chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: RAB
Symptoms: Myalgia, Pain
Clinical narrative: A 52 year old female pt developed increased muscle weakness and fatigue, muscle spasms and pain on inspiration after receiving RabAvert therapy. The pt received RabAvert on the following dates: 21May04, 24May04, 28May04 and 04Jun04. Past medical history consisted of systemic lupus erythematous and hypertension. The pt also has a history of weakness, fatigue and muscle spasms at night, prior to starting RabAvert. About one month ago and prior to the 1st RabAvert injection, the pt developed pain on inspiration described as it hurt to breathe, self treated with two days of penicillin she already had at home. Concomitant medications included Plaquinil, Dextra, Spironolactone and Topral (Topral discontinued two weeks ago). The pt sustained a bite from a feral kitten and was treated with 4 out of 5 doses of RabAvert at a clinic with a fifth dose scheduled, as well as planned testing for a titer. The pt experienced increased weakness and fatigue after starting RabAvert as well as muscle spasms in her arms and legs. The weakness and fatigue are described as a rubbery, pre flu-like achiness. The muscle spasms occur occasionally and are described as not severe and like flutters. They are now occurring under the left shoulder blade and on her left side. The difficulty breathing, described as hurts to breathe, had reoccurred a few days prior to the report. An initial visit to see her rheumatologist for this problem was planned for the following day. The events had not improved at the time of this report.
Age: 26.0
Sex: M
Vaccine: RAB
Symptoms: Muscle spasms, Muscle twitching, Salivary hypersecretion
Clinical narrative: A 26 year old patient (RD) experienced increased salivation, muscle twitch, and muscle spasm after immunization with RabAvert for post exposure treatment. He received RabAvert at the end of May 2004. His past medical history was unspecified. He was not on any concomitant medications. However, he was note for alcohol use during the vaccination period by stating, "drank too much during the rabies vaccines." Approximately three weeks post vaccination with RabAvert, the patient complained of increased salivation, muscle twitching all over his body and muscle spasm. All adverse events continued to persist at the time of this reporting.
Age: 36.0
Sex: M
Vaccine: RAB
Symptoms: Blister, Lymphadenopathy, Pruritus, Skin burning sensation
Clinical narrative: A 35 year old male patient (CC) developed blisters on the left side of his forehead and pea sized lymph node in from of his left ear and neck after receiving his fifth dose of RabAvert on 06/07/04. The patient incurred a cat bite on his left leg. The patient received the post exposure series at the local health department. On the day of his fifth and last immunization on 06/07/04, the patient developed some itchy blisters on the left side of his forehead and a pea sized lymph node in front of his left ear and neck. Reportedly, he had no fever, nausea, malaise or other symptoms and no known allergies to the components if RabAvert. The physician assessed the events as related to the drug. Follow up received 06/25/04: Per reporter, date of birth is 09/28/1968. The patient began the RabAvert series in May. New events mentioned were itch and burns and were treated with Benadryl (25 mg three times per day as needed), and hydrocortisone cream. Lab work was drawn and results remain undisclosed. The patient did not return for additional follow up. Lot numbers and expiration dates unavailable.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Injection site pain, Nausea, Vomiting
Clinical narrative: A 21 year old female patient (JC) experienced injection site pain, nausea, vomiting and headache after receiving RabAvert for prophylactic vaccination and inoculation against rabies. Medical history and concomitant medications remained unknown. The patient received one dose of Imovax rabies vaccine on 06/10/04, intramuscularly in the right arm. One week later she received RabAvert on 06/17/04 at 11:00, one ml intramuscularly in the left arm. One hour later, she experienced a headache, injection site soreness and nausea, which proceeded to vomiting. She treated the headache with oral Ibuprofen. The headache, nausea and vomiting were all resolved by 10:00 PM that same evening, the injection site pain was resolved on 06/19/04. The patient was scheduled to continue the vaccine series on 06/10/04.
Age: 45.0
Sex: F
Vaccine: RAB
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Pain
Clinical narrative: A 45 year old patient (JC) experienced body aches, injection site pain, fatigue, headache and myalgia while receiving RabAvert. The patient received RabAvert on 06/18/04 via injection into the deltoid. She has no past medical history or concomitant medications. The patient received her first dose of RabAvert for pre exposure prophylaxis and developed arm soreness, tiredness, headache, overall body aches and sore muscles. The events improved but were still persisting at the time of this report. Follow up received 06/06/04: The patient was vaccinated intramuscularly with RabAvert on 06/18/04 in her right arm. By that afternoon she developed right are soreness, headache, body aches and muscle soreness. The symptoms lasted approximately two to three days and abated. The patient did not receive any further RabAvert injections.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Drooling, Dyspnoea, Facial palsy, Nervous system disorder
Clinical narrative: A 36 year old female patient developed an increased effort to breath after receiving a second dose of RabAvert, batch no. 334011. The patient received the first dose of RabAvert, 1 ml via intramuscular injection, for pre exposure prophylaxis on 06/11/04, and the second dose on 06/17/04. The patient was well until 06/21/04, when she experienced a sensation of "an increased effort to breath" which lasted less than a day and spontaneously remitted. However, the previous event was followed with symptoms of drooping face, drooling and inability to drink from a straw. No other generalized or focal symptoms mentioned. The patient was to see her physician soon. The reporter assessed the event as possible related to the drug. Follow up received 07/13/04: The events of facial paralysis and related neurological disorder and drooling started on 06/23/04, six days after receiving the second dose of RabAvert. The patient stated on 07/08/04 (three weeks after receiving the second dose) that facial paralysis continued but had improved with no treatment. The patient had not seen her primary physician.
