports the outcome of the patient as not yet recovered. Causality assessment was reported by the agency as dubious for ENGERIX B. Follow-up information received on 13 March 2014 from the Regulatory Authority. The subject''s date of birth was provided. The patient was 43 years old in 1997, at the time of the event. The subject belonged to association under reference 927. On 05 October 1990, the subject received 1st dose of ENGERIX B (batch number, route and site unknown). On 19 September 1995, the subject received 2nd dose of ENGERIX B (batch number, route and site unknown) (drug dose administration interval too long). From 03 to 05 December 1997, the subject was hospitalised to monitor right eye visual acuity decreased (3/10) that had progressed over the past six months. Optic neuritis was stated. Brain MRI showed multiple hypersignals in supratentorial white matter, not enhanced with Gadolinium. The subject was treated with three bolus of SOLUMEDROL but visual acuity did not improve. Last information received by agency via association by mail on 14 February 2014: On 25 December 2013, the subject died. The cause of the death was unknown. According to the agency, based on the foreign method of assessment, optic neuritis was dubiously related to ENGERIX B.


VAERS ID: 526560 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Unknown  
Location: Foreign  
Vaccinated:2014-03-10
Onset:2014-03-15
   Days after vaccination:5
Submitted: 2014-03-20
   Days after onset:5
Entered: 2014-03-24
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR J0365 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, 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? Yes
   Date died: 2014-03-15
   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: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA033795

Write-up: Initial report received from a healthcare professional (physician) on 17 March 2014. A 03-month-old patient (gender was unknown), whose medical history and concomitant medications were not reported, had received an intramuscular first dose of 0.5 ml of IMOVAX POLIO (batch number J0365-1 and site of administration was not reported) and had also received an intramuscular second dose of HEPATITIS B VACCINE (manufacturer other, batch number was unknown and site of administration was not reported) on 10 March 2014. On 15 March 2014, 5 days after receiving vaccine, the patient developed fever and died. The patient''s corrective treatment and laboratory investigations were not reported. The patient died on 15 March 2014 and the outcome of fever was unknown. Documents held by sender: none.


VAERS ID: 526600 (history)  
Form: Version 1.0  
Age: 0.2  
Sex: Male  
Location: Foreign  
Vaccinated:2014-03-18
Onset:2014-03-18
   Days after vaccination:0
Submitted: 2014-03-24
   Days after onset:6
Entered: 2014-03-25
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR J0444 / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-18
   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: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Unknown
CDC Split Type: 2014SA034476

Write-up: Initial report received from healthcare professional on 18 March 2014. A 02-month-old male patient, whose medical history and concomitant medications were not reported, had received 0.5 ml intramuscular first dose of IMOVAX POLIO (batch number: J0444-1, site of administration was not reported) on 18 March 2014 at 09:00 AM. Few minutes after receiving IMOVAX POLIO vaccine, the patient died. The patient''s corrective treatment and laboratory investigations were not reported. Documents held by sender: none. Cause(s) of Death: unknown cause of death.


VAERS ID: 526658 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2012-11-07
Onset:2012-11-26
   Days after vaccination:19
Submitted: 2014-03-21
   Days after onset:479
Entered: 2014-03-25
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO
TD: TD ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, 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? Yes
   Date died: 2012-11-26
   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: Unknown
Current Illness:
Preexisting Conditions: Unknown; no information regarding the patient''s genderl health status was provided.
Allergies:
Diagnostic Lab Data: None
CDC Split Type: 2014SA022748

