chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: TD
Symptoms: Abdominal pain, Drug administered at inappropriate site, Incorrect route of drug administration, Urticaria
Clinical narrative: Initial report received on 05/Jun/2006 from a health care professional. A 19-year-old female patient who was recovering from nipple piercing had received a subcutaneous injection of Decavac, lot number U1587BA, in the stomach on 04/Jun/2006 at 07;30 am. Fifteen hours post-vaccination, the patient developed a sore abdomen with walts. The patient returned to the emergency room for evaluation. No relevant diagnostic tests or laboratory data were collected. At the time of this report, it was unknown if the patient had recovered from these adverse events.
Sex: F
Vaccine: TD
Symptoms: Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: Initial report received on 20/Jun/2006 from a  health care professional. A female patient with a history of  asthma, gastroesophageal reflux disease (GERD) and allergy to sulfa drugs had received an intramuscular injection of Decavac, lot number U1730EA, in the left deltoid on 14/Jun/2006. Five days post-immunization, the patient developed myalgia and paresthesia in the left arm, and numbness in the left hand. She was medically evaluated and prescribed Ancef, Ice, and physical therapy. Reportedly, no relevant diagnostic tests/laboratory data were collected. The patient last received a Tetanus Diphtheria vaccination on 06/Jun/1991. The patient's recovery status was reported as unknown. The reporter for this case is the same as for case 2006-01545.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity
Clinical narrative: A 58-year-old female patient with past medical history of hypothyroidism, depression and allergy to certain medications including Thorazine, had received a dose of Decavac, lot number U1221CA, in the left deltoid on 20/May/2006. The route of administration of the vaccine was not reported. Approximately five days post-immunization on 25/May/2006, the patient developed dull aching pain in the lower extremities. Her pain was still persisting two weeks later. Treatment received was not reported. The recovery status of the patient was reported as not recovered. Follow-up information received on 07/Aug/2006. Per the reporter, it is unknown if the patient had received any previous vaccinations of Tetanus or Diphtheria. The reason the patient received the Decavac was that she had a lacerated finger. No relevant diagnostic tests/laboratory date were performed. After receiving the Decavac injection on 20/May/2006, the patient went out of state and later called this reporter to report the dull aching pain in the lower extremities. The patient was not seen in this facility after this. Reportedly, the patient's recovery status is unknown. No further information is expected. A corrective version was created on 02 April 2007 with the LRD of the previous version (07 August 2006) in order to document "yes" to medically confirmed in the record.
Age: 28.0
Sex: M
Vaccine: TD
Symptoms: Injection site swelling, Swelling
Clinical narrative: Initial report was received on 04/Jul/2006, and follow-up information was received on 15/Sep/2006 from a physician in the U.S.A. A 28-year-old male patient with no current illnesses had received an intramuscular dose of Decavac, lot number U178GA, in the left deltoid, on 31/Jul/2006 in the morning. The expiration date of the Decavac was reported as 12/Dec/2007. Three days post-immunization, the patient reported swelling under his "deltoid". He was medically evaluated, and the physician stated the swelling was "not lymph node swelling" The patient was to be seen as necessary. Treatments received were not reported. From follow-up information received on 15/Sep/2006, the patient also had swelling under the left armpit, The onset date of the swelling under the left armpit was not reported. The previously reported swelling under the "deltoid" was reported as not being red or tender. At the time of this report, the patient had recovered from these adverse events.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Initial report received on 07/Aug/2006 from a health care professional. A 35-year-old female patient with no current illnesses, and a history of allergy to codeine, migraine headaches, seizures, and gastroesophageal reflux had received a left deltoid dose of Decavac, lot number U1621BA, on 4/Aug/2006. The route of administration was not reported. One to two days later, she developed swelling, tenderness, and redness approximately four inches in diameter, and itching. The patient required medical evaluation but the treatments or diagnostic testing/laboratory data were not provided. The recovery status of the patient was reported as not recovered. The reporter for this case is the same as for case 2006-02088.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Pruritus, Swelling, Tenderness
Clinical narrative: Initial report received on 07/Aug/2006 from a health care professional. A 37-year-old female patient with no illnesses and a history of hypertension had received a right deltoid dose of Decavac in 2006. The route of administration , lot number, and specific date of vaccination were not reported. Approximately 48 hours post-immunization, the patient developed swelling, tenderness, and extensive redness approximately three inches in diameter and itching. The Decavac may have been administered with a 5/8 or 1/2 inch needle. Treatment received was not reported. Reportedly, the patient recovered completely in approximately one week. The reporter for this case is the same as for case 2006-02087.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Chicken Pox
Sex: F
Vaccine: TD
Symptoms: Injection site infection
Clinical narrative: Initial report received on 09/Aug/2006 from another manufacturer, report number 1-72861229, (initial report was form the patient who is also a physician). An adult patient (gender and age not specified) had self-administered an injection of Decavac, lot number not reported, on an unspecified date. Route and site of administration were not reported. At an unspecified amount of time post-vaccination, the patient developed an injection site infection. Recovery status was not reported. Additional medically relevant information not provided.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Contusion, Full blood count normal, Injection site pain, Injection site swelling, Liver function test normal