Age: 36.0
Sex: M
Vaccine: RAB
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: A 36 year old male patient (CS) experienced pain of the left foot and left ankle swelling after immunization with RabAvert, batch no. 334011. The patient received RabAvert pre exposure prophylaxis. Dose and route remain unspecified. The patient received the first does of RabAvert on 06/17/04, after which he noticed pain in the base of the plantar surface of his toes on his left foot. After taking an over the counter unidentified medication, the pain emitted after two days. After the second dose of RabAvert, the patient noted pain and swelling of his left ankle, that persisted for two days. The reporter assessed the events as possibly related to the drug. Follow up received 08/02/04: Both RabAvert doses were received intramuscularly in the deltoid. The reporter stated no additional information regarding outcome, treatment received or resolution dates for reported adverse events was available.
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Diarrhoea, Myalgia, Nausea, Pain, Palpitations
Clinical narrative: A 36 year old female patient developed diarrhea, muscle pain, fever, nausea, lower extremity pain and palpitations after receiving RabAvert. On 06/22/04, the patient received her first dose of RabAvert, 1 ml intramuscularly. Her second dose was administered on 06/29/04. Past medical history was significant for gastroesophageal reflux disease (GERD). Concomitant medication included Protonix. The patient received her first RabAvert injection without adverse reactions. Twelve to fourteen hours after the second RabAvert dose, she experienced muscle pain, nausea, fever, diarrhea, pain in her lower extremity and heart palpitations. The same night, she took Ibuprofen and awoke the following day symptom free. The events resolved within 12 hours of onset and RabAvert therapy was continued.
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: A 36 year old female patient developed diarrhea, muscle pain, fever, nausea, lower extremity pain and palpitations after receiving RabAvert. On 06/22/04, the patient received her first dose of RabAvert, 1 ml intramuscularly. Her second dose was administered on 06/29/04. Past medical history was significant for gastroesophageal reflux disease (GERD). Concomitant medication included Protonix. The patient received her first RabAvert injection without adverse reactions. Twelve to fourteen hours after the second RabAvert dose, she experienced muscle pain, nausea, fever, diarrhea, pain in her lower extremity and heart palpitations. The same night, she took Ibuprofen and awoke the following day symptom free. The events resolved within 12 hours of onset and RabAvert therapy was continued.
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Back pain, Cold sweat, Headache, Pyrexia
Clinical narrative: A  female patient experienced sharp pain under her breast and back, headache and fever after treatment with RabAvert. RabAvert was given for pre exposure prophylaxis on 07/01/04 and 07/08/04 (dosage and route unspecified). On 07/14/04, she developed a sudden sharp pain under her breast and radiating to the back. She became clammy, feverish and experienced a headache. To ease the pain, she laid on the floor. Her temperature that evening was 99.2 F (37.3C) and the pain had subsided. The following morning, the fever and headache continued.
Age: 45.0
Sex: M
Vaccine: RAB
Symptoms: Abdominal pain, Arthralgia, Immunoglobulins decreased, Musculoskeletal stiffness, Myalgia
Clinical narrative: A 45 year old male patient experienced joint pain in his elbows, ankles and knees, increasing muscle pain, lateral abdominal pain, fever, sore neck, nasal congestion and stiff neck, while being treated with RabAvert. He received RabAvert on 07/15/04, 07/18/04 and 07/21/04 and was planning to get the next dose on 07/28/04. His medical history was significant for treatment with Rabies Immune Globulin (RIG) after receiving a cat bite in Thailand. He developed a rash post RIG treatment which was treated with Clarinex, Atarax and Prednisone. Concomitant medication included acetaminophen. On 07/26/04, 5 days past the 3rd dose of RabAvert the patient complained of fever and joint pain in his elbows, knees and ankles. The following day he complained of increasing muscle pain, lateral abdominal pain, sore neck, nasal congestion and stiff neck. The patient's fever was 99F in the doctor's office. He was referred to an infectious disease physician. Following up information received 08/19/04: Following a cat bite, the patient received 3 doses of Rabipur before returning to the US. In the US he received 2 does of RabAvert. After the fifth dose, the patient was informed that his antibody level was inadequate and a sixth dose would be required. The dates of Rabipur and RabAvert administrations were provided. All of the previously reported events were resolved within 2 days. The events pyrexia and nasal congestion were deleted as the patient denied having a fever or nasal congestion. Follow up information received 08/23/04: The date of onset for the reported events except for low antibody levels was corrected to 07/15/04.
