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VAERS Report 2157406

Case Report Section

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: abxb13aa


Date report was received
2022-03-04
Date form completed
Date Vaccinated
2021-07-12
Date of Onset
0
Number of days (onset date – vaccination date)
0
Adverse Event Description

pain, redness, injection site hardening up to 6/12 hours, fever 37.9 after 6/12 hours, disease, abnormal crying and irritability up to 6/12 hours; pain, redness, injection site hardening up to 6/12 hours, fever 37.9 after 6/12 hours, disease, abnormal crying and irritability up to 6/12 hours; pain, redness, injection site hardening up to 6/12 hours, fever 37.9 after 6/12 hours, disease, abnormal crying and irritability up to 6/12 hours; pain, redness, injection site hardening up to 6/12 hours, fever 37.9 after 6/12 hours, disease, abnormal crying and irritability up to 6/12 hours; pain, redness, injection site hardening up to 6/12 hours, fever 37.9 after 6/12 hours, disease, abnormal crying and irritability up to 6/12 hours; pain, redness, injection site hardening up to 6/12 hours, fever 37.9 after 6/12 hours, disease, abnormal crying and irritability up to 6/12 hours; pain, redness, injection site hardening up to 6/12 hours, fever 37.9 after 6/12 hours, disease, abnormal crying and irritability up to 6/12 hours; this case was reported by a physician via regulatory authority and described the occurrence of injection site redness in a 3-month-old female patient who received men b nvs (bexsero) (batch number abxb13aa, 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 12th july 2021, the patient received bexsero (intramuscular) .5 ml and meningococcal b vaccine pre-filled syringe device. on 12th july 2021, less than a day after receiving bexsero and meningococcal b vaccine pre-filled syringe device, the patient experienced injection site redness (serious criteria other: serious as per reporter), injection site pain (serious criteria other: serious as per reporter), injection site induration (serious criteria other: serious as per reporter), crying abnormal (serious criteria other: serious as per reporter), irritability (serious criteria other: serious as per reporter), malaise (serious criteria other: serious as per reporter) and fever (serious criteria other: serious as per reporter). on 13th july 2021, the outcome of the injection site redness, injection site pain, injection site induration, crying abnormal, irritability, malaise and fever were recovered/resolved. it was unknown if the reporter considered the injection site redness, injection site pain, injection site induration, crying abnormal, irritability, malaise and fever 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: on 12th july 2021, patient's body temperature was recorded to be 37.9 degree celsius. duration of events injection site redness, injection site pain, injection site induration, crying abnormal, irritability, malaise and fever was 1 day. note: as per event verbatim event skin induration was updated to injection site induration. initial information received from physician via regulatory authority on 25th february 2022: pain, redness, injection site hardening up to 6/12 hours, fever 37.9 after 6/12 hours, disease, abnormal crying and irritability up to 6/12 hours

Lab Data
test date: 20210712; test name: body temperature; result unstructured data: (test result:37.9,unit:degree c,normal low:,normal high:)
List of symptoms
malaise crying irritability injection site induration injection site pain injection site erythema 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