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VAERS Report 2157404

Case Report Section

Vaer Report Details

Age: 0

Gender: Female

State: Outside US

Patient Died?
No
Vaccine information

Name: MENINGOCOCCAL B (BEXSERO)

Type: Meningococcal group b vaccine, rDNA absorbed

Manufacturer: NOVARTIS VACCINES AND DIAGNOSTICS

Lot: abxb76ac


Date report was received
2022-03-04
Date form completed
Date Vaccinated
2021-09-17
Date of Onset
0
Number of days (onset date – vaccination date)
0
Adverse Event Description

fever greater than or equal to 39.5; fever greater than or equal to 39.5; this case was reported by a other health professional via regulatory authority and described the occurrence of hyperpyrexia in a 7-month-old female patient who received men b nvs (bexsero) (batch number abxb76ac, expiry date unknown) for prophylaxis. co-suspect products included meningococcal b recom vaccine + aloh + omv pre-filled syringe device (meningococcal b vaccine pre-filled syringe device) injection syringe for prophylaxis. on 17th september 2021, the patient received bexsero (intramuscular) and meningococcal b vaccine pre-filled syringe device. on 17th september 2021, less than a day after receiving bexsero and meningococcal b vaccine pre-filled syringe device, the patient experienced hyperpyrexia (serious criteria gsk medically significant and other: serious as per reporter) and restlessness (serious criteria other: serious as per reporter). on 20th september 2021, the outcome of the hyperpyrexia and restlessness were recovered/resolved. it was unknown if the reporter considered the hyperpyrexia and restlessness to be related to bexsero and meningococcal b vaccine pre-filled syringe device. this report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences. additional details were reported as follows: patient received bexsero on right thigh. on 17th september 2021, the body temperature of patient was recorded as greater than or equal to 39.5 degree celsius. the duration for events hyperpyrexia and restlessness was 3 days. initial information was received from a other health professional via regulatory authority on 25th february 2022: fever greater than or equal to 39.5. reporter's comments: inoculation site: right thigh

Lab Data
test date: 20210917; test name: body temperature; result unstructured data: (test result:greater than or equal to 39.5,unit:degree c,normal low:,normal high:)
List of symptoms
restlessness hyperpyrexia
Patient Died?
No
Date Died
NA
Birth defect
false
Vaccine Administered By:
Unknown
Vaccine Purchased By:
Unknown
Patient visit ER?
No
Patient Hospitalized?
No
Stay in hospital
No
Days in hospital
Unspecified
Permanent disability?
No
Allergies:
na
Current Illness
na