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This is VAERS ID 584986

History of Changes from the VAERS Wayback Machine

First Appeared on 10/14/2017

VAERS ID: 584986
VAERS Form:1
Age:0.42
Sex:Female
Location:Foreign
Vaccinated:2013-08-19
Onset:2013-08-19
Submitted:2015-07-07
Entered:2015-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER J01101 / UNK UN / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER VN920622 / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G19208 / UNK UN / IM

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Cardiac arrest, Death, Hypoxia, Irritability, Nuclear magnetic resonance imaging, Resuscitation, Syncope, Polymerase chain reaction, Toxicologic test normal, Culture negative

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2013-08-19
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOVICOL; Unknown
Current Illness:
Preexisting Conditions: Constipation; Vitiligo
Allergies:
Diagnostic Lab Data: 19-AUG-2013, Culture, negative; 19-AUG-2013, Nuclear magnetic resonance imaging, not reported; 19-AUG-2013, Polymerase chain reaction, negative; 19-AUG-2013, Toxicologic test, negative; Weight, 8 kg; Metabolic screen: 19-Aug-2013: not reported; Septic screen: 19-Aug-2013: not reported
CDC 'Split Type': 2013BAX043887

Write-up: This case was considered invalid as it is a duplicate of 2013315917. This case has been migrated from another database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up report may indicate in the appropriate field that it is an initial report. This is a regulatory report of fatal hypoxia, cardiac arrest, apnoea, syncope and irritable in a 5 month old Female patient subsequent to NEISVAC-C (0.5 ml Suspension for injection in pre-filled syringe). This report was received by Regulatory Authorities (reference number: 22297675) via a Physician and forwarded to Baxter. Suspect Product Details: on 19Aug2013 at 1430 hours, the patient received NEISVAC-C, intramuscularly (lot number, dose and injection site were not reported). The patient also received vaccinations with PEDIACEL, intramuscularly and PREVENAR 13, intramuscularly on the same date and time. The lot numbers, doses and injection sites were not reported. The action taken was Not Applicable. Baxter and the Reporter considered PEDIACEL and PREVENAR 13 as co-suspect drugs. Event Details: On 19Aug2013, about four hours after having been vaccinated (1900 hours), the patient became irritable. At an unreported time, the patient experienced syncope (described as collapsed). The patient recovered from the syncope at an unreported time. At 2030 hours, the patient was apnoeic which led to cardiac arrest. The patient was successfully resuscitated by 2110 hours. However, the patient died on 19Aug2013 due to hypoxia (described as severe hypoxic injury). The cause of the cardiac arrest was unknown despite magnetic resonance imaging, toxicology tests, septic screen and a metabolic screen. An unspecified culture and polymerase chain reaction (PCR) were negative, no evidence of sepsis. An autopsy was not performed. Outcome: Hypoxia: Fatal, Cardiac Arrest: Recovered/resolved, Apnoea: Not reported, Syncope: Recovered/resolved, Irritable: Not reported. Medical History: Constipation, Vitiligo. Concomitant Therapy: MOVICOL. Causality Assessment: Unassessible for all suspect products. The reporter stated it was "unclear" whether the vaccinations played any part in the collapse. Follow-up Information (28Feb2014): Additional information was received from a physician. Suspect product information was added or revised. Suspect Product Details: The lot number for NEISVAC-C was VN920622. The lot number for the PEDIACEL used was J0110-1 and the lot number for the PREVENAR 13 that was used was G19208. Follow-up Information (14Apr2014): Batch review results for NEISVAC-C lost number VN920622 were received. The review did not reveal any quality issues. This batch (VN920622) of NEISVAC-C was manufactured and released in compliance with established procedures and specifications. This investigation did not identify any product quality issues with this batch that could be associated with the reported events. Follow-up Information (22May2014): Follow-up information received from the physician. Suspect product details were added (unit dose). Suspect Product Details: On 19Aug2013, at 14:30 the patient received NEISVAC-C one dose (lot number VN920622) administered intramuscularly (site of administration not reported). Follow-up (02Jul2015): This is a follow-up report to notify that the case 2013BAX043887 and 2013315917 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 2013315917.