Clinical narrative: Initial report received on 21/Aug/2006 from a health care professional. A 55-year-old female, with a history of rheumatoid arthritis, had received an intramuscular, left deltoid injection of Decavac, lot number U1786DA, on 14/Aug/2006. The vaccination was the patient's ten year booster. Seven days post-vaccination, the patient developed bruising over her left arm. tenderness and swelling at the injection site. She was examined " in the office"  on the same day. Liver function tests and a CBC were ordered, but results were not provided. Concomitant medications included methotrexate, Advil folic acid and Tylenol # 3. At the time of this report, the patient had not recovered. Follow-up information received on 20/Sep/2006 from a physician. The event involved the "mediolateral aspect of the upper arm and up to left medial epicondyle," The reporter also notes "associated with severe pain." The patient was subsequently examine by a physician. CBC and liver function test were normal. The onset date for the event was amended to 19/Aug/2006, five days post-vaccination. The patient recovered in three weeks from the time of vaccination.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Pain
Clinical narrative: Initial report received on 21/Aug/2006 from a health care professional. A 55-year-old female, with a history of rheumatoid arthritis, had received an intramuscular, left deltoid injection of Decavac, lot number U1786DA, on 14/Aug/2006. The vaccination was the patient's ten year booster. Seven days post-vaccination, the patient developed bruising over her left arm. tenderness and swelling at the injection site. She was examined " in the office"  on the same day. Liver function tests and a CBC were ordered, but results were not provided. Concomitant medications included methotrexate, Advil folic acid and Tylenol # 3. At the time of this report, the patient had not recovered. Follow-up information received on 20/Sep/2006 from a physician. The event involved the "mediolateral aspect of the upper arm and up to left medial epicondyle," The reporter also notes "associated with severe pain." The patient was subsequently examine by a physician. CBC and liver function test were normal. The onset date for the event was amended to 19/Aug/2006, five days post-vaccination. The patient recovered in three weeks from the time of vaccination.
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Medication error, Swelling, Tenderness, Wrong drug administered
Clinical narrative: Initial report received on 21/Sep/2006 from the patient's parent. A 22-year-old female patient with no current illnesses, no known allergies, and a history  of depression had received a 0.1 mL intradermal injection of Decavac, lot number U1786DA in the left forearm, on 18/Sep/2006 at 08;00 am, instead of Tubersol 5 TU. Within hours post-immunization, the patient developed redness, swelling and tenderness that became worse over the next 24 hours. The patient had also developed red streaks going up her arm. She was evaluated by a physician and treated with Keflex and Kenalog. At the time of this report, the patient had not recovered from these adverse events. Follow-up information received from a health care professional, on 17 November 2006, The reporter left a message to the patient, who did not call back. The reporter updated that the adverse events occurred on the forearm and noted that " streak to AC". Follow-up information received from a health care professional, on 21 December 2006. The reporter clarified the previously reported term "streak to AC" as a streak to the "antecubital space". No further information is expected.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Cluster of 3 patients (individual patient identification provided) experienced injection site reaction with Decavac (lot number U1587BA) received from a nurse in the USA on 16 November 2006. A 37-year-old female patient developed redness, swelling, pain and itchiness at the site, 3 hours after she received an injection of Decavac (lot number U1587BA, routed of administration not reported) in the left arm on 03 November 2006. The symptoms lasted for 1 week. The patient recovered. Follow-up information received on 05 March 2007 from a health care professional. Decavac was administered intramuscularly. Additional medically relevant information was not reported. This case has the same reporter as case 2006-03127, 2006-03128, 2006-031129.
Age: 51.0
Sex: F
Vaccine: TD
Symptoms: Injection site reaction, Mass, Pruritus
Clinical narrative: Cluster of 3 patients (individual patient identification provided) experienced injection site reaction with Decavac (lot number U1587BA) received from a nurse in the USA on 16 November 2006. A 51 year old, female patient (who is also a physician) developed a "large lump, not red very itchy" after she received an injection of Decavac (lot number U1587BA, route of administration not reported) in the left are on 03 November 2006. The patient recovered. Follow-up information received on 05 March 2007 from the patient who is also a health care professional. Decavac was administered intramuscularly. No other vaccines were administered on 03 November 2006. This case has the same reporter as cases 2006-03126, 2006-03128, 2006-03129.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Body temperature increased, Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Cluster of 3 patients (individual patient identification provided) experienced injection site reaction with Decavac (lot number U1587BA) received from a nurse in the USA on 16 November 2006. A 56 year old female patient developed a large lump, hot, red, itchy after she received an injection of Decavac (lot number U1587BA (corrected), route of administration not reported) in the left arm on 03 November 2006. She also had nauses and a temperature of 99 (degrees). At the time of vaccination, she had osteoarthritis, hypothyroid and pancreatitis. The patient recovered. This case has the same reporter as cases 2006-03126, 2006-03127, 2006-03129. Corrective new version was created on 22 November 2006. No additional information was received. Follow-up information received on 05 March 2007 from a health care professional. Decavac was administered intramuscularly on 03 November 2006.
