Sex: F
Vaccine: RAB
Symptoms: Lymphadenopathy
Clinical narrative: swollen supraclavicular node; Case reference number US-BN-2021-000023 is a spontaneous case report initially received from a physician via Agency (reference number USBAV21-0023) on 19-Jan-2021, and concerns a 20-year-old female patient.  The patient's medical history included neck fusion.  The patient had no concomitant medications.  On 11-Jan-2021, the patient received RabAvert (Inactivated Rabies Virus Vaccine, Batch no. ARBA731B, exp. 30-Sep-2023, for batch no was stated that they did not have the one on the actual vaccine used, but this was from the boxes that were with the vaccine) at standard dose for pre-exposure vaccination, it was stated that the patient works in a vet office.  On 18-Jan-2021, the patient received second dose of RabAvert (Inactivated Rabies Virus Vaccine, Batch no. ARBA731B, exp. 30-Sep-2023, for batch no. was stated that they did not have the one on the actual vaccine used, but this was from the boxes that were with the vaccine, batch no. for diluent was AD01A09C) at standard dose, site of injection was left arm, for pre-exposure vaccination.  On 19-Jan-2021, approximately 12 hours after second dose, the patient developed swollen supraclavicular node.  On 01-Feb-2021, the patient still had a lymph node of 2 x 2 cm and non tender.  On an unspecified date, in Feb-2021, the patient received the third dose of RabaVert (Batch no. was not provided) at unknown dose in the right arm.  It was stated that patient was advised to watch, and to contact the primary care physician if no resolution in the next few weeks. Patient was also told to watch for side effect on the right side.  *At the time of this report it was known that the patient did not experineced any adverse event after the third vaccination.*  The reporter stated that the 'swollen supraclavicular node' did not make sense because it did not drain the arm and asked was it related or not related to the Rabavert and should the patient proceed with the third vaccine.   The reporter assessed the event as serious due to medically significance and *probably* related to RabaVert.  Additional information was received on 20-Jan-2021 included snapshot of this case.  Additional information received from GSK on 20-Jan-2021 included updated patient initials, batch no. and expiration date, batch no. for diluent, new reporter, time of onset of the event.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).   Follow up information was received from a non health care professional on 05-Feb-2021: Information included patient's date of birth, updated information that patient had no concomitant medication, updated medical history, onset date of the event, information that the third dose was given, seriousness and causality assessment were updated.   Follow up information was received from a non health care professional on 12-Feb-2021: Information included that the patient did not experienced any adverse event after third vaccination and causality.; Reporter's Comments: Lymphadenopathy is listed for Rabavert as per the local SmPC and Global Datasheet. Reportedly, twelve hours after the second dose of vaccine had been administered, the patient developed swollen supraclavicular node. Due to plausible temporal relationship, as well as due to lack of other possible causes that could explain the development of the reported event, the causality is assessed as possibly related to RabAvert.; Sender's Comments: Lymphadenopathy is listed for Rabavert as per the local SmPC and Global Prescriber Information version 006. Reportedly, twelve hours after the second dose of vaccine had been administered, the patient developed swollen supraclavicular node. Due to plausible temporal relationship, as well as due to lack of other possible causes that could explain the development of the reported event, the causality is assessed as possibly related to RabAvert.