Changed on 2/14/2018

VAERS ID: 584986 Before After
VAERS Form:1
Age:0.42
Sex:Female
Location:Foreign
Vaccinated:2013-08-19
Onset:2013-08-19
Submitted:2015-07-07
Entered:2015-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER J01101 / UNK UN / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER VN920622 / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G19208 / UNK UN / IM

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Cardiac arrest, Death, Hypoxia, Irritability, Nuclear magnetic resonance imaging, Resuscitation, Syncope, Polymerase chain reaction, Toxicologic test normal, Culture negative

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2013-08-19
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOVICOL; Unknown
Current Illness:
Preexisting Conditions: Constipation; Vitiligo
Allergies:
Diagnostic Lab Data: 19-AUG-2013, Culture, negative; 19-AUG-2013, Nuclear magnetic resonance imaging, not reported; 19-AUG-2013, Polymerase chain reaction, negative; 19-AUG-2013, Toxicologic test, negative; Weight, 8 kg; Metabolic screen: 19-Aug-2013: not reported; Septic screen: 19-Aug-2013: not reported
CDC 'Split Type': 2013BAX043887

Write-up: This case was considered invalid as it is a duplicate of 2013315917. This case has been migrated from another database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up report may indicate in the appropriate field that it is an initial report. This is a regulatory report of fatal hypoxia, cardiac arrest, apnoea, syncope and irritable in a 5 month old Female patient subsequent to NEISVAC-C (0.5 ml Suspension for injection in pre-filled syringe). This report was received by Regulatory Authorities (reference number: 22297675) via a Physician and forwarded to Baxter. Suspect Product Details: on 19Aug2013 at 1430 hours, the patient received NEISVAC-C, intramuscularly (lot number, dose and injection site were not reported). The patient also received vaccinations with PEDIACEL, intramuscularly and PREVENAR 13, intramuscularly on the same date and time. The lot numbers, doses and injection sites were not reported. The action taken was Not Applicable. Baxter and the Reporter considered PEDIACEL and PREVENAR 13 as co-suspect drugs. Event Details: On 19Aug2013, about four hours after having been vaccinated (1900 hours), the patient became irritable. At an unreported time, the patient experienced syncope (described as collapsed). The patient recovered from the syncope at an unreported time. At 2030 hours, the patient was apnoeic which led to cardiac arrest. The patient was successfully resuscitated by 2110 hours. However, the patient died on 19Aug2013 due to hypoxia (described as severe hypoxic injury). The cause of the cardiac arrest was unknown despite magnetic resonance imaging, toxicology tests, septic screen and a metabolic screen. An unspecified culture and polymerase chain reaction (PCR) were negative, no evidence of sepsis. An autopsy was not performed. Outcome: Hypoxia: Fatal, Cardiac Arrest: Recovered/resolved, Apnoea: Not reported, Syncope: Recovered/resolved, Irritable: Not reported. Medical History: Constipation, Vitiligo. Concomitant Therapy: MOVICOL. Causality Assessment: Unassessible for all suspect products. The reporter stated it was "unclear" whether the vaccinations played any part in the collapse. Follow-up Information (28Feb2014): Additional information was received from a physician. Suspect product information was added or revised. Suspect Product Details: The lot number for NEISVAC-C was VN920622. The lot number for the PEDIACEL used was J0110-1 and the lot number for the PREVENAR 13 that was used was G19208. Follow-up Information (14Apr2014): Batch review results for NEISVAC-C lost number VN920622 were received. The review did not reveal any quality issues. This batch (VN920622) of NEISVAC-C was manufactured and released in compliance with established procedures and specifications. This investigation did not identify any product quality issues with this batch that could be associated with the reported events. Follow-up Information (22May2014): Follow-up information received from the physician. Suspect product details were added (unit dose). Suspect Product Details: On 19Aug2013, at 14:30 the patient received NEISVAC-C one dose (lot number VN920622) administered intramuscularly (site of administration not reported). Follow-up (02Jul2015): This is a follow-up report to notify that the case 2013BAX043887 and 2013315917 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 2013315917.