Age: 55.0
Sex: F
Vaccine: TD
Symptoms: Nausea
Clinical narrative: Cluster of 3 patients (individual patient identification provided) experienced injection site reaction with Decavac (lot number U1587BA) received from a nurse in the USA on 16 November 2006. A 56 year old female patient developed a large lump, hot, red, itchy after she received an injection of Decavac (lot number U1587BA (corrected), route of administration not reported) in the left arm on 03 November 2006. She also had nauses and a temperature of 99 (degrees). At the time of vaccination, she had osteoarthritis, hypothyroid and pancreatitis. The patient recovered. This case has the same reporter as cases 2006-03126, 2006-03127, 2006-03129. Corrective new version was created on 22 November 2006. No additional information was received. Follow-up information received on 05 March 2007 from a health care professional. Decavac was administered intramuscularly on 03 November 2006.
Age: 36.0
Sex: F
Vaccine: TD
Symptoms: Exfoliative rash, Psoriasis, Rash erythematous
Clinical narrative: Initial report received from a health care professional in the USA on 17 November 2006. A 36 year old, female patient (with a medical history of eczema, high stress and an allergy to penicillin) developed a red, scaly rash on her legs, arms and torso, approximately 1 week after she received an intramuscular injection of Decavac (lot number U1789BA) in the left deltoid on 26 October 2006. The reporter stated the rash "appear to be areas of inflamed psoriasis", where the majority was on the legs and lower arm. The patient denied a local reaction at the injection site. She had strep throat at the  time of vaccination. At the time of the report, the patient had not recovered. Follow-up information received on 09 January 2007. The patient was taking a Z-Pak concomitantly, not Z-rock as previously reported. The patient's adverse event was additional treated with Benadryl, Prednisone, Zyrtec, Batamethasone 0.05 % ointment, and Drithrocreme 0.5%. IF the subject's symptoms persist. she is to see a dermatologist. At the time of this report, the patient had not recovered. Follow-up information received on 05 February 2007 from a health care professional. The psoriasis resolved as of December 2006.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Injection site bruising, Injection site discharge, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Initial report received from a health care professional in the USA on 04 December 2006. A 35 year old female patient complained of pain down into her elbow, bruising around the site, 5 days after she received Decavac (lot number U1786CA), intramuscularly in the right deltoid on 25 October 2006. The patient received a "Flu shot" on 24 October 2006. On 01 November 2006, the patient was still in pain. On 20 November 2006, she complained on pus coming out of injection site. On 22 November, a prescription was given for pain. At the time of vaccination, she was being followed-up for her thyroid. Follow-up information received on 12 January 2007 from a health care professional. The patient complained of "a lot of pain in the arm where TD was given" Her right upper arm was red and indurated, and very tender to palpation. There was no fluctuance and no streaks. She was treated with Vicodin 5-500 mg every six hours as needed for pain. During a general encounter visit on 05 January 2007, it was noted that the patient was doing much better and had not complain of arm pain. She recovered from the events. Additional information is not expected. This case has the same reporter as case 2006-03339.
Age: 35.0
Sex: F
Vaccine: TD
Symptoms: Pain in extremity
Clinical narrative: Initial report received from a health care professional in the USA on 04 December 2006. A 35 year old female patient complained of pain down into her elbow, bruising around the site, 5 days after she received Decavac (lot number U1786CA), intramuscularly in the right deltoid on 25 October 2006. The patient received a "Flu shot" on 24 October 2006. On 01 November 2006, the patient was still in pain. On 20 November 2006, she complained on pus coming out of injection site. On 22 November, a prescription was given for pain. At the time of vaccination, she was being followed-up for her thyroid. Follow-up information received on 12 January 2007 from a health care professional. The patient complained of "a lot of pain in the arm where TD was given" Her right upper arm was red and indurated, and very tender to palpation. There was no fluctuance and no streaks. She was treated with Vicodin 5-500 mg every six hours as needed for pain. During a general encounter visit on 05 January 2007, it was noted that the patient was doing much better and had not complain of arm pain. She recovered from the events. Additional information is not expected. This case has the same reporter as case 2006-03339.
