chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: MNQ, PPV, TD
Symptoms: Myalgia, Pain
Clinical narrative: Initial report was received 05 June 2008 from a health care professional. A 54-year-old male patient had received an intramuscular right deltoid injection of DECAVAC, lot number U2067DA, and an intramuscular right deltoid injections of MENACTRA, lot number U2632AA, and an intramuscular, left deltoid injection of PNEUMOVAX, lot number 0380U (Manufactured by Merck) on 03 June 2008 and one day later, he developed a 7cm by 6cm area of blotchy redness and edema with tenderness at the left deltoid region. The patient also complained of chills, muscle aches and pains, and generalized fatigue. Laboratory and diagnostic testing was marked "N/A" by the reporter. The patient had no pre-existing medical conditions and had not been ill at the time of vaccination. The patient had not been evaluated by their physician. At the time of the report, the patient's recovery status was not provided.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: A cluster of four cases of injection site swelling, heat and tenderness in addition to large nodule at injection site out of an unknown number of patients who received DECAVAC (lot number and route/site of administration unknown. Follow-up information received from a health care professional on 25 August 2008 provided patient identification. This case now includes information concerning a 62-Year-old female patient, with a history of allergy to DARVOCET N and history of cat bite to the left hand, who received an intramuscular injection of DECAVAC (lot number U2294DA, site of administration unknown) on 30 June 2008. It was initially reported that on an unspecified date in June 2008, the patient experienced injection site swelling, heat and tenderness in addition to a large nodule at injection site. Follow-up indicated that the patient also experienced injection site pain and was unable to raise her arm for a few days. The events did not require an emergency room or doctor visit. It was reported that the patient recovered; date of recovery not provided. The reporter of this case is the same as case 2008-02713. From the original cluster of four cases, two patients have been identified and two patients remain unidentified.
Age: 63.0
Sex: F
Vaccine: PPV, TD
Symptoms: Abdominal discomfort, Abdominal distension, Abdominal pain, Back pain, Depressed level of consciousness
Clinical narrative: Initial report received from a consumer on 08 August 2008. A 63-year-old female patient received a left deltoid intramuscular injection of DECAVAC (lot number not reported) and a right deltoid intramuscular injection of PNEUMOVAX (manufacturer Merck, lot number not reported) on 20 March 2008. Three to four days after vaccinations, the patient experienced generalized illness and began sleeping a lot. Within 12 days after vaccinations, the patient experienced digestive distress, including abdominal pain that caused her to double over. The pain came in waves and lasted several hours. The patient also experienced abdominal swelling and diarrhea, which lasted for two months, then mostly resolved. On an unspecified date, the patient experienced swelling and pain in the left deltoid which lasted one month. After the swelling decreased, tenderness continued. Tenderness, noticed upon touching the area, lasted for one month. Three weeks after the vaccinations, the patient broke out in a raised, itchy rash. Some bumps were red, varied slightly in size and were very small. The rash appeared on her face, arms and back and lasted approximately two months. Three to four weeks after the vaccinations, the patient began experiencing memory problems. She also began to slow down physically, became sluggish, felt groggy and was not as alert as usual. Her hands had swollen to the point where she had gone up one ring size. At this same time, the patient also began having a tingling feeling in her arms and hands, which was felt more in the right hand than the left. In April 2008, the patient began having headaches nearly every day. The headache pain woke her from her sleep. Once she got up out of bed and began moving about, the headaches would subside. Headaches are still occurring, but have tapered off; they were more frequent over a two month period, and have began to occur less frequently over months three and four. Six to eight weeks after the vaccinations, the patient experienced dry, red eyes. The patient also developed swelling in the neck and it was painful to move her head. In addition, the patient had upper back pain in the shoulder area. At the time of the report, the patient reported feeling much better, but was still not her usual self. Some symptoms persisted. The patient added that, at one point during this time (onset date not reported), she also had aching in the elbows of both arms. She experienced what she believed was a "circulatory problem", which included leg pain in addition to numbness in the legs when sitting for an extended period of time. Outcome was reported as 'not recovered'. Follow-up information was received 14 October 2008 from a physician. The physician confirmed the lot number for ADACEL had been U2287CA and the lot number for PNEUMOVAX had been 1035F. Per the physician, the patient refused to be seen for follow-up. The physician reviewed the case information and had no additional information to provide at this time.