Changed on 6/14/2018

VAERS ID: 584986 Before After
VAERS Form:1
Age:0.42
Sex:Female
Location:Foreign
Vaccinated:2013-08-19
Onset:2013-08-19
Submitted:2015-07-07
Entered:2015-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER J01101 / UNK UN / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER VN920622 / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G19208 / UNK UN / IM

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Cardiac arrest, Death, Hypoxia, Irritability, Nuclear magnetic resonance imaging, Resuscitation, Syncope, Polymerase chain reaction, Toxicologic test normal, Culture negative

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2013-08-19
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOVICOL; Unknown
Current Illness:
Preexisting Conditions: Constipation; Vitiligo
Allergies:
Diagnostic Lab Data: 19-AUG-2013, Culture, negative; 19-AUG-2013, Nuclear magnetic resonance imaging, not reported; 19-AUG-2013, Polymerase chain reaction, negative; 19-AUG-2013, Toxicologic test, negative; Weight, 8 kg; Metabolic screen: 19-Aug-2013: not reported; Septic screen: 19-Aug-2013: not reported
CDC 'Split Type': 2013BAX043887

Write-up: This case was considered invalid as it is a duplicate of 2013315917. This case has been migrated from another database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up report may indicate in the appropriate field that it is an initial report. This is a regulatory report of fatal hypoxia, cardiac arrest, apnoea, syncope and irritable in a 5 month old Female patient subsequent to NEISVAC-C (0.5 ml Suspension for injection in pre-filled syringe). This report was received by Regulatory Authorities (reference number: 22297675) via a Physician and forwarded to Baxter. Suspect Product Details: on 19Aug2013 at 1430 hours, the patient received NEISVAC-C, intramuscularly (lot number, dose and injection site were not reported). The patient also received vaccinations with PEDIACEL, intramuscularly and PREVENAR 13, intramuscularly on the same date and time. The lot numbers, doses and injection sites were not reported. The action taken was Not Applicable. Baxter and the Reporter considered PEDIACEL and PREVENAR 13 as co-suspect drugs. Event Details: On 19Aug2013, about four hours after having been vaccinated (1900 hours), the patient became irritable. At an unreported time, the patient experienced syncope (described as collapsed). The patient recovered from the syncope at an unreported time. At 2030 hours, the patient was apnoeic which led to cardiac arrest. The patient was successfully resuscitated by 2110 hours. However, the patient died on 19Aug2013 due to hypoxia (described as severe hypoxic injury). The cause of the cardiac arrest was unknown despite magnetic resonance imaging, toxicology tests, septic screen and a metabolic screen. An unspecified culture and polymerase chain reaction (PCR) were negative, no evidence of sepsis. An autopsy was not performed. Outcome: Hypoxia: Fatal, Cardiac Arrest: Recovered/resolved, Apnoea: Not reported, Syncope: Recovered/resolved, Irritable: Not reported. Medical History: Constipation, Vitiligo. Concomitant Therapy: MOVICOL. Causality Assessment: Unassessible for all suspect products. The reporter stated it was "unclear" whether the vaccinations played any part in the collapse. Follow-up Information (28Feb2014): Additional information was received from a physician. Suspect product information was added or revised. Suspect Product Details: The lot number for NEISVAC-C was VN920622. The lot number for the PEDIACEL used was J0110-1 and the lot number for the PREVENAR 13 that was used was G19208. Follow-up Information (14Apr2014): Batch review results for NEISVAC-C lost number VN920622 were received. The review did not reveal any quality issues. This batch (VN920622) of NEISVAC-C was manufactured and released in compliance with established procedures and specifications. This investigation did not identify any product quality issues with this batch that could be associated with the reported events. Follow-up Information (22May2014): Follow-up information received from the physician. Suspect product details were added (unit dose). Suspect Product Details: On 19Aug2013, at 14:30 the patient received NEISVAC-C one dose (lot number VN920622) administered intramuscularly (site of administration not reported). Follow-up (02Jul2015): This is a follow-up report to notify that the case 2013BAX043887 and 2013315917 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 2013315917.


