Sex: F
Vaccine: RAB, YF
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Laboratory test normal
Clinical narrative: RabAvert and YF-Vax administered at the same site; Pt. had redness, warmth and soreness at the injection site; Pt. had redness, warmth and soreness at the injection site; Pt. had redness, warmth and soreness at the injection site; Case reference number US-BN-2021-002299, initially downloaded from Vaccine Adverse Event Reporting System (VAERS) on 27-Sep-2021, is a spontaneous case received from consumer via health authority (VAERS ID: 1526009-1) and concerns a 64-year-old female patient.  The patient's medical history details were not provided.  The patient's concomitant medications included Amitiza (lubiprostone), Synthyroid (Levothyroxine sodium), simvastatin and Myrbetriq (Mirabegron).  On 20-Jul-2021, patient was vaccinated with the first dose of RabAvert (Inactivated Rabies Virus Vaccine; batch number: ARBA571B), at an unknown dose, administered intramuscularly in the right arm, for an unknown indication.  On the same date, the patient was vaccinated with the co-suspect YF-VAX (Yellow Fever Vaccine Live; batch number: UJ372AA), at an unknown dose, administered subcutaneously in the right arm, for an unknown indication (explicitly codes as Vaccination error').  On 22-Jul-2021 (also reported as on 23-Jul-2021), the patient experienced redness, warmth and soreness at the injection site.  It was reported that the physician prescribed the patient Kepflex 500mg, BID for a five day course, although the patient didn't start the medication.  On 24-Jul-2021, the patient visited Emergency Department, where she was prescribed Doxycycline 100 mg BID and had laboratory tests performed, with results reported as laboratory test normal. It was reported that the patient started with the Doxycycline medication.  On 27-Jul-2021, the patient visited the clinic again, and it was reported that on examination the redness was lighter in colour, but that it spread a little bit more.  On an unspecified date, the patient recovered from the events of injection site redness, injection site warmth and injection site pain.  The case was assessed as not serious. Causality assessment was not provided.  No further information was provided.; Reporter's Comments: Injection site erythema and injection site pain are listed for RabAvert according to the PI and Prescriber Information, whilst injection site warmth is unlisted. Vaccination error is listed per convention. The patient was vaccinated with the first dose of RabAvert administered intramuscularly in the right arm, and on the same day, the patient was vaccinated with the co-suspect YF-VAX (Yellow Fever Vaccine Live) administered in the right arm, which is considered vaccination error. The patient experienced injection site erythema, injection site pain and injection site warmth two days after vaccination. The major confounding factor for the events is co-suspect vaccine (YF-VAX), administered on the same day. However, due to plausible temporal relationship and since contributory role of RabAvert cannot be excluded, the causality for the events of injection site erythema, injection site pain and injection site warmth is assessed as possibly related to the suspect vaccine. Vaccination error is not related to the suspect product, but to a decision of the prescribing physician. This case is considered non-serious.; Sender's Comments: Injection site erythema and injection site pain are listed for RabAvert according to the PI and Prescriber Information, whilst injection site warmth is unlisted. Vaccination error is listed per convention. The patient was vaccinated with the first dose of RabAvert administered intramuscularly in the right arm, and on the same day, the patient was vaccinated with the co-suspect YF-VAX (Yellow Fever Vaccine Live) administered in the right arm, which is considered vaccination error. The patient experienced injection site erythema, injection site pain and injection site warmth two days after vaccination. The major confounding factor for the events is co-suspect vaccine (YF-VAX), administered on the same day. However, due to plausible temporal relationship and since contributory role of RabAvert cannot be excluded, the causality for the events of injection site erythema, injection site pain and injection site warmth is assessed as possibly related to the suspect vaccine. Vaccination error is not related to the suspect product, but to a decision of the prescribing physician. This case is considered non-serious.