Sex: U
Vaccine: RAB
Symptoms: Illness, Immune system disorder, Infection, Laboratory test abnormal, Malaise
Clinical narrative: Scleroderma; barely move; It was awful; Stabbing pain at bottoms of feet, and inner wrists; Cat scratch infection and tick infections; Cat scratch infection; Suffering for quite awhile; It was quite disturbing and scary; It was quite disturbing and scary; Other pain; feel as though it messed up my immune system as well; get sick much more often; Stabbing pain at bottoms of feet, and inner wrists/ left shoulder pain; I am drained; Excruciating head pain; Case reference number US-BN-2021-002328 is a spontaneous case report initially received from a consumer via GSK (reference number unknown) on 07-Oct-2021, and concerns a patient of an unknown age.  The patient's medical history included headaches, approximately once every few years.  The patient's concomitant medication details were not provided.  On an unspecified day, approximately six years ago, the patient received the first dose of rabies vaccine (brand name unknown, Batch no. was not provided) at an unknown dose and route of administration, for an unknown indication.   On the same day, the patient experienced excruciating head pain (stabbing in one specific area, in back left lower side) which occurred a few hours after the shots. The patient called an emergency room and they said they could not evaluate the patient over the phone. The patient could barely move and was feeling awful. It was reported that it did go away after several hours. The patient also experienced stabbing pain at the bottoms of feet and inner wrists.   On an unspecified date, the patient had few more shots to receive but just one dose at a time, rather than several at once, as reported. The patient was still getting headaches and other pain, but it had improved. The patient also had left shoulder pain, all ice pick type stabbing for a few months. The patient had on and off pain, but not as intense. Before that, the patient barely had headaches, maybe once every few years. The patient was feeling better and ended up getting a cat scratch infection and in addition to other symptoms, all of the past pain came back, with full force and had continued ever since. The patient did not get it as often as used to, but it still was happening in the same areas and regularly though it may not be relentless for hours at a time anymore, but sporadic throughout the day. That pain was different than any typical headache or other pain the patient have had in life. The patient also had issues with tick infections. Since then, but with antibiotics (unspecified), all symptoms improved, except the pain that originated the same day as the rabies shots. Stabbing head pain also happened in same exact area.   The patient had no doubt the shot caused or triggered that. It seemed to came back when the patient's immunity was low or humidity, but it caused the patient a lot of suffering for quite awhile. It was quite disturbing and scary when it first happened, however the patient got used to it, but was drained. The patient felt as though it messed up immune system as well, since the patient got sick much more often, too. Also, what should had been infections that went away with antibiotics, went into years of treatment.   On an unspecified date, the patient had a test that showed nucleolar type cells, that may be linked to scleroderma. The patient went to rheumatologist at the beginning of the problems, but it could take years to diagnose an autoimmune disorder and they sent the patient to a neurologist. It was all years ago, as reported.  The reporter did not provide the seriousness and causality assessment, however it was noted that although the patient was not sure what the vaccine caused, the patient had very limited issues before it. Never had chronic, stabling pain and often headaches. The event of scleroderma was assessed as serious due to it's medical significance.  No further information was provided.; Reporter's Comments: Headache, arthralgia and asthenia are listed for Rabipur according to the Global Datasheet and USPI, whilst feeling abnormal, movement disorder, pain in extremity, pain, cat scratch, infection, immune system disorder, emotional distress, emotional disorder, fear, illness and scleroderma are unlisted for Rabipur according to the Global Datasheet and USPI. Reportedly, on an unspecified day, approximately six years ago, the patient received the first dose of rabies vaccine at an unknown dose and route of administration, for an unknown indication. On the same day, the patient experienced headache, feeling abnormal, movement disorder, pain in extremity and arthralgia (stabbing pain at the bottoms of feet and inner wrists). Later, on an unspecified date the patient developed arthralgia (left shoulder pain), pain, cat scratch and infection. Then the patient had issues with tick infection and since then, but with antibiotics (unspecified), all symptoms improved, except the pain that originated the same day as the rabies shot. Then, as reported, the patient developed the events of immune system disorder, emotional distress, emotional disorder, fear, asthenia and illness. Later, on an unspecified date, the patient had a test that showed nucleolar type cells, that may be linked to scleroderma. The patient's medical history included headaches. The patient's concomitant medication details were not provided. Due to suggestive temporal relationship and since contributory role of the suspect vaccine cannot be excluded, the causality for the events of headache, feeling abnormal, movement disorder, pain in extremity and arthralgia is assessed as possibly related. The causality for all the other events is assessed as unlikely at the moment, due to missing information and not having a clear temporal relationship between the administration of rabies vaccine and the development of the events. This case is considered serious due to medical significance.; Sender's Comments: Headache, arthralgia and asthenia are listed for Rabipur according to the Global Datasheet and USPI, whilst feeling abnormal, movement disorder, pain in extremity, pain, cat scratch, infection, immune system disorder, emotional distress, emotional disorder, fear, illness and scleroderma are unlisted for Rabipur according to the Global Datasheet and USPI. Reportedly, on an unspecified day, approximately six years ago, the patient received the first dose of rabies vaccine at an unknown dose and route of administration, for an unknown indication. On the same day, the patient experienced headache, feeling abnormal, movement disorder, pain in extremity and arthralgia (stabbing pain at the bottoms of feet and inner wrists). Later, on an unspecified date the patient developed arthralgia (left shoulder pain), pain, cat scratch and infection. Then the patient had issues with tick infection and since then, but with antibiotics (unspecified), all symptoms improved, except the pain that originated the same day as the rabies shot. Then, as reported, the patient developed the events of immune system disorder, emotional distress, emotional disorder, fear, asthenia and illness. Later, on an unspecified date, the patient had a test that showed nucleolar type cells, that may be linked to scleroderma. The patient's medical history included headaches. The patient's concomitant medication details were not provided. Due to suggestive temporal relationship and since contributory role of the suspect vaccine cannot be excluded, the causality for the events of headache, feeling abnormal, movement disorder, pain in extremity and arthralgia is assessed as possibly related. The causality for all the other events is assessed as unlikely at the moment, due to missing information and not having a clear temporal relationship between the administration of rabies vaccine and the development of the events. This case is considered serious due to medical significance.