Changed on 8/14/2018

VAERS ID: 584986 Before After
VAERS Form:1
Age:0.42
Sex:Female
Location:Foreign
Vaccinated:2013-08-19
Onset:2013-08-19
Submitted:2015-07-07
Entered:2015-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER J01101 / UNK UN / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER VN920622 / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G19208 / UNK UN / IM

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Cardiac arrest, Death, Hypoxia, Irritability, Nuclear magnetic resonance imaging, Resuscitation, Syncope, Polymerase chain reaction, Toxicologic test normal, Culture negative

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2013-08-19
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOVICOL; Unknown
Current Illness:
Preexisting Conditions: Constipation; Vitiligo
Allergies:
Diagnostic Lab Data: 19-AUG-2013, Culture, negative; 19-AUG-2013, Nuclear magnetic resonance imaging, not reported; 19-AUG-2013, Polymerase chain reaction, negative; 19-AUG-2013, Toxicologic test, negative; Weight, 8 kg; Metabolic screen: 19-Aug-2013: not reported; Septic screen: 19-Aug-2013: not reported
CDC 'Split Type': 2013BAX043887

Write-up: This case was considered invalid as it is a duplicate of 2013315917. This case has been migrated from another database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up report may indicate in the appropriate field that it is an initial report. This is a regulatory report of fatal hypoxia, cardiac arrest, apnoea, syncope and irritable in a 5 month old Female patient subsequent to NEISVAC-C (0.5 ml Suspension for injection in pre-filled syringe). This report was received by Regulatory Authorities (reference number: 22297675) via a Physician and forwarded to Baxter. Suspect Product Details: on 19Aug2013 at 1430 hours, the patient received NEISVAC-C, intramuscularly (lot number, dose and injection site were not reported). The patient also received vaccinations with PEDIACEL, intramuscularly and PREVENAR 13, intramuscularly on the same date and time. The lot numbers, doses and injection sites were not reported. The action taken was Not Applicable. Baxter and the Reporter considered PEDIACEL and PREVENAR 13 as co-suspect drugs. Event Details: On 19Aug2013, about four hours after having been vaccinated (1900 hours), the patient became irritable. At an unreported time, the patient experienced syncope (described as collapsed). The patient recovered from the syncope at an unreported time. At 2030 hours, the patient was apnoeic which led to cardiac arrest. The patient was successfully resuscitated by 2110 hours. However, the patient died on 19Aug2013 due to hypoxia (described as severe hypoxic injury). The cause of the cardiac arrest was unknown despite magnetic resonance imaging, toxicology tests, septic screen and a metabolic screen. An unspecified culture and polymerase chain reaction (PCR) were negative, no evidence of sepsis. An autopsy was not performed. Outcome: Hypoxia: Fatal, Cardiac Arrest: Recovered/resolved, Apnoea: Not reported, Syncope: Recovered/resolved, Irritable: Not reported. Medical History: Constipation, Vitiligo. Concomitant Therapy: MOVICOL. Causality Assessment: Unassessible for all suspect products. The reporter stated it was "unclear" whether the vaccinations played any part in the collapse. Follow-up Information (28Feb2014): Additional information was received from a physician. Suspect product information was added or revised. Suspect Product Details: The lot number for NEISVAC-C was VN920622. The lot number for the PEDIACEL used was J0110-1 and the lot number for the PREVENAR 13 that was used was G19208. Follow-up Information (14Apr2014): Batch review results for NEISVAC-C lost number VN920622 were received. The review did not reveal any quality issues. This batch (VN920622) of NEISVAC-C was manufactured and released in compliance with established procedures and specifications. This investigation did not identify any product quality issues with this batch that could be associated with the reported events. Follow-up Information (22May2014): Follow-up information received from the physician. Suspect product details were added (unit dose). Suspect Product Details: On 19Aug2013, at 14:30 the patient received NEISVAC-C one dose (lot number VN920622) administered intramuscularly (site of administration not reported). Follow-up (02Jul2015): This is a follow-up report to notify that the case 2013BAX043887 and 2013315917 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 2013315917.