Age: 63.0
Sex: F
Vaccine: PPV, TD
Symptoms: Diarrhoea, Dry eye, Erythema, Headache, Hypersomnia
Clinical narrative: Initial report received from a consumer on 08 August 2008. A 63-year-old female patient received a left deltoid intramuscular injection of DECAVAC (lot number not reported) and a right deltoid intramuscular injection of PNEUMOVAX (manufacturer Merck, lot number not reported) on 20 March 2008. Three to four days after vaccinations, the patient experienced generalized illness and began sleeping a lot. Within 12 days after vaccinations, the patient experienced digestive distress, including abdominal pain that caused her to double over. The pain came in waves and lasted several hours. The patient also experienced abdominal swelling and diarrhea, which lasted for two months, then mostly resolved. On an unspecified date, the patient experienced swelling and pain in the left deltoid which lasted one month. After the swelling decreased, tenderness continued. Tenderness, noticed upon touching the area, lasted for one month. Three weeks after the vaccinations, the patient broke out in a raised, itchy rash. Some bumps were red, varied slightly in size and were very small. The rash appeared on her face, arms and back and lasted approximately two months. Three to four weeks after the vaccinations, the patient began experiencing memory problems. She also began to slow down physically, became sluggish, felt groggy and was not as alert as usual. Her hands had swollen to the point where she had gone up one ring size. At this same time, the patient also began having a tingling feeling in her arms and hands, which was felt more in the right hand than the left. In April 2008, the patient began having headaches nearly every day. The headache pain woke her from her sleep. Once she got up out of bed and began moving about, the headaches would subside. Headaches are still occurring, but have tapered off; they were more frequent over a two month period, and have began to occur less frequently over months three and four. Six to eight weeks after the vaccinations, the patient experienced dry, red eyes. The patient also developed swelling in the neck and it was painful to move her head. In addition, the patient had upper back pain in the shoulder area. At the time of the report, the patient reported feeling much better, but was still not her usual self. Some symptoms persisted. The patient added that, at one point during this time (onset date not reported), she also had aching in the elbows of both arms. She experienced what she believed was a "circulatory problem", which included leg pain in addition to numbness in the legs when sitting for an extended period of time. Outcome was reported as 'not recovered'. Follow-up information was received 14 October 2008 from a physician. The physician confirmed the lot number for ADACEL had been U2287CA and the lot number for PNEUMOVAX had been 1035F. Per the physician, the patient refused to be seen for follow-up. The physician reviewed the case information and had no additional information to provide at this time.
Age: 63.0
Sex: F
Vaccine: PPV, TD
Symptoms: Hypoaesthesia, Local swelling, Malaise, Memory impairment, Ocular hyperaemia
Clinical narrative: Initial report received from a consumer on 08 August 2008. A 63-year-old female patient received a left deltoid intramuscular injection of DECAVAC (lot number not reported) and a right deltoid intramuscular injection of PNEUMOVAX (manufacturer Merck, lot number not reported) on 20 March 2008. Three to four days after vaccinations, the patient experienced generalized illness and began sleeping a lot. Within 12 days after vaccinations, the patient experienced digestive distress, including abdominal pain that caused her to double over. The pain came in waves and lasted several hours. The patient also experienced abdominal swelling and diarrhea, which lasted for two months, then mostly resolved. On an unspecified date, the patient experienced swelling and pain in the left deltoid which lasted one month. After the swelling decreased, tenderness continued. Tenderness, noticed upon touching the area, lasted for one month. Three weeks after the vaccinations, the patient broke out in a raised, itchy rash. Some bumps were red, varied slightly in size and were very small. The rash appeared on her face, arms and back and lasted approximately two months. Three to four weeks after the vaccinations, the patient began experiencing memory problems. She also began to slow down physically, became sluggish, felt groggy and was not as alert as usual. Her hands had swollen to the point where she had gone up one ring size. At this same time, the patient also began having a tingling feeling in her arms and hands, which was felt more in the right hand than the left. In April 2008, the patient began having headaches nearly every day. The headache pain woke her from her sleep. Once she got up out of bed and began moving about, the headaches would subside. Headaches are still occurring, but have tapered off; they were more frequent over a two month period, and have began to occur less frequently over months three and four. Six to eight weeks after the vaccinations, the patient experienced dry, red eyes. The patient also developed swelling in the neck and it was painful to move her head. In addition, the patient had upper back pain in the shoulder area. At the time of the report, the patient reported feeling much better, but was still not her usual self. Some symptoms persisted. The patient added that, at one point during this time (onset date not reported), she also had aching in the elbows of both arms. She experienced what she believed was a "circulatory problem", which included leg pain in addition to numbness in the legs when sitting for an extended period of time. Outcome was reported as 'not recovered'. Follow-up information was received 14 October 2008 from a physician. The physician confirmed the lot number for ADACEL had been U2287CA and the lot number for PNEUMOVAX had been 1035F. Per the physician, the patient refused to be seen for follow-up. The physician reviewed the case information and had no additional information to provide at this time.