Age: 59.0
Sex: M
Vaccine: TD
Symptoms: Adverse event, Anorexia, Arthralgia, Chills, Dysgeusia
Clinical narrative: Initial report received from a patient in the USA on 18 December 2006. A 59 year old, male patient (with a history of allergies to PCN and Keflex, mild hypertension and type II diabetes) complained of severe headache, fever (103-104F) for 8 days and chills, in the evening after he received an injection of Decavac (lot number U1704BA, route of administration not reported) in the left deltoid on 08 December 2006. He also developed loss of appetite and complained of metallic taste in mouth, severe pain in knees "or" ankles and a rash from head to toe. He received a previous dose of Decavac in 1989. At the time of the report, the fever resolved and the patient reported that he has not recovered. Follow-up information received on 22 January 2007. The patient received the decavac vaccination at 11:00 am on 08 December 2006, and the onset of the adverse events began at 10:00 pm on 08 December 2006. The recovery status of the patient was not reported.
Age: 59.0
Sex: M
Vaccine: TD
Symptoms: Headache, Pyrexia, Rash generalised
Clinical narrative: Initial report received from a patient in the USA on 18 December 2006. A 59 year old, male patient (with a history of allergies to PCN and Keflex, mild hypertension and type II diabetes) complained of severe headache, fever (103-104F) for 8 days and chills, in the evening after he received an injection of Decavac (lot number U1704BA, route of administration not reported) in the left deltoid on 08 December 2006. He also developed loss of appetite and complained of metallic taste in mouth, severe pain in knees "or" ankles and a rash from head to toe. He received a previous dose of Decavac in 1989. At the time of the report, the fever resolved and the patient reported that he has not recovered. Follow-up information received on 22 January 2007. The patient received the decavac vaccination at 11:00 am on 08 December 2006, and the onset of the adverse events began at 10:00 pm on 08 December 2006. The recovery status of the patient was not reported.
Sex: U
Vaccine: TD
Symptoms: Injection site nodule
Clinical narrative: Cluster of 5 cases out of an unspecified number of vaccines that received Decavac, lot number U1704CA and experienced hard nodule at injection site. Initial report received on 11 January 2007, form a healthcare professional in USA. 5 unidentifiable patients received in December 2006 and intramuscular dose of Decavac (lot number U1704CA), into the deltoid and experienced hard nodule at injection site after vaccination. B-D needle, 1 inch was used to administrate the vaccine. At the time of the report (11 January 2007), the patients had not recovered. No other information was provided. The reporter is the same as in case 2007-00091
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: A 65 year old  female received Decavac (lot number U1704CA) on 12 December 2006. A day later she experienced at injection site erythema and itch and on 11 January 2007 it developed into a painful 2 cm nodule, which affected the movement of the arm. No treatment was reported. At the time of the report (11 January 2007) the nodule and redness persisted and the patient had not recovered. The patient's medical history included : Hypertension (HTN), severe osteoarthritis (OA), subclavian DVT (Deep vain thrombosis), depression and total abdominal hysterectomy (TAH). concomitant vaccines and prior exposure were not reported. The reporter is the same as in case 2006-00090.
Age: 31.0
Sex: M
Vaccine: RAB
Symptoms: Adverse event, Tremor
Clinical narrative: Initial information received on 31/Aug/2006 from a company representative. This information was reported in the context of a litigation case and the initial information was reported by a health care professional. A 31 year old male patient received an initial dose of Imovax Rabies lot number W1419-3 on 16/Mar/2004, as part of post-exposure prophylaxis following a bat bite on the patient's left middle finger. It was not reported whether the bat was tested for rabies. On 14/Apr/2004, the patient reported that he had been experiencing "shakes" and the patient was administered the subsequent dose. It was not reported whether the patient recovered from the event. This patient experienced a subsequent adverse event of "jaw chattering" following the administration of the second dose of Imovax Rabies, which is reported in case 2006-02337.
Age: 31.0
Sex: M
Vaccine: RAB
Symptoms: Trismus
Clinical narrative: Initial information received on 31/Aug/2006 from a company representative.  This information was reported in the context of a litigation case, and the initial information was reported by a health care professional. A 31 year old male patient received a second dose of Imovax Rabies, lot number W1275 (invalid lot number) on 14/Apr/2004, as part of post-exposure prophylaxis following a bat bite on the patient's left middle finger. It was not reported whether the bat was tested for rabies. On 19/Apr/2004, the patient reported that he had been experiencing "jaw chattering" since receiving the dose on 14/Apr/2006. There was no mention of the patient being treated for the symptoms. It was not reported whether the patient continued with the rabies series or whether he recovered from the event. This patient experienced a previous adverse event of "shakes" following the administration of the first dose of Imovax Rabies which is reported in case 2006-02315.
