chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RAB
Symptoms: Nausea, Pyrexia, Swelling, Vomiting
Clinical narrative: From initial information received on 4/13/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a female patient (age not reported) received her third dose of IMOVAX RABIES, lot number W1419, route and site of administration not reported, on 4/5/04. Reportedly, the vaccine administered was for post-exposure. An unspecified time later, the patient experienced swelling of the arm, nausea, vomiting, and a temperature of 104 degrees F. The reporter believes that the patient was treated in the emergency room. The patient recovered from these events. She denies any reactions after receiving her first or second dose of the vaccine.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Back pain, Erythema, Insomnia, Pain, Pyrexia
Clinical narrative: From initial information received on 4/14/04 from the patient regarding an adverse event occurring in the USA, it was reported that a 32 year old female patient received a seventh dose post-exposure IMOVAX vaccination, lot number X0581, administered in the left deltoid on 4/8/04. An unspecified time later she complained of redness and pain in the left arm, a fever of 98.8 degrees F, difficulty sleeping, backache, and restlessness. The patient received the first four doses overseas and the rest of the doses at home (dose four lot # W1419 given on 1/22/04 and dose five lot number X0581 given on 3/22/04). The rabies series was given due to a dog bite she received while overseas. The redness has resolved, but the backache and other events persist. Additional information received 5/7/04: From the reporter's physician, report reviewed, no additional information is available at this time. No further information is anticipated, therefore, this case is closed.
Age: 31.0
Sex: F
Vaccine: RAB
Symptoms: Restlessness
Clinical narrative: From initial information received on 4/14/04 from the patient regarding an adverse event occurring in the USA, it was reported that a 32 year old female patient received a seventh dose post-exposure IMOVAX vaccination, lot number X0581, administered in the left deltoid on 4/8/04. An unspecified time later she complained of redness and pain in the left arm, a fever of 98.8 degrees F, difficulty sleeping, backache, and restlessness. The patient received the first four doses overseas and the rest of the doses at home (dose four lot # W1419 given on 1/22/04 and dose five lot number X0581 given on 3/22/04). The rabies series was given due to a dog bite she received while overseas. The redness has resolved, but the backache and other events persist. Additional information received 5/7/04: From the reporter's physician, report reviewed, no additional information is available at this time. No further information is anticipated, therefore, this case is closed.
Age: 38.0
Sex: F
Vaccine: RAB
Symptoms: Influenza like illness, Malaise, Similar reaction on previous exposure to drug
Clinical narrative: From initial information received on 4/12/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 37 year old female patient received her second dose of Rabies vaccine, lot number 1419 (lot number to be confirmed with the reporter), administered in the left deltoid on 2/16/04. Later that same day, the patient developed malaise and flu-like symptoms for two days. It was reported that the patient experienced the same symptoms after her first dose of Imovax rabies on 1/30/04. Reportedly the patient recovered from this experience.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Injection site rash, Insomnia, Myalgia, Pruritus
Clinical narrative: From initial information received on 13Apr04 from a pt regarding an adverse event occurring, it was reported that a 27 year old female pt received an Imovax rabies vaccination series, lot number, route and site of admin unk starting on 11Feb04. The pt received doses one through five on 11Feb04, 18Feb04, 18Mar04, 09Apr04 and 14Apr04, respectively. On 29Mar04, 11 days after third dose, the pt developed muscle soreness in her neck, back, shoulders and arm, difficulty sleeping, and a rash on her arm and leg with itching that lasted 48 hrs. The pt is still having muscle soreness, difficulty sleeping and lightheadedness. It is unk whether the pt fully recovered. From additional information received from a health care professional, it was reported that the pt had received her first dose of Tetanus toxoid admin IM in the left buttock on 09Apr04. She received a fourth dose of Imovax Rabies, lot number X05812, admin IM in the right arm on 09Apr04 and a fifth dose Imovax rabies, lot number X05812 administered IM in the right arm on 14Apr04. The responsible physician name and address was provided as well as the complete address of the pt. It is unk whether the pt fully recovered. No further information is anticipated, this case is considered closed.
Age: 20.0
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: From initial information received on 4/13/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 19 year old male patient received his second dose of IMOVAX RABIES, lot number X0581, route and site of administration not reported on 3/31/04. Within 48 hours of vaccination, the patient experienced dizziness, weakness, nausea, and vomiting as well as subjective feeling of fever. The patient previously experienced arm soreness and tenderness after receiving his first dose of Imovax rabies. Reportedly, the symptoms persist but are improving. The patient had not yet recovered from these events. From additional information received on 5/10/04 from the initial reporter, the patient was seen by a physician and recovered from the adverse events on an unspecified date. He returned to work on 4/19/04. It was also reported that the patient received his third dose of IMOVAX RABIES on 4/21/04. No adverse events were reported following administration of the third dose. No further information is anticipated, this case is considered closed. The reporter of this case is the same reporter of case 200401511.