Age: 45.0
Sex: M
Vaccine: RAB
Symptoms: Neck pain
Clinical narrative: A 45 year old male patient experienced joint pain in his elbows, ankles and knees, increasing muscle pain, lateral abdominal pain, fever, sore neck, nasal congestion and stiff neck, while being treated with RabAvert. He received RabAvert on 07/15/04, 07/18/04 and 07/21/04 and was planning to get the next dose on 07/28/04. His medical history was significant for treatment with Rabies Immune Globulin (RIG) after receiving a cat bite in Thailand. He developed a rash post RIG treatment which was treated with Clarinex, Atarax and Prednisone. Concomitant medication included acetaminophen. On 07/26/04, 5 days past the 3rd dose of RabAvert the patient complained of fever and joint pain in his elbows, knees and ankles. The following day he complained of increasing muscle pain, lateral abdominal pain, sore neck, nasal congestion and stiff neck. The patient's fever was 99F in the doctor's office. He was referred to an infectious disease physician. Following up information received 08/19/04: Following a cat bite, the patient received 3 doses of Rabipur before returning to the US. In the US he received 2 does of RabAvert. After the fifth dose, the patient was informed that his antibody level was inadequate and a sixth dose would be required. The dates of Rabipur and RabAvert administrations were provided. All of the previously reported events were resolved within 2 days. The events pyrexia and nasal congestion were deleted as the patient denied having a fever or nasal congestion. Follow up information received 08/23/04: The date of onset for the reported events except for low antibody levels was corrected to 07/15/04.
Age: 7.0
Sex: M
Vaccine: RAB
Symptoms: Pyrexia, Viral infection
Clinical narrative: A 9 year old male patient experienced fever while receiving RabAvert therapy. The child received RabAvert 1 ml intramuscularly on 07/27/04 for post exposure prophylaxis. Past medical history and concomitant medications were not provided. The patient had a possible exposure to the saliva of an unknown animal. He experienced a temperature of 102 degrees Farenheit after RabAvert was administered on 07/27/04. The family had contacted a physician (reporter) who planned on seeing the child in his office and obtaining labwork to determine if the child had an infection. The fever persisted at the time of this report. Follow up information received on 08/03/04: The patient is a 7 year old male child who experienced a viral illness while receiving RabAvert therapy. He received 3 doses of RabAvert on 07/27/04, 07/28/04 and 08/02/04 as well as Human Rabies Immune Globulin (HRIG) on 07/27/04 for exposure to a bat. The patient is described as a well child with no significant post medical history and taking no concomitant medications. The patient developed a fever and loose cough after receiving RabAvert and HRIG therapies. His lung fields were clear to auscultation and physical examination was negative. A complete Blood count including white blood cell count on 08/02/04 was normal, performed to rule out whooping cough that was a concern due to a recent outbreak in the county where the child resides. The mother was instructed to administer antipyretics for fever greater than 101 degrees Farenheit. A diagnosis of a viral illness was made. The physician reporter states that the unremitting fever is due to an intercurrent viral illness that is not related to RabAvert therapy.
Age: 26.0
Sex: M
Vaccine: RAB
Symptoms: Diarrhoea, Injection site pain, Pyrexia, Vomiting
Clinical narrative: A male patient of unknown age developed injection site pain, fever, vomiting and diarrhea while receiving RabAvert therapy as pre-exposure prophylaxis.  The patient received RabAvert intramuscularly on 07/08/2004 and 07/15/2004.  Past medical history and concomitant medications are not known. On 07/08/2004 the patient received the first RabAvert injection and afterward complained of mild transient soreness at the injection site, that resolved.  On 07/15/2004 he received the second RabAvert injection and an hour later developed a fever to 104.3 with vomiting and diarrhea.  These symptoms gradually resolved over the next three days. Follow up received 08/16/2004:  The patient was a 26 year old male with no significant medical history and no concomitant medications.  He received the third dose of RabAvert on 07/29/2004. The patient took over the counter medications for the fever and diarrhea, both of which resolved within 48 hours.  His significant other who did not receive any vaccinations, also experienced similar symptoms during the same time period.  The patient did not experience any adverse reactions after dose #3 of RabAvert.
Sex: F
Vaccine: RAB
Symptoms: Anorexia, Myalgia, Nausea, Pyrexia
Clinical narrative: A 26 year old female patient experienced anorexia, nausea, fever and myalgia while receiving RabAvert.  The patient received RabAvert 1ml into the arm for post exposure prophylaxis on 07/27/2004.  She had a history of acid reflux disease for which she took ranitidine and also took Ortho Tri-cyclen concomitantly. The patient was exposed to bat feces and received her first dose of RabAvert on 07/27/2004.  Following the injection she experienced a lack of appetite, nausea, a low grade fever to 99.5 maximum, and muscle aches all over.  She was taking Advil for the symptoms as needed.  The muscle aches diminished and the other symptoms remained at the time of this report.  The patient was scheduled for her second dose of RabAvert on 07/30/2004 and planned on completing the series.  She also had an appointment with her family physician on 07/30/2004.
Sex: F
Vaccine: RAB
Symptoms: Chest pain, Dizziness, Myalgia, Nausea, Pain
Clinical narrative: A female patient developed swelling and itchiness of the tongue, body ache, blurred vision, dizziness, nausea, chest pain and myalgia while receiving RabAvert.  The second dose of RabAvert, 1ml, was administered on 07/29/2004.  Past medical history and concomitant medication were not specified. After the first RabAvert dose, the patient stated her tongue felt itchy and swollen.  Benadryl was taken with relief of symptoms.  Later that evening, she complained of feeling achy.  She developed blurred vision, which improved but was present at the time of this report.  After the second RabAvert dose on 07/29/2004, she experienced a strange feeling of her head, dizziness, nausea, chest pain and muscle pain.  The muscle pains were persisting at the time of this report.