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Hypoaesthesia, Rash pruritic
Clinical narrative: Initial report receive on 27 November 2006 from a healthcare professional in USA. A 22 year old female patient received on 22 November 2006, first dose of Imovax (lot number 20905-2), intramuscular into the left arm. The patient, an anmimal worker received Imovax as pre exposure series.  On 23 November 2006, a day post vaccination, the patient developed itchy rash over her chest and also numbness. The patient was treated with Benadryl. The events resolved within 3 days and the patient recovered. The patient's medical history was not reported. Concomitant vaccines were not reported. Follow up information received on 11 January 2007. The patient received the vaccine in the morning of 22 Novermber 2006 and the onset of symptoms was in the morning of 23 November 2006. She experienced numbness and an itchy rash on her anterior chest wall. She did not have any medical history. At the time of the vaccination, she was not on any medications nor did she have any illness. She did not have any other immunization within 4 weeks of receiveing Imovax. She did not complete the series of rabies vaccinations.
Age: 45.0
Sex: M
Vaccine: RAB
Symptoms: Antibody test abnormal, No therapeutic response
Clinical narrative: Initial report received from a pharmacist on 30 January 2007. A patient (age and gender not reported) received a booster dose of Imovax (lot number "Z02034", route and site of administration not reported) on 07 August 2006. Her titer was checked and was "0.35". The patient received a pre-exposure rabies series with Rabavert (lot number 334011) in June 2004. Her titer was checked in June 2006 and was "0.43". No additional information was provided. Follow-up information received on 05 March 2007. The patient completed her original rabies series on 25 June 2004. Her first booster dose of Imovax (lot number Z03016) was given in the right deltoid. Her second booster dose of Imovax was given on 13 February 2007 in the left deltoid. Her rabies titer was measured on 22 June 2006 as 0.43 IU/mL (20.5 post-vaccination) and her rabies titer was measured again on 19 January 2007 as 0.35 IU/mL. The reporter mentioned the titer was even lower after booster #1. They are awaiting the results of the repeat titer after the second booster on 13 February 2007. The results should be available in  6-8 weeks. She was taking Cymbalta and Lisinopril. She had no illness at the item of vaccination.
Age: 68.0
Sex: F
Vaccine: RAB
Symptoms: Pain in extremity
Clinical narrative: Initial report received on 22/Sep/2006 from the patient. A 68 year old female patient had received an intramuscular, left arm, fifth dose injection of Imovax Rabies, lot number unknown, on 07/Sep/2006. The patient had experienced a "bat exposure." No information was reported regarding testing of the animal. Two days post vaccination, the patient experienced pain in her left arm and shoulder. Per the reporter, the event did not require examination by a physician. Other medications included extra-strength Tylenol and coumadin. Past medical history was reported as torn rotator cuff. At the time of this report, the patient had not recovered. This patient had experienced a separate event of pain and weakness in her right arm following dose four that is described in case 2006-02510.
Age: 68.0
Sex: F
Vaccine: RAB
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Initial report received on 22/Sep/2006 from the patient. A 68 year old female patient had received an intramuscular, right arm, fourth dose injection of Imovax Rabies,lot number unknown, on 24/Aug/2006. At an unspecified time post-vaccination, the patient experienced pain and weakness in her right arm. Recovery status for this event was not reported. This patient had a separate event of pain in the shoulder and arm following the fifth dose of Imovax that is recorded in case 2006-02504.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Headache, Injection site erythema, Injection site swelling, Migraine, Nausea
Clinical narrative: Initial information received on 23 October 2006 from the patient's parent. A 20 year old female patient received a first dose of Imovax Rabies, lot number not reported, intramuscularly in the left deltoid on 20 August 2006 following exposure to a bat. Four hours post vaccination, the patient developed redness and swelling at the injection site. She also had a fever of 102 degrees Fahrenheit, headache and nausea. The symptoms at the injection site were treated with ice packs. The patient subsequently received a second dose of Imovax Rabies, lot number reported, administered intramuscualry in the left deltoid on 23 August 2006. She received a third dose of Imovac Rabies, lot number Z0316-2, administered intramuscularly in the right deltoid on 27 August 2006. On 03 September 2006, ,the patient received a fifth dose of Imovax rabies, lot number Z0316-2, administered intramuscularly on 17 September 2006 in the left deltoid. The patient developed the same signs and symptoms after each subsequent dose as she experienced following dose one. The patient recovered from the events. Follow-up information received from the patient's mother on 12 December 2006. In additions to the previously aforementioned vaccines, the patient received a dose of Rabies Immunoglobulin (manufacture and lot number not reported) on 20 August 2006. As per the patient's mother, the patient is "suffering from chronic migraine headaches (daily basis)". The patient's recovery status has been changed to not recovered. No other information was provided at this time. The reported of this case is the same as for case 2006-02768.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia, Similar reaction on previous exposure to drug