Changed on 9/14/2018

VAERS ID: 584986 Before After
VAERS Form:1
Age:0.42
Sex:Female
Location:Foreign
Vaccinated:2013-08-19
Onset:2013-08-19
Submitted:2015-07-07
Entered:2015-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER J01101 / UNK UN / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER VN920622 / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G19208 / UNK UN / IM

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Cardiac arrest, Death, Hypoxia, Irritability, Nuclear magnetic resonance imaging, Resuscitation, Syncope, Polymerase chain reaction, Toxicologic test normal, Culture negative

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2013-08-19
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOVICOL; Unknown
Current Illness:
Preexisting Conditions: Constipation; Vitiligo
Allergies:
Diagnostic Lab Data: 19-AUG-2013, Culture, negative; 19-AUG-2013, Nuclear magnetic resonance imaging, not reported; 19-AUG-2013, Polymerase chain reaction, negative; 19-AUG-2013, Toxicologic test, negative; Weight, 8 kg; Metabolic screen: 19-Aug-2013: not reported; Septic screen: 19-Aug-2013: not reported
CDC 'Split Type': 2013BAX043887

Write-up: This case was considered invalid as it is a duplicate of 2013315917. This case has been migrated from another database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up report may indicate in the appropriate field that it is an initial report. This is a regulatory report of fatal hypoxia, cardiac arrest, apnoea, syncope and irritable in a 5 month old Female patient subsequent to NEISVAC-C (0.5 ml Suspension for injection in pre-filled syringe). This report was received by Regulatory Authorities (reference number: 22297675) via a Physician and forwarded to Baxter. Suspect Product Details: on 19Aug2013 at 1430 hours, the patient received NEISVAC-C, intramuscularly (lot number, dose and injection site were not reported). The patient also received vaccinations with PEDIACEL, intramuscularly and PREVENAR 13, intramuscularly on the same date and time. The lot numbers, doses and injection sites were not reported. The action taken was Not Applicable. Baxter and the Reporter considered PEDIACEL and PREVENAR 13 as co-suspect drugs. Event Details: On 19Aug2013, about four hours after having been vaccinated (1900 hours), the patient became irritable. At an unreported time, the patient experienced syncope (described as collapsed). The patient recovered from the syncope at an unreported time. At 2030 hours, the patient was apnoeic which led to cardiac arrest. The patient was successfully resuscitated by 2110 hours. However, the patient died on 19Aug2013 due to hypoxia (described as severe hypoxic injury). The cause of the cardiac arrest was unknown despite magnetic resonance imaging, toxicology tests, septic screen and a metabolic screen. An unspecified culture and polymerase chain reaction (PCR) were negative, no evidence of sepsis. An autopsy was not performed. Outcome: Hypoxia: Fatal, Cardiac Arrest: Recovered/resolved, Apnoea: Not reported, Syncope: Recovered/resolved, Irritable: Not reported. Medical History: Constipation, Vitiligo. Concomitant Therapy: MOVICOL. Causality Assessment: Unassessible for all suspect products. The reporter stated it was "unclear" whether the vaccinations played any part in the collapse. Follow-up Information (28Feb2014): Additional information was received from a physician. Suspect product information was added or revised. Suspect Product Details: The lot number for NEISVAC-C was VN920622. The lot number for the PEDIACEL used was J0110-1 and the lot number for the PREVENAR 13 that was used was G19208. Follow-up Information (14Apr2014): Batch review results for NEISVAC-C lost number VN920622 were received. The review did not reveal any quality issues. This batch (VN920622) of NEISVAC-C was manufactured and released in compliance with established procedures and specifications. This investigation did not identify any product quality issues with this batch that could be associated with the reported events. Follow-up Information (22May2014): Follow-up information received from the physician. Suspect product details were added (unit dose). Suspect Product Details: On 19Aug2013, at 14:30 the patient received NEISVAC-C one dose (lot number VN920622) administered intramuscularly (site of administration not reported). Follow-up (02Jul2015): This is a follow-up report to notify that the case 2013BAX043887 and 2013315917 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 2013315917.