Sex: F
Vaccine: RAB
Symptoms: Pruritus, Tongue oedema, Vision blurred
Clinical narrative: A female patient developed swelling and itchiness of the tongue, body ache, blurred vision, dizziness, nausea, chest pain and myalgia while receiving RabAvert.  The second dose of RabAvert, 1ml, was administered on 07/29/2004.  Past medical history and concomitant medication were not specified. After the first RabAvert dose, the patient stated her tongue felt itchy and swollen.  Benadryl was taken with relief of symptoms.  Later that evening, she complained of feeling achy.  She developed blurred vision, which improved but was present at the time of this report.  After the second RabAvert dose on 07/29/2004, she experienced a strange feeling of her head, dizziness, nausea, chest pain and muscle pain.  The muscle pains were persisting at the time of this report.
Age: 34.0
Sex: M
Vaccine: RAB
Symptoms: Muscle spasms
Clinical narrative: A 33 year old male patient experienced muscle spasms after being treated for exposure to a bat with RabAvert, lot number 334011, expiration 12/06.  Medical history and concomitant medication remained unspecified.  RabAvert (1ml, intramuscularly) was received on 08/02/2004 (left deltoid), 08/05/2004 (right deltoid) and 08/09/2004 (left deltoid). On 08/10/2004 the patient experienced muscle spasms in his left arm which he described as "constant, would disappear for an hour or so, then would return".  His physician felt it was a "local reaction", and advised him to call again on 08/14/2004 if it was continuing.  The muscle spasms stopped on 08/12/2004 with no treatment.
Age: 64.0
Sex: F
Vaccine: RAB
Symptoms: Alcohol poisoning, Anorexia, Asthenia, Blood triglycerides increased, Diarrhoea
Clinical narrative: A 64 year old female pt experienced nausea, malaise, neurological problems including slurred speech, slow thinking, trouble driving, inability to integrate traffic signals, feeling like she was drunk, and sleepiness at work. She also experienced vomiting, diarrhea, weakness, not being able to eat, and itching in the abdominal area, after being treated with RabAvert for post exposure prophylaxis after being bitten by a raccoon. She received five injections of RabAvert from June03 to Jul03, with the last one given 4 to 10 days late. The pt's medical history was significant for acute pancreatitis on approx 14Dec03, for which she was hospitalized for 4.5 days, and a history of triglycerides 17 times the normal range. Concomitant medications included Gemfibrozil. On 20Jun03, approx 2 days after the first injection of RabAvert, the pt experienced nausea, malaise, neurological problems including slurred speech, trouble driving, inability to integrate traffic signals, feeling like she was drunk, slow thinking and sleepiness at work. She also experienced vomiting, diarrhea, weakness and not being able to eat. In mid-July she experienced itching in the abdominal area. The symptoms lasted through mid Oct2003. The pt reported feeling better after that but still tired. Follow up received on 13Aug04: the pt was bitten by a young raccoon on 13Jun03. The dates of the RabAvert injections were provided. All of the reported events had resolved except for the high triglyceride levels that continued to be 17 times the normal. Follow up information received on 18Aug04: the pt was placed on seven days of Ciprofloxacin in May04 for post surgery prophylaxis. The RabAvert injections were on 17Jun03, 20Jun03, 24Jun03, 02Jul03 and 18Jul03. The triglyceride level increased from 2200 mg/dl on 17Jul04 to 3,518 mg/dl on 24Jul04 and remained elevated. The reporter thinks that the high triglyceride level is related to the RabAvert injections because all of her triglyceride results prior to the RabAvert injections were normal. No triglyceride testing was done after the RabAvert injections until June 2004. The results were reported in July04. Follow up information received on 20Sep04: Although the pt was hospitalized for 4.5 days for acute pancreatitis, the pt had a history of pancreatitis and this was considered a flare-up of her pre-existing condition. Her triglycerides returned to normal and all other symptoms resolved.
Age: 64.0
Sex: F
Vaccine: RAB
Symptoms: Dysarthria, Malaise, Nausea, Nervous system disorder, Pruritus
Clinical narrative: A 64 year old female pt experienced nausea, malaise, neurological problems including slurred speech, slow thinking, trouble driving, inability to integrate traffic signals, feeling like she was drunk, and sleepiness at work. She also experienced vomiting, diarrhea, weakness, not being able to eat, and itching in the abdominal area, after being treated with RabAvert for post exposure prophylaxis after being bitten by a raccoon. She received five injections of RabAvert from June03 to Jul03, with the last one given 4 to 10 days late. The pt's medical history was significant for acute pancreatitis on approx 14Dec03, for which she was hospitalized for 4.5 days, and a history of triglycerides 17 times the normal range. Concomitant medications included Gemfibrozil. On 20Jun03, approx 2 days after the first injection of RabAvert, the pt experienced nausea, malaise, neurological problems including slurred speech, trouble driving, inability to integrate traffic signals, feeling like she was drunk, slow thinking and sleepiness at work. She also experienced vomiting, diarrhea, weakness and not being able to eat. In mid-July she experienced itching in the abdominal area. The symptoms lasted through mid Oct2003. The pt reported feeling better after that but still tired. Follow up received on 13Aug04: the pt was bitten by a young raccoon on 13Jun03. The dates of the RabAvert injections were provided. All of the reported events had resolved except for the high triglyceride levels that continued to be 17 times the normal. Follow up information received on 18Aug04: the pt was placed on seven days of Ciprofloxacin in May04 for post surgery prophylaxis. The RabAvert injections were on 17Jun03, 20Jun03, 24Jun03, 02Jul03 and 18Jul03. The triglyceride level increased from 2200 mg/dl on 17Jul04 to 3,518 mg/dl on 24Jul04 and remained elevated. The reporter thinks that the high triglyceride level is related to the RabAvert injections because all of her triglyceride results prior to the RabAvert injections were normal. No triglyceride testing was done after the RabAvert injections until June 2004. The results were reported in July04. Follow up information received on 20Sep04: Although the pt was hospitalized for 4.5 days for acute pancreatitis, the pt had a history of pancreatitis and this was considered a flare-up of her pre-existing condition. Her triglycerides returned to normal and all other symptoms resolved.