Age: 49.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Breast mass, Injection site pain, Laboratory test abnormal, Lymphadenopathy
Clinical narrative: From initial information received on 20Apr04 from a physician regarding an adverse event occurring, it was reported that a female pt (age not reported) received her first dose of Imovax rabies pre-exposure series, lot number W14192, route and site of administration not reported, on an unspecified date. An unspecified time later, the pt experienced arthralgias, migraine headaches and enlarged mass in her chest wall. A work up for breast mass revealed an enlarged lymph node. Reportedly, the pt refused to receive the second dose of the vaccine. She is to follow up per recommendations. It is unk whether the pt recovered from these events. From additional information received on 23Apr04 from the pt, it was reported that she received the Imovax Rabies vaccine at 4:15PM on 20Apr04. Approx a half and hour later, the pt developed hives and a headache. She took Benadryl and ibuprofen at 4:50PM. The hives slowly went away over two hours. She did not experience any difficulty breathing, but did state that her arm is still sore and she still has a headache. The pt has not recovered from these adverse events. The pt had previously experienced hives after receiving Imovax Rabies (lot not reported) in Oct and Nov of 2003. She received three doses and experienced hives after each dose. The hives reportedly got worse after each vaccination. From additional information received on 24May04, it was reported the pt received Imovax Rabies vaccines on 05Oct03, 22Oct03 and on 12Nov03. The reaction was reported to the health dept in Apr 04. The pt did not contact the health dept at the time symptoms occurred. Reportedly the pt recovered from these events. No further information is anticipated, this case is considered closed.
Age: 49.0
Sex: F
Vaccine: RAB
Symptoms: Migraine, Urticaria, Vaccine positive rechallenge
Clinical narrative: From initial information received on 20Apr04 from a physician regarding an adverse event occurring, it was reported that a female pt (age not reported) received her first dose of Imovax rabies pre-exposure series, lot number W14192, route and site of administration not reported, on an unspecified date. An unspecified time later, the pt experienced arthralgias, migraine headaches and enlarged mass in her chest wall. A work up for breast mass revealed an enlarged lymph node. Reportedly, the pt refused to receive the second dose of the vaccine. She is to follow up per recommendations. It is unk whether the pt recovered from these events. From additional information received on 23Apr04 from the pt, it was reported that she received the Imovax Rabies vaccine at 4:15PM on 20Apr04. Approx a half and hour later, the pt developed hives and a headache. She took Benadryl and ibuprofen at 4:50PM. The hives slowly went away over two hours. She did not experience any difficulty breathing, but did state that her arm is still sore and she still has a headache. The pt has not recovered from these adverse events. The pt had previously experienced hives after receiving Imovax Rabies (lot not reported) in Oct and Nov of 2003. She received three doses and experienced hives after each dose. The hives reportedly got worse after each vaccination. From additional information received on 24May04, it was reported the pt received Imovax Rabies vaccines on 05Oct03, 22Oct03 and on 12Nov03. The reaction was reported to the health dept in Apr 04. The pt did not contact the health dept at the time symptoms occurred. Reportedly the pt recovered from these events. No further information is anticipated, this case is considered closed.
Age: 29.0
Sex: F
Vaccine: RAB
Symptoms: Dry mouth, Hyperhidrosis, Hypoaesthesia, Pain
Clinical narrative: From initial information received on 4/21/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 28 year old female patient received a pose-exposure IMOVAX RABIES vaccination, lot number X0581, administered IM in the left deltoid on 4/20/04 at3:45 PM. The dose number was not reported. The same day at 6:00 PM, the patient experienced pain and numbness in the left arm without loss of movement or use of her left upper extremity. She also experienced sweats, body aches, and a dry mouth. The health department is referring the patient to a physician for evaluation and administration of second post-exposure dose. Per the patient the symptoms were resolving as of 4/21/04. Additional information was received on 4/23/04 from a telephone contact with the initial reporter. She stated that since the patient's symptoms were resolving, no physician evaluation or treatment was obtained. The patient's employer, a veterinarian, is having her get a titer done to determine immunity. From additional information received on 5/18/04 from the initial reporter, the patient had still not had a titer drawn as of 5/11/04, but still plans to do so. They will notify the company when the results are obtained. Reportedly, the patient recovered from the events.
