Vaer Report Details
Age: 0
Gender: Female
State: Outside US
- Patient Died?
- No
- Vaccine information
-
Name: MENINGOCOCCAL (NO BRAND NAME)
Type: Meningococcal polysaccharide vaccine
Manufacturer: UNKNOWN
Lot: abxb82aa
- Date report was received
- 2022-03-04
- Date form completed
- Date Vaccinated
- 2021-08-19
- Date of Onset
- 0
- Number of days (onset date – vaccination date)
- 0
- Adverse Event Description
-
fever 37.5 over 12 hours and day 1, irritability and nervousism day 3; fever 37.5 over 12 hours and day 1, irritability and nervousism day 3; fever 37.5 over 12 hours and day 1, irritability and nervousism day 3; this case was reported by a physician via regulatory authority and described the occurrence of fever in a 3-month-old female patient who received men b nvs (bexsero) (batch number abxb82aa, 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 19th august 2021, the patient received bexsero (intramuscular) .5 ml and meningococcal b vaccine pre-filled syringe device. on 19th august 2021, less than a day after receiving bexsero and meningococcal b vaccine pre-filled syringe device, the patient experienced fever (serious criteria other: serious as per reporter), irritability (serious criteria other: serious as per reporter) and nervousness (serious criteria other: serious as per reporter). on 23rd august 2021, the outcome of the fever, irritability and nervousness were recovered/resolved. it was unknown if the reporter considered the fever, irritability and nervousness to be related to bexsero and meningococcal b vaccine pre-filled syringe device. this report is made without prejudice and does not imply any admission or liability for the incident or its consequences. additional details were reported as follows: on 19th august 2021, the body temperature of patient was recorded as 37.5 degree celsius. the duration for events fever, irritability and nervousness was 4 days. as per verbatim, nervousness occurred on day 3 but time to onset was captured as less than a day as per reported dates. initial information was received from a physician via regulatory authority on 28th february 2022: fever 37.5 over 12 hours and day 1, irritability and nervousism day 3
- Lab Data
-
test date: 20210819; test name: body temperature; result unstructured data: (test result:37.5,unit:degree c,normal low:,normal high:)
- List of symptoms
-
nervousness irritability pyrexia
- 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