Age: 64.0
Sex: F
Vaccine: RAB
Symptoms: Somnolence, Thinking abnormal, Vomiting
Clinical narrative: A 64 year old female pt experienced nausea, malaise, neurological problems including slurred speech, slow thinking, trouble driving, inability to integrate traffic signals, feeling like she was drunk, and sleepiness at work. She also experienced vomiting, diarrhea, weakness, not being able to eat, and itching in the abdominal area, after being treated with RabAvert for post exposure prophylaxis after being bitten by a raccoon. She received five injections of RabAvert from June03 to Jul03, with the last one given 4 to 10 days late. The pt's medical history was significant for acute pancreatitis on approx 14Dec03, for which she was hospitalized for 4.5 days, and a history of triglycerides 17 times the normal range. Concomitant medications included Gemfibrozil. On 20Jun03, approx 2 days after the first injection of RabAvert, the pt experienced nausea, malaise, neurological problems including slurred speech, trouble driving, inability to integrate traffic signals, feeling like she was drunk, slow thinking and sleepiness at work. She also experienced vomiting, diarrhea, weakness and not being able to eat. In mid-July she experienced itching in the abdominal area. The symptoms lasted through mid Oct2003. The pt reported feeling better after that but still tired. Follow up received on 13Aug04: the pt was bitten by a young raccoon on 13Jun03. The dates of the RabAvert injections were provided. All of the reported events had resolved except for the high triglyceride levels that continued to be 17 times the normal. Follow up information received on 18Aug04: the pt was placed on seven days of Ciprofloxacin in May04 for post surgery prophylaxis. The RabAvert injections were on 17Jun03, 20Jun03, 24Jun03, 02Jul03 and 18Jul03. The triglyceride level increased from 2200 mg/dl on 17Jul04 to 3,518 mg/dl on 24Jul04 and remained elevated. The reporter thinks that the high triglyceride level is related to the RabAvert injections because all of her triglyceride results prior to the RabAvert injections were normal. No triglyceride testing was done after the RabAvert injections until June 2004. The results were reported in July04. Follow up information received on 20Sep04: Although the pt was hospitalized for 4.5 days for acute pancreatitis, the pt had a history of pancreatitis and this was considered a flare-up of her pre-existing condition. Her triglycerides returned to normal and all other symptoms resolved.
Age: 7.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia, Vomiting
Clinical narrative: A 6 year old female pt experienced fever and vomiting while receiving RabAvert for post exposure prophylaxis. The pt received RabAvert 1.0ml on 15Jul04, 18Jul04, and 29Jul04. Past medical history was not provided. The child received no concomitant medications. In the evening following the last two doses of RabAvert on 22Jul04 and 29Jul04, the pt developed a temp to 102 F and vomiting lasting about 18 hrs. No specific treatment was stated. The physician reporter planned on giving a fifth dose of RabAvert on 12Aug04. The events were considered resolved.
Sex: U
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: A pt (age and gender unspecified) experienced urticaria after treatment with RabAvert. The pt received RabAvert on 02Aug04, 09Aug04 and 12Aug04. Following the 2nd dose of RabAvert, the pt developed urticaria. The pt reportedly received previous doses in the gluteal muscle and had not maintained compliance with the recommended timing.
Age: 18.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Arthralgia, Headache, Myalgia, Rash
Clinical narrative: A 18 year old female pt experienced abdominal pain, headache, arthralgia, myalgia, and rash while receiving RabAvert. She received four doses of Imovax Vaccine on 03Jun03, 06Jun03, 10Jun03, and 17Jun03 as well as a fifth dose of Rabies vaccine with RabAvert on 01Jul03. The pt had no illnesses at the time of vaccination and was on no concomitant medications. The pt was exposed to a rabid horse on 01Jun03 and the first dose of Imovax was initiated on 03Jun03. She then developed abdominal pain, joint pain, muscle pain and headache. Following each dose of Imovax and RabAvert the symptoms reappeared and increased in severity with each subsequent dose. The pt also developed a rash, described as a bumpy red rash on one finger and her eyelids. The outcome of the events is not known.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia, Vomiting
Clinical narrative: A 21 year old female pt experienced fever and vomiting after pre exposure vaccination with RabAvert. The pt received RabAvert IM on 04Aug04 and 11Aug04. Her allergies included sulfa and raspberries. Her past medical history and concomitant medications were unspecified. Approx 24 hours after receiving RabAvert on 11Aug04, the pt complained of 2 episodes of vomiting and a fever of 101.2F that persisted for 12 to 24 hours. No further details were provided.