Write-up: Based on information received on 13 March 2014, the report previously considered as non-valid became valid: patient gender reported in follow-up (identified patient). Invalid unsolicited case received from Health Authorities in a foreign country through the local affiliates on 10-FEB-2014. A non-identified patient (gender and age not reported) with no reported medical history and no reported concomitant medication had received a POLIOVIRUS VACCINE LIVE ORAL vaccine (Sanofi Pasteur, batch number not reported) as well as a DIPHTHERIA AND TETANUS VACCINE (batch number not reported) on an unknown date. On 26-NOV-2012, the patient died. No other information was provided at the time of the report. Additional information was received from a physician via the local affiliates in a foreign country on 13 March 2014. The patient was male, with a weight of 88.00 kg and height 182.00 cm. He received 2 drops oral POLIOMYELITIS VACCINE (ORAL) (manufacturer and lot not reported) and 0.5 mL intramuscular DIPHTHERIA AND TETANUS TOXOIDS (manufacturer and lot not reported) on 07 November 2012. The day of vaccination, the patient experienced a fever. According to the source patient record, "the patient had followed its course the day before his death, practicing a physical activity.". The vaccinations were reported as "school vaccination reminder 4th DTPolio". No autopsy was performed, and no antecedent noted. No additional testing was performed. According to the affiliate, the report was received from the health authorities, and no additional information was available. Upon internal review on 19 March 2014, lead-in sentence has been amended to clarify why this case is now valid.


VAERS ID: 526727 (history)  
Form: Version 1.0  
Age: 0.18  
Sex: Male  
Location: Foreign  
Vaccinated:2014-03-17
Onset:2014-03-17
   Days after vaccination:0
Submitted: 2014-03-25
   Days after onset:8
Entered: 2014-03-26
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CB938A / 1 LL / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H50850 / 1 RL / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Sudden infant death syndrome
SMQs:, Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-17
   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: Unknown, Premature delivery at 30th week; Unknown, Respiratory failure at birth
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014081374

Write-up: This is a spontaneous report received from the Regulatory Authority. Regulatory Authority report number 242813. A hospital physician (contactable through Regulatory Authority only) referred that a 9-week-old male patient received on 17Mar2014 at 09:30 first dose of PREVENAR 13 (Lot n. H50850 expiration date 31Jul3015) via an unspecified route of administration in the right thigh and first dose of INFANRIX HEXA (Lot n. A21CB938A expiration date 31May0215) via an unspecified route of administration in the left thigh. Medical history included premature delivery (at 30th week). respiratory failure (at birth), 2.9 kg weight at birth. The patient''s concomitant medications were not reported. The patient experienced sudden death on 17Mar2014. At 14:30 patient''s mother was not hearing patient''s breath and therefore carried by its own means the patient to the emergency room. The patient died on 17Mar2014. It was unknown if an autopsy was performed.


VAERS ID: 526852 (history)  
Form: Version 1.0  
Age: 1.1  
Sex: Female  
Location: Foreign  
Vaccinated:2013-10-30
Onset:2014-03-04
   Days after vaccination:125
Submitted: 2014-03-26
   Days after onset:21
Entered: 2014-03-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / 1 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Bacterial test negative, Culture throat, Death, Influenza virus test negative, Intensive care, Meningitis meningococcal, Streptococcus test negative, Upper respiratory tract infection
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-04
   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: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: The blood and cerebrospinal fluid samples were collected from the patient. However the reporter physician could not provide the results of test. Based on the information received from the laboratory supervisor; the blood culture remained negative for Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae. The laboratory supervisor verbally confirmed the test result but he refused to provide the results in written.
CDC Split Type: 2014SA034156

Write-up: Initial case was received from a health care professional via Sales representative on 17 March 2014. A 13-months-old female patient whose medical history and concomitant medication was not reported had received MENACTRA (dose, route and anatomical site of administration not reported) on 30 October 2013. On 25 February 2014, the patient was admitted to the hospital. The patient started treatment with suspected upper respiratory tract infection after the throat culture (the result of throat culture was not reported). On 26 February 2014, she was admitted to the private hospital and was transferred to Hospital with suspected meningococcal meningitis for the reason that the patient had an eruption. The patient was closely monitored by the reporting physician in the pediatric intensive care unit. The blood was closely monitored by the reporting physician in the pediatric intensive care unit. The blood and cerebrospinal fluid samples were collected from the patient. However the reporter physician could not provide the results of test. The patient died on 04 March 2014. Comment: This case could not be considered as the lack of efficacy. Because, MENACTRA is indicated in children aged from 12 months to 15 years as two doses (three months apart) according to our local labeling information. However, MENACTRA was administered to the patient as a single dose. The list of documents held by sender: None.