Changed on 10/14/2018

VAERS ID: 584986 Before After
VAERS Form:1
Age:0.42
Sex:Female
Location:Foreign
Vaccinated:2013-08-19
Onset:2013-08-19
Submitted:2015-07-07
Entered:2015-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER J01101 / UNK UN / IM
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER VN920622 / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH G19208 / UNK UN / IM

Administered by: Unknown      Purchased by: Unknown
Symptoms: Apnoea, Cardiac arrest, Death, Hypoxia, Irritability, Nuclear magnetic resonance imaging, Resuscitation, Syncope, Polymerase chain reaction, Toxicologic test normal, Culture negative

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died:2013-08-19
Permanent Disability? No
Recovered? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOVICOL; Unknown
Current Illness:
Preexisting Conditions: Constipation; Vitiligo
Allergies:
Diagnostic Lab Data: 19-AUG-2013, Culture, negative; 19-AUG-2013, Nuclear magnetic resonance imaging, not reported; 19-AUG-2013, Polymerase chain reaction, negative; 19-AUG-2013, Toxicologic test, negative; Weight, 8 kg; Metabolic screen: 19-Aug-2013: not reported; Septic screen: 19-Aug-2013: not reported
CDC 'Split Type': 2013BAX043887

Write-up: This case was considered invalid as it is a duplicate of 2013315917. This case has been migrated from another database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up report may indicate in the appropriate field that it is an initial report. This is a regulatory report of fatal hypoxia, cardiac arrest, apnoea, syncope and irritable in a 5 month old Female patient subsequent to NEISVAC-C (0.5 ml Suspension for injection in pre-filled syringe). This report was received by Regulatory Authorities (reference number: 22297675) via a Physician and forwarded to Baxter. Suspect Product Details: on 19Aug2013 at 1430 hours, the patient received NEISVAC-C, intramuscularly (lot number, dose and injection site were not reported). The patient also received vaccinations with PEDIACEL, intramuscularly and PREVENAR 13, intramuscularly on the same date and time. The lot numbers, doses and injection sites were not reported. The action taken was Not Applicable. Baxter and the Reporter considered PEDIACEL and PREVENAR 13 as co-suspect drugs. Event Details: On 19Aug2013, about four hours after having been vaccinated (1900 hours), the patient became irritable. At an unreported time, the patient experienced syncope (described as collapsed). The patient recovered from the syncope at an unreported time. At 2030 hours, the patient was apnoeic which led to cardiac arrest. The patient was successfully resuscitated by 2110 hours. However, the patient died on 19Aug2013 due to hypoxia (described as severe hypoxic injury). The cause of the cardiac arrest was unknown despite magnetic resonance imaging, toxicology tests, septic screen and a metabolic screen. An unspecified culture and polymerase chain reaction (PCR) were negative, no evidence of sepsis. An autopsy was not performed. Outcome: Hypoxia: Fatal, Cardiac Arrest: Recovered/resolved, Apnoea: Not reported, Syncope: Recovered/resolved, Irritable: Not reported. Medical History: Constipation, Vitiligo. Concomitant Therapy: MOVICOL. Causality Assessment: Unassessible for all suspect products. The reporter stated it was "unclear" whether the vaccinations played any part in the collapse. Follow-up Information (28Feb2014): Additional information was received from a physician. Suspect product information was added or revised. Suspect Product Details: The lot number for NEISVAC-C was VN920622. The lot number for the PEDIACEL used was J0110-1 and the lot number for the PREVENAR 13 that was used was G19208. Follow-up Information (14Apr2014): Batch review results for NEISVAC-C lost number VN920622 were received. The review did not reveal any quality issues. This batch (VN920622) of NEISVAC-C was manufactured and released in compliance with established procedures and specifications. This investigation did not identify any product quality issues with this batch that could be associated with the reported events. Follow-up Information (22May2014): Follow-up information received from the physician. Suspect product details were added (unit dose). Suspect Product Details: On 19Aug2013, at 14:30 the patient received NEISVAC-C one dose (lot number VN920622) administered intramuscularly (site of administration not reported). Follow-up (02Jul2015): This is a follow-up report to notify that the case 2013BAX043887 and 2013315917 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 2013315917.

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