Age: 53.0
Sex: F
Vaccine: HEPAB, RAB
Symptoms: Rash, Throat tightness
Clinical narrative: From initial information received on 21Apr04 from a health care professional regarding an adverse event occurring, it was reported that a 51 year old female pt received her third pre exposure Imovax Rabies vaccination, lot number W14193, on 04Mar04. That same day, the pt experienced a full body rash (the reporter was unaware of the type of rash) and thickening of the throat. She was treated by a physician with Benadryl and a prednisone pack. The recovery status of the pt was not reported. From additional information received on 18May04 it was reported that the pt also received her third dose of Twinrix vaccine, lot number HAB235A4, admin IM in physician and vaccine administrator were provided. No further information is anticipated, this case is considered closed. The reporter of this case is the same reporter of case 200401720.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Back pain, Chest discomfort, Chills, Diarrhoea
Clinical narrative: From initial information received on 4/22/04 from the patient regarding an adverse event occurring in the USA, it was reported that she, a 36 year old female who handles raccoons received three doses of pre-exposure Rabies vaccine. The patient received her first dose of Imovax Rabies vaccine, lot number W1419, administered in the right upper arm at 10:30 AM on 2/23/04. Two days later the patient developed a fever, swollen glands, and chest tightness. The symptoms subsided with a course of amoxicillin. In mid-March 2004, the patient developed nausea, vomiting, headache, chills, and back pain that became worse. She did experience some relief with symptomatic treatment but symptoms have reoccurred and are continuing. From additional information received on 5/18/04 from a physician, information regarding the patient's follow up visit on 4/23/04 was provided. Per the reporter, the patient was seen to follow up on the rabies vaccine as well as recurrent illnesses. The physician stated that the patient had three prophylactic rabies vaccines, but evidently manufacturered, had a problem with one lot where there was actually live viruses in the vaccine. Reportedly, this wasn ot the patient's lot, but the manufacturer suggested that she is given two additional booster shots from a new lot. The patient stated that she has been sick on and off for the last month and a half and has seen one physician on one occasion and another on another occasion. The patient has intermittent problems with severe headaches, vomiting, intermittent diarrhea, stomach cramps, and general malaise. She is also feeling as if she had the flu. Reportedly the patient has seen a dermatologist with her nails and a culture was positive for a fungal infection. At times, the patient feels fatigued and mentally out of it. The patient was diagnosed with recurrent illnesses of unknown etiology and is to continue to be followed and treated by a dermatologist. The patient received a rabies vaccine on 4/23/04, the day of the office visit, and was to receive a second dose the following Monday. The decision where to go with the patient's recurrent flu viral like symptoms depend on lab test results and how the patient feels. This patient is the same patient as case 200401686 (dose 3). No further information is anticipated, this case is considered closed.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Fungal infection, Headache, Influenza like illness, Lymphadenopathy, Malaise
Clinical narrative: From initial information received on 4/22/04 from the patient regarding an adverse event occurring in the USA, it was reported that she, a 36 year old female who handles raccoons received three doses of pre-exposure Rabies vaccine. The patient received her first dose of Imovax Rabies vaccine, lot number W1419, administered in the right upper arm at 10:30 AM on 2/23/04. Two days later the patient developed a fever, swollen glands, and chest tightness. The symptoms subsided with a course of amoxicillin. In mid-March 2004, the patient developed nausea, vomiting, headache, chills, and back pain that became worse. She did experience some relief with symptomatic treatment but symptoms have reoccurred and are continuing. From additional information received on 5/18/04 from a physician, information regarding the patient's follow up visit on 4/23/04 was provided. Per the reporter, the patient was seen to follow up on the rabies vaccine as well as recurrent illnesses. The physician stated that the patient had three prophylactic rabies vaccines, but evidently manufacturered, had a problem with one lot where there was actually live viruses in the vaccine. Reportedly, this wasn ot the patient's lot, but the manufacturer suggested that she is given two additional booster shots from a new lot. The patient stated that she has been sick on and off for the last month and a half and has seen one physician on one occasion and another on another occasion. The patient has intermittent problems with severe headaches, vomiting, intermittent diarrhea, stomach cramps, and general malaise. She is also feeling as if she had the flu. Reportedly the patient has seen a dermatologist with her nails and a culture was positive for a fungal infection. At times, the patient feels fatigued and mentally out of it. The patient was diagnosed with recurrent illnesses of unknown etiology and is to continue to be followed and treated by a dermatologist. The patient received a rabies vaccine on 4/23/04, the day of the office visit, and was to receive a second dose the following Monday. The decision where to go with the patient's recurrent flu viral like symptoms depend on lab test results and how the patient feels. This patient is the same patient as case 200401686 (dose 3). No further information is anticipated, this case is considered closed.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: From initial information received on 4/22/04 from the patient regarding an adverse event occurring in the USA, it was reported that she, a 36 year old female who handles raccoons received three doses of pre-exposure Rabies vaccine. The patient received her first dose of Imovax Rabies vaccine, lot number W1419, administered in the right upper arm at 10:30 AM on 2/23/04. Two days later the patient developed a fever, swollen glands, and chest tightness. The symptoms subsided with a course of amoxicillin. In mid-March 2004, the patient developed nausea, vomiting, headache, chills, and back pain that became worse. She did experience some relief with symptomatic treatment but symptoms have reoccurred and are continuing. From additional information received on 5/18/04 from a physician, information regarding the patient's follow up visit on 4/23/04 was provided. Per the reporter, the patient was seen to follow up on the rabies vaccine as well as recurrent illnesses. The physician stated that the patient had three prophylactic rabies vaccines, but evidently manufacturered, had a problem with one lot where there was actually live viruses in the vaccine. Reportedly, this wasn ot the patient's lot, but the manufacturer suggested that she is given two additional booster shots from a new lot. The patient stated that she has been sick on and off for the last month and a half and has seen one physician on one occasion and another on another occasion. The patient has intermittent problems with severe headaches, vomiting, intermittent diarrhea, stomach cramps, and general malaise. She is also feeling as if she had the flu. Reportedly the patient has seen a dermatologist with her nails and a culture was positive for a fungal infection. At times, the patient feels fatigued and mentally out of it. The patient was diagnosed with recurrent illnesses of unknown etiology and is to continue to be followed and treated by a dermatologist. The patient received a rabies vaccine on 4/23/04, the day of the office visit, and was to receive a second dose the following Monday. The decision where to go with the patient's recurrent flu viral like symptoms depend on lab test results and how the patient feels. This patient is the same patient as case 200401686 (dose 3). No further information is anticipated, this case is considered closed.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Back pain, Chest discomfort, Chills, Diarrhoea