VAERS ID: 526856 (history)  
Form: Version 1.0  
Age: 1.7  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-26
Entered: 2014-03-27
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 4 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pneumococcal infection
SMQs:, Infective pneumonia (broad), Opportunistic infections (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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014082837

Write-up: This is a spontaneous report from a contactable physician via a sales representative. A 20-months-old female patient of an unspecified ethnicity, received four doses of PREVENAR 13 via an unspecified route of administration, on an unspecified dates, at single doses. The patient medical history and concomitant medications were not reported. The patient experienced infectious process by pneumococcus identified as etiologic agent (serotype 3) on an unspecified date. The patient died as a consequence of the event on an unspecified date. It was not reported if an autopsy was performed.


VAERS ID: 526931 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-26
Entered: 2014-03-28
   Days after submission:2
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: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1403RUS011092

Write-up: This spontaneous report as received from a physician via a company representative from social media refers to a several patients of unknown age and gender. On an unknown date, the several patients were vaccinated with GARDASIL (strength, dose, frequency, route, lot number and expiry date unknown). On an unknown date several patients died following vaccination (death). The outcome of several cases of death following vaccination was reported as fatal. Follow up information was received on 24-MAR-2014. According to the physician she saw the television six months ago, and there was a report on one female patient who died after receiving GARDASIL vaccine. In addition, she read in the Internet all kinds of articles around the "noise on GARDASIL" but did not remember exactly what. Additional information is not expected.


VAERS ID: 527098 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2013-10-02
Onset:2014-01-04
   Days after vaccination:94
Submitted: 2014-03-28
   Days after onset:82
Entered: 2014-03-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPH: DTAP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H016909 / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Constipation, Cyanosis, Enema administration, Intussusception, Pallor, Somnolence, Sudden infant death syndrome, Urine output decreased, Vomiting
SMQs:, Acute renal failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-01-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: The patient was diagnosed at US-intussusception. Air enema was successful. Another ultrasound was performed and the result was ok.
CDC Split Type: WAES1403ISR012065

Write-up: This spontaneous report as received from via an agency from a physician refers to a 4 month old female patient who on 02-OCT-2013, was vaccinated with the first dose of ROTATEQ lot # H016909, Exp. Date: 30-JUN-2014, oral (dose not reported). Concomitant therapies included PREVENAR and DTaP/Hib and IPV (unspecified). It was reported that on 10-NOV-2013, the patient was admitted in the hospital due to three days of vomiting and constipation. According to her parents she also had less urine than usual. There was no fever. According to the mother the baby was sleepy. The patient was diagnosed at US-intussusception. Air enema was successful. Another ultrasound was performed and the result was ok. The baby was released from the hospital on 11-NOV-2013. The baby died on 04-JAN-2014. The mother got up from her sleep and went to the baby. The baby was pale with blue spots on the face. Classification after death was sudden infant death syndrome (SIDS). The related ness for intussusception and sudden infant death syndrome (SIDS) and ROTATEQ was unknown. Additional information has been requested.


VAERS ID: 527128 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-03-27
Entered: 2014-03-31
   Days after submission:4
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Condition aggravated, Death, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Arrhythmia; Cardiac failure congestive; Diabetes mellitus
Preexisting Conditions: Myocardial infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014NZ036122

Write-up: Case number PHHY2014NZ036122 is an initial literature report received on 23 Mar 2014. The author described the spontaneous reports of adverse event related to seasonal influenza vaccine. This report refers to a patient of unspecified age and gender. The patient''s medical history included diabetes, myocardial infarction, cardiac arrhythmia and congestive heart failure. On an unknown date, the patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number unknown). After an unknown duration, the patient died of further myocardial infarction. It was unknown if an autopsy was performed. The event was assessed as temporally related to influenza vaccination by author.


VAERS ID: 527201 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Male  
Location: Foreign  
Vaccinated:2014-03-13
Onset:0000-00-00
Submitted: 2014-03-31
Entered: 2014-04-01
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPPHIB: DTP + IPV + ACT-HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Autopsy, Death, Sudden infant death syndrome
SMQs:, Neonatal 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014085331

Write-up: This is a spontaneous report received from the Health Authority. Regulatory Authority report number DE-PEI-PEI2014020702. A 9-week-old male patient of an unspecified ethnicity receive a dose of PREVENAR 13 (lot # not reported), via an unspecified route of administration and a dose of HEXYON (lot # not reported), via an unspecified route of administration, both on 13Mar2014. The patient medical history and concomitant medications were not reported. Two days later, during the night from 14Mar2014 to 15Mar2014, the patient died. An autopsy was performed and was without any pathological findings. SIDS (sudden infant death syndrome) was reported as the cause of death. No follow-up attempts needed. No further information expected.