Age: 63.0
Sex: F
Vaccine: PPV, TD
Symptoms: Oedema peripheral, Pain in extremity, Paraesthesia, Peripheral vascular disorder, Rash pruritic
Clinical narrative: Initial report received from a consumer on 08 August 2008. A 63-year-old female patient received a left deltoid intramuscular injection of DECAVAC (lot number not reported) and a right deltoid intramuscular injection of PNEUMOVAX (manufacturer Merck, lot number not reported) on 20 March 2008. Three to four days after vaccinations, the patient experienced generalized illness and began sleeping a lot. Within 12 days after vaccinations, the patient experienced digestive distress, including abdominal pain that caused her to double over. The pain came in waves and lasted several hours. The patient also experienced abdominal swelling and diarrhea, which lasted for two months, then mostly resolved. On an unspecified date, the patient experienced swelling and pain in the left deltoid which lasted one month. After the swelling decreased, tenderness continued. Tenderness, noticed upon touching the area, lasted for one month. Three weeks after the vaccinations, the patient broke out in a raised, itchy rash. Some bumps were red, varied slightly in size and were very small. The rash appeared on her face, arms and back and lasted approximately two months. Three to four weeks after the vaccinations, the patient began experiencing memory problems. She also began to slow down physically, became sluggish, felt groggy and was not as alert as usual. Her hands had swollen to the point where she had gone up one ring size. At this same time, the patient also began having a tingling feeling in her arms and hands, which was felt more in the right hand than the left. In April 2008, the patient began having headaches nearly every day. The headache pain woke her from her sleep. Once she got up out of bed and began moving about, the headaches would subside. Headaches are still occurring, but have tapered off; they were more frequent over a two month period, and have began to occur less frequently over months three and four. Six to eight weeks after the vaccinations, the patient experienced dry, red eyes. The patient also developed swelling in the neck and it was painful to move her head. In addition, the patient had upper back pain in the shoulder area. At the time of the report, the patient reported feeling much better, but was still not her usual self. Some symptoms persisted. The patient added that, at one point during this time (onset date not reported), she also had aching in the elbows of both arms. She experienced what she believed was a "circulatory problem", which included leg pain in addition to numbness in the legs when sitting for an extended period of time. Outcome was reported as 'not recovered'. Follow-up information was received 14 October 2008 from a physician. The physician confirmed the lot number for ADACEL had been U2287CA and the lot number for PNEUMOVAX had been 1035F. Per the physician, the patient refused to be seen for follow-up. The physician reviewed the case information and had no additional information to provide at this time.
Age: 63.0
Sex: F
Vaccine: PPV, TD
Symptoms: Sleep disorder, Sluggishness, Somnolence, Tenderness, Urticaria
Clinical narrative: Initial report received from a consumer on 08 August 2008. A 63-year-old female patient received a left deltoid intramuscular injection of DECAVAC (lot number not reported) and a right deltoid intramuscular injection of PNEUMOVAX (manufacturer Merck, lot number not reported) on 20 March 2008. Three to four days after vaccinations, the patient experienced generalized illness and began sleeping a lot. Within 12 days after vaccinations, the patient experienced digestive distress, including abdominal pain that caused her to double over. The pain came in waves and lasted several hours. The patient also experienced abdominal swelling and diarrhea, which lasted for two months, then mostly resolved. On an unspecified date, the patient experienced swelling and pain in the left deltoid which lasted one month. After the swelling decreased, tenderness continued. Tenderness, noticed upon touching the area, lasted for one month. Three weeks after the vaccinations, the patient broke out in a raised, itchy rash. Some bumps were red, varied slightly in size and were very small. The rash appeared on her face, arms and back and lasted approximately two months. Three to four weeks after the vaccinations, the patient began experiencing memory problems. She also began to slow down physically, became sluggish, felt groggy and was not as alert as usual. Her hands had swollen to the point where she had gone up one ring size. At this same time, the patient also began having a tingling feeling in her arms and hands, which was felt more in the right hand than the left. In April 2008, the patient began having headaches nearly every day. The headache pain woke her from her sleep. Once she got up out of bed and began moving about, the headaches would subside. Headaches are still occurring, but have tapered off; they were more frequent over a two month period, and have began to occur less frequently over months three and four. Six to eight weeks after the vaccinations, the patient experienced dry, red eyes. The patient also developed swelling in the neck and it was painful to move her head. In addition, the patient had upper back pain in the shoulder area. At the time of the report, the patient reported feeling much better, but was still not her usual self. Some symptoms persisted. The patient added that, at one point during this time (onset date not reported), she also had aching in the elbows of both arms. She experienced what she believed was a "circulatory problem", which included leg pain in addition to numbness in the legs when sitting for an extended period of time. Outcome was reported as 'not recovered'. Follow-up information was received 14 October 2008 from a physician. The physician confirmed the lot number for ADACEL had been U2287CA and the lot number for PNEUMOVAX had been 1035F. Per the physician, the patient refused to be seen for follow-up. The physician reviewed the case information and had no additional information to provide at this time.