Clinical narrative: From initial information received on 4/22/04 from a patient regarding an adverse event occurring in the USA, it was reported that a 36 year old female patient received her third pre-exposure IMOVAX RABIES vaccination because she handles raccoons, lot number W1419, administered in the right upper arm on 3/8/04. An unspecified amount of time later she experienced nausea, vomiting, headaches, chills, and worsening back pain. The patient is being followed up by her physician and is scheduled for blood work. The patient continued to experience headaches, swollen glands, chest tightness, and nausea and stated that she has been vomiting approximately two days per week. The patient received some relief with symptomatic treatment, but symptoms have recurred and are continuing. From additional information received on 5/18/04 from a health care professional, it was reported that the patient had three prophylactic rabies vaccine, but evidently the manufacturer had a problem with one lot where there was actually live viruses in the vaccine. The lot administered to the patient was not one of recalled lots but the manufacturer suggested the patient be administered two additional booster shots from a new lot. The patient had stated that she had been sick on and off for the last month and a half. She was seen by two physicians. She had intermittent problems with severe headaches, vomiting, intermittent diarrhea, stomach cramps and general malaise, feeling as if she had the flu. The patient was seen by a dermatologist for her nails. A culture was positive for fungal infection and she is now on Lamisil probably 500mg every day for the past three weeks. The patient also at times feel mentally out of it, fatigued. She was on Wellbutrin 150mg twice a day. The patient is to continue to be followed and treated by dermatologist. A rabies was given on 4/23/04 and a second one will be given on Monday, 4/26/04. Appropriate lab test are to be drawn including a pregnancy test. Depending on the results and how the patient feels, will decide further actions for her recurrent flu viral like symptoms.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Fatigue, Fungal infection, Headache, Influenza like illness, Lymphadenopathy
Clinical narrative: From initial information received on 4/22/04 from a patient regarding an adverse event occurring in the USA, it was reported that a 36 year old female patient received her third pre-exposure IMOVAX RABIES vaccination because she handles raccoons, lot number W1419, administered in the right upper arm on 3/8/04. An unspecified amount of time later she experienced nausea, vomiting, headaches, chills, and worsening back pain. The patient is being followed up by her physician and is scheduled for blood work. The patient continued to experience headaches, swollen glands, chest tightness, and nausea and stated that she has been vomiting approximately two days per week. The patient received some relief with symptomatic treatment, but symptoms have recurred and are continuing. From additional information received on 5/18/04 from a health care professional, it was reported that the patient had three prophylactic rabies vaccine, but evidently the manufacturer had a problem with one lot where there was actually live viruses in the vaccine. The lot administered to the patient was not one of recalled lots but the manufacturer suggested the patient be administered two additional booster shots from a new lot. The patient had stated that she had been sick on and off for the last month and a half. She was seen by two physicians. She had intermittent problems with severe headaches, vomiting, intermittent diarrhea, stomach cramps and general malaise, feeling as if she had the flu. The patient was seen by a dermatologist for her nails. A culture was positive for fungal infection and she is now on Lamisil probably 500mg every day for the past three weeks. The patient also at times feel mentally out of it, fatigued. She was on Wellbutrin 150mg twice a day. The patient is to continue to be followed and treated by dermatologist. A rabies was given on 4/23/04 and a second one will be given on Monday, 4/26/04. Appropriate lab test are to be drawn including a pregnancy test. Depending on the results and how the patient feels, will decide further actions for her recurrent flu viral like symptoms.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: From initial information received on 4/22/04 from a patient regarding an adverse event occurring in the USA, it was reported that a 36 year old female patient received her third pre-exposure IMOVAX RABIES vaccination because she handles raccoons, lot number W1419, administered in the right upper arm on 3/8/04. An unspecified amount of time later she experienced nausea, vomiting, headaches, chills, and worsening back pain. The patient is being followed up by her physician and is scheduled for blood work. The patient continued to experience headaches, swollen glands, chest tightness, and nausea and stated that she has been vomiting approximately two days per week. The patient received some relief with symptomatic treatment, but symptoms have recurred and are continuing. From additional information received on 5/18/04 from a health care professional, it was reported that the patient had three prophylactic rabies vaccine, but evidently the manufacturer had a problem with one lot where there was actually live viruses in the vaccine. The lot administered to the patient was not one of recalled lots but the manufacturer suggested the patient be administered two additional booster shots from a new lot. The patient had stated that she had been sick on and off for the last month and a half. She was seen by two physicians. She had intermittent problems with severe headaches, vomiting, intermittent diarrhea, stomach cramps and general malaise, feeling as if she had the flu. The patient was seen by a dermatologist for her nails. A culture was positive for fungal infection and she is now on Lamisil probably 500mg every day for the past three weeks. The patient also at times feel mentally out of it, fatigued. She was on Wellbutrin 150mg twice a day. The patient is to continue to be followed and treated by dermatologist. A rabies was given on 4/23/04 and a second one will be given on Monday, 4/26/04. Appropriate lab test are to be drawn including a pregnancy test. Depending on the results and how the patient feels, will decide further actions for her recurrent flu viral like symptoms.