VAERS ID: 527309 (history)  
Form: Version 1.0  
Age: 1.26  
Sex: Female  
Location: Foreign  
Vaccinated:2014-03-10
Onset:2014-03-14
   Days after vaccination:4
Submitted: 2014-04-02
   Days after onset:19
Entered: 2014-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS A69CD402A / 1 LL / UN
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. J006318 / 1 RL / UN

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-03-14
   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: Immunisation
Preexisting Conditions: 02/2014, Bronchitis; 07/2013, Oral candidiasis; Pneumococcal vaccine, no adverse event; Diphtheria toxoid (+) hepatitis B virus vaccine (unspecified) (+) no adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1403DEU011914

Write-up: Information has been received from Sanofi Pasteur (Manufacturer Control # E2014-02515) on 24-MAR-2014. Case of fatal outcome (unknown cause of death) was received from the Health Authorities on 20-Mar-2014 (reference no. PEI2014019109). Case is medically confirmed. A 15-month-old female patient received a first dose of VARIVAX (lot-no. J006318, expiry date: 30-APR-2015) into the right thigh and a first dose of PRIORIX (GSK, lot-no. A69CD402A) into the left thigh on 10-Mar-2014. According to the parents, the same day the patient developed fever between 38 degrees C and 39 degrees C. Four days p.v., on 14-Mar-2014, the child was found lifeless by the parents in her bed. Resuscitation by the father over 10 minutes followed by resuscitation by the emergency physician for further 70 minutes without success. The public prosecution started investigations. An autopsy was performed, results were pending. The girl was healthy at the time of vaccinations. No concomitant or preceding medication. Medical history included oral thrush in Jul-213 and bronchitis in Feb-2014. Hexavalent and pneumococcal vaccines had been well tolerated. No pre-or perinatal complications. Term caesarean section birth. No malformations. Intrauterine death of a sibling at the 7th gestational month (Turner syndrome). Upon medical review the company judged relevant to code the following adverse event: "fever" which was mentioned in the report but not coded by HA.


VAERS ID: 527782 (history)  
Form: Version 1.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-11-01
Onset:0000-00-00
Submitted: 2014-04-04
Entered: 2014-04-07
   Days after submission:3
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 UN / IM

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Pneumonia, X-ray abnormal
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-02-13
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: Budesonide/formoterol fumarate; Clarithromycin; Unknown
Current Illness:
Preexisting Conditions: Arthritis rheumatoid; Pulmonary fibrosis
Allergies:
Diagnostic Lab Data: X-ray, Bilateral pneumonia
CDC Split Type: 2014091404

Write-up: This is a spontaneous report from a contactable physician received from the INFARMED. Regulatory Authority report number: PT-INFARMED-L201403-154. A 67-year-old female patient of an unspecified ethnicity received a dose of PREVENAR 13, from an unspecified lot number, via intramuscular route of administration on Nov2013. This was the first time the patient received pneumococcal 13-valent conjugate vaccine. Medical history included rheumatoid arthritis. It is unknown if the patient had any prior history of adverse reactions to other drugs. On Nov2013, the patient experienced bilateral pneumonia. The diagnosis of pneumonia was confirmed by x-ray, however the causal agent was not determined, since isolation and serotyping was not performed. The patient was hospitalized from 26Dec2013 to 17Jan2014 as a result of bilateral pneumonia. The patient was hospitalized a second time due to worsening of symptoms (unknown dates), and died in the hospital. The patient was deceased on 13Feb2014. The reported cause of death was bilateral pneumonia. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included x-ray (unknown date) revealing extensive bilateral pneumonia. The reporting physician and the regulatory considered the event was possibly related to pneumococcal 13-valent conjugate vaccine. The reporting physician did not suspect a quality problem.