Sex: U
Vaccine: TD
Symptoms: Influenza like illness, Injection site pain
Clinical narrative: Initial report received form a health professional on 04 November 2008. A cluster of three cases of flu-like symptoms and injection site tenderness out of an unknown number of patients who received DECAVAC (lot number U2294EA). The symptoms lasted approximately one week. The reporter was not sure if the symptoms had completely resolved, It was unknown if the symptoms required doctors visits. No additional information was provided. Follow-up information received  on 24 November 2008. The three patients were ages 50-60 years old and were males and females. The recovery status was not reported and remains unknown. Follow-up information received 02 February 2009 from a health care professional who reported that they did not remember the patient's names. No further information was provided. Documents held by sender: None
Age: 39.0
Sex: M
Vaccine: TD
Symptoms: Full blood count normal, Injection site pain, Metabolic function test, Musculoskeletal pain, Pain in extremity
Clinical narrative: A 39 year old male patient with a history of back pain and previous eye injury received an intramuscular left deltoid injection of DECAVAC (lot number U2332BA) on 30 October 2008. Several days post vaccination, the patient reported pain at the injection site of the left deltoid, pain in the left arm and shoulder. There was not any redness or swelling noted during the doctor's visit. The patient had positive range of motion and was able to perform his job. The patient's symptoms persisted over ten days. The patient was not recovered at the time of the report. Follow-up information was received from a health care professional on 04 December 2008. It was clarified that DECAVAC was administered to the right deltoid and that pain in the right shoulder developed two days after vaccination. It was further clarified that the pain was not in the deltoid, but rather around the socket. The patient reported that sit bothered him when he tried to throw a ball to his children. The patient had no fever or chills and no mass appreciated in the deltoid. At the time of the report, the pain had continued for six weeks. Outcome was reported to be unknown and the patient was still being evaluated. Documents held by sender. None.
Age: 39.0
Sex: M
Vaccine: TD
Symptoms: Red blood cell sedimentation rate normal, Urine analysis normal
Clinical narrative: A 39 year old male patient with a history of back pain and previous eye injury received an intramuscular left deltoid injection of DECAVAC (lot number U2332BA) on 30 October 2008. Several days post vaccination, the patient reported pain at the injection site of the left deltoid, pain in the left arm and shoulder. There was not any redness or swelling noted during the doctor's visit. The patient had positive range of motion and was able to perform his job. The patient's symptoms persisted over ten days. The patient was not recovered at the time of the report. Follow-up information was received from a health care professional on 04 December 2008. It was clarified that DECAVAC was administered to the right deltoid and that pain in the right shoulder developed two days after vaccination. It was further clarified that the pain was not in the deltoid, but rather around the socket. The patient reported that sit bothered him when he tried to throw a ball to his children. The patient had no fever or chills and no mass appreciated in the deltoid. At the time of the report, the pain had continued for six weeks. Outcome was reported to be unknown and the patient was still being evaluated. Documents held by sender. None.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Oedema peripheral
Clinical narrative: A 49-year-old female patient, who has medical condition of hyperlipidemia for which she takes ZOCOR, had received a left deltoid booster dose of DECAVAC (lot number U2032CA) on 13 January 2009. two days post vaccination; the patient experienced swelling of the entire left arm and has joint pain. The patient was evaluated by a physician and prescribed ibuprofen and over the counter BENADRYL. No relevant diagnostic testes or laboratory data were performed. The patient recovered three to five days after onset of the adverse events. Follow-up information received  09 February 2009 from a health care professional who confirmed the patient had no illness at the time of vaccination. No additional information was provided at the time of the report. Documents held by sender: None. The reporter for this case is the same as for case 2009-00245.
Age: 62.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Oedema peripheral
Clinical narrative: A 62-year-old male patient, who had medical condition of glaucoma and erectile dysfunction , had received a left deltoid booster dose of DECAVAC (lot number U2032CA) on 22 December 2008. One day post vaccination; the patient experienced swelling of the entire left arm and had joint pain. The patient was evaluated by a physician and prescribed Ibuprofen and over the counter Benadryl. No relevant diagnostic tests or laboratory data were performed. The patient recovered three to five days after onset of the adverse events. Follow-up information received 09 February 2009 from a health care professional  who confirmed the patient had no illness at the time of vaccination. No additional information was provided at the time of the report. Documents held by sender: None The reporter for this case is the same as for 2009-02244.