Age: 1.81
Sex: F
Vaccine: RAB
Symptoms: Pharyngitis, Pyrexia, Vomiting
Clinical narrative: A 22 month old female patient experienced fever and vomiting after receiving RabAvert for post exposure treatment. The patient received RabAvert ( dose and route unspecified ) on 08/20/2004 and 08/23/2004. The patient was also concomitantly treated with rabies immunoglobulin on 08/20/2004. She had no known drug allergies. Her past medical history and other concomitant medications were unspecified. The patient was scratched by a rabies infected stray rabbit and received rabbies immunoglobulin along with two doses of RabAvert as mentioned above. Approximately 10 hours post the second vaccination with RabAvert on 08/23/2004, she developed a fever of 101.5 degrees F (axillary) and vomited. She was given tylenol. On 08/24/2004, she continue to spike fevers ( temperature up to 102.4 degrees F ) and vomited. She was evaluated by a physician and a red throat was noted. Throat cultures were obtained and showed negative growth for Streptococcus. The patient was instructed to take Motrin every 4 hours. At the time of this report, the adverse events continued to persist. Follow up information received on 10/18/2004: The patient received additional doses of RabAvert on 08/24/2004, 09/02/2004 and 09/16/2004: The RabAvert lot number was provided. The fever reportedly persisted through 08/24/2004 and became low grade. Throat culture for streptococcus (group A ) was negitive on 08/24/2004. The fever completely resolved before the thrid dose of RabAvert on the 08/28/2004.
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Chills, Fatigue, Hypotension, Injection site pain
Clinical narrative: A 37 year old female patient experienced mild soreness, injection site soreness, fatigue, fever, chills, aching in gut around the liver and kidney areas, decrease in blood pressure and nausea while being treated with RabAvert intramuscularly for a dog bite. No significant medical history. Additional medications included a tetanus shot (with first dose) and rabbies immune globulin (with second dose). The patient experienced mild soreness, injection site soreness and fatigue following the first dose of RabAvert. Reportedly, the symptoms increased in intensity after the initial 24 hours and she experienced fever, chills and aching in her gut around the liver and kidney areas. The fever reached 101.4 degrees. Patient stated she had a decrease in blood pressure as evidenced by a feeling of vomiting and nausea when she got up to answer the door. Symptoms resolved after lying on her back for 15 minutes. A tetanus shot was given with the first dose of RabAvert and human rabies immune globulin was given with the second dose of RabAvert. Patient reported no symptoms following the second dose of RabAvert and that all of the symptoms have received. She decided to not complete the Rabivert series because the dog that bit her was not exhibiting any signs of rabies.
Age: 37.0
Sex: F
Vaccine: RAB
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: A 37 year old female patient experienced mild soreness, injection site soreness, fatigue, fever, chills, aching in gut around the liver and kidney areas, decrease in blood pressure and nausea while being treated with RabAvert intramuscularly for a dog bite. No significant medical history. Additional medications included a tetanus shot (with first dose) and rabbies immune globulin (with second dose). The patient experienced mild soreness, injection site soreness and fatigue following the first dose of RabAvert. Reportedly, the symptoms increased in intensity after the initial 24 hours and she experienced fever, chills and aching in her gut around the liver and kidney areas. The fever reached 101.4 degrees. Patient stated she had a decrease in blood pressure as evidenced by a feeling of vomiting and nausea when she got up to answer the door. Symptoms resolved after lying on her back for 15 minutes. A tetanus shot was given with the first dose of RabAvert and human rabies immune globulin was given with the second dose of RabAvert. Patient reported no symptoms following the second dose of RabAvert and that all of the symptoms have received. She decided to not complete the Rabivert series because the dog that bit her was not exhibiting any signs of rabies.
Age: 17.0
Sex: M
Vaccine: RAB
Symptoms: Fatigue
Clinical narrative: A 17 year old male patient experienced fatigue after receiving post exposure treatment with RabAvert following a dog bite while traveling to Peru. The patient received 5 doses of RabAvert, the first dose on 07/16/2004 and the last dose on 08/13/2004. During and after the entire rabies vaccine series the patient was very fatigued, sleeping 12 hours a day during summer vacation and continued to be very fatigued after returning to school. Laboratory tests revealed a billirubin of 4.1 mg/dl and urine protein of 100 mg/dl. The patient had no other associated symptoms. The patient reportedly had grown over four inches during the summer and liked to sleep 12 hours a day. At the time of this report the patient continued to be fatigued and the billirubin remained elevated. Epstein Barr Virus and Cytomegalovirus test results were both negative. The patient was sxheduled to see a liver specialist.
Sex: F
Vaccine: RAB
Symptoms: Drug administration error
Clinical narrative: A female nurse (LD), age unspecified, experienced drug exposure to the eye during administration of RabAvert to her patient. Her past medical history and concomitant medications were unspecified. During administration of RabAvert to her patient on 09/08/2004, the needle popped off from the syringe and some RabAvert solution went into her eye. She immediately flushed her infected eye with water. No burning, stinging, or other irritations noted and she was completely fine on that same day.