Clinical narrative: Initial information received on 23 October 2006 from the patient's parent. A 20 year old female patient received a first dose of Imovax Rabies, lot number not reported, intramuscularly in the left deltoid on 20 August 2006 following exposure to a bat. Four hours post vaccination, the patient developed redness and swelling at the injection site. She also had a fever of 102 degrees Fahrenheit, headache and nausea. The symptoms at the injection site were treated with ice packs. The patient subsequently received a second dose of Imovax Rabies, lot number reported, administered intramuscualry in the left deltoid on 23 August 2006. She received a third dose of Imovac Rabies, lot number Z0316-2, administered intramuscularly in the right deltoid on 27 August 2006. On 03 September 2006, ,the patient received a fifth dose of Imovax rabies, lot number Z0316-2, administered intramuscularly on 17 September 2006 in the left deltoid. The patient developed the same signs and symptoms after each subsequent dose as she experienced following dose one. The patient recovered from the events. Follow-up information received from the patient's mother on 12 December 2006. In additions to the previously aforementioned vaccines, the patient received a dose of Rabies Immunoglobulin (manufacture and lot number not reported) on 20 August 2006. As per the patient's mother, the patient is "suffering from chronic migraine headaches (daily basis)". The patient's recovery status has been changed to not recovered. No other information was provided at this time. The reported of this case is the same as for case 2006-02768.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Pt developed a rash, redness and itching in entire R arm
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Unknown pregnancy at time of vaccine about 6 weeks pregnant.  See form - Pt. unknown pregnant at time vaccine given.  Pt. didn't have an adverse reaction.
Age: 20.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Drug exposure during pregnancy, Metrorrhagia, Urine human chorionic gonadotropin positive
Clinical narrative: Unknown pregnancy at time of vaccine about 6 weeks pregnant.  See form - Pt. unknown pregnant at time vaccine given.  Pt. didn't have an adverse reaction.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Agitation, Barium enema, Haematochezia, Intussusception, Lethargy
Clinical narrative: Information has been received concerning a 4 month old patient who on 13-DEC-2006 was vaccinated with the second dose PO of Rotateq (Lot # 653755/0319F). On 26-FEB-2007 the patient developed intussusception which required unspecified surgery. Upon internal review, Intussusception which required surgery was considered an other important medical event. Further information has been received concerning a 4 month old male with a heart murmur who on 13-DEC-2006 was vaccinated with the third dose of Rotateq (Lot # 653755/0319F). Other vaccines administered the same day included Tripedia second dose LOT# U1891BA, PedvaxHib second dose, IPV lot # Y1032, Prevnar Lot #B08675K second dose. Other concomitant medications included Polytrim. On 26-FEB-2007, 76 days after vaccination the patient had signs of alternating lethargy, fussiness and a bloody stool. It was reported that the patient was diagnosed with intussusception by barium; enema which failed to reduce it. The patient went to surgery and the appendix was lead point. It was reported that it was doubtful this was due to Rotateq because it was two months after dose and appendix lead point. The patient was reported to be recovered. Intussusception was determined to be life threatening. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Surgery
Clinical narrative: Information has been received concerning a 4 month old patient who on 13-DEC-2006 was vaccinated with the second dose PO of Rotateq (Lot # 653755/0319F). On 26-FEB-2007 the patient developed intussusception which required unspecified surgery. Upon internal review, Intussusception which required surgery was considered an other important medical event. Further information has been received concerning a 4 month old male with a heart murmur who on 13-DEC-2006 was vaccinated with the third dose of Rotateq (Lot # 653755/0319F). Other vaccines administered the same day included Tripedia second dose LOT# U1891BA, PedvaxHib second dose, IPV lot # Y1032, Prevnar Lot #B08675K second dose. Other concomitant medications included Polytrim. On 26-FEB-2007, 76 days after vaccination the patient had signs of alternating lethargy, fussiness and a bloody stool. It was reported that the patient was diagnosed with intussusception by barium; enema which failed to reduce it. The patient went to surgery and the appendix was lead point. It was reported that it was doubtful this was due to Rotateq because it was two months after dose and appendix lead point. The patient was reported to be recovered. Intussusception was determined to be life threatening. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Agitation neonatal, Appendix disorder, Barium enema, Cardiac murmur, Haematochezia