Age: 31.0
Sex: F
Vaccine: HEPA, TD, TYP
Symptoms: Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Initial report received 27 February 2009 from a health care professional. A 31-year-old female patient had received an intramuscular right deltoid injection of DECAVAC, lot number U2067DA, and a left deltoid injection of Typhim Vi, lot number D0252AA on 23 February 2009 and an unspecified amount of time later, she developed a red and swollen arm (specific arm not reported) and a fever. The patient called her physician on 27 February 2009 to report the symptoms. The patient's recovery status was not provided at the time of the report. The case was a one out of a cluster of two case reports. The reporter for this case is the same as for case number 2009-00818. Documents held by sender: None
Age: 21.0
Sex: M
Vaccine: HEP, RAB, TD
Symptoms: Arthritis, Malaise, Nausea, Vomiting
Clinical narrative: Initial report received from a health care professional on 23 April 2008. A 21 year old, male patient (with no medical history) reported having symptoms of arthritis, nausea, vomited x 1, and malaise, within 24 hours after he received IMOVAX (lot number A0483-4) intramuscularly (site of administration not reported), DECAVAC (lot number U2017BA) intramuscularly (site of administration not reported) and Hep B (Merck, lot number AHBVB452AA) intramuscularly (site of administration not reported) on 16 April 2008. The symptoms cleared within 24 hours and the patient recovered. The patient did not have any illness at the time of the vaccinations and was not on any medications. Follow up information was received from a health care professional on 08 July 2008. The patient received a left deltoid injection of DECAVAC, a right deltoid injection of IMOVAX, and a left leg injection of Hep B. The patient recovered from the events.
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Initial report was received 15 May 2008 from a health care provider. A 26-year-old patient had received an intramuscular left deltoid infection of DECAVAC (lot number unknown) on 14 May 2008, and ten hours later, she experienced fever, chills, headache, and mild swelling with pain at the injection site. She had been seen by her physician and at the time of the report, she had not recovered from the event. She had no history of adverse events following prior vaccinations. It was unknown at the time of the report if she had received any other vaccinations concomitantly with DECAVAC. No further information was provided. Follow-up information was provided 21 July 2008 from a physician. According to the reporter, the patient had received an intradermal injection of Tubersol (arm and site not reported), lot number C2678AA on 13 May 2008, one day prior to receipt of DECAVAC. The reporter also indicated the patient had recovered from the event. The date of recovery was not provided. Follow up information was received from the physician on 11 August 2008. The patient received an injection of Tubersol two and a half inches below the antecubital fossa. The investigator reported that the etiology of the event was an adverse reaction to the DECAVAC injection. The patient recovered from the event on 20 May 2008.
Sex: M
Vaccine: TD
Symptoms: Fatigue, Glycosylated haemoglobin increased, Wrong drug administered
Clinical narrative: Initial report was received 20 May 2008 from a consumer, who is also the patient. Additional information was also 21 May 2008 from the patient's physician. A male patient had received two doses of DECAVAC, lot number U2293CA on 01 April 2008 instead of one dose Tetanus and one dose of Pneumonia vaccines. He was contacted by his physician the next day on 02 April 2008 who inquired about how he felt and wanted to advise him that he had received two doses of Tetanus instead of a dose of Tetanus vaccine and a dose of Pneumonia vaccine the previous morning. The patient reported that he had no reactions other than feeling a little more tired that day. The patient subsequently reported that his blood sugar readings had increased into the 300's on 02 April 2008 through 04 April 2008. He further noted that his A1C drawn on 12 April 2008 was noted to be consistent with an average reading of 400. According to the patient, the lot number for his Tetanus vaccinations had been 40B173 with an expiration date of 30 August 2010. Lot number verification was provided by the patient's physician who indicated the patient had received two left deltoid doses of TD vaccine, manufacturer by sanofi pasteur, lot number U2293CA with an expiration date of 07 May 2009. The patient also stated he began using LANTUS one year ago. No further information was provided at the time of the report. Follow-up information received on 20 June 2008 from the patient's physician. The patient's medical history included hypertension, diabetes and LANTUS. The patient had no illness at the time of vaccination. In April 2008, the patient's hemoglobin A1C was 11.5. According to the physician, the patient's sugar was generally not controlled. The physician reported that the patient fully recovered in the next two days. The physician did not think that there was any relationship between vaccination and sugar.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood culture negative, Blood pressure decreased, Fatigue, Hyperthermia, Intensive care
Clinical narrative: Shortly after the second GARDASIL shot in the series at the end of March 2007, my daughter became mysteriously ill, with very severe muscle pains and fever on 4/2/2007. On 4/4/2007, the condition worsened. She was brought to the ER where her blood pressure dropped drastically and symptoms intensified. She was airlifted to another hospital, nearly died, and spent a week in the ICU. For the next year, she was fatigued and overheated very easily. The physicians never came up with a definitive diagnosis. They suspected toxic shock syndrome, septicemia or some other infection, but no infection site was located, and all blood cultures and other tests were negative. Her illness remains a total mystery. My wife and I suspect that it could have been an immunologic reaction to the GARDASIL vaccine, and what we have learned since then seems to support this.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test normal, Myalgia, Pyrexia, Sepsis, Toxic shock syndrome