Age: 21.0
Sex: F
Vaccine: HEPA, RAB
Symptoms: Abdominal pain, Diarrhoea, Nausea
Clinical narrative: From initial information received on 4/22/04 and additional information received on 4/23/04 from a physician regarding an adverse event occurring in the USA, it was reported that a 20 year old female patient received her third dose of pre-exposure IMOVAX RABIES, lot number unknown, and a first dose of HEPATITIS A VACCINE, lot number 1165M, administered in the left deltoid on 3/24/04. The next day, on 3/25/04, the patient experienced severe abdominal cramps, nausea, and diarrhea, which lasted for five to six days. The patient reportedly recovered from this experience. The physician stated that he did not feel the patient's adverse events were related to the vaccinations. From information received on 5/28/04 from a health professional, it was reported that all information has been received and no additional information is available at this time. No further information is anticipated, this case is considered closed.
Age: 47.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Difficulty in walking, Dizziness, Fatigue, Malaise
Clinical narrative: From initial information received on 4/21/04 from the patient regarding an adverse event occurring in the USA, it was reported that a 48 year old female patient received an IMOVAX RABIES vaccination, lot number unknown, administered in the deltoid on 9/20/03. The patient completed the series between 9/30/03 and 10/25/03. Since 9/23/03, the patient experienced malaise, fatigue, weakness, crawling and not walking, dizziness and severe fingertip twitching, but is afebrile. She has symptoms, but they are slowly resolving. From additional information received on 5/10/04 from a healthcare professional, it was reported that the patient had no illnesses at the time of vaccination. The complete patient address and the correct spelling of the city for the responsible physician were provided. It was not reported whether the patient recovered. No further information is anticipated, this case is considered closed.
Age: 47.0
Sex: F
Vaccine: RAB
Symptoms: Muscle twitching
Clinical narrative: From initial information received on 4/21/04 from the patient regarding an adverse event occurring in the USA, it was reported that a 48 year old female patient received an IMOVAX RABIES vaccination, lot number unknown, administered in the deltoid on 9/20/03. The patient completed the series between 9/30/03 and 10/25/03. Since 9/23/03, the patient experienced malaise, fatigue, weakness, crawling and not walking, dizziness and severe fingertip twitching, but is afebrile. She has symptoms, but they are slowly resolving. From additional information received on 5/10/04 from a healthcare professional, it was reported that the patient had no illnesses at the time of vaccination. The complete patient address and the correct spelling of the city for the responsible physician were provided. It was not reported whether the patient recovered. No further information is anticipated, this case is considered closed.
Age: 45.0
Sex: F
Vaccine: RAB
Symptoms: Influenza like illness, Pyrexia, Swelling
Clinical narrative: From initial information received on 4/26/04 from a health care professional, it was reported that a 44 year old female patient received her fourth dose of IMOVAX RABIES, administered IM, on 4/22/04 as part of a pre-exposure series. The lot number was not reported. Two days post-vaccination, on 4/24/04, the patient complained of a swollen arm, flu-like symptoms and a high fever. Reportedly the patient recovered from this experience. The patient has a history of Lyme disease. She received a total of three doses of IMOVAX RABIES as part of a pre-exposure series. The dates of vaccination were 9/30/03, 10/7/04, and 10/28/03. All three doses were administered IM and were lot number W1419-2. No adverse events were reported after receipt of the first three doses. From additional information received on 6/10/04 from a health care professional, the patient's full name, address, and telephone number were provided. A correction was made to the responsible physician's name. No additional medical information was provided. The vaccination date for IMOVAX RABIES administered on 10/7/03 was previously entered in error as 10/7/04. The correct date of administration is 10/7/03.