Clinical narrative: Information has been received concerning a 4 month old patient who on 13-DEC-2006 was vaccinated with the second dose PO of Rotateq (Lot # 653755/0319F). On 26-FEB-2007 the patient developed intussusception which required unspecified surgery. Upon internal review, Intussusception which required surgery was considered an other important medical event. Further information has been received concerning a 4 month old male with a heart murmur who on 13-DEC-2006 was vaccinated with the third dose of Rotateq (Lot # 653755/0319F). Other vaccines administered the same day included Tripedia second dose LOT# U1891BA, PedvaxHib second dose, IPV lot # Y1032, Prevnar Lot #B08675K second dose. Other concomitant medications included Polytrim. On 26-FEB-2007, 76 days after vaccination the patient had signs of alternating lethargy, fussiness and a bloody stool. It was reported that the patient was diagnosed with intussusception by barium; enema which failed to reduce it. The patient went to surgery and the appendix was lead point. It was reported that it was doubtful this was due to Rotateq because it was two months after dose and appendix lead point. The patient was reported to be recovered. Intussusception was determined to be life threatening. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Irritability, Lethargy, Surgery, X-ray
Clinical narrative: Information has been received concerning a 4 month old patient who on 13-DEC-2006 was vaccinated with the second dose PO of Rotateq (Lot # 653755/0319F). On 26-FEB-2007 the patient developed intussusception which required unspecified surgery. Upon internal review, Intussusception which required surgery was considered an other important medical event. Further information has been received concerning a 4 month old male with a heart murmur who on 13-DEC-2006 was vaccinated with the third dose of Rotateq (Lot # 653755/0319F). Other vaccines administered the same day included Tripedia second dose LOT# U1891BA, PedvaxHib second dose, IPV lot # Y1032, Prevnar Lot #B08675K second dose. Other concomitant medications included Polytrim. On 26-FEB-2007, 76 days after vaccination the patient had signs of alternating lethargy, fussiness and a bloody stool. It was reported that the patient was diagnosed with intussusception by barium; enema which failed to reduce it. The patient went to surgery and the appendix was lead point. It was reported that it was doubtful this was due to Rotateq because it was two months after dose and appendix lead point. The patient was reported to be recovered. Intussusception was determined to be life threatening. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Agitation, Barium enema, Cardiac murmur, Haematochezia, Intussusception
Clinical narrative: Information has been received concerning a 4 month old patient who on 13-DEC-2006 was vaccinated with the second dose PO of Rotateq (Lot # 653755/0319F). On 26-FEB-2007 the patient developed intussusception which required unspecified surgery. Upon internal review, Intussusception which required surgery was considered an other important medical event. Further information has been received concerning a 4 month old male with a heart murmur who on 13-DEC-2006 was vaccinated with the third dose of Rotateq (Lot # 653755/0319F). Other vaccines administered the same day included Tripedia second dose LOT# U1891BA, PedvaxHib second dose, IPV lot # Y1032, Prevnar Lot #B08675K second dose. Other concomitant medications included Polytrim. On 26-FEB-2007, 76 days after vaccination the patient had signs of alternating lethargy, fussiness and a bloody stool. It was reported that the patient was diagnosed with intussusception by barium; enema which failed to reduce it. The patient went to surgery and the appendix was lead point. It was reported that it was doubtful this was due to Rotateq because it was two months after dose and appendix lead point. The patient was reported to be recovered. Intussusception was determined to be life threatening. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Lethargy, Surgery, X-ray
Clinical narrative: Information has been received concerning a 4 month old patient who on 13-DEC-2006 was vaccinated with the second dose PO of Rotateq (Lot # 653755/0319F). On 26-FEB-2007 the patient developed intussusception which required unspecified surgery. Upon internal review, Intussusception which required surgery was considered an other important medical event. Further information has been received concerning a 4 month old male with a heart murmur who on 13-DEC-2006 was vaccinated with the third dose of Rotateq (Lot # 653755/0319F). Other vaccines administered the same day included Tripedia second dose LOT# U1891BA, PedvaxHib second dose, IPV lot # Y1032, Prevnar Lot #B08675K second dose. Other concomitant medications included Polytrim. On 26-FEB-2007, 76 days after vaccination the patient had signs of alternating lethargy, fussiness and a bloody stool. It was reported that the patient was diagnosed with intussusception by barium; enema which failed to reduce it. The patient went to surgery and the appendix was lead point. It was reported that it was doubtful this was due to Rotateq because it was two months after dose and appendix lead point. The patient was reported to be recovered. Intussusception was determined to be life threatening. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Intussusception, Surgery
Clinical narrative: Information has been received concerning a 8 month old patient who on 01-MAR-2007 was vaccinated with the third dose of Rotateq (Lot # 655865/1109F). On 05-MAR-2007 the patient developed intussusception which required unspecified surgery and a barium enema. Upon internal review intussusception was determined to be an other important medical event. Follow-up information has been received concerning this 7 month old male (previously reported as 8 months) with no medical history or pre existing conditions who on 02-MAR-2007 was vaccinated with the third dose of Rotateq (Lot # 655865/1109F). It was reported that the patient was also vaccinated with Pediarix/2AC21B092AA/ third dose, ActHib, (lot # UF077AA) third dose, Prevnar (lot # B36258C) third dose on the same day. On 05-MAR-2007, three days after vaccination the patient presented with colicky abdominal pain, no bloody stool was noted and acute bilious vomiting, it was reported that a barium enema for a partially resolving ileocolic intussusception was done in addition an abdominal survey which showed no free air and no gas was seen on the right side of the abdomen. It was noted that the findings may be due to mild constipation with a concern intussusception. The patient was diagnosed with an ileocolic intussusception on 05-MAR-2007 and was hospitalized taken to surgery on 06-MAR-2007. On 06-MAR-2007 a laparotomy, reduction of intussusception and appendectomy were performed. The patient recovered on 26-MAR-2007. Intussuception was reported to be life threatening. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Appendicectomy, Barium enema, Constipation