Clinical narrative: Shortly after the second GARDASIL shot in the series at the end of March 2007, my daughter became mysteriously ill, with very severe muscle pains and fever on 4/2/2007. On 4/4/2007, the condition worsened. She was brought to the ER where her blood pressure dropped drastically and symptoms intensified. She was airlifted to another hospital, nearly died, and spent a week in the ICU. For the next year, she was fatigued and overheated very easily. The physicians never came up with a definitive diagnosis. They suspected toxic shock syndrome, septicemia or some other infection, but no infection site was located, and all blood cultures and other tests were negative. Her illness remains a total mystery. My wife and I suspect that it could have been an immunologic reaction to the GARDASIL vaccine, and what we have learned since then seems to support this.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMRV, PNC
Symptoms: Anaemia, Aphasia, Blood glucose, Chest X-ray, Convulsion
Clinical narrative: Pt had onset of new seizure activity 10 days after vaccines. Also noted to be anemic and neutropenic. Tx'ed w/ multiple anticonvulsants. Hospitalized 3-24-09 - 3-30-09. Anticonvulsants and bld transfer. Pt still on anticonvulsants.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMRV, PNC
Symptoms: Haemoglobin decreased, Lethargy, Lumbar puncture, Mean cell volume normal, Mobility decreased
Clinical narrative: Pt had onset of new seizure activity 10 days after vaccines. Also noted to be anemic and neutropenic. Tx'ed w/ multiple anticonvulsants. Hospitalized 3-24-09 - 3-30-09. Anticonvulsants and bld transfer. Pt still on anticonvulsants.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMRV, PNC
Symptoms: Neutropenia, Reticulocyte count decreased, Scan brain, Transfusion, Urine analysis
Clinical narrative: Pt had onset of new seizure activity 10 days after vaccines. Also noted to be anemic and neutropenic. Tx'ed w/ multiple anticonvulsants. Hospitalized 3-24-09 - 3-30-09. Anticonvulsants and bld transfer. Pt still on anticonvulsants.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMRV, PNC
Symptoms: Vision blurred
Clinical narrative: Pt had onset of new seizure activity 10 days after vaccines. Also noted to be anemic and neutropenic. Tx'ed w/ multiple anticonvulsants. Hospitalized 3-24-09 - 3-30-09. Anticonvulsants and bld transfer. Pt still on anticonvulsants.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMRV, PNC
Symptoms: Anaemia, Convulsion, Electroencephalogram, Haemoglobin decreased, Neutropenia
Clinical narrative: Pt had onset of new seizure activity 10 days after vaccines. Also noted to be anemic and neutropenic. Tx'ed w/ multiple anticonvulsants. Hospitalized 3-24-09 - 3-30-09. Anticonvulsants and bld transfer. Pt still on anticonvulsants.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMRV, PNC
Symptoms: Transfusion, White blood cell count decreased
Clinical narrative: Pt had onset of new seizure activity 10 days after vaccines. Also noted to be anemic and neutropenic. Tx'ed w/ multiple anticonvulsants. Hospitalized 3-24-09 - 3-30-09. Anticonvulsants and bld transfer. Pt still on anticonvulsants.
Age: 52.0
Sex: M
Vaccine: DTAP, DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse events. DTAP Given for Tdap.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Insomnia, Nausea, Tremor, Vomiting
Clinical narrative: Pt reports 1 mo after receiving vaccine that beginning night of vaccination nausea and vomiting persisting X 2 weeks, SOB 24 hrs after vaccine, insomnia X 3 weeks and tremors lasting 30sec - 5 minutes during 3 weeks time. Sought tx at clinic at 3 weeks s/p vaccination. No tx provided.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Disorientation, Dizziness, Flushing, Full blood count normal, Headache
Clinical narrative: Pt received Immunization on 4/22/09.  Onset of symptoms on 4/23/09.  Nausea, headache, Stiff neck, arm weakness, flushing, dizziness, lethargic, feelings of discrientation.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Lethargy, Muscular weakness, Musculoskeletal stiffness, Nausea, Red blood cell sedimentation rate normal
Clinical narrative: Pt received Immunization on 4/22/09.  Onset of symptoms on 4/23/09.  Nausea, headache, Stiff neck, arm weakness, flushing, dizziness, lethargic, feelings of discrientation.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Gave adult dose of HEP A instead of Pediatric dose
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Gave adult dose of Hep A instead of pediatric dose.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site inflammation, Local reaction
Clinical narrative: 4cm localized inflammation to left upper extremity - no streaking noted. No fever - began morning after varicella SC injection.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying
Clinical narrative: 4mo shots. High pitched crying x1 hour - inconsolable; slowly resolved over next hour - onset = 5 hours after injection - on follow up exam - family recalled similar incident after 2mo shots as well.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: Pt given vaccine 4/16/09 - Mother called with complaint of half dollar size of local swelling where shot given.  Told to ice ibuprofen or TYLENOL
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Glomerulonephritis, Injection site pain, Injection site swelling
Clinical narrative: (1) leg/injection site swollen and painful - o/v 24 hrs later. (2) glomerulonephritis (post strep) Dx'd 4/21/09.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Red, warm and itchy area over TRIPEDIA injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 10 mm diameter area of erythema on LT deltoid around immunization site. Instructed to apply cool compresses and call if area increases.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Cyanosis, Depressed level of consciousness, Heart rate normal, Nasopharyngitis
Clinical narrative: Patient fainted, difficult to arouse (12 sec) utilized ammonia to arouse. Patient stopped breathing during fainting spell. Patient cold, pale and clammy fingertips blue with c/o tingling in fingertips then legs. Blood pressure 92/58, pulse 60. RR16. 911 called. Patient transported to nearest ER.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Paraesthesia, Respiratory arrest, Respiratory rate, Syncope
Clinical narrative: Patient fainted, difficult to arouse (12 sec) utilized ammonia to arouse. Patient stopped breathing during fainting spell. Patient cold, pale and clammy fingertips blue with c/o tingling in fingertips then legs. Blood pressure 92/58, pulse 60. RR16. 911 called. Patient transported to nearest ER.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Urticaria, Vaccination complication
Clinical narrative: Child received Kinrix injection in R thigh on 4/27/2009.  On 4/28/09 - child seen by doctor diagnosed with (hives) reaction to Kinrix.  Given Benadryl.