VAERS ID: 528179 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-04-11
Entered: 2014-04-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Death neonatal, Foetal exposure during pregnancy, Neonatal asphyxia, Neonatal disorder
SMQs:, Acute central respiratory depression (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (narrow), Respiratory failure (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHHY2014NL044365

Write-up: Case number PHHY2014NL044365, is an initial literature report received on 08 Apr 2014. The authors described about a prospective cohort and spontaneously reported pregnancy-related adverse reactions with H1N1 influenza vaccination during pregnancy. This case refers to a stillborn fetus to a mother of unknown age. The mother medical history included obesity. The mother was vaccinated with H1N1 influenza (manufacturer and batch number: not reported) at week 29 of pregnancy (see linked mother case: PHHY2014NL044360). The fetus was exposed to the vaccine via transplacental route. The baby had a normal birth weight and there was no congenital malformations. The neonate died one week postpartum due to asphyxia during birth. The authors stated that there were no signs of an association between the perinatal death and the vaccination. The authors concluded that the present study adds further reassurance for the safe use of adjuvanted vaccines during pregnancy and facilitates decision making in future pandemics and epidemics.


VAERS ID: 528290 (history)  
Form: Version 1.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-04-14
Entered: 2014-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 UN / SYR

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:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0985472A

Write-up: This case was reported by a consumer (subject''s mother) and described the occurrence of death through unknown cause in a 13-year-old female subject who was vaccinated with HPV vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The subject''s medical history details and concomitant drugs were not reported. On an unspecified date, the subject received 2nd dose of HPV vaccine (unknown route and injection site; lot number not provided). At an unspecified time after vaccination with HPV vaccine, the subject died through unknown cause. The details about the adverse event were not reported. It was unknown whether an autopsy was performed. This case was one of the 5 cases received from the same source of information (web site of news), but different subjects and reporters.


VAERS ID: 528503 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-04-16
Entered: 2014-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Sudden infant death syndrome
SMQs:, Neonatal 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? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1404DEU008910

Write-up: This literature marketed report as received from a physician refers to an infant patient of unknown age. On an unknown date, the patient was vaccinated with ROTATEQ, oral, dose (unknown), frequency (unknown). Other suspect therapies included Hib (unspecified carrier), DTaP-IPV (unspecified carrier) and PNC (unspecified). On an unknown date, an infant developed SIDS (sudden infant death syndrome), within 24 hours after the dose of Hib (unspecified carrier), DTaP-IPV (unspecified carrier) and PNC (unspecified) and ROTATEQ. The outcome of event was fatal. Causality of the event was considered as related by the author. This report is linked to 1404DEU009082 and 1404DEU009083 by the same literature link. Additional information has been requested.


VAERS ID: 528505 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-04-16
Entered: 2014-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK UN / UN
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Death, Sudden infant death syndrome
SMQs:, Neonatal 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? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: WAES1404DEU009082

Write-up: This literature marketed report as received from a physician refers to a premature infant patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ (Lot number and expiry date was not reported), oral, dose, frequency. Other suspect therapies included DTaP-IPV-Hib and PCV (unspecified). On an unknown date, a premature infant who was a risk for SIDS died 3 days after the dose of DTaP-IPV-Hib and PCV (unspecified) and ROTATEQ. The outcome of event was reported as fatal. Causality of the event was considered as related by the author. This report is linked to 1404DEU008910 and 1404DEU009083 by the Same Literature Link. Additional information has been requested.


VAERS ID: 529083 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-04-22
Entered: 2014-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Other       Purchased by: Other
Symptoms: Cardiac arrest, Hepatitis B antibody
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (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: Opiate
Current Illness: Heroin dependence
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood test, see text; Three of 12 sites undertook blood testing to establish the subject''s HBV antibody concentrations either before or during the vaccination schedule; if the blood test showed the subject had sufficiently high concentrations of antibodies, the service would either not start the vaccination schedule or would not continue with the vaccination schedule if it had been started.
CDC Split Type: B0986435A