Clinical narrative: Information has been received concerning a 8 month old patient who on 01-MAR-2007 was vaccinated with the third dose of Rotateq (Lot # 655865/1109F). On 05-MAR-2007 the patient developed intussusception which required unspecified surgery and a barium enema. Upon internal review intussusception was determined to be an other important medical event. Follow-up information has been received concerning this 7 month old male (previously reported as 8 months) with no medical history or pre existing conditions who on 02-MAR-2007 was vaccinated with the third dose of Rotateq (Lot # 655865/1109F). It was reported that the patient was also vaccinated with Pediarix/2AC21B092AA/ third dose, ActHib, (lot # UF077AA) third dose, Prevnar (lot # B36258C) third dose on the same day. On 05-MAR-2007, three days after vaccination the patient presented with colicky abdominal pain, no bloody stool was noted and acute bilious vomiting, it was reported that a barium enema for a partially resolving ileocolic intussusception was done in addition an abdominal survey which showed no free air and no gas was seen on the right side of the abdomen. It was noted that the findings may be due to mild constipation with a concern intussusception. The patient was diagnosed with an ileocolic intussusception on 05-MAR-2007 and was hospitalized taken to surgery on 06-MAR-2007. On 06-MAR-2007 a laparotomy, reduction of intussusception and appendectomy were performed. The patient recovered on 26-MAR-2007. Intussuception was reported to be life threatening. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Laparotomy, Ultrasound abdomen, Vomiting
Clinical narrative: Information has been received concerning a 8 month old patient who on 01-MAR-2007 was vaccinated with the third dose of Rotateq (Lot # 655865/1109F). On 05-MAR-2007 the patient developed intussusception which required unspecified surgery and a barium enema. Upon internal review intussusception was determined to be an other important medical event. Follow-up information has been received concerning this 7 month old male (previously reported as 8 months) with no medical history or pre existing conditions who on 02-MAR-2007 was vaccinated with the third dose of Rotateq (Lot # 655865/1109F). It was reported that the patient was also vaccinated with Pediarix/2AC21B092AA/ third dose, ActHib, (lot # UF077AA) third dose, Prevnar (lot # B36258C) third dose on the same day. On 05-MAR-2007, three days after vaccination the patient presented with colicky abdominal pain, no bloody stool was noted and acute bilious vomiting, it was reported that a barium enema for a partially resolving ileocolic intussusception was done in addition an abdominal survey which showed no free air and no gas was seen on the right side of the abdomen. It was noted that the findings may be due to mild constipation with a concern intussusception. The patient was diagnosed with an ileocolic intussusception on 05-MAR-2007 and was hospitalized taken to surgery on 06-MAR-2007. On 06-MAR-2007 a laparotomy, reduction of intussusception and appendectomy were performed. The patient recovered on 26-MAR-2007. Intussuception was reported to be life threatening. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration, Intussusception, Laparotomy, Ultrasound abdomen, Vomiting
Clinical narrative: Information has been received concerning a 8 month old patient who on 01-MAR-2007 was vaccinated with the third dose of Rotateq (Lot # 655865/1109F). On 05-MAR-2007 the patient developed intussusception which required unspecified surgery and a barium enema. Upon internal review intussusception was determined to be an other important medical event. Follow-up information has been received concerning this 7 month old male (previously reported as 8 months) with no medical history or pre existing conditions who on 02-MAR-2007 was vaccinated with the third dose of Rotateq (Lot # 655865/1109F). It was reported that the patient was also vaccinated with Pediarix/2AC21B092AA/ third dose, ActHib, (lot # UF077AA) third dose, Prevnar (lot # B36258C) third dose on the same day. On 05-MAR-2007, three days after vaccination the patient presented with colicky abdominal pain, no bloody stool was noted and acute bilious vomiting, it was reported that a barium enema for a partially resolving ileocolic intussusception was done in addition an abdominal survey which showed no free air and no gas was seen on the right side of the abdomen. It was noted that the findings may be due to mild constipation with a concern intussusception. The patient was diagnosed with an ileocolic intussusception on 05-MAR-2007 and was hospitalized taken to surgery on 06-MAR-2007. On 06-MAR-2007 a laparotomy, reduction of intussusception and appendectomy were performed. The patient recovered on 26-MAR-2007. Intussuception was reported to be life threatening. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements and was released.