Age: 46.0
Sex: M
Vaccine: RAB
Symptoms: Pain
Clinical narrative: From initial information received on 4/28/04 from a health care facility regarding an adverse event occurring in the USA, it was reported that a 45 year old male patient received his third dose of post-exposure IMOVAX RABIES series, lot number X0582-2, administered IM in the left deltoid on 4/7/04. A few hours later, the patient experienced generalized aches lasting no longer than 24 hours, which then subsided. The same scenario was experienced with dose 4 on 4/10/04, dose 5 on 4/13/04, dose 6 on 4/20/04 and dose 7 on 4/27/04, lot numbers were not reported. The patient recovered from these events.
Age: 34.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Myalgia, Nausea, Similar reaction on previous exposure to drug, Vomiting
Clinical narrative: From initial information received on 4/30/04 from a nurse practitioner regarding an adverse event occurring in the USA, it was reported that a 33 year old female patient received her first dose of IMOVAX RABIES from a pre-exposure series, lot number W1419, route and site of administration not reported, on 1/20/04. That same day, the patient experienced headache, nausea, vomiting, and muscle aches. Reportedly, the symptoms lasted four days. The patient also received her second dose of IMOVAX RABIES and a third dose of the vaccine on unspecified dates. The lot numbers and routes and sites of administration were not reported. Reportedly, she experienced the same symptoms after the second and third dose, which lasted two days after each immunization. The patient's recovery status was not reported. From additional information received on 10/08/04 from a health care professional, it was reported that several unsuccessful attempts have been made by phone and certified mail to contact the patient for additional information. Per the reporter, the patient's recovery status is unknown. No further information is anticipated, this case is considered closed.
Age: 17.0
Sex: M
Vaccine: RAB
Symptoms: Diarrhoea, Headache, Migraine, Nausea, Vomiting
Clinical narrative: From initial information received on 5/10/04 from the patient's parent regarding an adverse event occurring in the USA, it was reported that a 17 year old male patient received his first dose of post-exposure IMOVAX RABIES on 3/27/04 and a second dose of IMOVAX RABIES on 3/30/04. Lot numbers, routes and sites of administration were not reported. 24 days after receipt of his second dose, the patient developed symptoms of headache, which progressively worsened to migraine, nausea, vomiting, and diarrhea. Reportedly, the symptoms lasted seven to ten days. Per mother, the patient is to see a physician for assessment, upon which either the physician or the mother will submit a report. Per recall, the patient is to receive three more doses of the vaccine. The patient's recovery status was not reported. From additional information received on 7/9/04, it was reported that the patient received the vaccines following an animal bite. The type of animal was not specified and it was not reported whether it was tested for rabies. He received the IMOVAX RABIES vaccination in an emergency room and was started on Augmentin on 3/30/04 by another physician. The lot numbers were not provided. It was not reported whether the patient continued the series or whether he recovered from these adverse events.
Age: 35.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Heart rate increased, Muscle twitching
Clinical narrative: From initial information received on 5/13/04 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a 35 year old female patient received her first dose of a pre-exposure IMOVAX RABIES series, lot number X0581, administered IM in the deltoid on 5/6/04 at 9:30 AM. Two hours later, at 11:30 AM, the patient experienced dizziness, muscle twitching and rapid heartbeat. She was not evaluated by a physician. The patient recovered from these events.
Age: 23.0
Sex: F
Vaccine: RAB
Symptoms: Disturbance in attention, Feeling cold, Hot flush, Pyrexia
Clinical narrative: From initial information received on 5/21/04 from a doctor's office regarding an adverse event occurring in the USA, it was reported that a 24 year old female patient received her first dose of a pre-exposure IMOVAX RABIES vaccination, lot number W0223 (route and site of administration unknown) on 9/4/03. One week later she complained of a fever of 102.6 degrees F, an inability to concentrate and hot and cold flashes. The patient received a second dose on 9/11/03, lot number W0223 (route and site of administration unknown), but never received her third. She had exposure on 12/30/03 and was given another dose, lot number W1419, (route and site of administration unknown) and experienced the same reactions within 24 hours. The patient recovered from these events.
Age: 49.0
Sex: F
Vaccine: RAB
Symptoms: Eyelid oedema, Face oedema, Headache, Injection site rash, Nausea
Clinical narrative: From initial information received on 5/26/04 from a health care professional, it was reported that a female patient, age not provided, received her second dose of IMOVAX RABIES vaccine on 5/22/04. Six hours post immunization, the patient complained of symptoms of headache, nausea, vomiting, fever of 102 degrees F, hives, a rash at the injection site, on her chest, neck and face and also swelling of her lips and eyelids. The patient's recovery status was not reported. From additional information received on 6/14/04 from a health care professional, the patient's date of birth was provided. The patient was 48 years old at the time of vaccination. The lot number of IMOVAX RABIES administered on 5/22/04 was X0581 and the vaccine was administered IM in the left deltoid. Concomitant medications at the time of vaccination included Celexa, Levoxyl, and Norvasc. The patient did not have any illnesses at the time of vaccination. Reportedly the patient recovered from these events. No further information is anticipated, this case is considered closed.