Write-up: This case was reported in a literature article and described the occurrence of cardiac arrest in an adult between 18 and 65 years of age, subject of unspecified gender who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). Concurrent vaccination possibly included hepatitis B vaccine recombinant; manufacturer unspecified; 1st or 1st and 2nd dose given on an unspecified date. The subject received the vaccine or vaccines as part of a study that targeted people undergoing treatment for heroin dependence and that excluded subjects who were pregnant, breastfeeding, had previously received hepatitis B vaccinations or had hepatitis B infection. A super accelerated schedule (vaccination days 0, 7, and 21) was used. No other information on the subject''s medical, family history or concurrent medication is available. Concurrent medications included Opioid substitution therapy. On an unspecified date, the subject received 1st, 2nd or 3rd dose of Hepatitis B vaccine (unknown route and injection site; lot number not provided). At an unspecified date, after vaccination with Hepatitis B vaccine, the subject experienced a cardiac arrest. It was unknown whether an autopsy was performed. No information has been provided regarding any clinical examination or investigations performed on the subject. Author''s conclusion: "No other adverse events were reported, and none was regarded as related to treatment. We noted no association between serious adverse events and trial condition (Fisher''s exact test p=0.50)". Summary: Poor adherence to treatment diminishes its individual and public health benefit. Financial incentives, provided on the condition of treatment attendance, could address this problem. Injecting drug users are a high-risk group for hepatitis B virus (HBV) infection and transmission, but adherence to vaccination programmes is poor. The author''s aimed to assess whether contingency management delivered in routine clinical practice increased the completion of HBV vaccination in individuals receiving opioid substitution therapy using a cluster randomised controlled trial, where they enrolled participants at 12 drug treatment services that provided opioid substitution therapy and nurse-led HBV vaccination with a super accelerated schedule (vaccination days 0, 7, and 21). Clusters were randomly allocated 1:1:1 to provide vaccination without incentive (treatment as usual), with fixed value contingency management), or escalating value contingency management. Both contingency management schedules rewarded on-time attendance at appointments. The primary outcome was completion of clinically appropriate HBV vaccination within 28 days. Sensitivity analyses were done, that examined vaccination completion with full adherence times and within a 3 month window. Modest financial incentives delivered in routine clinical practice significantly improve adherence to and completion of, HBV vaccination programmes of the three-injection vaccination schedule, in patients receiving opioid substitution therapy. Approximately half of subjects complete vaccination as scheduled. Drug treatment providers should employ contingency management to promote adherence to vaccination programmes. The effectiveness of routine use of contingency management to achieve long-term behaviour change remains unknown.


VAERS ID: 529573 (history)  
Form: Version 1.0  
Age: 0.12  
Sex: Male  
Location: Foreign  
Vaccinated:2014-04-02
Onset:2014-04-03
   Days after vaccination:1
Submitted: 2014-04-26
   Days after onset:23
Entered: 2014-04-28
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER J4172 / 1 UN / UN
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME) / SANOFI PASTEUR - / 1 UN / UN
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER 3C2901 / 1 UN / UN
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER V8091 / 1 MO / PO
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH H46982 / 1 UN / UN
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLA812AC / 1 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Crying, Death, Death neonatal, Diet refusal
SMQs:, Acute central respiratory depression (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-04-03
   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: B0988644A

Write-up: This case was reported by a healthcare professional and described the occurrence of death unspecified in a 6-week-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline), (non-gsk) OPV, (non-gsk) PENTAXIM, HepB (non-gsk), pneumococcal vaccine (non-gsk) and DTaP (non-gsk). The subject had no history of being unwell before or after immunization. On 2 April 2014, the subject received 1st dose of ROTARIX (oral), 1st dose of OPV (Non-GSK) (oral), 1st dose of PENTAXIM (unknown), 1st dose of HepB (Non-GSK) (unknown), 1st dose of Pneumococcal vaccine (Non-GSK) (unknown) and 1st dose of DTaP (Non-GSK) (unknown). On 3 April 2014, around 1 am, 1 day after vaccination with DTaP (Non-GSK), HepB (Non-GSK), OPV (Non-GSK), PENTAXIM, Pneumococcal vaccine (Non-GSK) and ROTARIX, the subject cried uncontrollably for a long period. He refused to feed and after some time, their parents put him to sleep. In the morning, the subject was found dead from an unknown cause of death. An autopsy was not performed, the subject was buried in the afternoon of 3 April 2014. The facility "Domestic" fridge was not functional therefore the vaccines were stored at Clinic and on the immunization day, the vaccines were transported in a cooler box. No possibility of mixing vaccines with other drugs since the cooler box was only used for vaccines. The cold chain on storage of vaccines was maintained. No other adverse events following immunisation had been reported at the clinic or surrounding clinics. Therefore, regulatory authority indicated that the vaccines will not be tested and were deemed safe due to the monitoring and controlling system in the county. No death certificate was available and the post mortem was refused indicating the exact cause of death. It was noted that there was no evidence that death of the baby was due to immunization. As no additional information could be obtained, the case has been closed.


