Sex: M
Vaccine: RAB
Symptoms: Abnormal sensation in eye, Acute stress disorder, Arthralgia, Inappropriate schedule of product administration, Product administered at inappropriate site
Clinical narrative: Uncontrollable trembling; Fluttering sensation behind the eyes and in the head; Tendinitis; Extreme fight or flight response; Joint pain; Skin eruptions; Random welts on the body; Low-grade fever; Patient administered RabAvert in a peculiar manner, delaying the dosing schedule, received four and a half doses because the last dose given two days late was administered in the wrong place, requiring an additional half dose; Patient administered RabAvert in a peculiar manner, delaying the dosing schedule, received four and a half doses because the last dose given two days late was administered in the wrong place, requiring an additional half dose; Patient administered RabAvert in a peculiar manner, delaying the dosing schedule, received four and a half doses because the last dose given two days late was administered in the wrong place, requiring an additional half dose; Case reference number US-BN-2023-001305 is a spontaneous case report initially received from a consumer via Communication (reference number: USBAV23-1037) on 24-Jul-2023 and concerns a male patient of unknown age.   The patient's relevant medical history and concomitant medication details were not provided.  On unspecified dates, the patient was vaccinated with the first, second and third dose of RabAvert (batch number not provided) at an unknown dose, route or site of administration for an unknown indication.   On an unspecified date, an unknown amount of time after the first dose of Rabipur, reported as two days late, the patient was vaccinated with the fourth dose of RabAvert (batch number not provided), administered in the wrong place (verbatim as reported), at an unknown dose and route of administration (explicitly coded as 'vaccine administered at inappropriate site' and 'inappropriate schedule of vaccine administered'). As reported, the patient administered RabAvert in a peculiar manner, delaying the dosing schedule (explicitly coded as 'inappropriate schedule of vaccine administered').  On an unspecified date, an unknown amount of time after the first dose of Rabipur, the patient was vaccinated with an additional half dose of RabAvert (batch number not provided), at an unknown dose, route or site of administration (explicitly coded as 'vaccine underdose' and 'inappropriate schedule of vaccine administered'). As reported, the administration in the wrong place required the additional half dose.  On an unspecified date, an unknown amount of time after the first dose of Rabipur, the patient developed a multitude of adverse reaction such as uncontrollable trembling, low-grade fever, fluttering sensation behind the eyes and in the head, random welts on the body, skin eruptions, extreme fight or flight response, joint pain and tendinitis.      At the time of the initial report, the outcome of the events uncontrollable trembling, low-grade fever, fluttering sensation behind the eyes and in the head, random welts on the body, skin eruptions, extreme fight or flight response, joint pain and tendinitis was unknown.   The reporter assessed the events of uncontrollable trembling, low-grade fever, fluttering sensation behind the eyes and in the head, random welts on the body, skin eruptions, extreme fight or flight response, joint pain and tendinitis as serious due to seriousness criteria of life threatening. Causality assessment for the same events was not provided.  Additional information received from on 25-Jul-2023 included local case ID.; Reporter's Comments: A male patient of unknown age was vaccinated with the fourth dose of RabAvert, administered in the wrong place, at an unknown dose and route of administration on an unspecified date, an unknown amount of time after the first dose of Rabipur, reported as two days late, which is considered as vaccine administered at inappropriate site and inappropriate schedule of vaccine administered. Reportedly, the patient was administered RabAvert in a peculiar manner, delaying the dosing schedule, which is considered as inappropriate schedule of vaccine administered. On an unspecified date, an unknown amount of time after the first dose of Rabipur, the patient was vaccinated with an additional half dose of RabAvert, which is considered as vaccine underdose and inappropriate schedule of vaccine administered. Reportedly, on an unspecified date, an unknown amount of time after the first dose of Rabipur, the patient developed serious events of uncontrollable trembling, low-grade fever, fluttering sensation behind the eyes and in the head, random welts on the body, skin eruptions, extreme fight or flight response, joint pain and tendinitis (life threatening). Arthralgia, rash, urticaria and pyrexia are listed, whilst tremor, abnormal sensation in eye, tendonitis and acute stress disorder are unlisted for RabAvert according to the guidelines. Inappropriate schedule of product administration, underdose and product administered at inappropriate site are considered as listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship, the absence of confounding factors and since the contributory role of the suspect vaccine cannot be excluded with certainty, the events have been conservatively considered as related to RabAvert. Inappropriate schedule of product administration, underdose and product administered at inappropriate site have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as serious due to life threatening criteria.; Sender's Comments: A male patient of unknown age was vaccinated with the fourth dose of RabAvert, administered in the wrong place, at an unknown dose and route of administration on an unspecified date, an unknown amount of time after the first dose of Rabipur, reported as two days late, which is considered as vaccine administered at inappropriate site and inappropriate schedule of vaccine administered. Reportedly, the patient was administered RabAvert in a peculiar manner, delaying the dosing schedule, which is considered as inappropriate schedule of vaccine administered. On an unspecified date, an unknown amount of time after the first dose of Rabipur, the patient was vaccinated with an additional half dose of RabAvert, which is considered as vaccine underdose and inappropriate schedule of vaccine administered. Reportedly, on an unspecified date, an unknown amount of time after the first dose of Rabipur, the patient developed serious events of uncontrollable trembling, low-grade fever, fluttering sensation behind the eyes and in the head, random welts on the body, skin eruptions, extreme fight or flight response, joint pain and tendinitis (life threatening). Arthralgia, rash, urticaria and pyrexia are listed, whilst tremor, abnormal sensation in eye, tendonitis and acute stress disorder are unlisted for RabAvert according to the guidelines. Inappropriate schedule of product administration, underdose and product administered at inappropriate site are considered as listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship, the absence of confounding factors and since the contributory role of the suspect vaccine cannot be excluded with certainty, the events have been conservatively considered as related to RabAvert. Inappropriate schedule of product administration, underdose and product administered at inappropriate site have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as serious due to life threatening criteria.