Sex: M
Vaccine: MEN, RAB
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Skin texture abnormal
Clinical narrative: The skin in that area had an altered texture; Redness around the injection site on the right arm; Midly discoloured, a dusky colour behind the redness; Baseball size area of redness/The area was very firm; Case reference number US-BN-2021-002567, initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 27-Dec-2021, is a spontaneous case received from a consumer via health authority VAERS (1939858-1) and concerns a 7-year-old male patient.  The patient's medical history and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with first two doses od RabAvert (inactivated rabies virus vaccine, batch number not reported), at an unknown dose or administered, for unknown indication.  On 08-Dec-2021, the patient was vaccinated with the third dose of RabAvert (inactivated rabies virus vaccine, batch number: ARBA911C), at an unknown dose, administered intramuscularly in the left arm, for unknown indication and with non-company co-suspect Meningococcal conjugate vaccine (batch number: AMVA636A), at an unknown dose, administered intramuscularly in the right arm, for unknown indication.  On an unspecified date in Dec-2021, unknown amount of time after vaccination, the patient experienced redness around the injection site on the right arm.  On 09-Dec-2021, the mother reported as upon inspection the patient had baseball size area of redness around the injection site, mildly discoloured, a dusky colour behind the redness. The area was very firm and the skin in that area had an altered texture. Ice packs and Tylenol were recommended as a treatment. After 36 hours there seems to be no improvement.  At the time of this report, the patient had not recovered from any of the events.  The reporter assessed the events as non-serious. The causality assessment was not provided.  No further information was provided.; Reporter's Comments: The 7-year-old male patient developed non-serious events of erythema, skin discolouration, skin induration and skin texture abnormal on the day 1 after the patient was vaccinated with the third dose of RabAvert in the left arm, for unknown indication, and with co-suspect Meningococcal conjugate vaccine in the right arm. The erythema, skin discolouration, skin induration and skin texture abnormal are not listed for RabAvert according to the PI and Datasheet. The patient's medical history and concomitant medications were not provided. The patient had not recovered from the events. The patient's co-suspect vaccination confounded the causality for the events. Therefore, because the event of erythema, as mother reported, developed around the injection site on the right arm, it has been considered as not related to RabAvert, but to Meningococcal conjugate vaccine. However, since the information about the limb where other events developed was not provided, and considering plausible temporal relationship, at the moment, the skin discolouration, skin induration and skin texture abnormal have been conservatively considered as related to RabAvert, since the contributory role of the suspect vaccine cannot be excluded. This case is considered as non-serious.; Sender's Comments: The 7-year-old male patient developed non-serious events of erythema, skin discolouration, skin induration and skin texture abnormal on the day 1 after the patient was vaccinated with the third dose of RabAvert in the left arm, for unknown indication, and with co-suspect Meningococcal conjugate vaccine in the right arm. The erythema, skin discolouration, skin induration and skin texture abnormal are not listed for RabAvert according to the PI and Datasheet. The patient's medical history and concomitant medications were not provided. The patient had not recovered from the events. The patient's co-suspect vaccination confounded the causality for the events. Therefore, because the event of erythema, as mother reported, developed around the injection site on the right arm, it has been considered as not related to RabAvert, but to Meningococcal conjugate vaccine. However, since the information about the limb where other events developed was not provided, and considering plausible temporal relationship, at the moment, the skin discolouration, skin induration and skin texture abnormal have been conservatively considered as related to RabAvert, since the contributory role of the suspect vaccine cannot be excluded. This case is considered as non-serious.