VAERS ID: 529722 (history)  
Form: Version 1.0  
Age: 8.0  
Sex: Male  
Location: Foreign  
Vaccinated:2011-05-24
Onset:0000-00-00
Submitted: 2014-04-29
Entered: 2014-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Death, Incomplete course of vaccination
SMQs:, Medication errors (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: UNK
CDC Split Type: B0988356A

Write-up: This case was reported by a nurse and described the occurrence of death, unknown cause in an 8-year-old male subject who was vaccinated with TWINRIX pediatric (GlaxoSmithKline). On 24 May 2011 the subject received the first dose of TWINRIX pediatric (unknown batch number, 1 injection, intramuscular) following a 0, 1 and 6 month vaccine schedule. At an unspecified time after vaccination with TWINRIX pediatric, the subject experienced death, unknown cause. It was reported that the subject "had only one dose three years ago and did not come back". It was reported that the subject failed to return for the second and third doses of TWINRIX pediatric. The subject died from an unknown cause.


VAERS ID: 529777 (history)  
Form: Version 1.0  
Age: 0.3  
Sex: Female  
Location: Foreign  
Vaccinated:2014-04-09
Onset:2014-04-10
   Days after vaccination:1
Submitted: 2014-04-29
   Days after onset:19
Entered: 2014-04-30
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR J1671 / 2 UN / UN
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 13H02A / 2 UN / SC

Administered by: Unknown       Purchased by: Unknown
Symptoms: Aphonia, Cough, Death, Hypotonia, Pharyngeal erythema, Pyrexia, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2014-04-18
   Days after onset: 8
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: Unknown
Allergies:
Diagnostic Lab Data: 09-APR-2014, Body temperature, 36.6 Centigrade; 10-APR-2014, Body temperature, 39 Centigrade; 12-APR-2014, Body temperature, reduced Centigrade
CDC Split Type: 2014113403

Write-up: This is a spontaneous report received from Agency under the regulatory authority report number of V14000043. A contactable physician reported that a 3-month-old female patient received on 09Apr2014 at 8:52 AM the second inoculation of subcutaneous PREVENAR 13 (Lot #: 13H02A) solution for injection in pre-filled syringe at single dose, with the second inoculation ACT-HIB (Lot #: J1671) an unknown dose. At the time the inoculations were given, the body temperature was 36.6 degrees Celsius. Medical history and concomitant medication were not reported. The patient had no family history. At 11:40 PM on 17Apr2014, the patient experienced respiratory arrest. The patient died on 18Apr2014. The cause of death was not reported. No information was given whether autopsy was performed or not. According to the reporting physician, in the afternoon of 10Apr2014, the patient had pyrexia of maximum 39 degrees Celsius. The patient visited the reporting physician and redness of the pharynx was found. Antibiotic was administered to the patient. On 12Apr2014, the body temperature had reduced but the patient lost his voice. Thus the patient visited the reporting physician. On 17Apr2014, the symptom did not change and thus the patient was visited again by the reporting physician and medication was given. After taking a bath at night, the patient had cough. At 11:40PM on the same day, the patient experienced respiratory arrest. The patent became limp. At the same time an ambulance was requested, the patient was taken to the reporting physician in a rush. The patient was transferred to an academic medical center. The patient died on 18Apr2014. The reporting physician classified the event as serious/death and assessed the causality with PREVENAR 13 as unassessable. The causality with ACT-HIB was not mentioned. The reporting physician also commented that the causal relationship with PREVENAR 13 was unknown, and that it was unknown whether other factors (such as other diseases) could be the causes of the event.