Sex: F
Vaccine: RAB
Symptoms: Back pain, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: An adult female patient, age unspecified , experienced diarrhea, severe fatigue, severe headache, nausea, fever (up to 100.2 F), chills, swollen joints and constant throbbing pain from the top of her head down the back of her legs, after receiving post-exposure treatment with RabAvert following exposure to animals in a petting zoo. The patient received her first RabAvert dose on 08/06/2004, the second on 08/09/2004, the thrid on 08/14/2004, the fourth on 08/21/2004 and the fifth on 09/04/2004. The patient was present at a petting zoo on 07/24/2004. She noticed an animal that did not look well but thought it was dehydrated due to the heat. Later a friend notified her that it was reported on the local news that anyone who was in the zoo between 07/13/2004 and 07/30/2004 should be treated for rabies because some of the animals were found to have rabies. After the first dose of RabAvert on 08/06/2004 the patient experienced headache, nausea, body aches, joint aches, muscle aches and fevers up to 100.2 F. She called her physician and was told these were typical symtoms. On 09/12/2004 she went to the emergency room because she was getting any better. Blood, urine tests and a chest x-ray were performed and the results reported as normal. She was taking Tylnol and Motrin without relief. On 09/13/2004 her family physician treated her with Vitamin B complex and gave her a prescription for Lortab, Phenergan and Glucofac-ZX (high potency vitamins) and referred her for an infectious disease specialist, who then referred her to the state health department. She was subsequently referred to Chiron because they were not familiar with rabies. At the time of this report the patient had not recovered from her symptoms with the exception of fever with chills and diarrhea which had improved without medication. She was still waiting for the results of the blood tests that were sent for analysis. She was concerned about not being able to work because her decreased performance staus due to constant fatigue and the other reported symtoms.
Sex: F
Vaccine: RAB
Symptoms: Influenza like illness, Joint swelling, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: An adult female patient, age unspecified , experienced diarrhea, severe fatigue, severe headache, nausea, fever (up to 100.2 F), chills, swollen joints and constant throbbing pain from the top of her head down the back of her legs, after receiving post-exposure treatment with RabAvert following exposure to animals in a petting zoo. The patient received her first RabAvert dose on 08/06/2004, the second on 08/09/2004, the thrid on 08/14/2004, the fourth on 08/21/2004 and the fifth on 09/04/2004. The patient was present at a petting zoo on 07/24/2004. She noticed an animal that did not look well but thought it was dehydrated due to the heat. Later a friend notified her that it was reported on the local news that anyone who was in the zoo between 07/13/2004 and 07/30/2004 should be treated for rabies because some of the animals were found to have rabies. After the first dose of RabAvert on 08/06/2004 the patient experienced headache, nausea, body aches, joint aches, muscle aches and fevers up to 100.2 F. She called her physician and was told these were typical symtoms. On 09/12/2004 she went to the emergency room because she was getting any better. Blood, urine tests and a chest x-ray were performed and the results reported as normal. She was taking Tylnol and Motrin without relief. On 09/13/2004 her family physician treated her with Vitamin B complex and gave her a prescription for Lortab, Phenergan and Glucofac-ZX (high potency vitamins) and referred her for an infectious disease specialist, who then referred her to the state health department. She was subsequently referred to Chiron because they were not familiar with rabies. At the time of this report the patient had not recovered from her symptoms with the exception of fever with chills and diarrhea which had improved without medication. She was still waiting for the results of the blood tests that were sent for analysis. She was concerned about not being able to work because her decreased performance staus due to constant fatigue and the other reported symtoms.
Sex: F
Vaccine: RAB
Symptoms: Pain, Pyrexia
Clinical narrative: An adult female patient, age unspecified , experienced diarrhea, severe fatigue, severe headache, nausea, fever (up to 100.2 F), chills, swollen joints and constant throbbing pain from the top of her head down the back of her legs, after receiving post-exposure treatment with RabAvert following exposure to animals in a petting zoo. The patient received her first RabAvert dose on 08/06/2004, the second on 08/09/2004, the thrid on 08/14/2004, the fourth on 08/21/2004 and the fifth on 09/04/2004. The patient was present at a petting zoo on 07/24/2004. She noticed an animal that did not look well but thought it was dehydrated due to the heat. Later a friend notified her that it was reported on the local news that anyone who was in the zoo between 07/13/2004 and 07/30/2004 should be treated for rabies because some of the animals were found to have rabies. After the first dose of RabAvert on 08/06/2004 the patient experienced headache, nausea, body aches, joint aches, muscle aches and fevers up to 100.2 F. She called her physician and was told these were typical symtoms. On 09/12/2004 she went to the emergency room because she was getting any better. Blood, urine tests and a chest x-ray were performed and the results reported as normal. She was taking Tylnol and Motrin without relief. On 09/13/2004 her family physician treated her with Vitamin B complex and gave her a prescription for Lortab, Phenergan and Glucofac-ZX (high potency vitamins) and referred her for an infectious disease specialist, who then referred her to the state health department. She was subsequently referred to Chiron because they were not familiar with rabies. At the time of this report the patient had not recovered from her symptoms with the exception of fever with chills and diarrhea which had improved without medication. She was still waiting for the results of the blood tests that were sent for analysis. She was concerned about not being able to work because her decreased performance staus due to constant fatigue and the other reported symtoms.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Depression, Pyrexia
Clinical narrative: A 20 year old female patient experienced depression while receiving RabAvert therapy. The patient received RabAvert in August 2004 for post exposure prophylaxis. Past medical history and concomitant medications were not provided. In August 2004, the patient was exposed to a bat and began RabAvert prophylaxis. On day three after starting RabAvert the patient complained of depression. She was seen by a physician who stated her examination was within normal limits and she had no other complaints during or after the RabAvert series. The depression had persisted at the time of this report. Follow up received 09/17/04: The patient received RabAvert doses beginning in late August 2004 on days zero, three and seven. The day 14 dose was administered in September 2004. The patient had no significant past medical history and no known history of depression. She was not on any concomitant medications. The patient developed depression after receiving RabAvert and was seen by a psychiatrist for her first visit for counseling one to two days ago. She was treated by the psychiatrist with a medication (unspecified) and the psychiatrist will see the patient again as the depression is not resolved. The patient also developed a low grade fever after the third dose of RabAvert, treated successfully with Tylenol. The fever resolved and she did not develop fever after the fourth dose. The psychiatrist's opinion was that the depression was not related to the vaccine. Follow up received 09/23/04: The patient received her fifth dose of RabAvert on 09/21/04. All immunizations were administered from the same lot and the lot number was provided.