Age: 18.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Unevaluable event
Clinical narrative: Non Stated
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash, Varicella
Clinical narrative: Pt. called today 4/29/09 at 12:10 PM to report breaking out with rash around injection site on 4/26/09. States has other areas involved now (legs, face, stomach) states went to MD today who states she has chickenpox. Placed on VALTREX.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic, Scab, Varicella
Clinical narrative: Pt received vaccine on 4/24/09.  She called on 4/27/09 to report that later 4/24/09 in the pm she broke out with a rash that looked liked chickenpox and was itchy.  Stated started weeping and now crusting over.
Age: 1.9
Sex: M
Vaccine: MMR, UNK
Symptoms: Autism spectrum disorder, Laboratory test abnormal, Regressive behaviour, Sensory disturbance, Social avoidant behaviour
Clinical narrative: Information has been received from a consumer concerning her approximately 24 month old son with no medical history or drug allergies who in January 2006, was vaccinated with a dose of MMR II. The patient received total of 4 vaccines (the names of the other vaccines was unknown) during the same visit. It was reported that the patient was a changed child after getting vaccinations in January 2006 (within 24 hours of vaccination). The son started to give blank stares, didn't look or address anybody with his eyes, and acted like a 4 month old baby instead of a 2 year old because he did not acknowledge anyone. He had sensory issues like problems picking up things. The patient was seen by a physician, autistic testing was performed. Within 6 months of the vaccination, he was diagnosed with autistic spectrum. He was recovering but has not received any vaccinations for 25 months. The reporter considered autistic spectrum to be disabling. No further information is available.
Age: 1.9
Sex: M
Vaccine: MMR, UNK
Symptoms: Staring
Clinical narrative: Information has been received from a consumer concerning her approximately 24 month old son with no medical history or drug allergies who in January 2006, was vaccinated with a dose of MMR II. The patient received total of 4 vaccines (the names of the other vaccines was unknown) during the same visit. It was reported that the patient was a changed child after getting vaccinations in January 2006 (within 24 hours of vaccination). The son started to give blank stares, didn't look or address anybody with his eyes, and acted like a 4 month old baby instead of a 2 year old because he did not acknowledge anyone. He had sensory issues like problems picking up things. The patient was seen by a physician, autistic testing was performed. Within 6 months of the vaccination, he was diagnosed with autistic spectrum. He was recovering but has not received any vaccinations for 25 months. The reporter considered autistic spectrum to be disabling. No further information is available.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Enterovirus serology test negative, Headache, Herpes zoster, Pain, Polymerase chain reaction
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 13-AUG-1998 was vaccinated with the first and only dose of VARIVAX (Merck) at 3 years of age. The patient had no prior medical history and was healthy. On 22-APR-2009, the patient developed a severe headache and took MOTRIN and then EXCEDRIN MIGRAINE without relief. The patient developed a rash which spread to her right flank that was painful, no fever was noted. The patient developed blurred vision and was seen in the emergency room and was admitted to the hospital. Enterovirus was suspected and a lumbar puncture was done. Polymerase chain reaction (PCR) test was done at the hospital and cerebral spinal fluid (CSF) was negative for enterovirus but positive for varicella zoster virus. The patient was diagnosed with shingles and treated with acyclovir. The physician didn't see discharge information on the ID consult so she thought the patient was still admitted. The physician expressed interest in the VZIP program and explained that they had additional CSF fluid in the lab which they would send for PCR testing. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral DNA test positive, Vision blurred
Clinical narrative: Information has been received from a physician concerning a 15 year old female who on 13-AUG-1998 was vaccinated with the first and only dose of VARIVAX (Merck) at 3 years of age. The patient had no prior medical history and was healthy. On 22-APR-2009, the patient developed a severe headache and took MOTRIN and then EXCEDRIN MIGRAINE without relief. The patient developed a rash which spread to her right flank that was painful, no fever was noted. The patient developed blurred vision and was seen in the emergency room and was admitted to the hospital. Enterovirus was suspected and a lumbar puncture was done. Polymerase chain reaction (PCR) test was done at the hospital and cerebral spinal fluid (CSF) was negative for enterovirus but positive for varicella zoster virus. The patient was diagnosed with shingles and treated with acyclovir. The physician didn't see discharge information on the ID consult so she thought the patient was still admitted. The physician expressed interest in the VZIP program and explained that they had additional CSF fluid in the lab which they would send for PCR testing. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Fatigue, Gaze palsy, Immediate post-injection reaction, Pallor