VAERS ID: 529778 (history)  
Form: Version 1.0  
Age: 0.32  
Sex: Female  
Location: Foreign  
Vaccinated:2013-02-01
Onset:2013-11-01
   Days after vaccination:273
Submitted: 2014-04-29
   Days after onset:179
Entered: 2014-04-30
   Days after submission:1
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 / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Death, Road traffic accident
SMQs:, Accidents and injuries (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: 30-NOV-2012, PREVENAR-13, 1st dose; Unknown, PREVENAR-13, 2nd dose; 30-NOV-2012, INFANRIX HEXA, 1st dose; Unknown, INFANRIX HEXA, 2nd dose; 30-NOV-2012, Rotavirus vaccine, 1st dose; 01-FEB-2013, Rotavirus vaccine, 2nd dose; 06-OCT-2012, Polio vaccine, 1st dose; 30-NOV-2012, Polio vaccine, 2nd dose
Allergies:
Diagnostic Lab Data:
CDC Split Type: 2014113348

Write-up: This is a spontaneous report from a contactable nurse. A 13-month-old female patient received third dose of PREVENAR 13, intramuscular on unknown date. The patient medical history was not reported. Concomitant medication included third dose of INFANRIX HEXA on 01Feb2013, second dose of Rotavirus vaccine on 01Feb2013. The patient previously received the following vaccines: first dose of PREVENAR-13 and ROTARIX on 30Nov2012, INFANRIX HEXA on unknown date, Polio on 06Oct2012; second dose of PREVENAR-13 and INFANRIX HEXA on unknown date, ROTARIX on 01Feb2013, Polio on 30Nov2012. The baby died of fatal injuries in a car accident, in Nov2013 and the mother was too distraught to give the exact date. It was not reported if an autopsy was performed. The patient died before booster dose could be given at 15 months. The mother was too distraught to give specific reasons for death, she has only mentioned that the baby died in a car crash. The death was not related to the PREVENAR 13 use. Follow-up attempts completed. No further information expected.


VAERS ID: 529807 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2014-04-28
Entered: 2014-04-30
   Days after submission:2
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
YF: YELLOW FEVER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: Unknown
Symptoms: Yellow fever vaccine-associated viscerotropic disease
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: Con Meds =Unknown; Prev Meds =Unknown
Current Illness:
Preexisting Conditions: Unknown
Allergies:
Diagnostic Lab Data: Lab tests unknown
CDC Split Type: 2014SA052634

Write-up: Initial report received from literature on 17 April 2014. The case is linked to case number 2014SA052261 and 2014SA052635 (same literature report). The following is a verbatim for the article abstract: Due to the risk of severe vaccine-associated adverse events, yellow fever vaccination in a specific country is only recommended in areas considered at risk for disease. From September 2008 through June 2009, two outbreaks of yellow fever in previously unvaccinated populations resulted in 21 confirmed cases with 9 deaths (case-fatality, 43%) in a specific state and 28 cases with 11 deaths (39%) in another state. Epizootic deaths of non-human primates were reported before and during the outbreak. Over 5.5 million doses of yellow fever vaccine were administered in the two most affected states. Vaccine-associated adverse events were associated with six deaths due to acute viscerotropic disease (0.8 deaths per million doses administered) and 45 cases of acute neurotropic disease (5.6 per million doses administered). Yellow fever vaccine recommendations were revised to include areas in a country previously not considered at risk for yellow fever. 06 patients (whose demographics, medical history and concomitant medications were not reported) received yellow fever (manufacturer unknown, batch number, route and anatomical site of administration not reported) on unspecified date. Among the 6 confirmed cases of yellow fever vaccine-associated acute viscerotropic disease, median age was 31 years (range 4-44 years) and 2 (33%) case patients were male. Rates of vaccine-associated viscerotropic disease in the three states that reported cases ranged from 0.4 to 1.6 cases per million doses administered. Laboratory tests and corrective treatments were not reported. At the time of this report, the outcome was fatal. Documents held by sender: None.


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