Age: 49.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia, Urticaria, Vomiting
Clinical narrative: From initial information received on 5/26/04 from a health care professional, it was reported that a female patient, age not provided, received her second dose of IMOVAX RABIES vaccine on 5/22/04. Six hours post immunization, the patient complained of symptoms of headache, nausea, vomiting, fever of 102 degrees F, hives, a rash at the injection site, on her chest, neck and face and also swelling of her lips and eyelids. The patient's recovery status was not reported. From additional information received on 6/14/04 from a health care professional, the patient's date of birth was provided. The patient was 48 years old at the time of vaccination. The lot number of IMOVAX RABIES administered on 5/22/04 was X0581 and the vaccine was administered IM in the left deltoid. Concomitant medications at the time of vaccination included Celexa, Levoxyl, and Norvasc. The patient did not have any illnesses at the time of vaccination. Reportedly the patient recovered from these events. No further information is anticipated, this case is considered closed.
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: From initial information received on 6/7/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 21 year old female patient received a second dose of IMOVAX RABIES, lot number W1419, on 11/21/03 as part of a post-exposure series. The route and site of administration were not reported. The same day, the patient experienced severe nausea, vomiting and diarrhea. The patient's recovery status was not reported. The reporter of this case is the same as for case 200402074.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia, Throat tightness
Clinical narrative: From initial information received on 6/17/04 from a registered nurse, regarding an adverse event occurring in the USA, it was reported that a 19 year old female patient received her fourth dose of IMOVAX RABIES, lot number X0581, administered in the left deltoid on 6/15/04 in the afternoon. The route of administration was not reported. It was not reported whether the patient received the vaccine as part of a pre- or post-exposure series. That same day, the patient developed soreness and swelling at the site of injection. That evening, she also experienced chills, shaking, and temperatures ranging from 97.8 to 99.0 degrees F. She also complained of a lump in her throat, but no difficulty in breathing was reported. The patient was instructed by the director of nursing at the reporting facility to apply a cold pack to the site of injection. She did not go to the emergency room. The patient's recovery status was not reported.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Tremor
Clinical narrative: From initial information received on 6/17/04 from a registered nurse, regarding an adverse event occurring in the USA, it was reported that a 19 year old female patient received her fourth dose of IMOVAX RABIES, lot number X0581, administered in the left deltoid on 6/15/04 in the afternoon. The route of administration was not reported. It was not reported whether the patient received the vaccine as part of a pre- or post-exposure series. That same day, the patient developed soreness and swelling at the site of injection. That evening, she also experienced chills, shaking, and temperatures ranging from 97.8 to 99.0 degrees F. She also complained of a lump in her throat, but no difficulty in breathing was reported. The patient was instructed by the director of nursing at the reporting facility to apply a cold pack to the site of injection. She did not go to the emergency room. The patient's recovery status was not reported.
Sex: U
Vaccine: RAB
Symptoms: Hypothyroidism, Medication error
Clinical narrative: From initial information received on 7/3/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a patient (age and gender not provided), received a dose of IMOVAX RABIES as part of a pre-exposure series in January or February 2004. The initial doses were part of the recalled lots and the patient had to receive two more doses on unspecified dates. No lot numbers were reported for any of the products. An unspecified amount of time later, the patient developed hypothyroidism. No specifics were provided regarding the adverse event nor the patient's recovery status.
Sex: F
Vaccine: RAB
Symptoms: Eyelid oedema
Clinical narrative: From initial information received on 8/3/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a female patient (age and date of birth not reported) received a dose of IMOVAX RABIES as part of a pre-exposure series on an unspecified date. The lot number, route and site of administration were not reported. An unspecified amount of time later, the patient developed eyelid swelling and sores on her nose that would not resolve. It was not reported whether the patient recovered from these events. The reporter had minimal information regarding this case.
Age: 1.09
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Coma, Convulsion
Clinical narrative: Pt brought to urgent care, non responsive, seizure-like behavior. Pt transported by ambulance to hospital ER, then another hospital for overnight observation.