Age: 12.0
Sex: M
Vaccine: RAB
Symptoms: Abdominal discomfort, Asthma, Chest discomfort, Fatigue, Headache
Clinical narrative: An 11 year old male patient experienced fever, headache, vomiting, hives and asthma symptoms after post exposure vaccination with RabAvert. The patient received his third does of RabAvert, 1 ml intramuscularly into the deltoid on 09/15/04. His post medical history was significant for asthma. His concomitant medications included Flovent and Albuterol. The patient tolerated his first and second doses of RabAvert without incident. On 09/16/04, on day after his third dose of RabAvert, the patient developed a fever of 102.5 degrees, headache and vomiting that resolved after two to three days. In addition, approximately 72 hours after the third dose, he also developed asthma symptoms (chest tightness) and hives. The asthma symptoms resolved with treatment of Flovent and Albuterol. The hives were limited to his arms and resolved without treatment. Prior to the occurrence of the asthma symptoms and hives, the patient was reportedly playing outside. Additional information received on 09/23/04: The patient received RabAvert due to exposure to a rabies positive bat at home. Prior to his third dose of RabAvert, the patient complained of fatigue, achiness and an upset stomach. His physician asserted that it was unclear whether the patient had a hypersensitivity reaction to RabAvert, or that he had a viral syndrome concomitant with the third RabAvert vaccination and later (72 hours) he exhibited asthmatic symptoms as he had done on previous occasions.
Age: 12.0
Sex: M
Vaccine: RAB
Symptoms: Pain, Pyrexia, Urticaria, Vomiting
Clinical narrative: An 11 year old male patient experienced fever, headache, vomiting, hives and asthma symptoms after post exposure vaccination with RabAvert. The patient received his third does of RabAvert, 1 ml intramuscularly into the deltoid on 09/15/04. His post medical history was significant for asthma. His concomitant medications included Flovent and Albuterol. The patient tolerated his first and second doses of RabAvert without incident. On 09/16/04, on day after his third dose of RabAvert, the patient developed a fever of 102.5 degrees, headache and vomiting that resolved after two to three days. In addition, approximately 72 hours after the third dose, he also developed asthma symptoms (chest tightness) and hives. The asthma symptoms resolved with treatment of Flovent and Albuterol. The hives were limited to his arms and resolved without treatment. Prior to the occurrence of the asthma symptoms and hives, the patient was reportedly playing outside. Additional information received on 09/23/04: The patient received RabAvert due to exposure to a rabies positive bat at home. Prior to his third dose of RabAvert, the patient complained of fatigue, achiness and an upset stomach. His physician asserted that it was unclear whether the patient had a hypersensitivity reaction to RabAvert, or that he had a viral syndrome concomitant with the third RabAvert vaccination and later (72 hours) he exhibited asthmatic symptoms as he had done on previous occasions.
Age: 51.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Fibromyalgia, Myalgia, Paraesthesia, Vaccine positive rechallenge
Clinical narrative: A 51 year old female pt experienced spots before her eyes, faintness, near blindness, and aches pains and tingling in her legs after receiving RabAvert for a stray cat bite. RabAvert was received IM on 13Sep04, 16Sep04, 21Sep04 and 28Sep04. Medical history included high blood pressure and type two diabetes. Concomitant medication included metformin, Toprol XL, Captopril, Risperdal, and Zoloft. A stray cat bit the pt on 11Sep04. On 13Sep04 she received her first injection of RabAvert in her hip and another medication (type unspecified) in the other hip. On 16Sep04 she received her second dose of RabAvert with no adverse events. On 21Sep04 she received her third dose. Immediately after receiving the injections she experienced spots before her eyes and nearly fainted. She also experienced aches, pains and tingling of the legs. The hospital staff had her sit down and the events resolved within 5 minutes without treatment. On 28Sep04 she received her fourth dose and experienced near blindness while driving home from the hospital. She did not stop driving, and the event resolved within 5 minutes with no treatment. She again experienced aches, pains and tingling in her legs, which she treated with oral ibuprofen orally and felt that the events were resolved. She stated she had never experienced any of these events before. Her physician told her that as her white count was fine, she probably has fibromyalgia.