Clinical narrative: Information has been received from a physician concerning a 22 year old female who on 23-APR-2009 was vaccinated with the second dose of GARDASIL. The patient received the first vaccination on 13-FEB-2009 (lot # reported as "660825/0423X"). After receiving the second dose on 23-APR-2009 the patient's face turned white, eyes rolled back in her head and she had a seizure. The physician reported that after the patient had a seizure she was sent to her primary care physician for further evaluation. The physician reported that the patient's primary care physician wanted the patient to go and have test done but the patient wanted the patient to go and have test done but the patient refused. The physician reported that the patient was still feeling tired and she was under a lot of stress but she was recovering. Follow-up information was received from a physician. The physician stated that the patient had a seizure that lasted 4-5 min with tonic, clonic posturing. The physician stated that the patient was "completely out". The patient "perked-up and came to with no postictal confusion". The physician stated that the patient had no history of seizures. The seizure occurred immediately after the patient received GARDASIL. The physician stated that he was not sure if the patient had the seizure due to GARDASIL or a drop in blood pressure. The physician did not know if the seizure was due to a neurological disorder. The physician stated that he thought the patient's Primary Care was another physician. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Stress, Tonic clonic movements
Clinical narrative: Information has been received from a physician concerning a 22 year old female who on 23-APR-2009 was vaccinated with the second dose of GARDASIL. The patient received the first vaccination on 13-FEB-2009 (lot # reported as "660825/0423X"). After receiving the second dose on 23-APR-2009 the patient's face turned white, eyes rolled back in her head and she had a seizure. The physician reported that after the patient had a seizure she was sent to her primary care physician for further evaluation. The physician reported that the patient's primary care physician wanted the patient to go and have test done but the patient wanted the patient to go and have test done but the patient refused. The physician reported that the patient was still feeling tired and she was under a lot of stress but she was recovering. Follow-up information was received from a physician. The physician stated that the patient had a seizure that lasted 4-5 min with tonic, clonic posturing. The physician stated that the patient was "completely out". The patient "perked-up and came to with no postictal confusion". The physician stated that the patient had no history of seizures. The seizure occurred immediately after the patient received GARDASIL. The physician stated that he was not sure if the patient had the seizure due to GARDASIL or a drop in blood pressure. The physician did not know if the seizure was due to a neurological disorder. The physician stated that he thought the patient's Primary Care was another physician. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Haemorrhage, Nausea, Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 19 year old female with no medical history and no known drug allergies who on 05-FEB-2009 was intramuscularly vaccinated with a 0.5 ml dose of GARDASIL (lot #660616/0570X). Concomitant therapy included vitamins (unspecified) (FLINTSTONES MULTIVITAMIN). The patient was pregnant while received GARDASIL. Her LMP was 25-JAN-2009. No adverse effect was reported. Lab diagnostic studies included prenatal screen. The patient had an office visit for medical attention. Follow up information was received from the registered nurse who reported that the 19 year old patient was a smoker with HPV infection. She had one previous pregnancy and pre-term delivery at 35.4 weeks by caesarean section in 2008. The patient was vaccinated with the first dose of GARDASIL on 05-FEB-2009. Concomitant therapy included vitamins (unspecified) (FLINTSTONES MULTIVITAMIN) for prenatal use. The patient experienced nausea during her pregnancy and was prescribed ZOFRAN 8mg every 12 hrs on 23-MAR-2009 for treatment. Her pregnancy was confirmed by sonogram at the first OB appointment on 26-MAR-2009. She was advised to quit smoking. There was no illness during the pregnancy. The patient was seen on 03-APR-2009 with known spotting. The patient also experienced heavy bleeding. She experienced spontaneous abortion complete in an emergency room while on vacation on 04-APR-2009, that was 8.2 weeks from her LMP. The patient was seen in the reporter's office on 08-APR-2009 and confirmed spontaneous abortion and by ultrasound. Upon internal review, spontaneous abortion was determined to be an other important medical event. Additional information is not expected.