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VAERS Report 2157407

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
2021-07-19
Date of Onset
0
Number of days (onset date – vaccination date)
0
Adverse Event Description

redness after 6/12 hours, swelling and hardening in the injection site after 6/12 hours until day 7, fever 38 after 6/12 hours; redness after 6/12 hours, swelling and hardening in the injection site after 6/12 hours until day 7, fever 38 after 6/12 hours; redness after 6/12 hours, swelling and hardening in the injection site after 6/12 hours until day 7, fever 38 after 6/12 hours; redness after 6/12 hours, swelling and hardening in the injection site after 6/12 hours until day 7, fever 38 after 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 19th july 2021, the patient received bexsero (intramuscular) .5 ml and meningococcal b vaccine pre-filled syringe device. on 19th 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 induration (serious criteria other: serious as per reporter), muscle swelling (serious criteria other: serious as per reporter) and fever (serious criteria other: serious as per reporter). on 27th july 2021, the outcome of the injection site redness, injection site induration, muscle swelling and fever were recovered/resolved. it was unknown if the reporter considered the injection site redness, injection site induration, muscle swelling and fever 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 provided as follows: on 19th july 2021, the body temperature was reported as 38 degree c. the duration of event was reported as 8 days. note: the tto for events was captured as less than a day as per vaccination day and event onset date, however in event verbatim it was reported as "after 6/12 hours". initial information received from physician via regulatory authority on 25th february 2022: redness after 6/12 hours, swelling and hardening in the injection site after 6/12 hours until day 7, fever 38 after 6/12 hours

Lab Data
test date: 20210719; test name: body temperature; result unstructured data: (test result:38,unit:degree c,normal low:,normal high:)
List of symptoms
injection site induration injection site erythema pyrexia muscle swelling
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