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|History of Changes from the VAERS Wayback Machine|
|Vaccination / Manufacturer||Lot / Dose||Site / Route|
|6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS||A21CD077A / UNK||- / -|
|MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER||VNS1S12D / UNK||- / -|
|PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH||W19703 / UNK||- / -|
Administered by: Other Purchased by: ??
Symptoms: Crying, Death, Pyrexia, Autopsy
Life Threatening? No
Birth Defect? No
Permanent Disability? No
Office Visit (V2.0)? No
ER or Office Visit (V1.0)? No
ER or ED Visit (V2.0)? No
Other Medications: VITAMIN D3; APIRETAL
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none, Comment:
Diagnostic Lab Data:
CDC 'Split Type': ESPFIZERINC2019354059
Write-up: fever; Persistent crying; This is a spontaneous report from a contactable Other Healthcare Professional (HCP) from the local Regulatory Authority and later downloaded from the Regulatory Authority (ES-AEMPS-533524). The Regulatory Authority report number is ES-AEMPS-533524. A 4-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) (lot# W19703, Exp date Sep2019) via an unspecified route of administration on 02Aug2019 at single dose for vaccination; meningococcal group C tetanus toxoid conjugate vaccine (NEISVAC-C) (lot# VNS1S12D, Exp date May2021) via an unspecified route of administration on 02Aug2019 at single dose for vaccination and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (INFANRIX HEXA) (lot# A21CD077A) via an unspecified route of administration on 02Aug2019 at unspecified dose for routine vaccination, Vitamin D3 pharma 2.000 UI/ml oral solution from 03Jun2019, paracetamol (APIRETAL 100 mg/ml oral solution) oral on 02Aug2019 for fever. The patient had no relevant medical history. The patient''s concomitant medications were not reported. The patient experienced fever from 02Aug2019 and persistent crying from 02Aug2019 that resulted in death. The patient was died on an unspecified date the night after vaccination (as reported). An autopsy was performed and results were not provided. Investigational results for Prevenar 13 lot# W19703 and NeisVac-C lot# VNS1S12D. Conclusion for Neisvac-C lot# VNS1S12D: there is no evidence to suggest that the reported Adverse Event is related to Manufacture, Packing or storage activities. Pfizer will take no further action at this time. Conclusion for Prevenar 13 lot# W19703: Packed lot W19703 and associated bulk lot 930214, met all Quality and compliance requirements at the time of release. There is no evidence to suggest that the reported Adverse Event is related to Manufacture, Packing or storage activities. Pfizer will take no further action at this time. Follow-up (19Aug2019): New information from the same contactable Other HCP received from local Product Quality Complaint group includes expiry date for the vaccine was provided. Follow-up (20Aug2019): New information from the same contactable Other HCP reported by the local Regulatory Authority included: the autonomous community code. Follow-up (23Aug2019, 23Aug2019): New information received from Product Quality Complaints Group includes: investigational results for Prevenar 13 lot# W19703, and NeisVac-C lot# VNS1S12D. No follow-up attempts are possible. No further information is expected. Follow-up (28Aug2019): New information from a physician downloaded from the Regulatory Authority (ES-AEMPS-533524) included: patient''s weight, reaction data (previously reported event "death" was deleted and replaced with new events fever and persistent crying, cause of death), and product details (vaccination date, additional suspect products Vitamin D3, paracetamol). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fever; Persistent crying
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