Age: 35.0
Sex: M
Vaccine: HEPA, IPV, MMR, TD, TYP
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Fatigue, Hepatic enzyme abnormal
Clinical narrative: From initial information received on 04May05 from a literature report regarding an adverse event, it was reported that a 35 year old male pt received multiple immunization as part of preparation for deployment. The vaccinations consisted of Diphtheria and tetanus, tuberculin PPD, Typhoid vaccine, oral polio, hep A, MMR. The trade names, manf, lot numbers, routes and sites of admin were not reported. The vaccines were all administered on a single occasion on an unspecified date. Several days post immunization, the pt started to feel ill with fatigue, malaise, and general flu-like symptoms that progressed over several days. One week later, he presented to his primary care physician. The pt had no significant surgical history or prior transfusions. The pt was currently taking a beta blocker and diuretic for hypertension. He denied any recent ingestion of over the counter supplements. The pt denied any family history of liver disorders or autoimmune diseases. He denied a smoking history and his alcohol intake was infrequent small quantities. The pt denied any allergies to medications or food. Physical exam was unremarkable. At presentation, the pt's lab tests were significant for elevated liver associated enzymes with an aspartate aminotransferase (AST) level of 1361U/L, alanine aminotransferase (ALT) of 2656U/L, and alkaline phosphatase of 152u/L. Total bilirubin was 4.8mg/dL, with a direct bilirubin component of 3.1mg/dl. Additional lab tests included total protein of 7.8mg/dl, albumin of 4.2mg/dl, and y-glutamyl transpeptidase biopsy performed one month after initial presentation showed severe chronic hepatitis with widespread parenchymal injury, chronic portal inflammation, numerous plasma cells, and piecemeal necrosis. These findings were suggestive of AIH. Steroid therapy was initiated, and after two months of therapy, the liver enzymes responded well, with AST decreasing to 46u/L and ALT to 73u/L. Azathioprine was added to the medical regimen at two months post steroid therapy and the liver enzymes increased, AST to 895u/L and ALT to 1922u/L, after seven weeks of therapy. Repeat autoimmune markers showed ASMA of 1;80 and negative ANA, with IgG elevated, at 1590mg/dl. Endoscopic retrograde cholangiopancreatography was normal. Azathioprine was discontinued, steroids were increased, and tacrolimus was initiated. The medical regimen over the next five years consisted of prednisone, 10-20mg daily, and tacrolimus, 1mg twice a day. Attempts to taper the prednisone lower than 10 mg caused significant elevations in AST and ALT. A repeat biopsy performed five years following presentation showed moderate inflammatory activity consisting of plasma cells with mild periportal fibrosis. It was not reported whether this pt recovered from these events.
Age: 35.0
Sex: M
Vaccine: HEPA, IPV, MMR, TD, TYP
Symptoms: Hepatitis, Influenza like illness, Injury, Laboratory test abnormal, Malaise
Clinical narrative: From initial information received on 04May05 from a literature report regarding an adverse event, it was reported that a 35 year old male pt received multiple immunization as part of preparation for deployment. The vaccinations consisted of Diphtheria and tetanus, tuberculin PPD, Typhoid vaccine, oral polio, hep A, MMR. The trade names, manf, lot numbers, routes and sites of admin were not reported. The vaccines were all administered on a single occasion on an unspecified date. Several days post immunization, the pt started to feel ill with fatigue, malaise, and general flu-like symptoms that progressed over several days. One week later, he presented to his primary care physician. The pt had no significant surgical history or prior transfusions. The pt was currently taking a beta blocker and diuretic for hypertension. He denied any recent ingestion of over the counter supplements. The pt denied any family history of liver disorders or autoimmune diseases. He denied a smoking history and his alcohol intake was infrequent small quantities. The pt denied any allergies to medications or food. Physical exam was unremarkable. At presentation, the pt's lab tests were significant for elevated liver associated enzymes with an aspartate aminotransferase (AST) level of 1361U/L, alanine aminotransferase (ALT) of 2656U/L, and alkaline phosphatase of 152u/L. Total bilirubin was 4.8mg/dL, with a direct bilirubin component of 3.1mg/dl. Additional lab tests included total protein of 7.8mg/dl, albumin of 4.2mg/dl, and y-glutamyl transpeptidase biopsy performed one month after initial presentation showed severe chronic hepatitis with widespread parenchymal injury, chronic portal inflammation, numerous plasma cells, and piecemeal necrosis. These findings were suggestive of AIH. Steroid therapy was initiated, and after two months of therapy, the liver enzymes responded well, with AST decreasing to 46u/L and ALT to 73u/L. Azathioprine was added to the medical regimen at two months post steroid therapy and the liver enzymes increased, AST to 895u/L and ALT to 1922u/L, after seven weeks of therapy. Repeat autoimmune markers showed ASMA of 1;80 and negative ANA, with IgG elevated, at 1590mg/dl. Endoscopic retrograde cholangiopancreatography was normal. Azathioprine was discontinued, steroids were increased, and tacrolimus was initiated. The medical regimen over the next five years consisted of prednisone, 10-20mg daily, and tacrolimus, 1mg twice a day. Attempts to taper the prednisone lower than 10 mg caused significant elevations in AST and ALT. A repeat biopsy performed five years following presentation showed moderate inflammatory activity consisting of plasma cells with mild periportal fibrosis. It was not reported whether this pt recovered from these events.