Sex: F
Vaccine: RAB
Symptoms: Fatigue, Inappropriate schedule of product administration, Pain
Clinical narrative: The third dose was administered on day 6 instead of day 7; Achy; Felt fatigued; Case reference number US-BN-2021-002201 is a spontaneous case report initially received from a non-health care professional via regulatory authority (reference number USBAV21-0421) on 19-Aug-2021 and concerns a 60-years-old female patient.   The patient's concurrent conditions included mild sarcoidosis in the lung and hemangioma on liver. The patient's historical condition included Grave's disease.  The patient's concomitant medication included Levoxyl (levothyroxine sodium) for unknown indication.  On 29-Jul-2021, the patient was vaccinated with the first dose of Rabipur (inactivated Rabies Virus Vaccine, batch number: not provided) intramuscularly at an unknown dose, and for a post exposure.   On the same day, the patient felt fatigued and achy throughout the course, but then with the shots being spaced out she would get better before she got the next one. The symptoms were mild, and the patient have been prescribed doxycycline.  On 01-Aug-2021, the patient was vaccinated with the second dose of Rabipur (inactivated Rabies Virus Vaccine, batch number: not provided) intramuscularly at an unknown dose, and for a post exposure.   On 06-Aug-2021, the patient was vaccinated with the third dose of Rabipur (inactivated Rabies Virus Vaccine, batch number: not provided) intramuscularly at an unknown dose, and for a post exposure. The patient reported, she was off on the third shot by a day (explicitly coded as 'Inappropriate schedule of vaccine administered').  On 12-Aug-2021, the patient was vaccinated with the fourth dose of Rabipur (inactivated Rabies Virus Vaccine, batch number: not provided) intramuscularly at an unknown dose, and for a post exposure.   The outcome for the events was unknown.  The reporter assessed the events fatigued and achy as non-serious and related to Rabipur.  No further information was provided.; Reporter's Comments: Fatigue is listed for RabAvert according to the PI and Prescriber Information, while pain is unlisted. Inappropriate schedule of product administration is listed by convention. On the same day when the patient was vaccinated with the first dose of Rabipur for post exposure prophylaxis, the events of fatigue and pain developed. The patient was off on the third shot by a day, which is considered as inappropriate schedule of product administration. Due to plausible temporal relationship, the causality for the events of fatigue and pain is assessed as possibly related to Rabipur. Inappropriate schedule of product administration is not related to the suspect product, but to a human action.; Sender's Comments: Fatigue is listed for RabAvert according to the PI and Prescriber Information, while pain is unlisted. Inappropriate schedule of product administration is listed by convention. On the same day when the patient was vaccinated with the first dose of Rabipur for post exposure prophylaxis, the events of fatigue and pain developed. The patient was off on the third shot by a day, which is considered as inappropriate schedule of product administration. Due to plausible temporal relationship, the causality for the events of fatigue and pain is assessed as possibly related to Rabipur. Inappropriate schedule of product administration is not related to the suspect product, but to a human action.